U.S. Environmental Protection Agency	September 2008

Supporting Documents for Risk-Based Prioritization

Supporting Documents for Initial Risk-Based Prioritization of
High Production Volume Chemicals

Zinc Dialkyldithiophosphates (ZDDP) Category

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl (CASRN 84605-29-8)

and iso-Pr) esters, zinc salts
Phosphorodithioic acid, mixed 0,0-bis(iso-Bu and pentyl) (CASRN 68457-79-4)
esters, zinc salts

Phosphorodithioic acid, mixed 0,0-bis(sec-Bu and	(CASRN 68784-31-6)

1,3-dimethylbutyl) esters, zinc salts
Phosphorodithioic acid, mixed 0,0-bis(sec-Bu and isooctyl) (CASRN 113706-15-3)
esters, zinc salts

Phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl	(CASRN 26566-95-0)

ester, zinc salts

(CA Index Name: Zinc, bis[0-(2-ethylhexyl) 0-(2-methylpropyl)
phosphorodithioato-.kappa.S,.kappa.S']-, (T-4)-)

Phosphorodithioic acid, mixed 0,0-bis(iso-Bu and	(CASRN 68988-46-5)

isooctyl and pentyl) esters, zinc salts
Phosphorodithioic acid, 0,0-bis(l,3-dimethylbutyl)	(CASRN 2215-35-2)

ester, zinc salt

(CA Index Name: Zinc, bis[0,0-bis(l,3-dimethylbutyl)
phosphorodithioato-.kappa.S,.kappa.S']-, (T-4)-)

Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester, zinc salt (CASRN 4259-15-8)
(CA Index Name: Zinc, bis[0,0-bis(2-ethylhexyl) phosphorodithioato-
.kappa.S,.kappa.S'] -, (T-4)-)

Phosphorodithioic acid, O,0-bis(isooctyl) ester, zinc salt	(CASRN 28629-66-5)

(CA Index Name: Zinc, bis(0,0-diisooctyl phosphorodithioato-.kappa.S,.kappa.S')-)
Phosphorodithioic acid, 0,0-diisodecyl ester, zinc salt	(CASRN 25103-54-2)

(CA Index Name: Zinc, bis(0,0-diisodecyl phosphorodithioato-
.kappa. S,.kappa.S')-)

Phenol, dodecyl-, hydrogen phosphorodithioate, zinc salt (CASRN 54261-67-5)
(CA Index Name: Zinc, bis[0,0-bis(dodecylphenyl) phosphorodithioato-
.kappa. S,.kappa.S']-)

Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt (CASRN 11059-65-7)
(CA Index Name: Zinc, bis[0,0-bis(tetrapropylenephenyl) phosphorodithioato-

.kappa.S,.kappa.S']-)

Contents:

•	Page 2: Background

•	Page 4: Screening-Level Risk Characterization: September 2008

•	Page 9: Screening-Level Hazard Characterization: September 2008

•	Page 29: Screening-Level Exposure Characterization: September 2008

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BACKGROUND

Screening-level hazard, exposure and risk characterizations for high production volume chemicals (HPV)
are important contributions to the chemicals cooperation work being done in North America1 through the
EPA Chemical Assessment and Management Program (ChAMP)2. These screening-level
characterizations are developed by EPA for individual chemicals or chemical categories to support initial
Risk-Based Prioritizations (RBPs) for HPV chemicals. These screening-level characterizations are
technical documents intended primarily to inform the Agency's internal decision-making process.
Accordingly, they are written for assessment professionals and assume a degree of technical
understanding. Each of the support documents is described below.

The Risk-Based Prioritizations are found in an accompanying document and are written for a general
audience. They present EPA's initial thinking regarding the potential risks presented by these chemicals
and future possible actions that may be needed.

Hazard Characterizations for HPV Chemicals

EPA's screening-level hazard characterizations are based primarily on the review of the summaries of
studies and other information submitted by the chemical sponsor(s) under the HPV Challenge Program3.
These studies included in the scope of the HPV Challenge comprise the Screening Information Data Set
(SIDS) of the Organization for Economic Cooperation and Development (OECD)4, an internationally
recognized battery of tests that provides the basic data necessary to make an initial evaluation of a
chemical's hazards and fate. In preparing the initial hazard characterizations, EPA also consulted a
variety of reliable sources5 for additional relevant information and considered its own comments and
public comments on the original submission as well as the sponsor's responses to comments and revisions
made to the submission. In order to determine whether any new hazard information was developed since
the time of an HPV submission, EPA also searched publicly available databases6 for information entered
from one year prior to the HPV submission through May 2008. The screening-level hazard
characterization is performed according to established EPA guidance7. A more detailed description of the
hazard characterization process is available on the EPA website8.

With respect to chemicals for which internationally-accepted OECD SIDS Initial Assessment Profiles
(SIAP) and Initial Assessment Reports (SIAR) were available, EPA did not generate its own screening-
level hazard characterization, but did check for and incorporate updated information in the risk
characterization.

Exposure Characterizations for HPV Chemicals

EPA recently received exposure-related data on chemicals submitted in accordance with the requirements
of Inventory Update Reporting (IUR)9. The 2006 IUR submissions pertain to chemicals manufactured in

1	U.S. EPA - U.S. Commitments to North American Chemicals Cooperation:
http://www.epa.gov/hpv/pubs/general/sppframework.htm.

2	U.S. EPA - ChAMP information: http://www.epa.gov/champ/.

3	U.S. EPA - HPV Challenge Program information: http://www.epa.gov/hpy.

4	U.S. EPA - Technical Guidance Document, OECD SIDS Manual Sections 3.4 and 3.5:
http://www.epa.gov/chemrtk/pubs/general/sidsappb.htm.

5	U.S. EPA - Public Database Hazard Information: http://www.epa.gov/hpvis/hazardinfo.htm.

6	U.S. EPA - Public Database Update Information: http://www.epa.gov/chemrtk/hpvis/updateinfo.htm.

7	U.S. EPA - Risk Assessment Guidelines: http://cfpub.epa.gov/ncea/raf/rafguid.cfm.

8	U.S. EPA - About HPV Chemical Hazard Characterizations: http://www.epa.gov/hpvis/abouthc.htm.

9	U.S. EPA - Basic IUR Information: http://www.epa.gov/opptintr/iur/pubs/guidance/basic-infonnation.h1m.

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(including imported into) the U.S. during calendar year 2005 in quantities of 25,000 pounds or more at a
single site. The reports include the identity, the quantity, and the physical form of the chemical
manufactured or imported, and the number of workers reasonably likely to be exposed during
manufacture of the chemical. For chemicals manufactured or imported in quantities of 300,000 pounds or
more at a single site, additional reported information includes: the industrial processing and uses of the
chemical; the number of industrial processing sites and workers reasonably likely to be exposed to the
chemical at those sites; the consumer and commercial uses of the chemical; and an indication whether the
chemical was used in products intended for use by children under 14 years of age.

EPA's screening-level exposure characterizations are based largely on the information submitted under
the IUR reporting, although other exposure information submitted to the Agency (for example, in HPV
submissions) or readily available through a limited set of publicly accessible databases10 was also
considered. The screening-level exposure characterizations identify a potential (high, medium, or low)
that each of five populations - the environment, the general population, workers, consumers, and children
- might be exposed to the chemical. In most cases, this potential doesn't address the quantity, frequency,
or duration of exposure, but refers only to the likelihood that an exposure could occur.

In many instances EPA is not able to fully disclose to the public all the IUR exposure-related data
reviewed or relied upon in the development of the screening-level documents because some of the
material was claimed as confidential business information (CBI) when it was submitted to the Agency.
These CBI claims do limit the Agency's ability to be completely transparent in presenting some
underlying exposure and use data for chemicals in public documents. EPA does consider all data,
including data considered to be CBI, in the screening-level exposure and risk characterization process,
and endeavors whenever possible to broadly characterize supporting materials claimed as confidential in
ways that do not disclose actual CBI.

Risk Characterizations for HPV Chemicals

EPA combines the information from the screening-level exposure characterization with the screening-
level hazard characterization to develop a qualitative screening-level risk characterization, as described in
the Agency's guidance on drafting risk characterizations11. These screening-level risk characterizations
are technical documents intended to support subsequent priority-setting decisions and actions by OPPT.
The purpose of the qualitative screening-level risk characterization is two-fold: to support initial risk-
based decisions to prioritize chemicals, identify potential concerns, and inform risk management options;
and to identify data needs for individual chemicals or chemical categories.

These initial characterization and prioritization documents do not constitute a final Agency determination
as to risk, nor do they determine whether sufficient data are available to characterize risk. Recommended
actions reflect EPA's relative judgment regarding this chemical or chemical category in comparison with
others evaluated under this program, as well as the uncertainties presented by gaps that may exist in the
available data.

10	U.S. EPA - Summary of Public Databases Routinely Searched:
http://www.epa.gov/chemrtk/hpvis/pubdtsum.htm.

11	U.S. EPA - Risk Characterization Program: http://www.epa.gov/osa/spc/2riskchr.htm.

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Supporting Documents for Risk-Based Prioritization

QUALITATIVE SCREENING-LEVEL RISK CHARACTERIZATION
OF HIGH PRODUCTION VOLUME CHEMICALS

CHEMICAL CATEGORY NAME
Zinc Dialkyldithiophosphates

SPONSORED CHEMICALS

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and iso-propyl) esters, zinc salts	CAS No. 84605-29-8

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl and pentyl) esters, zinc salts	CAS No. 68457-79-4

Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts	CAS No. 68784-31-6

Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and isooctyl) esters, zinc salts	CAS No. 113706-15-3

Phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl ester, zinc salt	CAS No. 26566-95-0

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl and isooctyl and pentyl) esters, zinc salts	CAS No. 68988-46-5

Phosphorodithioic acid, 0,0-bis(l,3-dimethylbutyl) ester, zinc salt	CAS No. 2215-35-2

Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester, zinc salt	CAS No. 4259-15-8

Phosphorodithioic acid, 0,0-bis(isooctyl) ester, zinc salt	CAS No. 28629-66-5

Phosphorodithioic acid, 0,0-diisodecyl ester, zinc salt	CAS No. 25103-54-2

Phenol, dodecyl-, hydrogen phosphorodithioate, zinc salt	CAS No. 54261-67-5

Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt	CAS No. 11059-65-7

September 2008

Prepared by

Risk Assessment Division
Economics, Exposure and Technology Division
Office of Pollution Prevention and Toxics
Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

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QUALITATIVE SCREENING-LEVEL RISK CHARACTERIZATION FOR
Zinc Dialkyldithiophosphates Category

1.	Category Justification

Zinc dialkyldithiophosphates (ZDDPs) consist of a phosphorodithioic acid structure with alkyl or
alkaryl ester substituent groups. The alkyl groups are saturated hydrocarbon chains that vary in
length (C3 - CIO) and in the extent of branching. Zinc dialkyldithiophosphates are synthesized
by reacting phosphorus pentasulfide (P2S5) with one or more primary or secondary C3 - C12
branched or linear alcohols to form the phosphorodithioic acid ester, which is further diluted
with 10 - 15% highly refined lubricating base oil (typical CAS Nos. 64742-54-7 and 64741-88-
4) before it is neutralized with zinc oxide. The lubricating base oil acts as a solvent in the
reaction, manages the viscosity and improves consistency of the final product. The members of
the ZDDP category are used as multi-functional anti-wear and anti-oxidants in passenger vehicle
motor oils, diesel engine oils and industrial oils. The highly refined lubricating base oil used in
the manufacture of the zinc dialkyldithiophosphates cannot be removed without altering the
structural and physical-chemical character of the zinc dialkyldithiophosphate molecules.
Therefore, many of the physical-chemical properties presented are qualitative estimates. These
chemicals can be grouped and evaluated together as they are structurally similar, all consisting of
alkyl (C3 - CIO) or alkaryl (CI2 alkylphenol) substituted phosphorodithioic acid structures
complexed with zinc. Based on these characteristics data for the tested category members are
extrapolated to provide estimates of similar properties for the untested members where
appropriate. EPA considered this grouping acceptable for the purposes of the HPV Challenge
Program and further accepts this category for prioritization in the Chemical Assessment and
Management Program (ChAMP).

2.	Physical-Chemical Properties and Environmental Fate

Zinc dialkyldithiophosphates are amber colored viscous liquids at ambient temperature that
contain 10-15 weight % highly refined lubricating base oil. De-oiled zinc
dialkyldithiophosphates are solid materials. Zinc dialkyldithiophosphates have low mobility and
negligible volatilization. Atmospheric photooxidation is not an important environmental fate
process since these compounds will exist in the particulate phase in the atmosphere.
Biodegradation is slow and bioaccumulation is not expected. The persistence and
bioaccumulation ranking for the members of this category are P3 (high) and B1 (low).

