Proposed Designation of Tris(2-chloroethyl) Phosphate (casrn 115-96-8) as a High-priority Substance for Risk Evaluation


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mpjfr	United States	Office of Chemical Safety and
¦¦hI Jmwk Environmental Protection Agency	Pollution Prevention
Proposed Designation of
Tris(2-chloroethyl) Phosphate
(CASRN 115-96-8)
as a High-Priority Substance
for Risk Evaluation
August 22,2019

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Table of Contents
List of Tables	iii
Acronyms and Abbreviations	iv
1.	Introduction	1
2.	Production volume or significant changes in production volume	3
Approach	3
Results and Discussion	3
3.	Conditions of use or significant changes in conditions of use	4
Approach	4
CDR Tables	5
CDR Summary and Additional Information on Conditions of Use	6
4.	Potentially exposed or susceptible subpopulations	7
Approach	7
Results and Discussion	7
5.	Persistence and bioaccumulation	8
Approach	8
Persistence and Bioaccumulation Summary	11
6.	Storage near significant sources of drinking water	12
Approach	12
Results and Discussion	12
7.	Hazard potential	12
Approach	12
Potential Human Health and Environmental Hazard Tables	13
8.	Exposure potential	16
Approach	16
Results and Discussion	16
9.	Other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority	20
10.	Proposed designation and Rationale	20
11.	References	21
ii

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List of Tables
Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds)	4
Table 2. Tris(2-chloroethyl) phosphate (CASRN 115-96-8) Categories and Subcategories of
Conditions of Use (2016 CDR Reporting Cycle)	5
Table 3. Tris(2-chloroethyl) phosphate (CASRN 115-96-8) Categories and Subcategories of
Conditions of Use (2012 CDR reporting cycle)	6
Table 4. Uses in Children's Products Information	7
Table 5. Physical and Chemical Properties of Tris(2-chloroethyl) Phosphate	8
Table 6. Environmental Fate Characteristics of Tris(2-chloroethyl) Phosphate	10
Table 7. Potential Human Health Hazards Identified for Tris(2-chloroethyl) Phosphate	14
Table 8. Potential Environmental Hazards Identified for Tris(2-chloroethyl) Phosphate	15
Table 9. Exposure Information for Consumers	17
Table 10. Exposure Information for the Environment and General Population	19
in

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Acronyms and Abbreviations
Term	Description
ACGIH	American Conference of Governmental Industrial Hygienists
ATSDR	Agency for Toxic Substances and Disease Registry
Biomon.	Biomonitoring
BOD	Biochemical oxygen demand
BP	Boiling point
CAA	Clean Air Act
CASRN	Chemical Abstracts Service Registry Number
CBI	Confidential Business Information
CDR	Chemical Data Reporting
CERCLA	Comprehensive Environmental Response, Compensation, and Liability Act
CFR	Code of Federal Regulations
Concen.	Concentration
CWA	Clean Water Act
CPDat	Chemical and Products Database
ECOTOX	Ecotoxicology Database
EPA	U.S. Environmental Protection Agency
EPCRA	Emergency Planning and Community Right-to-Know Act
FDA	U.S. Food and Drug Administration
FR	Federal Register
GC	Gas chromatography
HPLC	High performance liquid chromatography
IRIS	Integrated Risk Information System
IUR	Inventory Update Rule
K	Thousand
Koc	Organic carbon-water partition coefficient
Kow	Octanol-water partition coefficient
M	Million
MITI	Ministry of International Trade and Industry
iv

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Term
Description
MP
Melting point
NAICS
North American Industry Classification System
NIH
National Institute of Health
NIOSH
National Institute for Occupational Safety and Health
NR
Not reported
OECD
Organisation for Economic Co-operation and Development
•OH
Hydroxyl radical
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
PEL
Permissible Exposure Limit
POTW
Publicly owned treatment works
PPE
Personal protective equipment
PPM
Parts per million
RCRA
Resource Conservation and Recovery Act
REL
Recommended Exposure Limit
RY
Reporting Year
SOP
Standard Operating Procedure
SMILES
Simplified Molecular-Input Line-Entry System
T1/2
Half-life
TG
Test guidance
TLV
Threshold Limit Value
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TWA
Time weighted average
USGS
United States Geological Survey
VP
Vapor pressure
WS
Water solubility
V

