Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
l
0657
Study
Title
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
Laboratory
Project
ID:
DuPont­
10657
.
r
TEST
GUIDELINES:
U.
S.
EPA
Health
Effects
Test
Guidelines
OPPTS
870.3700
Prenatal
Developmental
Toxicity
Study
U.
S.
EPA
Federal
Register
(
August
5,
1999).
"
Dibasic
Esters;
Final
Enforceable
Consent
Agreement
and
Testing
Consent
Order."
Vol.
64,
No.
150,
pp.
42692­
42695.

AUTHOR:
Susan
M.
Munley,
M.
A.

STUDY
COMPLETED
ON:
April
15,2003
SPONSOR:
SOCMA
Dibasic
Esters
Group
1850
M
Street,
N.
W.,
Suite
700
Washington,
D.
C.
20036­
5810
PERFORMING
LABORATORY:
E.
I.
du
Pont
de
Nemours
and
Company
Haskell
Laboratory
for
Health
and
Environmental
Sciences
Elkton
Road,
P.
O.
Box
50
Newark,
Delaware
19714­
0050
WORK
REQUEST
NUMBER:
13495
SERVICE
CODE
NUMBER:
733
Page
1
of
207
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GOOD
LABORATORY
PRACTICE
COMPLIANCE
STATEMENT
This
study
was
conducted
in
compliance
with
U.
S.
EPA
TSCA
(
40
CFR
part
792)
Good
Laboratory
Practice
Standards,
which
are
consistent
with
the
OECD
Principles
of
Good
Laboratory
Practice
(
as
revised
in
1997)
published
in
ENV/
MC/
CHEM(
98)
17
except
for
the
item
documented
below.
The
item
listed
does
not
impact
the
validity
of
the
study.

The
test
substance
was
characterized
by
the
sponsor
prior
to
the
initiation
of
the
study.
Although
the
characterization
was
not
performed
under
Good
Laboratory
Practice
Standards,
the
accuracy
of
the
data
is
considered
sufficient
for
the
purposes
of
the
study.

Study
Director;
m.
alecApI
­­.

5/$
xdZm3
san
M.
Munley,
M#.
Dale
Research
Scientist
E.
I.
du
Pont
de
Ncmoursand
Company
2
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
QUALITY
ASSURANCE
STATEMENT
Haskell
Sample
Number(
s):

25136
Dates
of
Inspections:

Protocol:
May
20,2002;
June
17,24,2002
Conduct:
July
3,17,2002
Records,
Reports:
January
15­
17,20­
24,27,2003
Dates
Findings
Reported
to:

Study
Director:
May
28,2002;
June
17,2002;
January
23,27,2003
Management:
February
6,2003;
April
14,2003
Reported
by:
j5­
APR­
ao03
Date
Staff
Quality
Assurance
Auditor
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
CERTIFICATION
We,
the
undersigned,
declare
that
this
report
provides
an
accurate
evaluation
of
data
obtained
from
this
study.

InhalationEvaluatbnsby:
/
s­
45­
J
.
­&
u3
Linda
A
Malley,
W.
D.
Date
Senior
R­
h
Toxicologist
Issuedby
Study
Director:
13=
4 Y­­
aa23
SusanM.
Muley,
M/
AI
Date
4
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10457
TABLE
OF
CONTENTS
Page
GOOD
LABORATORY
PRACTICE
COMPLIANCE
STATEMENT
.........................................
2
QUALJTY
ASSURANCE
STATEMENT......................................................................................
3
CERTIFICATION
...........................................................................................................................
4
STUDY
INFORMATION...............................................................................................................
7
STUDY
PERSONNEL....................................................................................................................
8
SUMMARY
....................................................................................................................................
9
OBJECTIVE..................................................................................................................................
10
MATERIALS
AND
METHODS
..................................................................................................
10
A.
Test
Guidelines...................................................................................................................
10
B.
Test
Substance
and
Vehicle...............................................................................................
10
C.
Test
Species.......................................................................................................................
10
D.
Animal
Husbandry.............................................................................................................
11
E.
Quarantine
and
Pretest
Period
...........................................................................................
12
F.
Study
Design
.....................................................................................................................
12
G.
Selection
of
Dose
Levels
...................................................................................................
12
H.
Randomization
..................................................................................................................
12
I.
Inhalation
Exposure
System
..............................................................................................
13
J.
Characterization
of
Chamber
Atmosphere
........................................................................
14
K.
Animal
Euthanasia
............................................................................................................
15
L.
Parameters
to
be
Studied
...................................................................................................
15
M.
Control
of
Bias
..................................................................................................................
17
N.
Statistical
Analyses...............................................................................................................
18
RESULTS
AND
DISCUSSION....................................................................................................
19
Inhalation
Exposures
.....................................................................................................................
19
A.
Chamber
Concentrations
ofthe
Test
Substance................................................................
19
B.
Chamber.
Environmental
Conditions
.................................................................................
20
C.
Clinical
Observations
During
Exposure
............................................................................
21
Developmental
Evaluations...........................................................................................................
22
A.
Maternal
Findings..............................................................................................................
22
B.
Fetal
Findings
....................................................................................................................
23
CONCLUSIONS
...........................................................................................................................
24
RECORDS
AND
SAMPLE
STORAGE.......................................................................................
24
REFERENCES..............................................................................................................................
25
TABLES
........................................................................................................................................
27
1
2
3
4
5
6
7
8
9
10
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
FIGURES
......................................................................................................................................
48
APPENDICES...............................................................................................................................
52
LIST
OF
TABLES
Page
TABLE
CHAMBER
CONCENTRATIONS
OF
DMG
............................................................................................
29
TABLE
PARTICLE
SIZE
DISTRIBUTION
OF
DMG
...........................................................................................
31
TABLE
CHAMBER
ENVIRONMENTAL
CONDITIONS
....................................................................................
32
TABLE
MEAN
MATERNAL
BODY
WEIGHTS
...................................................................................................
34
TABLE
MEAN
MATERNAL
BODY
WEIGHT
CHANGES
.................................................................................
38
TABLE
MEAN
MATERNAL
FOOD
CONSUMPTION
........................................................................................
41
TABLE
CLINICAL
OBSERVATIONS...................................................................................................................
43
TABLE
REPRODUCTIVE
OUTCOME..................................................................................................................
44
TABLE
INCIDENCE
OF
FETAL
MALFORMATIONS
........................................................................................
45
TABLE
INCIDENCE
OF
FETAL
VARIATIONS.................................................................................................
46
LIST
OF
APPENDICES
APPENDIX
A
CERTIFICATE
OF
ANALYSIS
.........................................................................................................
53
APPENDIX
B
PROTOCOL
........................................................................................................................................
55
APPENDIX
C
DAILY
CHAMBER
CONCENTRATIONS
.......................................................................................
72
APPENDIX
D
DAILY
CHAMBER
ENVIRONMENTAL
CONDITIONS
...............................................................
76
APPENDIX
E
INDIVIDUAL
BODY
WEIGHTS.......................................................................................................
81
APPENDIX
F
INDIVIDUAL
BODY
WEIGHT
CHANGES
...................................................................................
108
APPENDIX
G
INDIVIDUAL
FOOD
CONSUMPTION..........................................................................................
125
APPENDIX
H
INDIVIDUAL.
CLINICAL
OBSERVATIONS.................................................................................
137
APPENDIX
I
GROSS
POSTMORTEM
FINDINGS
................................................................................................
155
APPENDIX
J
INDIVIDUAL
REPRODUCTIVE
DATA
.........................................................................................
162
APPENDIX
K
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
.............................................................
169
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
STUDY
INFORMATION
9th
Collective
Nomenclature:
Pentanedioic
acid,
dimethyl
ester
Synonyms/
Codes:
0
DBE­
5
DMG
H931363­
A
(
Lot
NO.)
H­
24300
Haskell
Number:
24300
CAS
Registry
Number:
1119­
40­
0
Composition:
99.61%
Dimethyl
glutarate
(
DMG­
DBES)
by
GC
Known
Impurities:
0.085%
Dimethyl
adipate
(
DMA­
DBEG)
by
GC
0.163%
Dimethyl
succinate
(
DMS­
DBE4)
by
GC
2.8
ppm
HCN
Physical
Characteristics:
Colorless
liquid
Stability:
The
test
substance
was
stable
under
the
conditions
of
the
study.

Sponsor:
SOCMA
Dibasic
Esters
Group
1850
M
Street,
N.
W.,
Suite
700
Washington,
D.
C.
20036­
5810
Study
InitiatedCompleted:
June
18,2002/
(
see
report
cover
page)

7
Dimethvl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicity
Study
in
Rabbits
DuPont­
10657
STUDY
PERSONNEL
Study
Director:
Susan
M.
Munley,
M.
A.
Inhalation
Consultant:
Linda
A.
Malley,
Ph.
D.
Management:
Eve
Mylchreest,
Ph.
D.
Robert
M.
Parker,
Ph.
D.,
D.
A.
B.
T
Supervisor:
Deborah
L.
Tyler
Primary
Technician:
William
P.
Boyer
Supervisor:
Arthur
J.
O Neill,
B.
S.
Inhalation
Technician:
John
A.
Nogaj,
B.
S.

Toxicology
Report
Preparation:
Mary
K.
LaRoe
Management:
Nancy
S.
Selzer,
M.
S.

Laboratory
Veterinarian:
Thomas
W.
Mayer,
D.
V.
M.,
A.
C.
L.
A.
M.
William
Singleton,
D.
V.
M.,
A.
C.
L.
A.
M.

8
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
SUMMARY
Dimethyl
glutarate
(
DMG)
was
administered
by
inhalation
to
groups
of
22
time­
mated
Hra:(
NZW)
SPF
rabbits.
The
inhalation
exposures
were
whole­
body
exposures
and
animals
were
exposed
for
approximately
6
hours
each
day
on
days
7
through
28
of
gestation.
Target
chamber
concentrations
were
0,
30,
100,300,
or
1000
mg/
m3.
During
the
in­
life
period,
maternal
body
weight,
food
consumption,
and
clinical
observation
data
were
collected
daily.
Animals
were
euthanized
on
day
29
of
gestation;
dams
were
subjected
to
a
gross
external
and
internal
postmortem
examination.
Gravid
uteri
were
removed,
weighed,
and
dissected
and
the
uterine
contents
were
described.
Each
live
fetus
was
weighed,
sexed,
and
examined
for
external,
visceral,
and
skeletal
alterations.

At
1000mg/
m3,
there
was
compound­
related
mortality;
one
animal
was
found
dead
on
gestation
day
13
and
one
animal
was
sacrificed
in
extremis
on
gestation
day
22.
Among
survivors,
there
were
compound­
related
reductions
in
maternal
body
weight
gains
and
food
consumption
and
there
were
compound­
related
clinical
observations
(
ocular
discharge
and
wet
fur).
At
300
mg/
m3,
evidence
of
compound­
related
maternal
toxicity
was
limited
to
reduced
maternal
body
weight
gains
and
increased
clinical
observations
(
ocular
discharge).

Under
the
conditions
of
the
current
study,
there
was
no
evidence
of
compound­
related
maternal
toxicity
at
30
or
100
mg/
m3
and
there
was
no
evidence
of
developmental
toxicity
at
any
level
tested.
Thus,
the
no­
observed­
effectlevel
(
NOEL)
afor
maternal
toxicity
was
considered
100
mg/
m3
and
the
NOEL
for
developmental
toxicity
was
considered
1000mg/
m3.

The
NOEL
for
this
study
is
defined
as
the
highest
dose
at
which
toxicologically
important
effects
attributable
to
the
test
substance
were
not
detected.
Thus,
for
this
study,
the
NOEL
is
equivalent
to
the
NOEL
as
defined
by
the
United
States
EnvironmentalProtection
Agency
(
1985)
and
to
the
no­
observed­
adverse­
effectlevel
(
NOAEL)
as
defined
by
the
European
Union
(
1994).

9
Dimethvl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
OBJECTIVE
The
objective
of
this
study
was
to
evaluate
the
developmental
toxicity
of
the
test
substance
when
administered
by
inhalation
to
pregnant
rabbits
or
from
around
the
time
of
implantation
to
near
the
end
of
gestation.

MATERIALS
AND
METHODS
A.
Test
Guidelines
The
study
design
complies
with
following
test
guidelines:

United
States
Environmental
Protection
Agency
(
EPA),
Office
of
Prevention,
Pesticides,
and
Toxic
Substances
(
OPPTS)
Health
Effects
Test
Guidelines,
OPPTS
870.3700
Prenatal
Developmental
Toxicity
Study
(
1998).'"

EPA
Consent
Agreement
and
Testing
Consent
Order.'
2'

B.
Test
Substance
and
Vehicle
The
sponsor
supplied
the
test
substance
and
an
analytical
standard
of
known
purity.
The
test
substance
was
assigned
Haskell
Laboratory
Number
24300.

C.
Test
Species
The
Hra:(
NZW)
SPF
rabbit
was
selected
for
this
study
to
provide
data
in
a
nonrodent
species
and
because
it
is
a
preferred
species
for
developmental
toxicity
testing.
The
Hra:(
NZW)
SPF
strain
was
chosen
because
extensive
background
information
is
available
from
the
literature,
the
supplier,
and
previous
studies
with
other
compounds
at
Haskell
Laboratory.

A
total
of
110
nulliparous,
time­
mated
female
rabbits
were
received
from
COVANCE,
Denver,
Pennsylvania.
Sixty­
six
female
rabbits
were
received
on
June
19,
2002
and
44female
rabbits
were
received
on
June
21,2002.
Body
weights
on
the
day
of
mating
defined
as
day
0
of
gestation
(
G)
were
supplied
by
the
vendor.
The
rabbits
for
this
study
were
approximately
6
months
old
and
were
at
either
day
1,2,
or
3G
upon
arrival.

10
Dimethvl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicitv
Studv
in
Rabbits
DuPont­
10657
D.
Animal
Husbandry
1.
Housing
Animal
rooms
were
maintained
at
an
acceptable
temperature
of
17­
23
°
C
(
targeted
at
20
°
C)
and
a
targeted
relative
humidity
of
50%
rf~
10%.
Animal
rooms
were
artificially
illuminated
(
fluorescent
light)
on
a
12­
hour
lighvdark
cycle
(
approximately
0600­
1800
hours).
Animals
were
housed
individually
in
suspended,
wire­
mesh,
stainless
steel
cages.
Nesting
material
was
not
provided
because
the
does
were
euthanized
prior
to
parturition.

To
address
logistical
considerations,
the
rabbits
on
this
study
were
housed
in
4
animals
rooms
near
the
exposure
chambers.
There
was
a
significant
aerosol
component
in
the
high
level
chamber;
therefore,
to
prevent
unintentional
exposure
of
control
or
lower
level
animals
to
the
residual
aerosol,
the
control
group
rabbits
were
housed
separately
in
one
room.
The
rabbits
exposed
to
1000mg/
m3were
housed
separately
within
a
hood
so
that
the
higher
air
flow
in
the
hood
promoted
evaporation
of
aerosol
deposits
on
the
fur.
The
remaining
3
groups
of
rabbits
were
housed
in
2
other
rooms.

2.
Feed
and
Water
On
the
day
of
arrival
and
daily
thereafter
each
rabbit
received
approximately
150
grams
per
day
of
PMINutrition
International,
Inc.
Certified
High
Fiber
Rabbit
LabDiet@
5325.
Food
was
not
available
during
inhalation
exposures.
Water
from
United
Water
Delaware
was
available
ad
libitum.

3.
Identification
Each
animal
was
assigned
a
unique
number
and
identified
with
a
microchip
implant
by
the
supplier
prior
to
shipping.
Upon
receipt,
each
animal
was
assigned
a
unique
Haskell
animal
number.
Both
the
Haskell
animal
number
and
the
number
provided
by
the
supplier
were
recorded
on
each
cage
card.
A
master
list
of
unique
Haskell
animal
numbers
and
corresponding
unique
supplier­
provided
animal
numbers
was
maintained
with
the
study
records.

4.
Health
Monitoring
Program
As
specified
in
the
Haskell
Laboratory
animal
health
and
environmental
monitoring
program,
the
following
procedures
are
performed
periodically
to
ensure
that
contaminant
levels
are
below
those
that
would
be
expected
to
impact
the
scientific
integrity
of
the
study:

Water
samples
are
analyzed
for
total
bacterial
counts
and
the
presence
of
coliforms,
lead,
and
other
contaminants.

Feed
samples
are
analyzed
for
total
bacterial,
spore,
and
fungal
counts.

Samples
from
freshly
washed
cages
and
cage
racks
are
analyzed
to
ensure
adequate
sanitation
by
the
cagewashers.

11
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Certified
animal
feed
is
used,
guaranteed
by
the
manufacturer
to
meet
specified
nutritional
requirements
and
not
to
exceed
stated
maximum
concentrations
of
key
contaminants,
including
specified
heavy
metals,
aflatoxin,
chlorinated
hydrocarbons,
and
organophosphates.
The
presence
of
these
contaminants
below
the
maximum
concentration
stated
by
the
manufacturer
would
not
be
expected
to
impact
the
integrity
of
the
study.

The
animal
health
and
environmental
monitoring
program
is
administered
by
the
attending
laboratory
animal
veterinarian.
Evaluation
of
these
data
did
not
indicate
any
conditions
that
affected
the
validity
of
the
study.

E.
Quarantine
and
Pretest
Period
Rabbits
were
quarantined
according
to
procedures
outlined
in
Haskell
Laboratory
SOP
LAOO3­
P
and
then
released
for
the
study
upon
approval
of
the
laboratory
animal
veterinarian s
designee.

F.
Study
Design
The
study
design
is
as
follows:

Group
I
II
III
N
V
Target
Concentrationa
(
mg/
m3)

Ob
30
100
300
1000
Mated
Females
22
22
22
22
22
a
DMG
was
administered
by
inhalation,
6
hours
per
day,
on
days
7­
286.
b
Conditioned
air.

G.
Selection
of
Dose
Levels
The
exposure
levels
and
route
of
exposure
for
the
current
study
were
selected
by
the
Sponsor.

H.
Randomization
Does
were
ranked
on
the
basis
of
day
0
gestation
body
weights
and
assigned
to
control
and
experimental
groups
by
random
sampling
from
the
ranked
list.
The
distribution
resulted
in
mean
body
weights
for
all
groups
that
were
not
statistically
different
(
p>
0.05).

12
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
I.
Inhalation
Exposure
System
(
Figure
1)

1.
Atmosphere
Generation
Chamber
atmospheres
were
generated
by
aerosolization
of
the
test
substance
in
air
with
a
Spraying
Systems
Nebulizer.
The
test
substance
was
metered
into
the
nebulizer
with
a
Cole
Palmer
Mastefflex@
Console
Drive
pump.
Filtered,
high­
pressure
air,
metered
into
the
nebulizer
by
a
Brooks
model
585li
Mass
Flow
Controller,
aerosolized
the
liquid
test
substance.
The
resulting
aerosol
and/
or
vapor
mixture
was
mixed
with
filtered,
high­
pressure
air
that
carried
the
mixture
to
the
exposure
chambers.
The
pumps
and
mass
flow
controllers
were
controlled
and
monitored
by
the
Camile
Inhalation
Toxicology
Automated
Data
System
(
CITADS).
The
concentration
of
the
test
substance
in
each
test
chamber
was
adjusted
by
varying
the
amount
of
liquid
test
substance
delivered
to
the
nebulizer.

Test
atmospheres
were
exhausted
through
a
water­
filled
scrubber
prior
to
discharge
into
the
exhaust
stack.

2.
Chamber
Construction
and
Design
All
exposure
chambers
were
constructed
of
stainless
steel
and
glass
(
NYU
style)
with
a
nominal
internal
volume
of
9
1113.
A
tangential
feed
at
the
chamber
inlet
promoted
uniform
chamber
distribution
of
the
test
atmosphere.

3.
Exposure
Duration
and
Mode
During
exposure,
rabbits
were
individually
restrained
in
wire
mesh
cages
and
exposed,
whole­
body,
inside
the
exposure
chamber.
Exposures
were
conducted
during
approximately
the
same
time
period
each
day
to
minimize
diurnal
physiological
variations.
Control
group
rabbits
were
treated
exactly
as
test
rabbits,
with
the
following
exceptions:
the
wire
exposure
cages
for
the
control
group
rabbits
were
slightly
larger
than
those
used
for
the
rabbits
in
the
treatment
groups
and
the
control
group
rabbits'
chamber
atmosphere
did
not
contain
the
test
substance.
The
chamber
volume
was
chosen
so
that
the
total
body
volume
of
the
test
animals
did
not
exceed
5%
of
the
chamber
volume.

Rabbits
were
exposed
approximately
6
hours
per
day
during
days
7­
286.
The
starting
time
of
each
exposure
was
defined
as
the
time
when
the
generation
system
was
turned
on.
The
ending
time
of
each
exposure
was
defined
as
the
time
when
the
generation
system
was
turned
off.
Rabbits
were
exposed
to
the
test
substance
during
both
the
time
it
took
to
reach
the
target
concentration,
and
the
time
it
took
for
the
test
substance
to
be
purged
from
the
chamber.
After
each
exposure,
the
rabbits
were
returned
to
their
home
cages.

The
animals
were
received
in
5
lots
based
on
their
day
of
gestation
upon
arrival.
Therefore,
the
initiation
of
exposures
was
staggered
over
5
days
such
that
each
lot
started
exposures
on
day
7G.

13
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
J.
Characterization
of
Chamber
Atmosphere
1.
Test
Substance
Sampling
and
Analysis
For
all
test
exposure
chambers,
the
vapor
component
of
the
atmospheric
concentration
of
DMG
was
determined
by
gas
chromatography.
For
the
test
exposure
chambers,
known
volumes
of
chamber
atmosphere
were
drawn,
at
approximately
90­
minute
intervals,
from
the
breathing
zone
of
the
animals
through
glass
impingers
containing
acetone
as
the
collection
medium.
The
control
chamber
was
similarly
sampled
once
daily
for
measurement
of
atmospheric
concentration.
Aliquots
of
impinger
solution
were
injected
on
a
Restek@
fused
silica
glass
(
inside
diameter
0.53
mm)
with
RTX­
502.2
coating
column
in
a
Hewlett­
Packard
model
6890
Series
Gas
Chromatograph
equipped
with
a
flame
ionization
detector.
The
atmospheric
concentration
of
the
test
substance
was
determined
from
a
standard
curve
derived
from
liquid
standards.
Standards
were
prepared
weekly
by
the
quantitative
dilution
of
DMG
liquid
in
known
volumes
of
acetone.

For
the
300
and
1000
mg/
m3exposure
chambers,
the
aerosol
component
of
the
atmospheric
concentration
of
DMG
was
determined
by
gravimetric
analysis.
Known
volumes
of
chamber
atmosphere
were
drawn,
at
approximately
30­
minute
intervals,
from
the
breathing
zone
of
the
animals
through
a
25
mm
filter
cassette
that
contained
a
pre­
weighed
Gelman
glass
fiber
(
Type
A/
E)
filter.
The
filters
were
weighed
on
a
Cahn
model
C­
31Microbalance@.
The
filter
weights
were
automatically
transferred
to
CITADS,
which
calculated
the
chamber
concentrations
based
on
the
difference
in
pre­
and
post­
sampling
filter
weights
divided
by
the
volume
of
chamber
atmosphere
sampled.
Gravimetric
sample
start­
and
stop­
times
for
each
sample
were
also
controlled
and
recorded
by
CITADS.
Prior
to
study
start,
gravimetric
samples
collected
from
the
30
and
100
mg/
m3chambers
indicated
that
no
aerosol
was
present
for
these
2
concentrations.

A
sample
to
determine
particle
size
distribution
(
mass
median
aerodynamic
diameter
and
percent
particles
less
than
1,3,
and
10
pm
diameter)
was
taken
once
per
week
from
the
1000
mg/
m3
exposure
chamber
with
a
Sierra@
Series
210
Cyclone
Preseparatodcascade
Impactor
and
Sierra@
Series
110
Constant
Flow
Air
Sam~
ler.'~)

2.
Environmental
Monitoring
Chamber
airflow
was
set
at
the
beginning
of
each
exposure
to
achieve
at
least
12
air
changes
per
hour
and
was
monitored
continually
with
a
calibrated
Brooks
model
5851i
Mass
Flow
Controller.
Chamber
temperature
was
targeted
at
17­
23
°
C
and
was
measured
with
an
Omega
Thermocouple
Thermometer.
Chamber
relative
humidity
was
targeted
at
50
&
10%
and
was
measured
with
Jumo
wet­
bulb/
dry­
bulbresistance
temperature
detectors.
Airflow,
temperature,
and
relative
humidity
were
monitored
continually
with
CITADS
and
recorded
at
approximately
15­
minute
intervals
during
each
exposure.
Chamber
oxygen
concentration
was
targeted
to
be
at
least
19%.
Chamber
oxygen
concentration
was
measured
with
a
Biosystems
model
31OOR
Oxygen
Analyzer
and
was
recorded
twice
during
each
exposure.

14
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
I
0657
K.
Animal
Euthanasia
1.
Adults
Does
were
euthanized
by
the
intravenous
injection
of
sodium
pentobarbital.
The
identity
and
lot
number
of
the
euthanasia
solution
was
recorded
in
the
study
records.

2.
Fetuses
Fetuses
were
euthanized
by
intraperitoneal
injection
of
sodium
pentobarbital
after
external
examination
was
complete,
prior
to
performing
visceral
examinations.

L.
Parameters
to
be
Studied
1.
In­
life
Observations
of
Females
a.
Body
Weight
Body
weights
were
recorded
in
the
morning
on
the
day
after
arrival
through
day
29G.

b.
Food
Consumption
Food
consumption
was
measured
daily
on
days
4­
296.

c.
Clinical
Signs
Clinical
signs
were
recorded
each
morning
on
days
4­
296
and
each
afternoon
following
exposures
on
days
7­
286.
Observations,
at
approximately
hourly
intervals,
were
made
during
the
exposures
to
assess,
to
the
extent
possible,
the
overall
state
of
the
animals.
In
addition,
the
response
of
the
animals
to
a
sound
stimulus
while
in
the
chambers
was
recorded
before
vapor
generation
began,
after
approximately
3
hours
of
exposure,
and
prior
to
removal
of
the
animals
from
the
chambers.

2.
Postmortem
Observations
of
Females
Dying
Prior
to
Scheduled
Euthanasia
A
gross
external
and
visceral
examination
was
performed
within
24
hours
after
the
doe
was
found
dead
or
sacrificed
in
extremis.
Pregnancy
status
was
determined
and
the
uterine
contents
were
described.
Dead
rabbits
were
refrigerated
until
necropsied.

15
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
3.
Postmortem
Observations
of
Does
Aborting
or
Delivering
Early
a.
Dam
Observations
Dams
that
aborted
(
day
27G
or
earlier)
or
delivered
early
(
day
28
or
29G)
were
euthanized
within
24
hours
of
detection
and
a
gross
external
and
visceral
examination
was
performed.

b.
Fetal
Observations
Fetuses
remaining
in
the
uterus
or
aborteddelivered
early
were
examined
to
the
extent
possible.
Data
from
these
litters
were
maintained
with
the
raw
data
but
were
excluded
from
all
relevant
fetal
data
calculations.

4.
Postmortem
Observations
of
Does
Surviving
to
Scheduled
Euthanasia
a.
External
Appearance
Each
doe
was
examined
immediately
after
euthanasia
on
day
29G.

b.
Viscera
Viscera
were
examined
grossly
immediately
after
euthanasia.

C.
Uterine
Weight
The
intact
and
empty
uterus
of
each
doe
having
at
least
one
viable
fetus
was
weighed
to
permit
calculation
of
maternal
body
weight
adjusted
to
exclude
the
products
of
conception.

d.
Corpora
Lutea
The
count
for
each
ovary
of
darns
with
viable
fetuses
was
recorded.

e.
Implantations
For
each
female
with
visible
implants,
the
type
(
live
and
dead
fetuses,
and
resorptions)
and
their
relative
positions
were
recorded.
The
uterus
of
each
apparently
"
nonpregnant"
female
was
stained
with
ammonium
sulfide
to
detect
very
early
res~
rptions.'~'

5.
Fetuses
of
Does
Surviving
to
Scheduled
Euthanasia
a.
Number,
Location,
and
Condition
These
parameters
were
recorded
for
each
fetus.

b.
Fetal
Weight
The
body
weight
for
each
fetus
was
recorded.