3.	Hazard Characterization

Aquatic Organism Toxicity: The aquatic toxicity data submitted were generated using the Water
Accommodated Fraction method. The evaluation of available toxicity data for fish, aquatic
invertebrates and aquatic plants for C8 and higher ZDDPs indicates the potential acute hazard to
aquatic organisms is low based on no effects observed at the water solubility limit (saturation) of
two category members. The evaluation of available toxicity data for fish, aquatic invertebrates
and aquatic plants for C3 to C8 ZDDPs indicates the potential acute hazard to fish is moderate
and to aquatic invertebrates and aquatic plants is low, based on the one tested category member

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(CAS No. 84605-29-8). The physical-chemical properties of the substances in this category also
indicate they are soluble or miscible in water at concentrations that could be relevant to chronic
effects.

Human Health Toxicity: Acute oral and dermal toxicity of ZDDP category members is low.
Several repeated-dose dermal studies of ZDDP category chemicals showed moderate toxicity in
rabbits. An oral repeated-dose study in rats of one ZDDP category member showed moderate
systemic toxicity. An oral combined reproductive/developmental toxicity study in rats of one
ZDDP category member showed moderate systemic toxicity in the adult animals and moderate
postnatal developmental toxicity; there were no effects on reproductive parameters or
reproductive organs. In contrast, dermal repeated-dose studies in rabbits of several ZDDP
category members did show moderate toxicity to the male reproductive organs. ZDDP category
members were not mutagenic in bacterial cells, but showed a positive response in mammalian
cells. ZDDP category members did not induce chromosome aberrations when tested in vivo.

4. Exposure Characterization

Ten of the 12 zinc dialkyldithiophosphates category chemicals have aggregated production
volumes in the ranges of 94 million to 340.5 million pounds. The other two category members -
phosphorodithioic acid, mixed o,o-bis(iso-bu and isooctyl) (CAS#68988-46-5) and
phosphorodithioic acid, o,o-diisodecyl ester, zinc salt (CAS#25103-54-2) - do not have IUR
submissions. Non-confidential IUR information for many of the chemicals in the zinc
dialkyldithiophosphates category indicates that these chemicals are used as lubricants in the
manufacturing of other chemical products. Nine of the 12 chemicals in this category have IUR
submissions that indicate uses in commercial settings or consumer uses.

Information submitted as part of the HPV Challenge Program indicates that zinc
dialkyldithiophosphates are used to formulate finished lubricating oils including all types of
automotive and diesel engine crankcase, industrial oils and hydraulic fluids. The Hazardous
Substances Data Bank (HSDB) had information for two of the chemicals and list uses as
hydraulic and transmission fluids (CAS#28629-66-5) or additives in lubricating oils
(CAS#25103-54-2).

Potential Exposures to the General Population and the Environment: Based on the information
considered, including known uses, and the Agency's professional judgment, EPA identifies, for
the purposes of risk-based prioritization, a medium potential that the general population and the
environment might be exposed. Based on the predominant uses of zinc dialkylthiophosphates in
automotive and diesel crankcase oils, industrial oils, and hydraulic fluids, there may be potential
releases to land via disposal or accidental spills and to air via incineration of spent oil.
Persistence and bioaccumulation ratings for these chemicals are P3 and Bl. These ratings
suggest that these chemicals are very persistent in the environment; and are not bioaccumulative.

Potential Exposures to Workers: Based on the information considered, including IUR data and
information from HPV Test Plan, and the Agency's professional judgment, EPA identifies, for
the purposes of risk-based prioritization, a medium relative ranking for potential worker
exposure. This relative ranking is based on the potential for dermal exposure of a moderate

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number of workers, information on uses of the chemical substances including commercial uses,
and the production volume. Zinc dialkyldithiophosphates do not have OSHA Permissible
Exposure Limits (PELs).

Potential Exposures to Consumers: EPA identifies, for the purposes of risk-based prioritization,
a high potential that consumers might be exposed from products containing this chemical. Nine
of the twelve chemicals in this category have IUR submissions that indicate uses in commercial
settings or consumer uses. Information from public data sources indicate potential for exposure
to consumers who may periodically add lubricating oil to automotive crankcases or change their
own automotive engine oil.

Potential Exposures to Children: EPA identifies, for the purposes of risk-based prioritization, a
low potential that children might be exposed. None of chemicals reported uses in products
intended to be used by children. One chemical reported that such information was Not Readily
Obtainable. It is unlikely that children will be exposed to automotive and diesel crankcase oils,
industrial oils, and hydraulic fluids containing these chemicals.

5. Risk Characterization

The statements and rationale provided below are intended solely for the purpose of this
screening-level and qualitative risk characterization and will be used for prioritizing substances
for future work in the Chemical Assessment and Management Program (ChAMP).

Risk Statement and Rationale

Potential Risk to Aquatic Organism from Environmental Releases: (LOW/MEDIUM
CONCERN) EPA identifies a medium potential that aquatic organisms might be exposed
from environmental releases. Chemicals in the ZDDP category have high persistence and
low bioaccumulation. These characteristics in combination with the low acute toxicity to
aquatic invertebrates and aquatic plants for ZDDP category chemicals indicate a low
concern for potential risk from environmental releases. These characteristics in
combination with the moderate acute toxicity of one category member (CAS# 84605-29-
8) indicate a medium concern for potential risk to fish from environmental releases of this
category member and potentially other untested category members.

Potential Risk to the General Population from Environmental Releases: (MEDIUM
CONCERN) EPA identifies a medium potential that the general population might be
exposed from environmental releases. The potential human health hazard is moderate.
Therefore, taken together, there is a medium concern for potential risk to the general
population from environmental releases.

Potential Risk to Workers: (MEDIUM CONCERN) EPA identifies a medium relative
ranking for potential worker exposure. ZDDP category chemicals do not have an OSHA
Permissible Exposure Limit (PEL). The potential human health hazard is moderate.
Therefore, taken together, the available information suggests a medium concern for
potential risks to workers.

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Potential Risk to Consumers: (MEDIUM CONCERN) EPA identifies a high potential
that consumers might be exposed. This is based on the use of consumer products
containing this chemical. The potential human health hazard is moderate. Therefore,
taken together, the available information suggests a medium concern for potential risks to
consumers.

Potential Risk to Children: (LOW CONCERN) EPA identifies a low potential that
children might be exposed. There are no uses in products specifically intended to be used
by children. It is unlikely that children will be exposed to finished lubricating oils used
for automotive and diesel engine crankcases, industrial oils and hydraulic fluids. An
animal study of one member of the ZDDP category showed moderate toxicity following
exposure during early life stages. However, given the lack of exposure to children, the
available information suggests a low concern for potential risks to children.

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Supporting Documents for Risk-Based Prioritization

SCREENING-LEVEL HAZARD CHARACTERIZATION
OF HIGH PRODUCTION VOLUME CHEMICALS

CHEMICAL CATEGORY NAME
Zinc Dialkyldithiophosphates

SPONSORED CHEMICALS

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and iso-propyl) esters, zinc salts	CAS No. 84605-29-8

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl and pentyl) esters, zinc salts	CAS No. 68457-79-4

Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts	CAS No. 68784-31-6

Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and isooctyl) esters, zinc salts	CAS No. 113706-15-3

Phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl ester, zinc salt	CAS No. 26566-95-0

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl and isooctyl and pentyl) esters, zinc salts	CAS No. 68988-46-5

Phosphorodithioic acid, 0,0-bis(l,3-dimethylbutyl) ester, zinc salt	CAS No. 2215-35-2

Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester, zinc salt	CAS No. 4259-15-8

Phosphorodithioic acid, 0,0-bis(isooctyl) ester, zinc salt	CAS No. 28629-66-5

Phosphorodithioic acid, 0,0-diisodecyl ester, zinc salt	CAS No. 25103-54-2

Phenol, dodecyl-, hydrogen phosphorodithioate, zinc salt	CAS No. 54261-67-5

Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt	CAS No. 11059-65-7

September 2008

Prepared by

Risk Assessment Division
Economics, Exposure and Technology Division
Office of Pollution Prevention and Toxics
Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

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September 2008

SCREENING-LEVEL HAZARD CHARACTERIZATION
Zinc Dialkyldithiophosphates

Introduction

CAS No.

84605-29-8

CAS

No.

68457-79-4

CAS

No.

68784-31-6

CAS

No.

113706-15-3

CAS

No.

26566-95-0

CAS

No.

68988-46-5

CAS

No.

2215-35-2

CAS

No.

4259-15-8

CAS

No.

28629-66-5

CAS

No.

25103-54-2

CAS

No.

54261-67-5

CAS

No.

11059-65-7

The sponsor, American Chemistry Council, submitted a Test Plan and Robust Summaries to EPA for the zinc
dialkyldithiophosphate (ZDDP) category on November 11, 2002. EPA posted the submission on the ChemRTK
HPV Challenge website on November 27, 2002

(http://www.epa.gov/chemrtk/pubs/summaries/zincdial/cl4066tc.htm'). EPA comments on the original submission
were posted to the website on April 1, 2003. Public comments were also received and posted to the website. The
sponsor submitted updated/revised documents on May 20, 2003 and April 19, 2005, which were posted to the
ChemRTK website on June 24, 2003 and June 3, 2005 respectively. The zinc dialkyldithiophosphates category
consists of the following chemicals:

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and iso-propyl) esters, zinc salts CAS No. 84605-29-8
Phosphorodithioic acid, mixed 0,0-bis(iso-butyl and pentyl) esters, zinc salts
Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts
Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and isooctyl) esters, zinc salts
Phosphorodithioic acid, 0-(-2-ethylhexyl) O-isobutyl ester, zinc salt
Phosphorodithioic acid, mixed 0,0-bis(iso-butyl and isooctyl and pentyl) esters, zinc salts
Phosphorodithioic acid, 0,0-bis(l,3-dimethylbutyl) ester, zinc salt
Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester, zinc salt
Phosphorodithioic acid, 0,0-bis(isooctyl) ester, zinc salt
Phosphorodithioic acid, 0,0-diisodecyl ester, zinc salt
Phenol, dodecyl-, hydrogen phosphorodithioate, zinc salt
Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt

This screening-level hazard characterization is based primarily on the review of the test plan and robust summaries
of studies submitted by the sponsor(s) under the HPV Challenge Program. In preparing the hazard characterization,
EPA considered its own comments and public comments on the original submission as well as the sponsor's
responses to comments and revisions made to the submission. In order to determine whether any new hazard
information was developed since the time of the HPV submission, a search of the following databases was made
from 2004 to June 2008: the NLM databases (ChemID to locate available data sources including Medline/PubMed,
Toxline, HSDB, ATSDR, EPA SRS, etc.), STN/CAS online databases (Registry file for locators, ChemAbs for
toxicology data, RTECS, Merck, etc.) and Science Direct. Structure(s) of the sponsored chemical(s) is included in
the appendix. The screening-level hazard characterization for environmental and human health toxicity is based
largely on SIDS endpoints and is described according to established EPA or OECD effect level definitions and
hazard assessment practices.

Category Justification

Zinc dialkyldithiophosphates (ZDDPs) consist of a phosphorodithioic acid structure with alkyl or alkaryl ester
substituent groups. The alkyl groups are saturated hydrocarbon chains that vary in length (C3 - C10) and in the
extent of branching. A typical structure for the zinc dialkyldithiophosphate component is shown below.

o-"S\

/\ ,-zV /P-o

° S	S	\

R	R

R = C3 - C10 (linear and/or branched) alkyl or C12 (branched) alkaryl

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Zinc dialkyldithiophosphates are synthesized by reacting phosphorus pentasulfide (P2S5) with one or more primary
or secondary C3 - C12 branched or linear alcohols to form the phosphorodithioic acid ester, which is further diluted
with 10 - 15% highly refined lubricating base oil (typical CAS Nos. 64742-54-7 and 64741-88-4) before it is
neutralized with zinc oxide. The lubricating base oil acts as a solvent in the reaction, manages the viscosity and
improves consistency of the final product.

The members of the ZDDP category are used as multi-functional anti-wear and anti-oxidants in passenger vehicle
motor oils, diesel engine oils and industrial oils. The highly refined lubricating base oil used in the manufacture of
the zinc dialkyldithiophosphates cannot be removed without altering the structural and physical-chemical character
of the zinc dialkyldithiophosphate molecules. Therefore, many of the physical-chemical properties presented are
qualitative estimates.

Although in its test plan review EPA suggested presenting the category in three subgroups, following review of the
updated/revised submission, EPA concluded that these chemicals can be grouped and evaluated together as they are
structurally similar, all consisting of alkyl (C3 - CIO) or alkaryl (C12 alkylphenol) substituted phosphorodithioic
acid structures complexed with zinc. Based on these characteristics data for the tested category members are
extrapolated to provide estimates of similar properties for the untested members where appropriate.