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1. Introduction
In section 6(b)(1)(B) of the Toxic Substances Control Act (TSCA), as amended, and in the U.S.
Environmental Protection Agency's implementing regulations (40 CFR 702.3)1, a high-priority
substance for risk evaluation is defined as a chemical substance that EPA determines, without
consideration of costs or other non-risk factors, may present an unreasonable risk of injury to
health or the environment because of a potential hazard and a potential route of exposure under
the conditions of use, including an unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant by EPA.
Before designating prioritization status, under EPA's regulations at 40 CFR 702.9 and pursuant
to TSCA section 6(b)(1)(A), EPA will generally use reasonably available information to screen
the candidate chemical substance under its conditions of use against the following criteria and
considerations:
•	the hazard and exposure potential of the chemical substance;
•	persistence and bioaccumulation;
•	potentially exposed or susceptible subpopulations;
•	storage near significant sources of drinking water;
•	conditions of use or significant changes in the conditions of use of the chemical
substance;
•	the chemical substance's production volume or significant changes in production volume;
and
•	other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority.
This document presents the review of the candidate chemical substance against the criteria and
considerations set forth in 40 CFR 702.9 for a may present risk finding. The information sources
used are relevant to the criteria and considerations and consistent with the scientific standards of
TSCA section 26(h), including, as appropriate, sources for hazard and exposure data listed in
Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012)
(40 CFR 702.9(b)). Final designation of the chemical substance as a high-priority chemical
substance would immediately initiate the risk evaluation process as described in the EPA's final
rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control
Act (40 CFR 702).
Tris(2-chloroethyl) phosphate (TCEP) is one of the 40 chemical substances initiated for
prioritization as referenced in the March 21, 2019 notice (84 FR 10491)2. EPA has determined
that TCEP is a suitable candidate for the proposed designation as a high-priority chemical
substance. The proposed designation is based on the results of the review against the
aforementioned criteria and considerations as well as review of the reasonably available
1	NOTE: For all 40 CFR 702 citations, please refer to:
https://www. regulations. gov/document?D=EP A-HO-OPPT -2016-0654-0108
2	https://www.federalregister.gov/documents/2019/03/21/2019-05404/initiation-of-prioritization-under-the-toxic-
subsfances-eontrol-act-fsca
1

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information on TCEP, including relevant information received from the public and other
information as appropriate.
EPA will take comment on this proposed designation for 90 days before finalizing its designation
of TCEP. The docket number for providing comments on TCEP is EPA-HQ-OPPT-2018-0476-
0002 and is available at www.regulations.gov.
The information, analysis, and basis for the review of the chemical is organized as follows:
• Section 1 (Introduction): This section explains the requirements of the amended TSCA
and implementing regulations - including the criteria and considerations — pertinent to
the prioritization and designation of high-priority chemical substances.
• Section 2 (Production volume or significant changes in production volume): This section
presents information and analysis on national aggregate production volume of the
chemical substance.
• Section 3 (Conditions of use or significant changes in conditions of use): This section
presents information and analysis regarding the chemical substance's conditions of use
under TSCA.
• Section 4 (Potentially exposed or susceptible subpopulations): This section presents
information and analysis regarding children, pregnant women, and workers, who could be
potentially exposed or susceptible subpopulations for the chemical substance.
• Section 5 (Persistence and bioaccumulation): This section presents information and
analysis regarding the physical and chemical properties of the chemical substance and the
chemical's fate characteristics.
• Section 6 (Storage near significant sources of drinking water): This section presents
information and analysis considered regarding the risk from the storage of the chemical
substance near significant sources of drinking water.
• Section 7 (HazardPotential): This section presents the hazard information relevant to the
chemical substance.
• Section 8 (Exposure Potential): This section presents information and analysis regarding
the exposures to the chemical substance.
• Section 9 (Other risk-based criteria): This section presents the extent to which EPA
identified other risk-based criteria that are relevant to the designation of the chemical
substance's priority.
• Section 10 (Proposed designation): Based on the results of the review performed and the
information and analysis presented, this section describes the basis used by EPA to
support the proposed designation.
2