16
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
C.
External
Alterations
The
alterations
detected
for
each
live
fetus
was
recorded.

d.
Soft
Tissue
Alterations
For
each
live
fetus,
fetal
sex
and
any
visceral
alterations
detected
were
re~
orded.'~)
A
transverse
section,
deep
enough
to
permit
examination
of
the
brain,
was
made
between
the
parietal
and
frontal
bones.
On
the
day
of
sacrifice,
the
eyelids
of
each
fetus
were
removed
to
examine
the
eyes
for
alterations.

e.
Skeletal
Alterations
After
fixation
in
alcohol,
the
alizarin­
stained
skeletons
were
examined
and
alterations
detected
were
recorded
for
each
live
fetus.

M.
Control
of
Bias
In
addition
to
random
assignment
to
groups,
all
does
were
coded
before
scheduled
euthanasia
and
remained
coded
during
the
collection
of
postmortem
and
fetal
data.

17
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
N.
Statistical
Analyses
Descriptive
statistics
including
mean,
standard
deviation,
and
standard
error
of
the
mean
were
used
to
summarize
exposure
concentration
and
environmental
data.

For
the
parameters
listed
below,
descriptive
statistics
were
performed
and
sequential
trend
tests
were
applied
to
the
data
as
tabulated
below.@)
If
a
significant
dose­
response
trend
was
detected,
data
from
the
top
dose
group
were
excluded
and
the
test
repeated
until
no
significant
trend
was
evident.
For
litter
parameters,
the
proportion
of
affected
fetuses
per
litter
or
the
litter
mean
was
used
as
the
experimental
unit
for
statistical
eval~
ation.'~)
The
level
of
significance
selected
was
p
e
0.05.

Parameter
Maternal
weight
Maternal
weight
changes
Maternal
food
consumption
Live
fetuses
Dead
fetuses
Resorptions
Nidations
Corpora
lutea
Incidence
of
fetal
alterations
Incidence
of
pregnancy
Clinical
observations
Maternal
mortality
Females
with
total
resorptions
Abortiondearly
deliveries
Fetal
weight
Sex
ratio
Trend
Test
Linear
contrast
of
means@)

Jonckheere's
test'"

Cochran­
Armitage
test'"

Linear
contrast
of
least
square
means'
10)

Where
the
data
were
tied
and
the
standard
large
sample
version
of
Jonckheere's
test
was
not
applicable,
exact
p
values
for
Jonckheere's
test
were
calculated
using
permutation
methodology.''
li
18
Dimethvl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicity
Study
in
Rabbits
DuPont­
10657
RESULTS
AND
DISCUSSION
Inhalation
Exposures
A.
Chamber
Concentrations
of
the
Test
Substance
(
Table
1,
Appendix
A,
Figures
2­
3)

1.
30mg/
m3
The
mean
vapor
concentrations
over
the
22­
day
exposure
period
ranged
from
30­
31
mg/
m3for
lots
A­
E,
and
the
overall
mean
concentration
for
all
5
lots
over
the
26­
day
sequence
of
exposures
was
30
zt
0.58
mg/
m3.
Daily
mean
concentrations
generally
ranged
from
93%­
123%
of
the
target
concentration
for
the
30
mg/
m3
group
(
with
the
exception
of
the
first
exposure
day
in
which
the
mean
was
19
mg/
m3).
Although
the
mean
daily
chamber
concentrations
occasionally
exceeded
90%­
110%
of
the
targeted
concentrations,
the
mean
concentrations
for
the
exposure
period
were
consistent
(
Figures
2­
3),
and
were
acceptable
for
evaluating
the
toxicity
at
the
targeted
concentrations.

Preliminary
exposures
conducted
prior
to
study
start
demonstrated
that
an
aerosol
component
was
not
present
for
this
concentration.
The
calculated
overall
nominal
concentration
was
43
mg/
m3.

2.
100mg/
m3
The
mean
vapor
concentrations
over
the
22­
day
exposure
period
ranged
from
99­
100mg/
m3for
lots
A­
E,
and
the
overall
mean
concentration
for
all
5
lots
over
the
26­
day
sequence
of
exposures
was
100
&
0.74
mg/
m3.
Daily
mean
concentrations
ranged
from
89%­
110%
of
the
target
concentration
for
the
100mg/
m3group.
Although
the
mean
daily
chamber
concentrations
were
occasionally
exceeded
90%­
110%
of
the
targeted
concentrations,
the
mean
concentrations
for
the
exposure
period
were
consistent
(
Figures
2­
3),
and
were
acceptable
for
evaluating
the
toxicity
at
the
targeted
concentrations.

Preliminary
exposures
conducted
prior
to
study
start
demonstrated
that
an
aerosol
component
was
not
present
for
this
concentration.
The
calculated
overall
nominal
concentration
was
129mg/
m3.

3.
300mg/
m3
The
mean
vapor
concentration
over
the
22­
day
exposure
period
was
300
mg/
m3
for
lots
A­
E,
and
the
overall
mean
vapor
concentration
for
all
5
lots
over
the
26­
day
exposure
period
was
300
.
e
2.7
mg/
m3.
The
mean
aerosol
concentrations
ranged
from
1.
O­
1.2mg/
m3
for
lots
A­
E,
and
the
overall
mean
aerosol
concentration
for
all
5
lots
over
the
26­
day
exposure
period
was
1.1
rt
0.11
mg/
m3.
Based
on
the
vapor
concentration
and
the
aerosol
concentration
(
and
rounding
19
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
to
2
significant
figures),
the
mean
total
calculated
concentrations
were
300
mg/
m3for
each
lot
and
for
the
overall
mean
for
all
5
lots
over
the
26­
day
sequence
of
exposures.
The
concentrations
ranged
from
90%­
110%
of
the
target
concentration
for
the
300
mg/
m3
group
were
consistent
for
the
exposure
period
(
Figures
2­
3),
and
were
acceptable
for
evaluating
the
toxicity
at
the
targeted
concentrations.

Since
the
amount
of
aerosol
in
the
300
mg/
m3chamber
was
low,
particle
size
of
the
aerosol
droplets
was
not
determined.

The
calculated
overall
nominal
concentration
was
590
mg/
m3.

4.
1000
mg/
m3
The
mean
vapor
concentration
over
the
22­
day
exposure
period
ranged
from
520­
530
mg/
m3for
lots
A­
E,
and
the
overall
mean
vapor
concentration
for
all
5
lots
over
the
26­
day
exposure
period
was
520
­
t
6.5
mg/
m3.
The
mean
aerosol
concentrations
ranged
from
470­
480
mg/
m3
for
lots
A­
E,
and
the
overall
mean
aerosol
concentration
for
all
5
lots
over
the
26­
day
exposure
period
were
480
f.
7.96
mg/
m3.
The
mean
daily
vapor
concentrations
ranged
from
450­
590
mg/
m3,
and
the
mean
daily
aerosol
concentrations
ranged
from
410­
580
mg/
m3for
all
5'
lots.
Based
on
the
vapor
concentration
and
the
aerosol
concentration
(
and
rounding
to
2
significant
figures),
the
mean
total
calculated
concentrations
were
1000mg/
m3for
each
lot
and
for
the
overall
mean
for
all
5
lots
over
the
26­
day
sequence
of
exposures.
The
concentrations
were
consistent
for
the
exposure
period
(
Figures
2­
3),
and
were
acceptable
for
evaluating
the
toxicity
at
the
targeted
concentrations.

The
mass
median
aerodynamic
diameter
(
MMAD)
ranged
from
8.0­
9.0
pm,
and
the
geometric
standard
deviation
(
GSD)
ranged
from
2.1
to
2.4
for
the
1000mg/
m3group.
In
the
1000
mg/
m3
group,
0.2%­
0.55%
of
the
particles
were
less
than
1pm,
8%­
11%
of
the
particles
were
less
than
3
pm,
and
54%­
62%
of
the
particles
were
less
than
10
pm.
Although
the
particle
size
was
larger
than
the
reported
respirable
range
for
rabbits,('
2)
the
animals
did
receive
a
sufficient
concentration
of
the
test
substance
to
produce
mortality
in
2
rabbits.

The
calculated
overall
no'minal
concentration
was
3160
mg/
m3.

Since
the
aerosol
concentration
was
the
highest
in
the
1000
mg/
m3
chamber,
distribution
of
the
aerosol
component
was
determined
prior
to
the
initiation
of
exposures
in
the
1000mg/
m3
chamber
only.
Thirteen
aerosol
concentration
measurements
were
collected
from
9
separate
sampling
locations,
and
the
concentrations
ranged
from
611­
716
mg/
m3.
The
Wilk­
Shapiro
test
of
normality
was
used
to
analyze
these
data,
and
the
chamber
concentrations
were
normally
distributed
with
no
significant
differences
detected
for
any
sampling
site.

B.
Chamber
Environmental
Conditions
(
Table
2,
Appendix
B)

The
overall
mean
chamber
temperatures
in
the
4exposure
chambers
during
the
total
of
26
exposures
for
all
5
lots
were
2
1­
22
°
C.
The
daily
mean
chamber
temperature
values
ranged
20
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
from
19­
24
°
C.
Although
the
chamber
temperature
slightly
exceeded
the
targeted
range
of
1723OC
the
slightly
higher
temperature
did
not
adversely
affect
the
health
of
the
animals,
based
on
their
clinical
appearance.

The
overall
mean
relative
humidity
values
in
the
4
exposure
chambers
during
the
total
of
26
exposures
for
all
5
lots
was
51%­
56%.
The
daily
mean
relative
humidity
values
in
the
4
chambers
ranged
from
45%­
64%.
Although
the
relative
humidity
exceeded
the
targeted
range
of
40%­
60%,
the
slightly
higher
relative
humidity
did
not
adversely
affect
the
health
of
the
animals,
based
on
their
clinical
appearance.

The
overall
mean
chamber
airflow
in
the
4
exposure
chambers
during
the
total
of
26
exposures
for
all
5
lots
exposure
was
1800­
1900Urnin.
The
daily
mean
airflow
values
in
the
4
chambers
ranged
from
1700­
2100L/
min.
The
airflow
in
the
chamber
was
adequate
to
achieve
at
least
12
air
changes
per
hour.

The
chamber
oxygen
content
was
21%
in
all
4
chambers
throughout
the
26­
day
exposure
sequence.

C.
Clinical
Observations
During
Exposure
For
each
exposure
concentration,
the
response
of
the
animals
to
an
alerting
stimulus
administered
prior
to
exposure,
during
exposure,
and
after
the
conclusion
of
the
exposure
period
was
normal.
In
addition,
although
some
animals
in
the
1000mg/
m3
chamber
had
wet
fur
from
deposition
of
the
aerosol
on
the
fur
during
exposure,
there
were
no
clinical
signs
of
toxicity
observed
during
exposure.

21
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Developmental
Evaluations
A.
Maternal
Findings
1.
Mortality
and
Reproductive
Outcome
(
Table
8,
Appendix
J)

There
was
no
compound­
related
mortality
at
exposure
levels
5
300
mg/
m3.
At
1000
mg/
m3,
one
female
was
found
dead
on
day
13G
and
another
female
was
sacrificed
in
extremis
on
day
22G.

There
were
no
compound­
related
effects
on
indicators
of
reproductive
outcome.
One
control
group
rabbit
aborted
on
day
19G
and
one
100
mg/
m3group
rabbit
delivered
early
prior
to
euthanasia
on
day
29G.
In
addition,
one
1000
mg/
m3
litter
consisted
entirely
of
late
resorptions.
The
findings
for
this
one
litter
were
not
considered
to
be
compound­
related
because
no
other
litters
were
similarly
affected
and
additionally,
there
was
no
increase
in
resorptions
for
litters
also
containing
live
fetuses.
At
1000mg/
m3,
there
was
a
significant
decrease
in
the
mean
number
of
nidation
sites
per
doe.
This
was
not
considered
related
to
the
exposure
because
implantation
is
considered
to
have
occurred
prior
to
the
start
of
exposures
on
day
7G.
Furthermore,
this
decrease
is
consistent
with
a
lower
mean
corpora
lutea
count
in
this
group.

2.
Body
Weights
and
Weight
Changes
(
Tables
4
and
5,
Appendices
E
and
F)

There
were
no
compound­
related
effects
on
maternal
body
weight
parameters
at
exposure
levels
I
100
mg/
m3.
There
were
significant
reductions
in
overall
weight
change
(
days
7­
296)
at
300
and
1000mg/
m3;
these
significant
effects
were
evident
at
the
onset
of
exposures
(
days
7­
9G)
and
generally
persisted
throughout
gestation.

3.
Food
Consumption
(
Table
6,
Appendix
G)

There
were
no
compound­
related
effects
on
maternal
food
consumption
at
exposure
levels
5
300
mg/
m3.
At
1000mg/
m3,
mean
food
consumption
was
significantly
reduced
when
averaged
over
the
exposure
period
(
days
7­
29G);
the
reduction
was
significant
and
pronounced
at
the
onset
of
exposures
(
days
7­
9G)
and
persisted
throughout
exposures
to
some
extent
as
well.

4.
Clinical
Observations
(
Table
7,
Appendix
H)

There
were
no
compound­
related
increased
clinical
observations
at
exposure
levels
2
100
mg/
m3.
At
300
and
1000
mg/
m3,
compound­
related
clinical
observations
included
clear
ocular
discharge;
at
1000mg/
m3,
all
animals
had
wet
fur.

22
Dimethyl
Glutarate
(
DMG):
Inhalation
DevelopmentalToxicity
Study
in
Rabbits
DuPont­
10657
5.
Postmortem
Findings
(
Appendix
I)

There
were
no
compound­
related
gross
postmortem
findings
at
any
level
tested.

B.
Fetal
Findings
1.
Mortality
and
Sex
Ratio
(
Table
8,
Appendix
J)

There
were
no
compound­
related
effects
on
embryofetal
viability
or
on
fetal
sex
ratio
at
any
level
tested.
The
mean
number
of
live
fetuses
per
litter
appeared
to
be
slightly
reduced
at
1000
mg/
m3,
however,
this
apparent
reduction
was
not
considered
compound­
related
and
is
believed
to
have
resulted
from
previously
discussed
reductions
in
mean
numbers
of
corpora
lutea
and
nidations
at
this
level
that
were
not
considered
compound­
related.

2.
Body
Weight
(
Table
8,
Appendices
J
and
K)

There
was
no
compound­
related
effect
on
fetal
body
weight
at
any
level
tested.

3.
Malformations
(
Table
9,
Appendix
K)

There
were
no
compound­
relatedfetal
malformations
at
any
level
tested.

4.
Variations
(
Table
10,
Appendix
K)

There
were
no
compound­
related
fetal
variations
at
any
level
tested.

There
was
a
significant
increase
in
retarded
sternebral
ossification
at
1000mg/
m3.
This
increase,
however,
was
not
considered
to
be
compound­
related;
rather,
the
statistical
significance
appears
to
be
the
result
of
an
unusually
low
control
group
value
relative
to
relevant
historical
control
group
data.
Current
study
incidences
for
this
finding
are
9
fetuses
(
4
litters),
15(
5),
15(
4),
12(
5),
and
28(
8)
for
the
0,30,100,300,
and
1000mg/
m3
groups
respectively.
In
comparison,
for
three
recently
completed
studies
(
DuPont­
7405,
DuPont­
3932,
and
DuPont­
1162)
control
group
incidences
for
this
finding
were
16
fetuses
(
9
litters),
29(
8),
and
38(
1
l),
respectively.
Furthermore,
there
are
no
other
data
supportive
of
a
compound­
related
fetal
effect
at
this
level.

23
Dimethvl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
CONCLUSIONS
Under
the
conditions
of
the
current
study,
there
was
no
evidence
of
compound­
related
maternal
toxicity
at
30
or
100mg/
m3
and
there
was
no
evidence
of
developmental
toxicity
at
any
level
tested.
Thus,
the
no­
observed­
effect
level
(
NOEL)
afor
maternal
toxicity
was
considered
100
mg/
m3
and
the
NOEL
for
developmental
toxicity
was
considered
1000
mg/
m3.

RECORDS
AND
SAMPLE
STORAGE
All
data
and
records
for
analytical
characterizations
conducted
by
the
sponsor
will
be
retained
by
the
sponsor.
Laboratory­
specific
or
site­
specific
raw
data,
such
as
personnel
files
and
equipment
records
will
be
retained
by
the
facility
where
the
work
was
done.

A
sample
of
the
test
substance
will
be
collected
for
archive
purposes
and
retained
at
Haskell
Laboratory,
Newark,
Delaware.
Specimens
(
if
applicable),
raw
data,
and
the
final
report
will
be
retained
at
Haskell
Laboratory,
Newark,
Delaware,
or
at
Iron
Mountain
Records
Management,
Wilmington,
Delaware.

a
The
NOEL
for
this
study
is
defined
as
the
highest
dose
at
which
toxicologically
important
effects
attributable
to
the
test
substance
were
not
detected.
Thus,
for
this
study,
the
NOEL
is
equivalent
to
the
NOEL
as
defined
by
the
United
States
Environmental
Protection
Agency(
13)
and
to
the
no­
observed­
adverse­
effect
level
(
NOAEL)
as
defined
by
the
European
Union.('
4)

24
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
1.

2.

3.

4.

5.

6.

7.

8.

9.
REFERENCES
United
States
(
U.
S.)
Environmental
Protection
Agency
(
EPA),
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPPTS)
(
1998).
OPPTS
870.3700
Prenatal
Developmental
Toxicity
Study.
Health
Efsects
Test
Guidelines.

United
States
(
U.
S.)
Environmental
Protection
Agency
(
EPA)
Federal
Register
(
August
5,
1999).
 
Dibasic
Esters;
Final
Enforceable
Consent
Agreement
and
Testing
Consent
Order. 
Vol.
64,
No.
150,
pp.
42692­
42695.

Calculation
described
in
Sierra
Instruments,
Inc.,
Bulletin
7­
79­
219IM,
Instruction
Manual:
Series
210
Ambient
Cascade
Impactors
and
Cyclone
Preseparators.

Salewski,
E.
(
1964).
Farbemethode
zum
makroskopischen
Nachweis
von
Implantationstellen
am
Uterus
der
Ratte.
Archiv.
Path.
Exp.
Pharmakol.
247:
367.

Staples,
R.
E.
(
1974).
Detection
of
visceral
alterations
in
mammalian
fetuses.
Teratology
9(
3):
A37­
A38.

Selwyn,
M.
R.
(
1995).
The
use
of
trend
tests
to
determine
a
no­
observable­
effect
level
in
animal
safety
studies.
J.
Am.
Col.
Toxicol,
14(
2):
158­
168.

Haseman,
J.
K.
and
Hogan,
M.
D.
(
1975).
Selection
of
the
experimental
unit
in
teratology
studies.
Teratology
12:
165­
171.

Snedecor,
G.
W.
and
Cochran,
W.
G.
(
1967).
Statistical
Methods,
6th
ed.
The
Iowa
State
University
Press,
Iowa,
pp.
246­
248,349­
352.

Jonckheere,
A.
R.
(
1954).
A
distribution­
free
K­
sample
test
against
ordered
alternatives.
Biometrika
41:
133­
145.

10.
Dempster,
A.
P.,
Selwyn,
M.
R.,
Patel,
C.
M.,
and
Roth,
A.
J.
(
1984).
Statistical
and
computational
aspects
of
mixed
model
analysis.
J.
Roy.
Statist.
SOC.,
C
(
Appl.
Statist.)
33(
2):
203­
214.

11.
Patefield,
W.
(
1982).
Exact
tests
for
trends
in
ordered
contingency
tables.
Appl.
Statist.
31~
32­
43.

12.
Raabe,
O.
G.,
Al­
Bayati,
M.
A.,
Teague,
S.
V.,
and
Rasolt,
A.
(
1988).
Regional
deposition
of
inhaled
monodisperse
coarse
and
fine
aerosol
particles
in
small
laboratory
animals.
Inhaled
Particles
VI
(
J.
Dodgson,
R.
I.
McCallum,
M.
R.
Bailey,
and
D.
R.
Fisher,
Eds.),
pp
53­
63.
Pergamon
Press,
Oxford.

13.
Hazard
Evaluation
Division,
Standard
Evaluation
Procedure,
Toxicity
Potential:
Guidance
for
Analysis
and
Evaluation
of
Subchronic
and
Chronic
Exposure
Studies.
Paynter,
O.
E.
et
25
Dimethvl
Glutarate
(
DMG):
Inhalation
Develo~
mentalToxicitv
Study
in
Rabbits
DuPont­
10657
al.
United
States
Environmental
Protection
Agency,
Office
of
Pesticide
Programs,
Washington,
D.
C.,
20460.
EPA­
540/
9­
85­
020,
June
1985.

14.
Risk
Assessment
of
Notified
New
Substances
Technical
Guidance
Document
(
XI/
283/
94­
EN),
Chapter
I,
Sections
2.24
and
2.25.

26
:
I
i
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
TABLES
27
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Tables
Explanatory
Notes
Notes
Chamber
Concentrations
of
DMG
Particle
Size
Distribution
of
DMG
Chamber
Environmental
Conditions
Values
are
reported
to
2
significant
figures.
Means
and
standard
errors
of
the
mean
were
calculated
prior
to
rounding
values.

Abbreviations
Chamber
Concentrations
of
DMG
Chamber
Environmental
Conditions
S.
E.
M.
­
standard
error
of
the
mean
mg/
m3
­
milligrams
per
cubic
meter
n
­
number
of
samples
28
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Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
TABLE
2
PARTICLE
SIZE
DISTRIBUTIGN
OF
DMG
 

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0.25
11
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10
8.8
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0.55
11
58
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8
54
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I!

Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
TABLE
9
INCIDENCE
OF
FETALMALFORMATIONS
Group:

Concentration
(
mg/
m3):

EXTERNAL
No.
examineda
Head­
Micromaxilla
Palate­
Cleft
Snout­
Naris
atresia
No.
affected
VISCERAL
No.
examined
Heart
and/
or
Greater
Vessels
Misshapen
Septal
Defect
No.
affected
HEAD
No.
examined
No.
affected
SKELETAL
No.
examined
Rib­
Fused
Skull­
Micromaxilla
Vertebra­
Hemi
No.
affected
DuPont­
10657
TOTAL
NUMBER
AFFECTED
..
..
..
O(
0)
2(
2)
a
No.
examined
and
affected,
including
the
number
affected
with
the
listed
malformations,
are
expressed
as
Fetuses
[
Litters]
or
Fetuses
(
Litters).
b
For
ease
of
reading,
zeros
have
been
replaced
with
dashes
for
the
listed
malformations.
c
In
Group
IV,
2
fetuses
from
the
same
litter
were
inadvertently
disarticulated.

Note:
Statistical
analyses
(
Jonckheere's
trend
test)
were
conducted
on
only
the
individual
endpoints.
The
overall
total
and
totals
by
exam
are
presented
for
information
only.
No
significant
trends
were
detected.

45
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
TABLE
10
INCIDENCE
OF
FETALVARIATIONS
Group
:
I
I1
I11
IV
V
Concentration
(
mg/
m3):
0
30
100
300
1000
DEVELOPMENTAL
VARIATIONS
EXTERNAL
No.
examineda
No.
affected
VISCERAL
No.
examined
No.
affected
HEAD
No.
examined
No.
affected
SKELETAL
No.
examined
190
[
211
189
[
20]
184
[
20]
195
[
21]
133
[
181
0
[
OI
0
[
OI
0
[
OI
0
EO1
0
[
OI
190
[
21]
189
[
20]
184
[
20]
195
[
21]
133
[
181
0
[
OI
0
[
OI
0
[
OI
0
[
OI
0
101
190
[
21]
189
[
20]
184
[
201
195
[
21]
133
1181
0
[
OI
0
101
0
to1
0
[
OI
0
LO1
190
[
21]
189
1201
184
[
20]
193
[
2l]
b
133
1181
Rib­
Supernumerary
137
(
21
122(
20)
122
96
(
17)
Sternebra­
Fused
­­­
c
1(
1)
­
2(
2)

No.
affected
137
(
21
122(
20)
122
19)
122(
21
97
[
181
TOTAL
WITH
DEVELOPMENTAL
VARIATIONS
137
(
21
122(
20)
122
19)
122(
21
971181
46
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
TABLE
10
(
Continued)

INCIDENCE
OF
FETALVAUTIONS
Group:
I
I1
I11
IV
V
Concentration
(
mg/
m3):
0
30
100
300
1000
VARIATIONS
DUE
TO
RETARDED
DEVELOPMENT
EXTERNAL
No.
examineda
No.
affected
VISCERAL
No.
examined
Kidney
Small
Papilla
­
Size
2
Papilla
­
Size
3
No.
affected
HEAD
No.
examined
No.
affected
SKELETAL
No.
examined
190[
211
189E201
184[
20]
195[
21]
1331181
0
[
OI
0
[
Ol
0
[
OI
0
[
OI
0
[
OI
190[
21]
189[
20]
184[
20]
195[
21]
133[
18]

190[
211
189[
201
184[
20]
1951211
133
[
18]

0
LO1
0
LO1
0
[
OI
0
[
OI
0
[
OI
Pelvis­
Retarded
Ossification
Skull­
Retarded
Ossification
Sternebra­
Retarded
Ossification
Vertebra­
Retarded
Ossification
No.
affected
TOTAL
WITH
VARIATIONS
DUE
TO
RETARDED
DEVELOPMENT
23(
13)
18(
8)
24
(
9)
17(
9)
36
(
9)

TOTAL,
WITH
VARIATIONS
142(
21)
131(
20)
134(
19)
127(
21)
106[
18]
a
No.
examined
and
affected,
including
the
number
affected
with
the
listed
variations
are
expressed
as
Fetuses
[
Litters]
or
Fetuses
(
Litters).
b
In
Group
IV,
2
fetuses
from
the
same
litter
were
inadvertently
disarticulated.
c
For
ease
of
reading,
zeros
have
been
replaced
with
dashes
for
the
listed
variations.

*
Significant
trend
(
Jonckheere's
test),
p
.=
0.05.

Note:
Statistical
analyses
(
Jonckheere's
trend
test)
were
conducted
on
only
the
individual
endpoints.
The
overall
total
and
totals
by
exam
are
presented
for
information
only.

47
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
FIGURES
P
0
II
vi
c1
3
10
t
0
0
W
0
0
v,
0*
0
0
m
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDICES
52
,

Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDIX
A
Certificate
of
Analysis
53
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
of
A­
Dale
:
Pye
:

<
DU
POND
E.
I.
DU
PONT
#
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NEWOURi
&
CO.
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IN­
WLMINGTON.
DELAWARE
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.
'
DU
PW
CO
.,:
409
E
WALLISVILLE
RD
HI
PORT
INDUSTRIES
HIGHLANDS
TX
77562
Sample
Number
990027264
Sampllng
Tim.
8/
37/
99
01:
43:
34
Lot
Numbsr
H931363­
A
Batch
Number
:
NIA
Type
of
Sample
:
OBI?
S
13E
Cust
Order
Number
:
INTRA
~

I
­~~

IT_
ests_
Performad
D­
101
­
KARL
FISCHER
D­
303
­
APHA
COLOR
D­
104
­
APPEARANCE
D­
lt8J
­
TURBIDITY
D­
6029BE
AClD
NUMBER
D­
603
­
DBE
BY
GC
D­
603
­
DBE
8Y
GC
4603
­
DBE
BY
QC
D­
603­
DEE
BY
QC
B­
603QBE
BY
GC
D­
610.
HCN
BY
ION
SE
naytics
e
cw
sptrtment
DBE­
5
PO
Number
:
BGSM0876SEl2
Date
Shipped
:
09/
12/
99
Tsnk
Truck
:
8032
Element
LowUmittiiahUn
WATER
0.025
%
0.1
APHA
COLOR
7
Pt­
co
.15
APPEARANCE
PASS
PASS
TURBIDITY
1
ppm
5
AClD
NUMBW
0.05
mg
KOWg
0.5
DMG­
DE5
99.6'
1
%
98.5
~

DMA­
DBEI
0.085
%
0.2
TOTAL
ESTER
99.858
36
99.5
MEOH
','
0%
0.3
OMS­
DBE4
0.163
%
1
HCN
2.8
ppm
15
Dimethvl
Glutarate
(
DMG I:
Inhalation
DeveloDmental
Toxicitv
Studv
in
Rabbits
DuPont­
10657
APPENDIX
B
Protocol
55
Dimethvl
Glutarate
(
DMG):
Inhalation
Develo~
mentalToxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Studyin
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
InhalationDevelopmentd
ToxicityStudy
in
Rabbits
Work
Request
Number
13495
Service
Code
Number
733
Protocol
Haskell
Animal
Welfare
CommitteeNo.
DGRT
SOGP
1
56
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutaratc
(
DMG):
Inhalation
Developmentrml
Toxicity
Study
in
Rabbits
DuPOnt­
10657
TABLE
OF
CONTENTS
&
g
OBJECTlVE..............................................................................................................................
3
REGULATORY
COMPLIANCE.............................................................................................
3
SPONSOR
AND
TEST
FACILITY
.........................................................................................
3
MATERIALS
AND
METHODS..............................................................................................
3
A.
Test
Substance...........................................................................................................................
3
B.
Animals......................................................................................................................................
3
1.
Species
(
Strain)...................................................................................................................
3
2.
Reason
for
Selection...........................................................................................................
4
3.
Source
.......................................................................................
....................
4
4.
Description..........................................................................................................................
4
5.
Identification.......................................................................................................................
4
c.
Husbandry..............................................................................................
;...................
i.....;;........
4
.
Caging.............................................................­.............................................,...............
4
.
Food
....................................................................................................................................
4
.
Water..................................................................................
z..;.
......:...................
..
iin.
l.
i............
5
.
EnvironmentalConditions
...................................................................................................
..
5
.
Animal
Health
Monitoring..................................................................................................
5
.
Quarantine...........................................................................................................................
5
D.
ExperimentalDesign.................................................................................................................
6
E.
Selection
of
Exposure
Levels
....................................................................................................
6
F.
Randomi~
tion...........................................................................................................................
6
G.
Cheration.
Administration.
and
Analysisof
Test
Atmospheres
..............................................
6
..
1.
Atmosphere'Generation......................................................................................................
6
2.
ChamberConditions............................................................................................................
7
3.
Administration
.......................................................................................
.............................
7
4.
Analyses
of
the
Test
Atmosphere
.......................................................................................
7
5.
Frequency
ofMeasures.......................................................................................................
8
H.
Safety
Precautions
and
Disposal
of
Waste
Material..................................................................
8
I.
Animal
Euthanasia.....................................................................................................................
9
1.
Adults..................................................................................................................................
9
2.
Fetuses.....................
...........................................................................................
9
J
.
Parametersto
be
Studied
...........................................................................................................
9
1.
In­
Life
Observationsof
Does..............................................................................................
9
2.
PostmortemObservations
of
Does
Dying
Prior
to
Scheduled
Euthanasia.............
............
9
3.
Observations
ofDoes
that
Abort
or
Deliver
Early
..............................................................
9
4.
PrstmortemObservations
of
Does
Surviving
to
Scheduled
Euthanasia...........................
10
5.
FetusesofDoesSurviving
to
Scheduled
Euthanasia........................................................
10
K.
Statistics...................................................................................................................................
12
L.
Control
of
Bias.........................................................................................................................
12
M.
Records
Maintenance......
..............................................................................................
13
CRITICAL
DATES...................................................................................................................
13
REPERENCES.........................................................................................................................
14
2
57
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPoM­
10657
OBJECTIVE
The
objective
ofthis
study
is
to
evaluate
the
developmental
toxicity
of
the
test
substance
when
administered
by
inhalation
to
pregnant
rabbits
or
from
around
the
time
of
implantation
to
the
end
of
gestation.