Il;i/;ii'(l ( hiii'iiclori/iilioii

/.me tlulkv klilhiophosphales are amber colored \ iscons liquids ;ii ambient temperature llial contain In-15 wemlil
limliK refined hihi'icatiim base oil De-oiled /me dialk\ klilhiophosphales are solid malerials /.me
di;ilk\ Idilliiopliosphales li;i\ e low mobility and iiculmihle \ olalili/alion \tniospheric plioloo\idalioii is nol an
important en\ iroiinieiilal late process since llicsc compounds u ill e\ist in llie paniculate phase in the atmosphere
liiodeuradatioii is slow and hioacciimiilalioii is not e\peeled The persistence and hioacciimiilatioii rankiim lor the
members of this calcuois are 1'^ (hmhiaiid I!I (low i

I lie aquatic toMcits data snhniitied were uciieraled iismu the Water \cconiniodated fraction method I lie
e\ alnation of a\ ailahle lo\ieil\ data lor lish. aquatic 11in ertehrates and aquatic plants lor ( X and lnulier /.DDI's
indicates the potential acute lia/ard to aquatic oruamsnis is low hased on no effects ohser\ ed al the water solnhilits
limn (saturation) ol'two calcuois members The e\aliiation ofa\ailahle lo\ieil\ data lor lish. ;it|ii;itle m\ertehrates
and aquatic plants lor to ( X /DDI's indicates the potential acute lia/ard to lish is moderate and to aquatic
in\ertehrates and aquatic plants is low. hased on the one tested cateuors nienihenC \S \o X4<>n5-2lJ-Xi The
ph\ sical-cheniical properties of the snhstances in this cateuors also indicate lhe> are soluble or niiscihle in w ater al
concentrations that conkl cause chrome ellects

\cnte oral and dermal to\icil> of /.DDI' caleuors members is low Se\ eral repeated-dose dermal studies of /.I )l >1*
calcuoi's cheniicals showed moderate lo\icil> in rabbits \n oral repeated-dose studs in rats of one /.DDI' calcuois
nieniber showed niodemie s\ steniic to\icit> \n oral combined iepiodiicti\ e de\ elopniental to\icil> stnd> in rats of
one /.DDI' calcuor\ nieniber showed moderate s\ steniic to\icit> in the adult animals and nioderate postnatal
de\ elopniental to\icit>. there were no effects on reproduce e parameters or reproduce e oruans In coiitrast.
dermal repeated-dose studies in rabbits of se\ em I /.DDI' cateuors nienibers did show moderate lo\icil> to the male
reproducee oruans /.DDI' cateuors nienibers were not niiitaueiiic in bacterial cells, but showed ;i positi\e
response in niammaliaii cells /DDI' cateuors nienibers did not induce chromosome abermtioiis w hen tested in
vivo.

Chrome Iomciis in aquatic oruamsnis remains a data uap under the IIPV Challenue I'rourani

11


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

1. Physical-Chemical Properties and Environmental Fate

The physical-chemical properties of the zinc dialkyldithiophosphates are summarized in Table la, while their
environmental fate properties are given in Table lb. The structures of the compounds are provided in the Appendix.

Physical-Chemical Properties Characterization

Zinc dialkyldithiophosphates are solid materials; however, the technical materials are manufactured and distributed
in highly refined lubricant base oil. The vapor pressure of these materials is negligible and the solubility is low.

Table la. Phvsical and Chemical Properties of Zinc Dialkvldithiophosphate Category'

Chemical name

CAS No.

Molecular
Weight

Melting
Point

Boiling Point

Vapor
Pressure3

Water
Solubility

(mg/L)

Log K„w

Phosphorodithioic acid, mixed
0,0-bis(l,3-dimethylbutyl and
isopropyl) esters, zinc salts

84605-29-8

578.1

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

15.8
(measured)

NA4

Phosphorodithioic acid, mixed
0,0-bis(isobutyl and pentyl)
esters, zinc salts

68457-79-4

578.1

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
15.8
(RA)

NA4

Phosphorodithioic acid, mixed
0,0-bis(sec-butyl and 1,3-
dimethylbutyl) esters, zinc salts

68784-31-6

606.2

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
15.8
(RA)

NA4

Phosphorodithioic acid, mixed
0,0-bis(sec-butyl and isooctyl)
esters, zinc salts

113706-15-3

662.3

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
15.8
(RA)

NA4

Phosphorodithioic acid, mixed
0-(2-ethylhexyl) O-(isobutyl)
ester, zinc salts

26566-95-0

648.3

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
15.8
(RA)

NA4

Phosphorodithioic acid, mixed
0,0-bis(isobutyl and isooctyl
and pentyl) esters, zinc salts

68988-46-5

634.2

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
15.8
(RA)

NA4

Phosphorodithioic acid, mixed
0,0-bis(l ,3-dimethylbutyl)
ester, zinc salt

2215-35-2

662.3

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
15.8
(RA)

NA4

Phosphorodithioic acid, mixed
0,0-bis(2-ethylhexyl) ester,
zinc salt

4259-15-8

774.5

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

1.09
(measured)

8.79 (est)4

Phosphorodithioic acid, mixed
0,0-bis(isooctyl) ester, zinc
salt

28629-66-5

774.5

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
1.09
(RA)

8.79 (est)4

Phosphorodithioic acid, mixed
0,0-diisodecyl ester, zinc salt

25103-54-2

886.7

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
1.09
(RA)

NA4

Phenol, dodecyl,-hydrogen
phosphorodithioate, zinc salt

54261-67-5

1303.3

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

No Data
1.09
(RA)

NA4

Phenol, tetrapropenyl-,
hydrogen phosphorodithioate,
zinc salt

11059-65-7

1303.3

NA2

Decomposes
at 120 °C

1.7xl9"4 Pa

0.18
(measured)

NA4

1	Petroleum Additives Panel Health Environmental and Regulatory Task Group. 2005. Revised Robust Summaries for Zinc
Dialkvlthiodiphosphates. http://www.epa.2ov/chemrtk/pubs/summaries/zincdial/cl4066tc.htm.

2	Not applicable. ZDDP category members are manufactured in base oils, which have high viscosity at ambient temperature.

3	Vapor pressure of the lubricating base oil.

4	US EPA. 2008. Estimation Programs Interface Suite™ for Microsoft® Windows, v 3.20. United States Environmental
Protection Aaencv. Washinaton. DC. USA. http://www.epa.aov/opptintr/exposure/pubs/episuite.htm. The model used to
estimate log Kow (KOWWIN v. 1.67) has been demonstrated to be accurate in predicting log K<,w between -4 and 10. All but
two of the members of the category are outside this range, so the values may not be reliable, but it is reasonable to conclude that
these estimates indicate that the log Kow values for these members of this category are high (> 4). The measurement of log Kow
for the ZDDP category members is not expected to provide useful information due to the presence of 10-15 % lubricating oil in
the final product.

12


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Supporting Documents for Risk-Based Prioritization

September 2008

Environmental Fate Characterization

Zinc dialkyldithiophosphates have low mobility and negligible volatilization. Atmospheric photooxidation is not an
important environmental fate process since these compounds will exist in the particulate phase in the atmosphere.
Biodegradation is slow and bioaccumulation is not expected. The persistence and bioaccumulation ranking for the
members of this category are P3 (high) and B1 (low).

Table lb. Environmental Fate Properties of Zinc Dialkvldithionhosnhatc Category1

Chemical name

CAS No.

Photo-
degradation
Half-life

Hydrolysis
Half-Life

Bio-
degradation

BCF4

Log
K„c4

Fugacitv

Persistence"'

Bio-
accumulation''

Phosphorodithioic acid,
mixed 0,0-bis(l,3dimethylbutyl
and isopropyl) esters, zinc salts

84605-29-8

No Data2

No Data3

5.9%
at 28 days
Not readily
biodegradable

22

6.3

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0,0-bis(isobutyl and
pentyl) esters, zinc salts

68457-79-4

No Data2

No Data3

No Data
Not readily
biodegradable
(RA)

3

6.6

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0,0-bis(sec-butyl and
1,3-dimethylbutyl) esters, zinc
salts

68784-31-6

No Data2

No Data3

No Data
Not readily
biodegradable

(RA)

3

6.9

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0,0-bis(sec-butyl and
isooctyl) esters, zinc salts

113706-15-3

No Data2

No Data3

No Data
Not readily
biodegradable
(RA)

3

7.9

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0-(2-ethylhexyl) O-
(isobutyl) ester, zinc salts

26566-95-0

No Data2

No Data3

No Data
Not readily
biodegradable
(RA)

3

8.1

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0,0-bis(isobutyl and
isooctyl and pentyl) esters, zinc
salts

68988-46-5

No Data2

No Data3

No Data
Not readily
biodegradable

(RA)

3

7.3

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0,0-bis(l,3-
dimethylbutyl) ester, zinc salt

2215-35-2

No Data2

No Data3

No Data
Not readily
biodegradable

(RA)

3

9.6

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0,0-bis(2-ethylhexyl)
ester, zinc salt

4259-15-8

No Data2

No Data3

No Data
Not readily
biodegradable
(RA)

7

5

No Data3

P3

B1

Phosphorodithioic acid,
mixed 0,0-bis(isooctyl) ester,
zinc salt

28629-66-5

No Data2

No Data3

No Data
Not readily
biodegradable

(RA)

7

4.9

No Data3

P3

B1

Phosphorodithioic acid,

mixed 0,0-diisodecyl ester, zinc

salt

25103-54-2

No Data2

No Data3

No Data
Not readily
biodegradable

(RA)

3

12

No Data3

P3

B1

Phenol, dodecyl, hydrogen
phosphorodithioate, zinc salt

54261-67-5

No Data2

No Data3

4.2-5.9%
at 28 days
Not readily
biodegradable

3

22

No Data3

P3

B1

Phenol, tetrapropenyl-, hydrogen
phosphorodithioate, zinc salt

11059-65-7

No Data2

No Data3

No Data
Not readily
biodegradable

(RA)

3

22

No Data3

P3

B1

'Petroleum Additives Panel Health Environmental and Regulatory Task Group. 2005. Revised Robust Summaries for Zinc

13


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Table lb. Environmental Fate Properties of Zinc Ditilky Idithiophosphate Category'





Photo-

Hvdrolvsis

Bio-

BCF4

Log

Fugacitv

Persistence""'

Bio-

Chemical name

CAS No.

degradation
Half-life

Half-Life

degradation



Koe4





accumulation''

Dialkylthiodiphosphates. http://www.epa.gov/chemrtk/pubs/summaries/zincdial/cl4066tc.htm.

2Atmospheric photooxidation is not an important environmental fate process since these compounds are not volatile and will exist in the
particulate phase in the atmosphere.

3The measurement of hydrolysis and fugacity for the ZDDP category members is not expected to provide useful information due to the
presence of 10-15 % lubricating oil in the final product.

4US EPA. 2008. Estimation Programs Interface Suite™ for Microsoft® Windows, v 3.20. United States Environmental Protection
Agency, Washington, DC, USA. http://www.epa.gov/opptintr/exposure/pubs/episuite.htm.

5FR 1999, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 213 (November
4, 1999) Page 60194-60204.	

Conclusion: Zinc dialkyldithiophosphates are amber colored viscous liquids at ambient temperature that contain
10-15 weight % highly refined lubricating base oil. De-oiled zinc dialkyldithiophosphates are solid materials. Zinc
dialkyldithiophosphates have low mobility and negligible volatilization. Atmospheric photooxidation is not an
important environmental fate process since these compounds will exist in the particulate phase in the atmosphere.
Biodegradation is slow and bioaccumulation is not expected. The persistence and bioaccumulation ranking for the
members of this category are P3 (high) and B1 (low).

2. Environmental Effects - Aquatic Toxicity

A summary of aquatic toxicity data submitted for SIDS endpoints is provided in Table 2. The table also indicates
where data for tested category members are read-across (RA) to untested members of the category.

Acute Toxicity to Fish

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and iso-propyl) esters, zinc salts (CAS No. 84605-29-8)
Rainbow trout (Oncorhynchus mykiss) were exposed to nominal concentrations (loading rates) of 0, 1.0, 1.8, 3.2, 5.6
and 10 mg/L water accommodated fractions (WAFs) under semi-static conditions for 96 hours. Analytical
monitoring was not conducted, but all the loading rates are below the reported measured water solubility of this
chemical (15.8 mg/L). Increased pigmentation and morbidity were observed at 5.6 and 10 mg/L. Mortality was 20,
70 and 100% at 3.2, 5.6 and 10 mg/L, respectively. The 96 hour LL50 (loading level likely to cause 50% mortality)
was 4.5 mg/L WAF.

96-h LCS0 = 4.5 mg/L

Phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt (CAS No. 4259-15-8)

Rainbow trout (O. mykiss) were exposed to nominal concentrations of 0, 10, 18, 32, 56 and 100 mg/L as WAFs
under semi-static conditions for 96 hours. No analytical measurements were made on the WAFs. An LC50 of 47
mg/L was provided in the test plan, but not in the robust summary. This implies effects were seen, but they are not
described in the robust summaries. EPA does not consider the loading rate as the no effect concentration when the
concentration exceeds the water solubility of the substance. Assuming that exposure concentration in the WAF is
the water solubility limit (saturation) for phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt, the no effect
concentration would be approximately 1.09 mg/L.

