ABSTRACT

The developmental toxicity of gasoline with ETBE (ethyl tert butyl
ether) vapor condensate was evaluated in 25 confirmed-mated female
Crl:CD®(SD)IGSBR rats/exposure group at target concentrations of 0,
2000, 10,000, and 20,000 mg/m3 in air.  The animals were exposed daily
for six hours from Gestation Day (GD) 5 through GD 20.  There were signs
of slight maternal toxicity early in the exposure period as indicated by
statistically significant decreases in body weight change in the 20,000
mg/m3 group for the GD 8–11 interval.  Statistically significant
decreases in food consumption also were evident at the GD 8-11 interval
for the 10,000 and 20,000 mg/m3 target concentration groups and at the
GD 11-14, and GD 5-20 intervals for the 20,000 mg/m3 target
concentration group.  However, no statistically significant decreases in
body weights were noted at any interval in any treatment group.  There
were no statistically significant differences for uterine implantation
data, external, visceral, and skeletal observations.  Thus, exposure to
gasoline with ETBE vapor condensate at a target concentration of 20,000
mg/m3 caused slight maternal toxicity but not developmental toxicity. 
Therefore the No Observable Adverse Effect Level for this study was
10,000 mg/m3 for maternal toxicity and 20,000 mg/m3 for developmental
toxicity.

i

	TABLE OF CONTENTS

   ABSTRACT		i

   TABLE OF CONTENTS		ii

   TITLE PAGE		vi

   APPROVAL SIGNATURES		vii

   PERSONNEL		viii

   QUALITY ASSURANCE STATEMENT 		ix

Section			Page

1.   SUMMARY		1-1

2.   INTRODUCTION		2-1

	STUDY INITIATION		2-1

	EXPERIMENTAL START DATE		2-1

	EXPERIMENTAL TERMINATION DATE		2-1

	INLIFE TEST PERIOD		2-1

	JUSTIFICATION FOR SELECTION OF TEST SYSTEM		2-1

	JUSTIFICATION OF DOSING ROUTE		2-2

	JUSTIFICATION OF DOSE SELECTION		2-2

	COMPLIANCE		2-2

3.   MATERIALS AND METHODS		3-1

	TEST SUBSTANCE		3-1

		Substance Identification		3-1

			Characterization of the Test Substance		3-1

			Analysis of Mixtures		3-2

			Sample Retention		3-2

			Carrier		3-2

		TEST SYSTEM		3-3

			Test Animal		3-3

			Animal Receipt Information		3-3

			Quarantine and Acclimation Period		3-3

			Number and Sex		3-3

			Age at Initiation of Gestation		3-3

			Weight at Initiation of Gestation		3-3

			Animal Identification		3-4

			Selection		3-4

			Feed		3-4

			Water		3-4

			Housing		3-5

			Environmental Conditions		3-5

ii

		EXPERIMENTAL DESIGN		3-7

			Mating		3-7

			Experimental Groups		3-7

			Administration of Test Substance and Exposure Schedule		3-7

			The Chamber		3-7

			The Test Atmosphere		3-8

			Experimental Evaluation		3-8

			Euthanasia and Cesarean Section		3-8

			Examination of fetuses		3-9

			Tissue Preservation		3-9

			Records		3-9

			Statistical Analysis		3-9

4.   RESULTS and CONCLUSION/DISCUSSION		4-1

		CLINICAL INLIFE OBSERVATIONS AND SURVIVAL		4-1

		GESTATION BODY WEIGHT		4-1

		GESTATION FOOD CONSUMPTION		4-1

		GROSS POSTMORTEM OBSERVATIONS		4-2

		UTERINE IMPLANTATION DATA		4-2

		FETAL BODY WEIGHT		4-2

		FETAL OBSERVATIONS		4-2

			External Observations		4-2

			Visceral Observations		4-3

			Skeletal Observations		4-3

		EXPOSURE DATA AND CHAMBER CONDITIONS		4-4

		DISCUSSION		4-5

		PROTOCOL EXCEPTIONS		4-6

5.   LIST OF ABBREVIATIONS		5-1

		STATISTICAL SYMBOLS AND ABBREVIATIONS		5-1

		UTERINE IMPLANTATION DATA ABBREVIATIONS		5-2

		FETAL EXTERNAL AND VISCERAL EXAMINATION

		ABBREVIATIONS		5-2

6.   REFERENCES		6-1

LIST OF TABLES

Table			Page

4-1.   Mean exposure concentrations		4-4

4-2.   Summary of chamber uniformity		4-4

iii

APPENDIX A

SURVIVAL BAR GRAPH		A-1

APPENDIX B

GESTATION OBSERVATIONS		B-1

APPENDIX C

GESTATION BODY WEIGHT		C-1

APPENDIX D

GESTATION FOOD CONSUMPTION		D-1

APPENDIX E

GROSS POSTMORTEM OBSERVATIONS		E-1

APPENDIX F

UTERINE IMPLANTATION DATA		F-1

APPENDIX G

FETAL BODY WEIGHT		G-1

APPENDIX H

FETAL OBSERVATIONS		H-1

APPENDIX I

INHALATION EXPOSURE DATA		I-1

APPENDIX J

ANALYTICAL CHEMISTRY REPORT		J-1

iv

	TABLE OF CONTENTS (CONT’D)

APPENDIX K

STATISTICIAN’S REPORT		K-1

APPENDIX L

HISTORICAL CONTROL DATA		L-1

APPENDIX M

FEED AND WATER ANALYSES		M-1

v



FINAL REPORT

PROJECT NUMBER:  171634

Test Substance: Gasoline WITH ETBE Vapor Condensate

(MRD-00-716)

Whole-Body Inhalation Developmental Toxicity Study in Rats

with Gasoline WITH ETBE Vapor Condensate (MRD-00-716)

PERFORMED FOR:

AMERICAN PETROLEUM INSTITUTE

1220 L Street Northwest

Washington, D.C. 20005-4070

PERFORMED AT:

EXXONMOBIL BIOMEDICAL SCIENCES, INC.

Laboratory Operations, Mammalian Toxicology Laboratory

1545 Route 22 East, P.O. Box 971

Annandale, New Jersey 08801-0971

STUDY COMPLETION DATE:  TBD

vi

	APPROVAL SIGNATURES

										

D. J. Devlin, Ph.D.						Date	

Director, Toxicology and Environmental Sciences

I hereby accept responsibility for the validity of these data and
declare that to the best of my knowledge, the study contained herein was
performed under my supervision in compliance with the EPA, United States
Environmental Protection Agency, Good Laboratory Practices (GLP)
Standards for Inhalation Exposure Health Effects Testing, 40 CFR, Part
79.60, 1994 with the following exception.

The storage of the sorbent tubes collected for the detailed capillary/GC
analysis was not documented.  The tubes were stored in the necropsy
freezer after sample collection until they were transferred to the
Analytical Chemistry Group for analysis.

Water and feed analyses were not performed in a GLP compliant
laboratory.  

These minor deviations from the EPA Good Laboratory Practice Standards
had no adverse effect on the integrity or results of the study.

										

G. W. Trimmer, B.A.						Date

Study Director

										

T.M. Gray, M.S. D.A.B.T.					Date

Sponsor

vii

	PERSONNEL

Study Director:						G. W. Trimmer, B.A.

	

Sponsor:							American Petroleum Institute

								1220 L Street Northwest

								Washington, D.C. 20005-4070

Sponsor Representative:					T. M. Gray, M.S., D.A.B.T.

Director, Laboratory Operations

(Study Initiation through October 31, 2004)			J. J. Freeman, Ph.D.,
D.A.B.T.

Laboratory Coordinator (effective November 1, 2004):	G. W. Trimmer, B.
A.

Toxicology and Animal Care Supervisor:			R. C. Forgash, B.S.

Compound Preparation Supervisor:				E. J. Febbo, M.S.

 

Analytical Chemistry Supervisor:				D. J. Letinski, M.S.

Quality Assurance/Archives Section Head

(Study Initiation through February 28, 2005)			W. J. Bover, Ph.D.

Quality Assurance/Archives Supervisor

(effective March 1, 2005)		:			R. Pristas, M.S.

Veterinarian:							R. L. Harris, D.V.M.

Reproductive Toxicology Consultant:				S. B. Harris, Ph.D.

Statistician:							M. J. Nicolich, Ph.D

Statistician Consultant:					G. Bukhbinder, Ph.D.

viii

DRAFT

												

QUALITY ASSURANCE STATEMENT  PRIVATE  

												

STUDY NUMBER:	171634

TEST SUBSTANCE:	MRD-00-716

STUDY SPONSOR:	American Petroleum Institute

												

Listed below are the inspections performed by the Quality Assurance Unit
of ExxonMobil Biomedical Sciences, Inc., the date(s) of inspection, and
the date(s) findings were reported to the Study Director and Management.

Study Phase 			Date(s) of		Reported to		Reported to

Inspected			Inspection		Study Director		Management 

Protocol			05 Nov 01		05 Nov 01		06 Nov 01,

										05,09 Apr 02

Allocation/”Weight” Sort	26 Apr 02		29 Apr 02		09,22 May 02

Daily/Monthly Watchdog	06 May 02		07 Aug 02		08,09 Aug 02	

Procedures

In-chamber Clinical		14 May 02		14 May 02		02,04 Oct 02

Observations

Uterus Staining		16 May 02		16 May 02		21 May 02

Skeletal Examination		28 Jun 02		08 Jul 02		09,11 Jul 02

Final Report			28 Aug- 01 Oct 02	01 Oct 02		10,16 Jan 07

Historical Control		31-Oct-04 Nov 02	07 Nov 02		10,16 Jan 07

Data

Second Review of		27 Nov 06, 		09 Jan 07	 	20,25 Jan 07

Final Report			07,08,12,28 Dec 06,    						

				09 Jan 07

Third Review of		18,21 Apr 08		21 Apr 08		24 Apr 08

Final Report 

The final report accurately reflects the methods, procedures and
observations documented in the raw data.

												

			Robert Pristas, M.S.				Date

			Quality Assurance Unit Coordinator			

ix



SUMMARY

This study was conducted to evaluate the potential developmental
toxicity of the test substance, Gasoline with ETBE Vapor Condensate
(GEVC).  GEVC was administered via whole-body inhalation exposure to
pregnant rats during the period of major organogenesis and fetal growth.
 GEVC was administered by whole-body inhalation exposure to 25
confirmed-mated Crl:CD®(SD)IGSBR female rats at target concentrations
of 0 (air control), 2000, 10,000, and 20,000 mg/m3 for six hours (plus
the theoretical equilibration time) daily from Gestation Day (GD) 5
through GD 20.  The Sponsor selected the exposure levels based upon
safety considerations and previously conducted mammalian toxicity
studies

Clinical observations were made daily during gestation.  Body weight and
food consumption measurements were made on GD 0, 5, 8, 11, 14, 17, 20,
and 21.  On GD 21 animals were sacrificed by CO2 asphyxiation followed
by exsanguination.  The reproductive organs and the abdominal and
thoracic cavities were examined grossly.  Uterine weights with ovaries
attached were recorded.  Uterine contents were examined, and the numbers
of live, dead and resorbed fetuses were recorded.  All fetuses were
weighed, sexed externally, and examined externally for gross
malformations.  Apparent non-gravid uteri were placed in 10% ammonium
sulfide solution for confirmation of non-pregnancy status.

The viscera of approximately one-half of the fetuses of each litter were
examined by fresh dissection.  After these fetuses were examined, they
were decapitated.  The heads were preserved in Bouin's solution for at
least two weeks, rinsed, and subsequently stored in 70% ethanol.  The
fetal heads were sectioned and examined with a dissecting microscope for
the presence of abnormalities.  The remaining fetuses judged to be alive
at the C-section were eviscerated, processed for skeletal staining,
stained for bone and cartilage, and examined for the presence of
skeletal malformations and variations.

There was evidence of slight maternal toxicity in this study at the
target concentration of 20,000 mg/m3.  A statistically significant
decrease in body weight change was evident in the 20,000 mg/m3 target
concentration group for the GD 8–11 interval.  Statistically
significant decreases in food consumption also were evident at the GD
8-11, GD 11-14, and GD 5-20 intervals for the 20,000 mg/m3 target
concentration group.  No statistically significant decreases in body
weights were noted at any interval in any treatment group.  The only
evidence of maternal toxicity at the 10,000 mg/m3 target concentration
was a statistically significant decrease in food consumption on GD 8-11;
this was not considered clear evidence of maternal toxicity, since no
other time intervals were significantly affected and since there was no
significant effect on maternal body weight or body weight gain at any
time interval. All dams survived to scheduled terminal sacrifice on GD
21.  At the GD 21 cesarean section, two 2000 mg/m3 target concentration
animals, one animal in the 10,000 mg/m3 target concentration group, and
one animal in the 20,000 mg/m3 target concentration group were found to
be not pregnant (i.e. no evidence of implantation sites).  

All animals were free of clinical or postmortem observations
attributable to treatment with GEVC. 

1-1

SUMMARY   (CONT'D)

There were no treatment-related statistically significant differences
between the control and the GEVC treated groups for uterine implantation
data, external observations, visceral and skeletal observations.  

In conclusion, administration of GEVC to rats by whole-body inhalation
exposure during the period of organogenesis and fetal growth produced
signs of slight maternal toxicity during the early period of dosing at
the target concentration of 20,000 mg/m3 as indicated by decreased body
weight change and decreased food consumption.  There were no treatment
related signs of toxicity in the fetuses.

Therefore, the No Observable Adverse Effect Level for maternal toxicity
was the target concentration of 10,000 mg/m3 and the No Observable
Adverse Effect Level for developmental toxicity in this study was
established at the target concentration of 20,000 mg/m3.

1-2



INTRODUCTION

This study was conducted to evaluate the developmental toxicity of
Gasoline with ETBE Vapor Condensate (MRD-00-716) administered whole-body
inhalation exposure to pregnant rats during the period of major
organogenesis and fetal growth.

This study was conducted for the American Petroleum Institute, 1220 L
Street Northwest, Washington, D.C. 20005-4070 (subsequently referred to
as the Sponsor).

The study was conducted by ExxonMobil Biomedical Sciences, Inc. (EMBSI)
Laboratory Operations, Mammalian Toxicology Laboratory, 1545 Route 22
East, P.O. Box 971, Annandale, New Jersey 08801-0971.  The EMBSI
Mammalian Toxicology Laboratory is accredited by the Association for
Assessment and Accreditation of Laboratory Animal Care (AAALAC
International).

STUDY INITIATION (PROTOCOL SIGNATURE DATE) 

April 12, 2002	

Experimental start date

April 27, 2002

Experimental termination date

July 19, 2002

Inlife Test Period

April 22, 2002 to May 22, 2002

Justification for Selection of Test System

The rat is one of the species required by the EPA for the developmental
toxicity testing requirement of Section 211b of the Clean Air Act.

2-1

INTRODUCTION (CONT'D)

Justification of Dosing Route

Exposure by inhalation is a likely route of human exposure.

Justification of Dose Selection

The high dose of 20,000 mg/m3 was selected based on safety concerns as
one-half of the Lower Explosive Limit.  The low dose (2000 mg/m3) was
expected to produce a No Adverse Effect Level based on the results of
previous subchronic and developmental studies conducted on this
material, related materials, or some combination thereof.  The mid dose
(10,000 mg/m3) was selected as the approximate mid point between the low
and high doses to produce a dose response relationship, if one existed
in this treatment range.

Compliance 

This study was conducted to meet/exceed compliance with the following
standards and requirements:

EPA, United States Environmental Protection Agency, Good Laboratory
Practices (GLP) Standards for Inhalation Exposure Health Effects
Testing. 40 CFR, Part 79.60, 1994.

EPA, United States Environmental Protection Agency, Vehicle Emissions
Inhalation Exposure Guideline. 40 CFR, Part 79.61, 1994.

Animal Welfare Act of 1966 (P.L. 89-544), as amended in 1970, 1976, and
1985.  Code of Federal Regulations, Title 9 [Animals and Animal
Products], Subchapter A - Animal Welfare Parts 1, 2, and 3.

This study was conducted in accord with the following guidelines and
standards:

EPA, United States Environmental Protection Agency, Health Effects Test
Guidelines OPPTS 870.3600 Inhalation Developmental Toxicity Study,
Public Draft, June 1996.

EPA, United States Environmental Protection Agency, Health Effects Test
Guidelines, OPPTS 870.3700, August 1998.

OECD, Organization for Economic Cooperation and Development, Guidelines
for the Testing Chemicals, Proposal for Updating Guideline 414, Jan
2001.

Guide for the Care and Use of Laboratory Animals, Institute of
Laboratory Animal Resources, Commission on Life Sciences, National
Research Council, National Academy Press, Washington, D.C., 1996.

2-2



MATERIALS AND METHODS

TEST SUBSTANCE 

Substance Identification

EMBSI Identification:  	MRD-00-716

Sponsor Identification:	Gasoline with ETBE Vapor Condensate

Supplier:			Chevron Research and Technology Company

Lot #:				API 01-05

Description:			Colorless liquid

Storage Condition:		Ambient outdoor conditions under nitrogen

 

Date Received:		Container numbersa: 	Expiration Date:

September 17, 2001		1A (2 b), 2A (2 b), 3A (2 b),

				4A (2 b)			September 30, 2006

	

a - Numbers in () are the Supplier's tank identification numbers

b - Large cylinder number

Characterization of the Test Substance

The stability, identity, strength, purity, and composition or other
characteristics that appropriately identified the test substance was
performed by the testing laboratory (EMBSI).  Documentation is
maintained at ExxonMobil Biomedical Sciences, Inc., Annandale, New
Jersey.  Characterization will be reported as part of EMBSI Study
167490.  Additionally, Appendix J shows the stability of the test
substance over the course of the exposure interval.

The documentation of methods of synthesis, fabrication, and/or
derivation of the test fuel were the responsibility of the Sponsor. 
This was not completed when the study initiated, but is currently with
the Sponsor.

3-1

TEST SUBSTANCE   (CONT'D)

Analysis of Mixtures

Nominal Concentration.  A nominal exposure concentration was calculated
on a daily basis.  The net weight of test substance used was determined
and was divided by the total volume of air passing through the chamber
to give the nominal concentration.

Analytical Concentration.  The concentration of the test atmosphere in
each chamber and the chamber room was determined approximately hourly
during each exposure by on-line gas chromatography.  The chamber
concentrations were measured in the breathing zone of the rats.  A
backup analytical device (calibrated infrared vapor monitor) was also
available.  The hourly chromatographic analyses showed five major
components of the test atmosphere and were used to assess the stability
of the test substance over the duration of the study.

Additionally, a sorbent tube sample of the test atmosphere was collected
by drawing a known volume of the test atmosphere from each chamber
through a calibrated critical orifice once during each week of the
study.  These samples were stored in a freezer until after the end of
the exposure phase of the study and then transferred to the analytical
chemistry laboratory.  The samples were desorbed and analyzed by the
detailed capillary/GC method used for the initial characterization
analysis of the liquid test substance. This analysis was done to
determine component proportions of the test material atmosphere compared
to the liquid test material. 

		

		

Chamber Homogeneity.  Distribution samples were drawn from twelve
different points within the chamber at each exposure level during the
validation of the exposure system for this study.

Particle Size Analysis.  A particle size determination of the aerosol
portion of the test atmosphere was conducted from the control and 20,000
mg/m3 target concentration during the chamber trials.  The sample was
taken using a multistage cascade impactor.  Preweighed glass fiber
filters were used to collect aerosol on each stage, which are associated
with specific cutoff diameters for aerodynamic particle size in microns.
 Since minimal aerosol was present, no further calculations were
performed for the aerodynamic diameter, geometric standard deviation, or
the estimated percents of the aerosol less than or equal to 1, 10, and
15 microns in size.

Sample Retention 

No retention samples were taken due to the practical and safety
considerations of storing a mixed gas/liquid phase substance under
pressure.

Carrier 

Air

3-2

TEST SYSTEM 

Test Animal 

Species:		Rat 

Strain/stock:		Crl:CD®(SD)IGSBR VAF/Plus

Supplier:		Charles River Laboratories, Inc.

			Raleigh, North Carolina

Animal Receipt Information (Females)

Receipt Date:				April 2, 2002

Shipping Reference Number:		70223589

Quarantine and Acclimation Period 

25 days; animals were checked for viability at least once daily. 

Number and Sex 

150 sexually mature virgin females

100 females were allocated to study groups after confirmation of mating;
the additional 50 females were ordered to assure there would be 100
mated females and to make the mating as efficient as possible without
exceeding the necropsy capacity of the laboratory.

50 sexually mature males (12-13 weeks old at the initiation of mating)
received for mating purposes from a different colony than the females to
assure they were not siblings.  These rats were also used for mating
with at least one other study.  The males also were received on April 2,
2002.

Age at Initiation of Gestation (Designated GD 0)

Females:	14 – 15 weeks

Weight at Initiation of Gestation (Designated GD 0)

Females:	240 to 299 grams

3-3

TEST SYSTEM   (CONT'D)

Animal Identification

Individual ear tags and corresponding cage identification.   

Selection   

More animals than required for the conduct of the study were purchased
and acclimated.  Animals determined to be unsuitable for inclusion on
this study because of poor health, outlying body weights, or other
abnormalities were excluded from selection by the Study Director, and/or
technical staff.

  

Feed 

Certified Rodent Diet Meal 5002, ad libitum 

Manufacturer:		PMI Nutrition International, LLC (formerly PMI Feeds,
Inc.)

			Richmond, Indiana 

Analysis:		Performed by PMI Nutrition International, LLC.  Copies of the
feed analyses are maintained in the EMBSI Toxicology Laboratory.  The
feed analyses were not conducted by a GLP-compliant laboratory.

Contaminants:	There were no known contaminants in the feed believed to
have been present at levels that may have interfered with this study.  

The availability of feed was checked daily for all animals.  Animals
were without food while in the exposure chambers.

Water 

Automatic watering system, ad libitum

Supplier:		ExxonMobil Research and Engineering Clinton Facility
De-ionized Water System.

Analysis:		Periodic analysis is the responsibility of the testing
laboratory.  A copy of the results is maintained at the testing
laboratory.  The analysis was not performed in a GLP-compliant
laboratory.

Contaminants:	There were no known contaminants in the water believed to
have been present at levels that may have interfered with this study.  

The availability of water was checked daily for all animals.  Animals
were without water while in the exposure chambers.

3-4

TEST SYSTEM (CONT'D)

Housing 

Room Number:	PE103

Chamber rooms:	PE102, PE110

Housing:		Single housed during the study period, except during mating.

Caging:		Suspended stainless steel and wire mesh with absorbent paper
below cages. 

Environmental Conditions

Animal Room

Temperature:		66.5 to 71.9 degrees Fahrenheit  

Humidity:		34.7 to 97.6 percent relative humidity (see Protocol
Exceptions)

Lighting:		Approximately 12 hours light (0600 to 1800 hours) and 12
hours dark (1800 to 0600 hours) by automatic timer.  

A computerized system monitored the temperature, humidity, and lighting
continuously.

Chambers

Temperature:		64 to 78 degrees Fahrenheit (see Protocol Exceptions and
Appendix I) 

Humidity:		42 to 100 percent relative humidity (see Protocol Exceptions
and Appendix I)   

Temperature and humidity were monitored continuously and recorded
approximately every 30 minutes during the exposure.

Light Intensity

Animal Room Light Intensity:	3.8 to 8.9 foot-candles

Chamber Room Light Intensity:	28.9 to 62.0 foot-candles

Light intensity was measured three times during the study (the first day
of exposures, during the second week of exposures and the last day of
exposures) in both the animal room and the chamber room.  Light
intensity was measured in the animal room in a cage approximately three
feet above the floor level.  In the chamber room the light intensity was
measured three feet above floor level in the approximate center of each
generation room.

3-5

TEST SYSTEM (CONT'D)

Environmental Conditions (cont’d)

Chamber Noise Levels and Oxygen Levels

Noise Level:		72.2 to 80.2 db

Oxygen Level:	19.7 to 20.7%

The oxygen level and the noise level were measured in each exposure
chamber on the first day of exposures, during the second week of
exposures and on the last day of exposures.

3-6

EXPERIMENTAL DESIGN

Mating

On the initial scheduled mating day, females were placed in males' cages
in a 1:1 (male:female) ratio.  Males and females were paired based on
sequential Physical Identification Numbers.  A sufficient number of
animals were co-housed in an attempt to produce an acceptable number of
mated animals to accommodate lab scheduling.  Mating was confirmed on
the following morning by observation of a copulatory plug (vaginal). 
The day on which mating was confirmed was considered Day 0 of gestation
(GD 0).  After confirmation of mating, each mated female was returned to
its own cage.  New females then were placed in the males' cages until
the required number of mated females was obtained by continuous
cohabitation in consideration of lab scheduling.  Mated females
subsequently were assigned to dose groups by a computer generated body
weight sorting program (WEIGHT) using the GD 0 body weights to ensure
mean body weight was similar between all groups on GD 0.

Experimental Groups

 PRIVATE  Group

 Number	Number of Females per Group	Target Dose

(mg/m3)

1. 	(Carrier Control)	25	 0

2. 	Low 	25	2000

3	. Intermediate 	25	10,000

4	. High	25	20,000



Administration of Test Substance and Exposure Schedule

The experimental and control animals were placed (whole body) into 1.0
M3-inhalation chambers that were operated under dynamic conditions. The
exposure period was six hours per day. The test substance atmosphere
generation system was started after the last animal was placed in the
exposure chambers and the generation system was stopped six hours later.
 The animals remained in the chambers for at least an additional 23
minutes (theoretical equilibration time) while the test atmosphere
cleared.  The animals were exposed from GD 5 through GD 20.

The Chamber

The chambers used for exposure are stainless steel and glass and have a
total volume of approximately 1.0 M3.  They operated at a flow rate
(approximately 12 air changes/hour) sufficient to ensure timely
equilibration.  The flow of air through each chamber was monitored
continuously using a calibrated flow measuring device and recorded
approximately every 30 minutes.  All chambers were maintained at a
slight negative pressure.  The pressure was monitored continuously and
recorded approximately every 30 minutes.

3-7

EXPERIMENTAL DESIGN   (CONT'D)

The Test Atmosphere

The control group was exposed to clean filtered air under conditions
identical to those used for groups exposed to the test substance.  The
test substance was administered fully vaporized in the breathing air of
the animals.  The test atmosphere composition and concentration remained
constant at each exposure level over the daily six-hour period. The
daily mean exposure concentrations generally were within ± 10% of the
target exposure levels with the exceptions listed in the Protocol
Exceptions section. 

Experimental Evaluation

Animals were examined for viability at least twice daily during the
study.  Body weights were taken prior to selection, and on GD 0, 5, 8,
11, 14, 17, 20, and 21.  Food consumption was measured for mated females
on GD 5, 8, 11, 14, 17, 20, and 21.  A clinical examination was given to
each female prior to selection, and daily during gestation. 
Additionally, group observations of the animals for mortality and
obvious toxic signs while in the chambers were recorded at 15, 30, 45,
and 60 minutes after initiation of the exposure and then hourly during
each exposure.

Euthanasia and Cesarean Section

Euthanasia of the dams was by CO2 asphyxiation followed by
exsanguination.  A gross necropsy was performed on all confirmed-mated
females.

The fetuses were placed in a refrigerator to slow down and eventually
terminate vital signs after the external examination and weighing.  

Mated females were euthanized on GD 21.  Body weights were recorded on
the day of necropsy. Uterine weights with ovaries attached were recorded
at the time of necropsy.  Uterine contents were examined and the numbers
and locations of implantation sites, early and late resorptions, live
and dead (alive or dead in utero) fetuses were counted.  Corpora lutea
also were counted.  The uteri of all apparently non-pregnant females
were stained with 10% ammonium sulfide to confirm pregnancy status.

Evaluations of dams during cesarean section and subsequent fetal
evaluations were conducted without knowledge of treatment group in order
to minimize bias.

3-8

EXPERIMENTAL DESIGN   (CONT'D)

Examination of Fetuses

Each live fetus (alive in utero) was weighed and examined externally for
gross malformations.  Fetal sex was determined by external examination
and confirmed internally only on those fetuses receiving visceral
examinations.

Prior to visceral examinations any live fetuses were euthanized by a
subcutaneous injection with sodium pentobarbital.  The viscera of
approximately one-half of the live fetuses (alive in utero) of each
litter were examined by fresh dissection (Staples, 1974; Stuckhardt and
Poppe, 1984).  After these fetuses were examined, they were decapitated.
 The heads were preserved in Bouin's solution for at least two weeks,
then rinsed and subsequently stored in 70% ethanol.  Free-hand razor
blade sections of the Bouin's-fixed fetal heads were examined for the
presence of abnormalities.  The remaining live fetuses (alive in utero)
were eviscerated, processed by double staining with Alizarin red and
Alcian blue, and examined for the presence of bone and cartilage
malformations and ossification variations. 

Fetus #2 of Dam IGL353 in the 2000 mg/m3 target concentration group was
a conjoined twin that was examined for both visceral and skeletal
anomalies.

Fetal evaluations were conducted without knowledge of treatment group in
order to minimize bias.

Tissue Preservation

Fetal heads were fixed in Bouin's solution and then preserved in 70%
ethanol.  The fetal skeletons were preserved in glycerine with thymol
after they were processed and stained.

Records

A copy of the protocol, final report, raw data, computer generated
listings of raw data, supporting documentation, and tissue specimens
were maintained in the EMBSI Toxicology Laboratory Archives until they
were returned to the Sponsor.

Statistical Analysis 

Statistical evaluation of equality of means was done by an appropriate
one way analysis of variance and a test for ordered response in the dose
groups.  First, Bartlett's Test was performed to determine if the dose
groups had equal variance (Snedecor and Cochran, 1989).  If the
variances were equivalent, the hypothesis that there was no difference
in response between the groups was tested using a standard one-way
analysis of variance (Snedecor and Cochran, 1989).  If the variances
were equal, the testing was done using parametric methods, otherwise
nonparametric techniques were used.  

3-9

EXPERIMENTAL DESIGN (CONT'D)

Statistical Analysis (Cont'd)

Continuous data were tested for statistical significance as follows: 
Where applicable, percentages were calculated and transformed by
Cochran's transformation, followed by the arc sine transformation
(Snedecor and Cochran, 1989).  The raw percentages and the transformed
percentages both were tested for statistical significance.  

For the parametric procedures, a standard one way ANOVA using the F
distribution to assess significance was used (Snedecor and Cochran,
1989).  If significant differences among the means were indicated,
Dunnett's Test was used to determine which treatment groups differed
significantly from control (Dunnett, 1964).  In addition to the ANOVA, a
standard regression analysis for linear response in the dose groups was
performed.  The regression also tested for linear lack of fit in the
model.

For the nonparametric procedures, the test of equality of means was
performed using the Kruskal-Wallis Test (Hollander and Wolfe, 1973).  If
significant differences among the means were indicated, Dunn's Summed
Rank Test was used to determine which treatment groups differed
significantly from the control (Hollander and Wolfe, 1973).  In addition
to the Kruskal-Wallis Test, Jonckheere's Test for monotonic trend in the
dose response was performed.  

Bartlett's Test for equal variance was conducted at the 1% level of
significance.  All other tests were conducted at the 5% and 1% level of
significance.  However, the 5% level of significance was considered
statistically significant for these analyses.  The 1% level of
significance was reported as additional information.

The following  data were not included in the statistical analyses:

Gestation body weight and body weight change data for females that were
not pregnant

Gestation food consumption for females that were not pregnant

Means and standard deviations were calculated for animal, exposure and
chamber environmental data.  The coefficient of variation also was
calculated when considered relevant for the exposure  data.

3-10

EXPERIMENTAL DESIGN (CONT'D)

Statistical Analysis (Cont'd)

Fetal body weight was analyzed by a mixed model analysis of variance
that provided an accurate statistical model of the biology.  The
analysis used the litter as the basis for analysis and effectively used
the litter size as a covariate.  The model considered dose group, litter
size, and fetal sex as explanatory variables.  If the overall effect of
dose, or the dose by sex effect, was statistically significant the dose
groups means were tested pairwise vs. the control group using least
squares means.  The least squares means allowed comparisons that
accounted for differences in litter size and sex.  The mathematical
model was based on a paper by Chen, et al (1996).  The analysis was run
using SAS with code suggested in Little, et al (1997).  

The analysis of anomalies (malformations or variations) was based on a
Generalized Estimating Equation (GEE) application of the linearized
model, Ryan (1992).  The model used the litter as the basis for analysis
and considered correlation among littermates by incorporating an
estimated constant correlation and the litter size as a covariate.  If
the overall effect of dose, or the dose by sex effect, was statistically
significant the dose groups were tested pairwise vs. the control group
using least squares means.  The least squares means allowed comparisons
that accounted for differences in litter size.  Three categories of
anomalies were tested, and within each category specific anomalies also
were tested.  In addition to the category specific anomalies a series of
combined analyses were performed within each category as applicable: 

Combined Malformations and Variations for All Fetuses

Combined Malformations and Variations for Alive Fetuses

Combined Malformations and Variations for Dead Fetuses 

Malformations for All Fetuses

Malformations for Alive Fetuses

Malformations for Dead Fetuses

Variations for All Fetuses

Variations for Alive Fetuses

	Variations for Dead Fetuses

	Combined – All Fetuses with Supernumerary Ribs

	Combined – All Fetuses with Hypoplastic Sternabrae

	Combined – All Fetuses with Hypoplastic Vertebral Centra

3-11



RESULTS AND CONCLUSIONS/DISCUSSION

CLINICAL INLIFE OBSERVATIONS AND SURVIVAL 

Survival Bar Graph:  Appendix A

Incidence of Gestation Observations:  Appendix B

Individual Gestation Observations:  Appendix B

All dams survived to scheduled terminal sacrifice on GD 21.  At the GD
21 cesarean section two 2000 mg/m3 target concentration animals, one
animal in the 10,000 mg/m3 target concentration group and one animal in
the 20,000 mg/m3 target concentration group were found to be not
pregnant (i.e. no evidence of implantation sites). 

There were no clinical signs indicative of maternal toxicity
attributable to the test material.  The majority of dams in all dose
groups were free of observable abnormalities during the entire gestation
period.  Clinical signs were limited to alopecia of the trunk for three
control dams and one dam from the 20,000 mg/m3 target concentration
group, and alopecia of the extremities was evident in one dam for the
10,000 mg/m3 target concentration group.  Clinical signs were not
evident in the 2000 mg/m3 target concentration dams.

GESTATION BODY WEIGHT

Mean Gestation Body Weight and Body Weight Change:  Appendix C

Individual Gestation Body Weight and Body Weight Change:  Appendix C

A statistically significant decrease in body weight change was evident
in the 20,000 mg/m3 target concentration group for the GD 8-11 interval.
 However, no statistically significant decreases in body weights were
noted at any interval in any treatment group compared to controls. 
Additionally, statistically significant linear trends (decreases) were
detected in body weight change for the GD 5-8, GD 8-11, GD 11-14, and GD
0-21C intervals and in the body weight for GD 14.  No other differences
in body weight change were evident.

GESTATION FOOD CONSUMPTION

Mean Gestation Food Consumption:  Appendix D

Individual Gestation Food Consumption:  Appendix D

Statistically significant decreases in food consumption were evident at
the GD 8-11 interval for the 10,000 and 20,000 mg/m3 target
concentration groups and at the GD 11-14, and GD 5-20 intervals for the
20,000 mg/m3 target concentration group.  Additionally, statistically
significant linear trends (decreases) were detected in food consumption
for the GD5-8, GD 8-11, GD 11-14, GD 17-20, GD 5-20, and GD 0-21
intervals. No other differences in food consumption were evident.

4-1

GROSS POSTMORTEM OBSERVATIONS

Incidence of Gross Postmortem Observations:  Appendix E

Individual Gross Postmortem Observations:  Appendix E

The gross postmortem examination of the dams revealed a diverticulum of
the right horn of the uterus that was filled with liquid for one control
dam.  Alopecia of the trunk was evident for three control dams and one
20,000 mg/m3 target concentration dam.  All other dams were free of
grossly observable abnormalities.

UTERINE IMPLANTATION DATA

Mean Uterine Implantation Data:  Appendix F

Individual Uterine Implantation Data:  Appendix F

There were no statistically significant differences in the uterine
implantation parameters between the control and the treated groups.