REGULATORY
COMPLIANCE
Thestudy
will
be
conducted
in
compliance
with
the
United
States
(
US)
Environmental
Protection
Agency
(
EPA)
ToxicSubstances
Control
Act
(
TSCA)
Good
Laboratory
Practice
Standards'"
which
areconsistent
with
Organisation
for
Economic
Cooperation
and
Development
(
OECD)
Principles
of
Good
Laboratory
Practice
(
as
revised
in
1997)
published
in
ENV/
MC!
CHEM(
98)
17.'
2'
The
test
substance
will
be
characterized
by
the
sponsorprior
to
the
initiation
of
this
study.
Although
the
characterization
will
not
be
performed
under
Goad
Laboratory
Practice
Standards,
the
accuracy
of
the
data
will
be
considered
sufficientfor
the
purposes
of
this
study.

This
study
design
complies
with
theU.
S.
EPA
Office
of
Ptevention.
Pesticides,
and
Toxic
Substances
(
OPPTS)'~'
and
the
Consent
Agreement
and
Testing
Consent
Order.'
4'
Areas
of
noncompliance
will
be
documented
in
the
final
report.

SPONSOR
AND
TEST
FACILlTY
This
study
is
sponsored
by
SOCMA
Dibasic
Esters
Group
(
1850
M
Street,
N.
W.,
Suite
700,
Washington,
D.
C.
20036­!%
lo),
The
study
will
be
conducted
at
DuPont
Haskell
Laboratory
for
Health
and
Environmental
Sciences,
E.
I.
du
Pontde
Nemours
and
Company,
Newark,
Delaware.

MATERIALS
AND
METHODS
A.
Test
Substance
The
test
substancewill
be
identified
in
this
protocol
and
in
the
study
records
as
Dimethyl
Glutarate
(
DMG)
or
by
the
Haskell
Sample
Number
24300.
The
Certificate
of
Analysis
(
COA)
will
be
maintained
with
the
study
records.

B.
Animals
1.
Species
(
Strain)
Hra:(
NZW)
SPFrabbits
58
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glumate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
2.
Reason
for
Selection
The
rabbit
was
selectedto
provide
data
in
a
nonrodent
species.
The
New
Zealand
white
strain
was
selected
because
background
data
are
available
from
the
literature,
the
supplier,
and
previous
studies
at
Haskell
Laboratory.

3.
Source
COVANCE,
Denver,
Pennsylvania.

4.
Dcscription
Nulliparous,
time­
mated
females
will
be
received
onJune
19
(
66
females)
and
June
21
(
44
females),
2002.
Body
weights
on
the
day
the
rabbits
are
mated,
day
0
of
gestation
(
day
OG)
will
be
supplied
by
the
vendor.
The
rabbits
for
this
study
will
be
requested
to
be
at
either
1,2,
or
3
days
ofgestation
upon
receipt,
and
approximately
6­
6.5
months
old.

5.
Identification
Each
animal
is
assigned
a
unique
number
and
identified
with
a
microchip
implant
by
the
supplier
prior
to
shipping.
Upon
receipt,
each
animal
wifl
be
assigned
a
unique
Haskeli
animal
number.
Both
the
Haskell
animal
number
and
the
number
provided
by
thesupplier
will
be
recorded
on
each
cage
card.
A
masterlist
ofunique
Haskell
animal
numbersand
correspondingunique
supplier­
providedanimal
numbers
will
be
maintainedwith
the
study
records.

C.
Husbandry
1.
Caging
Housedindividually
in
suspended,
wire­
mesh,
stainless
steel
cages.
Nesting
material
will
not
be
provided
because
the
does
will
be
sacrificed
before
part&
ti'in?.

To
address
logistical
considerations,
the
rabbits
on
this
study
will
be
housed
in
4
animals
rooms
near
the
exposure
chambers.
It
is
expected
that
there
will
be
a
significant
aerosol
component
in
the
high
level
chamk,
therefom
there
may
be
residual
test
substance
on
the
fur
of
the
high
level
rabbits
followingthe
whole­
body
exposures.
Thus,
the
control
group
rabbits
will
be
housed
separately
in
one
mom
to
prevent
any
potential
exposureto
test
substance.
The
ribbits
exposed
to
1000mdm3will
be
housed
separately
within
a
hood
so
that
khe
higher
air
flow
in
the
hood
will
promote
evaporation
ofaerosol
deposits
on
the
fur.
The
remaining
3
groups
of
rabbits
will
be
housed
in
2
other
rooms.

2.
Food
On
the
day
ofarrival
and
daily
thereafter
each
rabbit
will
receive
approximately
150grams
per
day
of
Purim@
Certified
Rabbit
Chow"#
5325;
food
will
not
be
available
during
inhalationexposures.

4
59
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
3.
Water
Water
from
United
Water
Delaware(
VWD)
will
be
available
ad
libitum,
except
during
inhalation
exposures.

4.
Environmental
Conditions
Fluorescent
illumination
will
be
provided
for
12
hours
daily
(
0600­
1801)
hours)
and
a
record
of
temperature
and
humidity
will
be
maintained
throughout
the
study.
Room
temperature
will
be
targeted
between
19
and
2l0C,
and
relative
humidity
betwccn
#%
and
60%.
Environmental
conditions
for
each
room
will
be
monitored
and
documented
daily,
Any
deviations
will
be
addressed
and
acknowledged
by
the
study
director.

5.
Animal
Health
Monitoring
As
specified
in
the
DuPont
Haskell
Laboratory
animal
health
and
environmental
monitoring
program,
the
following
procedures
areperformed
periodically
to
ensure
that
contamjnant
levels
arebelow
those
that
would
be
expected
to
impact
the
scientific
integrity
of
the
study:

Water
samplesare
analyzed
for
total
bacterial
counts,
and
the
presencc
of
colifoms,
lead,
and
other
contaminants.

Feedsamples
are
analyzed
for
total
bacterial,
spore
andfungal
counts.

Samples
from
freshly
washed
cages
and
cage
racksare
analyzed
to
ensure
adequate
sanitation
by
the
cagewashers.

Certified
animal
feed
is
used,
guaranteedby
the
manufacturerto
meet
specified
nutdional
requirements
and
not
to
exceed
stated
maximumConcentrationsof
key
contaminants,
including
specifiedheavy
metals,
aflatoxin,
chlorinated
hydrocarbons,
and
organophosphates.
The
presence
of
these
contaminants
below
the
maximum
concentrationstated
by
the
manufacturer
would
not
be
expected
to
impact
the
integrity
of
the
study.

The
animal
health
and
environmental
monitoring
program
is
administered
by
theattending
laboratory
animal
veterinarian.
Data
are
maintained
separatelyfrom
study
WCO&
and
may
be
included
in
the
final
repon
at
the
discretjon
of
the
study
director.

6.
Quarantine
The
rabbits
will
be
quarantined
accordingto
procedures
outlined
in
Haskcll
Laboratory
SOP
LAOO3­
P
and
released
fromquarantine
following
approval
from
the
laboratory
animal
veterinarian
or
a
designee.

60
"
I
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
DevelopmentalToxicity
Study
in
Rabbits
DuPont­
10657
D.
Experimental
Design
The
experimental
design
is
shownbelow:

Target
Concentrationa
Mated
GFOUD
~
rn~/
rn~
l
Females
I
Ob
22
II
30
22
JIT
loo
22
IV
300
22
V
1000
22
a
DMGwill
be
administered
by
inhalation,
6
hours
per
day,
on
days
7­
286.
b
Conditioned
air.

E.
Selection
of
Exposure
Levels
The
exposure
levels
and
route
of
exposure
for
the
current
study
were
selected
by
the
Sponsor.

F.
Randomization
AI1
animals
will
be
ranked
on
the
basis
of
day
0
gestation
body
weights
and
assigned
to
control
and
experimental
groups
by
random
sampling
from
the
ranked
list.
The
distribution
should
result
in
mean
body
weights
for
all
groups
that
are
not
stdtisticdly
different
(~~
4.05).
Does
that
lose
excessive
weight
or
appear
ill
prior
to
the
start
ofdosing
will
be
removedfromthe
study.

G.
Generation,
Administration,
and
Analysis
of
Test
Atmospheres
1.
Atmosphere
Generation
In
general,
each
group
of
rabbits
will
be
exposed
6hours
per
day
during
gestation
days
7­
28G.
The
starting
time
of
each
exposune
will
be
defined
as
the
time
when
the
generation
system
is
turned
on.
The
ending
time
of
each
exposure
will
be
defined
as
thetime
whenthe
generation
system
is
turned
off.
Rabbits
will
be
exposed
to
the
test
substance
during
both
the
time
it
takes
for
the
chamber
to
reach
concentration,
and
the
time
it
takes
for
the
test
substance
to
he
purged
from
the
chamber.
After
each
exposure,
rabbits
will
be
returned
to
their
home
cages.

Attempts
will
be
made
to
generate
respirable
atmosphem
ofthe
test
substance
that
approximate
the
physical
fonn
of
the
test
substance
expected
to
be
encountered
in
human
exposure
situations.
Test
atmospheres
will
be
generatedby
metering
the
test
substance
into
a
Spraying
System
nebulizer
with
an
infusion
pump
or
a
fluid­
meteringpump.
Filtered,
high­
pressure
air
introduced
into
the
nebulizer
will
atomize
the
liquid
test
substance.
The
resulting
aerosol
and
vapor
mixture
will
be
mixedwith
conditioned,
filtered
air
leading
to
the
inhalation
chambers+
The
concentration
of
the
test
substancein
each
test
chamberwill
be
adjusted
by
varying
the
amount
of
the
liquid
test
substance
delivered
to
the
nebuIizer.
Testatmospheres
will
be
generated
61
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhdation
DevelopmentalToxicity
Study
in
Rabbits
DuPont­
iO657
dynamicallyusing
airflowsneeded
to
achieve
at
least
12
air
changes
per
hour
in
the
exposure
chamber.
Uniform
distribution
of
the
test
substance
in
the
exposure
chamber
will
be
verified
prior
to
the
study
start.

All
componentsof
the
vapor
generation
system
will
be
fabricated
from
stainless
steel,
glass,
Neoprene@
or
Teflon@.
The
actual
generation
equipment
and
conditions
will
be
documented
in
the
study
records
and
described
in
the
final
report.

The
exposure
chambers
(
9m')
to
be
used
for
this
study
will
be
constructed
of
stainless
steel
and
glass.
Exposure
chambers
will
be
cubical
with
square­
pyramidalchamber
inlets
and
outlets
("
Ustyle);
a
tangential
feed
at
the
chamber
inlet
promotes
mixing
and
uniform
chamber
distribution
of
aerosol
andor
vapor.

2.
Chamber
Conditions
Anemometersprobes
located
in
the
chamber
inlet
will
monitor
total
chamber
airflow.
Chamber
temperatureswill
be
measured
by
thermistor
or
themocouple
probes;
relative
humidity
will
be
determined
by
weddry
bulb
type
resistance
temperature
detectors;
and
chamber
oxygen
concentrations
will
be
monitored
by
electrochemical
sensors.
Ideally,
chamberconditions
will
be
set
so
that
temperaturewill
be
17­
23
°
C;
relative
humidity
will
be
4096­
60%,
with
minimum
oxygen
content
of
19%.
However,
temperature
and
humidity
variations
outside
of
these
ranges
are
commonly
encountered
due
to
the
generation
procedures
used
and
the
characteristics
of
the
test
substance
itself.
Efforts
will
be
made
to
minimizetemperature
and
humidity
variations
during
this
study.
Potentially
adverse
effects
rcsulting
fromvariations
in
temperature,
relative
humidity,
or
oxygen
content
will
be
addressed
in
the
final
repon.

3.
Administration
Rabbits
will
be
exposed
whole­
body
to
the
test
substance.
Rabbits
will
be
placed
in
stainless
steel
cages
inside
the
exposurechamber.
Exposures
will
be
conducted
during
approximately
the
same
timeperiodeach
day
to
minimize
diurnal
physiological
variations.
Control
rabbits
will
be
treated
exactly
as
test
rabbits,
with
the
following
exceptions:
the
wire
exposwe
cages
for
the
control
rabbits
wili
be
slightly
larger
than
those
used
for
the
rabbits
in
the
treatment
groups
exposed
to
test
substance
and
the
control
rabbits'
chamber
atmosphere
will
not
contain
the
test
substance.

4.
Analyses
of
the
Test
Atmosphere
The
concentration
of
the
test
substance
in
the
300
and
loo0mgh3chambers
will
be
determined
by
gas
chromatographyand
gravimetric
analysis
for
the
vapor
and
aerosol
components,
respectively.
Sampleswill
be
taken
from
the
0,30,
and
100
mg/
tn3
chambers
forvapor
components
only,
since
he
mean
daily
aerosol
concentration
at
300mg/
m3
in
the
pilot
study
ranged
from
1.990­
6.731
mg/
m3,
and
therefore
the
aerosolconcentration
in
the
30
and
100
mg/
m3
chambersis
expected
to
be
negligible
or
nondetectable.
Knownvolumes
of
chamber
atmospherewill
be
drawn
from
the
breathing
zoneof
the
rabbits
though
a
samplingtrain
consisting
of
a
25mm
filter
cassette.
A
separate
sample
for
analysis
of
vapor
concentration
will
be
drawn
through
an
impjnger.
Aliyuots
of
impinger
solutions
will
be
injected
into
a
gas
7
62
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
DevelopmentalToxicity
Study
inRabbits
DuP~
ttt­
10657
chromatograph
equipped
with
a
flameionization
detector.
Liquid
standards
(
usually
3
standards
of
different
concentrations
spanningthe
range
of
test
substance
concentrations)
will
be
prepared
at
least
once
per
week
by
the
quantitative
dilution
of
the
test
substance
in
known
amountsof
acetone.
The
derived
chamber
concentrations
will
be
stored
in
a
computerized
database
for
future
data
collation
and
reporting;
hard
copies
of
collected
data
will
be
printed
daily.
The
filter
cassette
will
contain
a
preweighed
fiber
filter
to
capture
the
aerosol
portion
of
the
sampled
atmosphere.
The
impinger
will
contain
acetone
to
capture
the
vapor
portion,
Filters
will
be
weighed
on
a
Cahn
Automatic
Electrobalance.
The
aerosol
concentration
from
each
sample
will
be
determined
fromthe
pre­
and
post­
sampling
filter
weight
divided
by
the
volume
of
air
sampled.

Foreach
exposure,
the
mean
aerosol
concentration
will
be
added
to
the
mean
vapor
concentration
to
calculate
the
total
chamber
concentration
of
the
test
substance.

Samples
to
determine
particle
size
distribution
(
massmcdian
aerodynamic
diameter
and
percent
particles
less
than
1.3,
and
10
pm
diameter)
will
be
taken
from
the
high
concentration
chamber
once
per
week
with
a
Sierra@
Series210
Cyclone
Preseparator/
CascadeImpact
andlor
Sierra@
Series
110Constant
Flow
Air
Sampler
(
Calculationdescribed
in
Sierra
Instruments,
Inc.,
Bulletin
7­
79­
219IM,
Instruction
Manual:
Series
210
Ambient
Cascade
Impactors
and
Cyclone
Preseparators).
Since
the
aerosol
concentration
in
the
pilot
study
waslow
at
the
300
mg/
m3
concentration
and
is
expected
to
be
negligible
or
nondetectable
at
lower
concentrations,
particle
size
will
not
be
determined
at
concentrations
of
300mg/
m3
and
below.

The
generalprinciples
of
monitoring
chamber
atmospheresare
documented
in
the
Inhalation
Toxicology
SOP S.
Details
of
the
analytical
method(
s)
used
will
be
documented
in
the
study
records,
and
described
in
the
final
report.

5.
Frequency
of
Measures
The
atmospheric
concentration
of
the
test
substance
in
the
breathing
zonesof
the
rabbits
will
be
determined
approximately5
times
daily
forthe
30,100.300,
and
loo0
m@
m3chambers,
and
once
daily
for
the
controlchamber.
Moreor
less
frequent
samplesmay
be
takenat
the
discretion
ofthestudy
director.
The
chamberairflow,
temperature,
and
humidity
will
be
monitmed
continuously
and
recorded
at
least
every
30
minutes
during
exposure.
Oxygen
concentrations
will
be
monitored
and
recorded
at
least
twice
per
exposure
per
chamber.
The
actual
frequency
of
measures
will
be
recorded
in
the
study
records.

H.
Safety
Precautions
and
Disposal
of
Waste
Material
Good
industrial
hygiene
practices
will
be
followed
during
the
conduct
of
this
study
and
appropriate
personal
protective
equipment
(
PPE)
will
be
used
by
study
personnel.
Handling
of
test
substance,
chamber
waste
and
animal
carcasses
will
follow
procedures
outlined
in
standard
opcrating
procedures
and
in
the
Stine­
Haskell
Safety
and
Occupational
Health
Manual.
The
test
substance
will
be
released
to
the
atmosphere
by
permit
fromthe
State
of
Delaware.

8
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
Wont­
10657
1.
Animal
Euthanasia
1.
Adults
Does
will
be
euthanized
by
the
intravenous
injection
of
an
appropriate
euthanizing
agent.
The
identity
and
lot
number
of
the
agent
will
be
recorded
in
the
study
records.

2.
Fetuses
Fetuses
will
be
injected
withsodium
pentobarbital
prior
to
performing
visceral
examinations.

J.
Parameters
to
be
Studjed
1.
In­
Life
observations
of
Does
a.
Body
Weight
Body
weights
will
be
recorded
in
the
morning
on
the
day
after
arrival
through
day
29G.

b.
Food
Consumption
Food
consumed
will
be
measured
daily
on
days
4­
29G.

c.
Clinical
Signs
Clinical
signswill
be
recorded
each
morning
on
days
4­
29G
and
each
afternoon
following
exposures
on
days
7­
28G.
Clinical
signs
observed
at
othertimes
will
be
recordedby
exception.
Observations,
at
approximatelyhourly
intervals,
will
be
madeduring
the
exposures
to
assess,
to
the
extent
possible,
the
overall
state
of
the
animals.
In
addition,
the
responseof
the
animals
to
a
sound
stimulus
while
in
the
chamberswill
be
recorded
beforevapor
generation
begins,
after
approximately
three
hours
of
exposure,
andprior
to
removal
ofthe
animalsfromthe
chambers.

2.
Postmortem
ObservationsofDoesDying
Priorto
ScheduledEuthanasia
A
gross
external
and
visceral
examination
will
be
performed
within
24
hours
after
the
doe
is
found
dead.
Pregnancy
status
will
be
determined
and
the
uterine
contents
will
be
described.
Lesions
noted
will
be
retained
only
if
further
examination
is
necessary
(
at
the
discretion
of
the
study
director
or
a
designee).
Dead
rabbits
will
be
refrigerated
until
necmpsied.

3.
Observations
of
Does
that
AbortorDeliver
Early
a.
Dam
Observations
Damsthatabort
or
deliver
early
will
be
euthanized
within
24
hours
of
detection
and
a
gross
external
and
internal
examination
will
be
performed.
Lesions
noted
will
be
tetained
only
if
further
examination
is
necessary
(
at
the
discretion
of
the
study
directoror
a
designee).

64
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate(
DMG):
Inhalation
Developmental
Toxicity
Study
inRabbits
DuPont­
10657
b.
Fetal
Observations
Fetuses
remaining
in
the
uterus
or
aborteddelivered
early
will
be
examined
to
the
extent
possible.
Data
from
these
litters
will
be
maintained
with
the
raw
data
but
will
be
excluded
from
all
relevant
fetal
data
calculations.

4.
Postmortem
Observations
of
Does
Surviving
to
Scheduled
Euthanasia
a.
ExternalAppearance
Each
doe
will
be
examinedimmediately
after
euthanasia
on
day
290.

b.
Viscera
Viscera
will
be
examined
grosslyimmediately
after
euthanasia.
Lesions
noted
will
be
retained
only
if
further
examination
is
necessary.

c.
Uterine
Weight
The
intact
and
empty
uterus
of
each
doe
having
at
least
one
viable
fetus
will
be
weighed
to
permit
calculation
of
maternal
body
weight
adjusted
to
exclude
the
products
of
conception.

d.
Corpora
Lutea
The
count
for
each
ovary
of
dams
with
viable
fetuses
will
be
recorded.

e.
Implantations
For
each
female
with
visible
implants,
the
type(
live
and
dead
fetuses,
and
resorptions)
and
their
relative
positions
will
be
recorded.
The
uterus
of
each
apparent1
"
nonpregnant"
female
will
be
stained
with
ammonium
sulfide
to
detect
very
early
resorptions.
K
5.
Fetuses
of
Does
Survivingto
Scheduled
Euthanasia
a.
Number,
Location,
and
Condition
These
parameters
will
be
recorded
for
each
fetus.

b.
Fetal
Weight
The
body
weight
foreach
fetus
will
be
recorded.

c.
ExternalAlterations
The
alterations
detected
for
each
live
fetus
will
be
recorded.

10
65
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarafe
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
d.
Soft
Tissue
Alterations
For
each
live
fetus,
fetal
sex
and
any
visceral
alterations
detected
will
be
recorded.@)
A
transverse
section,
deep
enough
to
pennit
examination
of
the
brain,
will
be
made
between
the
parietal
and
Frontal
bones.
On
the
day
of
sacrifice,
the
eyelids
of
each
fetus
will
be
removed10
examine
the
eyes
for
alterations.

e.
Skeletal
Alterations
After
fixation
in
alcohol,
the
alizarin­
stained
skeletons
will
be
examined
and
alterations
detected
will
be
recorded
foreach
ljve
fetus.

f.
Dead
Fetuses
Dead
fetuses
will
be
examined
externally,
viscerally,
and
skeletally
to
the
extent
possible.
Data
fromthese
fetuses
will
be
excluded
from
all
calculations
performed
for
live
fetuses.

g.
Retention
of
Tissues
Fetal
organs
or
tissues
will
be
retained
if
deemed
necessary
forobtaining
a
definitive
diagnosis
of
a
visceral
exam
finding.
Bilateral
organs
will
be
retained
when
only
one
is
affected.
Sufficient
tissues
fromcontrol
fetuses
will
be
fixedto
provide
comparison
with
suspect
tissues,
if
needed;
if
not
needed,
tissues
will
be
discarded.

11
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
K.
Statistics
Sequential
trend
tests
will
be
applied
to
the
data
for
each
parameter
as
tabulated
below."'
If
a
significant
dose­
response
trend
is
detected,
data
from
the
top
dose
groupwill
be
excluded
and
the
test
repeated
until
no
significant
trend
is
evident.
Fur
litter
parameters,
the
proportion
of
affected
fetuses
per
litter
or
the
litter
mean
will
be
used
as
the
experimental
unit
for
statistical
evaluation.'
8'
The
level
of
significance
selected
will
be
p
<
0.05.
Additional
statistical
testswill
be
used,
and
otherparameters
analyzed,
if
deemed
necessary.

Parameter
Maternal
weight
Maternal
weight
changes
Maternal
food
consumption
Live
fetuses
Dead
fetuses
Resorptions
Implantations
Corpora
lutea
Incidence
of
fetal
alterations
Incidence
of
pregnancy
Clinical
observations
Maternal
mortality
Females
with
total
resorptions
Abortiondearly
deliveries
Fetalweight
Sex
ratio
Trend
Test
Linear
contrast
of
means[')

Jonckheere's
test'")

Cochran­
Annitage
test'')

Linear
contrastof
least
square
means('')

Where
the
data
aretied
and
the
standard
large
sample
version
of
Jonckhere's
test
is
not
applicable,
exact
p
values
for
Jonckheere's
test
will
be
calculated
using
permutation
methodology."')

L.
Control
of
Bias
In
addition
to
the
random
assignment
to
groups,
all
does
will
be
coded
before
autopsy
and
will
remain
coded
during
the
collection
of
postmortem
and
fetal
data.
Dimethyl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
inRabbits
DuPont­
10657
M.
Records
Maintenance
All
data
and
records
for
analytical
characterizationsconductedby
the
sponsor
will
be
archived
by
the
sponsor.
Laboratory­
specificor
site­
specific
raw
data,
such
as
personnel
files
and
equipment
records
will
be
retainedby
the
facility
where
the
work
was
done.

A
sample
of
the
test
substance
will
be
collected
for
archive
purposesand
retained
at
DuPont
Haskell
Laboratory,
Newark,
Delaware.
Specimcns,
raw
data,
and
the
find
report
will
be
retained
at
DuPont
Haskell
Laboratory,
Newark,
Delaware
or
at
Iron
Mountain
Records
Management,
Wilmington,
Delaware.

CRITICAL
DATES
Experimental
staft
date
(
first
day
of
exposure):
June
23,2002
Completion(
last
fetal
evaluation):
September2002
(
approximate)
Find
report
April
16,2003
68
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Olutarate
(
DMO):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DUPOIU­
10657
REFERENCES
1.
United
States
(
U.
S.)
Environmental
Protection
Agency
(
EPA),
Toxic
Substances
Control
Act
(
TSCA)
40
CFR
Part792.
2.
Organization
for
Economic
Cooperation
and
Development
(
OECD),
Principles
of
Good
LaboratoryPractice
(
as
revised
in
1997)
published
in
ENV/
MCICHEM(
98)
17.
3.
United
States
(
U.
S.)
Environmental
Protection
Agency
(
EPA).
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPPTS)(
1998).
OPPTS870.3700
Prenatal
Developmental
Toxicity
Study.
Health
Effects
Test
Guidelines.

4.
United
States
(
U.
S.)
Environmental
Protection
Agency
(
EPA)
Federal
Register
(
August
5,
1999).
 
Dibasic
Esters;
Final
EnforceableConsent
Agreement
and
Testing
Consent
Order. 
Vol.
64,
No.
150,
pp.
42692­
42695.
5.
Salewski,
E.
(
1964).
 
Farbemethode
zum
rnakroskopischen
Nachweis
von
Implantationsstellenam
Uterus
der
Ratte, 
Archiv.
Path.
Exp.
Pharmakol.,
M367.