No effects at saturation

14


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt (CAS No. 11059-65-7)

[In the robust summary, the chemical name is listed as zinc, bis[0,0-bis(tetrapropylenephenyl)
phosphorodithioata-S,SJ\ Rainbow trout (O. mykiss) were exposed to phenol, tetrapropenyl-, hydrogen
phosphorodithioate, zinc salt as WAFs under semi-static conditions for 96 hours. The loading rate was 100 mg/L
and no analytical measurements were made on the WAFs. No effects were noted at any of the WAF loading rates.
EPA does not consider the loading rate as the no effect concentration when the concentration exceeds the water
solubility of the substance. Assuming exposure concentration in the WAF is the water solubility limit (saturation)
for phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt, the no effect concentration would be
approximately 0.18 mg/L.

No effects at saturation

Acute Toxicity to Aquatic Invertebrates

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and isopropyl) esters, zinc salts (CAS No. 84605-29-8)

Water fleas (Daphnia magna) were exposed to phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and
isopropyl) esters, zinc salts as WAFs under semi-static conditions for 48 hours. The loading rates were 0, 10, 18,
32, 56 and 100 mg/L and no analytical measurements were made on the WAFs. Results reported by the sponsor
(48-h EL50 of 23 mg/L) is greater than, but relatively close to the water solubility limit for this chemical (15.8
mg/L). The no observed effect level was reported as the 10 mg/L loading rate, which is below the chemical's
solubility.

Low effects expected at saturation

Phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt (CAS No. 4259-15-8)

Water fleas (I). magna) were exposed to phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt as WAFs
under semi-static conditions for 48 hours. The loading rate was 100 mg/L and no analytical measurements were
made on the WAFs. No effects were noted at any of the WAF loading rates. EPA does not consider the loading rate
as the no effect concentration when the concentration exceeds the water solubility of the substance. Assuming that
exposure concentration in the WAF is the water solubility limit (saturation) for phosphorodithioic acid 0,0-bis
(2-ethylhexyl) ester, zinc salt, the no effect concentration would be approximately 1.09 mg/L.

No effects at saturation

Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt (CAS No. 11059-65-7)

[In the robust summary, the chemical name is listed as zinc, bis[0,0-bis(tetrapropylenephenyl)
phosphorodithioata-S,S.] Water fleas (D. magna) were exposed to phenol, tetrapropenyl-, hydrogen
phosphorodithioate, zinc salt as WAFs under semi-static conditions for 48 hours. The loading rates were 0, 10, 18,
32, 56 and 100 mg/L and no analytical measurements were made on the WAFs. 100% mortality was observed at the
100 mg/L loading rate; no effects were noted at any other loading rates. The sponsor reported a 48-h EL50 of 75
mg/L, which is several orders of magnitude above the reported measured water solubility for this chemical; hence
this test/data is questionable. EPA does not consider the loading rate as the no effect concentration when the
concentration exceeds the water solubility of the substance. Assuming that exposure concentration in the WAF is
the water solubility limit (saturation) for zinc, bis[0,0-bis(tetrapropylenephenyl)phosphorodithioate-S,S'], the no
effect concentration would be approximately 0.18 mg/L.

No effects at saturation

Toxicity to Aquatic Plants

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and isopropyl) esters, zinc salts (CAS No. 84605-29-8)

Green algae (Scenedesmus subspicatus) were exposed to phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl
and isopropyl) esters, zinc salts as WAFs under semi-static conditions for 72 hours. The loading rates were 0, 10,
20, 40, 80 and 160 mg/L and no analytical measurements were made on the WAFs. The sponsor reported EL50 for
biomass of 21 mg/L and EL50 for growth of 24 mg/L. These concentrations are greater than, but relatively close to
the chemical's water solubility. The no observed effect level was reported as the 10 mg/L loading rate, which is
below the chemical's solubility.

Low effects expected at saturation

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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt (CAS No. 4259-15-8)

Green algae (S. subspicatus) were exposed to phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt as
WAFs under semi-static conditions for 72 hours. The loading rates were 0, 10, 32, 220, 320 and 1000 mg/L and no
analytical measurements were made on the WAFs. Growth was reduced at loading rates of 100 and 1000 mg/L;
however these concentrations are well in excess of the chemical's water solubility; hence, these results are
questionable and suggest possible physical effects. Assuming that exposure concentration in the WAF is the water
solubility limit (saturation) for phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt, the no effect
concentration would be approximately 1.09 mg/L.

No effects at saturation

Phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt (CAS No. 11059-65-7)

[In the robust summary, the chemical name is listed as zinc, bisfO,0-bis(tetrapropylenephenyl)phosphorodithioata-
S,SJ\ Green algae (S. subspicatus) were exposed to phenol, tetrapropenyl-, hydrogen phosphorodithioate, zinc salt
as WAFs under semi-static conditions for 72 hours. The loading rates were 0 or 1000 mg/L and no analytical
measurements were made on the WAFs. No effects were noted at any of the WAF loading rates. EPA does not
consider the loading rate as the no effect concentration when the concentration exceeds the water solubility of the
substance. Assuming that exposure concentration in the WAF is the water solubility limit (saturation) for zinc,
bis[0,Obis(tetrapropylenephenyl) phosphorodithioate-S,S'], the no effect concentration would be approximately
0.18 mg/L.

No effects at saturation

Conclusion: The aquatic toxicity data submitted were generated using the Water Accommodated Fraction method.
The evaluation of available toxicity data for fish, aquatic invertebrates and aquatic plants for C8 and higher ZDDPs
indicates the potential acute hazard to aquatic organisms is low based on no effects observed at the water solubility
limit (saturation) of two category members. The evaluation of available toxicity data for fish, aquatic invertebrates
and aquatic plants for C3 to C8 ZDDPs indicates the potential acute hazard to fish is moderate and to aquatic
invertebrates and aquatic plants is low, based on the one tested category member (CAS No. 84605-29-8). The
physical-chemical properties of the substances in this category also indicate they are soluble or miscible in water at
concentrations that could cause chronic effects.

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September 2008

Table 2. Sum in sin of l-'.n\ imiimcnlsil l-'.ITecls- \(|ii;ilic ln\ici(\ l);i 1 ;i1

Endpoint

Phosphoro-

Phosphoro-

Phosphoro-

Phosphoro-

Phosphoro-

Phosphoro-

Phosphoro-

Phosphoro-

Phosphoro-

Phosphoro-

Phenol,

Phenol,



dithioic acid,

dithioic acid,

dithioic acid,

dithioic acid,

dithioic

dithioic acid,

dithioic acid,

dithioic acid,

dithioic acid,

dithioic acid,

dodecyl-,

tetra-



mixed 0,0-

mixed 0,0-

mixed 0,0-

mixed 0,0-

acid, 0-(2-

mixed 0,0-

0,0-bis(l,3-

0,0-bis(2-

o,o-

o,o-

hydrogen

propenyl-,



bis(l,3-

bis(iso-butyl

bis(sec-butyl

bis(sec-butyl

ethylhexyl)

bis(iso-butyl

dimethyl-

ethylhexyl)

bis(isooctyl)

diisodecyl

phosphoro-

hydrogen



dimethyl-

and pentyl)

and 1,3-

and isooctyl)

O-isobutyl

and isooctyl

butyl) ester,

ester, zinc

ester, zinc

ester, zinc

dithioate,

phosphoro-



butyl and

esters, zinc

dimethyl-

esters, zinc

ester, zinc

and pentyl)

zinc salt

salt

salt

salt

zinc salt

dithioate,



isopropyl)

salts

butyl) esters,

salts

salt

esters, zinc











zinc salt



esters, zinc
salts



zinc salts





salts















(84605-29-8)

(68457-79-4)

(68784-31-6)

(113706-15-3)

(26566-95-0)

(68988-46-5)

(2215-35-2)

(4259-15-8)

(28629-66-5)

(25103-54-2)

(51261-67-5)

(11059-65-7)

Fish



No Data

No Data

No Data

No Data

No Data

No Data



No Data

No Data

No Data



96-h LCS0

4.5 (in)

4.5

4.5

4.5

4.5

4.5

4.5

NES

NES

NES

NES

NES

(mg/L)



(RA)

(RA)

(RA)

(RA)

(RA)

(RA)

(m)

(RA)

(RA)

(RA)

(m)

Aquatic



No Data

No Data

No Data

No Data

No Data

No Data



No Data

No Data

No Data



Invertebrates

Low effects

Low effects at

Low effects at

Low effects at

Low effects

Low effects at

Low effects at

NES

NES

NES

NES

NES

48-h ECS0

at saturation

saturation

saturation

saturation

at saturation

saturation

saturation

(m)

(RA)

(RA)

(RA)

(m)

(mg/L)



(RA)

(RA)

(RA)

(RA)

(RA)

(RA)











Aquatic Plants



No Data

No Data

No Data

No Data

No Data

No Data



No Data

No Data

No Data



72-h EC50

Low effects

Low effects at

Low effects at

Low effects at

Low effects

Low effects at

Low effects at

NES

NES

NES

NES

NES

(mg/L)

at saturation

saturation

saturation

saturation

at saturation

saturation

saturation

(m)

(RA)

(RA)

(RA)

(m)





(RA)

(RA)

(RA)

(RA)

(RA)

(RA)











(m) = measured data (i.e., derived from testing); NES = No effects at saturation (water solubility limit); (RA) = read across; 1 All data generated from WAF are all
nominal concentrations.

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September 2008

3. Human Health Effects

A summary of health effects data submitted for SIDS endpoints is provided in Table 3. The table also indicates
where data for tested category members are read-across (RA) to untested members of the category.

Acute Oral Toxicity

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and isopropyl) esters, zinc salts (CAS No. 84605-29-8)

Sprague-Dawley rats (10/sex/dose) were administered single doses of phosphorodithioic acid, mixed
0,0-bis(l,3-dimethylbutyl and isopropyl) esters, zinc salts at 1500, 1825, 2221, 2702, 3288 or 4000 mg/kg-bw.
Mortality occurred at > 1825 mg/kg-bw within 93 hours of dosing. Other signs of toxicity included hypokinesia,
ataxia and diarrhea at all dose levels; ataxia was reported in animals receiving doses > 1825 mg/kg-bw. No changes
were seen during necropsy.

LDS0 = 3100 - 3200 mg/kg-bw

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl andpentyl) esters, zinc salts (CAS No. 68457-79-4)

Wistar rats (10 males/dose) were administered single doses of phosphorodithioic acid, mixed 0,0-bis(iso-butyl and
pentyl) esters, zinc salts at 2000, 3500, 5000 or 8750 mg/kg-bw. Mortality was seen at > 3500 mg/kg-bw within the
first 5 days of exposure. Lethargy, diarrhea, ptosis, chromorhinorrhea, piloerection and chromodacryorrhea were
reported findings at all doses. At necropsy, common findings among the animals that died were lung congestion,
gastrointestinal findings and staining around the mouth, nose and anus.

LDS0 = 3600 mg/kg-bw

Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts (CAS No. 68784-31-6)
Sprague-Dawley rats (5/sex/dose) were administered single doses of phosphorodithioic acid, mixed
0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts via gavage at 0, 1800, 2700, 4000 or 6000 mg/kg-bw.
Mortality occurred in males at > 4000 and in females at > 2700 mg/kg-bw. Other signs of toxicity included
diarrhea, depression, reduced food consumption, weakness, salivation and blood in urine. No treatment-related
necropsy findings were noted.

LDS0 (females) = 2900 mg/kg-bw
LDS0 (males) = 3400 mg/kg-bw

Phosphorodithioic acid, 0,0-bis(l,3-dimethylbutyl) ester, zinc salt (CAS No. 2215-35-2)

Sprague-Dawley rats (5/sex/dose) were administered single doses of phosphorodithioic acid,
0,0-bis( 1,3-dimethylbutyl) ester, zinc salt via gavage at 2000 or 5000 mg/kg-bw. Mortality occurred in both doses
within 4 days of exposure. Other signs of toxicity included diarrhea, stained and/or ruffled fur and hypoactivity.
Necropsy of animals that died revealed gastrointestinal effects along with bloody oral and nasal discharge.
2000 mg/kg-bw < LDS0 < 5000 mg/kg-bw

Phosphorodithioic acid, 0,0-bis(2-ethylhexyl) esters, zinc salt (CAS No. 4259-15-8)

Sprague-Dawley rats (10 males/dose) were administered single doses of phosphorodithioic acid,
0,0-bis(2-ethylhexyl) esters, zinc salt via gavage at 0, 2200, 3300 or 7500 mg/kg-bw. Mortality was seen at all
doses. Other signs of toxicity included diarrhea, depression and reduced food consumption.

LDS0 = 3100 mg/kg-bw

Acute Dermal Toxicity

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and isopropyl) esters, zinc salts (CAS No. 84605-29-8)
New Zealand White rabbits (2/sex) were exposed to a single dose of phosphorodithioic acid, mixed
0,0-bis( 1,3-dimethylbutyl and isopropyl) esters, zinc salts via the dermal route at 2000 mg/kg-bw for 24 hours. No
mortality was reported. Erythema in one animal and peeling of the skin in all animals were noted as a result of
exposure.