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2. Production volume or significant changes in production volume
Approach
EPA considered current volume or significant changes in volume of the chemical substance
using information reported by manufacturers (including importers). EPA assembled reported
information for years 1986 through 2015 on the production volume for TCEP reported under the
Inventory Update Reporting (IUR) rule and Chemical Data Reporting (CDR) rule.3 The national
aggregate production volume, which is presented as a range in order to protect individual site
production volumes that are confidential business information (CBI), is presented in Table 1.
Results and Discussion
Production volume of TCEP in 2015, as reported to EPA during the 2016 CDR reporting period,
was 25,000 to 100,000 pounds. Though the data are limited to ranges, the production volume for
TCEP has been generally decreasing over the time. Production volume of TCEP as reported to
EPA remained did not change from 1986-2002 and decreased between 2006 and 2013. The
production volume then increased in 2014 and decreased, again, in 2015 (Table 1).
3 Over time, the requirements for reporting frequency, production volume thresholds, and chemical substances under
the Chemical Data Reporting (CDR) rule have changed. CDR was formerly known as the Inventory Update Rule
(IUR). The first IUR collection occurred in 1986 and continued every four years through 2006. As part of two
rulemakings in 2003 and 2005, EPA made a variety of changes to the IUR, including to change the reporting
frequency to every five years to address burdens associated with new reporting requirements. Additional changes to
reporting requirements were made in 2011, including to suspend and replace the 2011 submission period with a
2012 submission period, return to reporting every four years, and require the reporting of all years beginning with
2011 production volumes. The reporting of production volumes for all years was added because of the mounting
evidence that many chemical substances, even larger production volume chemical substances, often experience wide
fluctuations in production volume from year to year. In addition, also as part of the 2011 IUR Modifications final
rule (76 FR 50816, Aug 16, 2011), EPA changed the name of the regulation from IUR to CDR to better reflect the
distinction between this data collection (which includes exposure-related data) and the TSCA Inventory itself (which
only involves chemical identification information).
3

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Table 1.1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds) ^
Chemical ID
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
Tris(2-chloro
ethyl) phosphate (TCEP) (115-
96-8)
>lMto
10M
>lMto
10M
>lMto
10M
>lMto
10M
>lMto
10M
500K to
<1M
CBI4
25Kto
100K
25Kto
100K
lOOKto
500K
25K to
100K
K = thousand, M = million, CBI = confidential business information
Reference: U.S. EPA (2013) and U.S. EPA (2017)
3. Conditions of use or significant changes in conditions of use
Approach
EPA assembled information to determine conditions of use or significant changes in conditions
of use of the chemical substance. TSCA section 3(4) defines the term "conditions of use" to
mean the circumstances, as determined by the Administrator, under which a chemical substance
is intended, known, or reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.
A key source of reasonably available information that EPA considered for determining the
conditions of use for TCEP was submitted by manufacturers (including importers) under the
2012 and 2016 CDR reporting cycles. CDR requires manufacturers (including importers) to
report information on the chemical substances they produce domestically or import into the
United States greater than 25,000 lbs per site, except if certain TSCA actions apply (in which
case the reporting requirement is greater than 2,500 lbs per site). CDR includes information on
the manufacturing, processing, and use of chemical substances. Based on the known
manufacturing, processing and uses of this chemical substance, EPA assumes distribution in
commerce. CDR may not provide information on other life-cycle phases such as distribution or
chemical end-of-life after use in products (i.e., disposal). While EPA may be aware of additional
uses, CDR submitters are not required to provide information on chemical uses that are not
regulated under TSCA.
For chemical substances under review that are included on the Toxics Release Inventory (TRI)
chemical list, information disclosed by reporting facilities in Part II Section 3 ("Activities and
Uses of the Toxic Chemical at the Facility") of their TRI Form R reports was used to supplement
the CDR information on conditions of use. There is not a one-to-one correlation between
conditions of use reported under CDR and information reported in Part II Section 3 of the TRI
Form R because facilities are not required to disclose in their Form R submissions the specific
uses of TRI chemical substances they manufactured on-site or imported. TCEP is not included
4 This information is withheld, because EPA is releasing the 2016 CDR data in stages. EPA released the initial 2016
CDR data in May 2017. The initial data included national production volume (released in ranges), other
manufacturing information, and processing and use information, except for information claimed by the submitter to
be confidential business information (CBI) or information that EPA is withholding to protect claims of CBI. EPA
anticipates releasing additional data after completion of an effort to obtain CBI substantiation required by the Frank
R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act.
4

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on the TRI chemical list. For purposes of this proposed designation, EPA assumed end-of-life
pathways that include releases to air, wastewater, and solid and liquid waste based on the
conditions of use.
CDR Tables
Based on the publicly available5 manufacturing information, industrial processing and use
information, and consumer and commercial use information reported under CDR, EPA
developed a list of conditions of use for the 2016 and 2012 reporting cycles (For purposes of this
proposed designation, EPA assumed end-of-life pathways that include releases to air,
wastewater, and solid and liquid waste based on the conditions of use. Table 2 and 3,
respectively).
Table 2. Tris(2-chloroethyl) phosphate (CASRN 115-96-8) Categories and Subcategories of
Conditions of Use6 (2016 CDR Reporting Cycle) 		
Life-Cycle Stage
Category
Subcategory of Use
Reference
Manufacture
Import
Import
U.S. EPA (2019)
Distribution in commercea h
Distribution in commerce
Distribution in
commerce