FETAL BODY WEIGHT

Mean Fetal Body Weight:  Appendix G

Individual Fetal Body Weight:  Appendix G

Statisticians Report:  Appendix K

There were no statistically significant decreases in mean fetal body
weight between the control and the treated groups. 

FETAL OBSERVATIONS

Incidence of Fetal Observations:  Appendix H

Individual Fetal Observations:  Appendix H

Statistician’s Report: Appendix K

There were no statistically significant or treatment-related differences
between the control and the treated groups for visceral and skeletal
variations and/or malformations.  There was a statistically significant
decrease in the incidence of external variations and malformations in
the 10,000 and 20,000 mg/m3 target exposure groups.  These decreases
were not considered indicative of developmental toxicity produced by
exposure to GEVC.

4-2

FETAL OBSERVATIONS (CONT'D)

External Observations

The incidences of external observations are presented in Appendices H
and K.  No malformations or variations were observed during the external
examination in the 10,000 and 20,000 mg/m3 target exposure groups. 
There was a statistically significant decrease in the incidence of
external variations and malformations in the 10,000 and 20,000 mg/m3
target exposure groups compared to controls; these decreases were not
considered indicative of developmental toxicity produced by exposure to
GEVC.  At the 2000 mg/m3 target concentration, the only external
malformation was a conjoined twin in one litter (Dam IGL353, Fetus #2). 
 Among the controls, there were two fetuses with malrotated hindpaw, one
fetus with domed head, and one dead fetus with multiple external
malformations; four control litters were affected.

Visceral Observations

The incidences of visceral observations are presented in Appendices H
and K.  The incidences of visceral malformations and variations did not
differ significantly from the control incidences.  Fetus #2 of Dam
IGL353 in the 2000 mg/m3 target concentration group was a conjoined twin
that had shared organs, small spleen, cecum not evident, small left
ventricle, a duplicate tongue, two aortas, elongated innominate,
supernumerary lobe of the lung, malpositioned carotid artery,
malpositioned subclavian artery, and malpositioned pulmonary artery. 
Visceral observations in the other fetuses in the study were minimal and
were limited to low incidences of umbilical artery arises from left,
hydroureter, hydronephrosis, and retinal fold.  Single incidences of
misshapen spleen, large atrial chamber, absent innominate artery, open
eye, and umbilical artery aneurysm, malpositioned carotid artery, and
malpositioned subclavian artery.  

Skeletal Observations

The incidences of skeletal observations are presented in Appendices H
and K.  The incidences of skeletal malformations and variations did not
differ significantly from the control incidences.  The most frequently
noted skeletal ossification variants were rudimentary lumbar ribs, bifid
centra of the thoracic vertebrae, dumbbell-shaped thoracic centra
anlage, and advanced ossification of the sternebrae.   

4-3

EXPOSURE DATA AND CHAMBER CONDITIONS

Summary of Exposure Data:  Appendix I

Analytical Chemistry Report – Appendix J

The range of chamber concentrations for the exposure period as
represented by the daily mean analytical data and nominal data of each
day are listed in Table 4-1:

Table 4-1 - Mean Exposure Concentrations (Analytical and Nominal)

Target concentration 	2000 mg/m3	10,000 mg/m3	20,000 mg/m3

	Analytical	Nominal	Analytical	Nominal	Analytical	Nominal

Mean	1988	1999	10327	10379	20541	19469

S.D.	87.7	124.2	280.2	293.4	518.3	314.5

Minimum	1733	1736	9762	9388	19785	18799

Maximum	2179	2375	10736	10789	21646	20071

S.D. - Standard deviation

Satisfactory chamber uniformity was observed for the 12 points in the
chamber that were analyzed.  The range of  concentrations for each
chamber are listed in Table 4-2.

Table 4-2 - Summary of Chamber Uniformity

Target concentration	2000 mg/m3	10,000 mg/m3	20,000 mg/m3

Mean	2058	10611	21233

S.D.	126.86	206.70	248.71

CV (%)	6.16	1.95	1.17

Minimum	1886	10373	20832

Maximum	2270	10997	21550

S.D. - Standard deviation

CV - Coefficient of variation

The particle size determination for the control chamber and 20,000 mg/m3
target concentration chamber detected particles at a level of 0 and 20
mg/m3 for each chamber, respectively.  These particles were judged to be
ambient background particles (e.g. animal dander) and not from the
generation of the test substance.

The oxygen levels in the chambers ranged from 19.7 to 20.7% at the
intervals when they were monitored.  The noise level in the chambers
ranged from 72.2 to 80.2 db.  The light intensity in the chamber room
ranged from 28.9 foot-candles to 62 foot candles.

The analyses of the chamber atmospheres by the analytical chemistry
group revealed that the concentrations of the components of GEVC were
stable over the course of the study.  The components present in the
highest concentrations in GEVC were isopentane (~32%), ETBE (~17%),
n-pentane (~10%),  n-butane (~9.5%), and 2-methylpentane (~5%).  Each of
the remaining components comprised less than 5% of the mixture (See
Appendix J for the results of the analyses).  

4-4

DISCUSSION

There were signs of slight maternal toxicity early in the exposure
period as indicated by a statistically significant decrease in body
weight change in the 20,000 mg/m3 target concentration group for the GD
8–11 interval.  Statistically significant decreases in food
consumption also were evident at the GD 8-11, GD 11-14, and GD 5-20
intervals for the 20,000 mg/m3 target concentration group.  However, no
statistically significant decreases in body weights were noted at any
interval in any treatment group.  The only evidence of maternal toxicity
at the 10,000 mg/m3 target concentration was a statistically significant
decrease in food consumption on GD 8-11.  Based on the lack of
statistically significant decreases in mean body weight and mean body
weight change for any interval in the 10,000 mg/m3 target concentration
group, it would appear that the decrease in food consumption during a
single interval in the 10,000 mg/m3 target concentration group was not
biologically significant.  Conversely, the statistically significant
decreased food consumption in the 20,000 mg/m3 target concentration
group was associated with a decrease in the body weight change in the GD
8-11 interval and was considered biologically significant.

There were no statistically significant differences attributable to
exposure for uterine implantation data, and external, visceral, and
skeletal observations.

In conclusion, administration of GEVC to rats by whole-body inhalation
exposure during the period of organogenesis and fetal growth at a target
concentration of 20,000 mg/m3 target concentration caused slight
maternal toxicity as indicated by decreased food consumption and
decreased body weight change.  No developmental toxicity attributable to
the test material was observed at any level of exposure to GEVC.

Therefore, the No Observable Adverse Effect Level for maternal toxicity
was 10,000 mg/m3 target concentration and the No Observable Adverse
Effect Level for developmental toxicity in this study was established at
the target concentration of 20,000 mg/m3.

4-5

PROTOCOL EXCEPTIONS

ANIMAL ROOM HUMIDITY;  The animal room humidity was outside the
protocol-defined ranged at the following times:

Date			Humidity (%RH)	Alarm Time		Time resolved

May 7, 2002		          71.3		    16:01		 Immediately

May 13, 2002		          71.9		    15:09		    15:28

May 14, 2002		          97.6		    12:47		    13:00

The causes of the excursions on May 7 and May 13, 2002 were unknown. 
The excursion on May 14, 2002 was caused by the equilibration of a new
humidity transmitter that was placed in the system to replace the
existing transmitter.

These short excursions had no effect on the study results or integrity.

MEAN CHAMBER CONCENTRATION:  The mean chamber concentration for the 2000
mg/m3 target concentration treatment group chamber was 1733 on April 27,
2002.  This deviation was due to problems with the rotameter.

CHAMBER TEMPERATURE AND HUMIDITY:  Due to the method used to generate
the test substance atmospheres, the chamber-room air was kept as cool as
possible to keep the temperature in the 10,000 mg/m3 and the 20,000
mg/m3 target concentration chambers from exceeding the protocol-defined
range.  The cooler room air resulted in three instances of the
temperature in the control chamber being below the protocol-defined
range and numerous instances of the temperature in the treated group
chambers exceeding the protocol-defined ranges early in the daily
exposures.  The decreased temperature also caused the humidity in the
control chamber to be above the protocol-defined range on numerous
occasions and also caused the humidity in the treated group chambers to
be above the protocol-defined range early in the daily exposure periods
on numerous occasions.  The very high humidities noted early in the
daily exposures were due to the chambers not being completely dry from
the previous days cleaning.  The individual temperature and humidity
deviations are noted in Appendix I as bold italicized values.

These deviations had no adverse effect on the study results or
integrity.

No other circumstances occurred that would have affected the quality or
integrity of the data.

4-6

 

LIST OF ABBREVIATIONS

STATISTICAL SYMBOLS AND ABBREVIATIONS

No difference		p(0.05		p(0.01		Statistical Statement

(PARAMETRIC)

A-						No statistical difference among the means

			     A		     A+		Significant difference among the means

L-						No linear response to the dose levels

			      L		     L+		Response is linearly related to dose

			      Q		     Q+		Linear response shows lack of fit

			       *		      **		Mean significantly different from control

								mean

(NONPARAMETRIC)

		K-						No statistical difference among the means

				      K		      K+		Means differ significantly

		J-						No ordered response to the dose levels

				       J		       J+		An ordered response to the dose levels

			       *		      **		Mean significantly different from control

								mean

	NT						Data not tested

5-1



LIST OF ABBREVIATIONS

UTERINE IMPLANTATION DATA ABBREVIATIONS

ABBREVIATION			PARAMETER

Resorp					Resorptions (early and late)

Implants				Implantation sites

CL					Corpora Lutea

Preimplant	Pre implantation loss = (corpora lutea - implantation
sites)/corpora lutea x 100

Postimplant	Post implantation loss = (implantation sites - total
live)/implantation sites x 100

Mal					Fetuses with malformations

Var					Fetuses with variations

Affected				Resorptions + dead + malformations

F/I Tran				Fetuses/implantation sites transformed

R/I Tran				Resorptions/implantation sites transformed

D/I Tran				Dead/implantation sites transformed

FETAL EXTERNAL AND VISCERAL EXAMINATIONS

+ = No observable abnormalities

Stunted = Any fetus weighing less than 4.00 grams

Organs and tissues examined

External:  	General body size, contour, and integrity (e.g.
head,spine,abdomen); limbs; 

digits; pinnae; eye bulges; palate/lip; tongue; snout/jaw; anogenital
region; tail

Visceral:	Urogenital system; adrenals; stomach; spleen; pancreas;
thymus; large/small

			Intestines; liver; lungs; heart and associated major vessels;
thyroid; trachea;

			Esophagus; brain ventricles (single free-hand razor section)

Malformations are anomalies that will not allow the fetus to survive
beyond parturition.  Malformations are indicated by a capitalized
footnote (e.g. "A").  

Developmental variations are anomalies that will not affect the
postnatal survival of the fetus.  Developmental variations are indicated
by a lower case footnote (e.g. "a").  

Observations are anomalies that generally are non-specific anomalies
such as stunted, pale coloration or discoloration of tissues, etc.  They
are indicated by an asterisk (e.g. "*").

5-2



REFERENCES

Animal Welfare Act of 1966 (P.L. 89-544), as amended in 1970, 1976, and
1985.  Code of Federal Regulations, Title 9 [Animals and Animal
Products], Subchapter A -Animal Welfare Parts 1, 2, and 3.

Chen, J.J., Gaylor, J.B. and Laborde, D.W. “Dose-response modeling of
growth for developmental toxicity”, Environmetrics, vol 7, pg 135-144,
1996.  

Dunnett, C., New Tables for Multiple Comparisons with a Control,
Biometrics 20, 1964, pp. 482-491.

EPA, United States Environmental Protection Agency, Good Laboratory
Practices (GLP) Standards for Inhalation Exposure Health Effects
Testing. 40 CFR, Part 79.60, 1994.

EPA, United States Environmental Protection Agency, Vehicle Emissions
Inhalation Exposure Guideline. 40 CFR Part 79.61, 1994.

EPA, United States Environmental Protection Agency, Health Effects Test
Guidelines OPPTS 870.3600 Inhalation Developmental Toxicity Study,
Public Draft, June 1996.

EPA, United States Environmental Protection Agency, Health Effects Test
Guidelines, OPPTS 870.3700, August 1998.

Guide for the Care and Use of Laboratory Animals, Institute of
Laboratory Animal Resources, Commission on Life Sciences, National
Research Council, National Academy Press, Washington, D.C., 1996.

Hollander, M. and Wolfe, D.A. Nonparametric Statistical Methods, John
Wiley and Sons, New York, 1973.

Little, Milliken, Stroup, and Wolfinger, “SAS System for Mixed
Models“, SAS Institute, Cary, NC, 1997, section 5.6.2, pg 203.

OECD, Organization for Economic Cooperation and Development, Guidelines
for the Testing of Chemicals, Proposal for Updating Guideline 414,
January 2001.

6-1

REFERENCES (CONT'D)

Ryan, L., “The use of generalized estimating equations for risk
assessment in developmental toxicity”, Risk Analysis, 12(3), pg
439-447, 1992.

SAS/STAT, V8.02, copyright © 1999-2001, SAS Institute, Inc., Cary, NC.

Snedecor, G.W., and Cochran, W.G., Statistical Methods, 8th ed., Iowa
State University Press, Ames, Iowa, 1989.

Staples, R.E., Detection of Visceral Alterations in Mammalian Fetus,
Teratology, 9:A-37, 1974. 

Stuckhardt, J.L. and Poppe, S.M., Fresh Visceral Examination of Rat and
Rabbit Fetuses Used in Teratogenicity Testing, Terato. Carcino.
Mutagen., 4, 1984, pp. 181-188.

6-2

APPENDIX A - SURVIVAL BAR GRAPH

TARGET DOSE: 0 MG/M3

ANIMAL

GD:





















	NUMBER

0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL359F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL360F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL370F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL374F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL395F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL383F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL386F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL394F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL402F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL411F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL422F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL347F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL427F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL400F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL408F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL393F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL419F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL434F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL445F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL446F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL465F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL490F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL406F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL418F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL474F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P



A-1



APPENDIX A - SURVIVAL BAR GRAPH

TARGET DOSE: 2000 MG/M3

ANIMAL

GD:





















	NUMBER

0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL346F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL361F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL376F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL381F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL405F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL382F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL390F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL358F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL398F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL350F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL353F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL420F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL435F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=N

IGL388F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL413F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL455F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=N

IGL414F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL433F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL441F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL457F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL466F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL475F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL488F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL432F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL477F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P



A-2



APPENDIX A - SURVIVAL BAR GRAPH

TARGET DOSE: 10,000 MG/M3

ANIMAL

GD:





















	NUMBER

0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL379F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL389F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL391F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL352F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL355F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL417F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL378F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL380F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL348F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL430F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL409F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL421F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL385F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=N

IGL423F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL440F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL399F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL452F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL436F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL454F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL461F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL469F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL470F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL473F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL407F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL442F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P



A-3



APPENDIX A - SURVIVAL BAR GRAPH

TARGET DOSE: 20,000 MG/M3

ANIMAL

GD:





















	NUMBER

0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL364F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL367F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL368F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL375F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL363F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL373F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL397F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL357F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL369F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL404F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL365F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL366F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL372F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL396F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL371F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL410F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL415F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL444F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL449F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL451F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=N

IGL458F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL471F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL424F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL428F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

IGL439F	(21)	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=	=P

NOTE:  	GD   -  GESTATION DAY	N   -  NOT PREGNANT

P   -  PREGNANT

=   -  24 HOURS



A-4

APPENDIX B - GESTATION OBSERVATIONS

(INCIDENCE OF GESTATION OBSERVATIONS BY TARGET DOSE)

























GESTATION























DAY	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

























SURVIVORS (A)























0 MG/M3	25	25	25	25	25	25	25	25	25	25	25	25	25	25	25	25	25	25	25	25	25
25

2000 MG/M3	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23
23	23

10,000 MG/M3	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24
24	24

20,000 MG/M3	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24
24	24

















	NO OBSERVABLE ABNORMALITIES















	0 MG/M3	25	25	25	25	25	25	24	24	23	23	23	22	22	22	22	24	23	22	22	22	22
22

2000 MG/M3	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23	23
23	23

10,000 MG/M3	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	23
23	23

20,000 MG/M3	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	24	23	23	23	23
23	23

























ALOPECIA 























0 MG/M3	0	0	0	0	0	0	1	1	2	2	2	3	3	3	3	1	2	3	3	3	3	3

2000 MG/M3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

10,000 MG/M3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	1

20,000 MG/M3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	1	1	1	1

























NOTE:  (A) -  TOTALS DO NOT INCLUDE NON-PREGNANT ANIMALS





	

B-1



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGET DOSE)

DOSE: 0 MG/M3

ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL359F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL360F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL370F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL374F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL395F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	-	-	-	-	-	-	-	+	-	-	-	-	-	-

	ALOPECIA TRUNK	-	-	-	-	-	-	-	-	+	+	+	+	+	+	+	-	+	+	+	+	+	+

IGL383F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL386F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL394F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-

	ALOPECIA TRUNK	-	-	-	-	-	-	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL402F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL411F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL422F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL347F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL427F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+































B-2



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGET DOSE)

DOSE: 0 MG/M3 (CONT'D)

ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL400F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL408F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL393F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL419F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL434F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL445F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL446F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL465F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL490F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL406F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL418F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL474F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	-	-	-	-	+	+	-	-	-	-	-

	ALOPECIA TRUNK	-	-	-	-	-	-	-	-	-	-	-	+	+	+	+	-	-	+	+	+	+	+



B-3



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGETE DOSE)

DOSE: 2000 MG/M3

ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL346F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL361F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL376F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL381F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL405F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL382F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL390F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL358F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL398F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL350F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL353F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL420F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL435F



























	ANIMAL NOT PREGNANT























	

B-4



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGET DOSE)

DOSE: 2000 MG/M3 (CONT'D)

ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL388F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL413F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL455F



























	ANIMAL NOT PREGNANT























IGL414F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL433F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL441F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL457F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL466F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL475F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL488F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL432F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL477F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+



B-5



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGET DOSE)

DOSE: 10,000 MG/M3

ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL379F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL389F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL391F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL352F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL355F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL417F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL378F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL380F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL348F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL430F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL409F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL421F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL385F



























	ANIMAL NOT PREGNANT























	

B-6



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGET DOSE)

DOSE: 10,000 MG/M3 (CONT'D)





























ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL423F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL440F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL399F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL452F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL436F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL454F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL461F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL469F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL470F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL473F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL407F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	-	-	-

	ALOPECIA EXTREMITIES

-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	+	+	+

IGL442F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+



B-7



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGET DOSE)

DOSE: 20,000 MG/M3

ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL364F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL367F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL368F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL375F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL363F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL373F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL397F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL357F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL369F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL404F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL365F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL366F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL372F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+



B-8



APPENDIX B - GESTATION OBSERVATIONS

(INDIVIDUAL GESTATION OBSERVATIONS BY TARGET DOSE)

DOSE: 20,000 MG/M3 (CONT'D)

ANIMAL



























NUMBER	 OBSERVATION

DAY:	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21

IGL396F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL371F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL410F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL415F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL444F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL449F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL451F



























	ANIMAL NOT PREGNANT























	IGL458F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL471F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL424F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL428F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+

IGL439F



























	NO OBSERVABLE ABNORMALITIES	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	+	-	-	-	-	-	-

	ALOPECIA TRUNK	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	+	+	+	+	+	+



B-9

APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE 

(MEAN GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE BY TARGET DOSE)

(SEE LIST OF ABBREVIATIONS FOR STATISTICAL SYMBOLS ON PAGES 5-1 AND 5-2)

(GRAMS)













	GD 0	GD 5	GD 8	GD 11	GD 14	GD 17	GD 20	GD 21	UTERUS	GD 21C

FEMALE	A-L-	A-L-	A-L-	A-L-	A-L	A-L-	A-L-	A-L-	A-L-	A-L-

0 MG/M3











MEAN	270	299.2	305.4	317.2	330.6	358.8	404.2	420.9	104.8	315.5

STD.DEV.	14.6	16.7	18.1	19.3	21.4	27.1	33.1	35.7	21.9	20.8

(N)	25	25	25	25	25	25	25	2	25	24













2000 MG/M3









	MEAN	267	292.3	300	311.8	324.5	354.6	403.8	421.7	106.4	315.2

STD.DEV.	13.7	19.6	19.1	19.3	21.5	23.7	28.1	30	22.1	22.9

(N)	23	23	23	23	23	23	23	23	23	23













10,000 MG/M3









	MEAN	270.2	299.1	302.8	312.7	325	352	398.8	418.7	100	318.7

STD.DEV.	13.1	14.8	14.5	16.2	17.6	23.4	32.5	32.8	26.8	16.7

(N)	24	24	24	24	24	24	24	24	24	24













20,000 MG/M3









	MEAN	269.9	295.5	298.9	307.3	317.6	347.5	394.8	413.5	104.8	308.8

STD.DEV.	13.7	19.1	18.5	19.1	19.3	20.8	22.9	26.9	14.9	20.7

(N)	24	24	24	24	24	24	24	24	24	24



























C-1



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE 

(MEAN GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE BY TARGET DOSE)

(SEE LIST OF ABBREVIATIONS FOR STATISTICAL SYMBOLS ON PAGES 5-1 AND 5-2)

(GRAMS)













	GD 0-5	GD 5-8	GD 8-11	GD 11-14	GD 14-17	GD 17-20	GD 20-21	GD 5-21	GD
0-21	GD 0-21C

FEMALE	A-L-	A-L	AL+	A-L	A-L-	K-J-	K-J-	A-L-	A-L-	A-L

0 MG/M3











MEAN	29.2	6.2	11.8	13.4	28.2	45.4	17.4	104.5	151.3	46.0

STD.DEV.	6.5	5.2	4.6	4.7	9	10	9.5	91.0	24.9	11.7

(N)	25	25	25	25	25	25	24	25	24	24













2000 MG/M3









	MEAN	25.3	7.7	11.8	12.7	30.1	49.2	17.9	129.3	154.7	48.2

STD.DEV.	9.9	5.9	4.4	4.5	8.2	8.6	6.4	23.6	23.3	15.2

(N)	23	23	23	23	23	23	23	23	23	23













10,000 MG/M3









	MEAN	28.9	3.7	10	12.3	27.1	46.8	19.9	119.6	148.5	48.5

STD.DEV.	7.3	6.2	5.8	4	8.1	13.1	5.3	25	28.5	13.3

(N)	24	24	24	24	24	24	24	24	24	24













20,000 MG/M3

   *







	MEAN	25.6	3.4	8.4	10.4	29.9	47.3	18.8	118	143.6	38.9

STD.DEV.	9.9	7.7	3.4	3.8	6.4	6.2	5.8	17.1	18.8	13.9

(N)	24	24	24	24	24	24	24	24	24	24

NOTE:    GD  - GESTATION DAY







	21C (DAY 21 CORRECTED) = DAY 21 BODY WEIGHT - UTERINE WEIGHT





C-2



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE 

(INDIVIDUAL GESTATION BODY WEIGHT BY TARGET DOSE)

(GRAMS)

DOSE:  0 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	UTERINE

NUMBER	0	5	8	11	14	17	20	21	21C	WEIGHT

IGL359F	257	280	283	282	294	328	372	406	307	99

IGL360F	270	297	297	308	323	351	401	417	309	108

IGL370F	268	308	312	327	343	373	396	403	289	114

IGL374F	258	282	280	293	303	320	364	380	281	99

IGL395F	277	303	306	318	337	370	422	445	320	125

IGL383F	271	293	301	315	333	371	415	444	325	119

IGL386F	249	274	285	298	312	337	391	403	297	106

IGL394F	267	296	299	317	334	369	409	431	311	120

IGL402F	274	308	309	323	336	374	431	460	331	129

IGL411F	269	300	307	322	337	373	408	427	327	100

IGL422F	269	295	306	314	331	366	421	425	312	113

IGL347F	290	321	332	343	359	384	434	448	343	105

IGL427F	241	276	283	292	296	295	316	309	294	15

IGL400F	275	303	313	329	350	392	450	460	330	130

IGL408F	291	313	335	346	360	400	450	474	364	110

IGL393F	250	281	288	294	305	325	367	393	301	92

IGL419F	258	280	290	295	310	331	380	398	291	107

IGL434F	299	326	338	344	366	395	457	476	349	127

IGL445F	253	285	284	300	311	335	381	402	298	104

IGL446F	271	294	298	309	313	340	379	405	304	101

IGL465F	291	341	344	355	366	397	452	454	343	111

IGL490F	280	314	316	337	352	377	421	B	398	92

IGL406F	288	316	321	335	341	363	411	422	325	97

IGL418F	263	298	307	320	332	355	389	409	316	93

IGL474F	271	295	301	315	322	350	389	411	306	105



C-3



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE 

(INDIVIDUAL GESTATION BODY WEIGHT BY TARGET DOSE)

(GRAMS)

DOSE:  2000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	UTERINE

NUMBER	0	5	8	11	14	17	20	21	21C	WEIGHT

IGL346F	276	300	313	326	338	359	406	427	323	104

IGL361F	265	296	300	308	325	351	407	421	309	112

IGL376F	258	266	269	281	296	331	375	390	290	100

IGL381F	261	287	284	295	304	321	366	380	294	86

IGL405F	255	288	289	298	317	352	403	430	307	123

IGL382F	267	293	304	318	333	367	423	444	324	120

IGL390F	253	282	293	301	307	337	378	397	297	100

IGL358F	273	296	300	314	328	366	423	432	300	132

IGL398F	243	259	283	292	304	344	398	410	289	121

IGL350F	270	279	288	309	320	352	403	426	308	118

IGL353F	292	331	333	347	369	413	472	494	365	129

IGL420F	261	296	308	323	342	366	419	431	333	98

IGL435F  NP









	IGL388F	283	318	322	334	347	373	421	438	334	104

IGL413F	261	278	290	294	303	337	382	396	292	104

IGL455F  NP









	IGL414F	270	282	298	305	316	348	393	409	301	108

IGL433F	261	288	291	314	321	353	412	437	320	117

IGL441F	287	312	320	325	343	372	411	428	317	111

IGL457F	264	279	281	293	298	316	360	388	305	83

IGL466F	272	298	307	320	330	367	426	447	327	120

IGL475F	291	341	349	358	370	385	415	419	376	43

IGL488F	240	271	274	288	295	316	348	358	298	60

IGL432F	280	304	315	329	344	388	449	477	339	138

IGL477F	258	279	290	300	313	341	397	419	302	117



C-4



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE 

(INDIVIDUAL GESTATION BODY WEIGHT BY TARGET DOSE)

(GRAMS)

DOSE:  10,000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	UTERINE

NUMBER	0	5	8	11	14	17	20	21	21C	WEIGHT

IGL379F	275	300	299	311	331	365	421	443	320	123

IGL389F	277	306	301	332	346	382	439	461	330	131

IGL391F	279	312	308	321	328	364	416	438	337	101

IGL352F	249	284	288	294	302	324	370	390	282	108

IGL355F	255	299	299	307	314	345	400	421	304	117

IGL417F	275	316	319	325	347	374	431	457	336	121

IGL378F	278	303	315	319	332	360	400	415	321	94

IGL380F	250	275	286	296	308	336	390	409	304	105

IGL348F	275	299	297	308	318	341	391	407	307	100

IGL430F	260	282	289	292	302	314	333	344	309	35

IGL409F	291	327	331	340	350	380	418	437	335	102

IGL421F	255	277	286	295	307	330	374	392	298	94

IGL385F  NP









	IGL423F	266	308	318	327	344	380	435	452	327	125

IGL440F	262	287	296	307	322	349	381	402	332	70

IGL399F	254	276	286	292	306	332	395	414	293	121

IGL452F	274	306	312	318	329	348	395	420	319	101

IGL436F	298	320	325	339	351	373	426	447	340	107

IGL454F	258	293	302	311	326	352	393	428	347	81

IGL461F	276	304	301	320	328	349	384	402	315	87

IGL469F	266	285	281	284	291	296	308	332	311	21

IGL470F	287	323	332	342	356	398	454	463	342	121

IGL473F	284	306	294	303	320	355	412	425	308	117

IGL407F	275	297	303	312	322	352	417	442	322	120

IGL442F	266	293	298	310	319	350	388	408	310	98



C-5



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE 

(INDIVIDUAL GESTATION BODY WEIGHT BY TARGET DOSE)

(GRAMS)

DOSE:  20,000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	UTERINE

NUMBER	0	5	8	11	14	17	20	21	21C	WEIGHT

IGL364F	271	291	291	298	311	337	394	410	287	123

IGL367F	257	303	298	309	323	356	406	420	314	106

IGL368F	287	314	317	330	341	373	415	435	325	110

IGL375F	269	300	293	303	312	337	384	405	320	85

IGL363F	257	274	283	292	299	319	348	357	305	52

IGL373F	260	280	273	280	287	316	359	375	282	93

IGL397F	280	302	298	306	315	345	396	417	299	118

IGL357F	267	302	296	308	321	344	386	402	305	97

IGL369F	254	284	285	298	309	336	382	399	298	101

IGL404F	251	279	283	292	302	331	382	398	294	104

IGL365F	255	269	275	277	290	320	373	388	278	110

IGL366F	271	289	296	300	311	345	389	410	298	112

IGL372F	287	312	315	318	332	370	419	435	325	110

IGL396F	274	278	290	301	319	360	406	423	316	107

IGL371F	277	303	301	309	318	346	395	422	315	107

IGL410F	256	285	292	294	307	335	391	405	300	105

IGL415F	264	281	307	312	325	360	408	431	307	124

IGL444F	293	331	329	339	354	375	421	444	339	105

IGL449F	283	306	320	326	339	371	426	445	332	113

IGL451F  NP









	IGL458F	256	278	279	290	297	335	388	402	293	109

IGL471F	267	282	283	295	301	322	360	378	293	85

IGL424F	284	320	329	341	348	391	438	477	364	113

IGL428F	299	345	345	354	357	378	428	451	336	115

IGL439F	259	284	295	302	305	339	381	396	286	110



C-6



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE

(INDIVIDUAL GESTATION BODY WEIGHT CHANGE BY TARGET DOSE)

(GRAMS)

DOSE:  0 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21	5-21	0-21	0-21C

IGL359F	23	3	-1	12	34	44	34	126	149	50

IGL360F	27	0	11	15	28	50	16	120	147	39

IGL370F	40	4	15	16	30	23	7	95	135	21

IGL374F	24	-2	13	10	17	44	16	98	122	23

IGL395F	26	3	12	19	33	52	23	142	168	43

IGL383F	22	8	14	18	38	44	29	151	173	54

IGL386F	25	11	13	14	25	54	12	129	154	48

IGL394F	29	3	18	17	35	40	22	135	164	44

IGL402F	34	1	14	13	38	57	29	152	186	57

IGL411F	31	7	15	15	36	35	19	127	158	58

IGL422F	26	11	8	17	35	55	4	130	156	43

IGL347F	31	11	11	16	25	50	14	127	158	53

IGL427F	35	7	9	4	-1	21	-7	33	68	53

IGL400F	28	10	16	21	42	58	10	157	185	55

IGL408F	22	22	11	14	40	50	24	161	183	73

IGL393F	31	7	6	11	20	42	26	112	143	51

IGL419F	22	10	5	15	21	49	18	118	140	33

IGL434F	27	12	6	22	29	62	19	150	177	50

IGL445F	32	-1	16	11	24	46	21	117	149	45

IGL446F	23	4	11	4	27	39	26	111	134	33

IGL465F	50	3	11	11	31	55	2	113	163	52

IGL490F	34	2	21	15	25	44	C	C	C	C

IGL406F	28	5	14	6	22	48	11	106	134	37

IGL418F	35	9	13	12	23	34	20	111	146	53

IGL474F	24	6	14	7	28	39	22	116	140	35



C-7



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE

(INDIVIDUAL GESTATION BODY WEIGHT CHANGE BY TARGET DOSE)

(GRAMS)

DOSE:  2000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21	5-21	0-21	0-21C

IGL346F	24	13	13	12	21	47	21	127	151	47

IGL361F	31	4	8	17	26	56	14	125	156	44

IGL376F	8	3	12	15	35	44	15	124	132	32

IGL381F	26	-3	11	9	17	45	14	93	119	33

IGL405F	33	1	9	19	35	51	27	142	175	52

IGL382F	26	11	14	15	34	56	21	151	177	57

IGL390F	29	11	8	6	30	41	19	115	144	44

IGL358F	23	4	14	14	38	57	9	136	159	27

IGL398F	16	24	9	12	40	54	12	151	167	46

IGL350F	9	9	21	11	32	51	23	147	156	38

IGL353F	39	2	14	22	44	59	22	163	202	73

IGL420F	35	12	15	19	24	53	12	135	170	72

IGL435F  NP









	IGL388F	35	4	12	13	26	48	17	120	155	51

IGL413F	17	12	4	9	34	45	14	118	135	31

IGL455F  NP









	IGL414F	12	16	7	11	32	45	16	127	139	31

IGL433F	27	3	23	7	32	59	25	149	176	59

IGL441F	25	8	5	18	29	39	17	116	141	30

IGL457F	15	2	12	5	18	44	28	109	124	41

IGL466F	26	9	13	10	37	59	21	149	175	55

IGL475F	50	8	9	12	15	30	4	78	128	85

IGL488F	31	3	14	7	21	32	10	87	118	58

IGL432F	24	11	14	15	44	61	28	173	197	59

IGL477F	21	11	10	13	28	56	22	140	161	44



C-8



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE

(INDIVIDUAL GESTATION BODY WEIGHT CHANGE BY TARGET DOSE)

(GRAMS)

DOSE:  10,000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21	5-21	0-21	0-21C

IGL379F	25	-1	12	20	34	56	22	143	168	45

IGL389F	29	-5	31	14	36	57	22	155	184	53

IGL391F	33	-4	13	7	36	52	22	126	159	58

IGL352F	35	4	6	8	22	46	20	106	141	33

IGL355F	44	0	8	7	31	55	21	122	166	49

IGL417F	41	3	6	22	27	57	26	141	182	61

IGL378F	25	12	4	13	28	40	15	112	137	43

IGL380F	25	11	10	12	28	54	19	134	159	54

IGL348F	24	-2	11	10	23	50	16	108	132	32

IGL430F	22	7	3	10	12	19	11	62	84	49

IGL409F	36	4	9	10	30	38	19	110	146	44

IGL421F	22	9	9	12	23	44	18	115	137	43

IGL385F  NP









	IGL423F	42	10	9	17	36	55	17	144	186	61

IGL440F	25	9	11	15	27	32	21	115	140	70

IGL399F	22	10	6	14	26	63	19	138	160	39

IGL452F	32	6	6	11	19	47	25	114	146	45

IGL436F	22	5	14	12	22	53	21	127	149	42

IGL454F	35	9	9	15	26	41	35	135	170	89

IGL461F	28	-3	19	8	21	35	18	98	126	39

IGL469F	19	-4	3	7	5	12	24	47	66	45

IGL470F	36	9	10	14	42	56	9	140	176	55

IGL473F	22	-12	9	17	35	57	13	119	141	24

IGL407F	22	6	9	10	30	65	25	145	167	47

IGL442F	27	5	12	9	31	38	20	115	142	44



C-9



APPENDIX C - GESTATION BODY WEIGHT AND BODY WEIGHT CHANGE

(INDIVIDUAL GESTATION BODY WEIGHT CHANGE BY TARGET DOSE)

(GRAMS)

DOSE:  20,000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21	5-21	0-21	0-21C

IGL364F	20	0	7	13	26	57	16	119	139	16

IGL367F	46	-5	11	14	33	50	14	117	163	57

IGL368F	27	3	13	11	32	42	20	121	148	38

IGL375F	31	-7	10	9	25	47	21	105	136	51

IGL363F	17	9	9	7	20	29	9	83	100	48

IGL373F	20	-7	7	7	29	43	16	95	115	22

IGL397F	22	-4	8	9	30	51	21	115	137	19

IGL357F	35	-6	12	13	23	42	16	100	135	38

IGL369F	30	1	13	11	27	46	17	115	145	44

IGL404F	28	4	9	10	29	51	16	119	147	43

IGL365F	14	6	2	13	30	53	15	119	133	23

IGL366F	18	7	4	11	34	44	21	121	139	27

IGL372F	25	3	3	14	38	49	16	123	148	38

IGL396F	4	12	11	18	41	46	17	145	149	42

IGL371F	26	-2	8	9	28	49	27	119	145	38

IGL410F	29	7	2	13	28	56	14	120	149	44

IGL415F	17	26	5	13	35	48	23	150	167	43

IGL444F	38	-2	10	15	21	46	23	113	151	46

IGL449F	23	14	6	13	32	55	19	139	162	49

IGL451F  NP









	IGL458F	22	1	11	7	38	53	14	124	146	37

IGL471F	15	1	12	6	21	38	18	96	111	26

IGL424F	36	9	12	7	43	47	39	157	193	80

IGL428F	46	0	9	3	21	50	23	106	152	37

IGL439F	25	11	7	3	34	42	15	112	137	27













NOTE: 	NP - ANIMAL NOT PREGNANT	GD  - GESTATION DAY	B - APPARENT BAD
VALUE

	C - CALCULATION COULD NOT BE PERFORMED DUE TO A BAD VALUE IN THE GD21
WEIGHT 

	21C (DAY 21 CORRECTED) = DAY 21 BODY WEIGHT - UTERINE WEIGHT



C-10

APPENDIX D - GESTATION FOOD CONSUMPTION

(MEAN GESTATION FOOD CONSUMPTION BY TARGET DOSE)