LDS0 > 2000 mg/kg-bw

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Phosphorodithioic acid, mixed 0,0-bis(isobutyl andpentyl) esters, zinc salts (CAS No. 68457-79-4)

New Zealand White rabbits (2/sex) were exposed to a single dose of phosphorodithioic acid, mixed 0,0-bis(isobutyl
and pentyl) esters, zinc salts at 20,000 mg/kg-bw to the abraded skin under semi-occlusive conditions for 24 hours.
No mortality was reported. Lethargy, diarrhea, ataxia, emaciation and ptosis were reported as a result of exposure.
LDS0 > 20,000 mg/kg-bw

Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts (CAS No. 68784-31-6)
New Zealand White rabbits (5/sex) were exposed to a single exposure of mixed phosphorodithioic acid, mixed
0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts at 5000 mg/kg-bw to the abraded skin under semi-
occluded conditions for 24 hours. No mortality was reported. Weight loss and sub-acute dermatitis were reported
as a result of exposure.

LDS0 > 5000 mg/kg-bw

Phosphorodithioic acid, mixed 0,0-bis(isobutyl and isooctyl and pentyl) esters, zinc salts (CAS No. 68988-46-5)
New Zealand White rabbits (5/sex) were exposed to a single exposure of phosphorodithioic acid, mixed
0,0-bis(isobutyl and isooctyl and pentyl) esters, zinc salts via dermal route at of 2000 mg/kg-bw for 24 hours. No
mortality was reported. Cyanosis, decreased motor coordination and loss of righting reflex were noted. Dermal
reactions, necrosis, edema and ulceration persisted through study termination. At necropsy, pitted kidney was seen
in one female.

LDS0 > 2000 mg/kg-bw

Phosphorodithioic acid, 0,0-bis(2-ethylhexyl) esters, zinc salt (CAS No. 4259-15-8)

New Zealand White rabbits (6 males) were exposed to a single dose of phosphorodithioic acid,

0,0-bis(2-ethylhexyl) esters, zinc salt at 5000 mg/kg-bw to abraded and non-abraded skin for 24 hours. One animal

in the abraded skin group died during the 14-day observation period. Other signs of toxicity were reduced food

consumption, muscular weakness and gross lesions in the liver and lungs.

LDS0 > 5000 mg/kg-bw

Phosphorodithioic acid, 0,0-diisodecyl ester, zinc salt (CAS No. 84605-29-8)

New Zealand White rabbits (5/sex) were exposed to a single dose of phosphorodithioic acid, 0,0-diisodecyl ester,
zinc salt at 8000 mg/kg-bw to abraded skin under semi-occlusive conditions for 24 hours. No mortality was
reported. Clinical signs of toxicity included moderate erythema and edema, decreased activity, abnormal gait,
Assuring and sloughing of the skin. Necropsy revealed white nodules in lung and stomach of one animal following
exposure.

LDS0 > 8000 mg/kg-bw
Repeated-Dose Toxicity

Phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt (CAS No. 4259-15-8)

Sprague-Dawley rats (5/sex/dose) were exposed to phosphorodithioic acid 0,0-bis (2-ethylhexyl) ester, zinc salt
daily via gavage at 0 (corn oil), 10, 50, 125, 250 and 500 mg/kg-bw/day for 7 days/week for 28 days. Mortality was
seen at 500 mg/kg-bw/day. Clinical signs included changes in fecal consistency and coloration, staining of various
body surfaces, rales, salivation and aggressive behavior at 125, 250 and 500 mg/kg-bw/day in both sexes. Rales and
salivation were also observed in the 50 mg/kg-bw/day males. Decreased body weight gains were seen in males at >
250 mg/kg-bw/day and in females at 500 mg/kg-bw/day. At necropsy, a thickened mucosa of the nonglandular
stomach was observed at 250 and 500 mg/kg-bw/day. Submucosal edema of the glandular and/or non-glandular
portions of the stomach was seen in one 250 mg/kg-bw/day male and all high-dose females. Three high-dose
females also had suppurative inflammation, primarily in the non-glandular portion of the stomach. Mean absolute
and relative adrenal weights in the 250 and 500 mg/kg-bw/day groups were increased in both sexes. No
histopathological lesions were seen associated with these increases.

LOAEL = 50 mg/kg-bw/day (based on rales and salivation)

NOAEL = 10 mg/kg-bw/day

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Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and isooctyl) esters, zinc salts (CAS No. 113706-15-3)
New Zealand White rabbits (10/sex/dose) were administered phosphorodithioic acid, mixed 0,0-bis(sec-butyl and
isooctyl) esters, zinc salts via the dermal route at 0, 5 or 25% (w/v) (approximately 0, 100 and 500 mg/kg-bw/day12,
respectively) for 5 days/week for 4 weeks. The vehicle control was Primol 185. Treatment-related mortality was
seen at the high dose. Emaciation, dermal thickening, lacrimation and ano-genital staining were among the observed
clinical signs. Marked, dose-related increases in the incidence and severity of erythema, edema, atonia,
desquamation, Assuring, eschar formation and exfoliation were seen at both dose levels. Many of these observations
were moderate to extreme in severity, particularly those in the high-dose group. Dermal irritation was observed in
the vehicle control and treatment groups, but occurred with greater incidence and severity in the treatment groups.
The mean body weights of the high-dose males and females were markedly reduced compared to vehicle control
throughout the study. A slight reduction in body weight was also seen in the low-dose animals. A marked reduction
in mean hemoglobin, hematocrit and erythrocyte counts was seen in the high-dose animals compared to vehicle
control. In addition, there were increases in mean platelet count in the high-dose males and slight (low dose) to
marked (high dose) increases in mean cholesterol levels. Marked decreases in the mean albumin levels were seen in
the high-dose animals. The mean plasma, erythrocyte and brain cholinesterase values of the high-dose animals and
low-dose females were decreased compared to the vehicle control. The mean absolute and relative (to body weight)
testes and epididymidal weights were markedly lower than vehicle control in the high-dose group. The mean
absolute and relative (to body weight) adrenal weights of the high-dose males and females were increased compared
to vehicle control. Dose-related increases in mean absolute and relative kidney weights were evident in both sexes
at both doses.

Subchronic inflammatory changes consisting of multifocal pneumonitis were present in some vehicle control and
treated animals. Macroscopic dermal changes included atonia, alopecia, exfoliation, Assuring and eschar formation.
Compound-related microscopic changes in the skin of low- and high-dose animals consisted of slight to moderately
severe hyperkeratosis, parakeratosis and epithelial hyperplasia. In some rabbits, these changes were accompanied
by an increase in the amount of collagen present in the dermis and/or focal to multifocal areas of suppurative
dermatitis. The severity of these lesions was greater at the high dose. In addition, the testes of the high-dose
animals were observed to be markedly smaller than those of the vehicle control males. Microscopic examination of
the testes revealed the presence of morphologic abnormalities in the seminiferous tubules of the testes of the high-
dose animals that were characterized by aspermatogenesis, diffuse tubular hypoplasia and a reduced mitotic activity.
LOAEL = 100 mg/kg-bw/day (based on clinical signs, dermal effects, and significant reductions in plasma,
erythrocyte and brain cholinesterase)

NOAEL = Not established

Phosphorodithioic acid, 0,0-bis(isooctyl) ester, zinc salt (CAS No. 28629-66-5)

New Zealand White rabbits (10/sex/dose) were administered phosphorodithioic acid, 0,0-bis(isooctyl) ester, zinc
salt via the dermal route at 0, 5 or 25% (w/v) (approximately 100 and 500 mg/kg-bw/day) for 5 days/week for a total
of 20 exposures. Mortality was seen at the high-dose. Dose-related emaciation was a common finding at both doses
in both sexes with greater severity in females. Dermal thickening was observed in most of the treated animals
during the last 2 weeks of the study. Ano-genital staining, nasal discharge and lacrimation were frequently observed
in the treated animals at both doses. Treated animals exhibited marked, dose-related increases in the incidence and
severity of erythema, edema, atonia desquamation, Assuring, eschar formation and exfoliation. The severity of these
observations was moderate to extreme in the high-dose group. Dermal irritation was also observed in the vehicle
control group with low incidence and severity. The mean body weights of males and females at both doses were
decreased throughout the study. Mean hemoglobin, hematocrit and erythrocyte counts were slightly to markedly
reduced compared to vehicle control. Decreased alkaline phosphatase, decreased albumin, increased blood urea
nitrogen, increased cholesterol and increased total and direct bilirubin were seen at both doses. In addition, mean
brain cholinesterase levels were slightly reduced in the treated animals. Dermal changes consisted of slight to
moderately severe hyperkeratosis, parakeratosis and epithelial hyperplasia. In some rabbits, these changes were
accompanied by an increase in the amount of collagen in the dermis and/or focal to multifocal areas of suppurative
dermatitis. The severity of these lesions was greater at the high-dose level. In treated males, there was a dose-
related, marked decrease in the absolute and relative testes and epididymides weights. Microscopic examination of
the testes from both dose groups revealed the presence of morphologic abnormalities in the seminiferous tubules of
the testes that were characterized by aspermatogenesis, diffuse tubular hypoplasia and a reduced mitotic activity.

12 Approximate conversion to mg/kg-bw/day is based on assumption of 100% absorption throughout this section.

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LOAEL = 100 mg/kg-bw/day (based on clinical signs, changes in clinical chemistry parameters, decreased body
weight, dermal effects and effects on testes)

NOAEL = Not established

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl andpentyl) esters, zinc salts (CAS No. 68457-79-4)

Rabbits (15 males/dose) were administered phosphorodithioic acid, mixed 0,0-bis(iso-butyl and pentyl) esters, zinc
salts via dermal route at 0 (vehicle) or 25% (w/v) (approximately 500 mg/kg-bw/day) for 5 days/week for 4 weeks.
Mortality, decreased body weights, emaciation, decreased food consumption, Assuring and exfoliation of the skin,
and higher incidence and/or severity of ano-genital staining were seen in treated animals when compared to controls.
Erythema, atonia and desquamation were observed in animals from both groups; however, the incidence and
severity was higher in animals exposed to phosphorodithioic acid, mixed 0,0-bis(iso-butyl and pentyl) esters, zinc
salts Hematological parameters were lower and clinical chemistry parameters (cholesterol, triglycerides and blood
urea nitrogen) were elevated in treated animals. Absolute and relative organ weights (epididymides, testes, prostate)
of exposed animals were reduced and kidney weights were increased when compared to control animals; these
changes remained following a 9-week extension period without treatment. Microscopic examination revealed that
treated animals had slight to moderately severe changes in the skin and testicular changes (moderate to severe
diffuse tubular hypoplasia and aspermatogenesis).

LOAEL = 500 mg/kg-bw/day (based on mortality, reduced body weight, dermal effects, clinical signs)

NOAEL = Not established

Phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl ester, zinc salt (CAS No. 26566-95-0)

New Zealand White rabbits (5/sex/dose) were administered phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl
ester, zinc salt at 0, 210, 430 and 860 mg/kg-bw/day to the abraded skin for 5 days/week for 3 weeks. Mortality was
seen at 430 and 860 mg/kg-bw/day. Decreased body weight, lethargy, anorexia, adipsia, emaciation and diarrhea
were noted prior to death. The survivors in the treated groups expressed signs of nasal and ocular discharge and
gastrointestinal effects. These effects increased in frequency over the course of the study. In some cases, lethargy,
ptosis, anorexia and adipsia accompanied by emaciation were also seen. Severe dermal reactions were observed in
all treated animals by the ninth dose. Decreased body weights were seen in all mid- and high-dose animals.
Leukocyte counts were increased slightly in all treated groups at termination. Dose-related moderate to severe
epithelial hyperplasia with surface exudate was observed in the treated skin of all treated rabbits. Ulceration and
necrosis were seen among the high-dose animals. Four of five high-dose and two of five mid-dose males exhibited
suppression of sperm formation. One control animal had severely reduced spermatogenesis. The high-dose animals
exhibited aspermia.

