UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

			OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

 																				September 17, 2007

MEMORANDUM:

Subject:	Revised Occupational and Residential Exposure Chapter for
Copper 8-Quinolinolate (Oxine-Copper) in Support of the Reregistration
Eligibility Decision (RED) Document for the Copper Salts (RED Case
4026). 

To:		Kathryn Jakob, Chemical Review Manager

		Regulatory Management Branch II

Antimicrobials Division (7510P)

			AND

		Timothy McMahon, PhD., Risk Assessor

		Senior Toxicologist

		Antimicrobials Division (7510P)

From: 		Doreen Aviado, Biologist

		Team Two

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Thru:		Nader Elkassabany, Team Leader

		Team Two

		Risk Assessment and Science Support Branch (RASSB)

		Antimicrobials Division (7510P)

		Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

DP Barcode: 	D337781

							CAS

Chemical Name:			PC Code:	Registry No.: 	Common Names:

Copper, bis(8-quinolinolato-N1,O8)-,	024002		10380-28-6	Copper
8-Quinolinolate;										Oxine-Copper; Oxine-Cu; 									Copper-8

Attached is the revised Occupational and Residential Exposure Chapter
for Copper 8-Quinolinolate based on text edits for aggregate risk
assessment in support of the Copper Salts RED (RED Case 4026). 



OCCUPATIONAL AND RESIDENTIAL EXPOSURE CHAPTER FOR

COPPER 8-QUINOLINOLATE (OXINE-COPPER) IN SUPPORT OF 

THE REREGISTRATION ELIGIBILITY DECISION (RED) DOCUMENT 

FOR THE COPPER SALTS

REREGISTRATION CASE 4026

September 17, 2007

Antimicrobials Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

TABLE OF CONTENTS

 TOC \f 

EXECUTIVE SUMMARY	3

1.0 INTRODUCTION	10

1.1 Purpose	10

1.2 Criteria for Conducting Exposure Assessments	10

1.3 Chemical Identification	12

1.4 Physical/Chemical Properties	13

2.0 USE INFORMATION	14

2.1 Formulation Types and Percent Active Ingredient	14

2.2 Summary of Use Patterns and Formulations	14

3.0 SUMMARY OF TOXICITY DATA	16

3.1 Acute Toxicity	16

3.2 Summary of Toxicity Endpoints	17

3.3 FQPA Considerations	19

4.0 RESIDENTIAL EXPOSURE ASSESSMENT	19

4.1 Summary of Registered Uses	19

4.2 Dietary Exposure	20

4.3 Drinking Water Exposure	20

4.4 Residential Exposure	20

4.4.1 Residential Handler Exposures	21

4.4.2 Residential Post-application Exposure	24

4.4.2.1 Outdoor Hard Surfaces/Remedial Fungistatic Surface Treatments	24

4.4.2.2 Treated Textiles	28

4.4.2.3 Treated Lumber	32

4.4.3 Data Limitations/Uncertainties	37

5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION	38

5.1 Acute and Chronic Dietary Aggregate Risk	39

5.2 Short and Intermediate Term Aggregate Exposure and Risks	39

6.0 OCCUPATIONAL EXPOSURE ASSESSMENT	40

6.1 Summary of Registered Uses	40

6.2 Occupational Handler Exposures	44

6.3 Occupational Post-application Exposures	47

   6.4 Wood Preservation	50

  HYPERLINK \l "_Toc120347553"  6.4.1 Non-Pressure Treatment Scenarios
(Handler and Post-application)	50

   HYPERLINK \l "_Toc120347554"  6.4.1.1 Scenarios Assessed by Worker
Function	   PAGEREF _Toc120347554 \h  50  

  HYPERLINK \l "_Toc120347559"  6.4.2 Pressure Treatment Scenarios
(Handler and Post-Application)	  PAGEREF _Toc120347559 \h  57  

6.5 Data Limitations/Uncertainties	60

7.0 REFERENCES	61

APPENDIX A: Summary of CMA and PHED Data	63

APPENDIX B: Calculation of DDAC Exposure Values	65

 

EXECUTIVE SUMMARY 

		This document is the Occupational and Residential Exposure Chapter for
the active ingredient, Copper, bis (8-quinolinolato-N1,O8)-, commonly
referred to as Copper 8-Quinolinolate or Oxine-Copper, as part of the
Reregistration Eligibility Decision (RED) document for the Copper Salts
(RED Case 4026).  It addresses the potential risks to humans that result
from the antimicrobial uses of products containing this chemical in
occupational and residential settings. 

		The Office of Pesticide Programs (OPP), Special Review and
Reregistration Division (SRRD) issued a drafted preliminary risk
assessment for a comprehensive RED on Copper compounds which was posted
to the Agency docket January 25, 2006 for public comment (EPA’s
Pesticide Docket EPA-HQ-OPP-2005-0558).  This Coppers RED included a
qualitative human health assessment of copper-containing pesticides from
four copper cases, including: Copper II Compounds (0649), Copper
Sulfates (0636), Copper and Oxides (4025), Copper Salts (4026) and
certain other coppers.  SRRD had determined that the Cupric ion is the
component of toxicological interest, regardless of the source of Copper.
 Since Copper (Cu) is a naturally occurring metal efficiently regulated
in the human system, and due to the lack of systemic toxicity associated
with Copper exposure, no toxicological endpoints were selected for human
health risk assessment purposes; therefore only a qualitative assessment
was conducted (USEPA, 2006).

		The Antimicrobials Division (AD) determined however that a separate
RED document would be developed for the copper salt, Copper
8-Quinolinolate, since the pesticide is used solely as an antimicrobial
and all registered products are under the regulatory purview of AD. 
Also, endpoints of concern have been identified from the available
toxicology database for Oxine-Copper, enabling AD to conduct a formal
risk assessment. 

	Copper 8-Quinolinolate (a.k.a. Oxine-Copper) is an organometallic
compound registered as an antimicrobial fungicide for control of decay,
sapstain, mold, rot, mildew and certain wood-boring insects (e.g.,
termites and powder-post beetles) in various preservative applications. 
It is approved for use primarily in industrial/commercial wood
preservation (Use Site Category X -wood preservatives) for non-pressure
and pressure treatments to control sapstain in freshly cut or debarked
lumber, and for protection against mold and decay in unfinished wood and
various wood products.  It may also be used as a protective wood coating
and water-repellent when applied to new and aged wood.  It is intended
for mainly exterior above-ground wood use applications and certain
interior structural wood construction, including: millwork,
sills/baseboards, siding, wooden components of decks, playsets, fences,
outdoor furniture, shingles, structural lumber, plywood, composites and
interior boat holds. Treated wood materials may be used in contact with
fruit, vegetables and other foodstuffs (indirect food contact) in areas
such as greenhouses for greenhouse items, produce picking
boxes/containers, mushroom trays and vegetable stakes.  

Oxine-Copper is also used industrially for materials preservation (Use
Site Category VII - materials preservatives ) as a fungistatic
dispersion incorporated into manufactured goods including:
paper/paperboard, adhesives, paints and cellulose-based
cordage/textiles. Copper 8-quinolinolate is additionally used to control
mold and mildew on industrial textiles (mainly military-issued or
government-specified) such as cloth and webbing used in military
tentage, tarps, canvas, burlap, rope, leather and nets (non-aquatic uses
only).  It may be used as a water-repellent coating for textiles as
well.  Oxine-Copper is used on hard and porous environmental contact
surfaces to remediate mold, mildew, and fungal decay (e.g., outdoor
painted surfaces, tile, brick/concrete, glass, metal, plastic, leather,
wood, and asphalt shingles). 

	The chemical is also used commercially in food handling settings as a
surface disinfectant to control potato ring rot in planters, seed
handling equipment, seed cutters, storage areas and transportation
equipment such as railroad cars and trucks (Use Site Category II- food
handling/storage establishments, premises, and equipment).

   

Oxine-Copper was first registered with the Agency as a pesticide on
January 5, 1956.  At present there are 27 active registrations for
products containing Copper 8-quinolinolate.  The technical grade active
ingredients (TGAIs) are powder concentrates registered to two companies,
Tanabe U.S.A., Inc. (96% a.i.) and Osmose, Inc. (96% a.i.).  These are
technical chemical source products for use by formulators in
manufacturing wood preservative and materials preservative end-use
products requiring EPA registration.  An additional product, recently
approved in 2006, is registered to James Hardie Building Products, Inc.
(98% a.i.) as a manufacturing use product (MUP) powder concentrate,
specified as an additive to control mold/mildew on cement and pulp/paper
(cellulose fiber) ingredients used to manufacture “backerboard”
(a.k.a. fiber-cement board).  The rest of the 24 registrations are
end-use products (EPs) as soluble concentrates, emulsifiable
concentrates and ready-to use (RTU) formulations.  The formulated
end-use products can range from 0.25% to 34.18% active ingredient.

The durations and routes of exposure evaluated in this assessment
include: short-term (ST ) (1 to 30 days ) and intermediate-term (IT- 30
days to 6 months) dermal route exposures; and, ST/IT and long-term (LT)
(longer than 6 months) inhalation route exposures for occupational
scenarios. A dermal end-point for LT exposure was not selected for
Oxine-Copper. 

Residential (non-occupational) handler scenarios were developed as ST
dermal and ST inhalation exposures. Residential post-application
scenarios included assessing child ST incidental oral and dermal contact
with treated wood, treated articles and environmental surfaces. 

 For the dermal and incidental oral exposure routes, a ST/IT (systemic)
NOAEL of 200 mg/kg/day was used and for inhalation route exposure, a
ST/IT/LT NOAEL of 5 mg/kg/day was selected.  A human dermal absorption
factor was not selected since the dermal endpoint was derived from a
route-specific study. An inhalation absorption factor of 100% was used
(default value, assuming oral and inhalation absorption are equivalent)
since an oral endpoint was selected for determining inhalation exposures
(USEPA, 2006a).

The uncertainty factor or “target” margin of exposure (MOE) for
dermal (occupational/residential) and incidental oral (residential)
route exposure is 100. Whereas, the target MOE is 1000 for inhalation
exposure scenarios for occupational and residential handlers. The Agency
may request a confirmatory inhalation toxicity study in cases where the
inhalation MOEs are below a value of 1,000 since the inhalation endpoint
is based on an oral study.  

		Based on registered use patterns from product labeling on file with
the Agency for Oxine-Copper, it has been determined that exposure to
handlers can occur in a variety of occupational and residential
environments.  Additionally, postapplication exposures are likely to
occur in these settings. The representative scenarios selected by the
Antimicrobials Division (AD) for assessment were evaluated using maximum
application rates as stated on the product labels. 

	To assess the handler risks, AD used surrogate unit exposure data from
the following proprietary sources: the Chemical Manufacturers
Association (CMA) antimicrobial exposure study, the Pesticide Handlers
Exposure Database (PHED), and for non-pressure wood treatments, the
proprietary sapstain study (SIG Task Force # 73154) was used
“Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III)” (Bestari et al., 1999, MRID 455243-04).  Also, the
exposure study sponsored by the American Chemistry Council (2002)
entitled “Assessment of Potential Inhalation and Dermal Exposure
Associated with Pressure Treatment of Wood with Arsenical Wood
Products” (ACC, 2002) was used for occupational pressure treatment
scenarios.  

	Agency standard values and EPA’s Health Effects Division’s (HED)
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments (USEPA, 2000 and 2001), were used to estimate
post-application/bystander exposures. Additionally, certain
chemical-specific wood leaching data on file with the Agency for
Oxine-Copper (MRID 436370-01) was used as a source for estimating
high-end, maximum residue load for child post-application exposure to
treated wood.

Handler Risk Summary

		For the residential handler dermal and inhalation risk assessment, the
MOEs were above the target MOE of 100 for dermal in all scenarios
assessed, and above the target MOE of 1000 for inhalation in most
scenarios except the following:  

Inhalation Exposure

Painting (amateur) treated paint, airless sprayer: ST MOE = 278.

		It should be noted that for MOEs below 1,000 the Agency may request a
confirmatory inhalation toxicity study to refine the potential risks
since the current inhalation endpoint is based on an oral NOAEL.  

		For the occupational handler dermal and inhalation risk assessment,
the MOEs were above the target MOE of 100 for dermal and above the
target MOE of 1000 for inhalation in most scenarios except the
following:

Dermal Exposure 

	The calculated dermal MOEs were all above the target MOE of 100 with
the use of glove PPE. Baseline dermal estimates for workers without
gloves indicated risk concerns for certain scenarios listed below.   

General wood preservative brush applications: ST/IT MOE = 47.

Painting (professional) wood coatings, low pressure sprayer: ST/IT MOE =
35.

Painting (professional) treated paint, airless sprayer: ST/IT MOE = 74.

Paper preservation, liquid pump: ST/IT MOE = 12.

Paint preservation, liquid pour: ST/IT MOE = 14.

Textile preservation, liquid pour: ST/IT MOE = 3.

Inhalation Exposure

	Most inhalation MOEs were above the target MOE of 1000, except for the
scenarios indicated below.  It should be noted that for MOEs below 1,000
the Agency may request a confirmatory inhalation toxicity study to
refine the potential risks since the current inhalation endpoint is
based on an oral NOAEL.  

General wood preservative brush applications: ST/IT/LT MOE = 758.

Paper preservation, liquid pump: ST/IT/LT MOE = 500.

Painting (professional) treated paint, airless sprayer: ST/IT/LT MOE =
83 / 833 (PPE).

Blender/Sprayer Operator (non-pressure sapstain treatment): ST/IT/LT MOE
= 212

Post-application/Bystander Risk Summary

	For the residential postapplication risk assessment, exposures
resulting from materials preservative/wood preservative treatments
yielded MOEs above the respective Agency targets (i.e., ST Dermal/ST
Incidental Oral  MOEs =100; ST Inhalation MOE = 1000) for all scenarios
except for the following:

Dermal Exposure 

Adult/Child dermal contact with treated textiles: ST MOEs = 4 and 67
(adult); 3 and 50 (child) when residue transfer was assumed as 100% and
5% respectively.

	Except for the post-application scenarios assessed for wood
preservatives in Section 6.4, occupational post-application exposures
were not assessed and assumed to be negligible. 	

Aggregate exposure risk summary

Non-dietary short- and intermediate-term aggregate assessments for
adults were not performed for Copper 8-Quinolinolate due to the varying
toxicity endpoints for the oral, dermal and inhalation studies
concerned. These toxicity endpoints were selected from separate studies,
each characterized by different toxicological effects. Therefore,
aggregating non-dietary exposure risks to Oxine-Copper from the use of
products in non-occupational environments was not considered
appropriate.  Also, the episodic nature of likely exposures and the low
probability of co-occurrence also supported this decision.  The majority
of registered products are for industrial/commercial-use and therefore
representative scenarios for residential exposure are limited to adult
handlers painting with wood preservative surface coatings/water
repellents or treated paint products containing Oxine-Copper as an
in-can preservative.  In addition, incidental oral exposure was not
assessed for adults nor were there any intermediate-term scenarios
developed for the dermal and inhalation routes.  

		Potential child post-application exposure is limited to contact with
residues on mainly in-service treated wood and on environmental outdoor
surfaces which may be treated for mold/mildew control by commercial
applicators in residential sites. Textile preservation appears to be
limited to industrial textiles and government-issued (military
specified) treatments for cellulose-based cotton, canvas, tentage/tarps,
cordage and paperboard.

However, due to uncertainties about potential use for treated textiles,
residential scenarios were developed.  For children/toddlers, inhalation
exposure was not assessed and aggregation of short-term incidental oral
and dermal exposures was not performed across routes of exposure as
toxicity endpoints of concern were derived from separate toxicity
studies.  However, it was possible to aggregate exposures within a route
of exposure to the extent reasonable. Thus, aggregation of incidental
oral exposures of children from mouthing of treated textiles with
hand-to-mouth activities and from exposure to treated outdoor hard
surfaces and lumber was performed. The total MOEs for incidental oral
exposure (MOE = 373) and for dermal exposure (MOE = 125) are above the
target MOE of 100 and hence are not of concern. 

		

Data Limitations and Uncertainties:

		There are a number of uncertainties associated with this assessment
and these have been reiterated from Sections 4.4.3 (residential) and 6.3
(occupational) respectively.  The data limitations and uncertainties
associated with the residential handler and postapplication exposure
assessments include the following:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handler Exposure Database (USEPA, 1998) (See Appendix A for summaries of
these data sources). Most of the CMA data are of poor quality,
therefore, AD may request that confirmatory monitoring data be generated
to support the values used in these assessments. 

The quantities handled/treated were estimated based on information from
various sources, including HED’s Standard Operating Procedures (SOPs)
for Residential Exposure Assessments (USEPA 2000, and 2001) and the AD
Draft SOP use table.  In certain cases, no standard values were
available for some scenarios.  Assumptions for these scenarios were
based on AD estimates and could be further refined from input from
registrants. 

The low pressure spray unit exposure data from PHED were used to assess
outdoor applications of wood preservative coatings (exterior of homes). 
As the low pressure spray data are representative of treating low to mid
level range targets (shrubs/greenhouse benches) and the scenario
assessed in this document represents treatments that may also occur
above the waist, the unit exposure value may underestimate exposure to
the head and the upper body.

The methods used to estimate child and adult exposures to treated
textiles are highly conservative and based on approaches from the
Residential SOPs (USEPA 2000, and 2001) for contact with porous treated
surfaces (clothing, mattresses and carpets). Without data on actual
treated textile residues, dissipation or dermal transfer coefficients,
these scenarios have a high degree of uncertainty associated with them.
The registrants input will assist in refining the MOEs and confirming
the Oxine-Copper textile use patterns.    

In this assessment, incidental ingestion and dermal exposures to treated
wood were estimated using surrogate DDAC data (3 (g/cm2).  The degree of
uncertainty (under- or overestimation) associated with using the DDAC
hand residue data for dermal and oral exposure from contacting treated
lumber are unknown.  The amount of residue measured on the test
subjects’ hands is variable and may be influenced by the duration of
exposure, how often wood is contacted, and the degree of contact (i.e.,
do the hand residues from the DDAC study mimic a child’s play activity
on decks and playsets?). In comparison, measured wood retention data
from a chemical-specific leaching study (MRID 436370-01) were used as a
surrogate to represent potential residue load for child contact. The
maximum surface retention (surface deposition) measured from lumber
spray-treated with Oxine-Copper (27 (g/cm2) was used as a conservative,
high-end estimate. There is a high degree of uncertainty associated with
this value as well.

Data are not available to assess the levels of Oxine-Copper in soil
contaminated from Oxine-Copper-treated wood (e.g., above ground
fabricated components of decks or playsets). Because of this data gap,
EPA was not able to estimate residential post-application dermal and
incidental oral ingestion exposure to soil contaminated with
Oxine-Copper residues.  It is assumed that any soil residues attributed
to weathering of in-service wood (playsets) will remain near these
structures for potential child exposure. [Note: Soil migration study
data (MRIDs 429255-03, 429255-04) on file with the Agency for
Oxine-Copper indicate that between 88-90% of the applied active remained
in 0-6 cm of the tested soil columns, indicating limited leaching and
migration from soil matrices (USEPA, 2006c).]

	The data limitations and uncertainties associated with the occupational
handler and postapplication exposure assessments include:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handlers Exposure Database (USEPA, 1998) (See Appendix A for summaries
of these data sources).   Since the CMA data are of poor quality, the
Agency may request that confirmatory data be submitted in order to
support the occupational scenarios assessed in this document.