(SEE LIST OF ABBREVIATIONS FOR STATISTICAL SYMBOLS ON PAGES 5-1 AND 5-2)

(GRAMS)













GD 0-5	GD 5-8	GD 8-11	GD 11-14	GD 14-17	GD 17-20	GD 20-21	GD 5-20	GD
0-21

FEMALE	A-L-	A-L+	A+L+	A+L+	A-L-	A-L	A-L-	AL+	A-L+

0 MG/M3









MEAN	119.6	70.6	69.6	72.4	71.7	77.3	24.5	361.5	505.6

STD.DEV.	13.1	8.4	7.8	7.4	10.7	9.2	4.4	36.6	49.6

(N)	25	25	25	25	25	25	25	25	25











	2000 MG/M3









MEAN	115.8	69.8	67.8	68.8	71.4	78.2	24.2	356	496

STD.DEV.	12.8	7.2	7.1	9.7	9.4	6.9	3.3	33.9	46.5

(N)	23	23	23	23	23	23	23	23	23











	10,000 MG/M3

     *







MEAN	118.4	67.3	63.8	67.5	68.7	75	23.2	342.3	483.8

STD.DEV.	13.4	8.1	7.5	5.8	6.4	7.4	5.4	30.8	42.6

(N)	24	24	24	24	24	24	24	24	24























20,000 MG/M3

  **	  **



       *

	MEAN	117.3	64.9	61.0	64.1	68.3	74	22.9	332.4	472.5

STD.DEV.	14.5	8.5	5.8	6.5	6.7	6.3	3.7	29.5	43.1

(N)	24	24	24	24	24	24	24	24	24











	NOTE:  GD - GESTATION DAY































D-1



APPENDIX D - GESTATION FOOD CONSUMPTION

(INDIVIDUAL GESTATION FOOD CONSUMPTION)

(GRAMS)

TARGET DOSE:  0 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21

IGL359F	100	60	55	57	64	66	27

IGL360F	107	63	63	65	68	72	21

IGL370F	123	68	73	75	77	62	12

IGL374F	113	58	63	65	62	67	22

IGL395F	119	67	67	73	81	83	25

IGL383F	110	69	66	75	77	78	29

IGL386F	110	60	62	69	68	72	19

IGL394F	114	64	65	73	71	76	22

IGL402F	132	75	71	76	78	85	33

IGL411F	115	70	69	77	76	73	23

IGL422F	114	66	70	78	77	81	23

IGL347F	133	84	77	79	75	84	25

IGL427F	120	69	72	71	58	75	21

IGL400F	110	70	78	85	89	92	27

IGL408F	130	84	80	79	81	87	31

IGL393F	110	68	64	63	60	66	25

IGL419F	106	70	59	63	63	67	24

IGL434F	139	86	82	83	83	94	27

IGL445F	113	68	67	69	65	70	24

IGL446F	114	69	64	63	67	66	25

IGL465F	162	92	88	77	83	85	31

IGL490F	131	71	77	81	85	88	29

IGL406F	124	70	70	68	69	80	22

IGL418F	125	77	75	80	75	74	22

IGL474F	115	66	64	65	40	89	24



D-2



APPENDIX D - GESTATION FOOD CONSUMPTION

(INDIVIDUAL GESTATION FOOD CONSUMPTION)

(GRAMS)

TARGET DOSE:  2000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21

IGL346F	117	74	72	71	71	75	26

IGL361F	113	69	62	73	70	80	19

IGL376F	97	60	59	65	69	72	20

IGL381F	112	62	62	62	61	71	20

IGL405F	112	67	62	73	72	77	25

IGL382F	116	74	71	75	77	82	25

IGL390F	118	69	59	61	65	69	20

IGL358F	113	65	64	68	75	77	22

IGL398F	103	66	61	66	72	76	21

IGL350F	103	65	67	66	73	76	28

IGL353F	142	80	78	83	90	93	27

IGL420F	126	74	76	83	79	89	24

IGL435F  NP







IGL388F	132	75	73	72	72	76	25

IGL413F	111	72	64	63	76	81	22

IGL455F  NP







IGL414F	103	76	63	69	71	71	24

IGL433F	111	68	76	40	42	79	31

IGL441F	110	72	66	73	73	72	21

IGL457F	105	62	62	61	61	71	22

IGL466F	115	74	70	64	69	79	27

IGL475F	153	89	87	88	88	94	29

IGL488F	117	57	66	63	69	72	24

IGL432F	124	73	74	76	78	85	28

IGL477F	110	63	65	67	69	82	26



D-3



APPENDIX D - GESTATION FOOD CONSUMPTION

(INDIVIDUAL GESTATION FOOD CONSUMPTION)

(GRAMS)

TARGET DOSE:  10,000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21

IGL379F	116	66	65	71	72	76	23

IGL389F	121	77	73	74	79	84	26

IGL391F	127	68	67	68	72	83	29

IGL352F	114	68	52	63	61	67	22

IGL355F	126	65	62	61	67	69	23

IGL417F	129	73	68	75	70	81	27

IGL378F	81	65	56	63	64	71	21

IGL380F	102	63	62	66	67	75	25

IGL348F	123	64	64	62	64	73	26

IGL430F	108	65	59	63	62	67	22

IGL409F	143	81	74	70	77	73	24

IGL421F	115	63	64	65	68	71	22

IGL385F  NP







IGL423F	141	83	78	79	79	85	24

IGL440F	118	67	64	72	71	73	26

IGL399F	102	60	56	60	63	73	22

IGL452F	116	68	59	64	62	69	26

IGL436F	128	76	67	70	65	76	27

IGL454F	122	73	70	77	72	87	27

IGL461F	107	57	62	68	67	72	25

IGL469F	106	55	52	56	54	55	20

IGL470F	132	76	73	74	80	84	24

IGL473F	121	48	50	64	72	80	23

IGL407F	117	65	61	65	71	83	0

IGL442F	126	69	73	69	69	74	23



D-4



APPENDIX D - GESTATION FOOD CONSUMPTION

(INDIVIDUAL GESTATION FOOD CONSUMPTION)

(GRAMS)

TARGET DOSE:  20,000 MG/M3

ANIMAL	GD	GD	GD	GD	GD	GD	GD

NUMBER	0-5	5-8	8-11	11-14	14-17	17-20	20-21

IGL364F	111	62	56	60	59	68	19

IGL367F	117	61	60	68	73	80	22

IGL368F	125	71	69	73	75	75	24

IGL375F	121	52	58	62	70	76	24

IGL363F	98	61	54	58	63	68	18

IGL373F	109	51	51	57	64	69	21

IGL397F	108	63	56	56	62	71	21

IGL357F	119	58	61	63	65	70	19

IGL369F	108	59	62	67	65	69	22

IGL404F	111	64	60	60	65	75	22

IGL365F	98	58	53	54	59	65	20

IGL366F	111	63	60	64	67	71	22

IGL372F	124	66	61	66	73	82	23

IGL396F	93	65	67	76	82	80	22

IGL371F	127	63	64	63	68	73	26

IGL410F	131	71	61	67	75	86	26

IGL415F	116	76	64	67	75	74	23

IGL444F	134	79	65	68	68	71	26

IGL449F	122	75	66	68	71	78	26

IGL451F  NP







IGL458F	101	57	57	55	62	68	21

IGL471F	108	54	53	56	64	67	23

IGL424F	140	79	71	77	85	90	36

IGL428F	156	80	74	72	63	79	24

IGL439F	127	70	62	62	66	71	19









	NOTE: 	GD - GESTATION DAY	NP - NOT PREGNANT

	D-5

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INCIDENCE OF GROSS POSTMORTEM OBSERVATIONS)

TARGET 	FEMALES

	0 MG/M3	2000 MG/M3	10,000 MG/M3	20,000 MG/M3

TOTAL AT TERMINAL SACRIFICE (A)	25	25	25	25

NO OBSERVABLE ABNORMALITIES	21	25	25	24

UTERUS: Diverticulum	1	0	0	0

Alopecia Trunk

	3	0	0	1

NO EVIDENCE OF UTERINE

IMPLANTATION SITES	0	2	1	1



NOTE:  (A) - INCLUDES NON-PREGNANT ANIMALS





E-1

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  0 MG/M3

IGL359F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL360F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL370F  -  	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL374F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL395F  -	GENERAL CONDITION:  Alopecia trunk.

IGL383F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL386F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL394F  -	GENERAL CONDITION:  Alopecia trunk.

IGL402F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL411F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL422F -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL347F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL427F  -	UTERUS (Right horn): Diverticulum, contains extreme amount of
liquid.

IGL400F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL408F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL393F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL419F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

E-2

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  0 MG/M3  (CONT'D)

IGL434F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL445F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL446F  -	 ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL465F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL490F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL406F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL418F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL474F  -	GENERAL CONDITION:  Alopecia trunk.

E-3

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

IGL346F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

	

IGL361F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL376F  -  	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL381F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL405F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

	

IGL382F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL390F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL358F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL398F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL350F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL353F -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL420F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL435F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

	NOTE:  No evidence of uterine implantation sites.

IGL388F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL413F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL455F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

	NOTE:  No evidence of uterine implantation sites.

IGL414F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

E-4

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  2000 MG/M3  (CONT'D)

IGL433F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL441F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL457F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL466F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL475F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL488F -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL432F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL477F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

E-5

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  10,000 MG/M3

IGL379F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL389F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL391F  -  	ALL TISSUES AND ORGANS:  No observable abnormalities.

	

IGL352F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL355F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

	

IGL417F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL378F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL380F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL348F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL430F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL409F -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL421F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL385F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

	NOTE:  No evidence of uterine implantation sites.

IGL423F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL440F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL399F -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL452F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

E-6

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  10,000 MG/M3 (CONT'D)

IGL436F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL454F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL461F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL469F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL470F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL473F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL407F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL442F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

E-7

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  20,000 MG/M3

IGL364F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL367F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL368F  -  	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL375F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL363F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL373F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL397F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL357F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL369F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL404F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL365F -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL366F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL372F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL396F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL371F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL410F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL415F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

E-8

APPENDIX E - GROSS POSTMORTEM OBSERVATIONS

(INDIVIDUAL GROSS POSTMORTEM OBSERVATIONS)

TARGET DOSE:  20,000 MG/M3 (CONT'D)

IGL444F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL449F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL451F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

	NOTE:  No evidence of uterine implantation sites.

IGL458F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL471F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL424F  -	ALL TISSUES AND ORGANS:  No observable abnormalities.

IGL428F  -	ALL TISSUES AND ORGANS:  No observable abnormalities 

IGL439F  -	GENERAL CONDITION:  Alopecia trunk.

E-9

APPENDIX F - UTERINE IMPLANTATION DATA

(MEAN UTERINE IMPLANTATION DATA BY TARGET DOSE)

(SEE LIST OF ABBREVIATIONS FOR STATISTICAL SYMBOLS ON PAGES 5-1 AND 5-2)













Total	Male	Female

Implantation	Corpora	Total	Fetuses/	Resorptions/

	Live	Fetuses	Fetuses	Resorptions	Sites	Lutea	Dead	Implantation
Implantation

FEMALE	A-L-	A-L-	A-L-	K-J-	A-L-	A-L-	K-J-	K-J-	K-J-











	0 MG/M3









	MEAN	14.12	6.88	7.24	0.4	14.56	15.88	0.04	0.95	0.04

STD.DEV.	3.11	2.44	2.15	0.58	3	1.54	0.2	0.1	0.1

(N)	25	25	25	25	25	25	25	25	25











	2000 MG/M3









MEAN	14.3	6.61	7.7	0.61	14.91	15.96	0	0.96	0.04

STD.DEV.	3.4	2.54	2.46	1.31	3.36	2.57	0	0.08	0.08

(N)	23	23	23	23	23	23	23	23	23











	10,000 MG/M3









MEAN	13.54	7.13	6.42	0.58	14.13	15	0	0.96	0.04

STD.DEV.	3.95	2.86	2.75	0.78	4.07	2.9	0	0.05	0.05

(N)	24	24	24	24	24	24	24	24	24











	20,000 MG/M3









MEAN	14.25	7.13	7.13	0.33	14.63	15.08	0.04	0.98	0.02

STD.DEV.	2.27	2.07	2.13	0.48	2.32	2.24	0.2	0.03	0.03

(N)	24	24	24	24	24	24	24	24	24











	

F-1



APPENDIX F - UTERINE IMPLANTATION DATA

(MEAN UTERINE IMPLANTATION DATA BY TARGET DOSE)

(SEE LIST OF ABBREVIATIONS FOR STATISTICAL SYMBOLS ON PAGES 5-1 AND 5-2)













F/I	R/I	D/I	Dead/	% Preimplant	% Postimplant	Total	Total	Total 

	Tran	Tran	Tran	Implantation	Loss	Loss	Malformations	Variations	Affected

FEMALE	K-J-	K-J-	K-J-	K-J-	K-J-	K-J-	A-L-	A-L-	K-J-











	0 MG/M3









	MEAN	78.1	11.6	8.24	0	7.9	4.6	0.24	1.7	0.7

STD.DEV.	8.03	8.07	2.93	0	17.7	10.2	0.44	1.2	0.8

(N)	25	25	25	25	25	25	25	25	25











	2000 MG/M3









MEAN	78.4	11.6	7.71	0	7.5	3.8	0.17	1.3	0.8

STD.DEV.	6.85	6.85	1.64	0	14.2	7.8	0.39	1.4	1.3

(N)	23	23	23	23	23	23	23	23	23











	10,000 MG/M3









MEAN	77.5	12.5	8.30	0	7.8	3.8	0.08	1.9	0.7

STD.DEV.	5.60	5.60	3.07	0	19	5.2	0.28	1.8	0.8

(N)	24	24	24	24	24	24	24	24	24











	20,000 MG/M3









MEAN	79.6	10.1	7.93	0	3.2	2.5	0.08	1.8	0.5

STD.DEV.	3.68	3.63	1.70	0	4.4	3.3	0.28	1.5	0.5

(N)	24	24	24	24	24	24	24	24	24











	

F-2



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL 









	NUMBER	Live	Male	Female	Resorp	Implants	CL	Dead	Mal	Var

IGL359F	14	7	7	0	14	17	0	0	2

IGL360F	15	5	10	1	16	17	0	0	3

IGL370F	16	9	7	0	17	17	1	0	2

IGL374F	14	7	7	1	15	15	0	1	2

IGL395F	16	12	4	0	16	16	0	0	2

IGL383F	15	9	6	0	15	15	0	0	1

IGL386F	14	10	4	0	14	14	0	0	2

IGL394F	15	6	9	0	15	15	0	1	2

IGL402F	17	7	10	0	17	18	0	1	4

IGL411F	13	4	9	1	14	15	0	0	2

IGL422F	16	9	7	0	16	17	0	0	2

IGL347F	15	6	9	0	15	16	0	0	2

IGL427F	1	0	1	1	2	17	0	0	0

IGL400F	18	9	9	0	18	18	0	0	3

IGL408F	15	6	9	0	15	15	0	0	1

IGL393F	13	6	7	0	13	16	0	0	0

IGL419F	15	5	10	0	15	15	0	0	1

IGL434F	17	11	6	1	18	20	0	1	0

IGL445F	15	7	8	0	15	16	0	0	0

IGL446F	14	7	7	2	16	16	0	1	3

IGL465F	14	6	8	0	14	15	0	0	0

IGL490F	12	6	6	0	12	14	0	1	3

IGL406F	13	7	6	1	14	14	0	0	0

IGL418F	12	6	6	1	13	13	0	0	4

IGL474F	14	5	9	1	15	16	0	0	1



F-3



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL 	F/I	R/I	D/I







NUMBER	Tran	Tran	Tran







IGL359F	82.321	7.679	7.6795







IGL360F	75.523	14.478	7.1808







IGL370F	75.964	6.965	14.0363







IGL374F	75.037	14.963	7.4176







IGL395F	82.82	7.181	7.1808







IGL383F	82.583	7.418	7.4176







IGL386F	82.321	7.679	7.6795







IGL394F	82.583	7.418	7.4176







IGL402F	83.035	6.965	6.9653







IGL411F	74.499	15.501	7.6795







IGL422F	82.82	7.181	7.1808







IGL347F	82.583	7.418	7.4176







IGL427F	45.000	45.000	20.7049







IGL400F	83.232	6.768	6.7681







IGL408F	82.583	7.418	7.4176







IGL393F	82.029	7.971	7.9712







IGL419F	82.583	7.418	7.4176







IGL434F	76.367	13.633	6.7681







IGL445F	82.583	7.418	7.4176







IGL446F	69.296	20.705	7.1808







IGL465F	82.321	7.679	7.6795







IGL490F	81.702	8.299	8.299







IGL406F	74.499	15.501	7.6795







IGL418F	73.898	16.102	7.9712







IGL474F	75.037	14.963	7.4176









F-4



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL 









	NUMBER	Live	Male	Female	Resorp	Implants	CL	Dead	Mal	Var

IGL346F	15	7	8	0	15	15	0	0	0

IGL361F	15	7	8	0	15	16	0	0	1

IGL376F	13	7	6	1	14	15	0	0	1

IGL381F	11	4	7	6	17	18	0	0	1

IGL405F	18	9	9	0	18	19	0	0	0

IGL382F	15	6	9	0	15	15	0	0	1

IGL390F	13	3	10	1	14	14	0	0	1

IGL358F	18	11	7	0	18	21	0	0	0

IGL398F	16	10	6	0	16	16	0	0	1

IGL350F	16	7	9	0	16	16	0	0	0

IGL353F	19	7	12	0	19	20	0	1	5

IGL420F	13	7	6	1	14	14	0	0	0

IGL435F  NP









IGL388F	14	3	11	0	14	14	0	0	1

IGL413F	13	7	6	0	13	15	0	0	2

IGL455F  NP









IGL414F	15	8	7	2	17	17	0	0	1

IGL433F	16	3	13	0	16	17	0	1	5

IGL441F	15	8	7	1	16	17	0	0	2

IGL457F	12	6	6	1	13	13	0	0	3

IGL466F	16	9	7	1	17	17	0	0	1

IGL475F	4	2	2	0	4	10	0	0	1

IGL488F	8	4	4	0	8	13	0	0	0

IGL432F	19	11	8	0	19	20	0	1	2

IGL477F	15	6	9	0	15	15	0	1	2



F-5



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL 	F/I	R/I	D/I







NUMBER	Tran	Tran	Tran







IGL346F	82.583	7.418	7.4176







IGL361F	82.583	7.418	7.4176







IGL376F	74.499	15.501	7.6795







IGL381F	53.553	36.448	6.9653







IGL405F	83.232	6.768	6.7681







IGL382F	82.583	7.418	7.4176







IGL390F	74.499	15.501	7.6795







IGL358F	83.232	6.768	6.7681







IGL398F	82.82	7.181	7.1808







IGL350F	82.82	7.181	7.1808







IGL353F	83.414	6.587	6.5868







IGL420F	74.499	15.501	7.6795







IGL435F  NP









IGL388F	82.321	7.679	7.6795







IGL413F	82.029	7.971	7.9712







IGL455F  NP









IGL414F	69.941	20.06	6.9653







IGL433F	82.82	7.181	7.1808







IGL441F	75.523	14.478	7.1808







IGL457F	73.898	16.102	7.9712







IGL466F	75.964	14.036	6.9653







IGL475F	75.523	14.478	14.4776







IGL488F	79.818	10.182	10.1821







IGL432F	83.414	6.587	6.5868







IGL477F	82.583	7.418	7.4176









F-6



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  10,000 MG/M3

ANIMAL 









	NUMBER	Live	Male	Female	Resorp	Implants	CL	Dead	Mal	Var

IGL379F	16	8	8	0	16	16	0	0	3

IGL389F	16	10	6	0	16	16	0	0	0

IGL391F	15	8	7	2	17	17	0	0	1

IGL352F	14	7	7	2	16	17	0	0	2

IGL355F	17	8	9	0	17	17	0	0	7

IGL417F	16	11	5	0	16	16	0	0	2

IGL378F	13	8	5	2	15	15	0	0	1

IGL380F	15	9	6	0	15	16	0	0	2

IGL348F	14	10	4	1	15	15	0	1	1

IGL430F	4	3	1	0	4	13	0	0	0

IGL409F	14	3	11	0	14	15	0	0	0

IGL421F	12	4	8	1	13	13	0	0	0

IGL385F  NP









IGL423F	18	7	11	1	19	19	0	0	0

IGL440F	9	7	2	0	9	9	0	0	1

IGL399F	17	10	7	0	17	17	0	0	3

IGL452F	14	7	7	1	15	16	0	0	2

IGL436F	15	11	4	1	16	18	0	0	1

IGL454F	11	4	7	2	13	13	0	0	4

IGL461F	11	6	5	0	11	13	0	0	3

IGL469F	2	1	1	0	2	6	0	0	0

IGL470F	18	12	6	0	18	18	0	0	4

IGL473F	15	7	8	1	16	16	0	0	2

IGL407F	16	6	10	0	16	16	0	0	5

IGL442F	13	4	9	0	13	13	0	1	1



F-7



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  10,000 MG/M3

ANIMAL 	F/I	R/I	D/I







NUMBER	Tran	Tran	Tran







IGL379F	82.82	7.181	7.1808







IGL389F	82.82	7.181	7.1808







IGL391F	69.941	20.06	6.9653







IGL352F	69.296	20.705	7.1808







IGL355F	83.035	6.965	6.9653







IGL417F	82.82	7.181	7.1808







IGL378F	68.584	21.417	7.4176







IGL380F	82.583	7.418	7.4176







IGL348F	75.037	14.963	7.4176







IGL430F	75.523	14.478	14.4776







IGL409F	82.321	7.679	7.6795







IGL421F	73.898	16.102	7.9712







IGL385F  NP









IGL423F	76.738	13.263	6.5868







IGL440F	80.406	9.594	9.5941







IGL399F	83.035	6.965	6.9653







IGL452F	75.037	14.963	7.4176







IGL436F	75.523	14.478	7.1808







IGL454F	66.907	23.094	7.9712







IGL461F	81.33	8.671	8.6708







IGL469F	69.296	20.705	20.7049







IGL470F	83.232	6.768	6.7681







IGL473F	75.523	14.478	7.1808







IGL407F	82.82	7.181	7.1808







IGL442F	82.029	7.971	7.9712









F-8



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  20,000 MG/M3

ANIMAL 









	NUMBER	Live	Male	Female	Resorp	Implants	CL	Dead	Mal	Var

IGL364F	17	10	7	0	17	17	0	0	3

IGL367F	15	11	4	0	15	15	0	0	2

IGL368F	16	10	6	0	16	16	0	0	1

IGL375F	11	8	3	1	12	13	0	0	2

IGL363F	6	5	1	0	6	7	0	0	1

IGL373F	13	4	9	1	14	14	0	0	1

IGL397F	16	8	8	0	16	17	0	0	1

IGL357F	15	6	9	0	16	17	1	0	5

IGL369F	14	5	9	1	15	16	0	0	3

IGL404F	14	5	9	0	14	15	0	0	0

IGL365F	15	9	6	1	16	16	0	0	0

IGL366F	15	8	7	0	15	15	0	1	1

IGL372F	15	10	5	1	16	16	0	0	4

IGL396F	14	6	8	0	14	15	0	0	0

IGL371F	14	6	8	1	15	16	0	0	2

IGL410F	15	6	9	0	15	15	0	0	4

IGL415F	16	9	7	0	16	17	0	1	0

IGL444F	14	5	9	0	14	15	0	0	3

IGL449F	15	7	8	0	15	15	0	0	2

IGL451F  NP









IGL458F	14	6	8	0	14	14	0	0	0

IGL471F	11	4	7	0	11	11	0	0	0

IGL424F	15	8	7	1	16	17	0	0	4

IGL428F	16	6	10	1	17	16	0	0	2

IGL439F	16	9	7	0	16	17	0	0	1

NOTE:	NP - ANIMAL NOT PREGNANT







F-9



APPENDIX F  - UTERINE IMPLANTATION DATA 

(INDIVIDUAL UTERINE IMPLANTATION DATA)

(SEE LIST OF ABBREVIATIONS ON PAGE G-2 FOR ABBREVIATIONS)

TARGET DOSE:  20,000 MG/M3

ANIMAL 	F/I	R/I	D/I







NUMBER	Tran	Tran	Tran







IGL364F	83.035	6.965	6.9653







IGL367F	82.583	7.418	7.4176







IGL368F	82.82	7.181	7.1808







IGL375F	73.222	16.779	8.299







IGL363F	78.222	11.778	11.7783







IGL373F	74.499	15.501	7.6795







IGL397F	82.82	7.181	7.1808







IGL357F	75.523	7.181	14.4776







IGL369F	75.037	14.963	7.4176







IGL404F	82.321	7.679	7.6795







IGL365F	75.523	14.478	7.1808







IGL366F	82.583	7.418	7.4176







IGL372F	75.523	14.478	7.1808







IGL396F	82.321	7.679	7.6795







IGL371F	75.037	14.963	7.4176







IGL410F	82.583	7.418	7.4176







IGL415F	82.82	7.181	7.1808







IGL444F	82.321	7.679	7.6795







IGL449F	82.583	7.418	7.4176







IGL451F  NP









IGL458F	82.321	7.679	7.6795







IGL471F	81.33	8.671	8.6708







IGL424F	75.523	14.478	7.1808







IGL428F	75.964	14.036	6.9653







IGL439F	82.82	7.181	7.1808







NOTE:	NP - ANIMAL NOT PREGNANT







F-10

APPENDIX G – FETAL BODY WEIGHT

(MEAN FETAL BODY WEIGHTS BY SEX)

Target Concentration



MALES

FEMALES



	0 mg/m3







	Mean

5.46

5.18



	SD

0.41

0.39



	(N)

24

25













2000 mg/m3







Mean

5.45

5.19



	SD.

0.38

0.44



	(N)

23

23













10,000 mg/m3







Mean

5.41

5.19



	SD

0.44

0.39



	(N)

24

24













20,000 mg/m3







Mean

5.43

5.11



	SD

0.47

0.44



	(N)

24

24



	

G-1

APPENDIX G – FETAL BODY WEIGHT

Mean fetal weight, the least squares mean fetal weight

Exposure Group

(mg/m3)	n litters 	n fetuses	observed fetus mean (gm)	Least squares
fetus mean (gm)

0	25	353	5.32	5.33

2,000	23	329	5.31	5.34

10,000	24	325	5.30	5.29

20,000	24	342	5.27	 5.25



G-2



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS)

(GRAMS)

TARGET DOSE: 0 MG/M3

ANIMAL















      Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL359F	M	5.08	5.50	5.17	5.66	4.88	5.56	5.12







	72.12	Mean	5.28	5.02

IGL359F	F	5.01	4.82	5.27	5.45	4.81	4.34	5.45









S.D.	0.29	0.40

IGL360F	M	5.18	5.58	5.65	5.43	5.83









	78.15	Mean	5.53	5.05

IGL360F	F	5.08	5.06	5.19	5.19	4.74	5.17	4.75	5.12	5.12	5.06





	S.D.	0.24	0.17

IGL370F	M	5.25	4.84	4.82	5.01	5.08	4.90	5.21	5.34	4.62





	80.03	Mean	5.01	4.99

IGL370F	F	4.66	5.07	5.14	5.40	5.42	4.50	4.77









S.D.	0.23	0.36

IGL374F	M	5.44	5.50	5.62	5.92	4.89	5.00	5.72







	73.78	Mean	5.44	5.10

IGL374F	F	5.24	5.28	5.16	4.59	5.15	5.15	5.12









S.D.	0.37	0.23

IGL395F	M	5.44	5.88	5.76	5.76	5.64	5.73	5.48	5.94	5.78	5.68	6.02	5.65



90.97	Mean	5.73	5.55

IGL395F	F	5.43	5.83	5.56	5.39











	S.D.	0.17	0.20

IGL383F	M	5.71	5.71	6.05	5.61	5.58	5.74	5.35	5.99	5.98





	85.26	Mean	5.75	5.59

IGL383F	F	5.56	5.41	6.12	5.60	5.55	5.30









	S.D.	0.23	0.28

IGL386F	M	5.07	5.39	5.59	5.48	5.40	5.98	5.43	5.74	5.61	5.16





74.89	Mean	5.49	5.01

IGL386F	F	5.05	5.09	4.72	5.18











	S.D.	0.27	0.20

IGL394F	M	6.26	5.90	5.62	5.95	5.98	5.84









85.57	Mean	5.93	5.56

IGL394F	F	5.87	5.72	5.76	5.65	5.14	5.69	5.44	5.64	5.11







S.D.	0.21	0.27

IGL402F	M	5.98	5.77	6.00	5.71	5.49	5.83	3.19







	92.56	Mean	5.42	5.46

IGL402F	F	5.77	5.37	5.88	5.56	5.10	5.06	5.31	5.59	5.50	5.45





	S.D.	1.00	0.26

IGL411F	M	5.80	6.53	5.99	5.96











73.10	Mean	6.07	5.42

IGL411F	F	5.50	5.50	5.04	5.75	5.39	5.54	4.71	5.73	5.66







S.D.	0.32	0.34

IGL422F	M	5.14	5.13	5.69	5.01	5.31	5.50	5.09	4.81	5.27





	80.95	Mean	5.22	4.86

IGL422F	F	4.70	5.05	4.89	5.01	5.19	4.30	4.86









S.D.	0.26	0.29

IGL347F	M	5.14	5.36	5.11	5.20	4.93	5.04









74.35	Mean	5.13	4.84

IGL347F	F	4.76	4.88	4.95	5.04	4.87	4.66	4.73	4.86	4.82







S.D.	0.15	0.12

IGL427F	M















6.25	Mean	NA	6.25

IGL427F	F	6.25















S.D.	NA	NA

IGL400F	M	5.52	5.30	5.47	5.67	5.92	5.47	5.61	5.55	5.75





	96.47	Mean	5.58	5.13

IGL400F	F	5.37	4.85	5.18	5.32	5.15	4.49	4.96	5.24	5.65







S.D.	0.18	0.33

IGL408F	M	5.24	5.53	5.16	5.14	5.72	5.56









78.00	Mean	5.39	5.07

IGL408F	F	5.14	4.96	5.07	4.99	5.33	5.10	5.13	4.99	4.94







S.D.	0.24	0.12

G-3



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS)

(GRAMS)

TARGET DOSE: 0 MG/M3

ANIMAL















    Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL393F	M	5.33	5.28	5.21	5.15	5.25	4.78









65.81	Mean	5.17	4.97

IGL393F	F	5.31	5.40	5.03	4.51	4.97	4.80	4.79









S.D.	0.20	0.31

IGL419F	M	5.19	5.39	5.26	5.69	5.26









	77.59	Mean	5.36	5.08

IGL419F	F	5.17	5.11	5.50	4.86	4.82	5.07	4.99	5.27	4.91	5.10





	S.D.	0.20	0.20

IGL434F	M	5.31	4.19	5.42	5.12	5.22	5.08	5.34	5.33	5.58	5.08	5.48



	86.63	Mean	5.20	4.91

IGL434F	F	4.76	4.85	5.30	5.10	4.61	4.86









	S.D.	0.37	0.25

IGL445F	M	5.64	5.28	5.39	3.64	5.57	5.41	5.05







	76.27	Mean	5.14	5.04

IGL445F	F	4.96	4.84	4.92	5.24	5.05	5.23	5.00	5.05







	S.D.	0.69	0.14

IGL446F	M	5.50	5.16	5.69	5.29	5.00	5.68	5.61







	71.77	Mean	5.42	4.83

IGL446F	F	4.53	4.94	4.82	5.16	4.46	4.98	4.95









S.D.	0.27	0.25

IGL465F	M	5.76	5.73	5.88	5.73	5.40	5.34









76.86	Mean	5.64	5.38

IGL465F	F	5.26	5.46	5.20	5.30	5.38	5.74	5.24	5.44







	S.D.	0.22	0.17

IGL490F	M	5.58	5.73	5.76	5.57	5.54	5.45









63.46	Mean	5.61	4.97

IGL490F	F	5.40	4.97	5.51	2.90	5.50	5.55









	S.D.	0.12	1.04

IGL406F	M	5.33	5.89	6.17	5.70	5.40	5.66	5.45







	71.38	Mean	5.66	5.30

IGL406F	F	5.45	5.35	5.53	5.23	5.09	5.13









	S.D.	0.30	0.18

IGL418F	M	5.95	5.88	5.37	5.78	5.93	5.46









67.12	Mean	5.73	5.46

IGL418F	F	5.15	5.22	5.53	5.47	5.69	5.69









	S.D.	0.25	0.23

IGL474F	M	5.72	5.47	5.80	5.64	5.72









	77.95	Mean	5.67	5.51

IGL474F	F	5.26	5.59	4.80	5.77	5.22	5.89	5.74	5.70	5.63







S.D.	0.13	0.35















	Mean	75.09



















	S.D.	16.48



	

G-4



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS) 

(GRAMS)

TARGET DOSE: 2000 MG/M3

ANIMAL















    Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL346F	M	5.06	4.97	5.21	5.35	4.84	5.04	5.21







	75.51	Mean	5.10	4.98

IGL346F	F	5.01	4.90	4.85	4.90	4.82	4.94	5.19	5.22







	S.D.	0.17	0.15

IGL361F	M	5.40	5.37	5.40	5.83	5.82	5.67	5.77







	82.74	Mean	5.61	5.44

IGL361F	F	5.11	5.54	5.24	5.83	5.72	5.51	5.32	5.21







	S.D.	0.21	0.26

IGL376F	M	5.62	5.54	5.20	5.66	5.74	5.61	5.62







	71.56	Mean	5.57	5.43

IGL376F	F	5.25	5.63	5.33	5.33	5.37	5.66









	S.D.	0.17	0.17

IGL381F	M	5.28	4.26	5.84	4.97











56.12	Mean	5.09	5.11

IGL381F	F	5.09	5.22	4.94	4.60	5.23	5.50	5.19









S.D.	0.66	0.28

IGL405F	M	5.10	5.38	5.29	5.34	5.40	5.62	5.36	5.26	5.14





	91.67	Mean	5.32	4.86

IGL405F	F	4.81	4.82	4.94	4.80	4.97	4.91	4.87	4.65	5.01







S.D.	0.15	0.11

IGL382F	M	5.96	5.87	6.06	6.12	5.33	5.92









85.40	Mean	5.88	5.57

IGL382F	F	5.40	5.67	5.55	5.65	5.50	5.88	5.46	5.59	5.44







S.D.	0.28	0.15

IGL390F	M	5.52	5.46	5.63











	69.84	Mean	5.54	5.32

IGL390F	F	4.86	5.24	5.42	5.42	5.19	5.76	5.47	5.03	5.59	5.25





	S.D.	0.09	0.27

IGL358F	M	5.68	5.58	5.50	5.48	5.53	5.46	5.34	5.36	5.39	5.91	5.86



	98.21	Mean	5.55	5.30

IGL358F	F	5.17	5.45	5.50	5.35	5.24	5.27	5.14









S.D.	0.19	0.14

IGL398F	M	4.90	5.19	5.17	5.16	5.48	5.31	5.48	5.38	5.47	5.50





83.19	Mean	5.30	5.03

IGL398F	F	5.27	4.80	5.09	5.28	4.86	4.85









	S.D.	0.20	0.22

IGL350F	M	5.93	5.22	5.33	5.48	5.63	5.65	6.02







	85.54	Mean	5.61	5.14

IGL350F	F	4.97	5.09	5.34	5.45	5.03	4.91	5.20	5.12	5.17







S.D.	0.29	0.17

IGL353F	M	5.12	4.37	4.75	4.99	5.12	5.00	4.68







	88.78	Mean	4.86	4.56

IGL353F	F	4.30	4.53	4.44	4.37	4.73	4.69	4.71	4.37	4.88	4.63	4.46	4.64



	S.D.	0.28	0.18

IGL420F	M	5.22	5.58	5.64	4.70	5.07	4.89	5.00







	65.33	Mean	5.16	4.87

IGL420F	F	5.34	4.69	5.03	4.07	5.10	5.00









	S.D.	0.35	0.44

IGL435F NP



















	IGL388F	M	5.45	6.03	5.69











	75.08	Mean	5.72	5.26

IGL388F	F	5.43	5.48	5.07	4.91	5.35	5.93	5.36	5.51	4.86	5.21	4.80





S.D.	0.29	0.34

IGL413F	M	5.81	5.75	5.36	5.43	5.50	5.58	5.48







	71.36	Mean	5.56	5.41

IGL413F	F	5.06	5.31	5.57	5.72	5.39	5.40









	S.D.	0.17	0.23



G-5



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS)