LOAEL = 210 mg/kg-bw/day (based on dermal effects, increased leukocyte counts and suppressed sperm
formation)

NOAEL = Not established

Phosphorodithioic acid mixed 0,0-bis(iso-butyl and isooctyl, and pentyl) esters, zinc salts (CAS No. 68988-46-5)
Rabbits (18 males/dose) were administered phosphorodithioic acid mixed 0,0-bis(iso-butyl and isooctyl, and
pentyl) esters, zinc salts via dermal route at 3, 5, 25 and 100% (approximately, 60, 100, 500 and 2000 mg/kg-
bw/day) or the vehicle control (base oil) for 5 days/week for 3 weeks. Untreated and sham controls were included.
A 6-week recovery period followed the exposure period. All animals treated at the 100% dose level, 15 of 18 in the
25% and 1 of 18 in the vehicle and 5% dose groups died or were sacrificed moribund. No deaths occurred in the
3%, sham or untreated control groups. During recovery, three animals in the vehicle control and one at 5% were
sacrificed moribund. Erythema and edema were observed in all treated rabbits within 24 hours of the first
application. Severity was proportional to phosphorodithioic acid mixed 0,0-bis(iso-butyl and isooctyl, and pentyl)
esters, zinc salts concentration and duration of exposure. Severe erythema and/or eschar formation were observed at
later scoring periods in test and vehicle control animals. Other findings included hyperirritability, diarrhea,
decreased motor activity, ataxia, loss of righting reflex, ocular discharge, redness in the genital area and rippling of
skin. Severe body weight losses were seen at the 25 and 100% dose levels. Marked decreases in body weight of the
vehicle control, 3 and 5% groups were noted throughout the study. Recovery from body weight losses began
following termination of treatment with the vehicle or phosphorodithioic acid mixed 0,0-bis(iso-butyl and isooctyl,
and pentyl) esters, zinc salts. Reductions in several hematology parameters were noted in the vehicle and treated
groups at the termination of treatment. Increases in the percentages of mature heterophiles and corresponding
decreases in lymphocytes were detected. Mean absolute weights of testes, prostate and epididymis were markedly
lower in the vehicle and treated groups than in the sham or untreated control groups, but there were no significant

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differences when the vehicle controls were compared to the treated groups. Vehicle and test material related effects
noted on the skin, hematology parameters and weights of reproductive organs observed during treatment were no
longer different at the end of the 6-week recovery period. Gross necropsy findings included discoloration, scaling,
scabbing, hair loss and skin thickening at the dosing site. Treated animals also exhibited enlargement of the
prefemoral lymph node, discoloration of the lungs and liver red foci in the gastric mucosa and trichobezoars in the
stomach. One animal in each of the 5%, 25% and vehicle control groups had small soft testes. Necropsy
observations following recovery noted less frequent and less severe skin lesions, enlargement of the prefemoral and
respiratory lymph nodes and heart, lung and liver discoloration. In general, vehicle (base oil) treated animals had a
higher incidence of lesions following recovery than did the treated animals. The skin of the vehicle and treated
animals had acanthosis and acute and severe inflammation with pus formation at the treatment site. In treated
animals, the acanthosis was followed by escharotic dermatitis, which involved the deeper layers of the skin and
resulted in blood and fluid loss. Following the 6-week recovery period, the lesions of the epidermis had abated. A
low incidence of orchitis (testicular inflammation) and maturation arrest at the primary spermatocyte level was
observed in the testes of vehicle and treated animals following the treatment and recovery periods. Effects noted at
3 and 5% of phosphorodithioic acid mixed 0,0-bis(iso-butyl and isooctyl, and pentyl) esters, zinc salts were similar
to those observed with the vehicle, suggesting that toxic effects observed at these dose levels were principally due to
the vehicle.

LOAEL = 500 mg/kg-bw/day (based on mortality, dermal effects, decreased body weights, clinical signs and effect
on hematological parameters)

NOAEL = 100 mg/kg-bw/day

Reproductive/Developmental Toxicity

Phosphorodithioic acid, 0,0-bis(2-ethylhexyl) ester, zinc salt (CAS No. 4259-15-8)

In a combined reproductive/developmental toxicity screening test, Sprague-Dawley rats (12/sex/dose) were
administered phosphorodithioic acid, 0,0-bis(2-ethylhexyl) ester, zinc salt via gavage at 0, 30, 100 or 200 mg/kg-
bw/day. Dosing regimens were as follows: F0 males, 28 days total (14 days pre-mating, 14-day mating period); F0
females, at least 43 days total (14 days pre-mating, mating; 25 days of gestation and 4 days of lactation). Mortality
was seen in males at the high dose. Two females in the mid-dose group and one female in the high-dose group were
euthanized on lactation days 1 or 2 due to total litter loss. All other animals survived to their scheduled sacrifice.
Clinical signs noted in the dead or sacrificed animals included staining, matting of fur, respiratory distress, hunched
appearance and mucoid diarrhea. Clinical signs in the surviving mid- and high-dose males and females included
post-dosing salivation, brown staining, respiratory distress and diarrhea. No treatment-related clinical findings were
observed in the low-dose animals. A microscopic examination of the reproductive organs of these animals did not
reveal any treatment-related effects. Other reproductive parameters (mating and fertility indices, days between
pairing and coitus, gestation length and parturition) were unremarkable in all treated groups. The pre-mating (weeks
1-4) mean body weight gain of the high-dose males was reduced compared to control. The mean body weights of
the low- and mid-dose males and all treated female groups were unremarkable during the pre-mating period.
Gestation and lactation body weights were unremarkable in all treated groups. There was no effect on food
consumption in any treated groups during the pre-mating, gestation and lactation periods. With the exception of the
gastric irritation noted above in several unscheduled deaths, the macroscopic and microscopic findings were
unremarkable.

F1 pup body weights, live litter size and sex ratios were not affected by treatment. An increased number of dead
pups were noted in the mid-dose group on day 0 of lactation. Pup viability indices were reduced in the mid-dose
(during lactation days 1 and 4) and high-dose (lactation day 4) groups. This was attributed to total litter loss by
three females (two mid-dose and one high-dose females). Increased pup deaths were observed in the mid- and high-
dose groups during the post-natal period. An increased incidence of pups without milk in the stomach was noted in
the 100 mg/kg-bw/day group. No treatment-related effects were evident during necropsy of the pups found dead
and scheduled pup necropsies.

LOAEL (systemic toxicity) = 100 mg/kg-bw/day (based on mortality, clinical signs)

NOAEL (systemic toxicity) = 30 mg/kg-bw/day

LOAEL (reproductive/developmental toxicity) = 100 mg/kg-bw/day (based on increased postnatal mortality)
NOAEL (reproductive/developmental toxicity) = 30 mg/kg-bw/day

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Genetic Toxicity — Gene Mutation
In vitro

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and iso-propyl) esters, zinc salts (CAS No. 84605-29-8)
Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts (CAS No. 68784-31-6)
Phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl ester, zinc salt (CAS No. 26566-95-0)

Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester, zinc salt (CAS No. 4259-15-8)

Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 or TA1538 and Escherichia coli WP2uvrA were
exposed to the above-listed zinc dialkyldithiophosphates in separate assays at concentrations of 1 - 10,000 ng/plate
in the presence and absence of metabolic activation. Cytoxicity was evaluated in each assay. Solvent (ethanol or
acetone) and positive controls showed appropriate responses. None of the tested substances showed mutagenic
activity in the presence or absence of metabolic activation.

The above-listed chemicals were not mutagenic in these assays.

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl andpentyl) esters, zinc salts (CAS No. 68457-79-4)
Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and isooctyl) esters, zinc salts (CAS No. 113706-15-3)
Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester, zinc salt (CAS No. 4259-15-8)

Phosphorodithioic acid, mixed 0,0-bis(iso-butyl and isooctyl and pentyl) esters, zinc salts (CAS No. 68988-46-5)
Phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl ester, zinc salt (CAS No. 26566-95-0)

Mouse lymphoma cells (strain L5178Y) were exposed to the above-listed zinc dialkyldithiophosphates in separate
assays at concentrations of 0.0013 - 0.024 |iL/mL in the presence and absence of metabolic activation. All
chemicals showed negative mutagenic activity without metabolic activation. Two chemicals, phosphorodithioic
acid, mixed 0,0-bis(sec-butyl and isooctyl) esters, zinc salts (CAS No. 113706-15-3) and phosphorodithioic acid,
mixed 0,0-bis(iso-butyl and isooctyl and pentyl) esters, zinc salts (CAS No. 68988-46-5), tested positive for gene
mutation in the presence of metabolic activation. The remaining chemicals showed equivocal evidence (considered
positive) for gene mutations in the presence of metabolic activation.

The above-listed chemicals were mutagenic in these assays.

Genetic Toxicity — Chromosomal Aberrations

In vivo

Phosphorodithioic acid, mixed 0,0-bis(l,3-dimethylbutyl and iso-propyl) esters, zinc salts (CAS No. 84605-29-8)
Phosphorodithioic acid, mixed 0,0-bis(sec-butyl and 1,3-dimethylbutyl) esters, zinc salts (CAS No. 68784-31-6)
Phosphorodithioic acid, 0-(2-ethylhexyl) 0-(2-methylpropyl) esters, zinc salt (CAS No. 26566-95-0)
Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester, zinc salt (CAS No. 4259-15-8)

Swiss Albino Crl:CD-l (male and female) were administered the above listed zinc dialkyldithiophosphates via
intraperitoneal route in separate assays at doses ranging from 6 to 50 mg/kg-bw. Several animals showed clinical
signs including mortality, piloerection, tremors and hypoactivity and were prostrate prior to death. Bone marrow
was sampled at 24, 48 and/or 72 hours post-treatment. Erythrocytes were harvested, washed, stained and evaluated
for the presence of micronuclei. None of the chemicals induced micronuclei in bone marrow erythrocytes.
The above-listed chemicals did not induce micronuclei in these assays.

Conclusion: Acute oral and dermal toxicity of ZDDP category members is low. Several repeated dose dermal
studies of ZDDP category chemicals showed moderate toxicity in rabbits. An oral repeated-dose study in rats of one
ZDDP category member showed moderate systemic toxicity. An oral combined reproductive/developmental
toxicity study in rats of one ZDDP category member showed moderate systemic toxicity in the adult animals and
moderate postnatal developmental toxicity; there were no effects on reproductive parameters or reproductive organs.
In contrast, dermal repeated-dose studies in rabbits of several ZDDP category members did show moderate toxicity
to the male reproductive organs. ZDDP category members were not mutagenic in bacterial cells, but showed a
positive response in mammalian cells. ZDDP category members did not induce chromosome aberrations when
tested in vivo.

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Table 3. Siimman of Human lleallh Data

l.ndpoinls

Phiisphnni-

dilhiiik
;uid. miu-d
(),()-l>is( 1,3-
dimi-lh> 1-
l>ll l\ 1 illld
isii-|)ni|)\ 1)

I'SllTS, /.illl'

suits

Plmsphiini-
dilhiiik ;uid,
miu-d (),()-
l)is(isii-l)iii\ 1
;ind |K'iii\ 1)
i-sk-rs, /iiu-
s;i It s

Phiisphiini-
dilhiiik ;uid,
miu-d (),()-
l>is(si-i-l>ui\ 1
;iihI 1,3-
(lillU'lll\ 1-

l)lll\ 1) I'SllTS,
/.illl' s;ilis

Phiisphiini-
dilhiiik :uid,
miu-ri (),()-

l>is(si-i-l>ui\ 1
;ind isiniii\ 1)
i-su-rs, /.iiu-
s;ills

Phiisphiini-
(lilhiiiii ;ii'id,

()-(2-
i-lh> lhi-\\ 1)
()-isiil>iii\ 1
i-sk-r, /.iiu-
s;ill

Phiisphnni-
(lilhiiiii ;iiid,
mi\i-tl (),()-
l)is(isii-l>iii\ 1
iiiul isiiiiii\ 1
;iikI |)i-ni\ 1)
i-sk-rs, /.iiu-
s;i ll s

Phiisphiini-
dilhiiiii mill,
(),()-his(l,3-
(liim-i h\ 1-
l)iil\ 1) i-sii-r,
/.iiu- suit

Phiisphnni-
dilhiiiii ;iiid,
(),()-his(2-
i-lh\ llu-\\ 1)
i-sii-r, /.iiu-
s;ill

Phiisphiini-
dillliiiii ;uid,
(),()-
l)is(isiiiiii\l)
i-sii-r, /.iiu-
s;ill

Phiisphnni-
dilhiiiii ;iiid,
(),()-
diisiidi-i\ 1
i-sii-r, /.iiu-
s;ill

Plll-llol,
dndi-i \ I-,
h\ dn i»i-n
phiisphiini-
dilhin;iii-,
/.illl' s;ill

Plii-md, u-lr;i-
|>ni|)i-n\ I-,
h\ dn i»i-n
phiisphiini-
dilllio;ili-, /.illl'
Sill)



(N4fi05-2'>-N)

(fiS457-7'M)

K.N7N4-3U.)