Processing/Industrial uses
Processing/Industrial uses
Processing/Industrial
uses

Disposala
Disposal
Disposal

a CDR includes information on the manufacturing, processing, and use of chemicals. CDR may not provide
information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e.,
disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle stage.
b EPA is particularly interested in information from the public on distribution in commerce.
5	Some specific chemical uses may be claimed by CDR submitters as confidential business information (CBI) under
section 14 of TSCA. In these cases, EPA has indicated that the information is CBI.
6	Certain other uses that are excluded from TSCA are not captured in this table.
5

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Table 3. Tris(2-chloroethyl) phosphate (CASRN 115-96-8) Categories and Subcategories of
Conditions of Use7 (2012 CDR reporting cycle)			
Life-Cycle Stage
Category
Subcategory of Use
Reference
Manufacture
Import
Import
U.S. EPA (2019)

Processing
Incorporation into
formulation, mixture, or
reaction product
Flame retardant in paint
and coating
manufacturing
U.S. EPA (2019)

Processing
Recycling
Recycling
U.S. EPA (2019)
Distribution in commercea b
Distribution in commerce
Distribution in
commerce

Commercial uses
Paints and coatings
Paints and coatings
U.S. EPA (2019)
Consumer uses
Paints and coatings
Paints and coatings
U.S. EPA (2019)
Disposala
Disposal
Disposal

11 CDR includes information on the manufacturing, processing, and use of chemicals. CDR may not provide
information on other life-cycle phases such as distribution or chemical end-of-life after use in products (i.e.,
disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle stage.
b EPA is particularly interested in information from the public on distribution in commerce.
CDR Summary and Additional Information on Conditions of Use
Production and/or import of TCEP was reported by one site, Aceto Corporation, to the 2012 and
2016 CDR. In the 2016 CDR, industrial use information was reported as not known or
reasonably ascertainable and consumer use was not reported. In addition, recycling was reported
as not known or reasonably ascertainable. In the 2012 CDR, consumer and/or commercial use of
TCEP in paints and coatings was reported. Consumer uses were identified in additional
databases, which are included in the Exposure Potential section (Section 8).
Also, in the 2012 CDR, industrial processing (incorporation into formulation, mixture or reaction
product) as a flame retardant in the paint and coating manufacturing sector was reported. Due to
the limited reported information, it is difficult to determine whether significant changes in
conditions of use occurred.
In a public comment, the Aerospace Industries Association indicated that the aerospace industry
uses TCEP as a as a constituent within products or formulations for the manufacture, operation
and maintenance of aerospace products. This substance can be used as an additive plasticizer and
viscosity regulator with flame-retarding properties for polyurethane, polyesters, polyvinyl
chloride and other polymers. TCEP is also used in the production of unsaturated polyester resins
and in acrylic resins, adhesives and coatings. Specific aerospace industrial uses include, but may
not be limited to, resins and elastomeric coatings, polyurethane casting for aircraft interiors and
as a flame retardant (EPA-HQ-OPPT-2018-0476-0006).
7 Certain other uses that are excluded from TSCA are not captured in this table.
6

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4. Potentially exposed or susceptible subpopulations
Approach
In this review, EPA considered reasonably available information to identify potentially exposed
or susceptible subpopulations, such as children, women of reproductive age, consumers, workers,
or the elderly. EPA analyzed processing and use information included on the CDR Form U that
indicates whether the chemical substance is used in products and articles subject to TSCA and
are intended for children. These data provide an indication about whether children or other
susceptible subpopulation may be potentially exposed (e.g., workers, women of reproductive
age). EPA also used human health hazard information to identify potentially exposed or
susceptible subpopulations.
Results and Discussion
There were no reports to the 2016 CDR for TCEP in products intended for children, while the
2012 CDR reported the use of TCEP in children's products as not known or reasonably
ascertainable (Table 4). Previous EPA assessments indicated that TCEP was reported as used in
children's products, based on information from other databases. Due to potential developmental
and reproductive hazards, women of reproductive age are included as a potentially exposed or
susceptible subpopulation with respect to TCEP. At this stage, EPA identified children, women
of reproductive age, workers and consumers as subpopulations who may be potentially exposed
or susceptible subpopulations for TCEP.
Children
EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles
intended for children over time for TCEP. Table 4 summarizes the non-CBI CDR information
regarding commercial and consumer use and notes whether the chemical substance was
identified as used in products intended for children. Previous EPA assessments indicated that
TCEP was reported as used in children's products in the Washington State Children's Safe
Product Act Database (U.S. EPA 20.1.5a) and the chemical has been measured in infant and toddler
products such as car seats, changing table pads, and nursing pillows ( 4 2015a).
Table 4. Uses in Children's Products Information8
Chemical
Year
Product Category
(Product Concentration,
Number of Workers)
Consumer or
Commercial
Used in Products
Intended for
Children
Tris(2-chloroethyl)
phosphate (TCEP)
(115-96-8)
2012
Paints and coatings
NKRA
NKRA
2016
CDR did not include any reports as used in products intended for
children
Note(s): NKRA = Not Known or Reasonably Ascertainable.
Reference: U.S. )19)
8 Certain other uses that are excluded from TSCA are not captured in this table.
7