The low pressure spray unit exposure data from PHED were used to assess
both outdoor environmental surface treatments (materials preservative)
and applications of wood coatings/water repellents (wood preservatives).
 As the low pressure spray data are representative of treating low to
mid level range targets (shrubs/greenhouse benches) and the scenarios
assessed in this document represents treatments that may also occur
above the waist, the unit exposure value may underestimate exposure to
the head and the upper body.

For the wood preservative pressure treatment scenarios, surrogate CCA
exposure data were used for lack of chemical-specific exposure data for
this use pattern. For the wood preservative non-pressure treatment
scenarios, surrogate DDAC exposure data were used for the lack of
chemical-specific exposure data.  Limitations and uncertainties
associated with the use of these data include:

The assumption was made that exposure patterns for workers at treatment
facilities using CCA and DDAC would be similar to exposure patterns for
workers at treatment facilities using Oxine-Copper, and therefore the
exposures could be used as surrogate data for workers that treat wood
with Oxine-Copper based formulations.

For environmental modeling, it was assumed that the leaching process
from wood treated with Oxine-Copper would be similar to that of CCA and
DDAC. However, due to the lack of robust data for Oxine-Copper -treated
wood, it is not possible to verify this assumption. 

The quantities handled/treated were estimated based on information from
various sources, including Agency standard assumptions, HED’s Standard
Operating Procedures (SOPs) for Residential Exposure Assessments (USEPA,
2000 and 2001), and professional judgment based on Agency understanding
of industrial practices.  In certain cases, no standard values were
available for some scenarios.  Assumptions for these scenarios were
based on AD estimates and could be further refined with input from
registrants.  

1.0	 INTRODUCTION

		1.1	Purpose 

		In this document, the Antimicrobials Division (AD) presents the
results of its review of the potential human health effects of
occupational and residential exposure to Oxine-Copper. This information
is for use in EPA's development of the stand alone assessment for the
copper salt, Copper 8-Quinolinolate, as part of the Reregistration
Eligibility Decision document (RED) for Copper Salts (Case 4026).  

		The Office of Pesticide Programs (OPP), Special Review and
Reregistration Division (SRRD) issued a drafted preliminary risk
assessment for a comprehensive RED on Copper compounds which was posted
to the Agency docket January 25, 2006 for public comment (EPA’s
Pesticide Docket EPA-HQ-OPP-2005-0558).  This Coppers RED included a
qualitative human health assessment of copper-containing pesticides from
four copper cases, including: Copper II Compounds (0649), Copper
Sulfates (0636), Copper and Oxides (4025), Copper Salts (4026) and
certain other coppers.  SRRD had determined that the Cupric ion is the
component of toxicological interest, regardless of the source of Copper.
 Since Copper (Cu) is a naturally occurring metal efficiently regulated
in the human system, and due to the lack of systemic toxicity associated
with Copper exposure, no toxicological endpoints were selected for human
health risk assessment purposes; therefore only a qualitative assessment
was conducted (USEPA, 2006).

		The Antimicrobials Division (AD) determined however that a separate
RED document would be developed for the copper salt, Copper
8-Quinolinolate, since the pesticide is used solely as an antimicrobial
and all registered products are under the regulatory purview of AD. 
Also, endpoints of concern have been identified from the available
toxicology database for Oxine-Copper, enabling AD to conduct a formal
risk assessment. 

		1.2	Criteria for Conducting Exposure Assessments

		An occupational and/or residential exposure assessment is required for
an active ingredient if (1) certain toxicological criteria are triggered
and (2) there is potential exposure to handlers (mixers, loaders,
applicators, etc.) during use or to persons entering treated sites after
application is complete.  For Copper 8-Quinolinolate (Oxine-Copper),
both criteria are met.

In this document, scenarios were assessed by using unit exposure data to
estimate occupational and residential handlers’ exposures. Unit
exposures are estimates of the amount of exposure to an active
ingredient a handler receives while performing various handler tasks and
are expressed in terms of micrograms or milligrams (1mg = 1,000 µg) of
active ingredient per pounds of active ingredient handled.  A series of
unit exposures have been developed that are unique for each scenario
typically considered in assessments (i.e., there are different unit
exposures for different types of application equipment, job functions,
and levels of protection).  The unit exposure concept has been
established in the scientific literature and also through various
exposure monitoring guidelines published by the USEPA and international
organizations such as Health Canada and OECD (Organization for Economic
Cooperation and Development).

Using surrogate unit exposure data, maximum application rates from
labels, and EPA estimates of daily amount handled, exposures and risks
to handlers were assessed.  The exposure/risks were calculated using the
following equations:

Daily Exposure: Daily dermal or inhalation handler exposures are
estimated for each applicable handler task with the application rate,
quantity treated/handled in a day, and the applicable dermal or
inhalation unit exposure using the following formula:

Daily Exposure:	E = UE x AR x AT						(Eq. 1)

Where:  

E	=	Amount (mg or (g ai/day) deposited on the surface of the skin that
is available for dermal absorption or amount inhaled that is available
for inhalation absorption;

UE	=	Unit exposure value (mg ai/lb ai) derived from August 1998 PHED
data or from 1992 CMA data;

AR	=	Maximum application rate based on a logical unit treatment, such as
acres (A), square feet (sq. ft.), gallons (gal), or cubic feet (cu. ft).
Maximum values are generally used (lb ai/A, lb ai/sq ft, lb ai/gal, lb
ai/cu ft); and

AT 	=	Normalized application area based on a logical unit treatment such
as acres (A/day), square feet  (sq ft/day), gallons (gal/day), or cubic
feet (cu ft/day).

Daily Dose: The daily dermal or inhalation dose is calculated by
normalizing the daily exposure by body weight and adjusting, if
necessary, with an appropriate absorption factor.  An oral endpoint was
selected for inhalation exposures of all durations; therefore, an
absorption factor of 100% was used (default value, assuming oral and
inhalation absorption are equivalent).  A dermal absorption factor was
not necessary for the short-term and intermediate-term exposures because
the endpoint is based on a dermal study.  Daily dose was calculated
using the following formula:

Daily Dose:	ADD = E x ABS							(Eq. 2)

			   BW						

Where:

ADD 		= 	Absorbed dose received from exposure to a chemical in a given
scenario (mg active ingredient/kg body weight/day);

E 		=	Amount (mg ai/day) deposited on the surface of the skin that is
available for dermal absorption or amount inhaled that is available for
inhalation absorption;

ABS 		= 	A measure of the amount of chemical that crosses a biological
boundary such as lungs (% of the total available absorbed); and

BW		= 	Body weight determined to represent the population of interest in
a risk assessment (kg).

Margins of Exposure:  Non-cancer inhalation and dermal risks for each
applicable handler scenario are calculated using a Margin of Exposure
(MOE), which is a ratio of the daily dose to the toxicological endpoint
of concern.

Margins of Exposure:	MOE = NOAEL or LOAEL					(Eq. 3)

					ADD

Where:

MOE 			= 	Margin of exposure, value used to represent risk or how close
a chemical exposure is to being a concern (unitless);

NOAEL or LOAEL	= 	Dose level in a toxicity study, where no observed
adverse effects (NOAEL) or where the lowest observed adverse effects
(LOAEL) occurred in the study; and

ADD 			= 	Average daily dose or the absorbed dose received from exposure
to a chemical in a given scenario (mg ai/kg body weight/day).

	In addition to the target MOEs from Table 3.2 that were used for this
assessment, a series of assumptions and exposure factors served as the
basis for completing the handler risk assessment. Each general
assumption and factor for both residential and occupational assessments
is detailed below.  Assumptions specific to the use site category are
listed in each separate section of this document.  The general
assumptions and factors include:

The copper salt, Copper 8-Quinolinolate, is a broad spectrum fungicide
predominantly used as a wood preservative, a materials preservative, and
to a lesser degree as an environmental surface treatment and a
disinfectant against potato ring rot. As such, AD has patterned this
risk assessment on a series of likely scenarios for use sites believed
to be representative of the vast majority of Oxine-Copper use patterns.

Based on the adverse effects for the endpoints, the average body weight
of 70 kg was used for an adult (and 15 kg for children in the
post-application assessment) as appropriate to complete the non-cancer
risk assessment.  

Exposure factors used to calculate daily exposures to handlers were
based on applicable data, if available.  When appropriate data were
lacking, values from a scenario deemed similar were used. 

The maximum application rates allowed by product labeling were assumed. 


		1.3	Chemical Identification

	Copper 8-Quinolinolate is a coordination compound (i.e., a 1:2
coordination complex) between copper and the organic ligand
8-hydroxyquinoline.  Table 1.1 shows chemical identification information
for the Oxine-Copper technical grade active ingredient (TGAI). 

 



Chemical Name	

Copper, bis (8-quinolinolato-N1,O8)-	



Common Name	

Copper 8-Quinolinolate/ Oxine-Copper

Chemical Code	024002	

CAS Number	

10380-28-6

Molecular Formula	C18H12CuN2O2





		1.4	Physical/Chemical Properties

		Table 1.2 shows physical/chemical characteristics that have been
reported for Oxine-Copper.  The chemical is stable under normal
conditions and considered non-volatile. Due to the low solubility
properties of the TGAI in water and solvents, formulated end-use
products contain ingredients which provide solubilized forms of
Oxine-Copper for use in both water-, oil- and solvent-borne preservative
treatment solutions.

Table 1.2.  Physical/Chemical Properties of Oxine-Copper TGAI



Parameter	

Copper 8-Quinolinolate

Molecular Weight	                                                    
351.851



Color/Odor	

Olive Green/Odorless (slightly phenolic)



Physical State	

Crystalline powder



Specific Gravity	

1.63 g/ml

Stability	

Stable under normal conditions. Stable under UV irradiation. It is not
flammable, nor oxidizing.  



Melting Point	

270 o C (decomposes below MP)



Boiling Point	

Not determined



Water Solubility	

0.7 mg/L at 25 o C (Insoluble)



Solvent Solubility	

Insoluble in ethanol and common organic solvents (slightly soluble in
pyridine)

Kow	3.14

Vapor Pressure (VP)	Assumed to be non-volatile.  Cannot be calculated
even at 270 o C *

* (EPISuite Program estimated the VP of copper-8 as: 6.3 x 10-12  mm Hg)
 



Source: Certain data presented in Tables 1.1 and 1.2 were taken from an
October 27, 2006 Review Memorandum, “Product Chemistry Science Chapter
for Copper-8 Quinolinolate or Copper-Oxine” from A. Najm Shamim, PhD.,
	Chemist, AD.

2.0	 USE INFORMATION

		2.1	 Formulation Types and Percent Active Ingredient

	The twenty-seven (27) products containing Copper 8-Quinolinolate active
ingredient (a.i) are registered as either industrial-use technical
chemical source products or formulated end-use products for
industrial/commercial and residential use as fungicidal preservatives.  
Currently, there are three (3) registered manufacturing-use products
(MUPs) in the form of powder concentrates as technical grade active
ingredient (TGAI) and formulator-use chemical source products for
manufacturing pesticide end-use products (EPs).  The twenty-four (24)
formulated EPs containing Oxine-Copper are soluble concentrates,
emulsifiable concentrates and  ready-to-use (RTU) solutions.
Concentrations of Oxine-Copper in the MUPs are from 96% to 98%.  The
remaining EPs contain between 0.25% to 34.18% active ingredient.  The
majority of EPs are as solubilized formulations containing 10%
Oxine-Copper. There are no inert uses for Copper 8-Quinolinolate. 

	

		2.2	 Summary of Use Patterns and Formulations

	Oxine-Copper has been used for over 50 years as a contact fungicide for
the protection of wood and a wide range of materials. As part of the
re-registration process for Copper 8-Quinolinolate the Antimicrobials
Division (AD) has met with three registrants who manufacture the
technical grade active ingredient (TGAI) source products and MUPs to
better understand the allowed use patterns supported under this RED case
(USEPA, 2006b). When the MUPs and formulated end-use products for this
chemical were registered, data to address human exposure were "reserved"
(i.e., not imposed).  Therefore, EPA has no chemical-specific worker
monitoring study data, nor product use and human activity data, to best
characterize use patterns and develop occupational and residential
exposure dose estimates.

Osmose, Inc. and Tanabe USA, Inc. hold registrations for the technical
grade active ingredient MUPs (96% a.i. powders) from which registered
end-use products are formulated for wood preservative and/or materials
preservative uses. James Hardie Building Products, Inc. has a niche
market MUP (98% a.i. powder) used as an additive in the manufacture of
fiber-cement backerboard.  For the rest of the registrant community with
active product registrations for Oxine-Copper, the Agency has had to
rely on the most current accepted product labeling on file for the
numerous other products attributed predominantly to IBC Manufacturing
Co. (11 products), Rohm & Haas Co. (8 products), and Kop-Coat, Inc. (3
products). 

	The Agency determines potential exposures to handlers of the product by
identifying exposure scenarios from the various application methods that
are plausible, given the label uses. These scenarios are identified in
Table 2.1.  

Table 2.1. Potential Use Scenarios Based on Copper 8-Quinolinolate
Product Use Patterns 

Example Use Sites	Scenarios

Use Site Category X -Wood Preservatives



Used in the preservation of wood products against mold, rot, decay and
for sapstain control. Also repels termites and other insects. For
interior and exterior applications:

Fresh-cut and debarked  lumber, poles, posts, timbers;

Dry lumber, general structural wood, building construction lumber,
sub-flooring/framing lumber;

Wood products such as logs (including log home exterior wood protection,
poles, timbers, stakes, wood composites, boards,  plywood, fencing, wood
shingles, wood siding, millwork, sills/baseboards wood components for
decks, playsets, furniture, interior boat holds);

Wood in contact with foodstuffs (indirect-food contact) boxes, bins,
beverage cases, mushroom trays, fruit and vegetable produce containers,
pallets, nursery and greenhouse trays/flats.  	Application to wood by
pressure and non-pressure treatment methods in oil/solvent-borne or
water-based solutions.   

Industrial/Commercial and Residential:

Non-pressure treatment of above-ground and ground-contact wood and wood
products (including indirect food contact wood) through methods such as
dipping, conventional spray system, spray box, low pressure spray, low
volume spray machine, immersion,  brush, roller coater, and flood.

Surface application of protective coatings and water-repellents to wood
via low pressure spray/brush/roller.

Industrial/Commercial:

Pressure treatment of wood and wood products for above-ground uses
through methods such as vacuum and empty-cell (AWPA P8 Standard
specified for above-ground treated wood uses).  The minimum specified
retention (as Oxine-Copper active ingredient) for these applications is
0.32 kg/m3 (0.02 lb/ft3).  



Use Site Category VII - Material Preservatives



Used to protect various manufactured end products and treated articles
(fungistatic and water repellent treatments) for predominantly
commercial/industrial and government-specified uses, as well as
institutional and consumer use (residential household, farm and
greenhouse)

	

Industrial/Commercial - Incorporation during manufacture/processing to: 

Adhesives/glues; Cement; Paints and Coatings

Paper and paperboard (military-issued shoe counters/shoe boards, Kraft
paper, agricultural-use paper)

Textiles (industrial textiles/fabrics, industrial and military-issued
cotton, cotton duck, webbing, nets, rope/cordage, twine, canvas and
burlap);

	Industrial/Commercial– Impregnation of articles via Brush/Spray/Dip
to finished :

Textiles (industrial textiles/fabrics, industrial and military-issued
cotton, cotton duck, webbing, nets, rope/cordage, twine, canvas, burlap
and leather);

Paper and paperboard (Kraft paper, agricultural-use paper);

Leather



	Industrial/Commercial -Environmental outdoor surface treatments via
Brush or Spray for mold and mildew control to:

Painted surfaces, concrete, brick, glass, tile, metal, plastic, wood,
(paper)*, (leather)*, textiles and asphalt shingles.

* - Treatments to these materials may indicate potential indoor uses.   
Clarification of labeling is needed.





Use Site Category II - Food handling/storage establishments, premises
and equipment



	

Used for indoor hard surface disinfection against Potato Ring Rot on
surfaces in food handling/ processing equipment and premises. 

	

Industrial/Commercial – Non-mist Low Pressure Spray applications at
Potato processing, storage and transportation facilities: 

Potato (seed) Cutters/Handling Equipment/Planters/Storage Equipment

Railroad Boxcars (Feed/Food-full) (Non-residual Contact Treatment)

Railroad cars (Feed/Food-empty)

Trucks (Feed/Food-Full) (Non-residual Contact Treatment).





	From the use patterns shown in Table 2.1, AD selected exposure
scenarios representative of the vast majority of uses and those believed
to provide potential high-end dermal, inhalation, or incidental oral
ingestion exposure.  The representative scenarios assessed in this
document are shown in Table 4.1 (residential) and Table 6.1
(occupational).

3.0	SUMMARY OF TOXICITY DATA

	3.1	Acute Toxicity

	The acute toxicity database for this compound is considered complete. 
Animal studies conducted with technical grades of Copper 8-Quinolinolate
active ingredient show low acute oral toxicity (Toxicity Category IV)
and moderate acute dermal toxicity (Toxicity Category III).  Data
indicate moderate to severe acute inhalation toxicity (Toxicity Category
II), and severe primary eye irritation (Toxicity Category I).  The
compound exhibits low potential for dermal irritation (Toxicity Category
IV) and is not a dermal sensitizer. The acute toxicity data for
Oxine-Copper TGAI are summarized below in Table 3.1.

Table 3.1 Acute Toxicity Profile for Copper 8-Quinolinolate
(Oxine-Copper) TGAI

Guideline Number	Study/Test Substance 	MRID	Results	Toxicity Category

870.1100	Acute oral, rat

Oxine-copper, 99.5%	42921501	LD50 > 5000 mg/kg (combined)	IV

870.1200	Acute dermal, rat

Oxine-copper, 99.5%	42921502	LD50 > 2000 mg/kg (combined)

	III

870.1300	Acute inhalation, rat   Oxine-copper 96%

  Whole-body	43611901	LC50  = 0.089 mg/L	II

870.1300

	Acute inhalation, rat

Whole-body	00079231	LC50 = 0.82 mg/L	II

870.1300	Acute inhalation, rat   Oxine-copper 99.7%

Nose-only	41678401	LC50 = 0.15 mg/L	 II

870.2400	Primary Eye Irritation, rabbit

Oxine-copper 98%	41678402	Corneal opacity and conjunctival redness
through day 21 post-dose	I

870.2500	Primary Dermal Irritation, , rabbit	42921503	No irritation
observed	IV

870.2600	Dermal sensitization, guinea pigs

 Oxine-copper, 99.7%	42921504	Not a dermal sensitizer	N/A

Source:  June 13, 2006 Review Memorandum “Oxine Copper (copper
8-quinolinolate) - Endpoint Selection Report” from T.F. McMahon,
Ph.D., Senior Toxicologist, AD (USEPA, 2006a).

	3.2	Summary of Toxicity Endpoints

	On June 8, 2006, toxicity endpoints of concern were selected for
Oxine-Copper (Copper 8-Quinolinolate) by Antimicrobials Division
toxicologists’ and members of the former Antimicrobials Division
Toxicity Endpoint Selection Committee (ADTC) based on submitted
dose-response studies conducted with animals.  These dose-response
studies conducted with the technical grade active ingredient indicate
that Oxine-Copper does not elicit neurotoxic, reproductive or
developmental effects. Also, it is not mutagenic, nor is there evidence
of carcinogenicity based on available animal studies.

	For the non-dietary exposure assessment presented herein,
route-specific toxicity studies were found acceptable for selecting
incidental oral and dermal endpoints. However, the inhalation endpoint
relied on an oral study and therefore an additional 10x uncertainty
factor is applied. The endpoint selection memorandum (USEPA, 2006a)
noted a need for a repeated dose inhalation toxicity study with
Oxine-Copper to fulfill the current data gap and allow for adequate
assessment of risk from inhalation exposures arising from paint and wood
preservative uses.   Table 3.2 summarizes the selected toxicological
endpoints which are further detailed in the toxicology chapter and
preliminary risk assessment developed for this RED (USEPA, 2007).