(GRAMS)

TARGET DOSE: 2000 MG/M3

ANIMAL















    Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL455F  NP



















	IGL414F	M	5.10	5.23	5.18	5.41	5.18	5.26	5.59	5.49







78.53	Mean	5.31	5.16

IGL414F	F	5.14	5.15	4.98	5.23	4.99	5.30	5.30









S.D.	0.17	0.13

IGL433F	M	5.82	6.17	5.49











	83.29	Mean	5.83	5.06

IGL433F	F	2.27	5.34	5.34	5.39	5.46	4.42	5.01	5.74	5.55	5.69	4.89	5.16
5.55



S.D.	0.34	0.91

IGL441F	M	4.86	5.11	5.48	5.18	5.34	5.32	4.38	5.10







75.04	Mean	5.10	4.90

IGL441F	F	4.70	4.72	4.51	5.09	5.07	5.25	4.93









S.D.	0.34	0.26

IGL457F	M	5.30	5.67	5.32	5.30	5.06	5.60









63.48	Mean	5.38	5.21

IGL457F	F	5.23	5.11	5.04	5.32	5.62	4.91









	S.D.	0.22	0.25

IGL466F	M	5.40	5.51	5.56	5.69	5.75	5.54	5.46	5.48	5.72





	87.31	Mean	5.57	5.31

IGL466F	F	5.64	5.34	5.30	5.45	5.06	5.03	5.38









S.D.	0.12	0.21

IGL475F	M	6.76	6.68













26.18	Mean	6.72	6.37

IGL475F	F	6.62	6.12













	S.D.	0.06	0.35

IGL488F	M	5.11	5.59	5.24	5.34











41.39	Mean	5.32	5.03

IGL488F	F	4.99	5.11	4.97	5.04











	S.D.	0.20	0.06

IGL432F	M	5.46	5.81	5.46	5.96	5.62	5.46	5.08	5.71	5.30	5.50	5.83



	103.53	Mean	5.56	5.29

IGL432F	F	5.37	5.15	5.47	5.40	5.28	5.37	4.98	5.32







	S.D.	0.26	0.16

IGL477F	M	5.85	6.18	6.07	6.26	6.05	5.76









88.35	Mean	6.03	5.80

IGL477F	F	5.36	6.02	6.07	5.71	6.11	5.78	5.77	5.75	5.61







S.D.	0.19	0.24















	Mean	75.98



















	S.D.	17.46



	

G-6



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS)

(GRAMS)

TARGET DOSE: 10,000 MG/M3

ANIMAL















    Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL379F	M	5.53	5.73	5.76	5.92	5.83	5.76	5.64	5.62







88.12	Mean	5.72	5.29

IGL379F	F	5.84	5.33	5.04	5.43	5.24	5.42	5.07	4.96







	S.D.	0.12	0.28

IGL389F	M	6.36	6.13	5.74	6.07	6.17	6.20	6.11	6.07	6.11	6.38





96.35	Mean	6.13	5.84

IGL389F	F	5.79	5.79	6.24	5.58	5.69	5.92









	S.D.	0.18	0.23

IGL391F	M	4.51	5.12	5.34	5.25	4.84	5.11	4.65	5.15







72.60	Mean	5.00	4.66

IGL391F	F	4.66	4.95	4.63	4.84	4.69	4.41	4.45









S.D.	0.30	0.19

IGL352F	M	5.66	6.09	5.27	6.33	5.57	6.11	6.07







	79.89	Mean	5.87	5.54

IGL352F	F	5.63	5.35	5.47	5.55	5.53	5.75	5.51









S.D.	0.38	0.13

IGL355F	M	5.41	5.17	4.58	5.24	3.81	4.73	4.93	5.22







82.58	Mean	4.89	4.83

IGL355F	F	4.25	5.13	5.13	4.46	5.25	4.78	4.66	4.67	5.16







S.D.	0.52	0.35

IGL417F	M	5.49	5.15	5.39	5.39	5.61	5.82	5.18	5.26	5.53	5.55	5.58



	86.15	Mean	5.45	5.24

IGL417F	F	5.29	5.23	5.12	5.29	5.27











S.D.	0.20	0.07

IGL378F	M	5.50	5.26	5.21	5.30	5.34	5.51	5.60	5.45







68.45	Mean	5.40	5.06

IGL378F	F	5.19	5.21	4.78	5.19	4.91











S.D.	0.14	0.20

IGL380F	M	5.36	5.25	5.23	4.93	5.28	4.93	5.21	4.97	4.74





	75.68	Mean	5.10	4.96

IGL380F	F	4.99	4.84	4.95	5.18	4.76	5.06









	S.D.	0.21	0.15

IGL348F	M	5.13	5.04	5.01	5.44	5.49	5.13	5.59	5.52	5.27	5.18





72.73	Mean	5.28	4.98

IGL348F	F	4.94	5.03	5.07	4.89











	S.D.	0.21	0.08

IGL430F	M	5.75	5.98	5.99











	23.37	Mean	5.91	5.65

IGL430F	F	5.65















S.D.	0.14	NA

IGL409F	M	5.28	5.73	5.51











	72.27	Mean	5.51	5.07

IGL409F	F	4.76	4.86	4.81	5.19	4.91	5.09	5.35	5.36	5.12	5.13	5.17





S.D.	0.23	0.21

IGL421F	M	5.93	5.81	5.57	5.48











66.72	Mean	5.70	5.49

IGL421F	F	5.22	5.65	5.51	5.66	5.67	5.25	5.76	5.21







	S.D.	0.21	0.23

IGL385F  NP 



















	IGL423F	M	4.74	5.02	5.22	4.99	5.41	4.98	5.13







	89.87	Mean	5.07	4.94

IGL423F	F	4.88	4.89	4.93	5.02	4.74	5.13	5.23	4.97	4.96	4.88	4.75





S.D.	0.21	0.15

IGL440F	M	4.48	5.60	5.38	5.73	5.41	5.58	5.68







	48.10	Mean	5.41	5.12

IGL440F	F	4.80	5.44













	S.D.	0.43	0.45



G-7



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS)

(GRAMS)

TARGET DOSE: 10,000 MG/M3

ANIMAL















     Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL399F	M	5.72	4.52	5.35	5.28	5.62	5.13	5.48	5.15	5.12	5.53





88.98	Mean	5.29	5.15

IGL399F	F	4.79	5.31	5.07	4.97	5.40	5.53	5.01









S.D.	0.34	0.26

IGL452F	M	5.26	5.36	5.38	5.33	5.86	5.48	5.46







	73.33	Mean	5.45	5.03

IGL452F	F	5.25	4.85	5.61	4.95	4.75	5.11	4.68









S.D.	0.20	0.32

IGL436F	M	4.72	5.50	5.19	5.64	5.42	5.05	4.09	5.21	4.98	5.10	5.11



	75.86	Mean	5.09	4.96

IGL436F	F	5.21	5.22	4.70	4.72











	S.D.	0.42	0.29

IGL454F	M	4.89	4.86	5.64	5.12











55.99	Mean	5.13	5.07

IGL454F	F	5.02	5.56	5.41	4.39	5.02	5.04	5.04









S.D.	0.36	0.37

IGL461F	M	6.03	5.80	6.24	5.75	6.38	5.64









63.51	Mean	5.97	5.53

IGL461F	F	5.70	5.43	5.67	5.49	5.38











S.D.	0.29	0.14

IGL469F	M	6.21













	12.51	Mean	6.21	6.30

IGL469F	F	6.30















S.D.	NA	NA

IGL470F	M	4.98	5.45	4.86	5.07	5.29	4.76	4.53	4.88	4.79	5.09	5.26	5.15



88.36	Mean	5.01	4.71

IGL470F	F	4.36	5.06	4.36	4.85	4.64	4.98









	S.D.	0.26	0.30

IGL473F	M	5.78	5.62	6.04	5.59	5.35	5.34	5.44







	84.09	Mean	5.59	5.62

IGL473F	F	5.38	5.39	5.60	5.60	6.22	5.94	5.30	5.50







	S.D.	0.25	0.31

IGL407F	M	5.28	5.56	5.07	6.08	5.75	5.83









86.49	Mean	5.60	5.29

IGL407F	F	5.48	5.41	5.71	5.10	4.69	4.89	5.00	5.91	5.19	5.54





	S.D.	0.37	0.38

IGL442F	M	6.01	5.58	5.55	5.41











71.11	Mean	5.64	5.40

IGL442F	F	5.46	5.50	5.39	5.20	5.53	5.57	5.55	5.10	5.26







S.D.	0.26	0.17















	Mean	71.80



















	S.D.	20.14



	

G-8



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS)

(GRAMS)

TARGET DOSE: 20,000 MG/M3

ANIMAL















   Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL364F	M	4.95	5.93	5.49	6.05	5.35	5.61	5.60	5.43	5.29	5.51





90.53	Mean	5.52	5.05

IGL364F	F	4.97	5.52	5.02	5.41	5.09	5.07	4.24









S.D.	0.31	0.41

IGL367F	M	5.06	5.19	5.63	5.37	5.46	4.95	5.09	5.18	5.25	5.35	5.30



	77.68	Mean	5.26	4.96

IGL367F	F	4.79	5.28	4.91	4.87











	S.D.	0.19	0.22

IGL368F	M	5.33	5.06	5.19	3.18	4.81	5.22	5.25	5.57	5.61	5.94





81.64	Mean	5.12	5.08

IGL368F	F	4.85	4.95	5.27	4.94	5.36	5.11









	S.D.	0.75	0.20

IGL375F	M	5.68	5.62	5.48	5.75	3.44	5.51	5.60	5.48







57.78	Mean	5.32	5.07

IGL375F	F	5.39	5.04	4.79













S.D.	0.77	0.30

IGL363F	M	4.42	6.12	4.93	6.33	5.90









	33.30	Mean	5.54	5.60

IGL363F	F	5.60















S.D.	0.82	NA

IGL373F	M	5.83	5.34	5.32	5.33











67.49	Mean	5.46	5.07

IGL373F	F	5.09	5.07	5.15	4.94	4.64	5.19	4.99	5.31	5.29







S.D.	0.25	0.20

IGL397F	M	5.55	5.51	5.45	5.48	5.48	5.28	6.01	5.76







87.30	Mean	5.57	5.35

IGL397F	F	5.04	5.40	5.53	5.31	5.08	5.51	5.61	5.30







	S.D.	0.22	0.21

IGL357F	M	3.99	4.35	4.41	4.65	4.24	4.57









63.00	Mean	4.37	4.09

IGL357F	F	1.68	4.23	3.16	4.24	4.71	4.42	4.09	4.54	3.58	3.82





	S.D.	0.24	0.49

IGL369F	M	4.17	4.99	5.11	5.41	5.50









	70.26	Mean	5.04	5.01

IGL369F	F	5.31	4.87	5.15	4.81	4.92	4.96	5.29	4.99	4.78







S.D.	0.53	0.20

IGL404F	M	5.76	5.39	5.56	5.33	5.66









	75.28	Mean	5.54	5.29

IGL404F	F	5.42	5.10	5.17	5.60	5.19	5.36	5.19	5.44	5.11







S.D.	0.18	0.17

IGL365F	M	5.40	5.41	5.13	5.98	4.98	5.14	5.62	5.43	5.43





	78.45	Mean	5.39	4.99

IGL365F	F	5.09	5.30	4.68	4.81	5.14	4.91









	S.D.	0.30	0.23

IGL366F	M	5.83	5.46	5.69	6.17	6.04	5.88	5.73	5.45







82.10	Mean	5.78	5.12

IGL366F	F	3.46	5.24	5.16	5.65	5.33	5.37	5.64









S.D.	0.25	0.76

IGL372F	M	5.09	5.44	5.22	4.95	5.24	5.04	4.93	5.28	5.28	5.51





76.51	Mean	5.20	4.91

IGL372F	F	4.49	5.00	5.27	4.75	5.02











S.D.	0.19	0.30

IGL396F	M	5.55	5.89	5.39	5.61	5.46	5.52









76.34	Mean	5.57	5.37

IGL396F	F	5.18	5.48	5.25	5.41	5.18	5.49	5.37	5.56







	S.D.	0.17	0.15

IGL371F	M	5.82	5.96	5.56	5.60	5.95	5.69









79.74	Mean	5.76	5.65

IGL371F	F	5.08	5.45	5.94	5.88	5.99	5.68	5.49	5.65







	S.D.	0.17	0.30

The weight of the first female fetus in litter IGL357 was an outlier and
was not used in the statistical analyses

G-9



APPENDIX G - FETAL BODY WEIGHT

(INDIVIDUAL AND MEAN FETAL BODY WEIGHT AND LITTER WEIGHTS)

(GRAMS)

TARGET DOSE: 20,000 MG/M3

ANIMAL















    Litter Weights	Fetus Weights

NUMBER 	SEX















	Males	Females

IGL410F	M	5.46	5.69	5.48	5.51	5.39	5.28









77.95	Mean	5.47	5.02

IGL410F	F	5.30	5.09	4.96	4.78	5.01	4.79	5.21	5.07	4.93







S.D.	0.14	0.17

IGL415F	M	6.13	6.08	5.99	5.67	6.07	5.82	6.26	5.75	5.88





	92.33	Mean	5.96	5.53

IGL415F	F	5.66	5.49	5.57	5.46	5.50	5.52	5.48









S.D.	0.19	0.07

IGL444F	M	5.50	5.49	5.56	6.04	5.64









	76.36	Mean	5.65	5.35

IGL444F	F	5.17	5.73	5.25	5.74	5.31	5.05	5.25	5.29	5.34







S.D.	0.23	0.24

IGL449F	M	6.00	5.58	4.75	6.00	6.08	6.10	5.84







	83.54	Mean	5.76	5.40

IGL449F	F	4.45	5.39	5.77	5.47	5.69	5.56	5.55	5.31







	S.D.	0.48	0.41

IGL451F  NP



















	IGL458F	M	5.41	5.25	6.14	5.59	5.48	5.76









74.53	Mean	5.61	5.11

IGL458F	F	5.37	5.41	5.16	5.23	5.14	5.08	4.91	4.60







	S.D.	0.31	0.26

IGL471F	M	5.73	5.59	5.96	5.92











59.69	Mean	5.80	5.21

IGL471F	F	5.30	5.41	5.67	5.27	5.39	5.54	3.91









S.D.	0.17	0.59

IGL424F	M	5.48	5.68	5.74	5.31	5.36	5.39	5.68	5.53







79.28	Mean	5.52	5.02

IGL424F	F	4.57	4.93	5.20	5.21	4.80	5.32	5.08









S.D.	0.16	0.26

IGL428F	M	5.53	5.31	5.67	4.86	5.90	5.14









82.42	Mean	5.40	5.00

IGL428F	F	4.83	5.12	4.64	5.02	5.46	5.22	4.55	5.17	5.08	4.92





	S.D.	0.38	0.27

IGL439F	M	4.91	5.52	4.96	4.95	5.34	4.78	4.74	5.02	5.34





	79.19	Mean	5.06	4.80

IGL439F	F	4.16	4.90	4.61	5.26	4.70	4.86	5.14









S.D.	0.27	0.36















	Mean	75.11



	NOTE: NP- NOT PREGNANT







S.D.	12.34



	

G-10

APPENDIX H  -  FETAL OBSERVATIONS

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

TOTAL FETUSES WITH EXTERNAL VARIATIONS	0/354

0/329

0/325

0/343

TOTAL LITTERS WIT`H EXTERNAL VARIATIONS	[0/25]

[0/23]

[0/24]

[0/24]









	TOTAL FETUSES WITH EXTERNAL MALFORMATIONS	4/354

1/329

0/325

0/343

TOTAL LITTERS WITH EXTERNAL MALFORMATIONS	[4/25]

[1/23]

[0/24]

[0/24]









	TOTAL FETUSES WITH VISCERAL VARIATIONSa	5/178

2/165

3/162

0/172

TOTAL LITTERS WITH VISCERAL VARIATIONSa	[3/25]

2/23]

[2/24]

[0/24]









	TOTAL FETUSES WITH VISCERAL MALFORMATIONSa	5/178

4/165

1/162

2/172

TOTAL LITTERS WITH VISCERAL MALFORMATIONSa 	[5/25]

[4/23]

[1/24]

[2/24]









	TOTAL FETUSES WITH SKELETAL VARIATIONSb	39/176

29/165

42/163

42/171

TOTAL LITTERS WITH SKELETAL VARIATIONSb	[17/24]

[16/23]

[18/24]

[18/24]









	TOTAL FETUSES WITH SKELETAL MALFORMATIONS	1/176

1/165

1/163

0/171

TOTAL LITTERS WITH SKELETAL MALFORMATIONS	[1/24]

[1/23]

[1/24]

[0/24]









	EXTERNAL EXAMINATIONS







	               - TOTAL FETUSES EXAMINED:	354

329

325

343

               - TOTAL LITTERS EXAMINED:	[25]

[23]

[24]

[24]









	INDIVIDUAL EXTERNAL OBSERVATIONS







	               STUNTED  (<4.0 grams)	4

1

1

9

	[4]

[1]

[1]

[5]

INDIVIDUAL EXTERNAL MALFORMATIONS







	               CONJOINED TWIN	0

1

0

0

	[0]

[1]

[0]

[0]









	a – Includes head observations







	b – Includes calcaneus























































H-1



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL EXTERNAL MALFORMATIONS (CONT'D)







	               DOMED HEAD	1

0

0

0

	[1]

[0]

[0]

[0]









	               MALROTATED HIND PAW	2

0

0

0

	[2]

[0]

[0]

[0]

VISCERAL EXAMINATIONS







	             - TOTAL FETUSES EXAMINED:	177

165

162

172

             - TOTAL LITTERS EXAMINED:	[25]

[23]

[24]

[24]









	INDIVIDUAL VISCERAL VARIATIONS







	             MISSHAPEN SPLEEN	0

1

0

0

	[0]

[1]

[0]

[0]









	             UMBILICAL ARTERY ARISES FROM LEFT SIDE OF 	4

1

3

0

             URINARY BLADDER	[3]

[1]

[2]

[0]









	INDIVIDUAL VISCERAL MALFORMATIONS







	             ATRIAL CHAMBER LARGE	0

1

0

0

	[0]

[1]

[0]

[0]









	             CECUM NOT EVIDENT	0

1

0

0

	[0]

[1]

[0]

[0]









	             DOUBLE AORTA	0

1

0

0

	[0]

[1]

[0]

[0]



































































H-2



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL VISCERAL MALFORMATIONS (CONT'D)







	             DUPLICATE TONGUE	0

1

0

0

	[0]

[1]

[0]

[0]









	             INNOMINATE ELONGATED	0

1

0

0

	[0]

[1]

[0]

[0]









	             INNOMINATE ABSENT	1

0

0

0

	[1]

[0]

[0]

[0]









	             HYDRONEPHROSIS	2

1

0

0

	[2]

[1]

[0]

[0]









	             HYDROURETER	2

1

0

0

	[2]

[1]

[0]

[0]









	             LUNG SUPERNUMERARY LOBE	0

1

0

0

	[0]

[1]

[0]

[0]









	             MALPOSITIONED CAROTID ARTERY	1

1

0

0

	[1]

[1]

[0]

[0]









	             MALPOSITIONED SUBCLAVIAN  ARTERY	1

1

0

0

	[1]

[1]

[0]

[0]









	             MALPOSITIONED PULMONARY ARTERY	0

1

0

0

	[0]

[1]

[0]

[0]











































































H-3



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL VISCERAL MALFORMATIONS (CONT'D)







	             OPEN EYE	0

0

0

1

	[0]

[0]

[0]

[1]









	             RETINA FOLD	1

0

1

0

	[1]

[0]

[1]

[0]









	             SHARED ORGANS	0

1

0

0

	[0]

[1]

[0]

[0]









	             SPLEEN SMALL	0

1

0

0

	[0]

[1]

[0]

[0]









	             UMBILICAL ARTERY ANEURYSM	0

0

0

1

	[0]

[0]

[0]

[1]









	             VENTRICLE SMALL	0

1

0

0

	[0]

[1]

[0]

[0]

SKELETAL EXAMINATIONS







	               - TOTAL FETUSES EXAMINED:	176

165

163

171

               - TOTAL LITTERS EXAMINED:	[24]

[23]

[24]

[24]









	INDIVIDUAL OSSIFICATION OBSERVATIONS







	                         CALCANEUS ADVANCED	1

0

0

0

	[1]

[0]

[0]

[0]









































































	

H-4



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL OSSIFICATION VARIATIONS







	                SKULL







	                          HYPOPLASTIC	0

1

1

0

	[0]

[1]

[1]

[0]









	                          MISSHAPEN	0

1

0

0

	[0]

[1]

[0]

[0]

               STERNEBRAE







	                         ADVANCED	1

2

2

0

	[1]

[2]

[1]

[0]









	                         ASYMMETRIC	0

2

1

2

	[0]

[2]

[1]

[1]









	                         BIFID	0

1

0

1

	[0]

[1]

[0]

[1]









	                         DUMBBELL SHAPED	0

0

0

3

	[0]

[0]

[0]

[1]









	                         HYPOPLASTIC	0

0

1

1

	[0]

[0]

[1]

[1]









	                         MISSHAPEN	4

6

2

5

	[3]

[4]

[2]

[5]









	                         UNOSSIFIED	3

0

5

 10

	[3]

[0]

[3]

[6]









	

H-5



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL OSSIFICATION VARIATIONS (CONT'D)







	               FOREPAW







	                         UNOSSIFIED	1

0

0

0

	[1]

[0]

[0]

[0]

               RIBS 







	                         CERVICAL 	1

0

0

0

	[1]

[0]

[0]

[0]









	                         SHORT LAST THORACIC	2

0

1

0

	[2]

[0]

[1]

[0]









	                         RUDIMENTARY LUMBAR	17

15

23

24

	[9]

[10]

[13]

[13]









	                          WELL-FORMED LUMBAR	0

0

0

1

	[0]

[0]

[0]

[1]

               VERTEBRAE







	                         CENTRA BIFID	7

6

6

5

	[6]

[6]

[3]

[5]









	                         DUMBBELL-SHAPED CENTRA	3

1

3

2

	[3]

[1]

[2]

[2]









	                         CENTRA MISSHAPEN	0

0

1

0

	[0]

[0]

[1]

[0]









	                         CENTRA UNOSSIFIED	0

1

0

0

	[0]

[1]

[0]

[0]









	

H-6



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL OSSIFICATION VARIATIONS (CONT'D)







	               VERTEBRAE (CONT'D)







	                         LUMBAR CENTRA DUMBBELL SHAPED	1

1

1

0

	[1]

[1]

[1]

[0]

INDIVIDUAL CARTILAGINOUS STRUCTURAL VARIATIONS







	               FOREPAW ANLAGE







	                         MISSHAPEN	0

0

1

0

	[0]

[0]

[1]

[0]

               RIB ANLAGE







	                SUPERNUMERARY CERVICAL RIB	1

0

0

0

	[1]

[0]

[0]

[0]

               VERTEBRAE ANLAGE







	                         CERVICAL CENTRA BIFID	0

0

0

1

	[0]

[0]

[0]

[1]









	                         THORACIC CENTRA DUMBBELL SHAPED	12

4

9

3

	[8]

[4]

[5]

[3]

INDIVIDUAL OSSIFICATION MALFORMATIONS







	               SKULL







	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]

              PECTORAL GIRDLE







	                        CLAVICLE FUSED BETWEEN TWINS	0

1

0

0

	[0]

[1]

[0]

[0]









	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]































































	

H-7



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL OSSIFICATION MALFORMATIONS (CONT'D)







              STERNEBRAE







	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]

              FORELIMB







	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]









	              FOREPAW







	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]









	               RIBS







	                       FUSED BETWEEN TWINS	0

1

0

0

	[0]

[1]

[0]

[0]









	                         DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]

               VERTEBRAE







	                         DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]









	                         CERVICAL CENTRA FUSED	0

1

0

0

	[0]

[1]

[0]

[0]









	                         THORACIC CENTRA HEMICENTRA	0

1

0

0

	[0]

[1]

[0]

[0]









	

H-8



APPENDIX H  -  FETAL OBSERVATIONS 

(INCIDENCE OF FETAL OBSERVATIONS)









	TARGET DOSE:	0 MG/M3

2000 MG/M3

10,000 MG/M3

20,000 MG/M3

INDIVIDUAL OSSIFICATION MALFORMATIONS (CONT'D)







VERTEBRAE (CONT'D)







	                         THORACIC ONE LESS PRESACRAL	0

0

1

0

	[0]

[0]

[1]

[0]

              PELVIC GIRDLE







	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]

              HINDLIMB







	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]

              HINDPAW







	                        DUPLICATE BONES	0

1

0

0

	[0]

[1]

[0]

[0]

INDIVIDUAL CARTILAGINOUS MALFORMATIONS







	               RIB ANLAGE







	                         FUSED	1

0

0

0

	[1]

[0]

[0]

[0]





















H-9



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL359F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1        A          M              +              +             + 

 2        A          M              +                                   
        +      

 3        A          M              +              +             + 

 4        A          M              +                                   
      (c,d)            

 5        A          F              +              +             +      
        

 6        A          F              +                                   
        +

 7        A          F              +              +             + 

 8C       A          M              +                                   
     (a,b,e)

 9        A          F              +              +             +      
        

10        A          F              +                                   
        +

11        A          F              +              +             +      
         

12        A          M              +                                   
        + 

13        A          F              +              +             +      
                       

14        A          M              +                                   
        + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (V):  Unossified  

(b) - SKELETAL/RIBS (T13):  Short last rib; Right 

(c) - SKELETAL/VERTEBRAE (T11-12):  Bifid centra

(d) - SKELETAL/VERTEBRAE (T11-12 Anlage):  Dumbbell shaped centra

(e) - SKELETAL/VERTEBRAE (T9):  Dumbbell shaped centra

H-10



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL360F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
      (b,c)

 2         A         F              +              +              +

 3         A         F              +                                   
      (b,c)

 4         A         F              +              +              +

 5         A         F              +                                   
        +

 6         A         F              +              +              +

 7         A         F              +                                   
        +

 8C        A         F              +              +              +

 9         A         M              +                                   
        +

10         A         M              +              +              +

11         A         M              +                                   
        +

12         A         F              +              +              +

13         A         M              +                                   
        + 

 E

14         A         F              +              +              +     

15         A         F              +                                   
       (a) 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left

(b) - SKELETAL/VERTEBRAE (T10-11):  Bifid centra

(c) - SKELETAL/VERTEBRAE (T10-11 Anlage):  Dumbbell shaped centra   

H-11



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL370F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         M              +              +              +

 3         A         M              +                                   
        +

 4         A         F              +              +              +

 5         A         M              +                                   
        +

 6         A         M              +              +              +

 7         A         M              +                                   
        +

 8         A         M              +              +              +

 9C        A         F              +                                   
       (n) 

10         A         F              +              +              +

11         A         F              +                                   
        + 

12         A         M              +              +              +

13*        D         M      (A,B,C,D,E,F,G)    (H,i)        (J,K,L,M)

14         A         F              +              +              +

15         A         M              +                                   
       (o) 

16         A         F              +              +              +  

17         A         M              +                                   
        +  

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(A) - EXTERNAL:  Kyphosis                          (L) - ABDOMEN/THORAX:
 Malpositioned ovaries

(B) - EXTERNAL:  Ectrodactyly; all paws            (M) - ABDOMEN/THORAX:
 No cervical spinal column

(C) - EXTERNAL:  Brachydactyly; all paws           (n) - SKELETAL/RIBS
(L1):  Rudimentary; Right

(D) - EXTERNAL:  Acaudate                          (o) - SKELETAL/RIBS
(L1):  Rudimentary; Left

(E) - EXTERNAL:  Anal atresia 

(F) - EXTERNAL:  Anasarca

(G) - EXTERNAL:  Small eye bulge; Bilateral

(H) - HEAD:  Anophthalmia; Bilateral

(i) - HEAD:  Dilated lateral ventricles; Bilateral

(J) - ABDOMEN/THORAX:  Malpositioned uterus

(K) - ABDOMEN/THORAX:  Malpositioned kidneys

H-12



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL374F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
      (b,c)

 2         A         M              +            (A)             +

 3         A         F              +                                   
        +           

 4         A         M              +             +              +

 5         A         F              +                                   
        +

 6C        A         M              +             +              +

 7         A         F              +                                   
       (d)

 8         A         M              +             +              +

 9         A         F              +                                   
        + 

 E

10         A         M              +             +              +

11         A         F              +                                   
        +

12         A         M              +             +              +

13         A         F              +                                   
        +

14         A         M              +             +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(A) - HEAD:  Retinal fold; Left

(b) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(c) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

(d) - SKELETAL/VERTEBRAE (T9):  Dumbbell shaped centra

H-13



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL395F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +             +             +       
        

 2         A         M              +                                   
        + 

 3         A         M              +             +             +       
         

 4         A         M              +                                   
        +

 5         A         M              +             +             +       
        

 6         A         F              +                                   
        +

 7         A         M              +             +             +       
          

 8C        A         F              +                                   
        +

 9         A         F              +             +             +       
          

10         A         M              +                                   
       (a)  

11         A         M              +             +             +       
          

12         A         M              +                                   
        +   

13         A         M              +             +             +       
          

14         A         M              +                                   
        +

15         A         F              +             +             +       
                        

16         A         M              +                                   
       (b)    

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:  Fetus numbers 4 and 6 assigned randomly.

(a) - SKELETAL/VERTEBRAE (T11-12 Anlage): Dumbbell shaped centra

(b) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

H-14



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL383F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  1     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +             +      
         

 2         A         F              +                                   
        +

 3         A         M              +              +            (a)     
           

 4         A         M              +                                   
        + 

 5C        A         M              +              +             +      
         

 6         A         F              +                                   
        + 

 7         A         F              +              +             +      
          

 8         A         M              +                                   
        +

 9         A         F              +              +             +      
           

10         A         M              +                                   
        +  

11         A         F              +              +             +      
          

12         A         M              +                                   
        + 

13         A         M              +              +             +      
          

14         A         M              +                                   
        +

15         A         M              +              +             +      
                          

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE: 

(a) - ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder

H-15



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL386F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M             +                                    
       +

 2         A         F             +              +              +

 3         A         M             +                                    
     (b,c)

 4         A         M             +              +              +

 5         A         M             +                                    
       +

 6C        A         M             +              +              +

 7         A         M             +                                    
       +

 8         A         F             +              +              +

 9         A         M             +                                    
       +

10         A         F             +              +              +

11         A         F             +                                    
       +

12         A         M             +              +              +

13         A         M             +                                    
      (a)

14         A         M             +              +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (VI):  Advanced

(b) - SKELETAL/VERTEBRAE (T12):  Bifid centra

(c) - SKELETAL/VERTEBRAE (T12 Anlage):  Dumbbell shaped centra 

H-16



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL394

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +(*) 

 2         A         F              +             +               +     
          

 3         A         M              +                                   
        +

 4         A         M              +             +               +     
           

 5         A         M              +                                   
        +

 6C        A         M             (A)            +               +     
           

 7         A         M              +                                   
        +

 8         A         F              +             +               +     
          

 9         A         M              +                                   
        +

10         A         F              +             +               +     
          

11         A         F              +                                   
       (b)  

12         A         F              +             +               +     
          

13         A         F              +                                   
        +

14         A         F              +             +               +     
                           

15         A         F              +                                   
       (b)

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(A) - EXTERNAL:  Malrotated hindpaw; Left

(b) - SKELETAL/STERNEBRAE (VI):  Misshapen

(*) - SKELETAL/HINDPAW (Calcaneus): Advanced; Bilateral

H-17



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL402F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  4     MALFORMATIONS:  1

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         M              +             +              +      
           

 3         A         F              +                                   
        +

 4         A         M              +             +              +      
          

 5         A         F              +                                   
        +  

 6         A         F              +             +              +      
          

 7C        A         M              +                                   
       (h)

 8         A         F              +             +              +      
           

 9         A         M              +                                   
       (e) 

10         A         M              +             +              +      
           

11         A         F              +                                   
        +

12         A         M              +             +              +      
           

13*        A         M             (A)                                  
   (b,c,f,G,i)      

14         A         F              +             +              +      
           

15         A         F              +                                   
        +

16         A         F              +             +              +      
                         

17         A         F              +                                   
      (d,h)    

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(A) - EXTERNAL:  Domed head

(b) - SKELETAL/FOREPAW (Proximal phalanges 2-4):  Unossified; Bilateral

(c) - SKELETAL/STERNEBRAE (IV-V):  Unossified

(d) - SKELETAL/STERNEBRAE (VI):  Misshapen

(e) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

(f) - SKELETAL/RIBS (C7, C7 Anlage):  Cervical rib; Bilateral

(G) - SKELETAL/RIBS (C7 and T1 Anlage):  Fused; Anlage on C7 and T1 rib
fused before it meets sternebrae

(h) - SKELETAL/VERTEBRAE (T12 Anlage):  Dumbbell shaped centra 

(i) - SKELETAL/VERTEBRAE (T10 Anlage):  Dumbbell shaped centra

H-18



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL411F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +              +     
        

 2         A         F              +                                   
        +

 3         A         F              +              +              +     
        

 4         A         F              +                                   
        +  

 5         A         F              +              +              +     
         

 6         A         F              +                                   
       (b) 

 7         A         F              +              +              +     
          

 E

 8         A         M              +                                   
        + 

 9C        A         F              +              +              +     
          

10         A         F              +                                   
       (a)   

11         A         M              +              +              +     
          

12         A         M              +                                   
        +

13         A         M              +              +              +     
                           

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (VI):  Misshapen

(b) - SKELETAL/RIBS (L1):  Rudimentary; Right  

H-19



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL422F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         F              +             +              +      
           

 3         A         M              +                                   
        + 

 4         A         F              +             +              +      
          

 5         A         F              +                                   
       (b)   

 6         A         F              +             +              +      
          

 7         A         F              +                                   
       (a)  

 8         A         M              +             +              +      
           

 9C        A         F              +                                   
        +

10         A         M              +             +              +      
           

11         A         M              +                                   
        +

12         A         F              +             +              +      
           

13         A         M              +                                   
        +  

14         A         M              +             +              +      
           

15         A         M              +                                   
        +

16         A         M              +             +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (T13):  Short last rib; Right

(b) - SKELETAL/VERTEBRAE (T12 Anlage):  Dumbbell shaped centra

H-20

APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL347F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +             +

 2         A         F              +                                   
        +

 3         A         M              +              +             +

 4         A         F              +                                   
        +

 5         A         M              +              +             +

 6         A         F              +                                   
       (a) 

 7         A         M              +              +             +

 8         A         F              +                                   
       (a) 

 9C        A         F              +              +             +

10         A         M              +                                   
        +

11         A         F              +              +             +

12         A         M              +                                   
        +

13         A         F              +              +             +

14         A         M              +                                   
        +

15         A         F              +              +             +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

- SKELETAL/RIBS (L1):  Rudimentary; Left

H-21



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL427F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 E 

 1C        A         F              +              +             +      
                     

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-22



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL400F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         F              +              +             +