(1137l»r,-l 5-3)

(265Mi-')5-0)

(C,s*Jss-4r.-5»

(2215-35-2)

(425*^-15-S)

(2Sfi2'Wifi-5)

(25103-54-2)

(512C»1 -C»7-5)

(1 KI5'W.5-7)

Acute Oral

Toxicity

(mg/kg-bw)

3100

3600

2900

No Data
2900
(RA)

No Data
2900
(RA)

No Data
2900
(RA)

>2000
<5000

3100

No Data
3100
(RA)

No Data
3100
(RA)

No Data
3100
(RA)

No Data
3100
(RA)

Acute Dermal

Toxicity

(mg/kg-bw)

>2000

>2000

>5000

No Data
>2000
(RA)

No Data
>2000
(RA)

>2000

No Data
>2000
(RA)

>5000

No Data
>5000
(RA)

>8000

No Data
>8000
(RA)

No Data
>8000
(RA)

Repeated-dose
Toxicity-Oral
(NOAEL/
LOAEL

(mg/kg-bw/day)

No Data
NOAEL=
10

LOAEL =
50
(RA)

No Data
NOAEL=
10

LOAEL =
50
(RA)

No Data
NOAEL =
10

LOAEL =
50
(RA)

No Data
NOAEL=
10

LOAEL =
50
(RA)

No Data
NOAEL=
10

LOAEL=
50
(RA)

No Data
NOAEL =
10

LOAEL=
50
(RA)

No Data
NOAEL=
10

LOAEL =
50
(RA)

NOAEL =
10

LOAEL =
50

No Data
NOAEL=
10

LOAEL =
50
(RA)

No Data
NOAEL=
10

LOAEL=
50
(RA)

No Data
NOAEL=
10

LOAEL=
50
(RA)

No Data
NOAEL=
10

LOAEL=
50
(RA)

Repeated-dose
Toxicity- Dermal
(NOAEL/
LOAEL

(mg/kg-bw/day)

No Data
NOAEL=

NE
LOAEL=
500
(RA)

NOAEL =

NE
LOAEL =
500

No Data
NOAEL =

NE
LOAEL =
500
(RA)

NOAEL =

NE
LOAEL =
100

NOAEL =

NE
LOAEL =
210

NOAEL =

100
LOAEL =
500

NOAEL =

NE
LOAEL =
800

No Data
NOAEL =

NE
LOAEL=
100
(RA)

NOAEL =

NE
LOAEL =
100

No Data
NOAEL=

NE
LOAEL=
100
(RA)

No Data
NOAEL=

NE
LOAEL=
100
(RA)

No Data
NOAEL =

NE
LOAEL=
100
(RA)

Bold = measured data; (RA) = Read Across; NE = Not established

24


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Tabic 3. Sum man of Human llealih l);K;i

l.ndpoinls

Phiisphnni-

dilhiiik
aiid. miu-d
(),()-his( 1,3-
dimi-lh> 1-
l>n l\ 1 and
isn-|)ni|)\ 1)
i-sli-rs, /ini
sails

Phosplnini-
dilhiiik aiid,
miu-d (),()-
l)is(isii-l)ui\ 1
and |K'iil>l)
i-sli-rs, /.ini
sails

Phiisphiini-
dilhiuii aiid,
miu-d (),()-

l>is(si-i-l>ul\ 1

and 1,3-
dimi-lh> 1-
l»nl\ 1) i-sli-rs,
/.iiu sails

Phiisplnini-
dilhiiik acid.
mi\ed (),()-
l)is(sei-l)iil> 1
and is(nnl> 1)
eslers, /inc
sails

Phiisphiiro-
dilhink acid.

()-(2-
(,'lll\IIU'W 1)
()-isiil>iil> 1
esk-r, /.iiu-
sall

Phosplnini-
dilhiiik acid,
miu-d (),()-
l)is(isii-l)iii\ 1
and isiiiiii> 1
and |K-nl\ 1)
esk-rs, /.iill-
sails

Pllis(l,3-

iliiiiii h\ 1-
l)lll\ 1) I'M IT,
/iiu sail

Phosphiini-
dilhiiiii aiid.
(),()-his(2-
l-lll\ IIU'W 1)
1-SllT, /ilK
sail

Phiisphiini-
dilhiuii aiid.
(),()-
l)is(isiiiii'i\l)
I'SllT, /iiu

sail

Phosphiini-
(lilhiiiii aiid.
(),()-
diisiidi-i\ 1
I'SllT, /.iiu
sail

Phi-nnl.
dndi-i \ I-,
h\ dn i»i'ii
phiisphiini-
dilhiiiak'.
/iiu sail

Phi'ind, u-ira-
|>ni|K'ii\I-,
lixdni^i'ii
phosphiini-
dilhiiiak', /.iiu
sail



(S4605-29-S)

(6S457-71M)

(6X7S4-31-6)

(113706-15-3)

(26566-95-0)

(6S'JSS-46-5)

(2215-35-2)

(4259-15-S)

(2S62'J-66-5)

(25103-54-2)

(51261-67-5)

(11059-65-7)

Reproductive/

Developmental

Toxicity

NOAEL/

LOAEL

(mg/kg-bw/day)

No Data
NOAEL=
30

LOAEL =
100
(RA)

No Data
NO A F.I. =
30

LOAEL=
100
(RA)

No Data
NOAEL =

30

LOAEL =
100
(RA)

No Data
NOAEL = 30
LOAEL =
100
(RA)

No Data
NOAEL=
30

LOAEL=
100
(RA)

No Data
NOAEL =
30

LOAEL=
100
(RA)

No Data
NOAEL=
30

LOAEL =
100
(RA)

NOAEL =
30

LOAEL =
100

No Data
NOAEL=

30

LOAEL =
100
(RA)

No Data
NOAEL=
30

LOAEL=
100
(RA))

No Data
NOAEL=
30

LOAEL=
100
(RA)

No Data
NOAEL = 30
LOAEL =
100
(RA)

Genetic

Toxicity-Gene

Mutation

Negative

Positive
(Equivocal)

Negative

Positive

Positive
(mammal-
ian cell)
Negative
(bacteria)

Positive

Positive

Positive
(mammal-
ian cell)
Negative
(bacteria)

No Data
Positive
(RA)

No Data
Positive
(RA)

No Data
Positive
(RA)

No Data
Positive
(RA)

Genetic
Toxicity-
Chromosomal
Aberrations

Negative

No Data
Negative
(RA)

Negative

No Data
Negative
(RA)

Negative

No Data
Negative
(RA)

No Data
Negative
(RA)

Negative

No Data
Negative
(RA)

No Data
Negative
(RA)

No Data
Negative
(RA)

No Data
Negative
(RA)

Bold = measured data; (RA) = Read Across; NE = Not established

25


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U.S. Environmental Protection Agency	September 2008

Supporting Documents for Risk-Based Prioritization

Appendix

Zinc Dialkyldithiophosphates

CAS No.

Chemical Name

Structure

SPONSORED CHEMICALS

84605-29-8

Phosphorodithioic acid, mixed
0,0-bis(l,3-dimethylbutyl
and iso-propyl) esters, zinc
salts

tt\a/n {r

/\/V\



911 CI Name: Phosphoroditliioic acid, mixed 0,0-bis(l,3-
dimethylbutyl and iso-Pr) esters, zinc salts

68457-79-4

Phosphorodithioic acid,
mixed O,0-bis(iso-butyl and
pentyl) esters, zinc salts

> S -S }

VV vn

911 CI Name: Phosphoroditliioic acid, mixed 0,0-bis(iso-Bu and
pentyl) esters, zinc salts

68784-31-6

Phosphorodithioic acid, mixed
0,0-bis(sec-butyl and 1,3-
dimethylbutyl) esters, zinc
salts

YYvYVT"

/\/V\

911 CI Name: Phosphoroditliioic acid, mixed 0,0-bis(sec-Bu and
1,3-dimethylbutyl) esters, zinc salts

113707-15-3

Phosphorodithioic acid,
mixed 0,0-bis(sec-butyl and
isooctyl) esters, zinc salts

D c $ J

911 CI Name: Phosphoroditliioic acid, mixed 0,0-bis(sec-Bu and
isooctyl) esters, zinc salts

26566-95-0

Phosphorodithioic acid, 0-(-
2-ethylhexyl) O-isobutyl ester,
zinc salts

O s vs P
Zn



9'1 CI Name: Zinc, bis[0-(2-ethylhexyl) 0-(2-methylpropyl)
phosphoroditliioato-.kappa. S, .kappa. S'] -, (T-4)-

26


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Zinc Dialkyldithiophosphates

CAS No.

Chemical Name

Structure

SPONSORED CHEMICALS

68988-46-5

Phosphorodithioic acid,
mixed O,0-bis(iso-butyl and
isooctyl and pentyl) esters,
zinc salts

o o vs P

vV x <

/ Zn . t

„/¦V v\>

9'1 CI Name: Phosphorodithioic acid, mixed 0,0-bis(iso-Bu and
isooctyl and pentyl) esters, zinc salts

2215-35-2

Phosphorodithioic acid, 0,0-
bis(l,3-dimethylbutyl) ester,
zinc salts

S vS /

V V x <

9 1 CI Name: Zinc, bis[0,0-bis(l,3-dimethylbutyl)
phosphoroditliioato-.kappa. S, .kappa. S'] -, (T-4)-

4259-15-8

Phosphorodithioic acid, 0,0-
bis(2-ethylhexyl)ester, zinc
salts

9 1 CI Name: Zinc, bis[0,0-bis(2-ethylhexyl) phosphorodithioato-
.kappa.S,.kappa.S']-, (T-4)-

28629-66-5

Phosphorodithioic acid, 0,0-
bis(isooctyl) ester, zinc salt

P Zn . \

/V

9th CI Name: Zinc, bis(0,0-diisooctyl phosphoroditliioato-
.kappa. S,. kappa. S')-

25103-54-2

Phosphorodithioic acid, 0,0-
diisodecyl ester, zinc salts

\/\

/VV\

911 CI Name: Zinc, bis(0,0-diisodecyl phosphoroditliioato-
.kappa. S,. kappa. S')-

27


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Zinc Dialkyldithiophosphatcs

CAS No.

Chemical Name

Structure

SPONSORED CHEMICALS

54261-67-5

Phenol, dodecyl-, hydrogen
phosphorodithioate, zinc salts

CX c (y^jV/N/N/VV*

\/\/V

p zn -C

^x T^Ji

9th CI Name: Zinc, bis[0,0-bis(dodecylphenyl)
phosphorodithioato-.kappa. S, .kappa. S']-

11059-65-7

Phenol, tetrapropenyl-,
hydrogen phosphorodithioate,
zinc salts

'U^\ A, /\ /

,P Zn . \

9th CI Name: Zinc, bis[0,0-bis(tetrapropylenephenyl)
phosphorodithioato-.kappa. S, .kappa. S']-

28


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Screening Level Exposure Characterization for HPV Challenge

Chemical

Zinc Dialkyldithiophosphates Category

CAS #(s): 113706-15-3; 4259-15-8; 68988-46-5; 26566-95-0;
68457-79-4; 28629-66-5; 68784-31-6; 25103-54-2;
11059-65-7; 84605-29-8; 54261-67-5; 2215-35-2

September 2008

Prepared by

Exposure Assessment Branch
Chemical Engineering Branch
Economics, Exposure and Technology Division
Office of Pollution Prevention and Toxics
Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

29


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Screening Level Exposure Characterization

Zinc Dialkyldithiophosphates Category
Non-CBI Executive Summary

The 12 zinc dialkyldithiophosphates category chemicals have aggregated production/ import
volumes in the range of 94 million to 340.5 million pounds.13 The aggregated production/
import volumes exclude two of the twelve chemicals, phosphorodithioic acid, mixed 0,0-
bis(iso-bu and isooctyl) (CAS#68988-46-5) and zinc, bis (0,0-diisodecyl phosphorodithioato-
.kappa.S,.kappa) (CAS#25103-54-2), which do not have Inventory Update Reporting (IUR)
submissions. Non-confidential IUR information indicates that these chemicals were
manufactured and/or imported at the following companies and sites:

CAS#113706-15-3:

•	Infineum USA, L.P. / Linden, NJ

CAS#4259-15-8:

•	Rhein Chemie Corporation / Trenton, NJ

CAS#26566-95-0:

•	Confidential

CAS#68457-79-4:

•	Infineum USA, L.P. / Linden, NJ

CAS#28629-66-5:

•	Infineum USA, L.P. / Linden, NJ

CAS#68784-31-6:

•	Confidential

CAS#11059-65-7:

•	Confidential

CAS#84605-29-8:

•	Infineum USA, L.P. / Linden, NJ

CAS#54261-67-5:

•	Confidential

CAS#2215-35-2:

•	BP AMERICA INC. / Wayne, NJ

13 USEPA, 2006 Partial Updating of TSCA Chemical Inventory

30


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

There may be other companies and sites that are claimed confidential. Non-confidential IUR
information for many of the chemicals in the zinc dialkyldithiophosphates category indicates that
these chemicals are used as lubricants in the manufacturing of other chemical products. Nine of
the twelve chemicals in this category have IUR submissions that indicate uses in commercial
settings, or consumer uses.

Information submitted as part of the HPV Challenge Program indicates that zinc
dialkyldithiophosphates are used to formulate finished lubricating oils, including all types of
automotive and diesel engine crankcase, industrial oils and hydraulic fluids.14 The Hazardous
Substances Data Bank (HSDB) has information for two of the chemicals and lists the uses as
hydraulic and transmission fluids (CAS#28629-66-5) or additives in lubricating oils
(CAS#25103-54-2).15

Potential Exposures to the General Population and the Environment: Based on the information
considered, including known uses, and the Agency's professional judgment, EPA identifies, for
the purposes of risk-based prioritization, a medium potential that the general population and the
environment might be exposed.