Table 3.2     SEQ CHAPTER \h \r 1 Summary of Toxicological Doses and
Endpoints for Oxine-Copper for Use in Human Risk Assessments

  SEQ CHAPTER \h \r 1 Exposure

Scenario	Dose Used in Risk Assessment

(mg/kg/day) 	Target MOE, UF, 

Special FQPA SF* for Risk Assessment	Study and Toxicological Effects

Dietary Risk Assessments

Acute Dietary

(general population and females 13-49) 	No appropriate endpoints were
identified that represent a single dose effect.  

Therefore, this risk assessment is not required.



Chronic Dietary

(all populations)	NOAEL = 

5 mg/kg/day

	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)

Chronic RfD (cPAD) = 0.05 mg/kg/day	 Subchronic Toxicity in the Dog

MRID 42986802   (99.5% a.i.)

LOAEL = 50mg/kg/day, based on vomiting, decreased total plasma protein
and albumin, and reddened mucosa and hyperemia in the stomach and small
intestine.

Non-Dietary Risk Assessments

Incidental Oral Short-Term 

(1-30 days)

Intermediate-term

(30-days – 6months) 	NOAEL (maternal)  =  200 mg/kg/day

	Target MOE = 100

(UF =10x inter-species extrapolation, 10x intra-species variation) 

FQPA SF = 1	Prenatal Developmental Toxicity Study in the Rat   MRID
42986803   (98.5% a.i.)

LOAEL (maternal) = 800 mg/kg/day, based on clinical signs of toxicity
and decreased body weight gain in maternal rats.   

Dermal

Short-Term (1 to 30 days) and Intermediate-term (30 days- 6 months)

(residential and occupational)	NOAEL (systemic) = 

200 mg/kg/day  

	Target MOE = 100 

(UF = 10x inter-species extrapolation, 10x intra-species variation)

	28-Day Dermal Toxicity Study in the Rat  

MRID 42957802   (99.7% a.i.)

LOAEL (systemic)  = 1000 mg/kg/day, based on  necrosis of thymic
lymphocytes.

No evidence of dermal irritation from either this study or the acute
dermal study

Dermal

Long-Term ( >6 months)

(residential and occupational)	A long-term dermal endpoint is not
required for Oxine-copper. 

Inhalation (all durations)

(residential and occupational)	NOAEL = 5 mg/kg/day a  

	Target MOE = 1000

(UF = 10x inter-species extrapolation, 10x intra-species variation, 10x
route extrapolation)	 Subchronic Toxicity in the Dog

MRID 42986802   (99.5% a.i.)

LOAEL = 50mg/kg/day, based on vomiting, decreased total plasma protein
and albumin, reddened mucosa and hyperemia in the stomach and small
intestine.

Cancer	Oxine-Copper has not been formally classified as to
carcinogenicity.  

Source: June 13, 2006 Review Memorandum “Oxine Copper (copper
8-quinolinolate) – Endpoint Selection Report” from T.F. McMahon,
Ph.D., Senior Toxicologist, AD (USEPA, 2006a).

UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL =
no observed adverse effect level, LOAEL = lowest observed adverse effect
level, PAD = population adjusted dose (c = chronic), RfD = reference
dose, MOE = margin of exposure. 

a The inhalation absorption factor of 100% (default value, assuming oral
and inhalation absorption are equivalent) should be used since an oral
endpoint was selected for the inhalation exposure scenarios.  If results
are below an MOE of 1,000, a confirmatory inhalation study is warranted.

	3.3	FQPA Considerations  

	Neurotoxicity, Reproductive and Developmental Toxicity Study
Conclusions:

	There was no evidence to suggest a neurotoxic effect of Oxine-Copper
from the available toxicology data on this chemical.  There is one
acceptable reproductive toxicity study which showed no evidence of
primary reproductive effects.   Also, there was no evidence for a
primary developmental effect in either of the two acceptable
developmental toxicity studies available for Oxine-Copper done on the
rat and rabbit.   

	Recommendation for a Developmental Neurotoxicity Study:

	A developmental neurotoxicity study for Oxine-Copper is not needed at
this time. 

The available data show no neurotoxic effects from administration of the
chemical in experimental animal studies.

Hazard-based Recommendation for the FQPA safety factor:

	

	The ADTC concluded that the special hazard-based FQPA safety factor of
10x can be reduced to 1x.  The available developmental and reproductive
toxicity data for Oxine-Copper show no evidence of teratogenicity or
reproductive toxicity.  The studies are conducted according to
guidelines and show no evidence of increased susceptibility of
offspring.  There is no evidence for neurotoxicity of Oxine-Copper.

	 

4.0	RESIDENTIAL EXPOSURE ASSESSMENT 

	4.1	Summary of Registered Uses

The majority of registered products are intended for
industrial/commercial uses in the preservation of materials/wood during
manufacture, or through impregnation and surface treatments against
fungicidal decay in non-residential use sites.  However, some end-use
products containing Oxine-Copper are for protection of wood found in
residential sites as well as residential application of wood coatings
and water repellents.  Some are ready-to-use RTU products sold to
consumers for home/farm uses to protect outdoor wood surfaces (e.g.,
fencing, wood siding/shingles/roofs, log homes).

	Also, the Oxine-Copper-treated wood itself is used for fabrication of
residential structures (e.g., outdoor above-ground fencing, playsets,
decks) and in home renovation (interior sub-flooring and framing
lumber).  Material preservation of textiles are intended for mainly
industrial/government-specified (i.e., military-issued) end-use
applications (USEPA, 2006b).  However, the Agency cannot rule out the
possibility of consumers coming in contact with treated textiles (e.g.,
obtaining Army-grade canvas tents treated with Oxine-Copper). Commercial
remediation treatments to outdoor environmental surfaces in residential
sites (e.g., brick, concrete and tile) may also contribute to
residential post-application exposure.  Table 2.1 presents a summary of
all exposure scenarios that may occur from uses in residential settings
based on examination of product labels.  Table 4.1 identifies the
representative residential exposure scenarios considered for assessment
in this document.

	4.2	Dietary Exposure 

	The Agency has not set any tolerances for this chemical and certain
Oxine-Copper uses in preserved wooden articles (e.g., fruit/vegetable
containers) and paper may result in indirect food-contact residues. 
However, the U.S. Food and Drug Administration (U.S. FDA) permits use of
this preservative as an indirect food additive as cited in 21 CFR Part
176 [Indirect food additives: paper and paperboard components - 176.170
(b) (2)] and in 21 CFR Part 178 [Indirect food additives: adjuvants,
production aids, and sanitizers - 178.3800 (b) preservatives for wood]. 
Any risks pertinent to dietary exposures are discussed separately from
this chapter in the Preliminary Risk Assessment for this RED.

	4.3	Drinking Water Exposure 

Oxine-Copper is not used for potable water treatment, nor are effluents
containing this chemical expected in fresh water environments. Any risks
pertinent to drinking water exposures, if applicable, are discussed
separately from this chapter in the Preliminary Risk Assessment for this
RED. 

	4.4	Residential Exposure

	The exposure scenarios assessed in this document for the representative
uses selected by AD are shown in Table 4.1. The table also shows the
maximum application rate associated with the representative use and the
EPA Registration number for the corresponding product label.  For
handlers, the representative uses assessed include treatments to wood
surfaces (e.g., water repellents and coatings applied via brush, roller
and low-pressure coarse spray). Additionally, handler exposures were
assessed for the application of manufactured paint products containing
Oxine-Copper as a preservative (paint brush/roller and airless sprayer).
 

Table 4.1. Representative Uses Associated with Residential Exposure 



Representative Use	

Exposure Scenario	

Application Method	

EPA Reg. No.	

Maximum Application Rate

Using Wood Preservative Coatings/ Water Repellents 	ST Handler: Adult
Dermal and Inhalation	Paint brush,

Roller and Low-pressure coarse sprayer 

	1022-514 and 81819-1	0.675% ai ready-to-use (RTU) oil-based exterior
coating for log homes, wood roofs, siding, fences, rough sawn lumber,
new/old wood. 150-300 sq ft/gal. as one coat application.



Using Treated Paints/Coatings             (in-can preservative)	

ST Handler: Adult Dermal and Inhalation 

(aerosol particulates)6

	

Paint brush,

Roller,

Airless sprayer	

Commercially-treated article preserved with 2829-136 (e.g., exterior
house paint) 	

Solvent-based paint containing 1.0% ai incorporation to inhibit
mold/mildew. (Paint use applications unspecified).



Contact with treated Textiles (i.e., outdoor-use treated tents/tarps,
canvas exposed to the elements and prone to decay)

Note: Textiles are not Clothing Apparel, Bedding or Home-goods 	ST
Post-application: Adult dermal; Child Incidental oral ingestion and
Dermal

	NA	Commercially- treated articles preserved with 2829-42;     2829-49;
and 2829-112 	0.7-1.0% ai used to treat canvas fabric



Environmental Outdoor Hard Surface Treatments 

(i.e., mold and mildew control treatments to exterior environmental
surfaces ) 	ST Post-application: Child incidental oral ingestion and
Dermal

	

NA	

Commercial application done 

via Brush/Spray at residential sites with 

1022-489;

1022-490; and

75675-1

	

0.1% ai treatment solution used on painted/varnished surfaces, concrete,
brick, glass, tile, metals, plastic, wood, (paper)*, (leather)*,
textiles and asphalt shingles.

* - Treatments to these materials may indicate potential indoor uses.
Clarification of labeling is needed. 

Contact with treated Wood products (i.e., outdoor playsets, decks, wood
structures)

	ST Post-application: Child incidental oral ingestion and Dermal	NA	

Commercially- treated wood preserved with 2829-135 and 2829-136, used
for above-ground applications (via pressure and non-pressure methods)	

1.0% ai used to treat wood via pressure methods resulting in an active
ingredient retention of 0.02 lb/ft3.

Note: Only EPA registered products with specified use directions/use
applications are included in this table. 

Products listed were selected based on maximum use rates by application
method.

ST = Short-term exposure

6 Handler dermal and inhalation (to the particulates) exposure were
assessed for Oxine-Copper using PHED unit exposures. 

	

	4.4.1	Residential Handler Exposures

	The residential handler scenarios described in Table 4.1 were assessed
to determine dermal and inhalation exposures.  These scenarios were
assessed using PHED data and Equations 1-3 in Section 1.2, “Criteria
for Conducting Risk Assessment.”  Residential handlers using
Oxine-Copper-treated paint (as an in-can preservative) may have
inhalation exposures to aerosol particulates during airless spray
applications.  Aerosols are not anticipated for the wood coatings
applications using a low-pressure sprayer (non-misting).  In the case of
Oxine-Copper, the technical-grade chemical has a low vapor pressure (6.3
x 10-12 mm Hg) and therefore it is expected to be non-volatile in end
product formulations.  

  

The assumptions and factors used for those scenarios in which surrogate
data were used include:

Unit Exposure Values: Unit exposure values were taken from the Pesticide
Handlers Exposure Database (PHED) data presented in HED’s Residential
SOPs (USEPA, 1997). A summary of the PHED database is presented in
Appendix A.

For the low pressure sprayer (course spray) scenario, the PHED dermal
and inhalation unit exposure values for a residential handler pouring a
pesticide and applying it via a low pressure sprayer (handwand) were
used.  These ungloved unit exposure values (100 mg/lb a.i. for dermal
and 0.030 mg/lb a.i. for inhalation) represent a handler treating low
and mid-level targets (generally below the waist) while wearing short
pants and a short sleeve shirt, with no gloves. 

For the airless sprayer scenario, PHED dermal and inhalation unit
exposure values for a residential handler applying a pesticide using an
airless sprayer were used.  These unit ungloved exposure values (79
mg/lb a.i. for dermal and 0.83 mg/lb a.i. for inhalation) represent a
handler painting a residential bathroom wearing short pants and a short
sleeve shirt, with no gloves. 

For the brush/roller scenario, PHED dermal and inhalation unit exposure
values for a residential handler applying a pesticide using a paint
brush were used.  These unit exposure values (230 mg/lb a.i. for dermal
and 0.28 mg/lb a.i. for inhalation) represent a handler wearing short
pants and a short sleeve shirt, with no gloves.

Quantity handled/treated: The quantities handled/treated were estimated
based on information from various sources and assumptions. The density
of paint is assumed to be 10 lbs/gallon.

For the low pressure sprayer in wood coating applications it is assumed
that 50 lbs (approximately 5 gallons) of RTU product will be used.

For the airless sprayer in paint applications, it is assumed that 150
lbs (approximately 15 gallons) of treated paint will be used.  This is
based on the coverage of 200 ft2/gallon and a house size of 40 x 30 x 20
ft (surface area of 2,800 ft2).

For the brush/roller in paint applications, it is assumed that 20 lbs
(approximately 2 gallons) of treated paint will be used.  This is based
on the 90th percentile value of 8 gallons of latex paint used per year
divided by the mean frequency of 4 painting events/year.  	

Duration of Exposure: The duration of exposure for most homeowner
applications of paint products is believed to be best represented by the
short-term duration (1 to 30 days).  The Agency assumes that painting
events are episodic, not daily.  

Results

	The resulting short-term exposures and MOEs for the representative
residential handler scenarios are presented in Table 4.2. The calculated
ST MOEs were above the target dermal MOE of 100 for all scenarios.  The
high-end scenario developed for airless sprayer yielded a ST inhalation
MOE below the target of 1000, as 278, indicating a potential risk
concern. Confirmatory inhalation toxicity study data may be required to
address this. 

Table 4.2 Short-Term Oxine-Copper Residential Handlers Exposures and
MOEs 



Exposure Scenario

	

Method of Application	

Unit Exposure 

(mg/lb ai)	

Application Rate	

Quantity Handled/ Treated per day	

Absorbed Daily Dose (mg/kg/day)	

MOE (ST)





Dermala	

Inhalationb

	

Dermalc	

Inhalationd	

Dermal 

(Target = 100)e	

Inhalation (Target = 1000)f



Using

Wood Coatings

	Low Pressure Sprayer

	

100

	

0.030

	

0.675% ai by weight

	50 lbs

(5 gal)

	

0.482

	

0.00015

	

415

	

33,333



Using Treated Paint

	

Brush/roller

	

230

	

0.284

	

1.0% ai by weight

	

20 lb s

 (2 gal)	

0.657	

0.0008	

304	

6,250

	

Airless sprayer	

79

	

0.83

	

1.0% ai by

 weight	150 lbs (15 gal)	

1.69

	

0.018

	

118

	278





a	All dermal unit exposures represent ungloved replicates. The low
pressure sprayer, brush/roller, and airless sprayer unit exposures
represent short sleeve and short pant replicates.

b	No respirator used by exposed individual.

c	Dermal Daily Dose (mg/kg/day) = [dermal unit exposure (mg/lb ai) *
application rate (0.00675 or 0.01) * quantity handled * dermal
absorption factor (NA) / body weight (70 kg).

d	Inhalation Daily Dose (mg/kg/day) = [inhalation unit exposure (mg/lb
ai) * application rate (0.00675 or 0.01) * quantity handled * inhalation
absorption factor 100% / body weight (70 kg).

e	Dermal MOE = NOAEL (200 mg/kg/day) / Daily Dose. Target dermal MOE is
100.

f 	Inhalation MOE = NOAEL (5 mg/kg/day) / Daily Dose. Target inhalation
MOE is 1000.

	 



	4.4.2	Residential Post-application Exposures

 	For the purposes of this screening level assessment, post-application
scenarios have been developed to encompass potential high-end exposure
from various wood/materials preservative treatments.  As shown in Table
4.1, representative post-application scenarios assessed include child
contact with surface residues from Oxine-Copper treated wood (dermal and
incidental oral exposure) and residues remaining on treated outdoor hard
surfaces (dermal and incidental oral exposure to children).  Scenarios
were also developed for contact with  residues on treated textiles such
as tents and tarps (dermal exposure to adults and children and
incidental oral exposure to children).

	Typically, post-application exposures in residential settings are
assumed to occur over a short-term duration (1 to 30 days) as episodic,
not daily events.  AD does not believe that the use patterns for
Oxine-Copper will result in any intermediate-term residential exposures.

	

	4.4.2.1		Outdoor Hard Surfaces/Remedial Fungistatic Surface Treatments

Dermal Exposure to Children from Treated Outdoor Surfaces

Exposure Calculations

	There is the potential for dermal exposure to toddlers crawling on hard
outdoor surfaces (e.g., brick/tile or concrete surfaces of
walkways/patios) after periodic surface treatments with Oxine-Copper
products.  Exposures and MOEs were calculated for children contacting
treated hard surfaces in residential sites (short-term exposure). 

To determine toddler exposure to surface residues after commercial
remediation (via brush/spray), the following equation was used: 

PDD =  AR x DTF x DRF x CF1 x CF2 x SA

			BW			

where,

 	PDD	=	Potential daily dose;

AR	=	Application Rate (lb/ft2);

DTF	=	Dermal transfer factor (fraction, unitless);

DRF	=	Treatment Solution fraction remaining on hard surfaces (unitless);

CF1	=	Conversion factor (4.54x105 mg/lb);

CF2	=	Conversion factor (10.8 ft2/m2);

SA	=	Surface area of the body in contact with treated surface (m2); and

BW	=	Body weight (kg)

Assumptions

Toddlers (3 years old) were used to represent the 1 to 6 year old age
group.  A body surface area of 0.657 m2 and a body weight of 15 kg was
been assumed, which are the median values for 3 year olds (USEPA,
1997a).

The product labels (for 1022-489, 1022-490 and 75675-1) did not provide
information on the volume of product to be used for treating
hard-contact surfaces.  It was assumed that the diluted treatment
solution is applied at a rate of 1 gallon per 1,000 sq. ft. The maximum
application rate on the product labels for application to hard surfaces
is 0.1% ai [1:100 dilution in water of a 10% ai product (1022-489) =
0.1% ai in treatment solution]. Therefore, the water-based application
rate of 0.1% ai as a weight fraction (0.001) yields a density of
(0.00834 lb ai/gal) assuming the density of water (8.34 lbs/gal). 
Therefore, the application rate used in the post-application scenario is
0.00000834 lb ai/ft2.

Labels state “re-inspect annually and retreat as necessary” so
treatment  by commercial applicators for mold remediation are assumed to
be done at residential sites no more than once a year, twice at most. 

No data could be found regarding the quantity of solution residue left
on surfaces after treatment. As a conservative measure, it has been
assumed that 25% of the applied solution remains after treatment by
brush or spray.

No transferable residue data were available that could be used to
estimate the transfer of Oxine-Copper from hard surfaces to skin. 
Therefore, it is assumed that 10% of the deposition rate is available
for dermal transfer (USEPA, 2000, and 2001).

Results

	The calculated short-term dermal exposure dose and MOE is shown in
Table 4.3.  The dermal MOE of 4,484 is above the target MOE of 100 and
is therefore not of concern.