 3         A         F              +                                   
        +

 4         A         M              +              +             +

 5         A         F              +                                   
       (a)

 6         A         F              +              +             +

 7         A         F              +                                   
       (a) 

 8         A         M              +              +             +

 9         A         F              +                                   
       (b) 

10         A         M              +              +             +

11C        A         M              +                                   
        +

12         A         M              +              +             +

13         A         M              +                                   
        +

14         A         M              +              +             +

15         A         F              +                                   
        +

16         A         M              +              +             +

17         A         F              +                                   
        +

18         A         M              +              +             +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

(b) - SKELETAL/VERTEBRAE (T10):  Bifid centra

H-23



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL408F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  1     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         F              +             +              +

 3         A         M              +                                   
        +

 4         A         M              +             +              + 

 5         A         M              +                                   
        +

 6         A         M              +             +              +   

 7         A         M              +                                   
        +

 8         A         F              +             +              +

 9         A         M              +                                   
        +

10C        A         F              +             +              + 

11         A         F              +                                   
        + 

12         A         F              +             +              +

13         A         F              +                                   
        +

14         A         F              +             +             (a) 

15         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

- ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder 

H-24



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL393F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +              +     
          

 2         A         F              +                                   
         +

 3         A         M              +              +              +     
          

 4C        A         M              +                                   
         +

 5         A         F              +              +              +     
          

 6         A         M              +                                   
         + 

 7         A         M              +              +              +     
          

 8         A         F              +                                   
         +

 9         A         F              +              +              +     
         

10         A         M              +                                   
         + 

11         A         M              +              +              +     
          

12         A         F              +                                   
         +  

13         A         F              +              +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-25



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL419F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +             +      
           

 2         A         M              +                                   
        +

 3         A         F              +              +             +      
          

 4         A         M              +                                   
        +

 5         A         F              +              +             +      
           

 6C        A         F              +                                   
        +

 7         A         F              +              +             +      
         

 8         A         F              +                                   
        +

 9         A         F              +              +             +      
          

10         A         F              +                                   
        + 

11         A         M              +              +             +      
         

12         A         F              +                                   
      (a,b)  

13         A         M              +              +             +      
           

14         A         F              +                                   
        +

15         A         M              +              +             +      
                       

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(b) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

H-26



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL434F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         M              +             +               +

 3         A         M              +                                   
        +

 4         A         M              +             +               +

 5         A         M              +                                   
        +

 6         A         M              +             +               +

 7         A         M              +                                   
        +

 8         A         M              +             +               +

 9         A         F              +                                   
        +

10C        A         M              +             +               +

11         A         M              +                                   
        +

12         A         M              +             +             (A,B)

13         A         F              +                                   
        +

 L

14         A         F              +             +               +

15         A         F              +                                   
        +

16         A         F              +             +               +

17         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE: 

(A) - ABDOMEN/THORAX:  Hydroureter; Bilateral

(B) - ABDOMEN/THORAX:  Hydronephrosis; Bilateral

H-27



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL445F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +              +

 2         A         M              +                                   
         +

 3         A         M              +             +              +

 4         A         M              +                                   
         +

 5*        A         M              +             +              +

 6C        A         M              +                                   
         +

 7         A         M              +             +              +

 8         A         M              +                                   
         +

 9         A         F              +             +              +

10         A         F              +                                   
         +

11         A         F              +             +              +

12         A         F              +                                   
         +

13         A         F              +             +              +

14         A         F              +                                   
         +

15         A         F              +             +              + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

H-28



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL446F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  2     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +  

 2         A         F              +             +              +      
                         

 3         A         M              +                                   
        +

 4         A         F              +             +            (a,B,C)  
                    

 5         A         M              +                                   
        +

 6         A         M              +             +              +      
               

 E

 7         A         F              +                                   
        + 

 8C        A         M              +             +             (a)     
             

 9         A         F              +                                   
        +

10         A         M              +             +              +      
          

11         A         F              +                                   
       (d)  

12         A         F              +             +              +      
           

 E

13         A         M              +                                   
        + 

14         A         F              +             +              +      
            

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder

(B) - ABDOMEN/THORAX:  Hydroureter; Left 

(C) - ABDOMEN/THORAX:  Hydronephrosis; Left

(d) - SKELETAL/STERNEBRAE (V):  Unossified

H-29



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL465F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +              +      
          

 2         A         F              +                                   
        +

 3         A         F              +             +              +      
          

 4         A         F              +                                   
        +

 5         A         M              +             +              +      
          

 6         A         M              +                                   
        + 

 7         A         F              +             +              +      
          

 8C        A         F             (A)                                  
        +

 9         A         M              +             +              +      
        

10         A         F              +                                   
        + 

11         A         F              +             +              +      
          

12         A         M              +                                   
        +

13         A         M              +             +              +      
                       

14         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

- EXTERNAL:  Malrotated hind paw; Left

H-30



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  0 MG/M3

ANIMAL NUMBER:  IGL490F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        + 

 2         A         M              +              +            +       
           

 3         A         M              +                                   
       (e) 

 4         A         F              +              +            +       
           

 5         A         M              +                                   
       (e) 

 6         A         F              +              +            +       
         

 7         A         M              +                                   
        +

 8*        A         F              +              +         (A,B,C,D)  
                   

 9C        A         F              +                                   
        +

10         A         F              +              +            +       
           

11         A         M              +                                   
       (e)  

12         A         M              +              +            +       
                       

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(A) - ABDOMEN/THORAX:  Innominate artery absent

(B) - ABDOMEN/THORAX:  Malpositioned carotid branch; Left

(C) - ABDOMEN/THORAX:  Malpositioned carotid branch; Right

(D) - ABDOMEN/THORAX:  Malpositioned subclavian branch; Right

(e) - SKELETAL/RIBS (L1):  Rudimentary; Left

H-31



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL406F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
         +

 2         A         F              +             +               +

 3         A         F              +                                   
         +

 4         A         F              +             +               +

 5C        A         M              +                                   
         +

 6         A         M              +             +               +

 7         A         M              +                                   
         +

 8         A         M              +             +               +

 9         A         M              +                                   
         +

 E

10         A         F              +             +               +

11         A         F              +                                   
         +

12         A         F              +             +               +

13         A         M              +                                   
         +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-32



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL418F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  4     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
       (a) 

 2         A         F              +             +              +      
           

 3         A         F              +                                   
      (b,d) 

 E

 4         A         F              +             +              +      
           

 5         A         M              +                                   
       (c)  

 6C        A         M              +             +              +      
           

 7         A         F              +                                   
        +       

 8         A         M              +             +              +      
          

 9         A         M              +                                   
       (a) 

10         A         M              +             +              +      
           

11         A         F              +                                   
        + 

12         A         M              +             +              +      
            

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Bilateral

(b) - SKELETAL/RIBS (L1): Rudimentary; Left

(c) - SKELETAL/RIBS (L1): Rudimentary; Right

(d) - SKELETAL/VERTEBRAE (L1): Dumbbell shaped centra; Left

H-33



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    0 MG/M3

ANIMAL NUMBER:  IGL474F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         F              +             +              +

 3         A         F              +                                   
       (a) 

 4         A         F              +             +              +

 5         A         F              +                                   
        +

 E

 6C        A         F              +             +              +

 7         A         M              +                                   
        +

 8         A         M              +             +              +

 9         A         M              +                                   
        +

10         A         F              +             +              +

11         A         F              +                                   
        +

12         A         M              +             +              +

13         A         M              +                                   
        +

14         A         F              +             +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

- SKELETAL/RIBS (L1): Rudimentary; Left

H-34



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL346F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +             +              +      
           

 3         A         M              +                                   
        +

 4         A         F              +             +              +      
           

 5         A         F              +                                   
        +

 6         A         F              +             +              +      
           

 7C        A         M              +                                   
        +

 8         A         F              +             +              +      
           

 9         A         F              +                                   
        +

10         A         M              +             +              +      
           

11         A         F              +                                   
        +

12         A         M              +             +              +      
          

13         A         M              +                                   
        + 

14         A         F              +             +              +      
                           

15         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-35



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL361F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +             +             +

 2         A         F              +                                   
        +

 3         A         F              +             +             +

 4         A         F              +                                   
        +

 5         A         M              +             +             +

 6C        A         F              +                                   
        +

 7         A         F              +             +             +

 8         A         M              +                                   
      (a,b)

 9         A         F              +             +             +

10         A         M              +                                   
        +

11         A         M              +             +             +

12         A         F              +                                   
        +

13         A         M              +             +             +

14         A         M              +                                   
        +

15         A         F              +             +             + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (VI):  Advanced

(b) - SKELETAL/RIBS (L1): Rudimentary; Left

H-36



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL376F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  1     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         F              +             +            (a)

 3         A         M              +                                   
        +

 4         A         F              +             +             +

 5         A         F              +                                   
        +

 6         A         F              +             +             +

 7         A         M              +                                   
        +

 8C        A         M              +             +             +

 9         A         F              +                                   
        +

10         A         M              +             +             +

11         A         F              +                                   
        +

12         A         M              +             +             +

13         A         M              +                                   
        +

 E

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder

H-37



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL381F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 E

 1         A         F              +                                   
        +

 2         A         M              +             +              +

 3         A         M              +             +              + 

 4         A         F              +                                   
        + 

 5         A         F              +             +              +

 E

 6         A         M              +                                   
      (a,b)  

 E

 7         A         F              +             +              +      
  

 8         A         F              +                                   
        + 

 9C        A         M              +             +              + 

 E

10         A         F              +                                   
        +

 E

11         A         F              +             +              +

 E

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE: Fetus # 1 inadvertently eviscerated, therefore fetus # 1 received
a skeletal exam and fetus # 2 received a visceral and head exam.

(a) - SKELETAL/VERTEBRAE (T10):  Bifid centra

(b) - SKELETAL/VERTEBRAE (T10 Anlage):  Dumbbell shaped centra

H-38



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL405F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +               +

 2         A         F              +                                   
         +

 3         A         F              +             +               +

 4         A         M              +                                   
         +

 5         A         M              +             +               +

 6         A         F              +                                   
         +

 7         A         F              +             +               +

 8         A         F              +                                   
         +

 9         A         M              +             +               +

10C        A         F              +                                   
         +

11         A         M              +             +               +

12         A         M              +                                   
         +

13         A         M              +             +               +

14         A         M              +                                   
         +

15         A         F              +             +               +

16         A         M              +                                   
         +

17         A         F              +             +               +

18         A         M              +                                   
         +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-39



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL382F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +   

 2         A         F              +             +              +      
                         

 3         A         F              +                                   
        +

 4         A         F              +             +              +      
           

 5         A         M              +                                   
       (a)   

 6         A         M              +             +              +      
           

 7C        A         F              +                                   
        +

 8         A         F              +             +              +      
           

 9         A         F              +                                   
        + 

10         A         M              +             +              +      
           

11         A         M              +                                   
        + 

12         A         F              +             +              +      
           

13         A         F              +                                   
        +

14         A         M              +             +              +      
           

15         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE: 

(a) - SKELETAL/STERNEBRAE (VI):  Misshapen

H-40



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL390F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         F              +              +              +

 3         A         F              +                                   
       (a) 

 4         A         M              +              +              +

 5         A         M              +                                   
        +

 6C        A         F              +              +              +

 7         A         F              +                                   
        +

 8         A         M              +              +              +

 9         A         F              +                                   
        +

10         A         F              +              +              +

 E

11         A         F              +                                   
        +

12         A         F              +              +              +

13         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/VERTEBRAE (T11):  Bifid centra

H-41



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL358F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +             +              +      
           

 3         A         M              +                                   
        +

 4         A         F              +             +              +      
           

 5         A         M              +                                   
        +

 6         A         F              +             +              +      
           

 7         A         M              +                                   
        + 

 8         A         M              +             +              +      
           

 9C        A         M              +                                   
        +

10         A         M              +             +              +      
           

11         A         F              +                                   
        +

12         A         M              +             +              +      
           

13         A         M              +                                   
        + 

14         A         F              +             +              +      
           

15         A         M              +                                   
        +

16         A         F              +             +              +      
          

17         A         F              +                                   
        +

18         A         F              +             +              +      
                        

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-42



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL398F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +             +              +

 3         A         M              +                                   
        +

 4         A         F              +             +              +

 5         A         M              +                                   
        +

 6         A         F              +             +              +

 7         A         F              +                                   
        +

 8C        A         M              +             +              +

 9         A         F              +                                   
        +

10         A         M              +             +              +

11         A         M              +                                   
       (a)

12         A         M              +             +              +

13         A         M              +                                   
        +

14         A         M              +             +              +

15         A         F              +                                   
        +

16         A         F              +             +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left

H-43



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL350F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         F              +             +              +      
                        

 3         A         F              +                                   
        +

 4         A         F              +             +              +      
           

 5         A         M              +                                   
        + 

 6         A         M              +             +              +      
           

 7         A         M              +                                   
        +

 8C        A         M              +             +              +      
           

 9         A         F              +                                   
        +          

10         A         F              +             +              +      
           

11         A         M              +                                   
        +

12         A         F              +             +              +      
           

13         A         F              +                                   
        +

14         A         M              +             +              +      
           

15         A         M              +                                   
        +

16         A         F              +             +              +      
          

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-44



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL353F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  5     MALFORMATIONS:  1

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +             +

 2         A         M             (A)                       (B-K,*)  
(L,N,O,P,Q,R,s,t,u,W,X,z)

(AA,BB,cc,DD,ee,FF,GG,HH)

 3         A         F              +             +             +  

 4         A         F              +                                   
     (m,y) 

 5         A         M              +             +             +

 6         A         M              +                                   
      (v)

 7         A         F              +             +             +

 8         A         F              +                                   
       +

 9         A         F              +             +             +    

10C        A         M              +                                   
      (v) 

11         A         F              +             +             + 

12         A         M              +                                   
      (v) 

13         A         M              +             +             +   

14         A         F              +                                   
       +

15         A         F              +             +             +   

16         A         F              +                                   
       + 

17         A         F              +             +             +

18         A         M              +                                   
       +

19         A         F              +             +             +  

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

                                NOTE:  

                                (A) - EXTERNAL:  Conjoined twin; Joined
at thoracic region; 1 head, 8 limbs, 2 tails, 1 umbilicus

(B) - ABDOMEN/THORAX:  Liver, stomach, spleen, entire small intestine
shared

(C) - ABDOMEN/THORAX:  Spleen small

(D) - ABDOMEN/THORAX:  Cecum not evident; bifurcation appears in area
where cecum would normally reside

(E) - ABDOMEN/THORAX:  All thoracic and cranial organs shared

(F) - ABDOMEN/THORAX:  Supernumerary lung lobe; Left

(G) - ABDOMEN/THORAX:  Double aorta

(H) - ABDOMEN/THORAX:  Malpositioned carotid and subclavian branches;
Bilateral

(I) - ABDOMEN/THORAX:  Malpositioned pulmonary artery branch

(J) - ABDOMEN/THORAX:  Ventricle small; Left

(K) - ABDOMEN/THORAX:  Duplicate tongue

(*) - ABDOMEN/THORAX:  All other abdominal organs appear on each side

H-45

APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL353F (cont'd)

(L) -  SKELETAL/SKULL
(Supraoccipital,Interparietal,Parietals,Frontals,Nasals):  Duplication
or extra bones  

(m) -  SKELETAL/SKULL (Interparietal):  Misshapen

(N) -  SKELETAL/PECTORAL GIRDLE (Clavicle):  Right side of left twin
fused to left side of right twin

(O) -  SKELETAL/PECTORAL GIRDLE (All bones):  Duplication or extra
bones; Bilateral

(P) -  SKELETAL/FORELIMB (All bones ):  Duplication or extra bones

(Q) -  SKELETAL/FOREPAW (All bones):  Duplication or extra bones

(R) -  SKELETAL/STERNEBRAE (All bones):  Duplication or extra bones

(s) -  SKELETAL/STERNEBRAE (Left twin III):  Misshapen

(t) -  SKELETAL/STERNEBRAE (Left twin IV):  Bifid  

(u) -  SKELETAL/STERNEBRAE (Right twin I,IV):  Asymmetric form   

(v) -  SKELETAL/STERNEBRAE (VI):  Misshapen

(W) -  SKELETAL/RIBS (All bones): Duplication or extra bones

(X) -  SKELETAL/RIBS (Right twin T8 left, Left twin T8 right):  Fused;
Left

(y) -  SKELETAL/RIBS  (L1):  Rudimentary; Right

(z) -  SKELETAL/RIBS (Left twin L1):  Rudimentary; Right

(AA) - SKELETAL/VERTEBRAE (All bones):  Duplication or extra bones 

(BB) - SKELETAL/VERTEBRAE (Left twin CE 1-7):  Fused

(cc) - SKELETAL/VERTEBRAE (Left twin T2):  Unossified centra

(DD) - SKELETAL/VERTEBRAE (Left twin T3):  Hemicentra

(ee) - SKELETAL/VERTEBRAE (Left twin T11):  Bifid centra

(FF) - SKELETAL/PELVIC GIRDLE (All bones):  Duplication or extra bones;
Bilateral

(GG) - SKELETAL/HINDLIMB (All bones):  Duplication or extra bones;
Bilateral

(HH) - SKELETAL/HINDPAW (All bones):  Duplication or extra bones;
Bilateral

H-46



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL420F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +              +             +

 3         A         F              +                                   
        +

 4         A         F              +              +             +

 E

 5         A         M              +                                   
        +

 6         A         M              +              +             +

 7         A         M              +                                   
        +

 8C        A         M              +              +             +

 9         A         F              +                                   
        +

10         A         F              +              +             +

11         A         F              +                                   
        +

12         A         F              +              +             +

13         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-47



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL388F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         F              +             +              +

 3         A         M              +                                   
       (a)

 4         A         F              +             +              +

 5         A         F              +                                   
        +

 6         A         F              +             +              +

 7         A         F              +                                   
        +

 8C        A         F              +             +              +

 9         A         F              +                                   
        +

10         A         F              +             +              +

11         A         F              +                                   
        +

12         A         F              +             +              +

13         A         M              +                                   
        +

14         A         F              +             +              +  

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Right

H-48



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL413F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +            +       
            

 2         A         F              +                                   
        (b)

 3         A         M              +              +            +       
          

 4         A         M              +                                   
        (a)

 5         A         M              +              +            +       
          

 6         A         M              +                                   
         +

 7         A         M              +              +            +       
          

 8         A         M              +                                   
         +

 9C        A         F              +              +            +       
          

10         A         F              +                                   
         +

11         A         M              +              +            +       
          

12         A         F              +                                   
         +  

13         A         F              +              +            +       
          

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

(b) - SKELETAL/VERTEBRAE (T11):  Bifid centra

H-49



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL414F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        + 

 2         A         M              +              +             +      
          

 3         A         M              +                                   
        +

 4         A         F              +              +             +      
          

 5         A         M              +                                   
      (a,b)  

 6         A         M              +              +             +      
          

 7         A         M              +                                   
        +

 8         A         F              +              +             +      
          

 9C        A         F              +                                   
        +

10         A         F              +              +             +      
         

11         A         M              +                                   
        +  

12         A         F              +              +             +      
         

 E

 E

13         A         M              +                                   
        +

14         A         F              +              +             +      
                         

15         A         F              +                                   
        + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left

(b) - SKELETAL/VERTEBRAE (L1):  Dumbbell shaped centra

H-50



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL433F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  5     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1*        A         F              +              +           (A)      
             

 2         A         F              +                                   
        (b) 

 3         A         M              +              +            +       
          

 4         A         F              +                                   
        (e) 

 5         A         F              +              +            +       
          

 6         A         M              +                                   
         +

 7         A         F              +              +            +       
          

 8         A         F              +                                   
         +

 9         A         F              +              +            +       
          

10         A         F              +                                   
         +

11C        A         F              +              +            +       
          

12         A         F              +                                   
        (c)   

13         A         M              +              +            +       
          

14         A         F              +                                   
        (c)     

15         A         F              +              +            +       
                     

16         A         F              +                                   
        (d)  

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(A) - ABDOMEN/THORAX:  Enlarged atrial chamber; Right 

(b) - SKELETAL/STERNEBRAE (VI):  Misshapen

(c) - SKELETAL/RIBS (L1):  Rudimentary; Left

(d) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

(e) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

H-51



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL441F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +              +      
        

 2         A         M              +                                   
       (a)    

 3         A         M              +             +              +      
        

 E

 4         A         F              +                                   
        + 

 5         A         M              +             +              +      
          

 6         A         F              +                                   
        +

 7         A         M              +             +              +      
          

 8         A         M              +                                   
        + 

 9C        A         M              +             +              +      
          

10         A         M              +                                   
       (b)  

11         A         F              +             +              +      
          

12         A         F              +                                   
        + 

13         A         F              +             +              +      
         

14         A         M              +                                   
        + 

15         A         F              +             +              + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (VI):  Advanced

(b) - SKELETAL/STERNEBRAE (IV):  Asymmetric form

H-52



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL457F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +              +      
          

 2         A         F              +                                   
        (a)  

 3         A         M              +             +              +      
          

 4         A         M              +                                   
        (b) 

 5         A         F              +             +              +      
          

 6         A         M              +                                   
         +

 7         A         M              +             +              +      
         

 8C        A         M              +                                   
         +  

 9         A         M              +             +              +      
          

10         A         F              +                                   
        (a) 

 E

11         A         F              +             +              +      
                         

12         A         F              +                                   
         + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Left

(b) - SKELETAL/RIBS (L1): Rudimentary; Right

H-53



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL466F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +              +              +

 3         A         M              +                                   
        +

 4         A         M              +              +              +

 5         A         F              +                                   
        +

 6         A         M              +              +              +

 7C        A         F              +                                   
        +

 8         A         F              +              +              +

 9         A         F              +                                   
        +

10         A         F              +              +              +

11         A         M              +                                   
       (a) 

 E

12         A         M              +              +              +

13         A         M              +                                   
        +

14         A         F              +              +              +

15         A         M              +                                   
        +

16         A         F              +              +              +   

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Right

H-54



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL475F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1C        A         F              +             +              +

 2         A         F              +                                   
       (a,b)

 3         A         M              +             +              +

 4         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(b) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

H-55



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    2000 MG/M3

ANIMAL NUMBER:  IGL488F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
         +

 2         A         F              +              +              +

 3C        A         F              +                                   
         +

 4         A         M              +              +              +

 5         A         M              +                                   
         +

 6         A         F              +              +              +

 7         A         M              +                                   
         +

 8         A         F              +              +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-56



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL432F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         M              +             +                +    
           

 3         A         F              +                                   
        +

 4         A         M              +             +                +    
           

 5         A         F              +                                   
       (b)  

 6         A         F              +             +                +    
           

 7         A         M              +                                   
        +

 8         A         M              +             +                +    
         

 9C        A         M              +                                   
        +

10         A         M              +             +                +    
         

11         A         M              +                                   
        +

12         A         F              +             +                +    
         

13         A         M              +                                   
        +

14         A         F              +             +               (A)   
            

15         A         F              +                                   
        +

16         A         M              +             +                + 

17         A         F              +                                   
       (c)     

18         A         M              +             +                + 

19         A         M              +                                   
        + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(A) - ABDOMEN/THORAX:  Elongated innominate artery

(b) - SKELETAL/SKULL (Squamosal Process):  Hypoplastic; Left

(c) - SKELETAL/RIBS (L1):  Rudimentary; Right

H-57



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  2000 MG/M3

ANIMAL NUMBER:  IGL477F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  1     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +                 (a)

 2         A         F              +                                   
         +

 3         A         F              +             +                  +

 4         A         M              +                                   
         +

 5C        A         F              +             +                  +

 6         A         F              +                                   
       (d,e)  

 7         A         M              +             +                  +

 8         A         F              +                                   
         +

 9         A         M              +             +                (B,C)


10         A         M              +                                   
         +

11         A         F              +             +                  +

12         A         F              +                                   
         +

13         A         F              +             +                  +

14         A         M              +                                   
         +

15         A         M              +             +                  + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - ABDOMEN/THORAX:  Misshapen spleen

(B) - ABDOMEN/THORAX:  Hydroureter; Left

(C) - ABDOMEN/THORAX:  Hydronephrosis; Left 

(d) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(e) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

H-58



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL379F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +              +             +

 2         A         F              +                                   
       (a) 

 3         A         M              +              +             +

 4C        A         F              +                                   
        +

 5         A         M              +              +             +

 6         A         F              +                                   
       (a)

 7         A         M              +              +             +

 8         A         F              +                                   
       (b)

 9         A         M              +              +             +

10         A         M              +                                   
        +

11         A         M              +              +             +

12         A         F              +                                   
        +

13         A         F              +              +             +

14         A         M              +                                   
        +

15         A         F              +              +             +

16         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left   

(b) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral  

H-59



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL389F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +             +               +

 2         A         F              +                                   
         +

 3         A         F              +             +               +

 4         A         F              +                                   
         +

 5         A         M              +             +               +

 6         A         F              +                                   
         +

 7         A         M              +             +               +

 8         A         M              +                                   
         +

 9C        A         M              +             +               +

10         A         M              +                                   
         +

11         A         M              +             +               +

12         A         M              +                                   
         +

13         A         M              +             +               +

14         A         F              +                                   
         +

15         A         F              +             +               +

16         A         M              +                                   
         +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-60



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL391F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +              +              +

 2         A         M              +                                   
        +

 3         A         F              +              +              +

 E

 4         A         M              +                                   
        +

 5         A         F              +              +              +

 E

 6         A         M              +                                   
        +

 7C        A         F              +              +              +

 8         A         M              +                                   
        +

 9         A         M              +              +              +

10         A         M              +                                   
        +

11         A         M              +              +              +

12         A         F              +                                   
        +

13         A         F              +              +              + 

14         A         F              +                                   
       (a) 

15         A         F              +              +              + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (V):  Unossified

H-61



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL352F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         F              +             +             +       
         

 3         A         M              +                                   
       (b) 

 4         A         F              +             +             +       
          

 5         A         F              +                                   
        + 

 6         A         F              +             +             +       
          

 7C        A         M              +                                   
        +

 8         A         F              +             +             +       
        

 9         A         M              +                                   
       (a) 

 E

10         A         F              +             +             +       
          

11         A         M              +                                   
        + 

12         A         M              +             +             +       
        

13         A         F              +                                   
        +

14         A         M              +             +             + 

 E       

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/SKULL (Tympanics):  Hypoplastic

(b) - SKELETAL/RIBS (L1):  Rudimentary; Left

H-62



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL355F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  7     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +             +      
         

 2         A         M              +                                   
      (c,e,f)   

 3         A         M              +              +             +      
         

 4         A         F              +                                   
        (c) 

 5         A         F              +              +             +      
          

 6         A         M              +                                   
    (a,d,g,h,i)   

 7         A         M              +              +             +      
         

 8         A         F              +                                   
        (c)        

 9C        A         F              +              +             +      
         

10*        A         M              +                                   
        (a) 

11         A         F              +              +             +      
          

12         A         F              +                                   
        (a)     

13         A         M              +              +             +      
          

14         A         M              +                                   
         +   

15         A         F              +              +             +

16         A         F              +                                   
        (b)

17         A         M              +              +             +  

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(a) - SKELETAL/STERNEBRAE (V):  Unossified

(b) - SKELETAL/STERNEBRAE (III-IV):  Asymmetric form

(c) - SKELETAL/RIBS (L1):  Rudimentary; Left

(d) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

(e) - SKELETAL/VERTEBRAE (T13):  Bifid centra

(f) - SKELETAL/VERTEBRAE (T13 Anlage):  Dumbbell shaped centra

(g) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(h) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

(i) - SKELETAL/VERTEBRAE (L1):  Misshapen centra

H-63



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL417F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +             +            +

 2         A         M              +                                   
        (a) 

 3         A         M              +             +            +

 4         A         F              +                                   
        (b)

 5         A         F              +             +            +

 6         A         M              +                                   
         +

 7C        A         M              +             +            +

 8         A         M              +                                   
         +

 9         A         M              +             +            +

10         A         M              +                                   
         +

11         A         M              +             +            +

12         A         F              +                                   
         +

13         A         M              +             +            +

14         A         F              +                                   
         +

15         A         F              +             +            +

16         A         M              +                                   
         +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Bilateral

(b) - SKELETAL/RIBS (L1): Rudimentary; Left

H-64



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL378F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 L

 1         A         M              +                                   
       (a)

 2         A         M              +             +              +

 3         A         F              +                                   
        +

 4         A         F              +             +              +

 5         A         M              +                                   
        +

 6         A         F              +             +              +

 7C        A         F              +                                   
        +

 8         A         M              +             +              +

 9         A         M              +                                   
        +

10         A         M              +             +              +

11         A         M              +                                   
        +

12         A         M              +             +              +

 E

13         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Right

H-65



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL380F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
         +

 2         A         M              +             +                +

 3         A         F              +                                   
         +

 4         A         M              +             +                +

 5         A         M              +                                   
        (a)

 6         A         M              +             +                +

 7C        A         F              +                                   
         +

 8         A         M              +             +                +

 9         A         F              +                                   
         +

10         A         M              +             +                +

11         A         M              +                                   
         +

12         A         F              +             +                +

13         A         M              +                                   
         +

14         A         M              +             +                +

15         A         F              +                                   
        (a)

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

- SKELETAL/STERNEBRAE (VI): Advanced

H-66



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL348F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +             +             +

 E

 3         A         F              +                                   
        +

 4         A         M              +             +             +

 5         A         M              +                                   
        +

 6         A         M              +             +             +

 7         A         M              +                                   
        +

 8         A         F              +             +             +

 9C        A         M              +                                   
        +

10         A         M              +            (A)            +

11         A         M              +                                   
       (b)

12         A         M              +             +             +

13         A         F              +                                   
        +

14         A         F              +             +             +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:  Fetus numbers 3 and 5 found with identification tags detached,
numbers 

      arbitrarily assigned for skeletal exams

(A) - HEAD:  Retinal fold; Right

(b) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

H-67



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL430F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +              +              +

 3         A         F              +                                   
        +

 4C        A         M              +              +              +

 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-68



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL409F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +             +

 2         A         F              +                                   
        +

 3         A         F              +              +             +

 4         A         F              +                                   
        +

 5         A         F              +              +             +

 6         A         M              +                                   
        +

 7         A         F              +              +             +

 8C        A         F              +                                   
        +

 9         A         F              +              +             +

10         A         F              +                                   
        +

11         A         M              +              +             +

12         A         F              +                                   
        +

13         A         F              +              +             +

14         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-69



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL421F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +             +               +     
          

 2         A         F              +                                   
        + 

 3         A         M              +             +               +     
        

 4C        A         F              +                                   
        +

 5         A         F              +             +               +     
          

 6         A         F              +                                   
        +

 7         A         F              +             +               +     
         

 E

 8         A         F              +                                   
        + 

 9         A         M              +             +               +     
          

10         A         F              +                                   
        +

11         A         M              +             +               +     
                         

12         A         F              +                                   
        + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-70



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL423F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +              +              +

 2         A         M              +                                   
         +

 3         A         F              +              +              +

 4         A         F              +                                   
         +

 5         A         M              +              +              +

 6         A         M              +                                   
         +

 7         A         F              +              +              +

 8         A         F              +                                   
         +

 9         A         F              +              +              +

10         A         F              +                                   
         +

 EC

11         A         M              +              +              +

12         A         F              +                                   
         +

13         A         F              +              +              +

14         A         F              +                                   
         +

15         A         M              +              +              +

16         A         F              +                                   
         +

17         A         M              +              +              + 

18         A         F              +                                   
         +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-71



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL440F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +              +              +     
         

 3C        A         M              +                                   
        +

 4         A         M              +              +              +     
         

 5         A         F              +                                   
       (a)

 6         A         M              +              +              +     
   

 7         A         M              +                                   
        + 

 8         A         F              +              +              +     
                        

 9         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Left

H-72



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL399F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +              +

 2         A         M              +                                   
        +

 3         A         M              +              +              +

 4         A         F              +                                   
      (b,c)  

 5         A         M              +              +              +

 6         A         F              +                                   
      (d,e)  

 7C        A         F              +              +              +

 8         A         M              +                                   
        +

 9         A         M              +              +              +

10         A         M              +                                   
        +

11         A         F              +              +              +

12         A         F              +                                   
       (a) 

13         A         M              +              +              +

14         A         M              +                                   
        +

15         A         M              +              +              +

16         A         F              +                                   
        +

17         A         M              +              +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (VI):  Misshapen

(b) - SKELETAL/VERTEBRAE (T12):  Bifid centra

(c) - SKELETAL/VERTEBRAE (T12 Anlage):  Dumbbell shaped centra   

(d) - SKELETAL/VERTEBRAE (T11-12):  Bifid centra

(e) - SKELETAL/VERTEBRAE (T11-12 Anlage):  Dumbbell shaped centra

H-73



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL452F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
         +   

 2         A         M              +              +             +      
          

 3         A         F              +                                   
         +

 4         A         M              +              +             +      
          

 5         A         M              +                                   
        (a) 

 6C        A         F              +              +             +      
          

 7         A         M              +                                   
        (b)

 8         A         M              +              +             +      
        

 9         A         M              +                                   
         + 

 E

10         A         F              +              +             +      
          

11         A         F              +                                   
         + 

12         A         F              +              +             +      
          

13         A         F              +                                   
         +

14         A         F              +              +             +    

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (VI):  Misshapen

(b) - SKELETAL/RIBS (L1): Rudimentary; Left

H-74



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL436F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +              +             +

 3         A         M              +                                   
        +

 4         A         M              +              +             +

 5         A         M              +                                   
        +

 6         A         F              +              +             +

 EC

 7         A         F              +                                   
        +

 8         A         M              +              +             +

 9         A         M              +                                   
     (a,b,c)    

10         A         M              +              +             +

11         A         M              +                                   
        +

12         A         F              +              +             +

13         A         M              +                                   
        +

14         A         M              +              +             + 

15         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (V): Unossified

(b) - SKELETAL/VERTEBRAE (T8): Dumbell centra

(c) - SKELETAL/VERTEBRAE (T8 Anlage): Dumbbell shaped centra

H-75



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL454F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  4     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
       (a)  

 2         A         M              +             +               +

 3         A         M              +                                   
       (b)  

 E

 4         A         F              +             +               +

 5         A         F              +                                   
        +

 6         A         F              +             +               +

 7         A         F              +                                   
       (a) 

 8C        A         F              +             +               +

 9         A         F              +                                   
       (c) 

 E

10         A         F              +             +               +

11         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS: (L1):  Rudimentary; Left

(b) - SKELETAL/RIBS: (L1):  Rudimentary; Bilateral

(c) - SKELETAL/VERTEBRAE (T12 Anlage):  Dumbbell shaped centra

H-76



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL461F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  1     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +            +       
                      

 2         A         F              +                                   
         +

 3         A         M              +              +            +       
         

 4         A         M              +                                   
         +

 5         A         M              +              +            +       
          

 6C        A         F              +                                   
        (b) 

 7         A         F              +              +            +       
          

 8         A         M              +                                   
        (c)   

 9         A         F              +              +           (a)      
            

10         A         M              +                                   
         +

11         A         M              +              +            +   

                           

 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder

(b) - SKELETAL/FOREPAW (Metacarpal 1 anlage):  Misshapen; Left

(c) - SKELETAL/RIBS (L1):  Rudimentary; Left  

H-77



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL469F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 C1        A         F              +              +              +

 2         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-78



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL470F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  4     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
      (b,c)    

 2         A         M              +             +             +

 3         A         F              +                                   
        +

 4         A         M              +             +             +

 5         A         M              +                                   
        +

 6         A         M              +             +             +

 7         A         M              +                                   
     (d,e,f) 

 8         A         M              +             +             +

 9         A         M              +                                   
        +

10         A         M              +             +             +

11         A         F              +                                   
        +

12C        A         M              +             +             +

13         A         F              +                                   
       (g) 

14         A         M              +             +             +

15         A         F              +                                   
        +

16         A         M              +             +             +

17         A         M              +                                   
      (a,h)    

18         A         F              +             +             +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left

(b) - SKELETAL/VERTEBRAE (T10):  Bifid centra

(c) - SKELETAL/VERTEBRAE (T10 Anlage):  Dumbbell shaped centra

(d) - SKELETAL/VERTEBRAE (T8):  Dumbbell shaped centra

(e) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(f) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra

(g) - SKELETAL/VERTEBRAE (T10-11 Anlage):  Dumbbell shaped centra

				(h) - SKELETAL/VERTEBRAE (L1):  Dumbbell shaped centra 

H-79



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  10000 MG/M3

ANIMAL NUMBER:  IGL473F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +               +