6.
Staples,
R.
E.(
1974).
 
Detection
of
Visceral
Alterations
in
Mammalian
Fetuses,. 
Terdology,
9(
3):
A37­
A38.
7.
Selwyn,
M.
R.(
1995).
 
TheUse
of
Trend
Tests
to
Determine
a
No­
Observable­
EffectLevel
in
Animal
Safety
Studies. 
Journal
of
the
American
College
ofToxicology
14(
2):
158­
168.

8.
Haseman,
J.
K.
and
Hogan,
M.
D.
(
1975).
 
Selectionof
$
e
Experimental
Unit
in
Teratology
Studies, 
TerutoZogy,$
2(
2):
165­
171.

9.
Snedecor,
G.
W.
and
Cochran,
W.
0.
(
1967).
StatisticalMefhods,
6thed.,
The
Iowa
State
University
Press,
Iowa,
pp.
246­
248;
349­
352.

10.
Jonckheere,
A.
R.
(
1954).
 
A
Distribution­
Free
K­
sample
Test
Against
Ordered
Alternatives, 
Biomefnka.
41:
133­
145.

11.
Dempster,
A.
P.,
Selwyn,
M.
R.,
Patel,
C.
M.,
andRoth,
AJ.
(
1984).
 
Statistical
and
Computational
Aspects
of
Mixed
Model
Analysis, 
The
Journal
of
the
Royal
Statistical
Society,
Series
C
(
Applied
Statistics),
33(
2):
203­
214.

12.
Patefield,
W.
(
1982).
 
Ex;
actTests
for
Trends
in
Ordered
ContingencyTables, 
Applied
Stazistics
31:
32­
43.

69
Dimethvl
Glutarate
CDMG):
Inhalation
DeveloDmentd
Toxicitv
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalation
DevelopmentalToxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
CDMG):
Inhalation
DeveloDmental
Toxicitv
Study
in
Rabbits
­
5
Service
Code
Number
733
Protocol
15
70
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Dimethyl
Glutarate
(
DMG):
Inhalatinn
Devtlopmental
Toxicity
Study
in
Rabbits
Duponl­
10657
Dimethvl
Glutarate
(
DMGL
Inhalation
Develoumental
Toxicity
Studyin
Rabbits
Work
Reouest
Number
13495
Service
Code
Number
733
Protocol
­

S­
A
Dibasic
Eltm
Group
71
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDIX
C
Daily
Chamber
Concentrations
72
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
DAILY
CHAMBER
CONCE~
RATZONS_
j,
l
I
mu
L
,"_
i
EXPLANATORY
NOTES
ABBREVIATIONS:

S.
D.
­
standard
deviation
mg/
m3
­
milligrams
per
cubic
meter
n
­
numberofsamples
FOOTNOTES:

a
Standard
deviation
could
not
be
calculated
from
this
sample
size.
b
Due
to
equipment
malfunction,
the
exposure
for
the
100mg/
m3chamber
was
shortened
to
approximately
5
hours.

NOTES:

Values
are
reported
to
2
significant
figures.
Means
and
standard
deviations
were
calculated
prior
to
rounding
values.
Aerosol
concentration
was
only
measured
for
the
300
and
1000mg/
m3
chambers.

73
000
omoooooooooooo
00000ddoddodrloorld~
orldddid
o%
2go:
m
dd
d
d
d
d
rl
rl
d
d
d
d
d
d
d
d
d
11
00
0
0
00
0
0
0
0
0
0
0
0
0
00
0
0
0
0
0
0
0
0
0
­&
g
mmmmmmmmmmmmmmmmmmmmsmnmlm
00000000000000000000000000
I
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDIX
D
Daily
Chamber
Environmental
Conditions
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
DAILY
CHAMBER
ENVEONNIENTAL
CON?
maONS
.
_
LI
EXPLANATORY
NOTES
ABBREVIATIONS:

n
­
number
of
observations
FOOTNOTES:

a
Due
to
equipment
malfunction,
the
exposure
for
the
100mg/
rn3chamber
was
shortened
to
approximately
5
hours.

NOTES:

Values
are
reported
to
2
significant
figures.
Means
and
standard
deviations
were
calculated
prior
to
rounding
values,

77
.
E
a
.........................
~
000000000000000d000000000
I
ddddddddddddddddmddddddddd
NNNNNNNNNNNNNNNNNNNNNNNNNN
o~~
mrrddmrnodrrrrnm~
mmmd~
odd
mwwwmmmwmmwwmmmmmwmmmwwwww
l~
1111,1111111111111111111
H
'
1
dddddldddfddddddWddddddddd
NNNNNNNNNNNNNNNNNNNNNNNNNN
­
4
4
4
4
44444
444
4­
44­
44­
d"
­­­
777777777777~
777m7777~
77~~
1'
1
NNNNNNNNNNNNNNNNNNNNNNNNNN
000000000000
000000
000000000000
000000
mdmmmmmmmmmo
mmmmmm
NNNnn,,
dNdddddddddN0dddddd
__­­
Illggggl
I,
IIIIIIII
1g1
IIIII
000~~~~
000000000000~
000000
000
000000000000
000000
mmm
aoaammamammm
mamaam
ddd
drndddddddddd
rlddddd
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drmr~
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rmo~
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~
ddddddmAdNNNdNNNdNNNNNNmN
i:
m
00000000000000000000000000
00000000000000000000000000
ommmmmmadmammmmmmmmmmammmm
NdddddddNddddddddddddddddd
7~
777~
7777777777m7777777~~
NNNNNNNNNNNNNNNNNNNNNNNNNN
000
0000000000000000000
000
0000000000000000000
oommmmmmmmmmmmmmmmm
000~"~
0000000000000000000
000
0000000000000000000
000
mmrrarrrcoammammmmaa
NNN
ddrldddddddddddddddd
Y
00000000000000000000000000
00000000000000000000000000
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~
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NNNNNNNNdddddddddddddddddd
777777e~~
777~
777m777077777
NNNNNNNNNNNNNNNNNNNNWNNNNN
0000000000000000
000000000
0000000000000000
000000000
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mmommoomo
NNNNNNddNdNNNNNdOddNddNNdN
0000000000000000~
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0000000000000000
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dmmmmaarommmmmmm
commmmmmrm
NdddddddNddddddd
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­

'
77777777777e7777w777777777
NNNNNNNNNNNNNNNNNNNNNNNNNN
0000000000000000000
0000000000000000000
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Nddd,,­
dNdNdddddddddddNNNN
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9
i
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDIX
E
Individual
Body
Weights
81
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Individual
Body
Weights
Explanatory
Notes
Footnotes
a
Weight
calculated
using
the
final
body
weight
minus
the
weight
of
the
products
of
conception.

Abbreviations
=
Nodata
AB
=
Aborted
NP
=
Notpregnant
ED
=
Earlydelivery
R
=
Litter
totally
resorbed
SE
=
Sacrificed
in
extremis
FD
=
Founddead
82
,

Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
I:
0
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
0
DAY
4
DAY
5
DAY
6
DAY
7
DAY
8
35570
3008.0
3215.7
3063.6
3109.9
3047.8
3097.4
35572
4199.0
4334.6
4286.1
4231.5
4274.2
4317.0
35576
3533.0
3642.4
3476.3
3605.3
3693.6
3702.4
35578
3303.0
3548.7
3389.9
3337.6
3359.2
3359.7
35579
3135.0
3385.0
3365.6
3252.3
3269.3
3283.3
35597
3384.0
3480.6
3436.8
3457.1
3481.6
3459.5
35599
2932.0
3069.3
2996.4
2963,8
2788.5
2699.2
35601
3464.0
3575.0
3487.9
3643.4
3517.9
3584.0
35604
3754.0
3812.6
3783.0
3791
5
3752.8
3782.8
35616
3480.0
3424.5
3429.0
3474.3
3428.9
3499.7
35621
3202.0
3210,8
3177.2
3186.2
3203.6
3199.7
35628
3705.0
3647.7
3651.1
3868.4
3674.4
3706.8
35632
3982.0
3834.3
3854.0
3806.8
3827.1
3832.2
35639
3505.0
3570.9
3538.6
3529.8
3565.4
3542.0
35644
3598.0
3666.6
3612.6
3626.7
3626.3
3607.7
35646
3026.0
3075.1
3057.7­
3101.0
3099.1
3050.7
35656
4179.0
4107.3
4100.2
4075.3
4080.1
4137.3
35658
3871.0
3791.2
3783.1
3815.0
3804.0
3822.5
35659
3487.0
3481.8
3463.0
3473.9
3506.5
3502.5
35666
3648.0
3682.1
3671.2
3672.3
3673.1
3696.7
35675
3391.0
3336.9
3354.9
3351.3
3368.4
3442.2
35677
3198.0
3326.4
3351.7
3333.7
3361.0
3371.5
DuPont­
10657
DAY
9
~
~­
ANIMAL
STATUS
3071,2
4236.8
3754.0
3354.9
AB
3324.7
3482.6
3037.9
3596.8
3799.1
3490.1
3183.0
3697.5
3813.2
3569.1
3609.2
3046.5
4129.9
3811.6
3564.0
3699.9
3415.8
3372.2
Dimethvl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicitv
Studv
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
I:
0
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
10
DAY
11
DAY
12
DAY
13
DAY
14
DAY
15
DAY
16
ANIMAL
STATUS
35570
3113.0
3116.6
3158.0
3186.9
3239.7
3254.7
3243.4
35572
4279.2
4245.3
4309.5
4332.2
4372.0
4361.6
4393.1
35576
3695.1
3692.1
3774.8
3765.4
3841.1
3897.5
4027.8
35578
3348.8
3310.8
3325.6
3339.8
3318.8
3349.5
3356.3
AB
35579
3335.9
3322.3
3357.4
3405
.
O
3451.6
3490.4
3531.5
35597
3443.5
3468.9
3469.8
3467.6
3520.4
3535.0
3537.7
35599
2958.8
3024.3
3021.7
3050.5
3092.9
3111.5
3103.3
35601
3605.2
3659.0
3668.2
3709.3
3746.9
3753.1
3775.4
35604
3809.3
3836.3
3880.3
3922.6
3954.4
4044.9
4060.3
35616
3482.7
3498.9
3524.5
3596,
O
3635.7
3689.4
3698.2
35621
3205.6
3235.3
3214.0
3211.7
3259.8
3101.1
3334.8
35628
3737.2
3738.6
3769.5
3803.1
3852.2
3890.6
3859.2
35632
3890,
l
3870.8
3875.6
3880.5
3910.4
3937.9
3959.3
35639
3546.5
3542.1
3556.1
3587.6
3637.2
3663.2
3665.1
35644
3630.3
3632.7
3638.8
3662.4
3757.6
3796.4
3793.5
35646
3026.0
3027.9
2970.9
2998.8
3064.9
3158.7
3179.2
35656
4161.6
4175.2
4135.5
4180.8
4240.7
4221.9
4214.1
35658
3795.6
3811.0
3854.5
3872.1
3927.6
3911.1
3950.5
35659
3583.2
3588.1
3605.4
3629.0
3688.0
3689.5
3727.2
35666
3730.7
3706.0
3766.8
3738.0
3804.4
3818.7
3855.1
35675
3410.1
3392,3
3469.9
3542.3
3598.9
3628.4
3613.6
35677
3390.4
3396.4
3292.6
3418.5
3437.3
3481.9
3500.3
84
­­­
­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
I:
0
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
17
DAY
18
DAY
19
DAY
20
DAY
21
DAY
22
ANIMAL
STATUS
35570
3248.2
3238.8
3256.5
3244.3
3237.2
3253.8
35572
4414.1
4394.4
4428.4
4414.9
4442.1
4415.5
35576
4046.3
4056.5
3980.9
3972.3
4017.3
3969.8
35578
3369.7
3359.1
3267.9
AB
35579
3539.0
3543.0
3547.1
3595.1
3579.0
3622.4
35597
3572.0
3519.9
3544.9
3581.7
3569.1
3593.8
35599
3135.9
3130.9
3128.0
3160.2
3215.0
3255.0
35601
3744.1
3769.7
3775.3
3822.6
3823.5
3879.2
35604
4104.5
4075.6
4127.8
4113.9
4138.7
4132.9
35616
3730.1
3709.7
3732.6
3727.7
3753.6
3794.0
35621
3330.9
3324.5
3350.4
3328.6
3349.3
3345.3
35628
3845.1
3890.9
3931.5
3894.4
3944.0
3937.5
35632
3923.7
3979.9
3954.1
3952.8
3980.6
3908.7
35639
3658.0
3673.9
3665.9
3668.0
3694.9
3693.5
35644
3814.0
3736.3
3768.1
3770.4
3727.3
'
3767.5
35646
3172.2
3157.9
3157.2
3174.0
3166.4
3180.2
35656
4270.9
4255.0
4272.2
4261.7
4258.5
4259.6
35658
3928.2
3942.2
3953.3
3967.0
3969.1
4017.2
35659
3731.1
3741.0
3788.9
3784.8
3858.6
3809.3
35666
3853.6
3903.1
3915.8
3858.7
3878.6
3911.8
35675
3597.3
3613.3
3601.7
3590.8
3576.7
3615.9
35677
3429.2
3457.7
3475.3
3460.9
3460.1
3477.7
85
­­­
­­­
­­­
­­­
­­­
­­­
­­­

­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
I:
0
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
23
DAY
24
DAY
25
DAY
26
DAY
27
DAY
28
35570
3288.8
3332.7
3343.8
3367.9
3362.5
3374.4
35572
4436.3
4462.2
4476.4
4490.5
4479.3
4465.8
35576
3954.3
3976.0
4002.5
4032.4
4070.3
4071.7
35578
35579
3656.3
3687.1
3703.3
3730.9
3744.5
3722.2
35597
3629.1
3680.6
3697.8
3727.5
3755.6
3729.1
35599
3243.2
3244.1
3338.1
3375.0
3387.9
3435.8
35601
3788.9
3822.3
3860.6
3825.7
3949.1
3988.2
35604
4103.4
4142.6
4174.4
4217.0
4220.9
4273.4
35616
3782.4
3812.4
3812.2
3844.9
3801.7
3823.0
35621
3364.0
3388.3
3392.7
3391.2
3428.8
3448.0
35628
3951.4
4003.4
4001.1
4043.7
4013.7
4081.7
35632
3901.0
3960.6
3934.4
3940.3
3937.8
3959.2
35639
3753.8
3797.9
3812.1
3848.7
3882.8
3935.6
35644
3812.5
3815.9
3814.9
3840.8
3857.7
3882.2
35646
3248.8
3296.2
3294.7
3330.9
3386.5
3435.6
35656
4312.4
4324.3
4305.7
4322.2
4323.5
4307.3
35658
4006,
l
4048.9
4058.2
4097.3
4088.2
4149.0
35659
3838.9
3921.2
3946.0
3905.0
3849.3
3906.0
35666
3968.0
3998.4
4032.9
3998.2
4054.6
4002.0
35675
3602.8
3645.5
3646.8
3703.1
3747.1
3769.7
35677
3528.7
3538.9
3532.9
3559.7
3567.6
3583.7
DuPont­
10657
DAY
29
ANIMAL
STATUS
3426.9
4442.1
4167.3
AB
3766.4
3747.2
3401.5
3976.9
4249.5
3867.4
3973.9
3959.3
3903.5
3413.9
4320.4
4180.1
3958.0
4044.3
3841.4
3639.4
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
I:
0
mg/
m3
ANIMAL
NUMBER
DAY
29a
35570
3101.1
35572
4111.5
35576
3644.6
35578
35579
3337.9
35597
3294.4
35599
2988.9
35601
3510.5
35604
3700.2
35616
3402.4
35621
3544.9
35628
3099.0
35632
3616.1
35639
3455.5
35644
3493.0
35646
2882.4
35656
3923.4
35658
3699.6
35659
3446.4
35666
3591.4
35675
3304.8
35677
3144.9
DAYS
OF
GESTATION
ANIMAL
STATUS
AB
87
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
0
DAY
4
DAY
5
DAY
6
DAY
7
DAY
8
35573
3176.0
3322.3
3279.2
3252.3
3213.8
3218.9
35574
3774.0
3704.8
3684.2
3650.5
3633.9
3615.1
35584
2995.0
3025.4
3044.5
2996.9
3021.5
3004.6
35585
3236.0
3290.6
3194.8
3188.7
3156.2
3234.6
35588
4104­
0
3971.2
3918.2
3874.6
3892.9
3844.3
35593
3430.0
3461.0
3378.8
3398.4
3399.3
3430.9
35595
3264.0
3396.5
3356.3
3386.4
3406.8
3419.6
35600
3754.0
3647.1
3646.6
3706.4
3692.5
3679.1
35603
3335.0
3303.0
3254.1
3315.2
3278.6
3293.2
35606
2863.0
2960.7
2895.5
2896.0
2921.5
2926.4
35614
3830.0
3691.7
3695.2
3685.7
3677.5
3757.8
35617
3111.0
3184.4
3136.5
3095.4
3110.2
3183.1
35630
3232.0
3282.9
3238.7
3223.5
3242.4
3241.6
35633
3588.0
3494.2
3537.5
3548.1
3547.6
3627.4
35642
3416.0
3414.9
3363.0
3383.0
3506.0
3405.7
35647
3559.0
3719.9
3748.8
3783.4
3743f
9
3721.3
35649
4071.0
4122.4
4019.7
3899.6
4025.4
4002.7
35654
3548.0
3572.8
3568.5
3587.3
3603.5
3598,
O
35667
3613.0
3543.2
3542.7
3573.7
3574.8
3603.8
35669
3167.0
3149.9
3155.2
3192.1
3247.2
3232.3
35670
3429.0
3434.0
3465.0
3467.2
3497.3
3472.3
35674
3866.0
3833.1
3899.5
3767.1
3803.5
3840.3
DuPont­
10657
DAY
9
ANIMAL
STATUS
3188.4
3628.4
2989.4
3205.2
3845.7
3469.0
3416.8
3691.8
3347.0
NP
2957.6
3715.6
3124.5
3232.5
3583.3
3419.3
3712.4
4044.9
3571.3
NP
3599.0
3246.3
3479.8
3826.3
88
Dimethyl
Glutarate
(
DMG):
Inhalation
DevelopmentalToxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
10
DAY
11
DAY
12
DAY
13
DAY
14
DAY
15
DAY
16
ANIMAL
STATUS
35573
3189.6
3228.5
3279.5
3286.7
3323.2
3379.3
3438.9
35574
3622.2
3661.3
3671.2
3688.3
3716.5
3755.2
3785.4
35584
3009.2
2995.4
3028.1
3066.8
3072.4
3129.4
3165.6
35585
3223.1
3212.7
3215.0
3254.3
3277.7
3326.3
3383.2
35588
3857.1
3841.9
3867.7
3923.3
3942.9
3956.1
4006.6
35593
3446.1
3462.6
3480.2
3475.9
3516.2
3547.1
3526.7
35595
3419.2
3438.3
3437.4
3460.9
3512.2
3554.7
3576.8
35600
3705.3
3684.9
3685.2
3686.6
3732.6
3786.1
3825.8
35603
3349.7
3387.5
3359.1
3386.4
3365.9
3378.8
3440.5
NP
35606
2939.5
2963.4
2980.9
2997.3
3043.6
3084.5
3086.3
35614
3737.8
3742.1
3782.0
3848.9
3919.9
4017.1
4067.9
35617
3063.1
3165.7
3139.3
3192.1
3218.3
3256.3
3263.8
35630
3245.9
3250.7
3272.4
3290.8
3349.2
3376.3
3383.3
35633
3585.2
3582.8
3566.1
3588.5
3650.5
3712.3
3715.6
35642
3415.6
3396.1
3443.2
3468.7
3540.5
3585.7
3534.9
35647
3737.6
3775.1
3882.4
3927.6
4013.9
4086.7
4130.8
35649
4016.3
3985.7
3986,3
4051.4
4076.6
4111.7
4105.7
35654
3549.2
3581.7
3534.6
3551.8
3577.6
3607.3
3588.0
NP
35667
3585.7
3596.0
3625.5
3643.6
3655.9
3665.6
3680.7
35669
3229.8
3241.1
3278.4
3306.3
3347.7
3358.9
3394.4
35670
3483.3
3484.9
3523.9
3580.9
3587.1
3606.8
3624.9
35674
3843.8
3856.0
3894.1
3952.8
4038.1
4062.2
4082.8
89
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
17
DAY
18
DAY
19
DAY
20
DAY
21
DAY
22
ANIMAL
STATUS
35573
3481.2
3486.4
3495.7
3500.8
3517.8
3445.9
35574
3795.4
3821.3
3823.6
3829.4
3845.7
3849.3
35584
3146.6
3170.6
3155.6
3155.9
3202.2
3235.9
35585
3374.7
3381.0
3382.5
3384.1
3433.9
3437.6
35588
4032.9
4015.5
4004.8
4029.6
4025.0
4055.5
35593
3544.7
3557.2
3576.7
3591.0
3605.0
3639.8
35595
3549.9
3564.7
3541.7
3553.1
3543.3
3611.9
35600
3867.9
3887.3
3868.1
3876.1
3861.8
3891.1
35603
3442.7
3405.4
3471.2
3429.2
3430.0
3431.9
NP
35606
3087.5
3099.0
3128.8
3146.9
3159.2
3175.7
35614
4061.0
4110.6
4078.4
4048.8
4051.5
4080.8
35617
3196.7
3235.8
3203.9
3191.5
3285.1
3255.1
35630
3401.6
3433.3
3410.6
3445.6
3472.3
3491.0
35633
3672.8
3690.5
3669.2
3676.4
3703.3
3722.7
35642
3571.0
3539.3
3536.8
3530.7
3531.2
3485.5
35647
4170.4
4168.2
4120.4
4066.2
4062.3
4073,9
35649
4166.3
4193.2
4177.9
4164.2
4182.2
4179.2
35654
3517.1
3493.8
3492.0
3496.2
3472.7
3471.1
NP
35667
3704.3
3709.3
3726.0
3715.4
3746.4
3777.5
35669
3410.6
3412.4
3431.5
3444.6
3447.4
3469.3
35670
3590.8
3606.3
3620.0
3642.3
3652.3
3688.1
35674
4018.4
4077.6
4005.5
3957.2
4019.0
4013.3
90
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
23
DAY
24
DAY
25
DAY
26
DAY
27
DAY
28
35573
3545.6
3586.3
3608.5
3633.4
3645.7
3622.5
35574
3916.7
3907.5
3922.3
3944.1
3992.1
3993.4
35584
3260.6
3268.3
3287.0
3277.8
3257.9
3310.5
35585
3467.7
3542.2
3313.2
3209.3
3555.9
3548.7
35588
4114.6
4164.6
4205.1
4215.2
4285.0
4294.9
35593
3704.6
3714.9
3739.0
3788.6
3776.3
3778.9
35595
3623.9
3668.0
3669.8
3704.0
3708.9
3727.1
35600
3904.2
3893.8
3956.1
4018.7
4041.1
4008.7
35603
3439.5
3439.1
3474.2
3475.4
3479.5
3473.7
35606
3195.0
3214.2
3244.9
3276.2
3237.5
3279.0
35614
4114.6
4139.0
4139.1
4147.9
4133.2
4147.6
35617
3320.9
3377.4
3360.1
3362.5
3413.4
3397.7
35630
3509.6
3541.0
3590.6
3602.4
3610.6
3614.3
35633
3757.9
3777.0
3798.3
3822.9
3836.9
3838.1
35642
3564.3
3531.9
3561.7
3600.3
3610.4
3604.9
35647
4133.7
4181.7
4212.4
4258.6
4245.1
4283.7
35649
4214.6
4242.7
4264.7
4293.6
4285.7
4301.6
35654
3520.9
3494.1
3515.3
3495.3
3510.8
3479.5
35667
3773.4
3795.4
3807.7
3808.0
3844.3
3877.8
35669
3485.5
3519.6
3545.0
3590.7
3610.6
3644~.
7
35670
3726.6
3760.1
3791.7
3832.8
3862.5
3874.3
35674
4029.8
4063.4
4102.4
4112.8
4145.3
4162.8
DuPont­
10657
DAY
29
ANIMAL
STATUS
3655.1
4016.3
3310.3
3596.5
4314.1
3786.5
3772.0
4049.5
3505.2
NP
3323.5
4122.7
3415.0
3709.2
3859.9
3672.1
4343.5
4316.6
3541.7
NP
3915.4
3644.6
3926.2
4185.8
91
­­­