Table 4.3.  Short-term Post-application Dermal Exposure and MOE for
Children Contacting Treated Outdoor Hard Surfaces



Exposure Scenario	

Application Rate 

(lb ai/sq ft)	

Product remaining after treatment	

Percent Trans. Residue	

Body Area in contact with surface (m2)	

Absorbed potential daily dosea (mg/kg/day)	ST

Dermal MOEb

Target = 100



Treated Outdoor Hard surfaces - residential setting

	

8.34 x10-6

	

25%

	

10%

	

0.657

	

0.0446

	

4,484





a 	Absorbed Potential Daily Dose(mg/kg/day) = [(Application rate, lb
ai/ft2)*(conversion factor, 454 g/lb)* (conversion factor, 1,000 mg/g) *
(conversion factor, 1 ft2/0.093 m2) * (product remaining after hard
surface treatment, 25%) * (dermal transfer factor, 10%) * (body surface
area in contact with floor, 0.657 m2) * (dermal absorption , NA) ] /
(body weight, 15 kg)

b	Dermal MOE  = NOAEL (mg/kg/day) / Absorbed Potential Daily Dose
(mg/kg/day) [Where short-term dermal NOAEL (systemic) = 200 mg/kg/day]. 
Target MOE = 100.

Child Incidental Ingestion Exposure to Treated Floor Residues

Exposure Calculations

	In addition to dermal exposure, toddlers crawling on treated outdoor
hard surfaces will also be exposed to Oxine-Copper residues via
incidental oral ingestion through hand-to-mouth activity.  To calculate
incidental oral ingestion exposure to this chemical via hand-to-mouth
transfer, the methodologies established in the Standard Operating
Procedures (SOPs) for Residential Exposure Assessments (USEPA 2000 and,
2001) were used.  These SOPs use assumptions that are similar to those
used above in calculating the dermal exposure for toddlers crawling on
residential outdoor treated surfaces.  Exposure was calculated using the
following equations for hand-to-mouth transfer of pesticide residues to
toddlers:

PDD = SR x DTF x SA x EF x ET x SE x CF1				        

                                         BW

where:

PDD		=		Potential daily dose (mg/kg/day);

surface residue (μg/cm2);

DTF		=		Dermal transfer factor (unitless fraction);

SA		=		Surface area of the hands that contact both the treated area, and
the individuals mouth (cm2/event);

FQ		=		Frequency of hand-to-mouth events (events/hr); 

SE		=		Saliva extraction efficiency (unitless fraction); 

ET		=		Exposure Time (4 hrs/day);

CF1		=		Unit conversion factor (0.001 mg/µg); and

BW		=		Body weight (15 kg)

And

SR=AR x DRF x CF2 x CF3								

where:

SR		=		Surface residue (µg/cm2);

AR		=		Application rate (lb ai/ft2);

DRF		=		Treatment Solution fraction remaining on treated surface
(unitless);

CF2		=		Unit conversion factor (4.54x108 µg/lb); and

CF3		=		Unit conversion factor (1.08x10-3 ft2/cm2)

Assumptions 

Toddlers (3 years old) were used to represent the 1 to 6 year old age
group and are assumed to weigh 15 kg, the median for male and female
toddlers (USEPA, 2000 and 2001). 

Based on HED’s Residential SOP, it was assumed that the surface area
used for each hand-to-mouth event is 20 cm2.  For short-term exposures,
it is assumed that there were 20 events per hour (90th percentile,
according to the SOP).

The exposure time was 4 hours a day (USEPA, 2000 and 2001).

The saliva extraction efficiency was 50% (USEPA, 2000 and 2001).

The product labels (for 1022-489, 1022-490 and 75675-1) did not provide
information on the volume of product to be used for treating
hard-contact surfaces.  It was assumed that the diluted treatment
solution is applied at a rate of 1 gallon per 1,000 sq. ft. The maximum
application rate on the product labels for application to hard surfaces
is 0.1% ai [1:100 dilution in water of a 10% ai product (1022-489) =
0.1% ai in treatment solution]. Therefore, the water-based application
rate of 0.1% ai as a weight fraction (0.001) yields a density of
(0.00834 lb ai/gal) assuming the density of water (8.34 lbs/gal). 
Therefore, the application rate used in the post-application scenario is
0.00000834 lb ai/ft2.

Labels state “re-inspect annually and retreat as necessary” so
treatment  by commercial applicators for mold remediation are assumed to
be done at residential sites no more than once a year, twice at most. 

No data could be found regarding the quantity of solution residue left
on surfaces after treatment.  As a conservative measure, it has been
assumed that 25% of the applied solution remains after treatment by
brush or spray.

No transferable residue data were available that could be used to
estimate the transfer of Oxine-Copper from hard surfaces to skin. 
Therefore, it was assumed that 10% of the deposition rate is available
for dermal transfer (USEPA, 2000 and 2001).

Results

	The calculated short-term incidental oral exposure dose and MOE is
shown in Table 4.4.  The oral MOE is 36,765, which is over the target
MOE of 100 and therefore not of concern.

Table 4.4.  Short-term Incidental Oral Post-application Exposure and MOE


for Children Contacting Treated Outdoor Hard Surfaces





Exposure Scenario	

Appl. Rate

 (lb ai/

sq ft)	

Product remaining after treatment	

Surface Residuea (µg/cm2)	

Percent transferable residue	

Surface area mouthed (cm2/event) 	

Exposure Frequency (events/hr)	

Saliva Extraction Factor	

Exp. Time (hrs/day)	

Absorbed Potential Daily Doseb (mg/kg/day)	

ST Oral

MOEc

Target = 100 



Treated Outdoor Hard surfaces - residential setting	

8.34 x10-6

	

25%	

1.02	

10%	

20	

20	

50%	

4	0.00544	36,765



a 	Surface residue (µg/cm2) = (application rate, lb ai/ft2)*(product
fraction remaining on surface, 0.25)*(conversion factor to convert lb to
µg, 4.54E+08 µg/lb)*(conversion factor to convert ft2 to cm2, 1.08E-03
ft2/cm2)

b 	Absorbed Potential Daily Dose  (mg/kg/day) = [(Surface residue,
µg/cm2)*(transferable residue, 0.10)*(exposure time, 4
hrs/day)*(surface area of hands, 20 cm2/event)*(frequency of
hand-to-mouth activity, 20 events/hr)*(extraction by saliva, 50
%)*(conversion factor to convert µg to mg, 0.001 mg/µg)]/(body weight,
15 kg)

c 	MOE = NOAEL (mg/kg/day) / absorbed potential daily dose(mg/kg/day)
[Where short-term oral NOAEL (maternal) = 200 mg/kg/day].  Target MOE =
100.

	

	4.4.2.2		Treated Textiles

Dermal Exposure to Adults and Toddlers from Contacting Treated Textiles
(Canvas Tents)

	The Agency assumes that there is the remote potential for dermal
exposure to adults and children from contact with fabric (canvas tents)
treated for mildew control at military-specified levels of 1.0%
Oxine-Copper via factory impregnation. From our understanding of
registered use patterns, textiles treated with Oxine-Copper
preservatives meet the needs of niche markets for government
(military-issued) and industrial textiles.  Registrant input is needed
to confirm that residential consumers will have limited contact with
Oxine-Copper-treated textiles.

	This post-application assessment assumes the tent is new (i.e., not
laundered and not yet exposed to rainfall and outdoor elements) as a
conservative measure (i.e., the effect of dislodgeable residues being
diminished over time is not quantifiable).  It should be noted that it
was assumed that contact with these treated textile articles are
infrequent and episodic. Therefore, only short-term duration (1-30 days)
exposure was considered.  

Exposure Calculations

Potential doses are calculated as follows:

PDD = W x WFai x CF x TF								

 	         BW						

Where: 

PDD		= 	potential daily dose (mg/kg/day);

W		=	weight of treated textile (g/day);

WFai		= 	percent active ingredient in textile (%); 

TF		= 	percent transfer; 

CF		=	conversion factor (1000 mg/µg); and 

BW		=	body weight (kg).

And

W = (SW/SSA) * BSA* CF1															

Where:

W	=	weight of treated textile (g/day);

SW 	=	weight of medium-grade canvas cloth (g);

SSA 	= 	surface area of textile (m2); 

BSA	=	surface area of body in contact with textile (cm2); and

CF1	=	unit conversion factor (0.0001 m2/cm2).

Assumptions

The product is applied at a rate of 0.01 a.i. weight fraction to the
textile (based on maximum application rate of 1% a.i. for registered
products (EPA Reg. Nos. 2829-42 and 2829-49).

The median surface area of skin in contact with the textile is 2,955 cm2
for a 3-year-old toddler (as 50% of total surface area of a toddler)
(NAFTA guidance per USEPA, 1997a).  For adults, the median surface area
is 9,220 cm2 (as 50% of total surface area of an adult) (NAFTA guidance
per USEPA, 1997a). 

The canvas tent cloth textile is assumed to be medium weight Army Duck
Canvas (12 oz/yd2 ) with a density of  408 g/m2.  [This density estimate
is based on a weight specification chart from an internet source of
exported canvas textile (Bharat Textiles, 2007)].  As a conservative
approach it is assumed that adults and children are sleeping inside a
treated tent with no bedding between body and tent floor surfaces,
wearing short pants/tee-shirt or just undergarments. Also that contact
is on one side of the body (i.e., 50% body surface area contacting
cloth).  Therefore, the total weight of treated textile in contact with
human skin (high-end assumption) per day is equal to the density of the
fabric (408 g/m2) times the surface area (2,955 cm2 for toddlers, 9,220
cm2 for adults), or 121 g/day for toddlers, and 376 g/day for adults
when adjusted by a conversion factor of 0.0001 m2/cm2.

No data were available from which a transfer factor could be estimated. 
Potential doses were calculated using a conservative percent transfer of
100%, which assumes that all residues are transferable from textile
surfaces to the skin.  In cases where the MOEs did not meet the
Agency’s target MOE, potential doses were also calculated using a less
conservative percent transfer of 5%, which is based on approaches for
the amount of residue assumed to be transferable from carpeted surfaces
(USEPA, 2000 and 2001).  In these cases, confirmatory data are needed to
support the use of the lower transfer factor.  

Toddlers (3 years old) are assumed to weigh 15 kg. This is the mean of
the median values for male and female toddlers (USEPA, 1997a).  For
adults, a body weight of 70 kg has been assumed. (USEPA, 1997a).  

Results

	The calculations of the short-term dermal doses and MOEs for adults and
toddlers in contact with treated textiles are shown in Table 4.5.  The
dermal MOEs for adults and toddlers are all below the target MOE of 100,
denoting potential risk concerns.

Table 4.5:  Dermal Post-application Exposures and MOEs for Toddlers and
Adults Contacting Treated Textiles

Exposure Scenario	W (weight of treated textile per day)a  (g/day)	WFai 

(fraction a.i. in textile)	TF (percent transfer)	PDD (mg/kg/day)b	ST
Dermal MOEc   Target = 100

Toddler	121	0.01	100%	81	3



	5%	4	50

Adult	376	0.01	100%	54	4



	5%	3	67



a.	Weight of  treated textile in contact with skin (g/day) = (Density of
shirt 408 g/m2) * (surface area of body covered, cm2  as 2,955 cm2
toddler or  9,220 cm2 adult ) *  (0.0001 m2/cm2) 

b.	Absorbed Potential Daily Dose (mg/kg/day) = [(weight of treated
textile, g/day) * (weight fraction a.i. in treated cloth) * (percent
transfer) * (conversion factor, 1000 mg/g)] / (body weight, kg, as 15
toddler or 70 adult).

c. 	Dermal MOE = NOAEL (mg/kg/day) /Absorbed Potential Daily Dose [Where
short-term dermal (systemic) NOAEL = 200 mg/kg/day].  Target MOE = 100.

Incidental Oral Exposure to Toddlers Mouthing Treated Textiles (Canvas
Tents/Tarps)

	Based on the dermal scenario developed above, there is the potential
for incidental oral exposure to toddlers from mouthing textiles (e.g.,
canvas tents/tarps) treated with Oxine-Copper. 

    

Exposure Calculations 

Potential doses are calculated as follows:

PDD = C x SE x SA 								

	    BW							

Where: 

PDD	= 	potential daily dose (mg/kg/day);

C 	= 	concentration on Textile (mg/cm2);

SE	=	saliva extraction efficiency (%);

SA 	= 	surface area mouthed (cm2/day); and

BW 	= 	body weight (kg).

And

C = WFai x W x CF1 x CF2							

		

Where:

C		=	concentration on Textile (mg/cm2);

WFai		= 	weight fraction of a.i. in Textile (unitless); 

W 		= 	weight of Textile (g/m2);

CF1		=	unit conversion factor (1,000 mg/g); and

CF2		=	unit conversion factor (0.0001 m2/cm2).

Assumptions

The product is applied at a rate of 0.01 a.i. weight fraction to the
textile (based on maximum application rate of 1% a.i. for registered
products (EPA Reg. Nos. 2829-42 and 2829-49).

The textile is assumed to be medium weight Army Duck Canvas (12 oz/yd2 )
with a density of  408 g/m2.  [This density estimate is based on a
weight specification chart from an internet source of exported canvas
textile (Bharat Textiles, 2007)].

The saliva extraction efficiency was 50% (USEPA, 2000 and 2001).

The surface area of textile mouthed by toddlers is 20 cm2 (professional
judgment).

Toddlers (3 years old) are used to represent the 1 to 6 year old age
group.  For three-year olds, the median body weight is 15 kg (USEPA,
1997a).

Results

    Table 4.6 shows the calculation of the oral dose and oral MOE for
toddlers mouthing treated textiles. The MOE value is 735 which is above
the target MOE of 100 and is not of concern.

Table 4.6:  Incidental Oral Exposures and MOEs for Toddlers Mouthing
Treated Textiles (Canvas Tent/Tarp)

Weight of textile (g/m2)	Concentration on textilea 

(mg/cm2)	Surface area mouthed (cm2/day)	

Saliva extraction efficiency 

	Potential daily doseb (mg a.i./kg/day)	Incidental Oral MOEc

408	0.408	20	50%	0.272	735



a.	Concentration on textile (mg/cm2) = (Weight fraction a.i. in
clothing, 0.01) * (weight of textile, g/m2) * (1,000 mg/g) * (0.0001
m2/cm2)

b.	Potential Daily Dose (mg/kg/day) = (concentration on textile, mg/cm2)
* (surface area mouthed, cm2/day) * (saliva extraction efficiency 0.50)
/ (body weight, 15 kg).

c 	Oral MOE = NOAEL (mg/kg/day) / Potential Daily Dose [Where short-term
incidental oral (maternal) NOAEL = 200 mg/kg/day].  Target MOE = 100.	

			 

	4.4.2.3	Treated Lumber		

	Certain Oxine-Copper end-use products are labeled for wood preservative
uses in pressure and non-pressure treatments of wood products intended
for residential applications.  The Agency is concerned that there are
potential post-application exposures to individuals exposed to
Oxine-Copper-treated wood in residential settings (home and farm).  

The potential outdoor residential post-application exposure pathways
considered are outlined below for children.

Dermal contact with Oxine-Copper-treated wood products for above-ground
uses [e.g., residential playground equipment (playsets), posts, decks,
shingles, fencing, outdoor lumber, etc.];

Incidental ingestion due to hand-to-mouth contact with
Oxine-Copper-treated wood products;

Inhalation of wood dusts from fabrication of Oxine-Copper-treated wood
products;

Incidental ingestion of soil contaminated with Oxine-Copper;

Dermal contact with soil contaminated with Oxine-Copper (e.g., soil
contaminated by treated decks and playsets); and

Inhalation of soil dusts contaminated with Oxine-Copper (e.g., soil
contaminated by treated decks and playsets).

Other potential outdoor residential post-application exposure pathways
for adults are outlined below:

Dermal contact with wood/wood dusts from construction of decks and
playsets;

Incidental ingestion of wood dusts from construction of decks and
playground equipment; and,

Inhalation of wood dusts from construction of decks and playsets.

	Currently, there are no study data that can be used to estimate either
exposure to adults from inhalation of wood dusts during construction of
wood decks or to children exposed to treated wood.  Incidental ingestion
exposure for adults is expected to be negligible and dermal contact for
adults is expected to be lower than children for crawling on wood decks.
 Because children are more likely than adults to contact wood surfaces
using playground equipment (playsets), and because children have a
higher surface area to body weight ratio, they have been used to
represent the maximum exposed individual.  

At present, there are no available data to assess the levels of
Oxine-Copper residues in soil contaminated from Oxine-Copper-treated
wood (above ground fabricated components of decks or playsets).  Because
of this data gap, EPA was not able to estimate residential
post-application dermal and incidental ingestion exposures to soil
contaminated with Oxine-Copper.  In this assessment, incidental
ingestion and dermal exposures to children from contact with treated
wood were estimated using surrogate data.

Surrogate Data 	

	

	No chemical-specific residential post-application studies conforming to
Series 875 guidelines were available; however, data from the proprietary
study, “Measurement and Assessment of Dermal and Inhalation Exposures
to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of
Cut Lumber (Phase III)” (Bestari et al., 1999, MRID 455243-04, SIG
Task Force #73154) can be used as surrogate data to estimate
screening-level exposures for the following pathways: outdoor
residential dermal contact with Oxine-Copper-treated wood products used
in above-ground applications (e.g., residential playsets, posts, decks,
shingles, fencing, outdoor lumber, etc.); and outdoor residential
incidental ingestion due to hand-to-mouth contact with pressure-treated
wood products.  The DDAC study measured dermal and inhalation exposures
for various worker functions/positions for individuals handling
DDAC-containing wood preservatives for non-pressure treatment
application methods and for individuals that could then come into
contact with the preserved wood. 

Outdoor Residential Dermal Contact with Oxine-Copper-treated Wood
Products

Potential dermal doses are calculated as follows:

PDD = R x SA exposed 								

	    BW							

Where: 

PDD	= 	potential daily dose (mg/kg/day);

R 	= 	residue on skin after contact with treated wood (μg/cm2);

SA exposed=	Skin surface area in contact with treated wood (cm2);

BW	=	Body Weight of a toddler (kg)

The value for R used was based on two surrogate data sources: 1)
measured worker residue data for hands that are available in the DDAC
study (maximum concentration 3.0 µg/cm2 ); and, 2) a conservative
(high-end) surrogate value to represent skin residue concentration (as
27 µg/cm2) taken from a chemical-specific leaching study on
Oxine-Copper spray-treated hemlock-fir lumber (MRID 436370-01).  

	DDAC Study (MRID 455243-04)

	The DDAC data in Table 4.7 were used to approximate the residues
transferred from 	treated wood to skin for contact with
Oxine-Copper-treated wood.  No wood-wipe 	sampling data are available. 
The data from the following job descriptions in the 	DDAC study were
chosen because of the possibility of the contact with dry treated 	wood.


End Stacker - Operates an automated stacking system at the end of the
conveyor.  Lumber stacked into loads.

Stickman - Places sticks between stacks of wood manually.  At some
mills, this is done automatically by end stacker operator.

Tallyman - Staples information sheet on to wood.  May come in contact
with treated lumber. (Note: there were two reps available for tallyman)

Total Hand Residue Data (μg/cm2)

End Stacker	1.2

Stickman	0.6

Tallyman	0.8

Tallyman (Maximum Value)	3.0

Average Hand Residue	1.4



	These test subjects handled the dry treated wood from the non-pressure
treatments. Of 	the 20 test subjects measured for handling “dry”
wood in the DDAC study, 19 had 	detectable hand values (one value
non-detect) ranging from 0.04 to 3.0 µg/cm2 	(DDAC study page 104). The
highest value (most conservative) (3.0 µg/cm2) 	represents the
“Tallyman” that wore no gloves (DDAC study page 189).  This value 
was used in the assessment.