 2         A         M              +                                   
        +

 3         A         M              +              +               +

 E

 4         A         F              +                                   
       (a) 

 5         A         F              +              +               +

 6         A         F              +                                   
        +

 7C        A         M              +              +               +

 8         A         F              +                                   
        +

 9         A         F              +              +               +

10         A         F              +                                   
        +

11         A         M              +              +               +

12         A         M              +                                   
       (b) 

13         A         M              +              +               +

14         A         F              +                                   
        +

15         A         M              +              +               +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:   

(a) - SKELETAL/RIBS (L1): Rudimentary; Left

(b) - SKELETAL/RIBS (L1): Rudimentary; Bilateral

H-80



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL407F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  2     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +               + 

 2         A         F              +                                   
        +

 3         A         F              +              +               +

 4         A         M              +                                   
       (c) 

 5         A         M              +              +              (a)

 6         A         M              +                                   
        +

 7         A         M              +              +               +

 8         A         F              +                                   
        +

 9         A         F              +              +               +

10         A         F              +                                   
       (b) 

11C        A         F              +              +              (a)

12         A         F              +                                   
        +

13         A         F              +              +               +

14         A         F              +                                   
        +

15         A         M              +              +               + 

16         A         M              +                                   
       (c)   

 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder

(b) - SKELETAL/STERNEBRAE (VI):  Hypoplastic

(c) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

H-81



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    10000 MG/M3

ANIMAL NUMBER:  IGL442F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  1

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
         +

 2         A         F              +             +                +

 3         A         F              +                                   
         +

 4         A         F              +             +                +

 5C        A         M              +                                   
         +

 6         A         M              +             +                +

 7         A         F              +                                   
         +

 8         A         F              +             +                +

 9         A         F              +                                   
         +

10         A         M              +             +                +

11         A         F              +                                   
       (a,B)

12         A         M              +             +                +

13         A         F              +                                   
         +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (T13):  Short last rib; Right

(B) - SKELETAL/VERTEBRAE (L): One less presacral vertebrae

H-82



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL364F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
         +

 2         A         M              +             +               +

 3         A         M              +                                   
         +

 4         A         F              +             +               +

 5         A         F              +                                   
         +

 6C        A         M              +             +               +

 7         A         M              +                                   
        (a)

 8         A         M              +             +               +

 9         A         M              +                                   
         + 

10         A         M              +             +               +

11         A         F              +                                   
         +

12         A         M              +             +               +

13         A         F              +                                   
         +

14         A         M              +             +               +

15         A         F              +                                   
        (a)      

16         A         M              +             +               + 

17         A         F              +                                   
        (b)   

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left

(b) - SKELETAL/RIBS (L1):  Rudimentary; Bilateral

H-83



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL367F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +             +              +      
        

 2         A         M              +                                   
         +

 3         A         M              +             +              +      
          

 4         A         M              +                                   
         +  

 5         A         M              +             +              +      
         

 6         A         M              +                                   
         +

 7         A         F              +             +              +      
        

 8C        A         M              +                                   
        (a)  

 9         A         F              +             +              +      
        

10         A         M              +                                   
         + 

11         A         F              +             +              +      
           

12         A         M              +                                   
        (b) 

13         A         F              +             +              +      
         

14         A         M              +                                   
         + 

15         A         M              +             +              +      
                     

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (V):  Unossified

(b) - SKELETAL/RIBS (L1):  Rudimentary; Left

H-84



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL368F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         M              +             +            +

 3         A         M              +                                   
        +

 4         A         F              +             +            +

 5         A         M              +                                   
        +

 6*        A         M              +             +            +

 7         A         M              +                                   
        +

 8C        A         F              +             +            +

 9         A         M              +                                   
        +

10         A         M              +             +            +

11         A         M              +                                   
        +

12         A         M              +             +            +

13         A         F              +                                   
       (a)  

14         A         F              +             +            + 

15         A         M              +                                   
        +  

16         A         F              +             +            + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(a) - SKELETAL/VERTEBRAE (T9):  Dumbbell shaped centra

H-85



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL375F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 L

 1         A         F              +             +             +

 2         A         M              +                                   
        +

 3         A         M              +             +             +

 4         A         F              +                                   
       (c) 

 5         A         F              +             +             +

 6         A         M              +                                   
        +

 7         A         M              +             +             +

 8C*       A         M              +                                   
      (a,b) 

 9         A         M              +             +             +

10         A         M              +                                   
        +

11         A         M              +             +             +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(a) - SKELETAL/STERNEBRAE (V):  Unossified

(b) - SKELETAL/STERNEBRAE (VI): Misshapen

(c) - SKELETAL/RIBS (L1):  Rudimentary; Right

H-86



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL363F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +              +              +

 2         A         M              +                                   
        +

 3         A         M              +              +              +

 4C        A         M              +                                   
       (a)

 5         A         M              +              +              +

 6         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Right

H-87



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL373F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +              +

 2         A         F              +                                   
      (a,b)  

 3         A         M              +             +              +

 E

 4         A         F              +                                   
        +

 5         A         F              +             +              +

 6         A         F              +                                   
        +

 7         A         F              +             +              +

 8C        A         M              +                                   
        +

 9         A         F              +             +              +

10         A         M              +                                   
        +

11         A         F              +             +              +

12         A         F              +                                   
        +

13         A         M              +             +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(b) - SKELETAL/VERTEBRAE (T6):  Dumbbell shaped centra

H-88



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL397F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +              +

 2         A         M              +                                   
        +

 3         A         M              +              +              +

 4         A         M              +                                   
        +

 5         A         F              +              +              +

 6         A         F              +                                   
        +

 7         A         M              +              +              +

 8         A         M              +                                   
        +

 9         A         F              +              +              +

10         A         M              +                                   
        +

11C        A         F              +              +              +

12         A         M              +                                   
        +

13         A         F              +              +              +

14         A         F              +                                   
       (a)

15         A         M              +              +              +

16         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

- SKELETAL/RIBS (L1): Rudimentary; Left

H-89



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL357F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  5     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1*        D         F              +              +             +      
           

 2         A         F              +                                   
        + 

 3*        A         M              +              +             +      
           

 4*        A         F              +                                   
      (a,b)   

 5         A         F              +              +             +      
           

 6         A         F              +                                   
       (c)  

 7         A         M              +              +             +      
          

 8         A         F              +                                   
        + 

 9         A         F              +              +             +      
          

10         A         M              +                                   
      (c,d)   

11         A         M              +              +             +      
          

12C        A         M              +                                   
      (d,e)   

13         A         F              +              +             +      
          

14         A         M              +                                   
        +

15*        A         F              +              +             +      
                       

16*        A         F              +                                   
      (c,e)  

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(a) - SKELETAL/STERNEBRAE (II-IV):  Dumbbell-shaped 

(b) - SKELETAL/STERNEBRAE (V-VI):   Unossified

(c) - SKELETAL/STERNEBRAE (V):  Unossified

(d) - SKELETAL/STERNEBRAE (VI):  Asymmetric form

(e) - SKELETAL/STERNEBRAE (IV):  Dumbbell-shaped

H-90



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL369F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +               +

 2         A         M              +                                   
       (a)

 3         A         F              +             +               + 

 4         A         M              +                                   
        +

 E

 5C        A         F              +             +               + 

 6         A         M              +                                   
        + 

 7         A         M              +             +               +

 8         A         F              +                                   
       (c)

 9         A         F              +             +               + 

10         A         F              +                                   
        +

11         A         F              +             +               + 

12         A         F              +                                   
       (b)

13         A         M              +             +               +   

14         A         F              +                                   
        + 

 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (V):  Unossified

(b) - SKELETAL/STERNEBRAE (VI):  Misshapen

(c) - SKELETAL/RIBS (L1):  Rudimentary; Right

H-91



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL404F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1        A          M              +                                   
        +

 2        A          F              +             +             +

 3        A          F              +                                   
        + 

 4        A          M              +             +             +

 5        A          M              +                                   
        +

 6C       A          F              +             +             +

 7        A          F              +                                   
        +

 8        A          F              +             +             +

 9        A          M              +                                   
        +

10        A          M              +             +             +

11        A          F              +                                   
        +

12        A          F              +             +             +

13        A          F              +                                   
        +

14        A          F              +             +             +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-92



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL365F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +             +               +

 2         A         M              +                                   
        +

 3         A         M              +             +               +

 4         A         M              +                                   
        +

 5         A         F              +             +               +

 6         A         F              +                                   
        +

 E

 7C        A         M              +             +               +

 8         A         F              +                                   
        +

 9         A         M              +             +               +

10         A         F              +                                   
        +

11         A         M              +             +               +

12         A         M              +                                   
        +

13         A         F              +             +               +

14         A         M              +                                   
        +

15         A         F              +             +               +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-93



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL366F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1*        A         F              +                                   
      (b,c,d,e)

 2         A         M              +             +                 +

 3         A         F              +                                   
         +

 4         A         F              +            (A)                +

 5         A         M              +                                   
         +

 6         A         M              +             +                 +

 7C        A         M              +                                   
         +

 8         A         F              +             +                 +

 9         A         F              +                                   
         +

10         A         M              +             +                 +

11         A         M              +                                   
         +

12         A         F              +             +                 +

13         A         F              +                                   
         +

14         A         M              +             +                 +

15         A         M              +                                   
         +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

(A) - HEAD:  Open eye; Right

(b) - SKELETAL/STERNEBRAE (II,III,VI):  Hypoplastic

(c) - SKELETAL/STERNEBRAE (V):  Unossified

(d) - SKELETAL/STERNEBRAE (IV):  Bifid 

(e) - SKELETAL/RIBS (L1):  Rudimentary; Left 

H-94



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL372F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  4     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         F              +             +              +

 3         A         M              +                                   
       (a)

 4         A         M              +             +              +

 5         A         M              +                                   
       (b)

 6         A         M              +             +              +

 7         A         M              +                                   
        +

 8C        A         M              +             +              +

 9         A         F              +                                   
        +

10         A         F              +             +              +

11         A         M              +                                   
       (a)

 E

12         A         F              +             +              +

13         A         M              +                                   
       (a)

14         A         M              +             +              +

15         A         M              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Right

(b) - SKELETAL/RIBS (L1):  Rudimentary; Left

H-95



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL396F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
        +

 2         A         M              +              +              +

 3         A         F              +                                   
        +

 4         A         F              +              +              +

 5         A         F              +                                   
        +

 6C        A         M              +              +              +

 7         A         F              +                                   
        +

 8         A         F              +              +              +

 9         A         F              +                                   
        +

10         A         F              +              +              +

11         A         M              +                                   
        +

12         A         F              +              +              +

13         A         M              +                                   
        +

14         A         M              +              +              +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-96



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL371F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +               +     
          

 2         A         F              +                                   
         +

 3         A         M              +             +               +     
          

 4         A         M              +                                   
        (a)  

 5         A         F              +             +               +     
          

 6         A         M              +                                   
         + 

 7         A         F              +             +               +     
          

 8         A         M              +                                   
        (b)   

 EC

 9         A         F              +             +               +     
          

10         A         M              +                                   
         +

11         A         F              +             +               +     
          

12         A         F              +                                   
         +

13         A         M              +             +               +     
                         

14         A         F              +                                   
         + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left 

(b) - SKELETAL/RIBS (L1):  Rudimentary; Right 

H-97



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL410F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  4     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         M              +                                   
       (b) 

 2         A         M              +             +              +

 3         A         F              +                                   
       (c) 

 4         A         F              +             +              +

 5         A         F              +                                   
      (a,d)

 6         A         F              +             +              +

 7         A         F              +                                   
        +

 8C        A         M              +             +              +

 9         A         F              +                                   
        +

10         A         M              +             +              +

11         A         M              +                                   
    (c,e,f,g)  

12         A         F              +             +              +

13         A         F              +                                   
        +

14         A         F              +             +              +  

15         A         M              +                                   
        + 

 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (VI):  Misshapen

(b) - SKELETAL/RIBS (L1): Rudimentary; Bilateral

(c) - SKELETAL/RIBS (L1): Rudimentary; Right

(d) - SKELETAL/RIBS (L1): Rudimentary; Left

(e) - SKELETAL/RIBS (L1): Well-formed; Left

(f) - SKELETAL/VERTEBRAE (T12):  Bifid centra

(g) - SKELETAL/VERTEBRAE (T12 Anlage):  Dumbbell shaped centra

H-98



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL415F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  1

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +              +      
        

 2         A         M              +                                   
        +

 3         A         M              +             +              +      
        

 4         A         F              +                                   
        +

 5         A         F              +             +              +      
          

 6         A         F              +                                   
        +

 7         A         M              +             +              +      
          

 8C        A         F              +                                   
        +

 9         A         M              +             +              +      
          

10         A         M              +                                   
        + 

11         A         M              +             +             (A)     
         

12         A         F              +                                   
        + 

13         A         M              +             +              +      
         

14         A         M              +                                   
        +

15         A         M              +             +              +      
                           

16         A         F              +                                   
        +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

                                (A) - ABDOMEN/THORAX:  Umbilical artery
aneurysm 

			

H-99



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL444F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  3     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
        +

 2         A         M              +              +              +     
          

 3         A         F              +                                   
        +

 4         A         M              +              +              +     
          

 5         A         M              +                                   
        +

 6         A         F              +              +              +     
          

 7C        A         M              +                                   
     (a,c,d)    

 8         A         F              +              +              +     
         

 9         A         M              +                                   
        +

10         A         F              +              +              +     
          

11         A         F              +                                   
       (b)  

12         A         F              +              +              +     
          

13         A         F              +                                   
       (b)  

14         A         F              +              +              +     
                      

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (V):  Misshapen

(b) - SKELETAL/RIBS (L1):  Rudimentary; Left

(c) - SKELETAL/VERTEBRAE (T11):  Bifid centra

(d) - SKELETAL/VERTEBRAE (T11 Anlage):  Dumbbell shaped centra 

H-100



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL449F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +             +             +

 2         A         M              +                                   
        +

 3         A         F              +             +             +

 4         A         F              +                                   
        +

 5         A         F              +             +             +

 6         A         F              +                                   
        +

 7         A         M              +             +             +

 8         A         M              +                                   
       (a) 

 9         A         F              +             +             +

10C        A         F              +                                   
        +

11         A         F              +             +             +

12         A         M              +                                   
       (b) 

13         A         M              +             +             +

14         A         M              +                                   
        +

15         A         M              +             +             +

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1):  Rudimentary; Left

(b) - SKELETAL/VERTEBRAE (CE3 Anlage):  Bifid centra

H-101



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL458F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1        A          F              +                                   
        +

 2        A          M              +              +            +

 3        A          M              +                                   
        +

 4        A          F              +              +            +

 5C       A          F              +                                   
        +

 6        A          M              +              +            +

 7        A          M              +                                   
        +

 8        A          F              +              +            +

 9        A          F              +                                   
        +

10        A          M              +              +            +

11        A          M              +                                   
        +

12        A          F              +              +            +

13        A          F              +                                   
        +

14        A          F              +              +            + 

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

H-102



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL471F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  0     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +              +     
           

 2         A         F              +                                   
        +

 3         A         M              +              +              +     
           

 4         A         F              +                                   
        +

 5         A         F              +              +              +     
           

 6C        A         M              +                                   
        +

 7         A         F              +              +              +     
           

 8         A         M              +                                   
        +

 9         A         F              +              +              +     
           

10*        A         F              +                                   
        +

11         A         M              +              +              +     
                         

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

 *  - Stunted

H-103



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:  20000 MG/M3

ANIMAL NUMBER:  IGL424F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  4     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
       (a) 

 2         A         F              +             +              +

 3         A         M              +                                   
       (b) 

 E

 4         A         M              +             +              +

 5         A         M              +                                   
      (c,d) 

 6         A         F              +             +              +

 7C        A         M              +                                   
        +

 8         A         M              +             +              +

 9         A         M              +                                   
        +

10         A         M              +             +              +

11         A         F              +                                   
        +

12         A         M              +             +              +

13         A         F              +                                   
        +

14         A         F              +             +              +  

15         A         F              +                                   
       (a) 

   

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/STERNEBRAE (V):  Unossified

(b) - SKELETAL/STERNEBRAE (VI):  Misshapen

(c) - SKELETAL/VERTEBRAE (T10): Bifid centra

(d) - SKELETAL/VERTEBRAE (T10 Anlage): Dumbbell shaped centra

H-104



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL428F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  2     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +                                   
       (a)

 2         A         M              +              +              +

 3         A         M              +                                   
        +

 4         A         F              +              +              +

 5         A         M              +                                   
        +

 6         A         M              +              +              +

 7         A         F              +                                   
       (a) 

 8         A         F              +              +              +

 EC

 9         A         F              +                                   
        +

10         A         F              +              +              +

11         A         F              +                                   
        +

12         A         F              +              +              +

13         A         M              +                                   
        +

14         A         M              +              +              +

15         A         F              +                                   
        +

16         A         F              +              +              +   

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/RIBS (L1): Rudimentary; Left

H-105



APPENDIX H - INDIVIDUAL FETAL OBSERVATIONS

(ABBREVIATIONS PRESENTED BELOW OBSERVATIONS)

TARGET DOSE:    20000 MG/M3

ANIMAL NUMBER:  IGL439F

NUMBER OF FETUSES WITH EXTERNAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH VISCERAL VARIATIONS:  0     MALFORMATIONS:  0

NUMBER OF FETUSES WITH SKELETAL VARIATIONS:  1     MALFORMATIONS:  0

FETUS | STATUS |    SEX    |     EXTERNAL     |          VISCERAL       
  |  SKELETAL  |

 NO.  |        |           |                  |  HEAD  |  
ABDOMEN/THORAX  |            |

------|--------|-----------|------------------|--------|----------------
---|------------|

 1         A         F              +              +             +

 2         A         F              +                                   
        +

 3         A         M              +              +             +

 4         A         F              +                                   
        +

 5         A         M              +              +             +

 6         A         F              +                                   
       (a)

 7         A         M              +              +             +

 8         A         M              +                                   
        +

 9C        A         F              +              +             +

10         A         M              +                                   
        +

11         A         F              +              +             +

12         A         M              +                                   
        +

13         A         M              +              +             +

14         A         M              +                                   
        +

15         A         M              +              +             +

16         A         F              +                                   
        +  

A = ALIVE      M = MALE      E = EARLY RESORPTION      C = CERVIX

D = DEAD       F = FEMALE    L = LATE RESORPTION       + = NO OBSERVABLE
ABNORMALITIES

NOTE:

(a) - SKELETAL/VERTEBRAE (T11): Bifid centra

H-106

APPENDIX I  -  INHALATION EXPOSURE DATA

TABLE OF CONTENTS

EXPOSURE CHAMBERS 		I-2

TEST ATMOSPHERE GENERATION		I-2

CHAMBER ENVIRONMENTAL CONDITIONS		I-2

ANALYTICAL PROCEDURES 		I-3

CHAMBER HOMOGENEITY 		I-4

LIGHTING, NOISE, AND OXYGEN LEVELS		I-4

PARTICLE SIZE ANALYSIS		I-4

LIST OF FIGURES

Figure		Page

FIGURE I-1.  Schematic of generation and exposure system		I-5

FIGURE I-2.  Schematic of analytical calibration system		I-6

FIGURE I-3.  Analytical calibration response curves		I-9

LIST OF TABLES

Table		Page

TABLE I-1.  Mean exposure data		I-7

TABLE I-2.  Gas chromatograph operating conditions		I-8

TABLE I-3.  Summary of exposure data		I-10

TABLE I-4.  Summary of chamber distribution sampling		I-19

TABLE I-5.  Lighting, noise, and oxygen levels		I-20

TABLE I-6.  Particle size data		I-21

TABLE I-7.  Chamber temperatures and humidities		I-23

I-1

APPENDIX I  -  INHALATION EXPOSURE DATA

Exposure Chambers

   

The chambers used in this study were constructed of stainless steel and
glass and had a total volume of approximately 1.0 m3.  They were
operated at an airflow rate of 200 liters per minute ensuring 12 air
changes per hour and a theoretical equilibration time (T99) of 23
minutes.  The chamber volume and airflow were considered adequate to
ensure an oxygen level greater than 19% and an animal loading below 5%. 
The chamber airflow rate was monitored continuously with a calibrated
flow-limiting orifice and differential pressure gauge and recorded
approximately every 30 minutes.  All of the chambers were maintained at
a slight negative pressure to the room.

Test Atmosphere Generation

      

Figure I-1 presents a schematic of the test atmosphere generation and
exposure system.

Aliquots of the test substance for use in the daily conduct of the study
were received in gas cylinders (~20 L nominal volume) via a specially
constructed distribution manifold.  A manifold system maintained the
test substance under nitrogen pressure,  ensuring that the transferred
substance remained in liquid phase and retained the same composition as
the original container.  

The test substance was delivered via a diptube from the outlet valve of
the cylinder to a variable area rotameter which regulated the rate of
liquid flow into a heated glass round-bottom flask.  The test substance
volatilized within the flask and the resulting vapors mixed with the
supply air as they were drawn into the exposure chamber.  

Chamber Environmental Conditions

Chamber temperature and humidity were monitored by wet/dry bulb
hygrometers and recorded at approximately thirty minute intervals
throughout each exposure.

I-2

APPENDIX I  -  INHALATION EXPOSURE DATA 

Analytical Procedures

Schematic of the analytical calibration system: Figure I-2.

Analytical calibration response curve: Figure I-3

Mean exposure data: Table I-1

Gas chromatograph operating conditions: Table I-2

Summary of exposure data: Table I-3

Exposure concentrations were determined on both a nominal and analytical
basis.  Nominal concentrations for each exposure level were calculated
by weighing the tank containing the test substance before and after
exposure and dividing the net loss in weight by the total volume of air
passing through the chamber during the exposure.

Analytical exposure concentrations were determined hourly during each
exposure by on-line gas chromatography (Hewlett Packard 6890).  Samples
of the chamber atmosphere were continuously delivered to the GC via
1/8” teflon tubing connected to an automated 12-port multiposition gas
sampling valve.  The multiposition valve was programmed to sequentially
direct each stream to a sample loop which injected a fixed sample volume
(2 cc) directly onto the column for analysis.  A complete sampling cycle
was performed during each hour of exposure. 

The analytical system was calibrated against a series of known
concentrations of the test substance in air.  The air concentrations
were determined by injecting a weighed amount of the test substance from
a gas-tight syringe into a closed loop system of a known air volume (see
schematical drawing).  The closed loop system consisted of an infrared
vapor analyzer (MIRAN 1A-CVF, Foxboro Analytical) connected to the gas
sampling valve of the GC.  A metal bellows pump was used to circulate
the injected test substance vapors through the sample cell of the
infrared monitor and the gas sampling valve of the GC.  The response of
the infrared analyzer was monitored until the air concentration appeared
equilibrated and stable,  then three replicate samples were taken using
the gas sample loop of the GC.  The entire closed loop system was
cleared with clean air between each calibration injection.  The average
response of the GC (total peak area) for the four main constituents of
the atmosphere, at each air concentration was used to construct a linear
calibration for the test substance.

This method permitted the GC and the infrared analyzer (a backup
analytical method) to be calibrated simultaneously and  under conditions
similar to actual chamber sampling.  Once established, the calibration
was checked daily during the study by sampling a certified standard of
n-butane, the major component of the test substance mixture.

I-3

APPENDIX I  -  INHALATION EXPOSURE DATA

Chamber Homogeneity

Table I-4 presents a summary of the chamber distribution data.

During the method development trials for this study, samples were drawn
from twelve different points within the chamber at each target
concentration to demonstrate the homogeneity of test atmosphere
distribution.

Lighting, Noise and Oxygen Levels

Table I-5 presents a summary of the lighting, noise, and oxygen level
data.

Light intensity was measured three times during the study (the first day
of exposures, during the second week of exposures, and the last day of
exposures) in both the animal room and the chamber room.  Light
intensity was measured in the animal room in a cage approximately three
feet above the floor level.  In the chamber room the light intensity was
measured three feet above floor level in the approximate center of each
generation room.

Additionally, the oxygen level and the noise level were measured in each
exposure chamber on the first day of exposures, during the second week
of exposures, and on the last day of exposures.

Particle Size Analysis.  

Table I-6 presents a summary of the particle size data.

A particle size determination of the aerosol portion of the test
atmosphere was conducted during the chamber trials from the control and
20,000 mg/m3 target concentration chambers.  The particle size sampling
indicated aerosol concentrations of 0 and 20 mg/m3 for the control and
20,000 mg.m3 target concentration chambers.  These small concentrations
of aerosol were likely due to animal hair or dander.

The sample was taken using a multistage cascade impactor.  Preweighed
glass fiber filters were used to collect aerosol on each stage.  Each
stage was associated with specific cutoff diameters for aerodynamic
particle size in microns.

The flow of air and the duration of the flow were recorded in the data. 
This provided the information needed to convert the amount of aerosol
captured in the cascade impactor to a chamber concentration.

I-4

APPENDIX I  -  INHALATION EXPOSURE DATA 

FIGURE I-1  -  SCHEMATIC OF GENERATION AND EXPOSURE SYSTEM

I-5

 APPENDIX I  -  INHALATION EXPOSURE DATA 

FIGURE I-2  -  SCHEMATIC OF ANALYTICAL CALIBRATION SYSTEM

I-6

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-1  - MEAN EXPOSURE DATA

GROUP:	1	2	3	4

Target Exposure Concentration

(mg/m3)	

0	

2000	

10000	

20000

Mean Analytical Exposure Concentration

(mg/m3)	

0	

1988	

10327	20541

Average Chamber Temperature

(OF)	

69	

72	

75	

72

Average Chamber Relative Humidity

(% RH)	

62	

58	

54	

58



I-7

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-2  -  GAS CHROMATOGRAPH OPERATING CONDITIONS

GAS CHROMATOGRAPH:	Hewlett Packard 6890GC

DETECTOR:	Flame Ionization

COLUMN:	Supelco Part # 13867, MTO-SS, 2M 1/8”,

	Carbopack C 80/100 0.19% Picric Acid 15g

GAS FLOWS (cc/min):	H2  -  45.0

	Air  -  450.0

	Makeup Gas (Helium)  -  30.0

INLET TEMPERATURE:	100oC

INLET FLOW (cc/min)	Helium - 19.8

OVEN TEMPERATURE:	110oC

DETECTOR TEMPERATURE:	250oC

SAMPLE LOOP SIZE:	2 cc

ATTENUATION:	0

RUN TIME:	8.5 Minutes

I-8

APPENDIX I  -  INHALATION EXPOSURE DATA 

FIGURE  I-3 - ANALYTICAL CALIBRATION RESONSE CURVES

I-9

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-3  -  SUMMARY OF EXPOSURE DATA

	Group 1	Group 2	Group 3	Group 4 

Date	Mean	Nominal	Chamber	Mean	Nominal	Chamber	Mean	Nominal	Chamber	Mean
Nominal	Chamber

	(mg/m3)	(mg/m3)	oF	% Rh	(mg/m3)	(mg/m3)	oF	% Rh	(mg/m3)	(mg/m3)	oF	% Rh
(mg/m3)	(mg/m3)	oF	% Rh

27-Apr-02	0	0	67	64	1733	2088	69	59	10392	10360	71	58	21400	19922	69	59

28-Apr-02	0	0	68	64	1991	2089	70	58	10622	9388	74	51	21646	19743	70	57

29-Apr-02	0	0	68	55	2179	1933	70	50	10699	10363	74	47	21121	19524	70	57

30-Apr-02	0	0	68	65	2050	1950	70	58	10443	10272	73	58	21167	19432	70	59

1-May-02	0	0	70	59	1979	2375	71	58	10736	10581	75	49	20984	19547	72	55

2-May-02	0	0	69	64	2076	2069	71	64	10293	10335	75	54	20177	18992	72	61

3-May-02	0	0	70	58	1929	1924	72	61	10304	10297	76	50	21320	19390	72	58

4-May-02	0	0	68	64	2016	1736	71	61	9793	9913	74	59	20473	19208	72	56

5-May-02	0	0	68	64	1967	1924	74	52	10652	10435	75	53	20603	19501	72	58

6-May-02	0	0	69	70	1913	1896	71	69	9762	10168	75	61	20594	19035	72	65

7-May-02	0	0	70	65	1965	1981	73	62	10297	10306	76	57	20438	19501	73	61

8-May-02	0	0	70	62	1910	1914	72	59	9816	10056	75	58	19934	18799	73	61

9-May-02	0	0	70	58	1965	1856	73	59	10389	10632	75	57	20077	19921	71	62

10-May-02	0	0	70	65	2022	1976	73	60	10224	10246	76	55	19785	18965	73	62

11-May-02	0	0	71	65	1941	1953	75	59	10367	10443	76	55	20145	19547	74	59

12-May-02	0	0	70	69	2134	2032	74	59	10270	10435	75	61	20100	19274	74	66

13-May-02	0	0	70	72	1943	1956	74	59	10232	10364	76	59	20057	19578	74	61

14-May-02	0	0	70	55	2076	2018	72	50	10441	10611	76	47	20251	19531	73	49

15-May-02	0	0	69	61	2034	2032	72	57	10422	10646	75	54	20642	19526	73	54

16-May-02	0	0	68	58	1982	1969	70	58	10565	10789	75	52	20162	19350	71	54

17-May-02	0	0	68	64	2008	2093	70	58	10431	10606	74	54	20615	19790	71	58

18-May-02	0	0	68	59	1909	2244	71	51	9805	10442	74	50	20649	19551	71	54

19-May-02	0	0	68	65	1906	1936	72	58	10598	10763	73	59	20386	19767	71	58

20-May-02	0	0	66	63	2032	1988	70	58	10173	10385	73	53	21014	20071	70	58

21-May-02	0	0	67	54	2033	2035	69	56	10449	10628	74	47	19793	19257	70	54

MEAN	0	0	69	62	1988	1999	72	58	10327	10379	75	54	20541	19469	72	58

S.D.	0	0	1.3	4.6	87.7	124.2	1.6	4.2	280.2	293.4	1.2	4.4	518.3	314.5	1.4
3.8

Minimum	0	0	66	54	1733	1736	69	50	9762	9388	71	47	19785	18799	69	49

Maximum	0	0	71	72	2179	2375	75	69	10736	10789	76	61	21646	20071	74	66



I-10

APPENDIX I  -  INHALATION EXPOSURE DATA

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT’D)

GROUP 1  -  0 MG/M3 TARGET CONCENTRATION 



Nominal	Mean Analytical 	Mean	Mean

	Exposure	Concentration	Concentration	Temperature	Relative Humidity

Date	Number	(mg/m3)	(mg/m3)	(oF)	(%)

27-Apr-02	1	0	0	67	64

28-Apr-02	2	0	0	68	64

29-Apr-02	3	0	0	68	55

30-Apr-02	4	0	0	68	65

1-May-02	5	0	0	70	59

2-May-02	6	0	0	69	64

3-May-02	7	0	0	70	58

4-May-02	8	0	0	68	64

5-May-02	9	0	0	68	64

6-May-02	10	0	0	69	70

7-May-02	11	0	0	70	65

8-May-02	12	0	0	70	62

9-May-02	13	0	0	70	58

10-May-02	14	0	0	70	65

11-May-02	15	0	0	71	65



I-11

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT’D)

GROUP 1  -  0 MG/M3 TARGET CONCENTRATION 



Nominal	Mean Analytical 	Mean	Mean

	Exposure	Concentration	Concentration	Temperature	Relative Humidity

Date	Number	(mg/m3)	(mg/m3)	(oF)	(%)

12-May-02	16	0	0	70	69

13-May-02	17	0	0	70	72

14-May-02	18	0	0	70	55

15-May-02	19	0	0	69	61

16-May-02	20	0	0	68	58

17-May-02	21	0	0	68	64

18-May-02	22	0	0	68	59

19-May-02	23	0	0	68	65

20-May-02	24	0	0	66	63

21-May-02	25	0	0	67	54

Mean

0	0	69	62

S.D.

0	0	1.3	4.6



I-12

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT'D)

GROUP 2  -  2000 MG/M3 TARGET CONCENTRATION 



Nominal





	Mean 	Mean	Mean

	Exposure	Conc.	Hourly Analytical Concentrations (mg/m3)	Concentration
Temperature	Relative

Date	Number	(mg/m3)	1	2	3	4	5	6	(mg/m3)	(oF)	Humidity (%)

27-Apr-02	1	2088	2103	2128	1891	1498	1733	1042	1733a	69	59

28-Apr-02	2	2089	2159	1916	2035	2017	1785	2032	1991	70	58

29-Apr-02	3	1933	2135	2215	2274	2203	2149	2099	2179	70	58

30-Apr-02	4	1950	1923	2066	2074	2090	2178	1970	2050	70	58

1-May-02	5	2375	2020	2049	1874	2263	2051	1615	1979	71	58

2-May-02	6	2069	2101	2269	1978	2092	1898	2120	2076	71	64

3-May-02	7	1924	591	2222	2393	2076	2064	2225	1929	72	61

4-May-02	8	1736	1941	2028	1968	1979	1969	2212	2016	71	61

5-May-02	9	1924	2052	1795	2064	1987	1913	1989	1967	74	52

6-May-02	10	1896	1805	2052	1937	1902	1819	1965	1913	71	69

7-May-02	11	1981	2002*	1972	2029	1964	1879	1946	1965	73	62

8-May-02	12	1914	2022	2058	1953	1867	1746	1812	1910	72	59

9-May-02	13	1856	1875	2117	2034	1943	1918	1905	1965	73	59

10-May-02	14	1976	1992	1963	1927	2113	2051	2085	2022	73	60

11-May-02	15	1953	1915	1777	1986	2037	1914	2019	1941	75	59

a – Low value due to problems with the rotameter

* - Backup analytical system used

I-13

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT'D)

GROUP 2  -  2000 MG/M3 TARGET CONCENTRATION 



Nominal





	Mean 	Mean	Mean

	Exposure	Conc.	Hourly Analytical Concentrations (mg/m3)	Concentration
Temperature	Relative

Date	Number	(mg/m3)	1	2	3	4	5	6	(mg/m3)	(oF)	Humidity (%)

12-May-02	16	2032	2099	2099	2238	2110	2201	2058	2134	74	59

13-May-02	17	1956	1797	2044	2035	2112	2004	1663	1943	74	59

14-May-02	18	2018	2294	1988	2065	2048	1825	2238	2076	72	50

15-May-02	19	2032	1964	2078	2081	2142	2082	1859	2034	72	57

16-May-02	20	1969	2204	2131	2050	1623	1797	2089	1982	70	58

17-May-02	21	2093	2016	1977	2051	2041	2104	1858	2008	70	58

18-May-02	22	2244	1492	2346	1787	1858	2003	1966	1909	71	51

19-May-02	23	1936	1893	1861	1759	1784	2054	2085	1906	72	58

20-May-02	24	1988	2041	2177	2045	2073	1946	1912	2032	70	58

21-May-02	25	2035	1939	2112	2119	2020	2094	1913	2033	69	56

MEAN

1999





	1988	72	58

S.D.