­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
29a
ANIMAL
STATUS
35573
3216.6
35574
3452.3
35584
2959.8
35585
3176.6
35588
3764.9
35593
3308.1
35595
3231.8
35600
3484.9
35603
NP
35606
2832.3
35614
3602.7
35617
3088.8
35630
3269.6
35633
3506.2
35642
3283.4
35647
3799.3
35649
3765.7
35654
NP
35667
3501.6
35669
3259.3
35670
3433.7
35674
3717.8
92
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
0
DAY
4
DAY
5
DAY
6
DAY
7
DAY
8
35580
3021.0
3216.2
3132.1
3185.9
3202.3
3127.6
35582
2871.0
2798.2
2830.4
2774.8
2825.0
2836.5
35587
3665.0
3537.3
3455.7
3399.5
3349.5
3266.4
35589
3898.0
3825.8
3786.4
3804.8
3751.1
3818.1
35594
3058.0
3172.4
3102.2
3159.2
3188.3
3173.8
35596
3813.0
3909.9
3866.2
3858.1
3918.7
3876.2
35609
3529.0
3652.7
3608.5
3617.5
3598.7
3598.7
35610
3415.0
3554.9
3412.0
3447.5
3417.9
3412.4
35611
3315.0
3344.3
3369.5
3375.4
3406.7
3462.8
35615
3165.0
3541.6
3561.4
3550.5
3558,
l
3565.5
35622
4238.0
4184.7
4144.3
4162.3
4181.2
4238.3
35624
3486.0
3307.6
3428.5
3452.0
3509.6
3530.2
35627
3262.0
3251.7
3255.8
3295.6
3300.3
3334.0
35634
3695.0
3110.2
3200.0
3189.3
3203­
3
3174.1
35641
3634.0
3579.3
3603.9
3579.7
3608.5
3604.0
35643
3164.0
3223.6
3229,7
3206.2
3224.2
3296.7
35645
3480.0
3385.9
3253.5
3330.4
3405.7
3447.5
35652
4084.0
4104.9
4085.7
4087.9
4065.7
4100.9
35657
3261.0
3060.7
3173.9
3073.7
3129.3
3124.7
35660
3416.0
3357.3
3336.3
3344.2
3328.6
3362.2
35661
3620.0
3556.6
3540.5
3546.2
3567.3
3566.3
35662
3771.0
3726.5
3749.9
3734.8
3716.5
3779.0
DuPont­
10657
DAY
9
ANIMAL
STATUS
3181.6
2874.6
3305.0
3788.5
3209.0
3904.6
ED
3579.3
3433.9
3459.4
3570.4
4204.5 
3463.7
3307.8
3175.3
3590.3
3211.1
3413.9
4079.4
3108.1
NP
3384.2
3564.8
3709.0
93
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
10
DAY
11
DAY
12
DAY
13
DAY
14
DAY
15
35580
3222.8
3220.6
3200.8
3262.5
3352.0
3386.5
35582
2895.2
2907.2
2966.6
3002.5
2998.6
3015.6
35587
3235.9
3216.1
3194.0
3206.8
3171.0
3173.9
35589
3783.1
3807.2
3832.6
3893.7
3923.8
3991.0
35594
3229.5
3265.4
3205.6
3235.9
3297.1
3305.8
35596
3933.1
3962.1
4016.4
4098.6
4155.0
4088.3
35609
3576.1
3601.2
3622.8
3650.9
3622.0
3674.4
35610
3462.6
3443.7
3472.0
3481.8
3530.1
3569.1
35611
3437.3
3464.6
3482.6
3501.0
3528.4
3600.2
35615
3606.5
3591.3
3589.4
3648.6
3676.7
3723.4
35622
4248.0
4178.2
4237.5
4210.2
4280.1
4325.9
35624
3512­
3
3473.3
3484.6
3544.8
3585.2
3610.9
35627
3328.9
3325.5
3330.3
3382.9
3434.8
3459.8
35634
3212.4
3209.8
3215.1
3264.6
3334,8
3294.8
35641
3593.3
3596.7
3623.1
3647.4
3695.4
'
3725.9
35643
3189.2
3178.4
3230.1
3288.4
3316.5
3336.0
35645
3428.7
3390.3
3452.9
3468.0
3488.5
3516.5
35652
4072.0
4067.7
4067.2
4143.0
4162.4
4171.0
35657
3076.1
3112.7
3088.8
3128.2
3130.5
3106.5
35660
3360.8
3343.1
3368.5
3378.8
3393
*
7
3414.6
35661
3589.7
3638.3
3676.9
3717.2
3776.8
3823.7
35662
3730.6
3758.9
3806.3
3845.1
3885.2
3910.0
DuPont­
10657
DAY
16
ANIMAL
STATUS
3414.3
3076.2
3180.1
4000.0
3331.7
4114.2
ED
3662.0
3583.4
3474.9
3730.6
4379.2
3621.8
3444.9
3342.6
3705.6
3304.5
3568.1
4161.6
3098.7
NP
3423.5
3847.3
3938.9
94
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
17
DAY
18
DAY
19
DAY
20
DAY
21
DAY
22
ANIMAL
STATUS
35580
3380.6
3464.8
3476.1
3492.8
3448.5
3468.9
35582
3099.7
3126.4
3037.4
3090.4
3100.9
3152.6
35587
3207.8
3251.3
3280.1
3309.1
3322.9
3340.9
35589
4012.3
3999.8
3994.3
4033.1
4063.1
4078.9
35594
3301.3
3343.2
3300.8
3340.8
3341.8
3352.6
35596
4141.5
4171.2
4221.9
4355.6
4244.9
4316.1
ED
35609
3685.9
3660.5
3682.5
3695.8
3706.5
3727.4
35610
3574.4
3584.6
3600.8
3599.2
3639.2
3670.5
35611
3640.8
3604.5
3625.1
3621.4
3645.1
3692.9
35615
3697.6
3683.5
3682.9
3711.5
3715.2
3727.1
35622
4345.0
4318.3
4374.6
4323.0
4342.0
4237.%
35624
3640.4
3615.3
3606.2
3623.6
3634.3
3636.5
35627
3454.6
3444.2
3445.4
3468.8
3492.9
3491.3
35634
3269.7
3319.6
3338.5
3352.4
3467.3
3454.2
35641
3699.7
3692.1
3705.8
3561.1
3756.1
3745.7
35643
3273.1
3296.3
3300.1
3309.7
3332.6
3378.5
35645
3526.8
3582.2
3600.5
3612.1
3657.6
3656.3
35652
4169.2
4152.8
4172.6
4195.3
4199.8
4230.6
35657
3138.9
3077.2
3203.3
3126.4
3081.1
3146.2
NP
35660
3439.2
3435.8
3439.9
3425.8
3433.6
3431.2
35661
3853.5
3864.1
3888.0
3939.0
3937.4
3949.1
35662
3967.3
4001.9
4012.7
4027.8
4017.7
4040.4
95
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
23
DAY
24
DAY
25
DAY
26
DAY
27
DAY
28
35580
3492.1
3556.8
3530.6
3558.4
3573.9
3606.4
35582
3154.9
3200.6
3250.2
3296.7
3296.9
3285.6
35587
3368.3
3367.8
3438.3
3453.0
3476.6
3471­
6
35589
4098.2
4130.0
4135.7
4192.0
4214.6
4149.6
35594
3361.4
3421.0
3430.5
3458.4
3457.6
3494.7
35596
4267.4
4324.1
4333.7
4036.8
4344.4
4372.9
35609
3762.7
3785.2
3816.0
3829.9
3752.0
3891.0
35610
3684.6
3730.1
3735.5
3779.9
3847.4
3853.3
35611
3719.9
3731.6
3756.1
3768.2
3730.1
3690.9
35615
3712.4
3753.5
3798.7
3825.3
3772.6
3815.3
35622
4406.9
4370.1
4384.6
4386.6
4371.6
4379.7
35624
3670.5
3689.6
3718.5
3721.6
3728.5
3743.3
35627
3549.1
3546.3
3597.0
3608.5
3582.7
3637.9
35634
3516.1
3505.3
3544.6
3522.7
3572.4
3535.3
35641
3735.0
3785.0
3844.5
3729.5
3823.4
'
3817.3
35643
3429.9
3459.7
3478.4
3498.6
3519.6
3523.2
35645
3674.2
3706.8
3747.4
3743.3
3746.9
3762.6
35652
4250.3
4258.4
4261.5
4249.2
4306.1
4316.9
35657
3126.5
3101.8
3127.0
3216.7
3186.2
3196.3
35660
3451.9
3439.9
3444.0
3474.5
3485.7
3500.6
35661
3976.2
4001.0
3972.8
4039.2
4024.5
4051.2
35662
4035.5
4088.3
4083.6
4127.1
4147.9
4157.7
DuPont­
10657
DAY
29
ANIMAL
STATUS
3565.4
3284.1
3491.2
4162.6
3490.8
4087.6
ED
3921.2
3891.7
3710.8
3810.8
4468.8
3785.8
3660.6
3613.7
3819.7
3541.4
3853.7
4350.5
3212.3
NP
3511.4
4048.7
4171.4
96
­­­

­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
29a
35580
3101.0
35582
2852.6
35587
3051.0
35589
3663.3
35594
3158.8
35596
35609
3466.3
35610
3527.7
35611
3298.4
35615
3340.9
35622
4152.0
35624
3339.7
35627
3217.1
35634
3129.0
35641
3345.9
35643
2992.5
35645
3402.3
35652
3871.3
35657
35660
3326.2
35661
3646.8
35662
3676.9
ANIMAL
STATUS
ED
NP
97
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
IV:
300
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
0
DAY
4
DAY
5
DAY
6
DAY
7
DAY
8
35571
3835.0
3798.0
3801.6
3780.3
3828.7
3855.8
35577
3239.0
3283.5
3273.5
3302.8
3320.9
3314.5
35583
2897.0
2926.3
2893.8
2900.5
2928
.2
2979.4
35586
3573.0
3747.0
3702.1
3619.7
3669.7
3673.9
35591
3112.0
3131.2
3109.8
3150.0
3236.9
3185.1
35592
3658.0
3761.5
3659.7
3648.9
3666.8
3627.5
35607
3996.0
4070.4
3999.9
3983.0
4025.5
4015.0
35608
3326.0
3334.4
3315.2
3307.7
3332.4
3379.2
35618
3805.0
3749.4
3770.1
3779.1
3752.1
3816.5
35620
3290.0
3442.3
3475.3
3480.1
3417.5
3547.2
35625
3561.0
3575.4
3538.5
3606.2
3597.3
3615.5
35626
3091.0
3173.5
3136.9
3191.8
3150.3
3221.0
35631
3881.0
4069.9
4129.9
4143.9
4145.7
4100.8
35635
3044.0
3120.8
3083.5
3121.4
3130.5
3125.8
35637
3748.0
3887.8
3838.4
3777.2
3788.8
3833.5
35640
3174.0
3257.1
3188.
O
3155.4
3205.2
3170.9
35650
4154.0
4137.9
4168­
8
4222.5
4221.0
4105.3
35653
3581.0
3546.8
3583.5
3577.5
3586.1
3543.4
35663
3630.0
3536.9
3575.6
3577.3
3594.7
3687.8
35672
3586.0
3306.7
3317.8
3342.5
3370.3
3388.4
35676
3272.0
3195.9
3233.0
3222.4
3201.5
3208.3
35678
3215.0
3207.1
3165.8
3151.3
3211.1
3205.1
DuPont­
10657
DAY
9
ANIMAL
STATUS
3804.8
3267.8
2905.3
3588.4
3262.7
3667.3
3957.3
3318.0
3786.6
3485.9
3553.0
3150.4
4111.8
3105.8
3812.7
3177.9
4052.3
3567.2
3621.8
3373.8
3206.7
3211.4
NP
98
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
IV:
300
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
10
DAY
11
DAY
12
DAY
13
DAY
14
DAY
15
35571
3834.0
3833.0
3861.8
3856.6
3858.9
3935.0
35577
3296.9
3313.3
3342.0
3384.8
3400.0
3437.9
35583
2925.6
2927.6
2960.9
2987.7
3026,4
3040.1
35586
3626.2
3623.4
3646.0
3684.8
3716.7
3764.5
35591
3241.4
3266.4
3281.4
3340.9
3399.8
3506.5
35592
3687.0
3725.5
3707.3
3725.7
3729.5
3773.
a
35607
3972.4
3956.2
4031.4
3986.9
4075.6
4128.4
35608
3336.0
3355.5
3388.6
3390.3
3442.7
3467.9
35618
3806.3
3760.1
3763.0
3777.3
3825.8
3848.4
35620
3490.9
3498.5
3550.4
3639.6
3601.3
3665.4
35625
3597.4
3556.6
3537.1
3609.4
3655.5
3707.0
35626
3108.2
3209.0
3181.0
3233.3
3286.1
3313.9
35631
4162.6
4155.9
4055.9
4079.3
4161.1
4196.4
35635
3094.9
3116.7
3149.8
3178.2
3258.6
3272.
I
35637
3818.4
3821.2
3861.4
3903.4
3917.9
3892.1
35640
3139.2
3145.6
3167.0
3221.7
3270.0
3281.0
35650
4104.0
4133.8
4173.2
4117.3
4119.9
4170.5
35653
3602.9
3604.4
3654.1
3743.4
3745.8
3768.7
35663
3594.3
3600.3
3648.0
3764.7
3798,9
3802.9
35672
3395.9
3365.2
3445.8
3484.0
3448.6
3469.8
35676
3208.2
3191.5
3214.5
3218.5
3260.9
3237.8
35678
3168.5
3184.4
3220.3
3217.5
3224.2
3226.6
DuPont­
10657
DAY
16
ANIMAL
STATUS
4007.7
3460.4
3038.6
3740.7
3553.4
3751.2
4133.8
3448.8
3837.2
3674.7
3728.9
3331.3
4257.2
3261.8
3909.7
3210.2
4192.0
3742.7
3760.5
3503.4
3230.1
3223.8
NP
99
Dimethvl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
IV:
300
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
17
DAY
18
DAY
19
DAY
20
DAY
21
35571
4034.9
4037,5
4039.2
4034.9
4067.1
35577
3460.9
3505.6
3498.6
3530.4
3553.3
35583
3028.7
3062.4
3081.4
3139.7
3139.2
35586
3736.7
3719.8
3705.3
3724.8
3733.8
35591
3586.4
3574.4
3596.0
3614.5
3625.2
35592
3786.1
3755.8
3779.0
3802.5
3839.0
35607
4148.3
4131.0
4157.3
4154.2
4181.3
35608
3471.4
3461.5
3428.6
3462.4
3456.4
35618
3798.8
3797.1
3813.6
3812.6
3856.5
35620
3506.3
3639.7
3617.5
3643.5
3700.7
35625
3673.7
3741.4
3729.3
3771.5
3737.5
35626
3308.5
3285.5
3304.8
3311.3
3327.8
35631
4204.9
4196.0
4186.6
4205.2
4218.4
35635
3271.5
3294.6
3332.8
3399.0
3353.2
35637
3882.6
3890.4
3921.2
3931.4
3965.6
35640
3222.9
3233.3
3245.5
3265.9
3284.7
35650
4225.4
4233.2
4226.5
4229.9
4254.3
35653
3751.4
3741.0
3734.5
3754.5
3822.5
35663
3725.6
3738.9
3734.7
3783.5
3752.6
35672
3460.3
3446.5
3474.8
3515.0
3367.1
35676
3265.7
3282.1
3250.2
3266.5
3298.1
35678
3187.2
3189.7
3223.0
3236.2
3227.7
DuPont­
10657
DAY
22
STATUS
4096.1
3579.1
3146.8
3773.6
3645.8
3880.5
4192.3
3474.7
3795.4
3762.1
3769.8
3338.8
4208.4
,3380.1
3950.6
3301.9
4283.9
3755.4
3742.2
3250.6
3300.2
3272.2
NP
100
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
IV:
300
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
23
DAY
24
DAY
25
DAY
26
DAY
27
DAY
28
35571
4094.0
4140.0
4158.1
4202.9
4230.3
4227.4
35577
3632.5
3642.1
3640.7
3659.6
3647.7
3641.6
35583
3195.1
3228.5
3226.5
3278.4
3293.9
3295.7
35586
3781.3
3794.2
3829.0
3861.0
3867.6
3871.0
35591
3671.2
3642.8
3696.6
3713.7
3727.6
3717.5
35592
3913.1
3951.4
3988.1
4024,5
4073.8
3976.8
35607
4265.4
4306.4
4304.6
4300.3
4302.5
4380.2
35608
3487.7
3475.8
3563­
5
3560.2
3602.8
3645.4
35618
3855.4
3877.6
3897.8
3922.6
3904.6
3915.0
35620
3710.6
3767.2
3753.6
3777.8
3826.4
3783.8
35625
3820.8
3824.5
3838.4
3831.9
3869.8
3843.8
35626
3357.8
3411.2
3447.0
3465.8
3477.4
3505.8
35631
4213.4
4219.9
4241.8
4265.2
4272.8
4294.3
35635
3413.3
3438.0
3471.2
3481.7
3495.9
3523.9
35637
4000.7
4038.6
4028.8
4080.8
4073.5
4102.8
35640
3333.3
3337.6
3405.6
3392.0
3401.6
3417.9
35650
4348.6
4353.9
4466.3
4466.2
4447.5
4446.4
35653
3856.6
3880.8
3868.3
3872.5
3875.9
3830.8
35663
3752.5
3608.0
3849.4
3862.5
3856.4
3859.9
35672
3158.4
3551.6
3518.7
3565.6
3568.0
3590. 
O
35676
3352.1
3341.4
3359.7
3383.7
3411.6
3414.9
35678
3246.8
3211.2
3227.0
3239.8
3262.8
3268.8
DuPont­
10657
DAY
29
ANIMAL
STATUS
4253.3
3665.5
3315.2
3868.5
3651.9
4073.5
4458.9
3673.4
3931.6
3772.6
3858.5
3518.6
4294.0
3509.3
4113.7
3434.6
4472.2
3876.8
3964.2
3593.3
3450.2
3270.6
NP
101
­­­
Dimethvl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
IV:
300
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
29a
ANIMAL
STATUS
35571
3566.9
35577
3235.8
35583
2891.5
35586
3417.6
35591
3115.4
35592
3459.1
35607
3783.2
35608
3131.6
35618
3625.4
35620
3336.9
35625
3424.6
35626
3091.2
35631
3809.5
35635
3064.0
35637
3660.7
35640
3031.6
35650
3988.4
35653
3309.9
35663
3514.4
35672
3237.5
35676
3125.2
35678
NP
102
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
V:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
0
DAY
4
DAY
5
DAY
6
DAY
7
DAY
8
DAY
9
ANIMAL
35569
3710.0
3887.8
3861.4
3867.4
3882.3
3874.5
3886.5
35575
3292.0
3348.9
3323.8
3341.3
3334­
2
3383.8
3382.2
FD
35581
3133.0
3140.9
3149.8
3143.0
3180.8
3117.6
3193.4
35590
3446.0
3341.6
3290.3
3298.5
3268.1
3316.6
3370.9
R
35598
3672.0
3711.3
3722.6
3668.9
3631.4
3694.2
3622.3
35602
3187,
O
3257.4
3238.2
3045.7
3244.3
3185.4
3238.0
35605
2973.0
3112.1
3035.9
3036.7
3091.5
2902.1
3031.3
35612
3424.0
3597.1
3597.0
3533.5
3565.2
3635.3
3581.4
NP
35613
4096.0
3523.4
3665.9
3746.7
3786.0
3636.3
3410.1
35619
3117.0
3072.8
3019.8
3047.7
3017.7
3079.6
3095.4
35623
3764.0
3666.3
3665.2
3708.4
3700.3
3757.0
3766.6
35629
3603.0
3587.7
3606.9
3548.6
3616.0
3569.3
3598.7
35636
3417.0
3478.9
3531.0
3492.2
3474.8
3374
.>
3
3420.5
35638
3145.0
3119.8
3148.4
3158.6
3172.6
3145.2
3100.5
35648
3570.0
3578.4
3592.8
3585.5
3621.8
3467.3
3569.0
35651
3665.0
3622.3
3604.6
3590.9
3664.0
3426.9
3397.9
35655
4202.0
4034.4
4005.0
3994.7
4013.0
4121.3
4117.7
35664
3581.0
3559.1
3570.1
3565.6
3570.0
3553.8
3614.5
35665
3175.0
3231.0
3224.6
3233.4
3229.5
3262.0
3239.2
35668
3632.0
3647.0
3655.3
3699.8
3675.6
3614.1
3761.1
35671
3748.0
3709.0
3734.0
3709.1
3718.6
3607.2
3689.0
SE
35673
3370.0
3411.0
3405.1
3337.9
3351.4
3381.8
3394.0
103
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
V:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
10
DAY
11
DAY
12
DAY
13
DAY
14
DAY
15
35569
3895.5
3877.9
3913.3
3952.9
3957.9
3971.7
35575
3448.0
3476.5
3526.2
_­_
___
35581
3141.1
3188.1
3235.1
3227.6
3277.5
3316.4
35590
3323.9
3327.3
3371.2
3382.0
3371.6
3400.8
35598
3670.1
3674.7
3702.3
3749.7
3775.3
3795.3
35602
3239.8
3238.7
3256.4
3307.7
3310.0
3329.0
35605
3053.4
3032.3
3044.8
3069.1
3089.9
3127.6
35612
3549.9
3581.8
3556.7
3586.0
3574.0
3590.3
35613
3361.1
3331.9
3246.2
3207.0
3212.7
3201.3
35619
3069.6
3092.4
3098.7
3083.2
3117.4
3149.0
35623
3778.9
3750,
l
3726.5
3740.9
3762.2
3787.9
35629
3339.6
3595.5
3578.7
3594.0
3628.3
3626.2
35636
3452.1
3450.7
3495.8
3492.3
3525.7
3523.7
35638
3106.2
3162.8
3193.6
3251.3
3307.3
3357.2
35648
3637.9
3632.3
3627.3
3636.3
3667.9
3708.8
35651
3514.0
3527.5
3511.4
3570.9
3607.7
3624.8
35655
4065.4
4077.1
4099.9
4113.8
4126.8
4181.9.
35664
3591.4
3591.8
3650.9
3690.0
3746.8
3789.7
35665
3253.0
3260.6
3312.7
3348.7
3357.5
3330.2
35668
3760.9
3726.5
3782.8
3827.1
3826.5
3805.2
35671
3713.8
3707.4
3691.6
3658.8
3564.2
3526.9
35673
3392.6
3382.9
3438.1
3448.4
3470.9
3493.1
DuPont­
10657
DAY
16
ANIMAL
STATUS
3997.4
___
FD
3319.3
3420.8
R
3844.5
3306.0
3144.0
3617.7
NP
3309.3
3181.0
3825.6
3632.1
3564.5
3330.0
3691,8
3603.7
4210.3
3792.8
3350.6
3827.7
3306.8
SE
3511.3
104
­­­
­­­
­­­
­­­
­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
V:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
17
DAY
18
DAY
19
DAY
20
DAY
21
35569
4017.0
4013.6
4016.4
4002.4
4036.8
35575
35581
3297.1
3326.4
3299.2
3311,7
3348.3
35590
3436.7
3468.3
3450.4
3482.6
3479.1
35598
3830.9
3818.8
3793.6
3813.9
3606.4
35602
3299.7
3078.9
2928.6
2955.6
2831,7
35605
3177.4
3168.8
3183.8
3195.0
3046.9
35612
3644.5
3690.9
3691.9
3634.8
3507.1
35613
3441.9
3520.9
3596.1
3636.9
3630.1
35619
3184.2
3162.6
3188.8
3200.7
3224.3
35623
3792.4
3789.9
3801.6
3822.7
3858.6
35629
3667.7
3709.1
3704.5
3710.0
3822.6
35636
3566.5
3625.2
3607.2
3597.2
3609.8
35638
3345.9
3315.3
3348.8
3351.2
3375.4
35648
3700.8
3722.6
3707.2
3712.3
3711.2
35651
3613.7
3622.2
3621.5
3613.5
3634.2
35655
4274.6
4249.7
4217.1
4295.2
4362.2
35664
3773.4
3803.6
3789.7
3818.7
3824.1
35665
3381.9
3385.1
3383.6
3401.7
3449.6
35668
3877.1
3879.3
3878.8
3905.5
3888.5
35671
3242.7
3247.1
3154.0
3037.8
2944.7
35673
3510.9
3532.0
3531.1
3548.6
3523.4
DuPont­
1065 
7
DAY
22
ANIMAL
STATUS
3813.7
FD
3236.3
3392.2
R
3893.1
3108.5
3248.5
3658.3
NP
3601.5
3227.9
3843.2
3732.1
3631.4
3381.4
3716.7
3636.4
4354.7
3861.4
3481.3
3880.7
2847.9
SE
3537.7
­­­

­­­
­­­

­­­
­­­

­­­
­­­

­­­
­­­

­­­
­­­

­­­
­­­

­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
V:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
23
DAY
24
DAY
25
DAY
26
DAY
27
DAY
28
DAY
29
ANIMAL
STATUS
35569
4099.9
4129.9
4073.3
4120.6
4123.4
4147.5
4130.1
35575
FD
35581
3378.1
3418.0
3441.8
3451.0
3443.3
3428.9
3457.8
35590
3546.9
3581.7
3604.3
3648.5
3682.4
3672.6
3553.9
R
35598
3881.6
3883.6
3924.2
3948.5
3918.5
3953.7
3958.5
35602
2951.0
3174.7
3252.9
3303.2
3305.4
3312.7
3319.0
35605
3320.2
3278.8
3323.7
3367.7
3361.5
3389.1
3414.3
35612
3675.9
3721.1
3739.9
3722.9
3689.3
3728.3
3754.1
NP
35613
3589.4
3657.2
3449.8
3695.8
3661.1
3656.8
3700.5
35619
3277.1
3315.8
3125.2
3374.2
3378.5
3368.0
3375.6
35623
3782.2
3884.0
3703.6
3916.9
3904.7
3911.4
3931.7
35629
3762.9
3767.5
3609.0
3907.0
3874.2
3867.6
3865.0
35636
3609.0
3401.8
3584.5
3613.0
3643.4
3649.2
3641.6
35638
3403.8
3263.1
3464.3
3470.2
3490.2
3512.5
3542.7
35648
3751.1
3597.3
3752.2
3739.4
3757.0
3757.3
3768.6
35651
3675.3
3521.1
3703.6
3708.1
3694.0
3697.2
3759.6
35655
4305.5
4338.8
4348.3
4349.6
4329.9
4274.2
4306.7
35664
3869.2
3872.6
3876.0
3884.4
3875.1
3841.5
3886.6
35665
3526.9
3505.2
3549.4
3579.2
3589.0
3620,7
3626.8
35668
3932.7
3945.4
3961.5
3979.2
3979.1
3972.7
4021.8
35671
SE
35673
3550.9
3540.9
3542.1
3541.7
3566.3
3543.7
3550.8
106
­­­

­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Develo~
mentalToxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
ADULT
BODY
WEIGHTS
GROUP
V:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
DAY
29a
ANIMAL
STATUS
35569
3770.1
35575
FD
35581
3038.6
35590
3048.6
R
35598
3594.7
35602
2964.9
35605
3060.1
35612
NP
35613
3347.0
35619
2856.2
35623
3721.0
35629
3509.1
35636
3576.5
35638
3146.3
35648
3426.0
35651
3571.8
35655
3873.2
35664
3454.1
35665
3185.1
35668
3464.2
35671
SE
35673
3357.3
107
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDIX
F
Individual
Body
Weight
Changes
108
­­­
Dimethvl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicity
Studv
in
Rabbits
DuPont­
10657
Individual
Body
Weight
Changes
Explanatory
Notes
Footnotes
a
Weight
calculated
using
the
final
body
weight
minus
the
weight
of
the
products
of
conception.

Abbreviations
=
Nodata
AB
=
Aborted
NP
=
Notpregnant
ED
=
Earlydelivery
R
=
Litter
totally
resorbed
SE
=
Sacrificed
in
extremis
FD
=
Founddead
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
I:
o
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
0­
4
4­
7
0­
7
7­
9
9­
11
11­
13
13­
15
ANIMAL
STATUS
35570
207.7
­
167.9
39.8
23.4
45.4
70.3
67.8
35572
135,6
­
60.4
75.2
­
37.4
8.5
86.9
29.4
35576
109.4
51.2
160.6
60.4
­
61.9
73.3
132.1
35578
245.7
­
189.5
56.2
­
4.3
­
44.1
29.0
9.7
AB
35579
250.0
­
115.7
134.3
55.4
­
2.4
82.7
85.4
35597
96.6
1.0
97.6
1.0
­
13.7
­
1.3
67.4
35599
137.3
­
280.8
­
143.5
249.4
­
13.6
26.2
61.0
35601
111.0
­
57.1
53.9
78.9
62.2
50.3
43.8
35604
58.6
­
59.8
­
1.2
46.3
37.2
86.3
122.3
35616
­
55.5
4.4
­
51.1
61.2
8.8
97.1
93.4
35621
8.8
­
7.2
1.6
­
20.6
52.3
­
23.6
­
110.6
35628
­
57.3
26.7
­
30.6
23.1
41.1
64.5
87.5
35632
,147.7
­
7.2
,154.9
­
13.9
57.6
9.7
57.4
35639
65.9
­
5.5
60.4
3.7
­
27.0
45.5
75.6
35644
68.6
­
40.3
28.3
­
17.1
23.5
29.7
134.0
35646
49.1
24.0
73.1
­
52.6
­
18.6
­
29.1
159.9
35656
­
71.7
­
27.2
­
98.9
49.8
45.3
5.6
41.1
35658
­
79.8
12.8
­
67.0
7.6
­
0.6
61.1
39.0
35659
­
5.2
18.7
13.5
63.5
24.1
40.9
60.5
35666
34.1
­
9.0
25.1
26.8
6.1
32.0
80.7
35675
­
54.1
31.5
'
­
22.6
47.4
­
23.5
150.0
86.1
35677
128.4
34.6
163.0
11.2
24.2
22.1
63.4
110
­­­
­­­
­­­

­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
I:
o
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
15­
17
17­
19
19­
21
21­
23
23­
25
25­
27
27­
29
ANIMAL
STATUS
35578
35570
­
6.5
8.3
­
19.3
51.6
55.0
18.7
64.4
35572
52.5
14.3
13.7
­
5.8
40.1
2.9
­
37.2
35576
148.8
­
65.4
36.4
­
63.0
48.2
67.8
97.0
­
20.2
101.8
AB
35579
48.6
8.1
31.9
77.3
47.0
41.2
21.9
35597
37.0
­
27.1
24.2
60.0
68.7
57.8
­
8.4
35599
24.4
­
7.9
87.0
28.2
94.9
49.8
13.6
35601
­
9.0
31.2
48.2
­
34.6
71.7
88.5
27.8
35604
59.6
23.3
10.9
­
35.3
71.0
46.5
28.6
35616
40.7
2.5
21.0
28.8
29.8
­
10.5
65.7
35621
229.8
19.5
­
1.1
14.7
28.7
36.1
35628
­
45.5
86.4
12.5
7.4
49.7
12.6
35632
­
14.2
30.4
26.5
­
79.6
33.4
3.4
36.1
35639
­
5.2
7.9
29.0
58.9
58.3
70.7
76.5
35644
17.6
­
45.9
­
40.8
85.2
2.4
42.8
45.8
35646
13.5
­
15.0
9.2
82.4
45.9
91.8
27.4
35656
49.0
1.3
­
13.7
53.9
­
6.7
17.8
­
3.1
35658
17.1
25.1
15.8
37.0
52.1
30.0
91.9
35659
41.6
57.8
69.7
­
19.7
107.1
­
96.7
108.7
35666
34.9
62.2
­
37.2
89.4
64.9
21.7
­
10.3
35675
­
31.1
4.4
­
25.0
26.1
44.0
100.3
94.3
35677
­
52.7
46.1
­
15.2
68.6
4.2
34.7
71.8
111
­­­
­­­