	Oxine-Copper Study (MRID 436370-01) 

	A non-guideline leaching study is on file with the Agency for this
chemical, 	“Leaching of Copper Oxinate (Copper 8-Quinolinolate) From
Lumber Spray Treated 	with Maag Sapstain Control Formulations: Lab
Project Number: 17930425. 	Unpublished study prepared by Forintek Canada
Corp. 24 p.” (Byrne, A.; Minchin, 	D.,1991, MRID 436370-01).  It is
unclear if it has been formally reviewed for 	acceptance by EPA in
registering the end-use product.  However, since it is cited as 	a data
source in an environmental fate transport memorandum written in support
of 	Oxine-Copper reregistration (USEPA, 2006c), it is used in this
assessment.

	The study included data on the measured wood surface concentration of
Oxine-	Copper on hemlock-fir samples which were subjected to spray
treatments for sapstain 	control.  Data indicated that a conventional
spray system achieved a surface sample 	retention concentration (surface
deposition) of 27 µg/cm2 .  	For lack of  wood wipe 	sampling data on
Oxine-Copper residues, the 27 µg/cm2 Oxine-Copper retention 	level is
assumed to represent a maximum surface residue concentration, as a 
surrogate for hand residue load. 

SA exposed was determined using the following equation:

SA exposed =  SA total * (X handSA *  X hand,touching+X non-handSA * X
non-hand,touching)		

Where:

SA total 		=	 total surface area for a 3-year old toddler (cm2)

X handSA		=	fraction of total toddler surface area that is hand
(unitless)

X hand,touching	=	fraction of X handSA that contacts treated wood
(unitless)

X non-handSA	=	fraction of total toddler surface area that is unclothed,
other than hands (i.e., legs, arms, head)

X non-hand,touching	=	fraction of X non-handSA that contacts treated
wood (unitless)

The value for SA total used was 6,565 cm2, which is the average surface
area for a 3-year old toddler.  The values X handSA and X non-handSA are
0.0607 and 0.548, also based on the average surface area for a 3-year
old toddler (USEPA, 1997a).  The values for X hand,touching and X
non-hand,touching are 0.74 and 0.158, respectively.  These are the
values used in a USEPA model to determine chromated copper arsenate
(CCA) exposure on treated playground sets (USEPA, 2005a). 

Table 4.8 shows the results of the calculations.  The dermal MOEs are
greater than the target MOE of 100 (MOEs = 1156 and 129) and therefore
are not of concern.

Table 4.8.  Residential Post-application Dermal Exposures to
Oxine-Copper-treated Wood Products



Hand Residue Concentration from DDAC Study (ug/cm2)	Fraction of Hand
Touching Residues: Hand, touching	Fraction of Body Surface that is hand:
Hand SA	Fraction of Unclothed Body (Non-hand) skin touching residues: 

Non-Hand, touching	Fraction of body surface that is unclothed, non-hand
(i.e., legs, arms, head): 

Non-Hand SA	Total surface area of 3-yr old (cm2):

 SA Total	Surface Area in contact with residues

 (cm2): a

SA Exposed	PDD (mg/kg/day)b	ST Dermal MOEc

Target MOE = 100

3.0	0.74	0.0607	0.158	0.548	6565	863	0.173	1156

Surrogate Hand Residue Concentration 

(Maximum Surface Residue) from Oxine-Copper

Spray-treated Lumber

(MRID 436370-01 Study) (µg/cm2)





	1.55	129

27.0











a	SA exposed = (X hand,touching*X handSA+X non-hand,touching*X
non-hand,SA)*SA total

b	PDD=[Residue (either 3 μg/cm2  or 27 μg/cm2) x 0.001 mg/ μg x
SAexposed]/(Body Weight, 15 kg)

c	MOE  = NOAEL (mg/kg/day) / daily dose (mg/kg/day).  For dermal
exposures, the (systemic) NOAEL is 200 	mg/kg/day.  Target MOE = 100.

  SEQ CHAPTER \h \r 1 Outdoor Residential Hand-to-Mouth Contact with
Oxine-Copper-treated Wood Products

	The daily hand-to-mouth dose (mg/kg/day) is estimated using the
following equation:

Oral Dose t= Handt x Hand SA x SEF x  Frequency x CF1  x 
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				with dry wood) (μg/cm2); and Oxine-Copper surface residue 
(surrogate hand residue) concentration (μg/cm2),

	Hand SA	=	hand surface area (cm2/event),

SEF		=     	saliva extraction efficiency,

Frequency 	= 	frequency of exposure event (events/hr), 

	ET		=	exposure time (hr/day), 

	CF1		=	conversion factor (0.001 mg/µg), and

	BW		=	body weight (kg).

The highest hand residue value from the DDAC study (3.0 µg/cm2) was
used for this assessment. In comparison, as a high-end surrogate hand
residue value, chemical-specific data were also used from a leaching
study on Oxine-Copper spray-treated hemlock-fir lumber (MRID 436370-01)
which indicated that a conventional spray system achieved a surface
sample retention concentration (surface deposition) of 27 µg/cm2 .  In
this assessment, the 27 µg/cm2 Oxine-Copper retention level is assumed
to represent a maximum surface residue concentration, as a surrogate for
hand residue load. 

 

The palmar surface area of 3 fingers of a toddler, 20 cm2, is used to
estimate hand-mouthing as opposed to whole hand mouthing (USEPA, 2001
and 2005).

The rate of hand-to-mouth activity for outdoor playing is 7 events per
hour based on Freeman et. al (2001) at the 95th percentile.

 The exposure time (ET) is 2 hours and is consistent with the Agency’s
CCA assessment for time playing outdoors.  Although the 2 hour duration
represents “outdoor” time, it is used as a conservative estimate for
playing on decks and playsets.

The saliva extraction factor (SEF) is 50% and is based on the assumption
of 50 percent removal efficiency of residues from hands by human saliva
(USEPA, 2001 and 2005).

The mean body weight of a child, age 3, is 15 kg. 

	The results of the hand-to-mouth estimates are presented in Table 4.9. 
The estimated short-term MOEs for the hand-to-mouth exposure are above
the target MOE of 100 (MOEs = 7143 and 794) and therefore are not of
concern.  

Table 4.9: Residential Post-application Incidental Oral Exposures to
Oxine-Copper-treated Wood Products

Hand Residue concentration 

from DDAC Study (µg/cm2)	Finger

 Surface Area (cm2)	Exposure Frequency for Outdoor Playing (events/hr) 
Saliva Extraction Factor	Exposure Time (hrs/day)	Average Daily Oral Dose
a (mg/kg/day)	ST Oral MOEb

Target MOE = 100 

3.0

	20	7	50%	2	0.028	7143

Surrogate Hand Residue (Maximum Surface Residue) 

concentration from Oxine-Copper Spray-treated Lumber

 (MRID 436370-01 Study) (µg/cm2)









27.0





	0.252	794



a	Average Daily Oral Dose (mg/kg/day) = [hand t (either 3 μg/cm2  or 27
μg/cm2 ) x Hand SA (20 cm2) x SEF (50% as 0.50 ) x Frequency (7
events/hr) x Exposure Time (2 hrs/day) x 0.001 mg/μg] / BW (15 kg)

b	MOE  = NOAEL (mg/kg/day) / daily dose (mg/kg/day).  For incidental
oral exposures, the ST/IT (maternal) 	NOAEL is 200 mg/kg/day.  Target
MOE = 100.

		

	4.4.3	Data Limitations/Uncertainties

	There are several data limitations and uncertainties associated with
the residential handler and post-application exposure assessments. 
These include the following:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handler Exposure Database (USEPA, 1998) (See Appendix A for summaries of
these data sources). Most of the CMA data are of poor quality,
therefore, AD may request that confirmatory monitoring data be generated
to support the values used in these assessments. 

 

The quantities handled/treated were estimated based on information from
various sources, including HED’s Standard Operating Procedures (SOPs)
for Residential Exposure Assessments (USEPA 2000, and 2001) and the AD
Draft SOP use table.  In certain cases, no standard values were
available for some scenarios.  Assumptions for these scenarios were
based on AD estimates and could be further refined from input from
registrants. 

The low pressure spray unit exposure data from PHED were used to assess
outdoor applications of wood preservative coatings (exterior of homes). 
As the low pressure spray data are representative of treating low to mid
level range targets (shrubs/greenhouse benches) and the scenario
assessed in this document represents treatments that may also occur
above the waist, the unit exposure value may underestimate exposure to
the head and the upper body.

The methods used to estimate child and adult exposures to treated
textiles are highly conservative and based on approaches from the
Residential SOPs (USEPA 2000, and 2001) for contact with porous treated
surfaces (clothing, mattresses and carpets). Without data on actual
treated textile residues, dissipation or dermal transfer coefficients,
these scenarios have a high degree of uncertainty associated with them.
The registrants input will assist in refining the MOEs and confirming
the Oxine-Copper textile use patterns.    

In this assessment, incidental ingestion and dermal exposures to treated
wood were estimated using surrogate DDAC data (3 (g/cm2).  The degree of
uncertainty (under- or overestimation) associated with using the DDAC
hand residue data for dermal and oral exposure from contacting treated
lumber are unknown.  The amount of residue measured on the test
subjects’ hands is variable and may be influenced by the duration of
exposure, how often wood is contacted, and the degree of contact (i.e.,
do the hand residues from the DDAC study mimic a child’s play activity
on decks and playsets?). In comparison, measured wood retention data
from a chemical-specific leaching study (MRID 436370-01) were used as a
surrogate to represent potential residue load for child contact. The
maximum surface retention (surface deposition) measured from lumber
spray-treated with Oxine-Copper (27 (g/cm2) was used as a conservative,
high-end estimate. There is a high degree of uncertainty associated with
this value as well.

Data are not available to assess the levels of Oxine-Copper in soil
contaminated from Oxine-Copper-treated wood (e.g., above ground
fabricated components of decks or playsets). Because of this data gap,
EPA was not able to estimate residential post-application dermal and
incidental oral ingestion exposure to soil contaminated with
Oxine-Copper residues.  It is assumed that any soil residues attributed
to weathering of in-service wood (playsets) will remain near these
structures for potential child exposure. [Note: Soil migration study
data (MRIDs 429255-03, 429255-04) on file with the Agency for
Oxine-Copper indicate that between 88-90% of the applied active remained
in 0-6 cm of the tested soil columns, indicating limited leaching and
migration from soil matrices (USEPA, 2006c).]

5.0	RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION

	In order for a pesticide registration to continue, it must be shown
“that there is reasonable certainty that no harm will result from
aggregate exposure to pesticide chemical residue, including all
anticipated dietary exposures and other exposures for which there are
reliable information.” Aggregate exposure is the total exposure to a
single chemical (or its residues) that may occur from dietary (i.e.,
food and drinking water), residential, and other non-occupational
sources, and from all known or plausible exposure routes (oral, dermal,
and inhalation).  

In performing aggregate exposure and risk assessments, the Office of
Pesticide Programs has published guidance outlining the necessary steps
to perform such assessments (General Principles for Performing Aggregate
Exposure and Risk Assessments, November 28, 2001; available at
http://www.epa.gov/pesticides/trac/science/aggregate.pdf).  Steps for
deciding whether to perform aggregate exposure and risk assessments are
listed, which include: identification of toxicological endpoints for
each exposure route and duration; identification of potential exposures
for each pathway (food, water, and/or residential);  reconciliation of
durations and pathways of exposure with durations and pathways of health
effects; determination of which possible residential exposure scenarios
are likely to occur together within a given time frame; determination of
magnitude and duration of exposure for all exposure combinations;
determination of the appropriate technique (deterministic or
probabilistic) for exposure assessment; and determination of the
appropriate risk metric to estimate aggregate risk

	The use patterns of the products and probability of co-occurrence were
taken into account for the selection of which scenarios to incorporate
into the aggregate assessment.    SEQ CHAPTER \h \r 1 The following list
summarizes all of the potential sources of Oxine-Copper exposure for
adults and children that were considered for aggregate assessment as
detailed in the Preliminary Risk Assessment for this RED:

Adult Oxine-Copper exposure sources:

Dietary exposure from pulp/paper treated with Oxine-Copper

Dietary exposure from adhesives containing Oxine-Copper

Child Oxine-Copper exposure sources:

Dietary exposure from pulp/paper treated with Oxine-Copper

Dietary exposure to Oxine-Copper containing adhesives 

Incidental oral exposure to outdoor hard surfaces treated with
Oxine-Copper

Incidental oral exposure to treated tents/tarps

Incidental oral exposure to treated wood products (max. residue)

Dermal exposure to outdoor hard surfaces treated with Oxine-Copper

Dermal exposure to treated wood products (max. residue)

	5.1	Acute and Chronic Dietary Aggregate Risk

	Any risks pertinent to dietary exposures are discussed separately from
this chapter in the Preliminary Risk Assessment for this RED.

	5.2	  SEQ CHAPTER \h \r 1 Short- and Intermediate-Term Aggregate
Exposures and Risks

For Copper 8-Quinolinolate, a short-term non-dietary aggregate
assessment for adults is not performed.  Toxicity endpoints of concern
involving oral, dermal, and inhalation were selected from separate
studies with differing toxicological effects.  In addition, the nature
of the exposures from painting activities, mold remediation, and contact
with textiles (which are limited to industrial/government use items) are
episodic in nature and probability of co-occurrence is unlikely. 
Therefore, adult exposures are not aggregated.  Incidental oral exposure
was not assessed for adults nor were there any intermediate-term
scenarios developed for the dermal and inhalation routes.  

	For children/ toddlers, inhalation exposure was not assessed and
aggregation of incidental oral and dermal exposures is not performed
across routes of exposure as toxicity endpoints of concern were derived
from separate toxicity studies.  However, it is possible to aggregate
exposures within a route of exposure to the extent reasonable. Thus,
incidental oral exposures of children from mouthing of treated textiles
with hand-to-mouth activities and from exposure to treated outdoor hard
surfaces and lumber can be performed.   

Results of the short-term aggregate assessment for toddlers or children
to incidental oral post application exposures are presented in Table
5.2. 

Table 5.2. Short-term Aggregate  Risk Assessment for Incidental Oral
Exposures in Children

Exposure Routes	Exposure (mg/kg/day)	Margin of Exposure	Total MOE

Incidental oral aggregate

     -treated outdoor surfaces

     -mouthing textiles (tents/tarps)

     -surrogate hand residue (wood surfaces)	

0.00544

0.272

0.252	

36,765

735

794	

373



a: Aggregate MOE = 1/((1/MOE incid,oral) + (1/MOEincid,oral) +  (1/MOE
incid,oral)) where MOE = NOAEL (mg/kg/day) / absorbed daily dose
(mg/kg/day) [Incidental oral NOAEL (maternal): 200 mg/kg/day].

	Table 5.3 presents the results of short-term dermal aggregate exposure
and risk for children from dermal contact with treated outdoor hard
surfaces and treated wood.  The Margin of Exposure from children’s
dermal exposure from contact with treated textiles is alone of concern
(MOE = 50 assuming 5% residue transfer), and thus is not included in the
aggregate assessment.  Refinement of this exposure scenario is necessary
to arrive at a better estimate of risk.   

Table 5.3. Short-term Aggregate  Risks from  Dermal Exposures in
Children



Exposure Routes	Children

	Exposure (mg/kg/day)	Margin of Exposure

Treated Outdoor Hard Surfaces	0.0446	4,484

Wood Products	1.55	129

TOTAL MOE

125



a: Aggregate MOE = 1/ ((1/MOEtreated hard)  + (1/MOE wood products))
where MOE = NOAEL (mg/kg/day) / absorbed daily dose (mg/kg/day) [Dermal 
NOAEL (systemic): 200 mg/kg/day].

	The total MOEs for incidental oral exposure (MOE = 373) and for dermal
exposure (MOE = 125) are above the target MOE of 100 and hence are not
of concern. 	 

6.0	OCCUPATIONAL EXPOSURE ASSESSMENT

	6.1 	Summary of Registered Uses

	Potential occupational handler exposure can occur in various use sites,
which include food handling premises, commercial/industrial premises,
and even applications done in residential sites.  The exposure scenarios
assessed in this document for the representative uses selected by AD are
taken from Table 6.1. The table also shows the maximum application rate
associated with the representative use and the appropriate EPA
Registration number for the product label.  For handlers, the
representative uses assessed include various materials preservative and
wood preservative applications: mixing and loading of product
concentrates for materials preservative incorporation into
textile/paint/paper matrices (liquid pour/liquid pump of soluble
concentrates); application of treated paint (paint brush/roller and
airless sprayer) and protective wood coatings (low pressure sprayer);
and applications to outdoor hard surfaces for mold remediation
(brush/roller and low pressure sprayer).

	The “preservation of materials” refers to the scenario of a worker
adding the preservative to the material being treated through either
liquid pour or liquid pump methods.  Liquid pour refers to transferring
the antimicrobial product from a small container to an open vat.  Liquid
pump refers to transferring the preservative by connecting/disconnecting
a chemical metering pump from a tote or by gravity flow.  For the
preservation of wood at treatment plants and lumber mills, the methods
for treatment can vary (pressure/non-pressure), such that multiple
worker functions were analyzed.  Due to the complexity of the wood
preservative analysis, the results for handler and post-application
exposures are presented in a separate section, 6.4.





Table 6.1.  Representative Exposure Scenarios Associated with

 Occupational Exposures to Oxine-Copper



Representative Use	

Method of Application	

Exposure Scenario	

EPA Reg. No.	

Maximum Application Rate



Wood Preservatives (Use Site Category X)



Non-pressure treatment of wood and wood products in wood treatment
facilities 

	Handler Worker Functions

Diptank Operators

Blender/spray operators

Chemical operators

Post-Application Worker Functions

Graders

Trim saw operators

Clean-up crews

Construction Workers	

ST/IT/LT Handler & Post-application: Dermal and inhalation	3008-91

	Diptank operators and Blender/spray operators:

2.3 % ai water-borne treatment solution used (1:15 v/v dilution of
34.18% ai product)

Chemical operators and all other worker functions:

34.18% ai water-borne product concentrate handled.

 

Pressure treatment of wood and wood products in wood treatment
facilities 

	Handler Worker Functions

Treatment assistant

Treatment operator

Post-Application Worker Functions

Tram setter, stacker operator, loader operator, supervisor, test borer,
and tallyman	ST/IT/LT Handler & Post-application: Dermal and inhalation
2829-135;

2829-136	1.0 % ai solvent-borne treatment solution used (10% w/w
solution of 10% ai product) via vacuum/empty-cell methods

General Preservation of wood in commercial sites (non-pressure treatment
applications to wood including indirect food contact wood) 

	Brush/Spray and Dip methods employed for this use pattern 	ST/IT
Handler: Dermal and Inhalation 

	2829-135;

2829-136

	Dip 1.0 % a.i. solvent-based treatment solution (applied at a rate of
10% w/w of 10 % a.i. product)





	1022-489;

75675-1	Brush  3.3% ai water-based treatment solution (1:3dilution of
10% ai product) for ground-contact wood



Wood Preservative Coatings/ Water Repellents

	Paint brush,

Roller and Low-pressure coarse sprayer 

	ST/IT Handler: Dermal and Inhalation	1022-504;  1022-514; 81819-1
0.675%-0.8% ai ready-to-use (RTU) water and oil-based exterior coatings
for log homes, wood roofs, siding, fences, rough sawn lumber, new/old
wood. 150-300 sq ft/gal. as one coat application.