Based on the predominant uses of zinc dialkylthiophosphates in automotive and diesel crankcase
oils, industrial oils, and hydraulic fluids, there may be potential releases to land via disposal, or
accidental, spills and to air via incineration of spent oil.

Persistence and bioaccumulation ratings for these chemicals are P3 and Bl. These ratings
suggest that these chemicals are very persistent in the environment; and are not bioaccumulative.

Potential Exposures to Workers: Based on the information considered, including IUR data and
information from HPV Test Plan, and the Agency's professional judgment, EPA identifies, for
the purposes of risk-based prioritization, a medium relative ranking for potential worker
exposure. This relative ranking is based on the potential for dermal exposure of a moderate
number of workers, information on uses of the chemical substances including commercial uses,
and the production volume. Zinc dialkyldithiophosphates do not have OSHA Permissible
Exposure Limits (PELs).16

Potential Exposures to Consumers: EPA identifies, for the purposes of risk-based prioritization,
a high potential that consumers might be exposed from products containing this chemical. Nine
of the twelve chemicals in this category have IUR submissions that indicate uses in commercial
settings or consumer uses. Information from public data sources indicate potential for exposure
to consumers who may periodically add lubricating oil to automotive crankcases or change their
own automotive engine oil.17

14	ACCPAP, 2002. HPV Test Plan for Zinc Dialkyldithiophosphates. American Chemistry Council Petroleum
Additives Panel. Accessed, 6/16/08. http://www.epa.gov/chemrtk/pubs/summaries/zincdial/cl4066tp.pdf.

15	HSDB, 2008. Hazardous Substances Data Bank. Accessed, 6/16/08. http://toxnet.nlm.nih. gov/.

16	NIOSH, 1988. OSHA PEL Project Documentation, http://www.cdc.gov/niosh/pel88/npelcas.html Accessed,
6/17/08.

17	ACCPAP, 2002. HPV Test Plan for Zinc Dialkyldithiophosphates. American Chemistry Council Petroleum
Additives Panel. Accessed, 6/16/08. http://www.epa.gov/chemrtk/pubs/summaries/zincdial/cl4066tp.pdf.

31


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Potential Exposures to Children: EPA identifies, for the purposes of risk-based prioritization, a
low potential that children might be exposed. None of chemicals reported uses in products
intended to be used by children. One chemical reported that such information was Not Readily
Obtainable. It is unlikely that children will be exposed to automotive and diesel crankcase oils,
industrial oils, and hydraulic fluids containing these chemicals.

Below are tables summarizing non-confidential processing and use information in the IUR for
each of the individual chemicals in this category.

This exposure characterization was completed using both public, non-confidential sources, and
one or more IUR submissions that were available as of this writing.

32


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U.S. Environmental Protection Agency
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September 2008

Non Confidential IUR Data Summary: Phosphorodithioic acid, mixed 0,0-bis(sec-butyl
and isooctyl) esters, zinc salts (CAS#113706-15-3)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites*:
Maximum number of exposed workers**:

Highest non-CBI maximum concentration*:
Non-CBI physical forms*:

10 million to 50 million pounds

Infineum USA, L.P. / Linden, NJ

less than 100 (including those of manufacturing,

industrial processing and use)

up to 90% by weight

liquid

* There may be other companies/sites, concentrations, and physical forms that are claimed
confidential.

** There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



Table 1



Industrial Processing and I se Inrornialion



Reported in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Processing-incorporation into

All Other Chemical Product and

Lubricants

formulation, mixture, or reaction

Preparation Manufacturing



product





Additional line item(s) may be claimed as CBI

1 able 2

C ommercial/ C onsumer I ses
Reported in 2006 Il k

Commercial/ Consumer
Product Category Description

Highest maximum concentration
range

Use in Children's Products

Lubricants, greases and fuel
additives

31%-60%

NRO

Additional line item(s) may be
claimed as CBI





33


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phosphorodithioic acid, 0,0-bis(2-ethylhexyl)ester,
zinc salt (CAS#4259-15-8)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites*:
Maximum number of exposed workers**:

Highest non-CBI maximum concentration*
Non-CBI physical forms*:

10 million to 50 million pounds

Rhein Chemie Corporation / Trenton, NJ

1,000 or greater (including those of manufacturing,

industrial processing and use)

up to 90% by weight

pellets or large crystals; liquid

* There may be other companies/sites, concentrations, and physical forms that are claimed
confidential.

** There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



Table 1



Industrial Processing and I sc Inrornialion



Reported in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Processing-incorporation into

All Other Chemical

Lubricants

formulation, mixture, or reaction

Product and Preparation



product

Manufacturing



Additional line item(s) may be claimed as CBI

1 able 2

C ommercial/ C onsumer I ses
Reported in 2006 Il k

Commercial/ Consumer
Product Category Description

Highest maximum concentration
range

Use in Children's Products

Lubricants, greases and fuel
additives

1% - 30%

Confidential

Additional line item(s) may be
claimed as CBI





34


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phosphorodithioic acid, 0-(2-ethylhexyl) O-isobutyl
ester, zinc salt (CAS#26566-95-0)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites:
Maximum number of exposed workers*:

Highest non-CBI maximum concentration:
Non-CBI physical forms:

<500,000 pounds
confidential

less than 100 (including those of manufacturing,

industrial processing and use)

confidential

confidential

* There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



Table 1



Industrial Processing and I se Inrormalion



Ucporlcd in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

None reported



1 able 2





C ommercial/ C onsumer I ses



Ucporlcd in 2006 Il k



Commercial/ Consumer

Highest maximum concentration

Use in Children's Products

Product Category Description

range



None reported





35


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phosphorodithioic acid, mixed O,0-bis(iso-butyl
and pentyl) esters, zinc salts (CAS#68457-79-4)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites*:
Maximum number of exposed workers**:

Highest non-CBI maximum concentration*
Non-CBI physical forms*:

10 million to 50 million pounds
Infineum USA, L.P. / Linden, NJ
between 100 and 999 (including those of
manufacturing, industrial processing and use)
up to 90% by weight
liquid

* There may be other companies/sites, concentrations, and physical forms that are claimed
confidential.

** There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



Table 1



Industrial Processing and I se Inrormalion



Reported in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Processing-incorporation into

All Other Chemical Product and

Lubricants

formulation, mixture, or reaction

Preparation Manufacturing



product





Additional line item(s) may be claimed as CBI

1 able 2

C ommercial/ C onsumer I ses
Reported in 2006 Il k

Commercial/ Consumer
Product Category Description

Highest maximum concculralion

range

Lse in Children's Products

Lubricants, greases and fuel
additives

1% - 30%

No

Additional line item(s) may be
claimed as CBI





36


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U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phosphorodithioic acid, O,0-bis(isooctyl) ester, zinc
salt (CAS#28629-66-5)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites*:
Maximum number of exposed workers**:

Highest non-CBI maximum concentration*
Non-CBI physical forms*:

1 million to 10 million pounds
Infineum USA, L.P. / Linden, NJ
between 100 and 999 (including those of
manufacturing, industrial processing and use)
up to 90% by weight
liquid

* There may be other companies/sites, concentrations, and physical forms that are claimed
confidential.

** There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



Table 1



Industrial Processing and I se Inrormalion



Reported in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Processing-incorporation into

All Other Chemical

Lubricants

formulation, mixture, or reaction

Product and Preparation



product

Manufacturing



Additional line item(s) may be claimed as CBI

1 able 2

C ommercial/ C onsumer I ses
Reported in 2006 Il k

Commercial/ Consumer
Product Category Description

Highest maximum concculralion

range

Lse in Children's Products

Lubricants, greases and fuel
additives

61% - 90%

No

Additional line item(s) may be
claimed as CBI





37


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U.S. Environmental Protection Agency	September 2008

Supporting Documents for Risk-Based Prioritization

Non Confidential IUR Data Summary: Phosphorodithioic acid, mixed 0,0-bis(sec-butyl
and 1,3-dimethylbutyl) esters, zinc salts (CAS#68784-31-6)

Manufacturing/Import Information

Production and import volume:	1 million to 10 million pounds

List of non-CBI companies/ sites:	confidential

Maximum number of exposed workers*:	1,000 or greater (including those of manufacturing,

industrial processing and use)

Highest non-CBI maximum concentration:	confidential

Non-CBI physical forms:	confidential

* There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



Table 1



Industrial Processing and I sc Inrormalion



Ucporlcd in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Claimed as CBI



1 able 2





C ommercial/ C onsumer I ses



Ucporlcd in 2006 Il k



Commercial/ Consumer

Highest maximum concentration

Use in Children's Products

Product Category Description

range



Claimed as CBI





38


-------
U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phenol, tetrapropenyl-, hydrogen
phosphorodithioate, zinc salt (CAS#11059-65-7)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites:
Maximum number of exposed workers*:

Highest non-CBI maximum concentration:
Non-CBI physical forms:

1 million to 10 million pounds
confidential

1,000 or greater (including those of manufacturing,

industrial processing and use)

confidential

confidential

* There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



l a hie 1



Industrial Processing and I se Inrormalion



Ucporlcd in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Claimed as CBI



1 a hie 2





C ommercial/ C onsumer I ses



Ucporlcd in 2006 Il k



Commercial/ Consumer

Highest maximum concentration

Use in Children's Products

Product Category Description

range



Claimed as CBI





39


-------
U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phosphorodithioic acid, mixed 0,0-bis(l,3-
dimethylbutyl and iso-propyl) esters, zinc salts (CAS#84605-29-8)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites*:
Maximum number of exposed workers**:

Highest non-CBI maximum concentration*
Non-CBI physical forms*:

50 million to 100 million pounds

Infineum USA, L.P. / Linden, NJ

1,000 or greater (including those of manufacturing,

industrial processing and use)

up to 100% by weight

liquid

* There may be other companies/sites, concentrations, and physical forms that are claimed
confidential.

** There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.

Table 1

Industrial Processing and I se Information
Reported in 2006 Il k

Processing
Activity

Industrial
Sector

Function in
Ind. Sector

Processing-incorporation into
formulation, mixture, or reaction
product

All Other Chemical Product and
Preparation Manufacturing

Lubricants

Processing-incorporation into
formulation, mixture, or reaction
product

Other Basic Organic Chemical
Manufacturing

Lubricants

Additional line item(s) may be claimed as CBI



1 able 2

C ommercial/ C onsumer I ses
Reported in 2006 Il k

Commercial/ Consumer
Product Category Description

Highest maximum concentration
range

Use in Children's Products

Lubricants, greases and fuel
additives

1% - 30%

confidential

Additional line item(s) may be
claimed as CBI





40


-------
U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phenol, dodecyl-, hydrogen phosphorodithioate,
zinc salt (CAS#54261-67-5)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites:
Maximum number of exposed workers*:

Highest non-CBI maximum concentration:
Non-CBI physical forms**:

1 million to 10 million pounds
confidential

between 100 and 999 (including those of
manufacturing, industrial processing and use)
confidential
liquid

* There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.

** There may be other physical forms that are claimed confidential.



Table 1



Industrial Processing and I se Inrornialion



Ucporlcd in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Processing-incorporation into

All Other Chemical Product and

Lubricants

formulation, mixture, or reaction

Preparation Manufacturing



product





Additional line item(s) may be claimed as CBI

Table 2
C ommercial/ C onsumer I ses
Ucporlcd in 2006 Il k

Commercial/ Consumer
Product Category Description

Highest maximum concentration
range

Use in Children's Products

Lubricants, greases and fuel
additives

1% - 30%

No

Additional line item(s) may be
claimed as CBI





41


-------
U.S. Environmental Protection Agency
Supporting Documents for Risk-Based Prioritization

September 2008

Non Confidential IUR Data Summary: Phosphorodithioic acid, 0,0-bis(l,3-dimethylbutyl)
ester, zinc salt (CAS#2215-35-2)

Manufacturing/Import Information

Production and import volume:

List of non-CBI companies/ sites*:
Maximum number of exposed workers**:

Highest non-CBI maximum concentration*
Non-CBI physical forms*:

10 million to 50 million pounds

BP AMERICA INC. / Wayne, NJ

1,000 or greater (including those of manufacturing,

industrial processing and use)

up to 60% by weight

liquid

* There may be other companies/sites, concentrations, and physical forms that are claimed
confidential.

** There may be additional potentially exposed industrial workers that are not included in this
estimate since not all submitters were required to report on industrial processing and use and/or
there may be at least one use that contains a "Not Readily Obtainable" (NRO) response among
the submissions.



Table 1



Industrial Processing and I se Inrornialion



Reported in 2006 Il k



Processing

Industrial

Function in

Activity

Sector

Ind. Sector

Processing-incorporation into

All Other Chemical Product and

Lubricants

formulation, mixture, or reaction

Preparation Manufacturing



product





Additional line item(s) may be claimed as CBI

1 able 2

C ommercial/ C onsumer I ses
Reported in 2006 Il k

Commercial/ Consumer
Product Category Description

Highest maximum concentration
range

Use in Children's Products

Lubricants, greases and fuel
additives

1% - 30%

confidential

Additional line item(s) may be
claimed as CBI





42


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