­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
I:
o
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
7­
29
7­
29a
ANIMAL
STATUS
AB
53.3
­
162.7
­
49.0
35570
35572
35576
35578
35579
35597
35599
35601
35604
35616
35621
35628
35632
35639
35644
35646
35656
35658
35659
35666
35675
35677
379.1
167.9
473.7
497.1
265.6
613.0
459.0
496.7
438.5
901.6
,278.0
146.8
393.9
277.2
314.8
240.3
376.1
457.5
371.2
473.0
278.4
68.6
­
187.2
200.4
­
7.4
­
52.6
­
26.5
­
211.0
­
109.9
­
133.3
­
216.8
­
156,7
­
104.4
­
54.1
­
81.7
­
63.6
­
216.1
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
0­
4
4­
7
0­
7
7­
9
9­
11
11­
13
35573
146.3
­
108.5
37.8
­
25.4
40.1
58.2
35574
­
69.2
­
70.9
­
140.1
­
5.5
32.9
27.0
35584
30.4
­
3.9
26.5
­
32.1
6.0
71.4
35585
54.6
­
134.4
­
79.8
49.0
7.5"
41.6
35588
­
132.8
­
78.3
­
211.1
­
47.2
­
3.8
81.4
35593
31.0
­
61.7
­
30.7
69.7
­
6.4
13.3
35595
132.5
10.3
142.8
10.0
21.5
22.6
35600
­
106.9
45.4
­
61.5
­
0.7
­
6.9
1.7
35603
­
32.0
­
24.4
­
56.4
68.4
40.5
­
1.1
35606
97.7
­
39.2
58.5
36.1
5.8
33.9
35614
­
138.3
­
14.2
­
152.5
38.1
26.5
106.8
35617
73.4
­
74.2
­
0.8
14.3
41.2
26.4
35630
50.9
­
40.5
10.4
­
9.9
18.2
40.1
35633
­
93.8
53.4
­
40.4
35.7
­
0.5
5.7
35642
­
1.1
91.1
90.0
­
86.7
­
23.2
I
72.6
3564t7
160.9
24.0
184.9
­
31.5
62.7
152.5
35649
51.4
­
97.0
­
45.6
19.5
­
59.2
65.7
35654
24.8
30.7
55.5
­
32.2
10.4
­
29.9
35667
­
69.8
31.6
­
38.2
24.2
­
3.0
47.6
35669
­
17.1
97.3
80.2
­
0.9
­
5.2
65.2
35670
5.0
63.3
68.3
­
17.5
5.1
96.0
35674
­
32.9
­
29.6
­
62.5
22.8
29.7
96.8
DuPont­
10657
13
­
15
I"
I
ANIMAL
STATUS
92.6
66.9
62.6
72.0
32.8
71.2
93.8
99.5
­
7.6
NP
87.2
168.2
64.2
85.5
123.8
117.0
159.1
60.3
55.5
NP
22.0
52.6
25.9
109.4
113
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
IS:
30
mg/
rn3
ANIMAL
DAYS
OF
GESTATION
NUMBER
15­
17
17­
19
19­
21
21­
23
23­
25
25­
27
27­
29
ANIMAL
STATUS
35573
101.9
14.5
22.1
27.8
62.9
37.2
9.4
35574
40.2
28.2
22.1
71.0
5.6
69.8
24.2
35584
17.2
9.0
46.6
58.4
26.4
­
29.1
52.4
35585
48.4
7.8
51.4
33.8
­
154.5
242.7
40.6
35588
76.8
­
28.1
20.2
89.6
90.5
79.9
29.1
35593
­
2.4
32.0
28.3
99.6
34.4
37.3
10.2
35595
­
4.8
­
8.2
1.6
80.6
45.9
39.1
63.1
35600
81.8
0.2
­
6.3
42.4
51.9
85.0
8.4
35603
63.9
28.5
­
41.2
9.5
34.7
5.3
25.7
NP
35606
3.0
41.3
30.4
35.8
49.9
­
7.4
86.0
35614
43.9
17.4
­
26.9
63.1
24.5
­
5.9
­
10.5
35617
­
59.6
7.2
81.2
35.8
39.2
53.3
1.6
35630
25.3
9.0
61.7
37.3
81.0
20.0
98.6
35633
­
39.5
­
3.6
34.1
54.6
40.4
38.6
23.0
35642
­
14.7
­
34.2
­
5.6
33.1
­
2.6
48.7
61.7
35647
83.7
­
50.0
­
58.1
71.4
78.7
32.7
98.4
35649
54.6
11.6
4.3
32.4
50.1
21.0
30.9
35654
­
90.2
­
25.1
­
19.3
48.2
­
5.6
­
4.5
30.9
NP
35667
38.7
21.7
20.4
27.0
34.3
36.6
71.1
35669
51.7
20.9
15.9
38.1
59.5
65.6
34.0
35670
­
16.0
29.2
32.3
74.3
65.1
70.8
63.7
35674
­
43.8
­
12.9
13.5
10.8
72.6
42.9
40.5
114
­­­

­­­
I
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROUP
11:
30
mg/
m3
ANIMAL
NUMBER
7­
29
35573
441.3
35574
382.4
35584
288.8
35585
440.3
35588
421.2
35593
387.2
35595
365.2
35600
357.0
35603
226.6
35606
402.0
35614
445.2
35617
304.8
35630
466.8
35633
312.3
35642
166.1
35647
599.6
35649
291.2
35654
­
61.8
35667
340.6
35669
397.4
35670
428.9
35674
382.3
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

DAYS
OF
GESTATION
7­
2ga
ANIMAL
STATUS
2.8
­
181.6
­
61.7
20.4
­
128.0
­
91.2
­
175.0
­
207.6
NP
­
89.2
­
74.8
­
21.4
27.2
­
41.4
­
222.6
55.4
­
259.7
NP
­
73.2
12.1
­
63.6
­
85.7
115
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
111:
100
mg/
rn3
ANIMAL
DAYS
OF
GESTATION
NUMBER
0­
4
4­
7
0­
7
7­
9
9­
11
11­
13
35580
195.2
­
13.9
181.3
­
20.7
39.0
41.9
35582
­
72.8
26.8
­
46.0
49.6
32.6
95.3
35587
­
127.7
­
187.8
­
315.5
­
44.5
­
88.9
­
9.3
35589
­
72.2
­
74.7
­
146.9
37.4
18.7
86.5
35594
114.4
15.9
130.3
20.7
56.4
­
29.5
35596
96.9
8.8
105.7
­
14.1
57.5
136.5
35609
123.7
­
54.0
69.7
­
19.4
21.9
49.7
35610
139.9
­
137.0
2.9
16.0
9.8
38.1
35611
29.3
62.4
91.7
52.7
5.2
36.4
35615
376.6
16.5
393.1
12.3
20.9
57.3
35622
­
53.3
­
3.5
­
56.8
23.3
­
26.3
32.0
35624
­
178.4
202.0
23.6
­
45.9
9.6
71.5
35627
­
10.3
48.6
38.3
7.5
17.7
57.4
35634
­
584.8
93.1
­
491.7
­
28.0
34.5
54.8
35641
­
54.7
29.2
­
25.5
­
18.2
6.4
50.7
35643
59.6
0.6
60.2
­
13.1
­
32.7
110.0
35645
­
94.1
19.8
­
74.3
8.2
­
23.6
77.7
35652
20.9
­
39.2
­
18.3
13.7
­
1117
75.3
35657
­
200.3
68.6
­
131.7
­
21.2
4.6
15.5
35660
­
58.7
­
28.7
­
87.4
55.6
­
41.1
35.7
35661
­
63.4
10.7
­
52.7
­
2.5
73.5
78.9
35662
­
44
*
5
­
10.0
­
54.5
­
7.5
49.9
86.2
DuPont­
10657
13­
15
ANIMAL
STATUS
124.0
13.1
­
32.9
97.3
69.9
­
10.3
ED
23.5
87.3
99.2
74.8
115.7
66.1
76.9
30.2
78.5
47.6
48.5
28.0
­
21.7
NP
35.8
106.5
64.9
116
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicitv
Study
in
Rabbits
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
15­
17
17­
19
19­
21
21­
23
23­
25
25­
27
35580
­
5.9
95.5
­
27.6
43.6
38.5
43.3
35582
84.1
­
62.3
63.5
54.0
95.3
46.7
35587
33.9
72.3
42.8
45.4
70.0
38.3
35589
21.3
­
18.0
68.8
35.1
37.5
78.9
35594
­
4.5
­
0.5
41.0
19.6
69.1
27.1
35596
53.2
80.4
23.0
22.5
66.3
10.7
35609
11.5
­
3.4
24.0
56.2
53.3
­
64.0
35610
5.3
26.4
38.4
45.4
50.9
111.9
35611
40.6
­
15.7
20.0
74.8
36.2
­
26.0
35615
­
25.8
­
14.7
32.3
­
2.8
86.3
­
26.1
35622
19.1
29.6
­
32.6
64.9
­
22.3
­
13.0
35624
29.5
­
34,2
28.1
36.2
48.0
10.0
35627
­
5.2
­
9.2
47.5
56.2
47.9
­
14.3
35634
­
25.1
68.8
128.8
48.8
28.5
27.8
35641
­
26.2
6.1
50.3
.21.1
109.5
­
21.1
35643
­
62.9
27.0
32.5
97.3
48.5
41.2
35645
10.3
73.7
57.1
16.6
73.2
­
0.5
35652
­
1.8
3.4
27.2
50.5
11.2
44.6
35657
32.4
64.4
­
122.2
45.4
0.5
59.2
35660
24.6
0.7
­
6.3
18.3
­
7.9
41.7
35661
29.8
34.5
49.4
38.8
­
3.4
51.7
35662
57.3
45.4
5.0
17.8
48.1
64.3
DuPont­
10657
27­
29
ANIMAL
STATUS
­
8.5
­
12.8
14.6
­
52.0
33.2
­
256.8
ED
169.2
44.3
­
19.3
38.2
97.2
57.3
77.9
41.3
­
3.7
21.8
106.8
44.4
26.1
NP
25.7
24.2
23.5
117
­­­

­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROUP
111:
100
mg/
m3
ANIMAL
NUMBER
7­
29
35580
363.1
35582
459.1
35587
141.7
35589
411.5
35594
302.5
35596
168.9
35609
322.5
35610
473.8
35611
304.1
35615
252.7
35622
287.6
35624
276.2
35627
360.3
35634
410.4
35641
211.2
35643
317.2
35645
448.0
35652
284.8
35657
83.0
35660
182,8
35661
481.4
35662
454.9
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

DAYS
OF
GESTATION
7­
29a
ANIMAL
STATUS
­
101.3
27.6
­
298.5
­
87.8
­
29.5
ED
­
132.4
109.8
­
108.3
­
217.2
­
29.2
­
169.9
­
83.2
­
74.3
­
262.6
­
231.7
­
3.4
­
194.4
NP
­
2.4
79.5
­
39.6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
IV:
300
rng/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
0­
4
4­
7
0­
7
7­
9
9­
11
35571
­
37.0
30.7
­
6.3
­
23.9
28.2
35577
44.5
37.4
81.9
­
53.1
45.5
35583
29.3
1.9
31.2
­
22.9
22.3
35586
174.0
­
77.3
96.7
­
81.3
35.0
35591
19.2
105.7
124.9
25.8
3.7
35592
103.5
­
94.7
8.8
0.5
58.2
35607
74.4
­
44.9
29.5
­
68.2
­
1.1
35608
8.4
­
2.0
6.4
­
14.4
37.5
35618
­
55.6
2.7
­
52.9
34.5
­
26.5
35620
152.3
­
24.8
127.5
68.4
12.6
35625
14.4
21.9
36.3
­
44.3
3.6
35626
82.5
­
23.2
59.3
0.1
58.6
35631
188.9
75.8
264.7
­
33.9
44.1
35635
76.8
9.7
86.5
­
24.7
10.9
35637
139.8
­
99.0
40.8
23.9
8.5
35640
83.1
­
51.9
31.2
­
27.3
­
32.3
35650
­
16.1
83.1
67.0
­
168.7
81.5
35653
­
34.2
39.3
5.1
­
18.9
37.2
35663
­
93.1
57.8
­
35.3
27.1
­
21.5
35672
­
279.3
63.6
­
215.7
3.5
­
8.6
35676
­
76.1
5.6
­
70.5
5.2
­
15.2
35678
­
7.9
4.0
­
3.9
0.3
­
27.0
11­
13
13­
15
ANIMAL
STATUS
23­
6
78.4
71.5
53.1
60.1
52.4
61.4
79.7
74.5
165.6
0.2
48.1
30.7
141.5
34.8
77.6
17.2
71.1
141.1
25.8
52.8
97.6
24.3
80.6
­
76.6
117.1
61.5
93.9
82.2
­
11.3
76.1
60.3
­
16.5
53.2
139.0
25.3
164­
4
38.2
118.8
­
14.2
27.0
19.3
33.1
9.1
NP
119
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
IV:
300
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
15­
17
17­
19
19­
21
21­
23
23­
25
25­
27
27­
29
ANIMAL
STATUS
35571
99.9
4.3
27.9
26.9
64.1
72.2
23.0
35577
23.0
37.7
54.7
79.2
8.2
7.0
17.8
35583
­
11.4
52.7
57.8
55.9
31.4
67.4
21.3
35586
­
27.8
­
31.4
28.5
47.5
47.7
38.6
0.9
35591
79.9
9.6
29.2
46.0
25.4
31.0
­
75.7
35592
12.3
­
7.1
60.0
74.1
75.0
85.7
­
0.3
35607
19.9
9.0
24.0
84.1
39.2
­
2
*
1
156.4
35608
3.5
­
42.8
27.8
31.3
75.8
39.3
70.6
35618
­
49.6
14.8
42.9
­
1.1
42.4
6.8
27.0
3
562
0
­
159.1
111.2
83.2
9.9
43.0
72.8
­
53.8
35625
­
33.3
55.6
8.2
83.3
17.6
31.4
­
11.3
35626
­
5.4
­
3.7
23.0
30.0
89.2
30.4
41.2
35631
8.5
­
18.3
31.8
­
5.0
28.4
31.0
21.2
35635
­
0.6
61.3
20.4
60.1
57.9
24.7
13.4
35637
­
9.5
38.6
44.4
35.1
28.1
44.7
40.2
35640
­
59.1
22.6
39.2
48.6
72.3
­
4.0
33.0
35650
54.9
1.1
27.8
94.3
117.7
­
18.8
24.7
35653
­
17.3
­
16.9
88.0
34.1
11.7
7.6
0.9
35663
­
77.3
9.1
17.9
­
0.1
96.9
7.0
107.8
35672
­
9.5
14.5
­
107.7
­
208.7
360.3
49.3
25.3
35676
27.9
­
15.5
47.9
54.0
7..
6
51.9
38.6
35678
­
39.4
35.8
4.7
19.1
­
19.8
35.8
7.8
NP
120
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
IV:
300
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
7­
29
7­
29a
ANIMAL
STATUS
35571
424.6
­
261.8
35577
344.6
­
85.1
35583
387.0
­
36.7
35586
198.8
­
252.1
35591
415.0
­
121.5
35592
406.7
­
207­
7
35607
433.4
­
242.3
35608
341.0
­
200.8
35618
179.5
­
126.7
35620
355.1
­
80.6
35625
261.2
­
172.7
35626
368.3
­
59.1
35631
148.3
­
336.2
35635
378.8
­
66.5
35637
324.9
­
128.1
35640
229.4
­
173.6
35650
251.2
­
232.6
35653
290.7
­
276.3
35663
369.5
­
80.3
35672
223.0
­
132.8
35676
248.7
­
76.3
35678
59.5
NP
121
­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
v:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
0­
4
4­
7
0­
7
7­
9
9­
11
11­
13
13­
15
ANIMAL
STATUS
35569
177.8
­
5.5
172.3
4.2
­
8.6
75.0
18.8
35575
56.9
­
14.7
42.2
48.0
94.3
FD
35581
7.9
39.9
47.8
12.6
­
5.3
39.5
88.8
35590
­
104.4
­
73.5
­
177.9
102.8
­
43.6
54.7
18.8
R
35598
39.3
­
79.9
­
40.6
­
9.1
52.4
75.0
45.6
35602
70.4
­
13.1
57.3
­
6.3
0.7
69.0
21.3
35605
139.1
­
20.6
118.5
­
60.2
1.0
36.8
58.5
35612
173.1
­
31.9
141.2
16.2
0.4
4.2
4.3
NP
35613
­
572.6
262.6
­
310*
0
­
375.9
­
78.2
­
124.9
­
5.7
35619
­
44.2
­
55.1
­
99.3
77.7
­
3.0
­
9.2
65.8
35623
­
97.7
34.0
­
63.7
66.3
­
16.5
­
9.2
47.0
35629
­
15.3
28.3
13.0
­
17.3
­
3.2
­
1.5
32.2
35636
61.9
­
4.1
57.8
­
54.3
30.2
41.6
31.4
35638
­
25.2
52.8
27.6
­
72.1
62.3
88.5
105.9
35648
8.4
43.4
51.8
­
52.8
63.3
4.0
72.5
35651
­
42.7
41.7
­
1.0
­
266.1
129.6
43.4
53.9
35655
­
167.6
­
21.4
­
189.0
104.7
­
40.6
36.7
68.1
35664
­
21.9
10.9
­
11.0
44.5
­
22.7
98.2
99.7
35665
56.0
­
1.5
54.5
9.7
21.4
88.1
­
18.5
35668
15.0
28.6
43.6
85.5
­
34.6
100.6
­
21.9
35671
­
39.0
9.6
­
29.4
­
29.6
18.4
­
48.6
­
131.9
SE
35673
41.0
­
59.6
­
18.6
42.6
­
11.1
65.5
44.7
122
­­­
­­­
­­­
­­­

­­­
­­­

­­­
­­­

­­­
­­­

­­­
Dimethvl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicity
Studv
in
Rabbits
DuPont­
10657
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

GROUP
v:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
15­
17
17­
19
19­
21
21­
23
23­
25
25­
27
27­
29
ANIMAL
STATUS
35569
45.3
­
0.6
20.4
63.1
­
26.6
50.1
6.7
35575
FD
35581
­
19.3
2.1
49.1
29.8
63.7
1.5
14.5
35590
35.9
13.7
28.7
67.8
57.4
78.1
­­
128.5
R
35598
35.6
­
37.3
­
187.2
275.2
42.6
­
5.7
40.0
35602
­
29.3
­
371.1
­
96.9
119.3
301.9
52.5
13.6
35605
49.8
6.4
­
136­
9
273.3
3.5
37.8
52.8
35612
54.2
47.4
­
184.8
168.8
64.0
­
50.6
64.8
NP
35613
240.6
154.2
34.0
­
40.7
­
139.6
211.3
39.4
35619
35.2
4.6
35.5
52.8
­
151.9
253.3
­
2.9
35623
4.5
9.2
57.0
­
76.4
­
78.6
201.1
27.0
35629
41.5
36.8
118.1
­
59.7
­
153.9
265.2
­
9.2
35636
42.8
40.7
2.6
­
0.8
­
24.5
58.9
­
1.8
35638
­
11.3
2.9
26.6
28.4
60.5
25.9
52.5
35648
­
8.0
6.4
4.0
39.9
1.1
4.8
11.6
35651
­
11.1
7.8
12.7
41.1
28.3
­
9.6
65.6
35655
92.7
­
57.5
145.1
­
56.7
42.8
­
18.4
­
23.2
35664
­
16.3
16.3
34.4
45.1
6.8
­
0.9
11.5
35665
51.7
1.7
66.0
77.3
22.5
39.6
37.8
35668
71.9
1.7
9.7
44.2
28.8
17.6
42.7
35671
­
284.2
­
88.7
­
209.3
SE
35673
17.8
20.2
­
7.7
27.5
­
8.8
24.2
­
15.5
­­­

­­­
­­­

­­­

­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROUP
v:
1000
mg/
m3
ANIMAL
NUMBER
7­
29
35569
247.8
35575
35581
277.0
35590
285.8
35598
327.1
35602
74.7
35605
322.8
35612
188.9
35613
­
85.5
35619
357.9
35623
231.4
35629
249.0
35636
166.8
35638
370.1
35648
146.8
35651
95.6
35655
293.7
35664
316.6
35665
397.3
35668
346.2
35671
35673
199.4
INDIVIDUAL
BODY
WEIGHT
CHANGES
(
grams)

DAYS
OF
GESTATION
7­
29a
ANIMAL
STATUS
­
112.2
FD
­
142.2
­
219.5
R
­
36.7
­
279.4
­
31.4
NP
­
439.0
­
161.5
20.7
­
106.9
101.7
­
26.3
­
195.8
­
92.3
­
139.8
­
115.9
­
44.4
­
211.4
SE
5.9
124
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDIX
G
Individual
Food
Consumption
125
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Individual
Food
Consumption
Explanatory
Notes
Abbreviations
=
No
data
AB
=
Aborted
NP
=
Not
pregnant
ED
=
Earlydelivery
R
=
Litter
totally
resorbed
SE
=
Sacrificed
in
extremis
FD
=
Founddead
126
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
I:
o
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
4­
7
7­
9
9­
11
11­
13
13­
15
15­
17
35570
147.3
152.9
151.5
150.5
150.4
151.9
35572
150.6
150.1
152.2
149.5
148.8
153.7
35576
127.6
150.5
149'.
0
151.7
148.1
150.5
35578
148.2
152.3
151.4
154.3
152.2
152.3
35579
149.2
151.2
148.9
151.4
149.9
153­
9
35597
152.7
154.1
149.4
150.6
152.5
154.5
35599
124.4
84.5
151.5
149.9
152,9
152.8
35601
150.7
152.8
149.4
149.9
153.9
151.9
35604
152.5
152.4
149.8
149.6
152.0
149.9
35616
150.5
150.4
149.1
151.0
152.4
150.4
35621
149.0
150.3
147.8
146.7
125.8
150.4
35628
151.1
152.3
154.0
152.2
154.1
151.0
35632
151.7
150­
9
153.9
151.9
148.9
147.1
35639
150.4
149.2
152.1
119.2
86.9
114.4
35644
150.5
150.9
150.5
147.5
152.7
149.6
35646
150.7
102.8
90.6
85.7
113.3
150.8
35656
151.1
151.9
151.5
153.1
153.6
145.7
35658
152.3
151.8
152.0
152.7
152.7
150.3
35659
150.3
153.7
148.7
149.8
149.1
148.4
35666
152.5
151.8
150.6
152,9
152.8
148.3
35675
150.3
153.4
148.2
152.5
151.0
153.1
35677
150.2
151.6
151.8
150.3
152.7
152.9
DuPont­
10657
17­
19
ANIMAL
STATUS
149.9
153.9
152.6
150.7
AB
148.8
151.8
151.1
148.9
148.3
149.9
150.8
149.3
151.4
142.8
148.9
139.4
150.8
151.5
151.7
150.0
153.1
152.1
­­­
­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
I:
o
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NlJMBER
19­
21
21­
23
23­
25
25­
27
27­
29
7­
29
ANIMAL
STATUS
35570
149.0
151.7
148.7
151.2
151.2
150.8
35572
151.0
147.8
150.2
152.3
146.6
150.5
35576
153.2
152.1
149.2
148.6
150.5
150.5
35578
AB
35579
150.9
153.1
150.0
151.6
148.8
150.8
35597
148.1
152.6
150.4
150.5
149.9
151.3
35599
148.9
151.4
152.1
151.6
150.0
145.2
35601
149.4
153.1
150.1
148.4
151.6
150.8
35604
148.2
151.2
149.9
150.3
150.8
150.2
35616
152.4
153.6
151.0
152.6
149.5
151.1
35621
148.3
151.2
149.9
149.4
151.1
147.4
35628
149.9
148.6
148.6
153.4
151.2
151.3
35632
151.2
147.3
150.3
151.7
150.2
150.4
35639
150.0
148.5
152.2
149.4
129.3
135.8
35644
153.3
151,
O
152.6
151.4
150.8
,
150.8
35646
150.3
149.3
153.5
150.8
148.1
130.4
35656
149.6
151.9
152.7
149.2
147.5
150.7
35658
152.0
151.4
153.1
146.7
149.9
151.3
35659
150.3
154.9
151.1
149.0
149.0
150.5
35666
151.8
147.4
148.4
149.9
152.3
150.6
35675
147.9
152.0
152.2
151.9
152.5
151.6
35677
151.4
149.6
155.2
153.3
153.1
152.2
128
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
4­
7
7­
9
9­
11
11­
13
13­
15
15­
17
35573
148.0
151.9
153.0
152.2
153.1
152.1
35574
140.1
149.1
150.7
153.1
150.6
151.8
35584
150.6
153.2
151.4
152,4
148.4
154.4
35585
152.4
152.9
152.8
154.1
148.4
150.8
35588
151.2
150.7
149.3
151.5
152.1
151.1
35593
152.3
152.4
147.1
154.2
151.8
152,
l
35595
151.9
153.0
149.0
148.8
149.0
152.1
35600
150.7
152.5
151.2
150.1
150.9
151.4
35603
151.8
151.4
150.8
152.9
153.8
150.0
35606
152.6
152.0
151.4
149.4
152.8
151.6
35614
150.7
151.1
153.2
151.8
152.8
153.5
35617
147.8
149.3
152.6
150.5
148.7
149.6
35630
150.2
150.3
150.9
149.7
150.8
151.6
35633
151.2
152.1
152.9
150.8
151.3
150.6
35642
152.0
148.7
151.2
152.0
151.2
153.7
35647
150.8
147.9
149.5
152.4
151.7
'
149.4
35649
152.3
153.7
149.3
150.1
90.6
121.7
35654
152.8
150.0
147.1
151.5
151.8
151.0
35667
150.7
150.4
149.4
153.6
150.9
151.3
35669
151.7
153.6
151.9
152.5
150.4
149.9
35670
151.9
151.5
151.2
150.1
153.1
148.5
35674
152.4
153.1
153.7
152.6
152.6
114.1
DuPont­
10657
17­
19
ANIMAL
STATUS
153.4
149.6
153.7
153.4
151.2
152.9
149.6
152.8
153.7
NP
152.1
148.8
153.4
149.8
152.6
149.8
150.7
149.5
151.2
NP
148.1
150.6
150.9
90.1
129
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
11:
30
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
19­
21
21­
23
23­
25
25­
27
27­
29
7­
29
ANIMAL
STATUS
35573
153.1
120.1
151.9
152.9
149.6
149.4
35574
151.2
151.1
151.3
150.8
148.9
150.7
35584
149.3
150.6
150.4
147.9
148.5
150.9
35585
148.1
149.3
152.6
91.8
149.1
145.7
35588
152.1
151.4
149.4
147.4
151.8
150.7
35593
151.0
152.1
149.6
146.7
149.3
150.8
35595
153.2
153.5
151.2
148.1
149.7
150.6
35600
146.6
152.1
146.4
147.5
151.2
150.2
35603
149.4
149.8
151.1
152.0
146.3
151.0
NP
35606
151.9
152.1
138.8
150.3
149.7
150.2
35614
149.8
153.9
150.1
151.0
147.7
151.2
35617
151.4
151.6
151.9
151.4
147.7
150.7
35630
152.1
151.2
152.3
149.7
147.8
150.5
35633
149.2
152.9
150.2
150.1
122.3
148.6
35642
149.4
152.8
150.9
146.2
148.6
150.4
35647
150.9
148.8
153.2
152.3
150.4
150.6
35649
153.9
152.2
150.6
150.8
148.6
142.8
35654
153.6
151.1
151.9
150.2
149.6
150.8
NP
35667
152.4
151.3
151.0
148.7
151.8
150.8
35669
148.6
153.0
149.6
151,
l
150.9
151.1
35670
150.3
149.6
153.9
148.6
150.6
150.7
35674
97.0
152.9
152.1
149.7
146.8
137.7
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
4­
7
7­
9
9­
11
11­
13
13­
15
15­
17
17­
19
ANIMAL
STATUS
35580
147.4
148.1
151.2
119.0
150.6
152.7
148.7
35582
148.6
150.1
149.9
151.5
150.5
151.6
149.8
35587
105.5
32.3
16.5
1.3
16.3
45.1
74.6
35589
152.1
153.8
148.9
153.6
151.1
153.4
149.8
35594
151.4
151.8
151.3
151.0
152.0
153.6
153.7
35596
151.2
153.7
151.6
149.7
153.5
152.2
148.1
ED
35609
152.2
153.6
149.9
153.1
149.6
153.2
152.0
35610
148,6
154.1
150.1
152.6
150.1
153.6
152.1
35611
152.8
153.4
151.9
152.8
152.9
151.4
150.4
35615
153.4
149.4
152.4
152.1
152.6
153.8
147.6
35622
153.0
149.9
150.3
149.4
152.8
152.5
147.8
35624
123.2
148.6
151.4
145.5
151.9
151.1
151.1
35627
152.3
150.9
153.4
148.8
151.9
150.9
150.4
35634
151.8
153.6
151.4
153.6
151,7
150.4
151.6
35641
151.2
153.8
149.8
153.8
153.9
151.0
149.5
35643
153.5
152.1
149.9
154.8
151.3
148.8
153.2
35645
116.4
150.4
151.6
152.2
154.6
147.2
152.6
35652
149.4
149.8
152.8
149.9
150.9
149.5
150.2
35657
151.8
151.3
149.4
151.5
151.1
147.2
150.5
NP
35660
153.6
153.2
152.1
149.7
147.3
153.9
149.4
35661
151.5
153.8
149.7
152.6
151.0
148.4
151.4
35662
150,6
151.7
148.4
152.4
151.4
148.3
147.8
131
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
111:
100
mg/
m3
ANIMAL
DAYS
OF'
GESTATION
NUMBER
19­
21
21­
23
23­
25
25­
27
27­
29
7­
29
ANIMAL
STATUS
35580
150.1
153.0
146.9
149.1
153.7
147.5
35582
150.4
149.4
149.2
151.6
153.7
150.7
35587
112.3
140.1
151.5
152.6
151.1
81.2
35589
150.3
149.2
147.0
149.9
152.6
150.8
35594
150.9
148.5
151.9
150.4
147.6
151.1
35596
149.5
150.9
151.5
151.5
153.7
151.4
ED
35609
153.6
147.6
149.7
149.0
150.4
151.0
35610
152.6
149.4
151.1
150.3
154.1
151.8
35611
150.1
151.1
150.8
150.4
150.9
151.5
35615
151.3
152.6
150.7
147.2
150.8
151.0
35622
152.0
149.7
149.7
152.0
149.5
150.5
35624
149.4
152.0
147.5
150.9
152.9
150.2
35627
148.5
149.7
149.0
151.2
152.2
150.6
35634
150.6
149.8
146.5
153.1
148.8
151.0
35641
129.3
151.9
149.0
152.1
149.9
,
149.4
35643
149.9
151.2
151.9
151.1
151.6
151.4
35645
151.8
149.6
153.1
151.6
151.8
151.5
35652
150.4
151.4
146.8
150.1
151.1
150.3
35657
153.9
149.6
151.4
152.3
150.1
150.7
NP
35660
152.3
149.9
151.0
153.0
148.9
151.0
35661
150.1
150.6
150.9
151.8
150.5
151,0
35662
153.7
152.4
148.3
148.9
153.2
150.6
132
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
IV:
300
mg/
m3
15­
17
151.7
153.0
150.1
152.3
148.6
152.9
151.6
153.3
148­
4
149.5
148.2
152.9
152.4
149.9
146.7
'
148.9
153.3
139.3
153.8
150.2
128.9
150.8
DuPont­
10657
17­
19
ANIMAL
STATUS
152.9
151.3
151.2
149.8
149.9
152.3
151.1
148.0
147.8
148.3
153.8
151.3
150.2
151.9
152.4
151.6
150.5
152.5
153.2
147.7
150.1
151.7
NP
ANIMAL
NUMBER
4­
7
7­
9
9­
11
11­
13
13­
15
35571
150.8
152.7
151.9
151.9
151.6
35577
152.0
154.5
150.4
153.0
150.2
35583
140.6
104.8
149.9
152.1
151.3
35586
153.0
149.9
149.4
152.7
151.1
35591
153.1
150.9
151,4
148.8
152.0
35592
151.3
130.3
150.8
149.4
151.9
35607
151.5
149.0
150.6
151.7
152.0
35608
152.1
130.9
150.6
149.3
151".
4
35618
151.5
146.8
150.4
149.9
151.9
35620
151.2
115.9
152.1
152.7
152.0
35625
150.6
140.7
150.1
149.8
152.1
35626
149.4
135.1
153.0
147.1
152.1
35631
152.9
138.9
150.5
150.4
153.7
35635
152.5
150.7
149.9
153.7
151.8
35637
151.6
152.4
151.7
153.9
153.9
35640
146.9
128.3
146.8
150.5
131.4
35650
150.6
52.3
150.1
149.9
150.3
35653
149.8
118.4
149.3
153.8
154.2
35663
152.1
148.9
153.8
150.3
132.9
35672
152.0
154.0
152.1
151.2
142.1
35676
153.2
135.1
151.9
150.0
118.7
35678
151.9
135.7
150.7
152.4
151.9
DAYS
OF
GESTATION
Dimethyl
Glutarate
(
DMG):
Inhalation
DeveloDmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROUP
IV:
300
mg/
m3
ANIMAL
NUMBER
19­
21
35571
149.9
35577
151.9
35583
153.0
35586
147.8
35591
152.0
35592
151.0
35607
150.4
35608
152.4
35618
148.6
35620
150.7
35625
151.8
35626
151.9
35631
151.7
35635
149.1
35637
153.6
35640
149.8
35650
150.6
35653
150.0
35663
151.4
35672
120.4
35676
153.6
35678
151.3
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