Material Preservatives (Use Site Category VII)



Paints/Coatings 

(in-can preservative incorporation)	

Preservation of paint

Liquid pour

Liquid pump

Commercial/

Professional painter

Brush/Roller

Airless sprayer

	

ST/IT/LT Handler: Dermal and Inhalation

ST/IT Prof Painter:

Dermal and Inhalation (aerosol particulate) 6	

2829-136

Treated article preserved with 2829-136 (e.g., exterior house paint) 	

1.0 % a.i. incorporation by volume of the material to be treated (10 %
product by volume treated x 10 % a.i. in product) Note: Adhesives are
incorporated at 0.1 % ai 

[Solvent-based]





Paper and Paperboard 

	Liquid pump

(i.e., incorporation at the size press during manufacture of paper and
paperboard sheets)

	

ST/IT/LT Handler: Dermal and Inhalation	

2829-112

	

0.24% a.i. incorporation by weight of the material to be treated (3.2%
product by weight of material treated x 7.5% a.i. in product)

[Water-based]



	Brush/Spray and Dip impregnation methods employed for this use pattern

1022-489;

75675-1

	0.4% ai water-based treatment solution impregnation (1:25 dilution of
10% ai products)





Textiles

[Industrial-use and government-specified (e.g., military-issued)
cloth/webbing/ropes used for tents/tarps, cotton duck/canvas, paper,
paperboard for shoe construction]	

Liquid pour

Liquid pump

(i.e., incorporation at the padder during textile processing)

Brush/ 	

ST/IT/LT Handler: Dermal and Inhalation

	2829-42;

2829-49;

2829-112

	

0.7% ai (industrial-use) to

1.0 % ai (government-use) incorporation by weight of the material to be
treated (10 % w/w  of 10 % a.i. products for 2829-42 and 2829-49)

[Solvent- & Water-based]



	Brush/Spray and Dip impregnation methods employed for this use pattern

2829-135;

2829-136;

60061-22

	Mildew inhibitor to cotton duck, canvas, cotton webbing and rope

Dip: 

0.2% ai to 1.0 % ai (government-use);

1.0% ai as RTU (60061-22)

[Solvent-based]



Material Preservatives (Use Site Category VII)



Environmental Outdoor Hard Surface Treatments 

(i.e., mold and mildew control treatments to exterior environmental
surfaces )	

Brush/Spray

Tank-type garden sprayer  (i.e., Low pressure sprayer)	

ST/IT Handler: Dermal and Inhalation

	

1022-489;

1022-490;

75675-1

	

0.1% ai water-based treatment solution (1:100 dilution of 10% ai
product; 1:50 dilution of 5% ai product) used on paint/varnish,
concrete, brick, glass, tile, metals, plastic, wood, (paper)*,
(leather)*, textiles and asphalt shingles.

* - Treatments to these materials may indicate potential indoor uses.
Clarification of labeling is needed. 





Food Handling/Storage Establishments, Premises and Equipment (Use Site
Category II)



Indoor Hard Surfaces Disinfection for Potato Ring Rot

  

(e.g., potato processing planters, seed handling equipment, seed
cutters, storage areas, truck/railcar transportation equipment.)

	

Spray- Low pressure spray non-mist nozzle 20 psi	

ST/IT Handler: Dermal and Inhalation	

1022-489;

1022-490; and 

75675-1	

0.05% ai water-based treatment solution (1:200 dilution of 10% ai
product; 1:100 dilution of 5% ai product)

Note: Only EPA registered products with specified use directions/use
applications are included in this table.  Products listed were selected
based on maximum use rates by application method.  

ST = Short-term exposure, IT = Intermediate-term exposure, LT= Long-term
exposure. 

6 Handler dermal and inhalation  exposure (to aerosol  particulates)
were assessed for Oxine-Copper using PHED unit exposures. 

	       6.2   Occupational Handler Exposures

	Certain occupational handler scenarios included in Table 6.1 were
assessed to determine dermal and inhalation exposures.  If application
methods were similar across use patterns, then only those scenarios with
maximum application rates were assessed as representative of potential
exposure for the other handler scenarios.  The general assumptions and
equations that were used to calculate occupational handler risks are
provided in Section 1.2, Criteria for Conducting the Risk Assessment.
The majority of the scenarios were assessed using CMA data and Equations
1-3.  However, for the occupational scenarios in which CMA data were
insufficient, other data and methods were applied. 

	

Unit Exposure Values (UE):  Dermal unit exposure values were taken from
the proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handlers Exposure Database (USEPA, 1998).  

For the liquid pour scenarios for materials preservatives, the unit
exposure depends on the material being treated.  The following CMA unit
exposures were available and used for the assessment of the risk
associated with the treatment of the specified materials.

 Paint and Textiles: CMA preservative gloved data.  The dermal UE is
0.135 mg/lb a.i. and the inhalation UE is 0.00346 mg/lb a.i.. The values
are based on 2 replicates where the test subjects were wearing a single
layer of clothing and chemical resistant gloves. Since no baseline
dermal (unlgoved) unit exposure data are available for preservative uses
in paints or textiles, the baseline dermal exposures were evaluated
using the cooling tower CMA data (50.3 mg/lb ai). 

For the liquid pump scenarios, the unit exposure depends on the material
being treated. The following CMA unit exposures were available and used
for the assessment of the risk associated with the treatment of the
specified materials.

 Paint and Textiles:  CMA preservative gloved data.  The dermal UE is
0.00629 mg/lb a.i. and the inhalation UE is 0.000403 mg/lb a.i.  The
values are based on two replicates where the test subjects were wearing
a single layer of clothing and chemical resistant gloves. Since no
baseline dermal (unlgoved) unit exposure data are available for
preservative uses in paints or textiles, the baseline dermal exposures
were evaluated using the cooling tower CMA data (0.454 mg/lb ai). 

Pulp and Paper:  CMA pulp and paper gloved data.  The dermal UE is
0.00454 mg/lb a.i. and the inhalation UE is 0.000265 mg/lb a.i. The
values are based on 7 replicates where the test subjects were wearing a
single layer of clothing and chemical resistant gloves. Since no
baseline dermal (unlgoved) unit exposure data are available for
preservative uses in adhesives, paint, or textiles, the baseline dermal
exposures were evaluated using the cooling tower CMA data (0.454 mg/lb
ai). Only closed application methods were assessed for pulp/paper based
on industrial practices. Therefore, a liquid pour scenario for
preservation of paper/paperboard with Oxine-Copper was not developed.

For the low pressure sprayer (course spray) scenarios, the occupational
PHED dermal and inhalation unit exposure values for a handler pouring a
pesticide and applying it via a low pressure sprayer (handwand) were
used (PHED scenario 32).  The unit exposure values of 100 mg/lb a.i. for
ungloved dermal, 0.43 mg/lb a.i. for gloved replicates, and 0.030 mg/lb
a.i. for inhalation represent a handler treating low and mid-level
targets, generally below the waist (greenhouse benches and shrubs) while
wearing a single layer of clothing. 

For roller/brush scenarios, the occupational PHED dermal and inhalation
unit exposure values for paintbrush applications (PHED scenario 22) were
used (single layer of clothing).  The inhalation exposure value is 0.28
mg/lb a.i. The dermal unit exposures are 180 mg/lb a.i. for ungloved
replicates and 24 mg/lb a.i. for gloved replicates. 

For the airless sprayer scenario, the occupational PHED dermal and
inhalation unit exposure values for airless sprayer application (PHED
scenario 23) were used (single layer of clothing). The inhalation
exposure value is 0.83 mg/lb a.i. The dermal unit exposures are 38 mg/lb
a.i. for ungloved replicates and 14 mg/lb a.i. for gloved replicates. 

Quantity handled/treated: The quantity handled/treated values were
estimated based on information from various sources.  The following
assumptions were made:

For the liquid pour scenarios, the quantity of the chemical that is
handled depends on the material that is being treated.  The following
values were used for the different materials:

Paint:  2,000 lbs (approximately 200 gallons, weight based on a density
10 lb a.i./gal) (USEPA, 2005).	

Textiles:  10,000 lbs (USEPA, 2005).

For the liquid pump scenarios the quantity that is handled depends on
the material that is being treated.  The following values were used for
the different materials:

Paint:  10,000 lbs (approximately 1,000 gallons, weight based on a
density of 10 lb a.i./gal) (USEPA, 2005).

Textiles:  10,000 lbs (USEPA, 2005).

Paper/Papeboard:  These applications are expected to be similar to
textile treatments, but a standard value of 500 tons is used as a
high-end assumption (500 tons x 2204.622 lb/ton = 1102311 lbs). 

For the low pressure sprayer (course spray) scenarios, it was assumed
that 100 lbs (approximately 12 gallons of water-based treatment solution
having a density of water 8.34 lb/gal) are used for the outdoor hard
surface treatments (Agency assumption); and for the wood coating
scenario it was assumed that 500 lbs (approximately 50 gallons of paint
with a density of 10 lb/gal) of treated paint are used. (USEPA, 2005).

For the roller/brush painting scenario, it was assumed that 50 lbs
(approximately 5 gallons of paint with a density of 10 lb/gal) of
treated paint are used (USEPA, 2005).

For the airless sprayer scenario, it was assumed that 500 lbs
(approximately 50 gallons of paint with a density of 10 lb/gal) of
treated paint are used. (USEPA, 2005).

Duration of Exposure: The MOEs were calculated as ST/IT dermal and
ST/IT/LT inhalation based on end-point selection in Table 3.2.  It is
assumed however, that occupational handlers will have exposures of
short- and intermediate-term durations only.   

Exposure Calculations and Results

	The resulting exposures and MOEs for the representative occupational
handler scenarios are presented in Table 6.2. The calculated dermal MOEs
were all above the target MOE of 100 with the use of glove PPE. Baseline
dermal estimates for workers without gloves indicated risk concerns for
certain scenarios listed below.   It should be noted that the baseline
(ungloved) dermal MOEs for the material preservation of paints, textiles
and paper were calculated using unit exposure values (liquid pour/liquid
pump) from the cooling tower CMA data set because data for baseline
dermal unit exposures were not available for preservative scenarios.   

General wood preservative brush applications: ST/IT MOE = 47.

Painting (professional) wood coatings, low pressure sprayer: ST/IT MOE =
35.

Painting (professional) treated paint, airless sprayer: ST/IT MOE = 74.

Paper preservation, liquid pump: ST/IT MOE = 12.

Paint preservation, liquid pour: ST/IT MOE = 14.

Textile preservation, liquid pour: ST/IT MOE = 3.

	Most inhalation MOEs were above the target MOE of 1000, except for the
scenarios  indicated below.  It should be noted that for MOEs below
1,000 the Agency may request a confirmatory inhalation toxicity study to
refine the potential risks since the current inhalation endpoint is
based on an oral NOAEL.  

General wood preservative brush applications: ST/IT/LT MOE = 758.

Paper preservation, liquid pump: ST/IT/LT MOE = 500.

Painting (professional) treated paint, airless sprayer: ST/IT/LT MOE =
83 / 833 (PPE).

	6.3  	Occupational Post-application Exposures

	Except for the post-application scenarios assessed for wood
preservatives in Section 6.4, occupational post-application exposures
are assumed to be negligible. 	

	

Table 6.2  Short-, Intermediate-, and Long-Term Risks Associated with
Occupational Handlers



Exposure Scenario	

Method of Application	

Unit Exposure (mg/lb a.i.)	Application Rate (% a.i. by weight)	

Quantity Handled/ Treated per day	

Absorbed Daily Dose (mg/kg/day)c	

MOEd





Baseline Dermala	

PPE-Gloves Dermalb	

 Inhalation

	

Baseline Dermala

	

PPE-

Gloves Dermalb

	Inhalation

	

Baseline Dermal

 (Target MOE = 100)a	

PPE-Gloves Dermal

 (Target MOE = 100) b	Inhalatione

 

(Target MOE = 1000)











ST/IT	

ST/IT	ST/IT/LT



Wood Preservatives (Use Site Category X) *



General Wood Preservative Application by Professionals	Brush	180	24	0.28
0.033	50 lbs	4.24	0.566	0.0066	47	353	758

Application of Wood Coatings by Professionals	

Brush/ Roller	180	24	

0.28	0.008	

50 lbs	1.03	0.137	0.0016	194	1,460	3,125

	

Low Pressure Sprayer	100	0.43  	0.030	0.008	

500 lbs	5.71	0.025	0.0017	35	8,000	2,941

Material Preservatives (Use Site Category VII)

Preservation of  Paper and Paperboard

	

Liquid Pump	0.454	0.00454	0.000265	0.0024	

(500 tons) 

1,102,311 lbs	17.16	0.172	0.01	12	1,163	500

	Brush

	180	24	0.28	0.004	50 lbs	0.514	0.069	0.0008	389	2,898	6,250



Preservation of Paint

(in-can preservative)

	

Liquid Pour

	50.3	

0.135	

0.00346	

0.01	

2,000 lbs	14.37	0.039	0.001	14	5,128	5,000

	

Liquid Pump	0.454	

0.00629	

0.000403	

0.01	

10,000 lbs	0.649	0.0089	0.0006	308	22,472	8,333



Preservation of Textiles

	

Liquid Pour

	50.3	

0.135	

0.00346	

0.01	

10,000 lbs	71.86	0.193	0.005	3	1,036	1,000

	

Liquid Pump	0.454	

0.00629	

0.000403	

0.01	

10,000 lbs	0.649 	0.0089 	0.0006	308	22,472	8,333

Material Preservatives (Use Site Category VII)



Application of Treated Paint by Professionals

	

Brush/ Roller	

180	

24	

0.28	

0.01	

50 lbs	1.29	0.17	0.002	155	1,176	2,500

	

Airless Sprayer	

38	

14	

0.83	

0.01	

500 lbs	2.71	1.0	0.060	74	200	83	833

PPE

Commercial application to outdoor hard surfaces 	Low Pressure Sprayer
100	0.43	0.030	0.001	100 lbs	0.143	0.00061	0.000043	1,399	327,869
116,280

	

	* Note:  Other Occupational scenarios for Wood Preservatives are
assessed separately in Section 6.4.

	

	ST= Short-term;  IT = intermediate-term, NA= No data available (or not
applicable for dermal absorption factor).

	Unit Exposure (UE) Data from CMA for most scenarios. PHED data used for
Brush/Roller and Airless Sprayer.

	a	Baseline Dermal:  Long-sleeve shirt, long pants, no gloves. It should
be noted that the baseline dermal unit exposures for the preservation of
paper, paint and textiles were from the cooling tower CMA data set
because baseline (ungloved) dermal unit exposures are not available for
the CMA data set on preservatives. 

 	b	PPE Dermal with gloves: baseline dermal plus chemical-resistant
gloves.  No gloved replicates available for CMA Low Pressure Spray
scenario.

	c	Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) *
absorption factor (NA for dermal; 100% (1.0) for  inhalation) *
application rate * quantity treated / Body weight (70 kg).

	d	MOE = NOAEL  (mg/kg/day) / Absorbed Daily Dose [Where ST/IT Dermal
NOAEL (systemic)  = 200 mg/kg/day; ST/IT/LT Inhalation NOAEL = 5
mg/kg/day].

	e	For PHED data, a protection factor of 90% can be applied to UE values
to represent use of organic vapor respirators as PPE.  Any PHED Baseline
inhalation painting scenarios (Brush/Roller or Airless Sprayer) with
MOEs below the target of 1000 were also assessed for use of PPE.



	

	6.4 	Wood Preservation

	Oxine-Copper is used industrially as a stand-alone preservative to
control sapstain, and protect against mold/mildew in softwood or
hardwood lumber.  It can also protect against insect damage for wood
used in mainly above-ground use applications.  Where ground- contact
protection is needed, usually higher concentrations of preservative
treatment solutions are used and applied via non-pressure methods  Wood
treated with Oxine-Copper has a greenish-brown color, and little or no
odor.

	Registered uses for Oxine-Copper include several wood preservative
treatments as wood surface coatings (e.g., water repellents applied via
brush, roller or spray) and impregnation into wood via non-pressure
(e.g., non-pressure dipping/immersion) and pressure techniques
(vacuum/empty-cell).  The products can be used on many different types
of wood including 1) green or fresh cut/debarked lumber, poles, posts,
and timbers; 2) manufactured wood products such as logs (including for
log home construction), plywood, and particle board (wood composites);
3) dry lumber; and 4) finished wood products such as millwork, shingles,
shakes, siding, plywood and structural lumber. The majority of the
products are intended for use at wood treatment facilities, 

	The exposure scenarios assessed in this document for the representative
wood preservation uses selected by AD are shown in Table 6.1.  Section
6.4.1 presents the exposure analysis for the handler and
post-application scenarios for non-pressure treatment scenarios and
Section 6.4.2 presents the exposure analysis for the handler and
post-application scenarios for pressure treatment scenarios. 

	6.4.1 	Non-Pressure Treatment Scenarios (Handler and Post-application)

	6.4.1.1		Scenarios Assessed by Worker Function 

	Handler and post-application scenarios that have been identified and
assessed using surrogate data.  The proprietary study, “Measurement
and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl
Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase
III)” (Bestari et al., 1999, MRID 455243-04) identified various worker
functions/positions for individuals that handle DDAC-containing wood
preservatives for non-pressure treatment application methods and for
individuals that could then come into contact with the preserved wood.
Representative worker functions/positions identified in the DDAC study
are presented below. It was assumed that the workers at facilities using
Oxine-Copper wood preservatives, and handling the treated wood are
performing similar tasks as those monitored in the DDAC study. This
study was sponsored by an industry consortium [Sapstain Industry Group
(SIG) Task Force # 73154]; therefore, data compensation issues apply for
use of these data as a surrogate source in assessing exposure.  

Handler:

Blender/spray operators are workers that add the wood preservative into
a blender/sprayer system for composite wood via closed-liquid pumping.

Chemical operators for a spray box system consist of chemical operators,
chemical assistants, chemical supervisors, and chemical captains.  These
individuals maintain a chemical supply balance and are assigned the task
of flushing and cleaning spray nozzles. 

Diptank Operators can be in reference to wood being lowered into the
treating solution through an automated process (i.e.: elevator diptank,
forklift diptank).  This scenario can also occur in a small scale
treatment facility in which the worker can manually dip the wood into
the treatment solution.

Post-application: 

Graders are expected to be positioned right after the spray box
sequence, where they grade the dry lumber by hand (i.e. detect faults). 
In the DDAC study, graders graded wet lumber; therefore, the exposures
to graders using Oxine-Copper are assumed to be the worst-case
scenarios.    

Trim saw operators operate the hula trim saw and consist of operators
and strappers.  In the DDAC study, hula trim saw operators handled dry
lumber. 

Millwrights repair all conveyer chains and are involved in a general
up-keep of the mill.  

Clean-up crews perform general cleaning duties at the mill.

Construction workers install treated plywood, oriented strand board,
medium density fiberboard, and others.  

	In lieu of chemical-specific data available regarding typical exposures
to Oxine-Copper as a wood preservative, surrogate data were used to
estimate exposure risks. The blender/spray operator position was
assessed using CMA unit exposure data and the remaining handler and
post-application positions were assessed using data from the DDAC study
(Bestari et al., 1999). 