124.2





	87.7	1.7	3.8



* - Backup analytical system used

I-14

APPENDIX I  -  INHALATION EXPOSURE DATA

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT’D)

GROUP 3 -  10,000 MG/M3 TARGET CONCENTRATION 



Nominal





	Mean	Mean	Mean



Exposure	Conc.	Hourly Analytical Concentration (mg/m3)	Concentration
Temperature	Relative

Date	Number	(mg/m3)	1	2	3	4	5	6	(mg/m3)	(oF)	Humidity (%)

27-Apr-02	1	10360	10533	10729	8758	10228	11168	10937	10392	71	58

28-Apr-02	2	9388	10829	9642	9711	11446	10142	11960	10622	74	51

29-Apr-02	3	10363	10510	11120	11077	10638	10446	10405	10699	74	47

30-Apr-02	4	10272	9950	9289	11872	10315	10541	10691	10443	73	58

1-May-02	5	10581	9829	10506	11152	10795	11065	11068	10736	75	49

2-May-02	6	10335	10172	10378	10258	10357	10393	10202	10293	75	54

3-May-02	7	10297	10000	10292	10727	10374	10522	9906	10304	76	50

4-May-02	8	9913	9753	10292	11027	7441	9886	10357	9793	74	59

5-May-02	9	10435	10748	10508	10788	10802	10290	10777	10652	75	53

6-May-02	10	10168	9746	9073	10210	9397	10114	10029	9762	75	61

7-May-02	11	10306	11503*	10241	10112	10047	10012	9867	10297	76	57

8-May-02	12	10056	9346	9589	10209	9670	10041	10042	9816	75	58

9-May-02	13	10632	10227	10262	10671	10553	10346	10276	10389	75	57

10-May-02	14	10246	10185	9932	10648	10116	10135	10329	10224	76	55

11-May-02	15	10443	10078	10575	10666	10333	10090	10463	10367	76	55



* - Backup analytical system used

I-15

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT'D)

GROUP 3  -  10,000 MG/M3 TARGET CONCENTRATION 



Nominal





	Mean 	Mean	Mean

	Exposure	Conc.	Hourly Analytical Concentration (mg/m3)	Concentration
Temperature	Relative

Date	Number	(mg/m3)	1	2	3	4	5	6	(mg/m3)	(oF)	Humidity (%)

12-May-02	16	10435	9945	9988	10161	10471	10579	10474	10270	75	61

13-May-02	17	10364	9900	10068	10249	10655	10209	10309	10232	76	59

14-May-02	18	10611	10147	10293	10392	10403	10649	10763	10441	76	47

15-May-02	19	10646	9513	10424	10249	10989	10762	10595	10422	75	54

16-May-02	20	10789	10412	10416	10719	10693	10660	10493	10565	75	52

17-May-02	21	10606	10172	10584	10214	10408	10617	10591	10431	74	54

18-May-02	22	10442	9100	9745	9832	9864	10150	10137	9805	74	50

19-May-02	23	10763	9761	10432	11103	10674	10626	10993	10598	73	59

20-May-02	24	10385	9866	10368	10566	10192	10133	9916	10173	73	53

21-May-02	25	10628	10033	10466	10250	10716	10584	10647	10449	74	47

MEAN

10379





	10327	75	54

S.D.

293.4





	280.2	1.2	4.4



* - Backup analytical system used

I-16

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT'D)

GROUP 4 -  20,000 MG/M3 TARGET CONCENTRATION 



Nominal





	Mean	Mean	Mean



Exposure	Conc.	Hourly Analytical Concentration (mg/m3)	Concentration
Temperature	Relative

Date	Number	(mg/m3)	1	2	3	4	5	6	(mg/m3)	(oF)	Humidity (%)

27-Apr-02	1	19922	21229	21107	20717	21913	22589	20845	21400	69	59

28-Apr-02	2	19743	20894	21824	21540	22071	21998	21550	21646	70	57

29-Apr-02	3	19524	21334	21752	21230	20981	20733	20689	21121	70	57

30-Apr-02	4	19432	19740	20830	21230	21195	22460	21550	21167	70	59

1-May-02	5	19547	20214	20531	21389	21281	21086	21404	20984	72	55

2-May-02	6	18992	18611	19921	19585	21056	21148	20743	20177	72	61

3-May-02	7	19390	20737	21288	21456	21500	21580	21358	21320	72	57

4-May-02	8	19208	20495	21303	20488	19770	20119	20664	20473	72	56

5-May-02	9	19501	20313	21205	20829	20625	20536	20107	20603	72	58

6-May-02	10	19035	19444	20189	20716	17551	20521	25144	20594	72	65

7-May-02	11	19501	19382*	20626	20747	21406	19892	20576	20438	73	61

8-May-02	12	18799	18743	19573	20462	20183	20005	20638	19934	73	61

9-May-02	13	19921	20342	19990	20308	19972	18632	21216	20077	71	62

10-May-02	14	18965	19491	20230	20272	18387	20199	20133	19785	73	62

11-May-02	15	19547	15234	21088	20859	21692	20900	21095	20145	74	59



* - Backup analytical system used

I-17

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-3  -  SUMMARY OF EXPOSURE DATA (CONT'D)

GROUP 4  -  20,000 MG/M3  TARGET CONCENTRATION 



Nominal





	Mean 	Mean	Mean

	Exposure	Conc.	Hourly Analytical Concentration (mg/m3)	Concentration
Temperature	Relative

Date	Number	(mg/m3)	1	2	3	4	5	6	(mg/m3)	(oF)	Humidity (%)

12-May-02	16	19274	18154	19894	20787	20241	22009	19513	20100	74	66

13-May-02	17	19578	20298	19879	20010	19612	20170	20370	20057	74	61

14-May-02	18	19531	19506	20204	20905	19819	20526	20542	20251	73	49

15-May-02	19	19526	20123	20852	20415	20941	20783	20737	20642	73	54

16-May-02	20	19350	18785	19978	20442	20500	20312	20954	20162	71	54

17-May-02	21	19790	19989	20182	20241	20200	22775	20303	20615	71	58

18-May-02	22	19551	20381	20949	20809	20550	20767	20439	20649	71	54

19-May-02	23	19767	20283	18377	21781	21244	18671	21963	20386	71	58

20-May-02	24	20071	19828	20809	21286	20966	21738	21454	21014	70	58

21-May-02	25	19257	19289	20130	21021	16493	20883	20942	19793	70	54

MEAN

19469





	20541	72	58

S.D.

314.5





	518.3	1.4	3.8



I-18

APPENDIX I  -  INHALATION EXPOSURE DATA

TABLE  I-4 - SUMMARY OF DISTRIBUTION SAMPLES 

SAMPLE

LOCATION	TARGET EXPOSURE LEVELS

	2000 MG/M3	10,000 MG/M3	20,000 MG/M3

Left Top Back	2073	10462	21155

Left Top Front	1965	10636	21532

Left Middle Back	2270	10385	20995

Left Middle Front	2183	10507	21408

Left Bottom Back	2184	10659	21124

Left Bottom Front	1926	10373	21294

Right Top Back	2135	10676	20832

Right Top Front	2031	10526	21550

Right Middle Back	1926	10997	21517

Right Middle Front	1886	10903	21399

Right Bottom Back	2162	10802	21026

Right Bottom Front	1960	10401	20969

MEAN	2058	10611	21233

S.D.	126.79	206.70	248.71

%CV	6.16	1.95	1.17

Minimum	1886	10373	20832

Maximum	2270	10997	21550



		NOTE:  Top, middle, bottom sample locations represent horizontal
planes within exposure chamber.  

		Left, right, front, back represent corners of each horizontal plane. 
Samples taken in series approximately 

	8 minute intervals.  

I-19

APPENDIX I  -  INHALATION EXPOSURE DATA 

TABLE I-5 LIGHTING, NOISE, AND OXYGEN LEVELS

Environmental Conditions

	April 27, 2002	May 8, 2002	May 21, 2002

Light Intensity: (fc)



	Room PE103  in a cage 3 feet above the floor.	8.9	3.8	5.3

Center of room PE 102 3 feet above the floor.	32.5	36.1	62

Center of room PE 110 3 feet above the floor.	34.1	28.9	45.3

Noise level:  (db)



	1m - 1: Door open	78.9	75.5	73.2

1m - 1: Through port	79.7	76.9	77.1

1m - 2: Door open	79.3	73.6	73.1

1m - 2: Through port	80.2	77.1	76.5

1m - 3: Door open	79.1	74.0	74.9

1m - 3: Through port	80.1	76.8	77.2

1m - 4: Door open	78.8	72.5	72.2

1m - 4: Through port	79.9	75.2	75.1

O2 Level: (%)



	(Reading upon removal)	No Alarm	No Alarm	No Alarms

1m - 1	20.7	20.3	19.9

1m - 2	20.7	20.4	20.2

1m - 3	20.7	20.3	19.7

1m - 4	20.7	20.2	19.9

1m-1, 1m-2, 1m-3, 1m-4 are exposure chamber designations.

fc = foot candles (measured with an Omega HHLM-2 Light Meter)

db = decibels (measured using an Omega HHSL-1 Sound Meter)

% = % oxygen (measured using a Biosystems Oxy Plus Single Sensor Gas
Detector with an alarm at 19.5% O2)

I-20

APPENDIX I  -  INHALATION EXPOSURE DATA

TABLE  I-6 - PARTICLE SIZE DATA 

0 MG/M3

 PRIVATE  IMPACTOR

STAGE	STAGE CONSTANT

((m)	FILTER WEIGHT

DIFFERENCE ((g)	PERCENT IN

SIZE RANGE

FILTER	0.30	0	0

8	0.54	0	0

7	0.84	0	0

6	1.50	0	0

5	2.60	0	0

4	4.10	0	0

3	6.80	0	0

2	17.0	0	0

1	28.0	0	0



TOTAL =0

	PARTICLE CONCENTRATION = 0 MG/M3

	PARTICLE SIZE DETERMINED WITH A SIERRA SERIES 210 CASCADE IMPACTOR

	CONDITIONS:

		SAMPLE FLOWRATE (Liters/Minute):  3		SAMPLE DURATION (Minutes):  3

		CALCULATION OF PARTICLE CONCENTRATION:

		SAMPLE VOLUME (Liters)= SAMPLE FLOW RATE*SAMPLE DURATION

		PARTICLE CONCENTRATION = 

		((TOTAL FILTER WEIGHT DIFFERENCE /1000 (g/mg)/(SAMPLE VOLUME))*1000
L/M3

I-21

APPENDIX I  -  INHALATION EXPOSURE DATA (CONT'D)

TABLE  I-6 - PARTICLE SIZE DATA (CONT'D)

20,000 MG/M3 TARGET CONCENTRATION 

 PRIVATE  IMPACTOR

STAGE	STAGE CONSTANT

((m)	FILTER WEIGHT

DIFFERENCE ((G)	PERCENT IN

SIZE RANGE

FILTER	0.30	0	0

8	0.54	10	5.6

7	0.84	70	38.9

6	1.50	0	0

5	2.60	50	27.8

4	4.10	40	22.2

3	6.80	0	0

2	17.0	0	0

1	28.0	10	5.6



TOTAL =180

	CONCENTRATION OF PARTICLES = 20 MG/M3

MEAN MEDIAN AERODYNAMIC DIAMETER = 2.368 (m

	PARTICLE SIZE DETERMINED WITH A SIERRA SERIES 210 CASCADE IMPACTOR

	CONDITIONS:

		SAMPLE FLOWRATE (Liters/Minute):  3		SAMPLE DURATION (Minutes):  3

		CALCULATION OF PARTICLE CONCENTRATION:

		SAMPLE VOLUME (Liters) = SAMPLE FLOW RATE*SAMPLE DURATION

		PARTICLE CONCENTRATION = 

		((TOTAL FILTER WEIGHT DIFFERENCE /1000 (g/mg)/(SAMPLE VOLUME))*1000
L/M3

I-22

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES

CHAMBER TEMPERATURES (ºF) - 0 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	64	66	66	66	68	68	68	68	68	68	68	68	68

28-Apr-02	66	68	68	68	68	68	68	68	68	68	68	68	68

29-Apr-02	68	68	68	68	68	68	68	68	68	68	68	68	68

30-Apr-02	66	66	68	68	68	68	68	68	68	68	68	68	68

1-May-02	68	68	68	70	70	70	70	70	70	70	70	70	70

2-May-02	68	68	68	68	68	68	68	68	70	70	70	70	70

3-May-02	68	70	70	70	70	70	70	70	70	70	70	70	70

4-May-02	68	68	68	68	68	68	68	68	68	68	68	68	68

5-May-02	68	68	68	68	68	68	68	68	68	68	68	68	68

6-May-02	64	64	68	68	70	70	70	70	70	70	70	70	70

7-May-02	68	70	70	70	70	70	70	70	70	70	70	70	70

8-May-02	66	68	70	70	70	70	70	70	70	70	70	70	70

9-May-02	68	70	70	70	70	70	70	70	70	70	70	70	70

10-May-02	67	69	69	70	70	70	70	70	70	70	70	70	70

11-May-02	68	70	70	72	72	72	72	72	72	72	72	72	72

12-May-02	68	68	70	70	70	70	70	70	70	70	70	70	70

13-May-02	68	70	70	70	70	70	70	70	70	70	70	70	70

14-May-02	68	70	70	70	70	70	70	70	70	70	70	70	70

15-May-02	66	68	68	68	70	70	70	70	70	68	68	68	68

16-May-02	68	68	68	68	68	68	68	68	68	68	68	68	68

17-May-02	68	68	68	68	68	68	68	68	68	68	68	68	68

18-May-02	66	66	66	68	68	68	68	68	68	68	68	68	68

19-May-02	66	68	68	68	68	68	68	68	68	68	68	68	68

20-May-02	66	66	66	66	66	66	66	66	66	66	66	66	66

21-May-02	66	66	66	66	66	66	66	66	68	68	68	68	68















	

I-23

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES

CHAMBER TEMPERATURES (ºF) - 2000 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	66	68	68	68	70	70	70	70	70	70	70	70	70

28-Apr-02	68	70	70	70	70	70	70	70	70	70	70	70	70

29-Apr-02	68	70	72	72	72	70	70	70	70	70	70	70	70

30-Apr-02	68	70	70	70	70	70	70	70	70	70	70	70	70

1-May-02	70	70	70	70	70	70	70	70	70	72	72	72	72

2-May-02	70	70	70	70	70	70	70	70	72	72	72	72	72

3-May-02	68	70	70	70	70	70	74	74	74	74	74	74	74

4-May-02	70	70	71	71	71	71	71	71	71	71	71	71	71

5-May-02	70	72	74	74	74	74	74	74	74	74	74	74	74

6-May-02	66	70	70	70	70	70	72	72	72	74	74	74	74

7-May-02	70	70	72	72	72	72	74	74	74	74	74	74	74

8-May-02	68	70	71	71	73	73	73	73	73	73	73	73	73

9-May-02	68	72	72	72	72	72	72	74	74	74	74	74	74

10-May-02	68	70	70	70	74	74	74	74	74	74	74	74	74

11-May-02	70	72	74	74	74	76	76	76	76	76	76	76	76

12-May-02	70	74	74	74	74	74	74	74	74	74	74	74	74

13-May-02	70	70	72	74	74	74	76	76	76	76	74	76	76

14-May-02	68	70	70	72	72	72	74	74	74	74	74	72	72

15-May-02	68	70	72	72	74	74	72	74	74	70	72	72	72

16-May-02	68	70	70	70	70	70	70	70	70	70	70	70	70

17-May-02	68	70	70	70	70	70	70	70	70	72	72	72	72

18-May-02	66	70	70	71	72	72	72	72	72	72	72	72	72

19-May-02	68	72	72	72	72	72	72	72	72	72	72	72	72

20-May-02	66	68	70	70	70	70	70	70	70	70	70	70	70

21-May-02	66	68	68	70	70	70	70	70	70	70	70	70	70















	

I-24

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES

CHAMBER TEMPERATURES (ºF) – 10,000 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	66	70	70	70	70	72	72	72	72	72	72	72	72

28-Apr-02	70	72	74	74	74	74	74	74	74	74	74	74	74

29-Apr-02	68	72	74	74	74	75	75	75	75	75	75	75	75

30-Apr-02	68	70	72	72	74	74	74	74	74	74	74	74	74

1-May-02	70	73	74	74	76	76	76	76	78	76	76	76	76

2-May-02	70	72	74	74	74	74	74	74	78	78	78	78	78

3-May-02	68	72	74	76	76	76	78	78	78	78	78	78	78

4-May-02	72	72	74	74	74	74	74	74	74	74	74	74	74

5-May-02	70	72	74	76	76	76	76	76	76	76	76	76	76

6-May-02	68	70	74	74	76	76	76	76	76	78	78	78	78

7-May-02	68	72	76	76	76	76	76	78	78	78	78	78	78

8-May-02	68	72	74	76	76	76	76	76	76	76	76	76	76

9-May-02	68	72	74	74	74	74	74	78	78	78	78	78	78

10-May-02	68	72	74	76	76	76	78	78	78	78	78	78	78

11-May-02	68	72	76	76	78	78	78	78	78	78	78	78	78

12-May-02	70	74	76	76	76	76	76	76	76	76	76	76	76

13-May-02	68	72	76	76	78	78	78	78	78	78	78	78	78

14-May-02	68	72	74	76	76	76	78	78	78	78	78	78	78

15-May-02	66	72	74	76	76	76	76	78	78	76	76	76	76

16-May-02	68	72	74	74	74	76	76	76	76	76	76	76	76

17-May-02	68	70	74	74	74	74	76	76	76	76	76	76	76

18-May-02	66	70	72	74	76	76	76	76	76	76	76	76	76

19-May-02	66	70	74	74	74	74	74	74	74	74	74	74	74

20-May-02	66	70	72	72	74	74	74	74	74	74	74	74	74

21-May-02	66	70	72	74	74	74	74	74	76	76	76	76	76















	

I-25

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES

CHAMBER TEMPERATURES (ºF) – 20,000 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	66	68	68	68	70	70	70	70	70	70	70	70	70

28-Apr-02	70	70	70	70	70	70	70	70	70	70	70	70	70

29-Apr-02	68	70	70	70	70	70	70	70	70	70	70	70	70

30-Apr-02	66	68	70	70	70	70	70	70	70	70	70	70	70

1-May-02	70	70	70	72	72	72	72	72	74	74	74	74	74

2-May-02	68	70	70	70	70	72	72	72	74	74	74	74	74

3-May-02	68	70	70	72	72	72	74	74	74	74	74	74	74

4-May-02	66	70	72	72	72	72	72	74	74	74	74	74	74

5-May-02	70	70	72	72	72	72	72	72	72	72	72	72	72

6-May-02	66	66	70	72	74	74	74	74	74	74	74	74	74

7-May-02	68	70	72	72	72	74	74	74	74	74	74	74	74

8-May-02	68	70	72	72	74	74	74	74	74	74	74	74	74

9-May-02	66	70	72	72	72	72	72	72	72	72	72	72	72

10-May-02	66	69	70	72	74	74	74	74	74	74	74	74	74

11-May-02	66	70	72	74	74	76	76	76	76	76	76	76	76

12-May-02	69	73	74	74	74	74	74	74	74	74	74	74	74

13-May-02	68	70	72	74	74	74	74	74	74	74	76	76	76

14-May-02	68	70	72	72	72	74	74	74	74	74	74	74	74

15-May-02	66	70	72	72	74	74	74	74	74	74	74	74	74

16-May-02	68	70	70	70	70	72	72	72	72	72	72	72	72

17-May-02	68	70	70	70	72	72	72	72	72	72	72	72	72

18-May-02	66	68	70	70	70	72	72	72	72	72	72	72	72

19-May-02	66	68	72	72	72	72	72	72	72	72	72	72	72

20-May-02	66	68	70	70	70	70	70	70	70	70	70	70	70

21-May-02	66	68	68	70	70	70	70	70	72	72	72	72	72















	

I-26

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES (CONT’D)

CHAMBER HUMIDITIES (%RH) - 0 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	70	62	62	62	64	64	64	64	64	64	64	64	64

28-Apr-02	62	64	64	64	64	64	64	64	64	64	64	64	64

29-Apr-02	55	55	55	55	55	55	55	55	55	55	55	55	55

30-Apr-02	71	71	64	64	64	64	64	64	64	64	64	64	64

1-May-02	64	64	64	57	57	57	57	57	57	57	57	57	57

2-May-02	64	64	64	64	64	64	64	64	64	64	64	64	64

3-May-02	64	57	57	57	57	57	57	57	57	57	57	57	57

4-May-02	64	64	64	64	64	64	64	64	64	64	64	64	64

5-May-02	64	64	64	64	64	64	64	64	64	64	64	64	64

6-May-02	100	90	76	72	64	64	64	64	64	64	64	64	64

7-May-02	72	64	64	64	64	64	64	64	64	64	64	64	64

8-May-02	71	72	60	60	60	60	60	60	60	60	60	60	60

9-May-02	64	57	57	57	57	57	57	57	57	57	57	57	57

10-May-02	71	64	64	64	64	64	64	64	64	64	64	64	64

11-May-02	72	64	64	57	65	65	65	65	65	65	65	65	65

12-May-02	72	72	68	68	68	68	68	68	68	68	68	68	68

13-May-02	72	72	72	72	72	72	72	72	72	72	72	72	72

14-May-02	55	57	48	48	48	48	48	57	64	64	64	57	57

15-May-02	62	64	64	64	57	57	57	57	57	64	64	64	64

16-May-02	64	64	64	64	55	55	55	55	55	55	55	55	55

17-May-02	64	64	64	64	64	64	64	64	64	64	64	64	64

18-May-02	62	62	62	55	55	55	55	55	55	55	64	64	64

19-May-02	71	64	64	64	64	64	64	64	64	64	64	64	64

20-May-02	62	62	62	62	71	71	62	62	62	62	62	62	62

21-May-02	53	53	53	53	53	53	53	53	55	55	55	55	55















	

I-27

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES (CONT’D)

CHAMBER HUMIDITIES (%RH) - 2000 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	62	64	64	64	57	57	57	57	57	57	57	57	57

28-Apr-02	64	57	57	57	57	57	57	57	57	57	57	57	57

29-Apr-02	64	57	50	50	50	48	48	48	48	48	48	48	48

30-Apr-02	64	57	57	57	57	57	57	57	57	57	57	57	57

1-May-02	64	57	57	57	57	57	57	57	57	57	57	57	57

2-May-02	64	64	64	64	64	64	64	64	65	65	65	65	65

3-May-02	64	64	64	64	64	64	58	58	58	58	58	58	58

4-May-02	64	64	60	60	60	60	60	60	60	60	60	60	60

5-May-02	64	57	51	51	51	51	51	51	51	51	51	51	51

6-May-02	90	76	76	76	76	76	65	65	65	58	58	58	58

7-May-02	64	72	65	65	65	65	58	58	58	58	58	58	58

8-May-02	72	57	57	57	58	58	58	58	58	58	58	58	58

9-May-02	72	57	57	57	57	57	57	58	58	58	58	58	58

10-May-02	72	64	64	64	58	58	58	58	58	58	58	58	58

11-May-02	64	65	58	58	58	52	59	59	59	59	59	59	59

12-May-02	68	58	58	58	58	58	58	58	58	58	58	58	58

13-May-02	72	72	65	58	58	58	52	52	52	52	66	52	52

14-May-02	55	48	57	50	50	50	44	44	44	51	51	50	50

15-May-02	55	57	57	57	51	51	57	58	58	64	57	57	57

16-May-02	64	57	57	57	57	57	57	57	57	57	57	57	57

17-May-02	64	57	57	57	57	57	57	57	64	57	57	57	57

18-May-02	62	52	52	53	50	50	50	50	50	50	50	50	50

19-May-02	64	57	57	57	57	57	57	57	57	57	57	57	57

20-May-02	62	64	57	57	57	57	57	57	57	57	57	57	57

21-May-02	53	55	55	57	57	57	57	57	57	57	57	57	57















	

I-28

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES (CONT’D)

CHAMBER HUMIDITIES (%RH) – 10,000 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	71	57	57	57	57	57	57	57	57	57	57	57	57

28-Apr-02	57	50	51	51	51	51	51	51	51	51	51	51	51

29-Apr-02	64	57	51	51	51	42	42	42	42	42	42	42	42

30-Apr-02	64	64	57	57	57	57	57	57	57	57	57	57	57

1-May-02	64	54	51	51	45	45	45	45	46	49	49	49	49

2-May-02	64	61	58	58	58	58	58	58	46	46	46	46	46

3-May-02	64	57	51	52	52	52	46	46	46	46	46	46	46

4-May-02	61	65	58	58	58	58	58	58	58	58	58	58	58

5-May-02	64	57	51	52	52	52	52	52	52	52	52	52	52

6-May-02	90	77	58	58	59	59	59	59	59	53	53	53	53

7-May-02	64	65	59	59	59	59	59	53	53	53	53	53	53

8-May-02	72	65	58	56	56	56	56	56	56	56	56	56	56

9-May-02	64	65	58	58	58	58	58	53	53	53	53	53	53

10-May-02	64	53	54	56	56	56	53	53	53	53	53	53	53

11-May-02	64	65	52	52	53	53	53	53	53	53	53	53	53

12-May-02	72	66	59	59	59	59	59	59	59	59	59	59	59

13-May-02	72	73	59	59	53	53	53	53	53	60	60	60	60

14-May-02	64	50	44	45	45	45	45	45	45	46	46	45	45

15-May-02	71	57	58	52	52	52	52	53	53	52	52	52	52

16-May-02	64	57	51	51	51	45	45	52	52	52	52	52	52

17-May-02	64	57	51	51	58	58	52	52	52	52	52	52	52

18-May-02	62	57	53	47	45	45	45	45	45	45	52	52	52

19-May-02	71	64	58	58	58	58	58	58	58	58	58	58	58

20-May-02	62	57	57	57	51	51	51	51	51	51	51	51	51

21-May-02	53	57	50	44	44	44	44	44	45	45	45	45	45















	

I-29

TABLE  I-7 – CHAMBER TEMPERATURES AND HUMIDITIES (CONT’D)

CHAMBER HUMIDITIES (%RH) – 20,000 mg/m3 Target Concentration

	Time from Start of Exposure (Hours)

	0	0.5	1	1.5	2	2.5	3	3.5	4	4.5	5	5.5	6

27-Apr-02	62	64	64	64	57	57	57	57	57	57	57	57	57

28-Apr-02	57	57	57	57	57	57	57	57	57	57	57	57	57

29-Apr-02	55	57	57	57	57	57	57	57	57	57	57	57	57

30-Apr-02	71	64	57	57	57	57	57	57	57	57	57	57	57

1-May-02	57	57	57	57	57	57	57	57	51	51	51	51	51

2-May-02	72	64	64	64	64	57	57	57	58	58	58	58	58

3-May-02	64	57	64	57	57	57	51	51	51	58	58	58	58

4-May-02	71	64	57	57	57	57	57	51	51	51	51	51	51

5-May-02	57	64	57	57	57	57	57	57	57	57	57	57	57

6-May-02	90	90	77	69	58	58	58	58	58	58	58	58	58

7-May-02	64	72	57	65	65	58	58	58	58	58	58	58	58

8-May-02	72	72	65	65	58	58	58	58	58	58	58	58	58

9-May-02	62	64	57	57	57	57	57	65	65	65	65	65	65

10-May-02	71	72	72	65	58	58	58	58	58	58	58	58	58

11-May-02	71	72	65	58	58	56	59	52	52	52	52	59	59

12-May-02	64	69	66	66	66	66	66	66	66	66	66	66	66

13-May-02	72	72	65	58	58	58	58	58	58	58	59	59	59

14-May-02	55	57	50	50	50	44	44	44	44	51	51	51	51

15-May-02	62	64	57	57	51	51	51	51	51	51	51	51	51

16-May-02	64	57	57	57	57	50	50	50	50	50	50	57	57

17-May-02	64	57	57	57	57	57	57	57	57	57	57	57	57

18-May-02	62	55	57	57	57	50	50	50	50	50	50	57	57

19-May-02	62	64	57	57	57	57	57	57	57	57	57	57	57

20-May-02	62	64	57	57	57	57	57	57	57	57	57	57	57

21-May-02	53	55	55	57	57	57	57	57	50	50	50	50	50



I-30

	APPENDIX J - ANALYTICAL CHEMISTRY REPORT

	

	SUMMARY

Charcoal tube sorbent tube samples were received by the Analytical
Chemistry Laboratory from  inhalation chamber exposures and were
characterized for hydrocarbon distribution using capillary gas
chromatography with flame ionization detection (GC/FID).  Sorbent tube
samples were stored in a freezer pending analysis.

	SAMPLE PREPARATION

The front and back sections of each charcoal sample tube were desorbed
and analyzed separately to 

assess potential sampling breakthrough.  The charcoal tube sections were
desorbed with 3.0 mL  carbon disulfide (CS2) for at least 30 minutes. 
Aliquots were then analyzed by GC-FID.

	STANDARDIZATION

A standard mixture was prepared in CS2 containing each of the 18 target
hydrocarbons plus ETBE oxygenate.  Analysis of the standard mixture was
used to confirm the relative retention times of each target hydrocarbon
and was not used for quantitative purposes.  

CHARACTERIZATION

Characterization of the neat MRD-00-716 (gasoline vapor condensate with
ETBE) was performed separately and will be reported as part of EMBSI
Study 167490. Neat test substance characterization included a similar
analysis of the relative distribution of target hydrocarbons and
oxygenate as was performed for the chamber sorbent tube samples. 

J-1

APPENDIX J - ANALYTICAL CHEMISTRY REPORT

INSTRUMENT CONDITIONS FOR MRD-00-716

ON CHARCOAL SORBENT TUBE 

The following GC conditions and equipment were used to determine the
hydrocarbon distribution of test substance on chamber characterization
sorbent tubes:

GC	Perkin Elmer XL Autosystem

FID Range	FID (2^5)

Detector Temperature; (gas flows)	225°C (H2 45 mL/min; Air  450 mL/min)

Injector Temperature (Split ratio)	225°C (split injection 20:1)

Injection Volume	0.2µL or 0.5µL*  

Analytical Column	Supleco Petrocol DH 150 fused silica capillary column
(150m x 0.25mm; 1.0µm film thickness)

Oven Temperature Program	35(C (hold 130 minutes); ramp @ 2(C/minute to
200(C  

Data Collection	Perkin Elmer Nelson Turbochrom (TC4) version 4.1.2 

Carrier Gas Program	65 psi (He)

*0.2µL injected of 10,000mg/m3 and 20,000mg/m3 samples, 0.5µL injected
of 2000mg/m3 samples.

RESULTS

Hydrocarbon characterization was performed on an area percent basis for
each of the 18 

target hydrocarbons and ETBE oxygenate. Results are listed in Table J-1.
  

The relative distribution of hydrocarbons and oxygenate measured on the
chamber characterization charcoal tubes was in good agreement with that
measured in the characterization of neat MRD-00-716 test substance. 

										

D. J. Letinski						Date

Analytical Chemist

J-2

APPENDIX J - ANALYTICAL CHEMISTRY REPORT

TABLE J - 1















MRD-00-716 CHAMBER CHARACTERIZATION - SORBENT TUBES HYDROCARBON
DISTRIBUTION















Sample Date	30-Apr-02	8-May-02	14-May-02	21-May-02

Inhalation ID	1	2	3	4	5	6	7	8	9	10	11	12

	 mg/m3	 mg/m3	 mg/m3	 mg/m3

	2000	10,000	20,000	2000	10,000	20,000	2000	10,000	20,000	2000	10,000
20,000

Compound	RESULTS   ARE   in   "AREA %"  of   TARGET   HYDROCARBONS

isobutane	1.7	1.5	1.7	1.8	1.7	1.6	1.7	1.7	1.7	1.7	1.6	1.7

n-butane	9.6	8.7	9.7	10.0	9.6	9.4	9.5	9.7	9.5	9.7	9.3	9.6

isopentane	31.8	32.1	32.6	32.5	32.7	32.6	32.2	32.3	32.6	32.4	32.1	33.1

n-pentane	9.8	10.0	9.9	9.9	10.0	10.0	9.8	9.9	10.0	9.9	9.9	10.1

trans-2-pentene	2.2	2.2	2.2	2.2	2.2	2.2	2.1	2.2	2.2	2.2	2.2	2.2

2-methyl-2-butene	3.2	3.3	3.2	3.2	3.2	3.2	3.2	3.2	3.2	3.2	3.2	3.3

2,3-dimethylbutane	1.7	1.5	1.7	1.5	1.5	1.5	1.7	1.7	1.5	1.5	1.7	1.5

2-methylpentane	4.9	5.0	4.9	4.8	4.9	4.9	4.9	4.9	4.9	4.9	4.9	4.9

3-methylpentane	3.1	3.2	3.1	3.1	3.1	3.1	3.1	3.1	3.1	3.1	3.1	3.1

n-hexane	2.6	2.7	2.6	2.6	2.6	2.6	2.6	2.6	2.6	2.6	2.6	2.6

ETBE	17.1	17.6	16.9	16.6	17.0	17.2	17.1	17.1	17.1	16.9	17.4	16.9

methylcyclopentane	1.4	1.4	1.3	1.3	1.4	1.4	1.4	1.4	1.4	1.3	1.4	1.3

2,4-dimethylpentane	1.1	1.2	1.1	1.1	1.1	1.1	1.1	1.1	1.1	1.1	1.1	1.1

benzene	2.2	2.0	1.9	2.2	1.9	1.9	2.2	1.9	1.9	2.2	1.9	1.9

2-methylhexane	1.2	1.3	1.2	1.2	1.2	1.2	1.2	1.2	1.2	1.2	1.2	1.1

2,3-dimethylpentane	1.3	1.3	1.2	1.2	1.2	1.2	1.2	1.2	1.3	1.2	1.3	1.2

3-methylhexane	1.4	1.4	1.4	1.4	1.3	1.4	1.4	1.3	1.4	1.4	1.4	1.3

isooctane	1.5	1.6	1.4	1.4	1.4	1.5	1.4	1.3	1.5	1.5	1.5	1.3

toluene	2.3	2.3	2.1	2.2	2.1	2.1	2.3	2.1	2.1	2.2	2.3	1.9

Sum	100	100	100	100	100	100	100	100	100	100	100	100

No hydrocarbon target compounds were detected on the back section of the
sorbent tubes analyzed. 



J-3

APPENDIX K – STATISTICIAN’S REPORT

Analysis Of Fetal Data From A Whole-Body Inhalation Developmental
Toxicity 

Study In Rats With Baseline Gasoline with ETBE Vapor Condensate
(MRD-00-713)

This report details the statistical analysis of fetal body weight and
anomaly data from ExxonMobil Study 171634.  The study was conducted to
evaluate the potential developmental toxicity of Baseline Gasoline with
ETBE Vapor Condensate (GEVC).  GEVC was administered via whole-body
inhalation exposure to pregnant rats during the period of major
organogenesis and fetal growth.  GEVC was administered by whole-body
inhalation exposure to 25 confirmed-mated Crl: CD®(SD) IGSBR female
rats at target doses of 0 (air control) 2000, 10,000, and 20,000 mg/m3
for six hours (plus the theoretical equilibration time) daily from
Gestation Day (GD) 5 through GD 20. 

The fetal body weight was analyzed by a mixed model analysis of variance
that provided an accurate statistical model of the biology.  The
analysis used the litter as the basis for analysis and effectively used
the litter size as a covariate.  The model considered dose group, litter
size, and fetal sex as explanatory variables.  When the overall effect
of dose, or the dose by sex effect, was statistically significant the
dose groups means were tested pairwise vs. the control group using least
squares means.  The least squares means allowed comparisons that
accounted for differences in litter size and sex.  The mathematical
model is based on a paper by Chen, et al (1996).  The analysis was run
using SAS with code suggested in Little, et al (1997).  

The analysis of anomalies (malformations, variations, or observations)
was based on a Generalized Estimating Equation (GEE) application of the
linearized model, Ryan (1992).  The model used the litter as the basis
for analysis and considered correlation among littermates by
incorporating an estimated constant correlation and the litter size as a
covariate.  When the overall effect of dose, or the dose by sex effect,
was statistically significant the dose groups were tested pairwise vs.
the control group using least squares means.  The least squares means
allows comparisons that account for differences in litter size.  There
were three categories of anomalies tested, and within each category
specific anomalies were also tested.  In addition to the category
specific anomalies a series of combined analyses were performed within
each category: 

Combined Malformations and Variations for All Fetuses

Combined Malformations and Variations for Alive Fetuses

Combined Malformations and Variations for Dead Fetuses 

Malformations for All Fetuses

Malformations for Alive Fetuses

Malformations for Dead Fetuses

Variations for All Fetuses

Variations for Alive Fetuses

Variations for Dead Fetuses

In some cases there were no dead fetuses in a category.

K-1

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

Table I lists the four categories and corresponding sub-categories. 
Within each category several subcategories were combined into a group of
similar anomalies.  For example in the Category Skeletal the separate
sub-categories of “SKELETAL/RIBS (C7): Cervical rib; Bilateral”,
“SKELETAL/RIBS: Rudimentary supernumerary ribs”, and
“SKELETAL/RIBS (L1):  Well-formed; Left” were combined into a
sub-category “SKELETAL/RIBS:  supernumerary Ribs(combined)”.  In
this combined category an animal is counted once when he, or she,
exhibits more than one characteristic.  The sub-categories that were
combined are listed in the Sub-categories Combined column of Table 1 by
the sub-category number.  The analyses were run using SAS.  