DAYS
OF
GESTATION
21­
23
23­
25
25­
27
27­
29
7­
29
ANIMAL
STATUS
149.7
152.6
152.4
149.9
151.5
152.8
152.5
153.9
150.3
152.2
150.8
151.9
150.8
150.8
147.0
148.3
154.3
151.4
149.7
150.6
153.4
151.6
149.1
150.6
150.7
151.5
151.9
147.8
148.2
148.9
151.7
151.2
152.3
153.4
151.4
152.5
151.4
151.7
149.9
149.2
148.2
151.2
152.3
152.7
149.8
152.4
151.8
148.3
151.2
147.7
151.5
152.2
150.9
152.9
150.3
152.4
147.0
150.0
149.0
149.2
151.4
148.3
150.1
151.9
149.9
148.2
147.0
152.0
151.4
150.5
147.4
150.2
150.5
152.9
151.4
152.1
150.3
152.1
112.2
143.1
149.3
150.3
152.0
147.3
141.4,
151.2
121.8
128.8
120.4
140.0
151.0
152.6
151.2
149.6
149.9
94.6
150.9
150.1
147.9
141.9
152.6
151.8
149.2
149.8
144.7
151.3
149.0
149.5
153.2
149.7
NP
134
­­­
­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
v:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
4­
7
7­
9
9­
11
11­
13
13­
15
15­
17
17­
19
ANIMAL
STATUS
35569
152.1
122.2
150.3
152.9
148.3
148.7
149.9
35575
150.9
138.9
147.4
76.6
FD
35581
152.6
126.5
148.0
150.4
131.6
147.8
151.5
35590
149.3
115.4
148.4
150.3
151.6
148.4
150.9
R
35598
151.1
148.5
147.8
151.2
151.3
150.4
148.3
35602
152.2
114.8
147.1
152.4
125.0
97.1
4.9
35605
151.0
90.2
146.8
150.8
150.0
150.2
150.7
35612
149.6
151.0
149.2
149.6
150.3
151.8
150.9
NP
35613
138.9
22.9
5.8
11.1
19.5
83.6
148.5
35619
149.5
140.7
149.2
148.3
150.1
152.0
149.9
35623
151.8
146.2
149.1
148.6
152.2
151.6
148.7
35629
151.8
151.6
122.0
152.5
152.7
152.1
150.4
35636
153.3
73.9
147.7
152.1
150.1
150.7
152.8
35638
152.2
77.4
135.1
148.8
151.9
149.4
148.6
35648
152.3
80.1
153.1
150.6
150.3
150.4
150.6
35651
151.6
22.7
151.9
152.4
153.0
'
146.7
152.4
35655
151.7
143,6
149.1
150.1
148.3
154.0
148.8
35664
152.6
121.3
150.8
152.5
151.5
151.8
151.1
35665
152.2
129.8
151.8
151.1
151.2
148.8
146.6
35668
151.7
103.5
153.7
153.4
151.0
151.2
148.3
35671
150.5
100.7
153.7
152.8
140.8
2.2
0.8
SE
35673
152.9
134.3
149.0
151.6
152.1
151.4
149.0
135
­­­

­­­
­­­
­­­
­­­

­­­
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FOOD
CONSUMPTION
(
grams/
day)

GROUP
V:
1000
mg/
m3
ANIMAL
DAYS
OF
GESTATION
NUMBER
19­
21
21­
23
23­
25
25­
27
27­
29
7­
29
ANIMAL
STATUS
35569
148.3
149.0
147.6
148.9
145.9
146.5
_­

­­_
FD
R
NP
SE
35575
35581
35590
35598
35602
35605
35612
35613
35619
35623
35629
35636
35638
35648
35651
35655
35664
35665
35668
35671
35673
_­_
149.4
153.6
148.2
144.5
147.6
152.4
76.0
139.0
147.8
148.9
153.6
148.0
146.1
150.5
151.4
111.9
150.4
150.0
145.9
141.3
149.3
152.8
151.4
150.6
148.2
149.7
149.6
94.3
113.2
153.2
149.3
145.6
153.3
149.1
150.4
149.7
147.6
151.1
150.2
148.0
148.3
146.9
148.5
142.6
124.3
151.6
149.5
139.7
102.1
150.7
149.8
139.2
124.1
149.6
146.0
135.9
147.1
149.5
148.2
149.0
111.0
114.1
78.6
134.8
147.7
150.4
148.1
147.7
153.9
149.4
149.5
146.5
149.1
146.2
133.0
45.4
118.4
149.4
150.0
150.8
148.8
150.4
146.5
150.2
149.6
148.9
148.3
150.9
148.6
150.3
2.5
147.3
133.5
142.4
147.8
96.6
150.6
150.6
148.3
145.5
149.5
147.4
151.2
149.8
143.6
147.9
152.2
149.4
150.4
147.0
_­

148.9
148.9
151.7
151.8
151.4
Dimethvl
Glutarate
(
DMG):
Inhalation
Develor>
mentalToxicitv
Studv
in
Rabbits
DuPont­
10657
APPENDIX
H
Individual
Clinical
Observations
137
Dimethvl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Individual
Clinical
Observations
Explanatory
Notes
Footnotes
a
The
first
observation
recorded
each
day
(
in
the
morning)
is
indicated
by
 
a, 
the
second
by
 
b. 
Twice
daily
observations
were
made
on
days
7­
286.
If
no
signs
were
observed
during
the
study
examinations,
the
 
b 
entries
are
omitted
from
the
printout.

A
post­
exposure
clinical
observation
was
inadvertently
not
recorded
for
one
animal
(
Animal
Number
35633)
on
one
day
(
July
4,2002).
This
protocol
deviation
did
not
adversely
impact
the
study
because
it
affected
one
animal
for
one
day
and
clinical
observations
were
recorded
pre­
exposure
and
for
all
subsequent
protocol­
specified
times.

138
F
M
v)

2
Y
E
II
I1mil
m
m
m
m
ol
OI
a
a
m
N
N
NNII
N­
N
....
....
N
N
­.
N
N....
­
11
w
II
cow
N
­
11
I1
.
....
....
..
NN
5.
.

r
II
rr
N
II..
­
11
.
....
....
..
NN
....
nw
II
w
N
II
....
....
..
....
ZmIl
­
Ln
MN
II
N
u)
­
11
­....
....
..
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APPENDIX
I
Gross
Postmortem
Findings
155
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Gross
Postmortem
Findings
Explanatory
Notes
Abbreviations
AB
=
Aborted
NP
=
Notpregnant
ED
=
Earlydelivery
R
=
Litter
totally
resorbed
SE
=
Sacrificed
in
extremis
FD
=
Founddead
=
No
data
NAD
=
No
abnormalities
detected
156
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROSS
POSTMORTEM
FINDINGS
Group
I:
0
mg/
m3
Animal
Animal
Number
Status
Structure(
s)
35570
35572
35576
35578
AB
35579
Lungs
35597
Lungs
35599
35601
35604
35616
35621
35628
35632
35639
35644
35646
35656
35658
35659
35666
35675
35677
Findinn(
s)

NAD
NAD
NAD
NAD
Discoloration;
red
mottling
left
lobe
Discoloration;
red
mottling
all
lobes
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
157
DuPont­
10657Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
GROSS
POSTMORTEM
FTNDINGS
Group
11:
30
mg/
m3
Animal
Animal
Number
Status
S
tructure(
s2
35573
35574
35584
35585
35588
35593
35595
35600
35603
NP
35606
35614
35617
35630
35633
35642
35647
35649
35654
NP
35667
35669
35670
35674
Findinn(
s2
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROSS
POSTMORTEM
FINDINGS
Group
III:
100
mg/
m3
Animal
Animal
Number
Status
35580
35582
35587
35589
35594
35596
ED
35609
35610
35611
35615
35622
35624
35627
35634
35641
35643
35645
35652
35657
NP
35660
35661
35662
Structure(
s1
Finding(
s)

NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROSS
POSTMORTEM
FINDINGS
Group
IV:
300
mg/
m3
Animal
Animal
Number
Status
Structure(
s)
Finding(
s)

3557
1
35577
35583
35586
35591
35592
35607
35608
35618
35620
35625
35626
35631
35635
35637
35640
35650
35653
35663
35672
35676
35678
NP
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
160
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
GROSS
POSTMORTEM
FINDINGS
Group
V:
1000mg/
m3
Animal
Animal
Number
Status
Structure(
s)
35569
35575
FD
35581
35590
R
35598
35602
35605
35612
NP
35613
35619
35623
35629
35636
35638
35648
35651
35655
35664
35665
35668
3567
1
SE
Gallbladder
35673
Finding(
s)

NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
Large;
5.0
X2.0
cm
NAD
Dimethvl
Glutarate
(
DMG):
Inhalation
Develo~
mentalToxicitv
Studv
in
Rabbits
DuPont­
10657
APPENDIX
J
Individual
Reproductive
Data
162
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
DevelopmentalToxicity
Study
in
Rabbits
DuPont­
10657
Individual
Reproductive
Data
Explanatory
Notes
Abbreviations
AB
=
Aborted
NP
=
Not
pregnant
ED
=
Early
delivery
R
=
Litter
totally
resorbed
SE
=
Sacrificed
in
extremis
FD=
Found
dead
­

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data
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2
I
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
APPENDIX
K
Individual
Fetal
Weights
and
Alterations
169
­­­
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
Individual
Fetal
Weights
and
Alterations
Explanatory
Notes
For
ease
of
recording,
many
of
the
findings
have
been
abbreviated
or
coded,
as
listed
below:
ar
=
Arch(
es)
bil
=
Bilateral
cen
=
Centrumorcentra
It
=
Left
lu
=
Lumbar
NAD
=
No
abnormalities
detected
rt
=
Right
th
=
Thoracic
=
No
data
*
Subcutaneous
hemorrhage
that
was
not
present
in
utero.

Renal
papillary
sizes
refer
to
papillary
development
using
the
scheme
of
Woo
and
Hoar.(
3)

Alterations
are
classed
as:
N
=
Notes
DV
=
Developmental
Variations
VR
=
Variation
due
to
Retarded
Development
M
=
Malformations
Numbers
are
used
to:

0
Indicate
renal
papillary
size
0
Identify
specific
sternebra
0
Refer
to
skeletal
position
for
ribs
or
vertebra
0
Specify
skull
bones
according
to
the
following
key:
1.
Interparietal
8.
Squamosal
2.
Parietal
9.
Tympanic
annulus
3.
Frontal
10.
Basioccipital
4.
Nasal
1
1.
Exoccipital
5.
Premaxilla
12.
Supreoccipital
6.
Maxilla
13.
Hyoid
7.
Zygoma
170
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
CLASSIF­
STRUCTURE
FINDING(
S)
ICATION
GROUP
I:
0
mg/
m3
DOE
#/
FETUS
#
FETUS
WT
35570
1
36.70
2
30.80
3
34.82
4
35.19
5
35.72
6
31.06
7
30.32
8
23.36
35572
1
47.91
2
48.29
3
47,03
4
44*
97
5
40.76
6
41.75
35576
1
49.10
2
40.98
3
40.82
4
38.44
5
43.90
6
42.85
7
33.29
8
34.98
9
39.85
10
45.55
Rib
Rib
Rib
Sternebra
Rib
Rib
Sternebra
Rib
Rib
Skull
Kidney
Rib
Sternebra
Skull
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
It
full
rt)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
short
rt
full
It)
DV
Retarded
Ossification
(
2
It)
VR
Papilla
­
Size
3
(
RT)
VR
Supernumerary
(
th13
full
bill
DV
Retarded
Ossification
(
6)
VR
NAD
NAD
Retarded
Ossification
(
7
It)
VR
Supernumerary
(
th13
short
It)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
short
bill
DV
Supernumerary
(
th13
site
It)
DV
Supernumerary
(
th13
short
bill
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bil)
DV
17
1
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
I:
o
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35579
1
2
3
4
5
41.28
35.56
30.36
20.23
20.38
Rib
Rib
Rib
Kidney
Rib
Rib
Pelvis
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Papilla
­
Size
3
(
bil)
Supernumerary
(
th13
short
It)
Supernumerary
(
th13
full
It)
Retarded
Ossification
DV
DV
DV
VR
DV
DV
6
20.92
Rib
Pelvis
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
pubis
bil)
VR
DV
7
8
9
10
11
12
29.23
44.26
23.86
26.35
24.57
28.03
Rib
Rib
Rib
Rib
Rib
Skull
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
7
It)
Supernumerary
(
th13
full
bil)
(
pubis
bil)
VR
DV
DV
DV
DV
DV
VR
DV
35597
46.31
NAD
42.55
NAD
40.86
37.50
Rib
Rib
Supernumerary
(
full
13
bil)
Supernumerary
(
full
13
bill
DV
DV
40.72
Rib
Supernumerary
(
short
13
rt)
DV
43.50
Rib
Supernumerary
(
full
13
bill
DV
Pelvis
Retarded
Ossification
(
pubisbi1)
VR
7
42.19
NAD
8
39.68
Rib
Supernumerary
(
full
13
bil)
DV
9
37.56
Rib
Supernumerary
(
full
13
bil)
DV
35599
1
46.82
NAD
2
35.22
NAD
3
4
28.55
31.56
Rib
Rib
Supernumerary
(
th13
short
rt)
Supernumerary
(
th13
full
bil)
DV
DV
172
1
2
3
4
5
6
7
8
9
10
1
2
3
4
5
6
7
1
2
3
4
5
6
7
8
'
I
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
I:
o
mg/
m3
DOE
#/
CLASS1F­
FETUS
#
FETUS
WT
STRUCTURE
FINDING(
S)
ICATION
~

35599
(
Cont.)
5
37.64
6
41.11
7
41.89
8
40.00
9
35.88
35601
40.89
38.91
41.45
38.57
41.57
47.39
39.36
37.25
30.38
30.00
35604
51.10
46.47
48.37
50.10
35.37
45.90
37.93
35616
51.17
48.14
39.24
42.25
54.21
49.28
47.33
42.99
Rib
Rib
Rib
Kidney
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
NAD
NAD
Supernumerary
(
th13
short
rt)
DV
NAD
Papilla
­
Size
3
(
rt)
VR
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
bil)
DV
NAD
NAD
Supernumerary
(
th13
full
rt)
DV
Supernumerary
(
th13
full
It)
DV
NAD
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
It
short)
DV
Supernumerary
(
th13
full
bill
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
NAD
NAD
173
1
2
3
4
5
6
7
8
9
10
11
12
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
I:
o
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35621
45.17
40.15
51.28
40.68
38.81
35.38
35.03
28.20
31.76
37.32
26.63
36.23
35628
26.89
33.45
53.59
44.79
39.18
40.32
35632
1
47.19
2
39.75
3
45.75
4
53.13
5
46.26
6
54.97
35639
1
48.42
2
38.40
3
44.56
4
36.29
5
33­
49
NAD
NAD
Rib
NAD
Supernumerary
(
site
13
It)
DV
Rib
Rib
Supernumerary
(
short
13
It)
Supernumerary
(
th13
full
bil)
DV
DV
NAD
Rib
Rib
Kidney
Supernumerary
(
th13
full
It)
Supernumerary
(
th13
short
bil)
Papilla
­
Size
3
(
bil)
NAD
DV
DV
VR
NAD
Rib
Rib
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
rt)
Supernumerary
(
th13
full
rt)
Supernumerary
(
th13
full
bil)
DV
DV
DV
DV
DV
DV
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
Rib
Rib
Sternebra
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
DV
DV
VR
DV
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
Supernumerary
(
th13
full
Supernumerary
(
th13
full
Supernumerary
bil)
bill
bil)
DV
DV
DV
Rib
(
th13
rt
short
It
full
Supernumerary
(
th13
full
bil)
DV
DV
174
1
2
3
4
5
6
7
8
9
10
!

Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
­
1_

INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
I:
o
mg/
m3
DOE
#/
FETUS
#
FETUS
WT
STRUCTURE
35639
(
Cont.
1
6
44.17
Rib
7
45.61
Kidney
Rib
8
46.14
Rib
9
43.83
Rib
10
37.44
Rib
35644
1
46.69
2
41.19
3
41.86
Rib
4
30.58
Rib
5
48.54
6
44.33
Rib
7
44.09
Rib
8
33.15
Rib
35646
42.85
41.94
Rib
30.51
34.71
Rib
44.20
Rib
38.80
33.59
Rib
41.79
Rib
35.33
41.30
Rib
11
47.79
Rib
35656
1
42.97
Rib
2
38.32
Rib
3
36.76
Rib
4
45.17
Rib
CLASSIF­
FINDING(
S)
ICATION
Supernumerary
(
th13
full
bil)
DV
Papilla
­
Size
3
(
bil)
VR
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
It
short)
DV
NAD
NAD
Supernumerary
(
th13
short
It
full
rt)
DV
Supernumerary
(
th13
short
It)
DV
NAD
Supernumerary
(
th13
site
It)
DV
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
It
site
rt)
DV
Supernumerary
(
th13
full
It)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
full
bil)
DV
175
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
I:
o
mg/
m3
DOE
#/
CLASS1F­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35656
(
Cont.)
5
39.89
Rib
6
30.85
Rib
7
42.80
35658
1
49.07
2
30.52
Kidney
Rib
3
41.33
Rib
4
41.37
Rib
5
36.96
Rib
6
47.50
Rib
7
47.94
Kidney
Rib
8
46.50
Rib
9
46.85
Rib
35659
1
39.13
Rib
2
37.43
3
32.98
Rib
4
30.31
5
20.86
Rib
Pelvis
6
23.25
Rib
7
30.55
Rib
8
28.87
Rib
9
38.09
Rib
10
39.74
11
38.57
12
34.34
Rib
35666
1
43.67
Rib
Sternebra
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
NAD
Papilla
­
Size
3
(
bil)
VR
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Papilla
­
Size
3
(
bil)
VR
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
short
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
pubis
bill
VR
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bill
DV
NAD
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
rt
full
It)
DV
Retarded
Ossification
(
6)
VR
176
1
2
3
4
5
6
7
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
.
Ai
1
a\
~
1
F"

INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
I:
o
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.
STRUCTURE
35666
(
Cont.)
2
38.55
Rib
3
39.87
Rib
4
36.78
5
37.22
Rib
Sternebra
6
41.09
Sternebra
7
41.51
Sternebra
8
37.84
9
39.93
35675
1
44.94
Rib
2
43.93
Rib
3
40.43
Rib
Sternebra
4
37.46
Rib
5
40.04
Rib
6
42.65
Rib
7
43.55
Rib
8
39.04
Rib
9
41.46
Rib
35677
42.03
37.91
Rib
32.42
30.55
Rib
35.51
Rib
35.69
Rib
36.50
Kidney
Rib
8
37.90
9
37.
a7
Rib
10
28.11
Rib
11
28.52
Rib
CLASS1F­
FINDING(
S)
ICATION
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
short
It
full
rt)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
NAD
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
short
bill
DV
Supernumerary
(
site
13
It)
DV
Supernumerary
(
th13
full
bil)
DV
Papilla
­
Size
3
(
bill
VR
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
It)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
It
full
rt)
DV
177
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
I
o
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT
.
STRUCTURE
FINDING
(
S)
ICATION
35677
Cont
.)
12
29.21
Rib
Supernumerary
(
th13
full
bil)
DV
178
1
2
3
4
5
6
7
8
9
10
1
2
3
4
5
6
7
8
9
10
11
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
11:
30
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35573
40.83
38.34
32.89
Rib
36.27
36.64
Rib
26.84
Rib
32.62
42,18
Rib
37.93
33.96
35574
46.41
Rib
44.28
Rib
39.65
Rib
35.90
Rib
28.28
Rib
37.51
Rib
41.91
41.17
Rib
50.65
Rib
41.81
Rib
48.64
Rib
35584
1
44.40
Rib
Rib
Skull
2
44.40
Rib
3
40.11
Rib
4
40.03
Rib
5
44.80
6
40.47
Rib
7
33.75
Rib
NAD
NAD
Supernumerary
(
th13
full
It)
DV
NAD
Supernumerary
(
th13
full
rt)
DV
Supernumerary
(
th13
short
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
NAD
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Fused
(
thl2
It
proximal)
M
Retarded
Ossification
(
7
It)
VR
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
short
rt
full
It)
DV
Supernumerary
(
th13
full
bil)
DV
179
1
2
3
4
5
6
7
8
9
10
11
12
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
11:
30
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35585
1
45.02
Rib
2
46.90
3
42.13
Rib
4
41.19
Rib
5
45.38
Rib
6
43.97
Rib
7
45.31
Rib
8
35.31
Rib
35588
40.54
Rib
36.63
Rib
40.71
Rib
28.10
Rib
31.48
Rib
29.53
Rib
44.63
Rib
39.04
Rib
40.58
Rib
39.66
Rib
38.37
36.26
Rib
35593
1
39.93
2
42.10
Rib
3
36.59
Rib
4
33.85
5
36.85
Rib
6
35.11
Rib
7
29.79
Rib
8
31.10
Rib
9
24.23
Rib
10
36.28
Rib
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
rt
full
It)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
NAD
Supernumerary
NAD
Supernumerary
(
th13
short
Supernumerary
NAD
Supernumerary
(
th13
short
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
It
full
rt)
DV
(
th13
full
bil)
DV
rt
full
It)
DV
(
th13
short
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
bil)
DV
(
th13
full
rt)
DV
180
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
7
8
9
I
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
11:
30
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35593
(
Cont.)
Rib
11
36.24
Rib
35595
54.64
Rib
46.01
42.09
Rib
48.22
Rib
41.37
Rib
47.70
Rib
47.22
45.75
Rib
50.93
Rib
35600
1
29.76
Rib
2
44.33
Rib
3
42.28
Kidney
Rib
4
38.25
Rib
5
30.92
Rib
6
37.30
Rib
7
41.03
Rib
8
40.10
Rib
9
41.93
10
43.67
Rib
11
45.27
Rib
35606
42.48
Sternebra
41.60
41.23
Rib
45.11
Rib
48.24
51.84
46.58
45.50
41.77
Fused
(
th12
It
proximal)
M
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
It)
Dv
Supernumerary
(
th13
full
It)
DV
Supernumerary
(
th13
full
rt)
DV
Papilla
­
Size
3
(
rt)
VR
Supernumerary
(
th13
full
bil)
DU
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
rt)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
6)
VR
NAD
Supernumerary
(
th13
short
bill
DV
Supernumerary
(
th13
full
rt)
DV
NAD
NAD
NAD
NAD
NAD
1
2
3
4
5
6
7
8
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
11:
30
mg/
m3
DOE
#/
CLASS1F­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35614
1
37.30
Rib
Sternebra
2
32.95
Rib
Sternebra
3
36.04
Sternebra
4
33.55
5
32.83
6
34.84
Rib
Sternebra
7
33.12
Rib
8
32.42
Sternebra
9
34.07
10
32.29
Sternebra
11
29.53
12
28,16
Sternebra
13
34.21
35617
46.34
Rib
38.16
Rib
36.08
Rib
28.62
28.22
27.65
41.87
Rib
31.76
Rib
35630
1
48.82
Rib
2
42.35
3
46.99
Rib
4
40.59
Rib
Skull
5
44.92
Rib
6
47.94
7
45.70
Rib
8
43.31
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
short
It)
DV
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
NAD
NAD
Supernumerary
(
th13
short
rt
full
It)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
6)
VR
NAD
Retarded
Ossification
(
6)
VR
NAD
Retarded
Ossification
(
6)
VR
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short:
bill
DV
NAD
NAD
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
short
bill
DV
NAD
Supernumerary
(
short
13
It)
DV
Supernumerary
(
th13
short
bil)
DV
Retarded
Ossification
(
7
rt)
VR
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
NAD
182
1
2
3
4
5
6
7
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
7
8
9
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
11:
30
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35633
44.37
Rib
39.46
Rib
40.05
Rib
42.26
Rib
43.50
Rib
34.82
Rib
41.28
35642
40.60
36.68
Rib
37.64
30.85
36.93
29.95
33.32
43.56
39.33
Sternebra
35647
48.33
48.14
46.75
Rib
39.04
47.53
48.20
48.77
Rib
45.06
38.47
Rib
10
34.89
35649
1
51.53
Rib
2
45.85
Rib
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
It)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bill
DV
NAD
NAD
Supernumerary
(
th13
full
bill
DV
NAD
NAD
NAD
NAD
NAD
NAD
Retarded
Ossification
(
6)
VR
NAD
NAD
Supernumerary
(
th13
full
bill
DV
NAD
NAD
NAD
Supernumerary
(
site
13
It)
DV
NAD
Supernumerary
(
th13
short
It
full
rt)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
It
full
rt)
DV
183
1
2
3
4
5
6
7
1
2
3
4
5
6
7
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
11:
30
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35649
3
4
5
6
(
Cont.)
41.73
33.95
34.54
35.43
Rib
Rib
Rib
Supernumerary
(
th13
short
Supernumerary
Supernumerary
NAD
It
full
rt)
(
th13
full
bill
(
th13
full
bil)
DV
DV
DV
7
8
9
10
11
28.63
56.82
42.10
32.76
35.18
Rib
Rib
Rib
Rib
Rib
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
(
th13
full
rt)
(
th13
full
bil)
(
th13
full
bill
(
th13
full
bil)
(
th13
full
bil)
DV
DV
DV
DV
DV
35667
45.48
50.41
39.90
39.23
Rib
Rib
Sternebra
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
NAD
DV
DV
VR
38.18
NAD
44.25
44.13
Rib
Rib
Supernumerary
(
th13
short
bil)
Supernumerary
DV
8
39.92
Rib
Supernumerary
(
th13
full
bil)
(
th13
short
rt
full
It)
DV
DV
35669
44.42
NAD
45.46
39.91
40.10
40.89
37.38
43.31
Rib
Rib
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
DV
DV
DV
DV
35670
1
42.35
NAD
2
44.29
Rib
Supernumerary
(
TH13
full
bil)
DV
3
4
40.49
45.51
Sternebra
Sternebra
Rib
Retarded
Ossification
(
6)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
VR
VR
DV
184
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
11:
30
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.