Blender/Spray Operators

	Exposures and risks to the blender/spray operators were assessed using
Equations 1 through 3 in Section 1.2.  The surrogate unit exposures were
taken from the CMA study (USEPA, 1999).  Specifically, the liquid pump
preservative unit exposures for gloved workers were used in this
assessment.  The dermal unit exposure was 0.00629 mg/lb ai and the
inhalation unit exposure was 0.000403 mg/lb ai. These values are based
on two replicates where the test subjects were wearing a single layer of
clothing and chemical resistant gloves.  The quantity of the wood being
treated was derived from other wood preservative estimates (USEPA, 2004)
for the amount of wood slurry treated because no chemical specific data
were available for Oxine-Copper.  It was assumed that batches of wood  
SEQ CHAPTER \h \r 1 slurry are treated in 10,000 gallon tanks, and that
eight batches of wood slurry are treated per day (one per hour for an
8-hr work shift).  Additionally, it was assumed that each batch requires
3,000 gallons of preservatives and the remainder volume of the tank
consists of wood slurry (7,000 gallons of wood slurry per batch).  Since
wood chips have a density of approximately 380 kg/m3 (SIMetric, 2005),
the total amount of wood slurry treated per day would be 178,000 lbs
(i.e., 8 batches/day * 7,000 gallons/batch * 0.003785 m3/gallon * 380
kg/m3 * 2.2 lb/kg).    SEQ CHAPTER \h \r 1 The assumptions used for
batch sizes and the quantity of preservative needed are consistent with
an assessment performed previously by the EPA. The Oxine-Copper
assessment was conducted based on use-application of a 2.3 % ai
solution.  This represents the maximum application rate for both diptank
and spray methods for sapstain treatment as per product labeling for EPA
Reg. No. 3008-91.  This product is a 34.18 % ai concentrate used to make
water-based treatment solutions of up to 2.3% ai [i.e., 1:15 v/v use
dilution (0.0666) x 34.18 % ai in product = 2.3 % ai].  Product labeling
cites use of eye protection and rubber gloves as PPE.

	Table 6.3 provides the short-, intermediate-, and long-term doses and
MOEs for the blender/spray operators adding the preservative to the wood
slurry.  The dermal ST/IT MOE was 540 which is above the target MOE of
100 and therefore not of concern.  The inhalation ST/IT/LT MOE was below
the Agency target of 1,000, as 212, denoting a potential risk concern. 
For inhalation MOEs below 1,000 the Agency may request a confirmatory
inhalation toxicity study since the current inhalation endpoint is based
on an oral NOAEL.

Table 6.3. Short-, Intermediate-, and Long-term Exposures and MOEs for
Wood Preservative Blender/Spray Operators

Exposure Scenario

	Dermal Unit Exposurea

(mg/lb ai)	Inhalation Unit Exposureb

(mg/lb ai)	Application Ratec

(% ai in solution/

day)	Wood Slurry Treatedd

(lb/day)	Absorbed Daily Dosee 

(mg/kg/day)	MOEsf





	Dermal	Inhalation	Dermal

ST/IT

Target=100	Inhalation

ST/IT/LT

Target = 1000

Occupational Handler

CMA Liquid Pump	0.00629	0.000403	2.3	178,000	0.37	0.0236	540	212

ST =	Short-term duration; IT =Intermediate-term duration; and LT =
long-term.

Dermal unit exposure: Single layer clothing with chemical resistant
gloves.

Inhalation unit exposure: Baseline, with no respirator.	

c.	The maximum application rate for both diptank and sapstain spray
application methods is 2.3% ai solution based on product labeling
(3008-91).  

d.	Wood slurry treated = (8 batches/day * 7,000 gallons/batch * 0.003785
m3/gallon * 380 kg/m3 * 2.2 lb/kg)	

e.	Absorbed Daily Dose = unit exposure (mg/lb ai) x App Rate (% ai/day
as 2.3%; the ai weight fraction is 0.023) x Quantity treated (lb/day) x
absorption factor (NA for dermal and 100% for inhalation) / BW (70 kg)

f.	MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL =
200 mg/kg/day for dermal and 

	ST/ /IT/LT NOAEL = 5 mg/kg/day for inhalation].  Target MOE is 100 for
dermal exposure and 1000 for inhalation 	exposure.

Chemical Operators, Graders, Millwrights, Clean-up Crews, and Trim Saw
Operators

	Exposures to chemical operators, graders, millwrights, trim saw
operators, and clean-up crews were assessed using surrogate data from
the DDAC study (Bestari et al., 1999). This study examined
individuals’ exposure to DDAC while working with anti-sapstains and
performing routine tasks at 11 sawmills/planar mills in Canada.  Dermal
and inhalation exposure monitoring data were gathered for each job
function of interest using dosimeters and personal sampling tubes. 
These sample media were then analyzed for DDAC, and the results were
reported in terms of mg DDAC exposure per person per day.  The study
reported average daily exposures for workers in various categories. 
Exposure data for individuals performing the same job functions were
averaged together to determine job specific averages.  Total exposures
from 2 trim saw workers, 13 grader workers, 11 chemical operators, 3
millwrights, and 6 clean-up staff were used. 

	The individual dermal and inhalation exposures from the DDAC study are
presented in Table B-1 in Appendix B.  To determine Oxine-Copper
exposures, the average DDAC exposures measured on individuals (in terms
of total mg DDAC) were multiplied by a modification factor of 0.427 to
account for the difference in percent active ingredient between
Oxine-Copper and DDAC (34.18 % Oxine-Copper in the wood preservative
product versus 80% DDAC in the comparative wood preservative product).
The pound (lb) active ingredient handled by each person or the percent
(%) active ingredient in the treatment solution was not provided for
these worker functions. 

The following equation was used to calculate daily dose for
Oxine-Copper: 

Daily Dose = DDAC UE x CR x AB 

           	         BW

Where

DDAC UE	=	DDAC dermal or inhalation unit exposure (mg/day);

CR		=	Conversion ratio (34.18 % Oxine-Copper / 80% DDAC) ;

AB	=	Absorption factor (NA for dermal, 100% for inhalation); and

BW		=	Body weight (70 kg).

In using this methodology, the following assumptions were made:

DDAC and Oxine-Copper end products will be used in similar quantities. 

The procedures for applying both chemicals are similar. 

The physical-chemical properties that affect the transport of the
chemical are similar. (This assumes similar product densities for the
DDAC and Oxine-Copper water-borne solutions).

The limits of detections (LOD) for inhalation residues from   SEQ
CHAPTER \h \r 1 chemical operators, graders, mill wrights, and clean-up
staff replicates were not provided in the DDAC report.  For lack of
better data, it was assumed that the inhalation LODs for these worker
positions are equal to the LOD of the diptank operator replicates (5.6
(g).  For all measurements below the air concentration associated with
this detection limit, half the detection limit was used.  The dermal LOD
for all operators is also 5.6 (g.

In the DDAC study, dermal exposures to hands were measured separately
from the rest of the body.  For each replicate, the body dose
measurements and hand dose measurements were summed for a total dermal
dose.

Air concentrations were reported in the DDAC study. To convert air
concentrations ((g/m3) into terms of inhalation unit exposure (mg/day),
the air concentrations were multiplied by an inhalation rate of 1.0
m3/hr for light activity (EPA 1997a), sample duration of 8 hrs/day, and
a conversion factor of 1 mg/1000 (g.  Table B-1 in Appendix B presents
the inhalation and dermal DDAC exposures.

Average DDAC dermal and inhalation exposures were multiplied by a
conversion ratio of 0.427 to account for the differences in Oxine-Copper
and DDAC concentrations [i.e., (34.18 % Oxine-Copper / 80% DDAC)].  

Table 6.4 provides the short-, intermediate-, and long-term doses and
MOEs for chemical operators, graders, millwrights, clean-up crews, and
trim saw operators.  For all worker functions, the dermal MOEs are above
the target MOE of 100 for ST/IT durations assessed.  For all worker
functions, the inhalation MOEs are above the target MOE of 1000 for
ST/IT/LT durations, and therefore are not of concern. Therefore, a
confirmatory inhalation toxicity study is not warranted based on the
results of this assessment.

Table 6.4. Short-, Intermediate- and Long-Term Exposures and MOEs for
Wood Preservative Chemical Operators, Graders, Trim Saw Operators, and
Clean-Up Crews

Exposure Scenarioa 

(number of volunteers)	Dermal UEb 

(mg/day)	Inhalation UEb 

(mg/day)	Conversion Ratioc 	Absorbed Daily Dosesd 

(mg/kg/day)	MOEse





Dermal	Inhalation	Dermal

ST/IT

Target = 100	Inhalation

ST/IT/LT

Target = 1000

Occupational Handler



Chemical Operator (n=11)	9.81	0.0281	0.0427	0.060	0.00017	3,333	29,412

Occupational Post-application



Grader (n=13)	3.13	0.0295	0.0427	0.019	0.00018	10,526	27,778



Trim Saw (n=2)	1.38	0.061	0.0427	0.0084	0.00037	23,809	13,513



Millwright (n=3)	12.81	0.057	0.0427	0.078	0.00035	2,564	14,286



Clean-Up (n=6)	55.3	0.60	0.0427	0.337	0.0037	593	1,351

ST = 	Short-term duration; IT = Intermediate-term duration; and LT =
long-term

a.	The exposure scenario represents a worker wearing either long-sleeved
or short-sleeved shirts, cotton work trousers, and cotton glove
dosimeter gloves under chemical resistant gloves. Volunteers were
grouped according to tasks they conducted at the mill.

b.	Dermal and inhalation unit exposures are from Bestari et al (1999). 
Refer to Table B-1 in Appendix B for the calculation of the dermal and
inhalation exposures. Inhalation exposure (mg/day) was calculated using
the following equation: air concentration ((g/m3) x inhalation rate (1.0
m3/hr) x sample duration (8 hr/day) x unit conversion (1 mg/1000 (g). 
The inhalation rate is from USEPA, 1997a. 

c.	Conversion Ratio = 34.18% Oxine-Copper / 80% DDAC

d.	Absorbed Daily dose (mg/kg/day) = exposure (mg/day) * conversion
ratio (0.427) * absorption factor (NA for dermal and 100% for
inhalation)/body weight (70 kg). 

e.			MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL
= 200 mg/kg/day for dermal and ST/IT/LT NOAEL = 5 mg/kg/day for
inhalation]. Target MOE is 100 for dermal exposure and 1000 for
inhalation exposure.

Diptank Operators

	Exposures to diptank operators were also assessed using surrogate data
from the DDAC study (Bestari et al., 1999). The diptank scenario
assessment was conducted differently than for the other job functions
because the concentration of DDAC in the diptank solution was provided. 
Typical registered product use rates for dip treatments (dipping,
diptank, immersion) are at levels of 0.11% to 1.25% ai. Non-pressure dip
treatment of wood intended for ground contact is usually specified for
levels of 1.0% ai or more. The exposures were estimated based on the
maximum application rate for dipping treatment to control sapstain cited
on product labeling for EPA Reg. No. 3008-91 which is a 34.18 % ai
concentrate used to make water-based treatment solutions of up to 2.3%
ai [i.e., 1:15 v/v use dilution (0.0666) x 34.18 % ai in product = 2.3 %
ai].  Product labeling cites use of eye protection and rubber gloves as
PPE.

	The exposure data for diptank operators wearing gloves were converted
into “unit exposures” in terms of mg a.i. for each 1% of
concentration of the product. The calculation of the dermal and
inhalation unit exposures (2.99 and 0.046 mg/1% solution, respectively)
is presented in Table B-2 in Appendix B.  The air concentrations
presented in the DDAC study were converted to unit exposures using an
inhalation rate of 1.0 m3/hr (light activity) and a sample duration of 8
hrs/day.

The following equations are used to estimate dermal and inhalation
handler exposure: 

Daily Dose = DDAC UE x AI x AB 

		BW

Where

DDAC UE	=	DDAC dermal unit exposure (mg/ 1% in solution);

AI		=	AI (2.3% ai in solution/day);

AB	=	Absorption factor (NA for dermal, 100% for inhalation); and

BW		=	Body weight (70 kg).

	Table 6.5 provides the short-term and the intermediate- and long-term
doses and MOEs for diptank operators. The dermal ST/IT MOE was 2.037
which is above the target MOE of 100 and therefore not of concern.  The
inhalation ST/IT/LT MOE exceeded the Agency target of 1,000, as 3,311,
and is also not of concern.  Therefore, a confirmatory inhalation
toxicity study is not warranted based on the results of this exposure
scenario.



 Table 6.5.  Short-, Intermediate-, and Long-Term Exposures and MOEs
for Diptank Operator 

Exposure Scenarioa

(number of replicates)	Dermal Unit Exposureb 

(mg DDAC/1% solution)	Inhalation Unit Exposureb 

(mg DDAC/1% solution)	App Rate 

(% a.i. in solution/ day)c 	Absorbed Daily Dosesd 

(mg/kg/day)	MOEse





Dermal	Inhalation	Dermal

ST/IT

 

Target MOE = 100	Inhalation

ST/IT/LT 

Target MOE = 1000

Occupational Handler



Dipping, with gloves (n=7)

	2.99	0.046	2.3	0.0982	0.00151	

2,037

	3,311

ST = 	Short-term duration;  IT =Intermediate-term duration; and LT =
long-term.

a. 	The exposure scenario represents a worker wearing long-sleeved
shirts, cotton work trousers, and gloves. Gloves were worn only when
near chemical, not when operating the diptank.

b.	Dermal and inhalation unit exposures are from DDAC study (MRID
455243-04). Refer to Table B-2 in Appendix B for the dermal and
inhalation unit exposure calculations. Inhalation exposure (mg) was
calculated using the following equation: Air concentration (mg/m3) x
Inhalation rate (1.0 m3/hr) x Sample Duration (8 hr).  The inhalation
rate is from USEPA, 1997a.

c.	The maximum application rate for sapstain control dip application
method is 2.3% ai solution (3008-91).  

d.	Absorbed Daily dose (mg/kg/day) = unit exposure (mg/1% ai solution) *
percent active ingredient in solution (2.3) * absorption factor (NA for
dermal and 100% for inhalation) / body weight (70 kg).

e.			MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL
= 200 mg/kg/day for dermal and ST/IT/LT NOAEL = 5 mg/kg/day for
inhalation]. Target MOE is 100 for dermal exposure and 1000 for
inhalation exposure.

Construction Workers

	Not enough data exists to estimate the amount of exposure associated
with construction workers who install treated wood.  In particular,
values for the transfer coefficient associated with a construction
worker handling the wood could not be determined. However, it is
believed that the construction worker using a trim saw will have larger
dermal and inhalation exposures than the installer, due to the amount of
sawdust generated and the greater amount of hand contact that would be
necessary to handle the wood when using a saw compared to installing the
wood.



	6.4.2	Pressure Treatment Scenarios (Handler and Post-Application)

	

	Oxine-Copper wood preservatives may be used to treat wood and wood
products using pressurized application methods, specifically empty-cell
vacuum pressure techniques.  Pressure treatment solutions of solubilized
Oxine-Copper are predominantly oil or solvent-based.  However, there are
a few water-borne products registered as well. Typical registered
product use rates for pressure treatment are at levels of 0.25% ai. The
maximum rate of application used in this assessment is 1% ai solution
based on product labeling for EPA Reg. Nos. 2829-135 and 2829-136 which
are 10% ai concentrates, and indicate that pressure treatment use
solutions of up to 1% ai can be made [i.e., 10% w/w use dilution (10) x
10% ai in product (0.10) = 1% ai].  

	Oxine-Copper is listed in the American Wood-Preservers’Association
(AWPA) Book of Standards for treatment of several softwood species used
in exposed, above-ground applications. AWPA has standardized oil-borne
treatments using solubilized Oxine-Copper in their AWPA Standard P8 for
oil-borne preservatives.  The minimum specified retention (as
Oxine-Copper active ingredient) for these applications is 0.32 kg/m3
(0.02 lb/ft3).

	Chemical-specific exposure data are not available on Oxine-Copper for
assessment of pressure treatment exposure.  Therefore, the assessment
relies on surrogate chromated copper arsenate (CCA) data (ACC, 2002) and
was based on the approach used in a previous Agency exposure assessment
(USEPA, 2003).  

Surrogate Unit Exposure Data

	

	Dermal and inhalation exposures for pressure treatment uses are derived
from information in the exposure study sponsored by the American
Chemistry Council (2002) entitled “Assessment of Potential Inhalation
and Dermal Exposure Associated with Pressure Treatment of Wood with
Arsenical Wood Products” (ACC, 2002).  In this study, a treatment
solution of CCA was approximately 0.5 percent active ingredient.  The
CCA exposure monitoring study has been reviewed by the Agency and is
considered a valid surrogate source of data for pressure treatment
applications and is therefore used in estimating exposure to
Oxine-Copper.  

small (5 ≤ n ≤ 15).  

	The measured CCA dermal and inhalation exposure values were normalized
by the treatment solution concentration used at each of the 3 facilities
(i.e., unit exposure reported as µg arsenic/ppm treatment solution). 
The normalization by treatment solution concentration was performed to
extrapolate the measured exposures in the CCA study (monitored at ~0.5%
ai solution) to the maximum Oxine-Copper treatment solution
concentration (1% ai solution).  Table 6.6 presents the dermal and
inhalation unit exposure values normalized to the treatment solution
concentration in ppm for (1) all sites, (2) treatment operator (TA
handler), (3) treatment assistant (TA handler), and (4) all
post-application job functions (TS, SO, LO, S, TB, TM).  

	Note: The U.S. and Canadian sites indicate a 7x difference in the mean
dermal exposures (US site mean is 0.40 µg As/ppm compared to the
Canadian site mean of 2.84 µg As/ppm).  It is recommended that
additional analysis be performed to determine if the increased exposure
levels at the Canadian site can be attributed to differences in
site-specific engineering controls or facility design.

Table 6.6.  Dermal and Inhalation Exposure Values from a CCA Pressure
Treatment Study (Exposure Data used as Surrogate Unit Exposures for
Oxine-Copper Assessment)

Site	Treatment Solution  	Statistic	Dermal Unit Exposure

((g As/ppm)	Air 

Concentrationb

((g As/m3/ppm)	Inhalation Unit Exposurec

((g As/ppm)

	%	ppma





All sites - All Data

(n = 64)	0.438 to 0.595	4,380 to 5,950	Average ± std	0.97 ± Unknown
0.00013 ± 0.00023	0.00104



	Median	0.36	0.00013	0.00104



	90th percentile	2.07	0.00077	0.00617



	Maximum	7.74	0.0011	0.00882

All sites - Handler Treatment Operator

(n = 15)	0.438 to 0.595	4,380 to 5,950	Average ± std	2.04 ± 2.68
0.00032 ± 0.00038	0.00257



	Median	0.37	0.00013	0.00104



	90th percentile	5.39	0.00092	0.00737



	Maximum	7.74	0.0011	0.00882

All sites - Handler Treatment Assistant

(n = 10)	0.438 to 0.595	4,380 to 5,950	Average ± std	0.24 ± 0.14
0.0001 ± 0.00004	0.000802



	Median	0.23	0.00013	0.00104



	90th percentile	0.40	0.00013	0.00104



	Maximum	0.52	0.00014	0.00112

All sites – Post-application: All job functions (TS, SO, LO, S, TB,
TM)

(n = 39)	--	--	Average ± std	0.74 ± 0.73	0.00020 ± 0.00025	0.00160



	Median	0.42	0.00013	0.00104



	90th percentile	1.81	0.00050	0.00401



	Maximum	3.11	0.0011	0.00882

	a.	ppm = (% treatment solution) * (10,000).

	b.	Air concentration was calculated as (g collected per sample per ppm
/ (480 min per day x 2 L/min).

	c.	Inhalation unit exposure = air concentration ((g As/m3/ppm) *
breathing rate for light activities (0.0167 	m3/min) * sample duration
(480 min).  Values shown in bold are used for the assessment.

Exposure Calculations

The following equation was used to estimate dermal and inhalation
handler exposure: 

Absorbed Daily Dose = 	UE x AI x AB 

	      	       BW

Where

UE	=	Unit exposure (mg As/ppm);

AI	=	Percent active ingredient (1% ai in solution);

AB	=	Absorption factor (Not applicable [NA] for dermal, 100% for
inhalation); and

BW	=	Body weight (70 kg).