Table I

Anomaly Categories and Corresponding Sub-categories

Category	Sub-Category	Sub-categories combined

Head	1- HEAD:  Anolphthalmia; Bilateral



2- HEAD:  Dilated lateral ventricles; Bilateral



3- HEAD:  Open eye; Right



4- HEAD:  Retina fold

	External	1- EXTERNAL:  Acaudate                                        
                               



2- EXTERNAL:  Anal atresia



3- EXTERNAL:  Anasarca



4- EXTERNAL:  Brachydactyly; all paws                                   
                     



5- EXTERNAL:  Conjoined twin; Joined at thoracic region; 1 head, 8
limbs, 2 tails, 1 umbilicus



6- EXTERNAL:  Domed head



7- EXTERNAL:  Ectrodactyly; all paws



8- EXTERNAL:  Kyphosis



9- EXTERNAL:  Malrotated hindpaw; Left



10- EXTERNAL:  Small eye bulge; Bilateral

	

K-2

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

Table I

Malformation Categories and Corresponding Sub-categories

Abdomen/Thorax	1- ABDOMEN/THORAX:  All other abdominal organs appear on
each side                                  



2- ABDOMEN/THORAX:  All thoracic and cranial organs shared



3- ABDOMEN/THORAX:  Cecum not evident; bifurcation appears in area where
cecum would normally reside



4- ABDOMEN/THORAX:  Double aorta



5- ABDOMEN/THORAX:  Duplicate tongue



6- ABDOMEN/THORAX:  Elongated innominate artery



7- ABDOMEN/THORAX:  Enlarged atrial chamber; Right



8- ABDOMEN/THORAX:  Hydronephrosis



9- ABDOMEN/THORAX:  Hydroureter



10- ABDOMEN/THORAX:  Innominate artery absent



11- ABDOMEN/THORAX:  Liver, stomach, spleen, entire small intestine
shared



12- ABDOMEN/THORAX:  Malpositioned carotid



13- ABDOMEN/THORAX:  Malpositioned carotid and subclavian branches;
Bilateral



14- ABDOMEN/THORAX:  Malpositioned kidneys



15- ABDOMEN/THORAX:  Malpositioned ovaries



16- ABDOMEN/THORAX:  Malpositioned pulmonary artery branch



17- ABDOMEN/THORAX:  Malpositioned subclavian branch; Right



18- ABDOMEN/THORAX:  Malpositioned uterus



19- ABDOMEN/THORAX:  Misshapen spleen



20- ABDOMEN/THORAX:  No cervical spinal column



21- ABDOMEN/THORAX:  Spleen small



22- ABDOMEN/THORAX:  Supernumerary lung lobe; Left



23- ABDOMEN/THORAX:  Umbilical artery aneurysm



24- ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder



25- ABDOMEN/THORAX:  Ventricle small; Left



26- ABDOMEN/THORAX:  Abnormal spleen	19,21

	27- ABDOMEN/THORAX:  Abnormal thoracic/cervical blood vessels
6,10,13,12,16,17

	28- ABDOMEN/THORAX:  Malpositioned urogenital organs	14,15,18



K-3

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

Table I

Malformation Categories and Corresponding Sub-categories

Skeletal	1- SKELETAL/FORELIMB (All bones ):  Duplication or extra bones 
      



2- SKELETAL/FOREPAW (All bones):  Duplication or extra bones



3- SKELETAL/FOREPAW (Metacarpal 1 anlage):  Misshapen; Left



4- SKELETAL/FOREPAW (Proximal phalanges 2-4):  Unossified; Bilateral



5- SKELETAL/HINDLIMB (All bones):  Duplication or extra bones; Bilateral



6- SKELETAL/HINDPAW (All bones):  Duplication or extra bones; Bilateral



7- SKELETAL/HINDPAW (Calcaneus): Advanced; Bilateral



8- SKELETAL/PECTORAL GIRDLE (All bones):  Duplication or extra bones;
Bilateral



9- SKELETAL/PELVIC GIRDLE (All bones):  Duplication or extra bones;
Bilateral



10- SKELETAL/RIBS (All bones): Duplication or extra bones



11- SKELETAL/RIBS (C7 and T1 Anlage):  Fused; Anlage on C7 and T1 rib
fused before it meets sternebrae



12- SKELETAL/RIBS (C7, C7 Anlage):  Cervical rib; Bilateral



13- SKELETAL/RIBS (L1): Well-formed; Left



14- SKELETAL/RIBS (Right twin T8 left, Left twin T8 right):  Fused; Left



15- SKELETAL/RIBS (T13):  Short last rib; Right



16- SKELETAL/RIBS:  Rudimentary supernumerary ribs



17- SKELETAL/SKULL (Interparietal):  Misshapen



18- SKELETAL/SKULL (Squamosal Process):  Hypoplastic; Left



19- SKELETAL/SKULL
(Supraoccipital,Interparietal,Parietals,Frontals,Nasals):  Duplication
or extra bone



20- SKELETAL/SKULL (Tympanics):  Hypoplastic



21- SKELETAL/STERNEBRAE (All bones):  Duplication or extra bones



22- SKELETAL/STERNEBRAE (VI):  Advanced



23- SKELETAL/STERNEBRAE:  Asymmetric sternebrae



24- SKELETAL/STERNEBRAE:  Bifid sternebrae



25- SKELETAL/STERNEBRAE:  Dumbbell-shaped sternebrae



26- SKELETAL/STERNEBRAE:  Hypoplastic sternebrae



27- SKELETAL/STERNEBRAE:  Misshapen sternebrae



28- SKELETAL/STERNEBRAE:  Unossified sternebrae



29- SKELETAL/VERTEBRAE (All bones):  Duplication or extra bones



30- SKELETAL/VERTEBRAE (CE3 Anlage):  Bifid centra



31- SKELETAL/VERTEBRAE (L): One less presacral vertebrae



32- SKELETAL/VERTEBRAE (L1):  Misshapen centra



33- SKELETAL/VERTEBRAE (Left twin CE 1-7):  Fused



34- SKELETAL/VERTEBRAE (Left twin T2):  Unossified centra



35- SKELETAL/VERTEBRAE (Left twin T3):  Hemicentra



36- SKELETAL/VERTEBRAE:  Bifid vertebral centra



37- SKELETAL/VERTEBRAE:  Dumbbell-shaped vertebral centra



38- SKELETAL/VERTEBRAE:  Dumbbell-shaped vertebral centra anlage



39- SKELETAL/RIBS:  Supernumerary ribs	13,17,14

	40- SKELETAL/STERNEBRAE:  Hypoplastic sternebrae	24,25,26,28

	41- SKELETAL/VERTEBRAE:  Hypoplastic vertebral centra	35,36,37,38



K-4

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

RESULTS:

BODY WEIGHT ANALYSIS

There was no statistically significant difference in the mean fetal
litter weights among the dose groups.  Table II shows the mean fetal
weight and the least squares mean fetal weight.  The weight difference
between the male and female pups was not consistent across the dose
groups; therefore only the mean pup weight respective of sex is
presented.

Table II

Mean fetal weight, the least squares mean fetal weight

Exposure Group

(mg/m3)	n litters 	n fetuses	observed fetus mean (gm)	Least squares
fetus mean (gm)

0	25	353	5.32	5.33

2,000	23	329	5.31	5.34

10,000	24	325	5.30	5.29

20,000	24	342	5.27	5.25



ANOMALY ANALYSES

The analyses of the incidence of combined external variations and
malformations (all fetuses) and of combined external malformations (all
fetuses) indicated a statistically significant increased incidence in
the control group relative to the dosed groups.  This finding is
considered a statistical anomaly. 

None of the malformation or variation analyses indicated statistically
significant differences among the dose groups. Incidence tables are
provided in the appendix.

CONCLUSION:

Based on these findings, administration of the test substance at the
exposures tested is not associated with a change in mean litter fetal
body weight or any change in head, external, abdomen/thorax and skeletal
malformations/variations.

									

Mark J. Nicolich, Ph.D.			Date

Statistician

ExxonMobil Biomedical Sciences, Inc

1545 Route 22 East

PO Box 971

Annandale, NJ 08801-0971

									

George Bukhbinder, Ph.D.			Date

Consultant

K-5

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

References:  

Chen, Gaylor, and Laborde, “Dose-response modeling of growth for
developmental toxicity”, Environmetrics, vol 7, pg 135-144, 1996. 

Little, Milliken, Stroup, and Wolfinger, “SAS System for Mixed
Models“, SAS Institute, Cary, NC, 1997, section 5.6.2, pg 203.

Ryan, L., “The use of generalized estimating equations for risk
assessment in developmental toxicity”, Risk Analysis, 12(3), pg
439-447, 1992.

  

SAS/STAT, V8.02, copyright © 1999-2001, SAS Institute, Inc., Cary, NC.

K-6

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                    APPENDIX

                                    Anomaly Counts      

                                         Study # 171634      

                                                     Head Variations and
Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          2          
2   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          1          
1   

                  20000 MG/M3       24          172          1          
1   

 

 

 

 

                         Head Variations and Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          177          1          
1   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          1          
1   

                  20000 MG/M3       24          171          1          
1   

 

 

 

 

                         Head Variations and Malformations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           1          
1   

                  20000 MG/M3        1           1           0          
0   

 

 

 

 

                                  Head Variations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

K-7

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                  Head Variations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          177          0          
0   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                  Head Variations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           1          
1   

                  20000 MG/M3        1           1           0          
0   

 

 

 

 

                                 Head Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          2          
2   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          1          
1   

                  20000 MG/M3       24          172          1          
1   

 

 

 

 

                                 Head Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          177          1          
1   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          1          
1   

                  20000 MG/M3       24          171          1          
1   

 

 

 

K-8

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                 Head Malformations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           1          
1   

                  20000 MG/M3        1           1           0          
0   

 

 

 

 

                                       head - individual

                                HEAD:  Anolphthalmia; Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                       head - individual

                          HEAD:  Dilated lateral ventricles; Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                       head - individual

                                     HEAD:  Open eye; Right

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          1          
1   

 

 

 

K-9

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                       head - individual

                                       HEAD:  Retina fold

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          164          0          
0   

                  10000 MG/M3       24          162          1          
1   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                       External Variations and Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          4          
4   

                   2000 MG/M3       23          329          1          
1   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                       External Variations and Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          353          3          
3   

                   2000 MG/M3       23          329          1          
1   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          342          0          
0   

 

 

 

 

                       External Variations and Malformations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           1          
1   

                  20000 MG/M3        1           1           0          
0   

 

 

 

K-10

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                               External Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          4          
4   

                   2000 MG/M3       23          329          1          
1   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

  

 

                               External Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          353          3          
3   

                   2000 MG/M3       23          329          1          
1   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          342          0          
0   

 

 

 

 

                               External Malformations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           1          
1   

                  20000 MG/M3        1           1           0          
0   

 

 

 

 

                                     external - individual

                                      EXTERNAL:  Acaudate

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

K-11

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     external - individual

                                    EXTERNAL:  Anal atresia

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                                     external - individual

                                      EXTERNAL:  Anasarca

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                                     external - individual

                               EXTERNAL:  Brachydactyly; all paws

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                                     external - individual

EXTERNAL:  Conjoined twin; Joined at thoracic region;

1 head, 8 limbs, 2 tails, 1 umbilicus

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          0          
0   

                   2000 MG/M3       23          329          1          
1   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

K-12

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     external - individual

                                     EXTERNAL:  Domed head

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                                     external - individual

                               EXTERNAL:  Ectrodactyly; all paws

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                                     external - individual

                                      EXTERNAL:  Kyphosis

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                                     external - individual

                              EXTERNAL:  Malrotated hindpaw; Left

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          2          
2   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

K-13

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     external - individual

                             EXTERNAL:  Small eye bulge; Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          354          1          
1   

                   2000 MG/M3       23          329          0          
0   

                  10000 MG/M3       24          325          0          
0   

                  20000 MG/M3       24          343          0          
0   

 

 

 

 

                       Visceral Variations and Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          6          
7   

                   2000 MG/M3       23          165          5          
6   

                  10000 MG/M3       24          162          2          
3   

                  20000 MG/M3       24          172          1          
1   

 

 

 

 

                       Visceral Variations and Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          177          5          
6   

                   2000 MG/M3       23          165          5          
6   

                  10000 MG/M3       24          162          2          
3   

                  20000 MG/M3       24          171          1          
1   

 

 

 

 

                       Visceral Variations and Malformations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           1          
1   

                  20000 MG/M3        1           1           0          
0   

 

 

 

K-14

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                Visceral Variations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          3          
4   

                   2000 MG/M3       23          165          2          
2   

                  10000 MG/M3       24          162          2          
3   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                Visceral Variations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          177          3          
4   

                   2000 MG/M3       23          165          2          
2   

                  10000 MG/M3       24          162          2          
3   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                Visceral Variations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           0          
0   

                  20000 MG/M3        1           1           0          
0   

 

 

 

 

                               Visceral Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          4          
4   

                   2000 MG/M3       23          165          4          
4   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          1          
1   

 

 

 

K-15

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                               Visceral Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          177          3          
3   

                   2000 MG/M3       23          165          4          
4   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          171          1          
1   

 

 

 

 

                               Visceral Malformations - combined 

                                          Dead Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3        1           1           1          
1   

                  20000 MG/M3        1           1           0          
0   

 

 

 

 

                                     visceral - individual

ABDOMEN/THORAX:  Cecum not evident;

bifurcation appears in area where cecum would normally reside

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                                 ABDOMEN/THORAX:  Double aorta

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

K-16

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     visceral - individual

                               ABDOMEN/THORAX:  Duplicate tongue

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                          ABDOMEN/THORAX:  Elongated innominate artery

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                        ABDOMEN/THORAX:  Enlarged atrial chamber; Right

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                                ABDOMEN/THORAX:  Hydronephrosis

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          2          
2   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

K-17

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     visceral - individual

                                  ABDOMEN/THORAX:  Hydroureter

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          2          
2   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                           ABDOMEN/THORAX:  Innominate artery absent

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                             ABDOMEN/THORAX:  Malpositioned carotid

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

  ABDOMEN/THORAX:  Malpositioned carotid and subclavian branches;
Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

K-18APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     visceral - individual

                             ABDOMEN/THORAX:  Malpositioned kidneys

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                             ABDOMEN/THORAX:  Malpositioned ovaries

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                     ABDOMEN/THORAX:  Malpositioned pulmonary artery
branch

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                    ABDOMEN/THORAX:  Malpositioned subclavian branch;
Right

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

K-19

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     visceral - individual

                             ABDOMEN/THORAX:  Malpositioned uterus

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                               ABDOMEN/THORAX:  Misshapen spleen

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                           ABDOMEN/THORAX:  No cervical spinal column

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                                 ABDOMEN/THORAX:  Spleen small

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

K-20

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     visceral - individual

                         ABDOMEN/THORAX:  Supernumerary lung lobe; Left

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                           ABDOMEN/THORAX:  Umbilical artery aneurysm

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          1          
1   

 

 

 

 

                                     visceral - individual

  ABDOMEN/THORAX:  Umbilical artery arises from left side of urinary
bladder

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          3          
4   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          2          
3   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                     visceral - individual

                             ABDOMEN/THORAX:  Ventricle small; Left

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

K-21

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                      visceral - combined

                                ABDOMEN/THORAX:  Abnormal spleen

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          0          
0   

                   2000 MG/M3       23          165          2          
2   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                      visceral - combined

                   ABDOMEN/THORAX:  Abnormal thoracic/cervical blood
vessels

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          2          
2   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                                      visceral - combined

                        ABDOMEN/THORAX:  Malpositioned urogenital organs

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       25          178          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          162          0          
0   

                  20000 MG/M3       24          172          0          
0   

 

 

 

 

                       Skeletal Variations and Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176         17         
39   

                   2000 MG/M3       23          165         16         
29   

                  10000 MG/M3       24          163         18         
42   

                  20000 MG/M3       24          171         18         
42   

 

 

 

K-22

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                       Skeletal Variations and Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176         17         
39   

                   2000 MG/M3       23          165         16         
29   

                  10000 MG/M3       24          163         18         
42   

                  20000 MG/M3       24          171         18         
42   

 

 

 

 

                                Skeletal Variations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176         17         
39   

                   2000 MG/M3       23          165         16         
29   

                  10000 MG/M3       24          163         18         
42   

                  20000 MG/M3       24          171         18         
42   

 

 

 

 

                                Skeletal Variations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176         17         
39   

                   2000 MG/M3       23          165         16         
29   

                  10000 MG/M3       24          163         18         
42   

                  20000 MG/M3       24          171         18         
42   

 

 

 

 

                               Skeletal Malformations - combined 

                                          All Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          1          
1   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          0          
0   

 

 

 

K-23

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                               Skeletal Malformations - combined 

                                         Alive Fetuses

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          1          
1   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                  SKELETAL/FORELIMB (All bones ):  Duplication or extra
bones

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                   SKELETAL/FOREPAW (All bones):  Duplication or extra
bones

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                    SKELETAL/FOREPAW (Metacarpal 1 anlage):  Misshapen;
Left

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          0          
0   

 

 

 

K-24

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

            SKELETAL/FOREPAW (Proximal phalanges 2-4):  Unossified;
Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

        SKELETAL/HINDLIMB (All bones):  Duplication or extra bones;
Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

         SKELETAL/HINDPAW (All bones):  Duplication or extra bones;
Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                       SKELETAL/HINDPAW (Calcaneus): Advanced; Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

K-25

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

skeletal - individual

SKELETAL/PECTORAL GIRDLE (All bones):

Duplication or extra bones; Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

skeletal - individual

SKELETAL/PELVIC GIRDLE (All bones):

Duplication or extra bones; Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

skeletal - individual

SKELETAL/RIBS (All bones): Duplication or extra bones

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

skeletal - individual

SKELETAL/RIBS (C7 and T1 Anlage):

Fused; Anlage on C7 and T1 rib fused before it meets sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

K-26

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

                    SKELETAL/RIBS (C7, C7 Anlage):  Cervical rib;
Bilateral

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          1          
1   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                             SKELETAL/RIBS (L1): Well-formed; Left

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          1          
1   

 

 

 

 

                                     skeletal - individual

         SKELETAL/RIBS (Right twin T8 left, Left twin T8 right):  Fused;
Left

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                          SKELETAL/RIBS (T13):  Short last rib; Right

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          2          
2   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          0          
0   

 

 

K-27

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

                          SKELETAL/RIBS:  Rudimentary supernumary ribs

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          9         
17   

                   2000 MG/M3       23          165         10         
15   

                  10000 MG/M3       24          163         13         
23   

                  20000 MG/M3       24          171         13         
24   

 

 

 

 

                                     skeletal - individual

                           SKELETAL/SKULL (Interparietal):  Misshapen

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                     SKELETAL/SKULL (Squamosal Process):  Hypoplastic;
Left

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

skeletal - individual

SKELETAL/SKULL (Supraoccipital,Interparietal,Parietals,Frontals,Nasals):

Duplication or extra bones

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

K-28

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

                            SKELETAL/SKULL (Tympanics):  Hypoplastic

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                 SKELETAL/STERNEBRAE (All bones):  Duplication or extra
bones

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                              SKELETAL/STERNEBRAE (VI):  Advanced

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          1          
1   

                   2000 MG/M3       23          165          2          
2   

                  10000 MG/M3       24          163          1          
2   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                          SKELETAL/STERNEBRAE:  Asymmetric sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          2          
2   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          1          
2   

 

 

K-29

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

                             SKELETAL/STERNEBRAE:  Bifid sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          1          
1   

 

 

 

 

                                     skeletal - individual

                        SKELETAL/STERNEBRAE:  Dumbbell-shaped sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          1          
3   

 

 

 

 

                                     skeletal - individual

                          SKELETAL/STERNEBRAE:  Hypoplastic sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          1          
1   

 

 

 

 

                                     skeletal - individual

                           SKELETAL/STERNEBRAE:  Misshapen sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          3          
4   

                   2000 MG/M3       23          165          3          
6   

                  10000 MG/M3       24          163          2          
2   

                  20000 MG/M3       24          171          5          
5   

 

 

 

K-30

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

                          SKELETAL/STERNEBRAE:  Unossified sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          3          
3   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          3          
5   

                  20000 MG/M3       24          171          6         
10   

 

 

 

 

                                     skeletal - individual

                  SKELETAL/VERTEBRAE (All bones):  Duplication or extra
bones

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                         SKELETAL/VERTEBRAE (CE3 Anlage):  Bifid centra

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          1          
1   

 

 

 

 

                                     skeletal - individual

                      SKELETAL/VERTEBRAE (L): One less presacral
vertebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          0          
0   

 

 

 

K-31

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

                           SKELETAL/VERTEBRAE (L1):  Misshapen centra

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          0          
0   

                  10000 MG/M3       24          163          1          
1   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                         SKELETAL/VERTEBRAE (Left twin CE 1-7):  Fused

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                     SKELETAL/VERTEBRAE (Left twin T2):  Unossified
centra

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

 

                                     skeletal - individual

                         SKELETAL/VERTEBRAE (Left twin T3):  Hemicentra

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          0          
0   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          0          
0   

                  20000 MG/M3       24          171          0          
0   

 

 

 

K-32

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                     skeletal - individual

                          SKELETAL/VERTEBRAE:  Bifid vertebral centra

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          6          
7   

                   2000 MG/M3       23          165          6          
6   

                  10000 MG/M3       24          163          3          
6   

                  20000 MG/M3       24          171          5          
5   

 

 

 

 

                                     skeletal - individual

                     SKELETAL/VERTEBRAE:  Dumbbell-shaped vertebral
centra

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          3          
3   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          2          
3   

                  20000 MG/M3       24          171          2          
2   

 

 

 

 

                                     skeletal - individual

                 SKELETAL/VERTEBRAE:  Dumbbell-shaped vertebral centra
anlage

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          8         
12   

                   2000 MG/M3       23          165          4          
4   

                  10000 MG/M3       24          163          5          
9   

                  20000 MG/M3       24          171          3          
3   

 

 

 

 

                                      skeletal - combined

                               SKELETAL/RIBS:  Supernumerary ribs

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          9         
18   

                   2000 MG/M3       23          165         10         
15   

                  10000 MG/M3       24          163         13         
23   

                  20000 MG/M3       24          171         13         
24   

 

 

K-33

APPENDIX K – STATISTICIAN’S REPORT (CONT’D)

                                      skeletal - combined

                          SKELETAL/STERNEBRAE:  Hypoplastic sternebrae

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          3          
3   

                   2000 MG/M3       23          165          1          
1   

                  10000 MG/M3       24          163          4          
6   

                  20000 MG/M3       24          171          7         
12   

 

 

 

 

                                      skeletal - combined

                       SKELETAL/VERTEBRAE:  Hypoplastic vertebral centra

                                   dams       fetuses      dams      
fetuses

                     DOSE        examined    examined    affected   
affected

                      0 MG/M3       24          176          7         
10   

                   2000 MG/M3       23          165          7          
8   

                  10000 MG/M3       24          163          4          
8   

                  20000 MG/M3       24          171          6          
6   

K-34

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY

TESTING FACILITY – ANNANDALE, NJ

SUPPLIER: Charles River Laboratories, Inc.

FEED: PMI Certified Rodent Chow (5002 Meal)

STUDY          NUMBER	STUDY DATES	SUPPLIER LOCATION/AREA	SPECIES/STRAIN
NUMBER OF LITTERS/FETUSES	% PREGNANT	DOSING ROUTE/CARRIER

9A	May 9, 2000 – 

June 2, 2000	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	25/398	100
Oral/Corn Oil

9B	May 9, 2000 – 

June 2, 2000	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	25/401	100
Oral/Corn Oil

10	May 19, 2001 – 

June 15, 2001	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	24/359	96
Inhalation/Air

11	August 19, 2001 – 

September 18, 2001	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	24/358	96
Inhalation/Air

12	November 18, 2001 -December 20, 2001	Raleigh, NC/R04
Crl:CD®(SD)IGSBR VAF/Plus	25/389	100	Inhalation/Air

13	February 3, 2002 – 

March 8, 2001	Raleigh, NC/R04	Crl:CD®(SD)IGSBR VAF/Plus	25/374	100
Inhalation/Air



L-1

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (UTERINE IMPLANTATION DATA)

	NUMBER

OF

LITTERS	

LIVE	

MALE	

FEMALE	

RESORPTIONS	

IMPLANTS	

CORPORA LUTEA	

DEAD	

FETUS/ IMPLANTS	

RESORPTIONS/ IMPLANTS	

F/I TRANSFORMED

HIGH

16.04	7.92	8.36	0.72	16.48	17.16	0	0.98	0.05	80.376320

LOW

14.92	7.17	7.42	0.32	15.50	15.96	0	0.95	0.02	77.306160

STUDY #











	13	25	14.96	7.36	7.60	0.72	15.68	15.96	0	0.95	0.05	77.306160

STD

3.12	2.45	2.42	0.84	3.09	3.18	0	0.07	0.07	6.507916

(N)

25	25	25	25	25	25	25	25	25	25

12	25	15.56	7.92	7.64	0.32	15.88	16.40	0	0.98	0.02	80.376320

STD

2.92	2.64	2.38	0.56	2.88	2.99	0	0.04	0.03	3.947106

(N)

25	25	25	25	25	25	25	25	25	25

11	24	14.92	7.17	7.75	0.63	15.54	16.04	0	0.96	0.04	78.114083

STD

2.19	2.57	2.27	0.77	1.82	1.94	0	0.05	0.05	5.545914

(N)

24	24	24	24	24	24	24	24	24	24

10	24	14.96	7.54	7.42	0.58	15.50	16.42	0	0.97	0.04	78.883958

STD

3.07	2.90	2.55	0.83	3.18	3.41	0	0.05	0.05	5.408551

(N)

24	24	24	24	24	24	24	24	24	24

9(B)	25	16.04	7.84	8.20	0.44	16.48	17.16	0	0.97	0.03	79.840760

STD

2.24	1.57	1.91	0.77	2.02	1.93	0	0.05	0.05	5.232909

(N)

25	25	25	25	25	25	25	25	25	25

9(A)	25	15.92	7.56	8.36	0.52	16.44	16.88	0	0.97	0.03	79.294360

STD

1.53	1.69	1.60	0.71	1.42	1.48	0	0.04	0.04	4.836482

(N)

25	25	25	25	25	25	25	25	25	25



L-2

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (UTERINE IMPLANTATION DATA)

	NUMBER

OF

LITTERS	

R/I TRANSFORMED	

D/I TRANSFORMED	

DEAD/ IMPLANTS	PRE IMPLANT LOSS	POST IMPLANT LOSS	

MALFORMATIONS	

VARIATIONS	

AFFECTED

HIGH

12.694280	7.473	0	5.1	5.1	0.25	1.4	1.00

LOW

9.624000	7.103	0	1.60	2.0	0.08	0	0.40

STUDY #









	13	25	12.694280	7.473	0	1.6	5.1	0.24	1.40	1.00

STD

6.507867	1.521	0	2.7	6.7	0.52	1.60	1.00

(N)

25	25	25	25	25	25	25	25

12	25	9.624000	7.326	0	3.0	2.0	0.10	1.40	0.40

STD

3.947128	0.905	0	3.9	3.4	0.30	1.20	0.60

(N)

25	25	25	25	25	25	25	25

11	24	11.886500	7.324	0	3.0	4.2	0.25	1.10	0.90

STD

5.545880	0.446	0	3.9	5.4	0.53	1.10	1.10

(N)

24	24	24	24	24	24	24	24

10	24	11.402500	7.455	0	5.1	3.3	0.17	0.70	0.80

STD

5.349722	1.087	0	12.6	5.4	0.38	0.80	0.80

(N)

24	24	24	24	24	24	24	24

9(B)	25	10.159600	7.117	0	3.9	2.8	0.08	0.00	0.50

STD

5.232766	0.478	0	7.0	5.0	0.40	0.00	0.80

(N)

25	25	25	25	25	25	25	25

9(A)	25	10.706120	7.103	0	2.5	3.1	0.12	0.10	0.60

STD

4.836645	0.318	0	4.3	4.3	0.33	0.40	0.70

(N)

25	25	25	25	25	25	25	25



L-3

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (FETAL BODY WEIGHTS)

	NUMBER

OF

LITTERS	

MALE	

FEMALE

HIGH

5.75	5.50

LOW

5.41	5.16

STUDY #



	13	25	5.49	5.17

STD

0.33	0.37

(N)

184	190

12	25	5.59	5.36

STD

0.36	0.32

(N)

198	191

11	24	5.52	5.25

STD

0.38	0.45

(N)

172	186

10	24	5.75	5.50

STD

0.35	0.34

(N)

181	178

9(B)	25	5.41	5.16

STD

0.45	0.39

(N)

196	205

9(A)	25	5.61	5.31

STD

0.38	0.37

(N)

189	209



L-4

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (EXTERNAL DATA)

STUDY #	13	12	11	10	9(B)	9(A)

NUMBER OF LITTER	25	25	24	24	25	25

NUMBER OF FETUSES	374	389	358	359	401	398

% STUNTED - F	0.27	0.26	0.84	0	1.25	0

% STUNTED - L	4.00	4.00	8.33	0	16.00	0









% EXT. VAR. - F	0	0	0	0	0	0

% EXT. VAR. - L	0	0	0	0	0	0

 







% EXT. MAL - F	0.53	0.26	0.56	0.28	0	0.50

% EXT. MAL. - L	8.00	4.00	8.33	4.17	0	8.00









Malrotated hindpaw - F	0.53	0.26	0.28	0.28

0.50

Malrotated hindpaw - L	8.00	4.00	4.17	4.17

8.00

Filamentous tail - F

	0.28



	Filamentous tail - L

	4.17











































	NOTE:    F - Fetus







                L - Litter







	Blank entries for an observation indicate that the observation was not
present in that study

L-5

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (INTERNAL DATA)

STUDY #	13	12	11	10	9(B)	9(A)

NUMBER OF LITTER	25	25	24	24	25	25

NUMBER OF FETUSES	182	195	181	178	197	201

% VIS. VAR. - F	0.55	0	0	0	0	1.00

% VIS. VAR. - L	4.00	0	0	0	0	4.00









% VIS. MAL. - F	2.19	0.51	2.21	1.69	1.02	0.50

% VIS. MAL. - L	12.00	4.0	16.67	12.50	4.00	4.00









Olfactory bulb: Misshapen  - F

0.51





Olfactory bulb: Misshapen - L

4.00





Microphthalmia - F



	0.51

	Microphthalmia - L



	4.00

	Retinal fold  - F	1.64

	1.12



Retinal fold - L	8.00

	8.33











NOTE:    F - Fetus







               L - Litter















	Blank entries for an observation indicate that the observation was not
present in that study

L-6

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (INTERNAL DATA)

STUDY #	13	12	11	10	9(B)	9(A)

NUMBER OF LITTER	25	25	24	24	25	25

NUMBER OF FETUSES	182	195	181	178	197	201

Hydronephrosis - F

	1.66



	Hydronephrosis - L

	12.50



	Ureter(s): Convoluted  - F





1.00

Ureter(s): Convoluted - L





4.00

Hydroureter - F

	0.55	0.56	0.51	0.50

Hydroureter - L

	4.17	4.17	4.00	4.00

Umbilical artery: Left of urinary bladder - F	0.55





	Umbilical artery: Left of urinary bladder - L	4.00





	Testis(es): Malpositioned  - L	0.55





	Testis(es): Malpositioned - F	4.00













	NOTE:    F - Fetus







               L - Litter

















L-7

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (SKELETAL DATA)

STUDY #	13	12	11	10	9(B)	9(A)

NUMBER OF LITTER	25	25	24	24	$	$

NUMBER OF FETUSES	192	194	177	181	$	$

% SKEL. VAR. - F	17.80	15.46	15.25	8.84	$	$

% SKEL. VAR. - L	76.00	60.00	54.17	50.00	$	$









% SKEL. MAL. - F	0	0	1.13	0	$	$

% SKEL. MAL. - L	0	0	8.33	0	$	$









Sternebrae: Advanced - F	1.05





	Sternebrae: Advanced - L	8.00





	Sternebrae: Bifid - F	0.52





	Sternebrae: Bifid - L	4.00





	Sternebrae: Hypoplastic - F

1.03





Sternebrae: Hypoplastic - L

4.00





Sternebrae: Unossified - F	1.05

1.7	1.10



Sternebrae: Unossified - L	8.00

8.33	8.33



Sternebral anlage: Hypoplastic - F

	2.82



	Sternebral anlage: Hypoplastic - L

	12.50



	Vertebrae: Absent multiple - F

	0.56



	Vertebrae: Absent multiple - L

	4.17



	Vertebral centra: Bifid- F	5.76	10.82	6.78	1.10



Vertebral centra: Bifid- L	36.00	48.00	29.17	8.33





L-8

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (SKELETAL DATA)

STUDY #	13	12	11	10	9(B)	9(A)

NUMBER OF LITTER	25	25	24	24	$	$

NUMBER OF FETUSES	192	194	177	181	$	$

Vertebral centra: Dumbbell/8-shaped - F	0.52	0.52

1.10



Vertebral centra: Dumbbell/8-shaped - L	4.00	4.00

8.33



Vertebral centra: Misshapen - F

	0.56



	Vertebral centra: Misshapen- L

	4.17



	Vertebral centra: Unossified - F

	0.56



	Vertebral centra: Unossified - L

	4.17



	Vertebrae: Supernumerary presacral Lumbar - F	0.52

0.56



	Vertebrae: Supernumerary presacral Lumbar - L	4.00

4.17



	Vertebral centra anlage: Bifid - F	0.52





	Vertebral centra anlage: Bifid - L	4.00





	Vertebral centra anlage: Dumbbell/8 shaped - F	5.24	1.55





Vertebral centra anlage: Dumbbell/8 shaped - L	28.00	12.00





Vertebral centra anlage: Hypoplastic - F

	1.69



	Vertebral centra anlage: Hypoplastic - L

	12.50



	Vertebral centra anlage: Misshapen - F

	0.56



	Vertebral centra anlage: Misshapen - L

	4.17



	Rib(s): Rudimentary lumbar - F	8.90	4.12	1.70	5.52



Rib(s): Rudimentary lumbar - L	40.00	24.00	12.50	25.00



Rib(s): Rudimentary thoracic - F	0.52





	Rib(s): Rudimentary thoracic - L	4.00





	Rib(s): Well formed lumbar - F	0.52





	Rib(s): Well formed lumbar - L	4.00





	

L-9

APPENDIX L - HISTORICAL CONTROL DATA FOR ANNANDALE, NJ FACILITY
(CONT’D)

 (SKELETAL DATA)

STUDY #	13	12	11	10	9(B)	9(A)

NUMBER OF LITTER	25	25	24	24	$	$

NUMBER OF FETUSES	192	194	177	181	$	$

Rib(s) anlage: Hypoplastic - F

	2.82



	Rib(s) anlage: Hypoplastic - L

	12.50



	Rib(s) anlage: Site of ossification - F

	1.13



	Rib(s) anlage: Site of ossification - L

	4.17











	NOTE:    F - Fetus







               L - Litter







               $ - Not examined

























L-10

APPENDIX M – FEED AND WATER ANALYSES

FEED ANALYSES

M-1

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

FEED ANALYSES

M-2

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-3

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-4

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-5

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-6

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-7

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-8

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-9

APPENDIX M – FEED AND WATER ANALYSES (CONT’D)

WATER ANALYSES

M-10

WHOLE-BODY INHALATION DEVELOPMENTAL TOXICITY STUDY IN RATS

WITH GASOLINE WITH ETBE VAPOR CONDENSATE MRD-00-716: 171634

 PAGE   

Page   PAGE  2  of   NUMPAGES  284 

Page   PAGE  202  of   NUMPAGES  284 

WHOLE-BODY INHALATION DEVELOPMENTAL TOXICITY STUDY IN RATS

WITH GASOLINE WITH ETBE VAPOR CONDENSATE MRD-00-716: 171634

Whole Body Inhalation Developmental Toxicity Study in Rats

With Gasoline Vapor with ETBE Condensate  (MRD-00-716):  171634

 PAGE   

Whole Body Inhalation Developmental Toxicity Study in Rats

With Gasoline Vapor with ETBE Condensate  (MRD-00-716):  171634

WHOLE-BODY INHALATION DEVELOPMENTAL TOXICICTY STUDY IN RATS

WITH GASOLINE VAPOR CONDENSATE WITH ETBE (MRD-00-716):  171634

 PAGE   

 

 

 

TREATED

GROUP CHAMBER

CONTROL CHAMBER

FLASK

ROTAMETER

TEST MATERIAL TANK

CRITICAL ORIFICE

MAGNAHELIC

GENERATION

CHAMBER

1.0 m3

CHAMBER

1.0 m3

CHAMBER

Miran

Miran

Pump

Pump

 OUT

 

IN

IN

OUT

IN

OUT

GC

GC

Line inlet

Select Stream

Disconnect

Stream Vent