35670
(
Cont.)
5
43.69
6
44.03
7
42.76
8
51.30
9
45.27
35674
38.82
43.17
21.65
21.35
36.71
32.16
7
33.57
8
29.71
9
34.30
10
35.93
11
37.17
STRUCTURE
Sternebra
Rib
Sternebra
Sternebra
Rib
Rib
Sternebra
Rib
Rib
Rib
Head
Palate
Snout
Tongue
Skull
Rib
Rib
Rib
CLASSIF­
FINDING(
S)
ICAT1ON
Retarded
Ossification
(
6)
Supernumerary
(
th13
short
rt)
Fused
(
3­
5misaligned)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
It)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)

NAD
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
rt)
NAD
NAD
Malformation
(
micromaxilla)
Cleft
Malformation
(
naris
atresia
bil)
Protruding
Malformation
(
micromaxilla)
Supernumerary
(
th13
full
bil)
NAD
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
rt)
NAD
VR
DV
DV
VR
DV
DV
VR
DV
DV
DV
M
M
M
N
M
DV
DV
DV
185
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
111:
100
mg/
m3
DOE
#/
CLASS1F­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35580
1
2
3
4
5
6
7
8
9
34.01
33.42
36.42
32.51
31.59
43.60
43.24
37.88
39.59
Kidney
Rib
Rib
Kidney
Rib
Rib
Rib
Rib
Rib
Papilla
­
Size
Supernumerary
Supernumerary
Papilla
­
Size
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
NAD
3
(
bill
th13
full
bil)
th13
full
bil)
3
(
bill
th13
full
bil)
th13
full
bill
th13
full
bil)
th13
full
bil)
th13
full
bil)
VR
DV
DV
VR
DV
DV
DV
DV
DV
10
37
*
54
Rib
Supernumerary
(
th13
full
bil)
DV
35582
48.73
41.08
38.80
44.13
40.97
36.04
33.30
29.29
36.01
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
Supernumerary
(
th13
(
th13
(
th13
(
th13
(
th13
(
th13
(
th13
(
th13
(
th13
full
bil)
full
bill
short
rt)
full
bil)
full
bil)
full
bil)
full
bil)
full
bil)
full
bill
DV
DV
DV
DV
DV
DV
DV
DV
DV
35587
37.54
Rib
Supernumerary
(
th13
full
bil)
DV
31.87
NAD
7
8
9
10
21.99
33.59
26.41
32.22
39.13
37.44
35.10
37.61
Rib
Rib
Rib
Kidney
Rib
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Papilla
­
Size
3
(
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bill
DV
DV
DV
VR
DV
DV
DV
DV
DV
186
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
111:
loo
mg/
m3
DOE
#/
FETUS
#
FETUS
WT
35589
49.46
40.37
38.43
38.81
32.03
32.89
7
33.90
8
33.86
9
48.13
10
40.92
35594
1
41.76
2
38.86
3
37.92
4
40.16
5
35.48
6
32.77
7
34.55
35609
1
45.98
2
25.20
3
47.09
4
38.56
5
26.84
6
35.48
7
33.87
8
39.55
9
30.30
10
48.78
CLASSIF­
STRUCTURE
FINDING(
S)
ICATION
Rib
Supernumerary
(
th13
full
bil)
DV
Rib
Supernumerary
(
th13
full
bil)
DV
NAD
Rib
Supernumerary
(
th13
full
bil)
DV
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
rt
full
It)
DV
DV
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
NAD
Rib
Supernumerary
(
th13
full
bil)
DV
Rib
Supernumerary
(
th13
full
bil)
DV
Rib
Supernumerary
(
th13
full
bil)
DV
Rib
Rib
Rib
Pelvis
Supernumerary
(
th13
ful
bill
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
DV
DV
DV
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
(
pubisbi1)
VR
DV
DV
Rib
Supernumerary
(
th13
short
bil)
NAD
DV
Rib
Supernumerary
(
th
13
short
bil)
DV
NAD
NAD
Rib
Rib
Supernumerary
(
th13
short
rt)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
187
1
2
3
4
5
6
7
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
111:
100
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35610
42.75
Rib
39.73
Rib
39.85
Rib
36.16
Rib
44.21
Rib
44.81
Rib
45.38
Rib
35611
1
39.30
Rib
Sternebra
2
28.07
Rib
Sternebra
3
35.89
Rib
4
29.13
Sternebra
5
29.40
Sternebra
6
32.17
Sternebra
7
40.21
Sternebra
8
29.49
Rib
Sternebra
9
27.93
10
33.55
Rib
Sternebra
35615
1
39.60
Rib
Skull
2
40.28
Rib
3
29.81
Rib
4
32.87
Rib
5
29.91
Rib
6
33.02
Sternebra
7
38.78
8
30.65
Rib
9
37.76
Rib
Supernumerary
(
th13
short
bill
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
It
full)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
It
short)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
It
short)
DV
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
It
short)
DV
Retarded
Ossification
(
6)
VR
NAD
Supernumerary
(
th13
It
short)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
rt)
DV
Retarded
Ossification
(
8
bil)
VR
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
rt
short
It
full)
DV
Supernumerary
(
th13
It
short
rt
full)
DV
Supernumerary
(
th13
short
bil)
DV
Retarded
Ossification
(
6)
VR
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
188
1
2
3
4
5
6
7
1
2
3
4
5
6
7
8
9
10
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
h
f
^#'
XI.­*
I
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
111:
100
mq/
m3
DOE
#/
FETUS
#
FETUS
WT.

35615
(
Cont.)

10
30.59
11
38.92
35622
1
51.40
2
51.88
3
47.94
4
44.60
5
47.36
35624
39.45
38.37
33.55
35.93
31.75
37.17
37.92
8
36.03
9
33.99
10
33.96
35627
45.39
42.90
36.70
32.36
43.67
31.69
37.50
29.72
30.14
28.77
STRUCTURE
Sternebra
Sternebra
Rib
Rib
Rib
Rib
Kidney
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Subcutis
Rib
Rib
Rib
Subcutis
Rib
CLASSIF­
FINDING(
S)
ICATION
Retarded
Ossification
(
6)
Retarded
Ossification
(
6)
NAD
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Papilla
­
Size
3
(
bill
Supernumerary
(
th13
short
bil)

Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
Hemorrhage
(
snout
*
1
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Hemorrhage
(
head
*)
Supernumerary
(
th13
full
bil)

NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
NAD
VR
VR
DV
DV
DV
DV
VR
DV
DV
DV
DV
DV
DV
DV
N
DV
DV
DV
N
DV
189
1
2
3
4
5
6
7
8
9
10
1
2
3
4
5
6
7
1
2
3
4
5
6
7
8
9
10
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
111:
100
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.

35634
42.03
43.91
38.72
40.09
29.90
43.29
49.08
48.64
36.34
28.97
35641
40.89
32.44
35.82
29.50
32.00
22.36
26.40
8
24.12
9
41.81
10
41.74
11
44.80
35643
39.82
49.52
45.01
39.67
44.21
42.55
41.07
51.13
45.16
52.15
CLASSIF­
STRUCTURE
FINDING(
S)
ICATION
Rib
Rib
Sternebra
Supernumerary
(
th13
full
It)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
DV
DV
VR
NAD
NAD
Sternebra
Skull
Kidney
Sternebra
Retarded
Ossification
Retarded
Ossification
Papilla
­
Size
3
(
bil)
Retarded
Ossification
NAD
6)
13
It)

6)
VR
VR
VR
VR
NAD
Rib
Rib
Supernumerary
(
full
13
bil)
Supernumerary
(
full
13
bil)
NAD
DV
DV
Rib
Supernumerary
(
short
13
It)
DV
NAD
Rib
Supernumerary
NAD
(
th13
short
rt
full
It)
DV
NAD
NAD
NAD
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
NAD
DV
DV
DV
DV
DV
DV
DV
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
190
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
111:
100
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
s)
ICATION
35645
1
39.81
Rib
2
38.11
Rib
Sternebra
3
31.85
Rib
4
34.82
Rib
5
35.37
Rib
6
37.95
Rib
7
35.43
8
37.46
Rib
9
32.40
10
37.58
35652
1
47.75
Rib
2
43,95
3
38.44
4
36.79
Rib
5
46.34
Rib
6
46.24
Rib
7
41.90
8
46.21
Rib
9
42.43
Rib
35660
1
48.07
Rib
2
51.62
Rib
3
46.11
Rib
35661
51.89
43.55
35.22
42.12
36.14
24.88
Supernumerary
(
th13
short
rt)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
NAD
Supernumerary
(
th13
full
rt)
NAD
NAD
Supernumerary
(
th13
full
bil)
NAD
NAD
Supernumerary
(
th13
site
It)
Supernumerary
(
th13
short
rt
site
It)
Supernumerary
(
th13
short
rt
full
It)
NAD
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)

Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
rt
short
It
full)
Supernumerary
(
th13
full
bil)

NAD
NAD
NAD
NAD
NAD
NAD
DV
DV
VR
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
191
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
111:
100
mg/
m3
DOE
#/
CLASS
IF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35661
(
Cont.)
7
40.66
8
41.22
9
46.72
10
44.65
11
38.21
35662
1
43.41
2
44.62
3
36.94
4
31.76
5
45.71
6
38.28
7
39.06
8
38.43
9
25.75
10
31.24
11
23.39
Rib
Kidney
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
NAD
NAD
NAD
Supernumerary
(
th13
short
bil)
NAD
Papilla
­
Size
3
(
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
rt
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
It)
NAD
NAD
Supernumerary
(
th13
short
rt
full
It)
Supernumerary
(
th13
full
bil)
DV
VR
DV
DV
DV
DV
DV
DV
DV
DV
DV
192
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
IV:
300
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.

35571
1
45­
76
2
47.34
3
42.94
4
47.61
5
49.05
6
47.21
7
48.67
8
45.39
9
45.28
10
45.93
35577
1
40.07
2
34.80
3
39.24
4
35.32
5
39.01
6
38.75
7
38.61
8
35.41
9
37.30
35583
1
40.04
2
40.44
3
48.24
4
32.64
5
44.54
6
49.34
CLASSIF­
STRUCTURE
FINDING(
S)
ICATION
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
NAD
NAD
Rib
Supernumerary
(
th13
short
It
full
rt)
DV
Rib
Rib
Supernumerary
Supernumerary
th13
full
bil)
th13
full
bill
DV
DV
Rib
Rib
Supernumerary
Supernumerary
th13
full
bil)
th13
full
bil)
DV
DV
Rib
Supernumerary
th13
full
It)
DV
NAD
Rib
Supernumerary
(
th13
full
bill
DV
Rib
Supernumerary
(
th13
short
It
full
rt)
DV
Rib
Rib
Rib
Supernumerary
(
th13
full
Supernumerary
(
th13
full
Supernumerary
(
th13
site
rt
full
It)
NAD
DV
DV
DV
NAD
Rib
Supernumerary
(
th13
full
DV
Kidney
Small
Papilla
­
Size
2
(
bilateral)
VR
Rib
Sternebra
Supernumerary
(
th13
full
Fused
(
4­
5)
DV
DV
Rib
Supernumerary
(
th13
full
DV
Sternebra
Rib
Retarded
Ossification,(
6
Supernumerary
(
th13
full
VR
DV
Rib
Rib
Sternebra
Supernumerary
(
th13
full
Supernumerary
(
th13
full
Retarded
Ossification
(
6
DV
DV
VR
Rib
Supernumerary
(
th13
full
DV
193
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
7
8
9
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
IV:
300
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35583
7
8
(
Cont.)
48.43
45.29
Rib
Sternebra
Rib
Supernumerary
(
th13
It
short
rt
full)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
DV
VR
DV
35586
49.09
NAD
41.79
NAD
34.84
NAD
37.38
NAD
30.20
NAD
35.16
NAD
46.32
NAD
39.73
NAD
10
38.06
30.17
Rib
Skull
Supernumerary
(
th13
short
It
full,
rt)
Retarded
Ossification
(
7
It)
DV
VR
35591
43.40
41.38
36.46
Rib
Rib
Supernumerary
(
th13
full
It)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
33.97
29.91
25.83
31.87
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
DV
32.78
43.07
Rib
Rib
Supernumerary
(
th13
full
It)
Supernumerary
DV
10
11
42.71
34.42
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
It
site
rt)
DV
DV
12
32.59
Rib
Supernumerary
(
th13
full
bil)
(
th13
full
It
site
rt)
DV
DV
35592
1
2
53.59
38.62
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
194
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
1
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
IV:
300
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.
STRUCTURE
35592
(
Cont.)
3
47.86
Rib
4
48.41
Rib
5
47.84
Rib
6
45.53
Rib
7
39.53
Rib
8
42.27
9
40.05
Rib
10
37.56
11
45.04
Rib
35607
1
47.67
Rib
2
45.22
Rib
3
43.67
Rib
4
42.35
Rib
5
37.79
Rib
Sternebra
6
49.38
Rib
7
46.19
Rib
8
40.70
Rib
9
40.16
10
36.07
Rib
11
29.88
Rib
12
33.49
Rib
13
33.23
Rib
35608
1
42.23
Sternebra
2
36.76
Rib
3
34.37
Rib
4
36.56
Rib
5
34.51
Rib
6
31.11
Rib
7
40.06
Rib
CLASSIF­
FINDING(
S)

Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
NAD
Supernumerary
(
th13
full
bil)
NAD
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
NAD
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
short
It
full
,
rt)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)

Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
rt
short)
Supernumerary
(
th13
full
It
short
rt)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
ICATION
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
VR
DV
DV
DV
DV
DV
DV
DV
VR
DV
DV
DV
DV
DV
DV
195
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
7
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
IV:
300
mg/
m3
DOE
#/
CLASS1F­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35608
(
Cont.)
8
32.58
Rib
9
38.12
Rib
10
36.89
11
25.30
12
27.01
Rib
35618
1
59.51
Rib
2
51.47
Rib
3
41.21
4
52.26
5
45.90
Rib
35620
35.80
44.27
34.07
Rib
32.40
28.00
31.36
44.61
46.24
41.40
Rib
35625
49.94
49.48
43.54
Rib
41.04
43.28
Rib
46.67
Kidney
46.02
35626
1
39.07
2
35.40
3
38.53
Supernumerary
(
th13
short
rt
full
It)
DV
Supernumerary
(
th13
full
bil)
DV
NAD
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
It)
DV
NAD
NAD
Supernumerary
(
th13
short
It)
DV
NAD
NAD
Supernumerary
(
th13
short
bil)
DV
NAD
NAD
NAD
NAD
NAD
Supernumerary
(
th13
short
bil)
DV
NAD
NAD
Supernumerary
(
th13
short
bil)
DV
NAD
Supernumerary
(
th13
short
bil)
DV
Papilla
­
Size
3
(
bil)
VR
NAD
NAD
NAD
NAD
196
1
2
3
4
5
6
7
8
9
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
I"

INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
­

GROUP
IV:
300
mg/
m3
DOE
#/
CLASS1F­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35626
(
Cont.)
4
38.37
5
37.25
6
37.30
Rib
Sternebra
7
40.55
8
35.11
Rib
9
35.01
35631
46.69
45.34
44.55
Rib
42.24
Rib
43.99
Rib
40.31
Rib
46.06
Rib
37.64
41.37
Skull
35635
1
40.23
Rib
Sternebra
2
36.16
Rib
3
36.35
Rib
Sternebra
4
42.78
Rib
Sternebra
5
40.03
6
42.21
Rib
Sternebra
7
38.72
8
38.74
Rib
Sternebra
NAD
NAD
Supernumerary
(
th13
full
bil)
DV
Retarded
Ossification
(
6)
VR
NAD
Supernumerary
(
th13
short
rt)
DV
NAD
NAD
NAD
supernumerary
(
th13
short
bil)
DV
Subernumerar;
(
th13
short
rt)
Supernumerary
(
th13
short
rt)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
NAD
Retarded
Ossification
(
hyoid
bent
bil)

Supernumerary
(
th13
short
It
full
rt)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
Supernumerary
(
th13
short
It
full
rt)
Retarded
Ossification
(
6)
NAD
Supernumerary
(
th13
full
It
short
rt)
Retarded
Ossification
(
6)
NAD
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
DV
DV
nv
DV
VR
DV
VR
DV
DV
VR
DV
VR
DV
VR
DV
VR
1
2
3
4
5
6
7
1
2
3
4
5
6
7
8
9
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
IV:
300
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35635
(
Cont.)
9
42.98
Sternebra
Retarded
Ossification
(
6)
VR
35637
1
2
45.54
37.90
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
DV
3
42.40
NAD
(
th13
short
rt
full
It)
DV
4
48.23
NAD
5
6
7
8
9
40.94
33.80
41.21
35.76
43.07
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
DV
DV
35640
51.24
NAD
51.20
NAD
46.24
40.00
45.75
Rib
Rib
Supernumerary
(
th13
short
bill
Supernumerary
(
th13
full
bil)
NAD
DV
DV
46.28
48.84
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
35650
50.88
48.61
46.88
47.16
43.33
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
DV
DV
43.81
32.98
Rib
Supernumerary
(
th13
full
bil)
NAD
DV
40.83
48.48
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
35653
1
2
27.44
40.24
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
198
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
7
8
9
Dimethyl
Glutarate
(
DMG):
Inhalation
DevelopmentalToxicity
Study
in
Rabbits
DuPont­
10657
i
**
*
"
I
iy
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
IV:
300
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35653
3
4
(
Cont.)
46.15
31.43
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
5a
37.27
NAD
ga
7
29.70
34.97
NAD
NAD
8
42.88
Rib
Supernumerary
(
th13
full
bil)
DV
9
39.98
NAD
10
41.17
Rib
Supernumerary
(
th13
full
bil)
DV
11
41.35
Rib
Supernumerary
(
th13
full
bil)
DV
12
31.50
Rib
Supernumerary
(
th13
full
bil)
DV
13
25.42
Rib
Supernumerary
(
th13
full
bill
DV
Pelvis
Retarded
Ossification
(
pubis
bil)
VR
35663
46.68
Rib
Supernumerary
(
thl3
short
It)
DV
39.50
NAD
39.09
Rib
Supernumerary
(
th13
short
It)
DV
33.60
NAD
41.70
NAD
42.98
NAD
38.55
NAD
43.40
NAD
38.11
NAD
35672
35.57
NAD
33.70
Rib
Supernumerary
(
th13
full
bil)
DV
32.98
NAD
30.59
NAD
28.48
Rib
Supernumerary
(
th13
full
bil)
DV
33.31
Rib
Supernumerary
(
th13
full
bil)
DV
33.45
36.12
26.81
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
rt)
Supernumerary
(
th13
full
bil)
DV
DV
DV
a
No
skeletal
examination;
fetus
was
inadvertently
disarticulated
during
skeletal
processing.

199
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
IV:
300
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING
(
S)
ICATION
35676
45.31
Rib
44.66
40.60
Rib
44.75
Rib
40.47
Rib
43.40
Rib
Supernumerary
(
th13
full
bil)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bil)
DV
200
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
v:
1000
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.

35569
1
41.72
2
35.67
3
41.32
4
33.22
5
32.95
6
39.33
7
35.02
8
37.26
35581
1
40.20
2
29.85
3
35.57
4
32.47
5
35.74
6
31.87
7
42.79
8
39.69
9
37.33
35598
1
39.02
2
34.98
3
36.33
4
36.05
5
41.71
STRUCTURE
Rib
Rib
Sternebra
Sternebra
Sternebra
Sternebra
Rib
Rib
Sternebra
Rib
Vertebra
Heart
&/
or
Greater
Ves
sels
Heart
&/
or
Greater
Vesse1s
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
CLASSIF­
FINDING(
SI
ICATION
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
full
bill
DV
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
short
rt
full
It)
DV
Supernumerary
(
th13
full
It)
DV
Retarded
Ossification
(
6)
VR
Supernumerary
(
th13
full
bil)
DV
Hemi
(
th6,8)
M
Misshapen
Heart
M
Septal
Defect
(
double
outlet)
M
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
full
It)
DV
Supernumerary
(
th13
full
bil)
DV
Supernumerary
(
th13
short
It
full
rt)
DV
Supernumerary
(
th13
short
bil)
DV
Supernumerary
(
th13
short
It
full
rt)
DV
Supernumerary
(
th13
full
bill
DV
Supernumerary
(
th13
short
rt)
DV
NAD
Supernumerary
(
th13
full
bil)
DV
NAD
NAD
NAD
201
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTEmTIONS
GROUP
v:
1000
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35598
(
Cont.)
6
30.95
7
37.90
8
39.64
35602
1
33.98
2
31.12
3
32.60
4
35.50
5
34.33
6
32.22
7
28.60
8
27.36
9
29.05
35605
1
49.44
2
43.75
3
41.13
4
50.66
5
48.01
6
47.03
35613
1
38.93
2
29.09
Rib
Rib
Rib
Rib
Pelvis
Rib
Rib
Rib
Pelvis
Rib
Pelvis
Rib
Pelvis
Rib
Sternebra
Rib
Rib
Rib
Rib
Rib
Rib
Rib
NAD
NAD
NAD
Supernumerary
th13
full
bil)
Supernumerary
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
rt
full
It)
Retarded
Ossification
(
pubis
bil)
Supernumerary
(
th13
short
rt
full
It)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
pubis
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
pubis
bi1)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
pubisbi1)

Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)

Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
DV
DV
VR
DV
DV
DV
VR
DV
VR
DV
VR
DV
VR
DV
DV
DV
DV
DV
DV
DV
202
1
2
3
4
5
6
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
v:
1000
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35613
(
Cont.)
Pelvis
Retarded
Ossification
3
4
5
6
7
28.97
29.25
34.63
29.38
25.86
Rib
Rib
Kidney
Rib
Sternebra
Rib
Sternebra
Rib
Sternebra
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Papilla
­
Size
3
(
bill
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bill
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Fused
(
4­
5)
(
pubisbil)
VR
DV
DV
VR
DV
VR
DV
VR
DV
DV
8
25.03
Sternebra
Rib
Pelvis
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
VR
DV
9
29.09
Rib
Supernumerary
(
th13
full
bil)
(
pubis
bi1)
VR
DV
35619
35.33
42.02
Sternebra
Retarded
Ossification
(
6)
NAD
VR
38.75
NAD
39­
41
NAD
39.36
25.53
Sternebra
Sternebra
Pelvis
Retarded
Ossification
(
6)
Fused
(
5­
6)
Retarded
Ossification
VR
DV
Skull
Retarded
Ossification
(
pubis
bi1)
VR
7
8
39.78
45.62
Sternebra
Sternebra
Retarded
Ossification
(
6)
Retarded
Ossification
(
6)
(
1;
2­
3,6­
8bil)
VR
VR
VR
9
10
11
36.45
36.30
42.64
Sternebra
Sternebra
Retarded
Ossification
(
6)
Retarded
Ossification,(
6)
NAD
VR
VR
35623
1
44.30
Rib
Sternebra
Supernumerary
(
th13
short
It)
Retarded
Ossification
(
6)
DV
VR
203
1
2
3
4
5
6
7
8
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
v:
1000
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.

35623
(
Cont.)
2
43.99
3
44.36
4
38.17
35629
44.53
37.97
41.09
34.40
28.18
34.37
37.96
33.44
35636
1
52.37
35638
1
41.89
2
37.86
31.44
35.93
31.57
38.34
32.17
38.04
35.21
35648
1
39.79
2
39.28
STRUCTURE
Rib
Sternebra
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
Rib
CLASS1F­
FINDING(
S)
ICATION
Supernumerary
(
th13
short
rt
full
It)
Retarded
Ossification
(
6)
NAD
Supernumerary
(
th13
short
rt
full
It)

Supernumerary
(
th13
full
bil)
NAD
NAD
Supernumerary
(
th13
full
bil)
NAD
NAD
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
short
It
full
rt)

Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
rt
full
It)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bill
Supernumerary
(
th13
full
bil)

Supernumerary
(
th13
full
It)
Supernumerary
(
th13
full
bil)
DV
VR
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
DV
204
1
2
3
4
5
6
7
8
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
v:
1000
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICATION
35648
3
4
5
6
7
(
Cont.)
36.70
45.69
40.27
31.44
42.08
Rib
Rib
Rib
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
DV
DV
DV
DV
DV
35651
1
47.88
Rib
Sternebra
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
DV
VR
2
55.33
Rib
Supernumerary
(
th13
full
bill
DV
3
49.96
Sternebra
Rib
Sternebra
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
­(
6)
VR
DV
VR
35655
41.42
44.89
Rib
Supernumerary
(
th13
short
rt)
NAD
DV
39.90
NAD
45.91
49.28
46.02
Rib
Rib
Supernumerary
(
site
13
It)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
40.59
NAD
38.43
NAD
35664
1
37.91
NAD
2
3
41.05
39.65
Rib
Supernumerary
NAD
(
th13
short
rt
full
It)
DV
4
41.34
NAD
5
6
7
37.93
39.13
36.40
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
NAD
DV
DV
8
9
32.16
36.55
Rib
Supernumerary
(
th13
site
It)
NAD
DV
205
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
v:
1000
mg/
m3
DOE
#/
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
CLASSIF­
ICATION
35665
1
2
3
4
5
42.26
40.39
39.25
39.08
38.69
Rib
Rib
Rib
Sternebra
Rib
Rib
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
short
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Supernumerary
DV
DV
DV
VR
DV
6
7
8
9
35.84
36.98
30.84
37.37
Sternebra
Rib
Sternebra
Rib
Rib
Rib
Skull
(
th13
short
rt
full
It)
Retarded
Ossification
(
6)
Supernumerary
(
th13
short
It)
Retarded
Ossification
(
6)
Supernumerary
(
th13
short
bil)
Supernumerary
(
th13
short
rt)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
DV
VR
DV
VR
DV
DV
DV
Sternebra
Retarded
Ossification
(
6)
(
1,12;
2
bill
VR
VR
35668
1
2
47.47
39.63
Rib
Rib
Sternebra
Supernumerary
(
th13
short
bill
Supernumerary
(
th13
short
rt)
Retarded
Ossification
(
6)
DV
DV
VR
38.71
34.86
Rib
Supernumerary
(
13
full
bill
NAD
DV
40.86
35.82
Rib
Rib
Vertebra
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
DV
DV
7
8
9
10
11
12
37.32
39.37
38.54
32.92
31.84
29.07
Rib
Rib
Rib
Rib
Sternebra
Rib
Sternebra
Rib
Sternebra
supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
Supernumerary
(
th13
rt
short
It
full)
Retarded
Ossification
(
6)
Supernumerary
(
th13
full
bil)
Retarded
Ossification
(
6)
(
cen
ce7)
VR
DV
DV
DV
DV
VR
DV
VR
DV
VR
Dimethyl
Glutarate
(
DMG):
Inhalation
Developmental
Toxicity
Study
in
Rabbits
DuPont­
10657
INDIVIDUAL
FETAL
WEIGHTS
AND
ALTERATIONS
GROUP
v:
1000
mg/
m3
DOE
#/
CLASSIF­
FETUS
#
FETUS
WT.
STRUCTURE
FINDING(
S)
ICAT1ON
35673
1
41.77
Rib
Supernumerary
(
th13
full
bill
DV
2
58.02
Rib
Supernumerary
(
th13
full
bil)
DV
3
50.22
Rib
Supernumerary
(
th13
full
bil)
DV
207