Results

	The estimated dermal and inhalation exposures and risks for
Oxine-Copper pressure treatment uses are presented in Table 6.7.  The
calculated ST/IT dermal MOEs are all above the target MOE of 100 and do
not pose a risk concern.  Also, the inhalation ST/IT/LT MOEs for all
scenarios and durations are above the target MOE of 1000, therefore, a
confirmatory inhalation toxicity study is not warranted based on the
screening-level results. 

Table 6.7.  Short-, Intermediate-, and Long-Term Exposures and MOEs for
Pressure Treatment Handler and Post-application Scenarios Related to
Oxine-Copper Use





Exposure Scenarioa	

Unit Exposurea 

((g As/ppm)

	

Application Rate 

(% ai solution) 	Absorbed Daily Dosesb 

(mg/kg/day)	MOEsc

	Dermal	Inhalation

Dermal	Inhalation	Dermal

ST/IT

Target = 100	Inhalation

ST/IT/LT

Target=1000

Occupational Handler

Treatment Operator (TO)	2.04	0.00257	1	0.291	0.000367	687	13,624

Treatment Assistant (TA)	0.24	0.000802	1	0.0343	0.000115	5,831	43,478

Occupational Post-application

All Job Functions

(Tram setter, stacker operator, loader operator, supervisor, test borer,
and tallyman) 	0.74	0.00160	1	0.106	0.000229	1,887	21,834

ST = 	Short-term duration; IT = Intermediate-term duration; and LT =
long-term.

a. 	Unit exposure values are taken from CCA study as shown above and in
Table 6.6.

μg) * absorption factor (NA for dermal; 100% for inhalation) / Body
weight (70 kg).

c.			MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL
= 200 mg/kg/day for dermal and ST/IT/LT NOAEL = 5 mg/kg/day for
inhalation]. Target MOE is 100 for dermal exposure and 1000 for
inhalation exposure.

	6.5	Data Limitations/Uncertainties tc \l2 "6.3	Data
Limitations/Uncertainties 

	There are several data limitations and uncertainties associated with
the occupational handler and post-application exposure assessments. 
These include:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handlers Exposure Database (USEPA, 1998) (See Appendix A for summaries
of these data sources).   Since the CMA data are of poor quality, the
Agency may request that confirmatory data be submitted in order to
support the occupational scenarios assessed in this document.

The low pressure spray unit exposure data from PHED were used to assess
both outdoor environmental surface treatments (materials preservative)
and applications of wood coatings/water repellents (wood preservatives).
 As the low pressure spray data are representative of treating low to
mid level range targets (shrubs/greenhouse benches) and the scenarios
assessed in this document represents treatments that may also occur
above the waist, the unit exposure value may underestimate exposure to
the head and the upper body.

For the wood preservative pressure treatment scenarios, surrogate CCA
exposure data were used for lack of chemical-specific exposure data for
this use pattern. For the wood preservative non-pressure treatment
scenarios, surrogate DDAC exposure data were used for the lack of
chemical-specific exposure data.  Limitations and uncertainties
associated with the use of these data include:

The assumption was made that exposure patterns for workers at treatment
facilities using CCA and DDAC would be similar to exposure patterns for
workers at treatment facilities using Oxine-Copper, and therefore the
exposures could be used as surrogate data for workers that treat wood
with Oxine-Copper based formulations.

For environmental modeling, it was assumed that the leaching process
from wood treated with Oxine-Copper would be similar to that of CCA and
DDAC. However, due to the lack of robust data for Oxine-Copper -treated
wood, it is not possible to verify this assumption. 

The quantities handled/treated were estimated based on information from
various sources, including Agency standard assumptions, HED’s Standard
Operating Procedures (SOPs) for Residential Exposure Assessments (USEPA,
2000 and 2001), and professional judgment based on Agency understanding
of industrial practices.  In certain cases, no standard values were
available for some scenarios.  Assumptions for these scenarios were
based on AD estimates and could be further refined with input from
registrants.  

7.0	REFERENCES tc \l1 "7.0	REFERENCES 

American Chemistry Council (ACC). 2002.  Assessment of Potential
Inhalation and Dermal Exposure Associated With Pressure Treatment of
Wood with Arsenical Wood Products.  MRID 4550211-01.

Bestari et al.. 1999. [Sapstain Industry Group (SIG)-Consortium Task
Force] Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III). Unpublished Study Prepared by University of Guelph.
309 p. (MRID 455243-04, SIG Task Force #73154).

Bharat Textiles. 2007. Weight/Density Estimate for Army Duck Canvas
taken from a Specification Chart on the internet site   HYPERLINK
"http://www.tentandcanvas.com/product.htm" 
http://www.tentandcanvas.com/product.htm  of this canvas exporter. Last
viewed April 18, 2007.

  SEQ CHAPTER \h \r 1 Freeman, N , Jimenez M, Reed KJ,Gurunathan S,
Edwards RD, Roy A, Adgate JL, Pellizzari ED, Quackenboss J, Sexton K,
Lioy PJ, 2001.  Quantitative analysis of children’s microactivity
patterns:  The Minnesota Children’s Pesticide Exposure Study.  Journal
of Exposure Analysis and Environmental Epidemiology.  11(6): 501-509.

SIMetric. 2005.    HYPERLINK
"http://www.simetric.co.uk/si_materials.htm" 
http://www.simetric.co.uk/si_materials.htm   Last viewed November 9,
2005.

USEPA.  1997.  Standard Operating Procedures (SOPs) for Residential
Exposure Assessments.  EPA Office of Pesticide Programs(Human Health
Effects Division (HED). Dated December 18, 1997.

USEPA.  1997a.  Exposure Factors Handbook. Volume I-II.  Office of
Research and Development.  Washington, D.C.  EPA/600/P-95/002Fa. August
1997.

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure
from the Pesticide Handler Exposure Database Version 1.1.   Washington,
DC:  U.S. Environmental Protection Agency.

  SEQ CHAPTER \h \r 1 USEPA. 1999.  Evaluation of Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (Amended on December
8,1992).  Memorandum from Siroos Mostaghimi, PH.D., USEPA to Julie
Fairfax, USEPA. Dated November, 4 1999.  DP Barcode D247642.

USEPA.  2000.  Standard Operating Procedures (SOPs) for Residential
Exposure Assessments. Prepared for EPA Office of Pesticide Programs,
Health Effects Division. Dated April 5, 2000.

USEPA.  2001.  HED Science Advisory Council for Exposure. Policy Update,
November 12, 2001.  Recommended Revisions to the Standard Operating
Procedures (SOPs) for Residential Exposure Assessment, February 22,
2001. 

  

USEPA. 2003.  Assessment of the Proposed Bardac Wood Preservative
Pressure Treatment Use.  Memorandum from Tim Leighton and Siroos
Mostaghimi.  February 11, 2003.

USEPA. 2004.  Occupational and Residential Exposure Assessment for
Carboquat WP-50.  Memorandum from Siroos Mostaghimi, USEPA to Velma
Noble, USEPA.   Dated November 4, 2004. DP Barcodes D303714 and D303938.

USEPA.  2005.  Antimicrobials Division’s Draft Standard Operating
Procedures for Occupational and Residential Exposure Assessments.  July,
2005. (Unpublished Internal Guidance).

USEPA.  2005a.  A Probabilistic Exposure Assessment for Children Who
Contact CCA-Treated Playsets and Decks.  Final Report, February, 2005. 
US EPA Office of Research and Development, National Exposure Research
Laboratory.

USEPA.  2006.  Coppers: Second Revised Human Health Chapter of the
Reregistration Eligibility Decision Document (RED). Reregistration Case
Numbers 0636, 0649, 4025 and 4026. DP Barcode 319683. Dated January 17,
2006. Document ID: EPA-HQ-OPP-2005-0558-0006. (EPA Docket:
EPA-HQ-OPP-2005-0558; Copper Cases; Coppers Reregistration Eligibility
Decision, Notice of Availability, January 25, 2006.).

USEPA. 2006a. Review Memorandum: Oxine Copper (copper 8-quinolinolate)
– Endpoint Selection Report from T.F. McMahon, Ph.D., Senior
Toxicologist, AD. June 13, 2006.

USEPA. 2006b. Meeting Minutes of SMART Meeting Conference Call for
Copper 8-Quniolinolate. Reregistration Case 4026. November 8, 2006. 
Transmittal from K. Avivah Jakob, Chemical Review Manager, USEPA to
Copper 8-Quniolinolate RED Team Members, USEPA. Dated November 16, 2006.

USEPA. 2006c. Review Memorandum: Environmental Fate Transport Assessment
for Copper 8-Quinolinolate from A. Najm Shamim, Ph.D., Chemist, AD.
November 3, 2006.

APPENDIX A:

Summary of CMA and PHED Data

Chemical Manufacturers Association (CMA) Data:

In response to an EPA Data Call-In Notice, a study was undertaken by the
Institute of Agricultural Medicine and Occupational Health of The
University of Iowa under contract to the Chemical Manufacturers
Association.  In order to meet the requirements of Subdivision U of the
Pesticide Assessment Guidelines (superseded by  Series 875.1000-875.1600
of the Pesticide Assessment Guidelines), handler exposure data are
required from the chemical manufacturer specifically registering the
antimicrobial pesticide.   The applicator exposure study must comply
with the assessment guidelines for “Applicator Exposure Monitoring”
in Subdivision U and the “Occupational and Residential Exposure Test
Guidelines” in Series 875.  For this purpose, CMA submitted a study on
 February 28, 1990, entitled "Antimicrobial Exposure Assessment Study
(amended on December 8, 1992)" which was conducted by William Popendorf,
et al..  It was evaluated and accepted by the Occupational and
Residential Exposure Branch (OREB) of Health Effect Division (HED),
Office of Pesticide Programs (OPP) of EPA in 1990.  The purpose of this
CMA study was to characterize exposure to antimicrobial chemicals in
order to support pesticide reregistrations (CMA, 1992).  The unit
exposures presented in the most recent EPA evaluation of the CMA
database (USEPA, 1999) were used in this assessment.

The Agency determined that the CMA study had fulfilled the basic
requirements of Subdivision U - Applicator Exposure Monitoring.  The
advantages of CMA data over other “surrogate data sets” is that the
chemicals and the job functions of mixer/loader/applicator were defined
based on common application methods used for antimicrobial pesticides. 
A few of the deficiencies in the CMA data are noted below:

The inhalation concentrations were typically below the detection limits,
so the unit exposures for the inhalation exposure route could not be
accurately calculated. 

QA/QC problems including lack of either/or field fortification,
laboratory recoveries, and storage stability information.

Data have an insufficient amount of replicates.

The Pesticide Handlers Exposure Database (PHED):

The Pesticide Handlers Exposure Database (PHED) has been developed by a
Task Force consisting of representatives from Health Canada, the U.S.
Environmental Protection Agency (EPA), and the American Crop Protection
Association (ACPA).  PHED provides generic pesticide worker (i.e.,
mixer/loader and applicator) exposure estimates.  The dermal and
inhalation exposure estimates generated by PHED are based on actual
field monitoring data, which are reported generically (i.e., chemical
specific names not reported) in PHED.  It has been the Agency’s policy
to use “surrogate” or “generic” exposure data for pesticide
applicators in certain circumstances because it is believed that the
physical parameters (e.g., packaging type) or application technique
(e.g., aerosol can), not the chemical properties of the pesticide,
attribute to exposure levels. [Note: Vapor pressures for the chemicals
in PHED are in the range of E-5 to E-7 mm Hg.]  Chemical specific
properties are accounted for by correcting the exposure data for study
specific field and laboratory recovery values as specified by the PHED
grading criteria.

PHED handler exposure data are generally provided on a normalized basis
for use in exposure assessments.  The most common method for normalizing
exposure is by pounds of active ingredient (ai) handled per replicate
(i.e., exposure in mg per replicate is divided by the amount of ai
handled in that particular replicate).  These unit exposures are
expressed as mg/lb ai handled.  This normalization method presumes that
dermal and inhalation exposures are linear based on the amount of active
ingredient handled.	



APPENDIX B:

Calculation of DDAC Unit Exposure ValuesTable B-1:  DDAC Dermal and
Inhalation Exposure Values for Chemical Operators, Graders, Millwrights,
Clean-up Crews, and Trim Saw Operators a

Replicate Number	Chemical Operator	Grader	Trim Saw Operator	Millwright
Cleanup Crew

	Dermal	Inhalation	Dermal	Inhalation	Dermal	Inhalation	Dermal	Inhalation
Dermal	Inhalation

	Potential exposure (mg)	Air Concentration ((g/m3) b, c	Potential
exposured (mg)	Potential exposure (mg)	Air Concentration

((g/m3) b, c	Potential exposure d (mg)	Potential exposure (mg)	Air
Concentration ((g/m3) b, c	Potential exposured (mg)	Potential exposure
(mg)	Air Concentra-tion ((g/m3) b, c	Potential exposured (mg)	Potential
exposure (mg)	Air Concentration ((g/m3) b, c	Potential exposured (mg)

1	3.5	10.1	0.0808	3.05	2.90	0.0232	0.78	2.83	0.0227	1.31	2.92	0.0233
68.3	2.99145	0.0239

2	6.11	2.80	0.0224	7.47	2.93	0.0234	1.98	12.3	0.0984	29.08	2.83	0.0226
0.720	2.78840	0.0223

3	6.07	2.79	0.0223	1.09	2.91	0.0233



8.03	15.6	0.1248	166	30.3	0.2424

4	46.37	2.82	0.0226	10.51	3.00	0.0240





	95.2	412	3.2960

5	0.94	2.93	0.0235	0.61	2.82	0.0226





	1.20	2.83585	0.0227

6	22.15	2.83	0.0227	0.98	2.85	0.0228





	0.260	2.80989	0.0225

7	21.45	2.77	0.0222	2.63	2.91	0.0233









	8	0.22	2.73	0.0218	5.23	2.85	0.0228









	9	0.44	2.77	0.0222	0.19	13.20	0.1056









	10	0.33	3.14	0.0251	1.47	2.89	0.0231









	11	0.29	2.88	0.0230	2.38	2.85	0.0228









	12



4.09	2.81	0.0225









	13



1.03	2.94	0.0235









	Arithmetic Mean	9.81	3.51	0.0281	3.13	3.68	0.0295	1.38	7.57	0.061	12.8
7.12	0.057	55.3	75.6	0.60

Minimum	0.22	2.73	0.0218	0.19	2.81	0.0225	0.78	2.83	0.0227	1.31	2.83
0.0226	0.260	2.79	0.0223

Maximum	46.4	10.1	0.081	10.51	13.2	0.106	1.98	12.3	0.098	29.1	15.6	0.125
166	412	3.30



a.	“Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III)” is the proprietary Sapstain Industry Group (SIG)
study that values were obtained from for this table (Bestari et al.,
1999, MRID 455243-04, SIG Task Force #73154 ).

b.	The inhalation LOD was not provided for chemical operators, graders,
trim saw operators, millwrights, or the clean-up crew.  Therefore, the
LOD provided for the diptank operator (5.6 (g) was used for these
positions.  Residues less than the LOD were adjusted to 1/2 LOD.

c.	The inhalation limit of detection was converted to (g/m3 using the
following equation: Air concentration ((g /m3) = 5.6 (g / [average flow
rate (L/min) * sampling duration (480 min) * 1000 L/m3.  Data was
obtained from Bestari et al (1999).  

d.	DDAC air concentrations were converted to inhalation exposure using
the following equation: Air concentration ((g /m3) x inhalation rate
(1.0 m3/hr) x Conversion factor (1mg/1000(g) x sample duration (8
hours/day).

Note: Arithmetic Mean values shown in bold typeface by job function are
recommended for use in dermal and inhalation exposure assessments for
non-pressure wood preservative treatments, where appropriate.

Table B-2:  Normalization of DDAC Dermal and Inhalation Exposure Values
for Diptank Operators a

Worker ID	Mill number	Sample Time (min)	DDAC

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e b (mg)	Total Dermal Exposure (mg)	Normalized Total Dermal Unit
Exposure c

(mg/ 1 % solution)	Air Conc.d 

(mg/m3)	Inhalation Exposure e (mg)	Normalized Inhalation Unit Exposure c

(mg /1% solution)

M7P1A	7	480	0.64	Rubber	0.5	3.44	3.94	6.16	0.003	0.024	0.0375

M7P1B	7	480	0.64	Rubber	0.32	2.02	2.34	3.66	0.003	0.024	0.0375

M8P4A	8	408	0.42	Rubber	0.04 f	1.34	1.38	3.29	0.003	0.024	0.057

M8P4B	8	480	0.42	Rubber	0.04 f	0.5	0.54	1.29	0.003	0.024	0.057

M8P7	8	480	0.42	Cotton	0.03	0.04	0.07	0.17	0.003	0.024	0.057

M11P9A	11	395	0.63	Leather	0.15	3.33	3.48	5.52	0.003	0.024	0.0381

M11P9B	11	480	0.63	Leather	0.1	0.45	0.55	0.87	0.003	0.024	0.0381

Arithmetic Mean	0.17	1.59	1.76	2.99	0.0030	0.0240	0.046

Standard Deviation	0.18	1.39	1.53	2.32	0.0000	0.0000	0.0103

Median	0.10	1.34	1.38	3.29	0.0030	0.0240	0.0381

Geometric Mean	0.10	0.83	0.99	1.86	0.0030	0.0240	0.045

90%tile	0.39	3.37	3.66	5.78	0.0030	0.0240	0.057

Maximum	0.50	3.44	3.94	6.16	0.0030	0.0240	0.057

 

a.	“Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III)” is the proprietary Sapstain Industry Group (SIG)
study that values were obtained from for this table (Bestari et al.,
1999, MRID 455243-04, SIG Task Force #73154).

b.	DDAC concentration that was detected in the monitoring study (MRID
#455243-04).

c.	Normalization of DDAC data for percent ai treatment.  Normalized Unit
Exposure (mg/1% ai solution) = Exposure (mg DDAC) / concentration in
diptank solution (% DDAC)

d.	All inhalation residues were <LOD (5.6 (g or 0.0056 mg/m3). 1/2 LOD
was used in all calculations (0.003 mg/m3). Air Concentration (mg/m3) =
5.6 (g / (~2 L/min flow rate x ~480 min) x 1000 L/m3 conversion x 0.001
(g /mg = 0.003 mg/m3

e.	Inhalation exposure (mg) = air concentration (mg/m3) x inhalation
rate (1.0 m3/hr) x sample duration (8 hours/day).

f.	Residues were <LOD for dermal samples M8P4A, M8P4B.  Sample size of
~11,231 cm2 x <0.007 ug/cm2 = LOD of 0.079 mg.  1/2 LOD reported (i.e.,
0.04 mg)

Note: Arithmetic Mean values shown in bold typeface are the recommended
Normalized Dermal and Inhalation Unit Exposure values for use in
exposure assessments for non-pressure wood preservative treatments,
where appropriate.

 	Based on an Agency query of the Office of Pesticide Programs
Information Network (OPPIN), there are several cancelled registrations
for Oxine-Copper products which represent use patterns no longer
supported for this pesticide. These include: agricultural fungicide uses
in greenhouse fogging applications as foliar treatments against powdery
mildew on ornamentals (e.g., cultivation of carnations, roses,
chrysanthemums), surface treatments against mold, rot and mildew on
walls, floors and ceilings in food processing establishment premises
(e.g., bakeries, canneries); also use in materials and wood preservation
for carpet underlays (for government and/or military sites), thread,
thatched roofs and cooling tower wood.   

 	Osmose, Inc. also holds the registration for an industrial-use EP
(34.18% a.i. soluble concentrate).

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