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Women of reproductive age (e.g., pregnant women per TSCA statute)
EPA identified studies that observed developmental and reproductive effects following exposure
to TCEP (Section 7, Table 7). Thus, women of reproductive age were identified as a potentially
exposed or susceptible subpopulation.
Consideration of women of reproductive age as a potentially exposed or susceptible
subpopulation was also based on exposure because women of reproductive age are potential
workers in the manufacturing, processing, distribution in commerce, use, or disposal of the
chemical substance.
Workers
Please refer to the Exposure Potential section for a summary of potential occupational exposures,
which EPA indicates that workers are potentially exposed or susceptible subpopulations based on
greater exposure.
Consumers
Please refer to the Exposure Potential section (Section 8) for a summary of potential consumer
exposures, which EPA indicates that consumers are potentially exposed or susceptible
subpopulations based on greater exposure.
5. Persistence and bioaccumulation
Approach
EPA reviewed reasonably available information on TCEP's persistence and bioaccumulation.
Table 5 and 6 summarize the physical and chemical properties and the environmental fate
characteristics, of TCEP, respectively.
Table 5. Physical and Chemical Properties of Tris(2-chloroethyl) Phosphate
Property or Endpoint
Value3
Reference
Molecular Formula
C6H12CI3O4P
CRC Handbook (Haynes, 2014)
Molecular Weight
285.489 g/mole
CRC Handbook (Haynes, 2014)
Physical State
Liquid
HSDB (20.1.5) citing Lewis (2007)
Melting Point
-55 °Cb
HSDB (20.1.5); ATSDR (20.1.2);
Toscano and Colman (20.1.2); Mackav
et al. (2006)
-58 °C (pour point DIN 51583,
ASTM D 97-66 method)
EC (2000); PhvsProD Database (U.S.
EPA. 20.1.2b)
-60 °C (approximate pour point)
EC (2000)
Less than -70 °C (pour point)
EC (2009); EC (2000)
Boiling Point
330 °C at 760 mm Hgb
CRC Handbook (Haynes, 2014);
ATSDR (20.1.2); Mackav et al.
(2006); HSDB (20.1.5)
320 °C decomposes
EC (2009)
8

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Property or Endpoint
Value8
Reference

Test substance purity: 99.5%


351 "Cat 760 mm Hg
decomposes rapidly at >220 °C;
thermal decomposition products:
carbon monoxide, hydrogen chloride,
2-chloroethane, and dichloroethane
IPCS (.1.998)

214 °C at 25 mm Hg
Mackay et al. (2006); Larranaga et al.
(2016) citing Muir (1984)

202 °C at 10 mm Hg
(ASTMD1160 method)
EC (2000)

145 °C at 0.5 mm Hg
180 °C at 3.75 mm Hg decomposes
EC (2000)
Density
1.39 g/cm3 at 25 °C
CRC Handbook (Haynes, 2014);
HSDB (20.1.5)

1.425 g/cm3 at 20 °C
ATSDR (20.1.2); IPCS (.1.998)

1.42 g/cm3 at 20 °C (DIN 51757
method)
EC (2000)

1.369 g/cm3
Mackay et al. (2006)
Vapor Pressure
1.6 x 10"5 mm Hg at 25 °Cb
Extrapolation from measured values:
0.43 hPa at 136.9 °C, 0.99 hPa at
143.5 °C, 2.03 hPa at 158.6 °C, 5.00
hPa at 174.1 °C, 15.03 hPa at 196.2 °C
(dynamic method)
PhvsProD Database (U.S. EPA.
20.1.2b): ECHA (20.1.8b)

8.6 x 10"6 mm Hg at 20 °C
(extrapolated)
OECD (2006): EC (2009)

0.06125 mm Hg at 25 °C
ATSDR (20.1.2): HSDB (20.1.5):
ECHA (20.1.8b) citing Dobry and
Keller (1957); Mackay et al. (2006)

0.5 mm Hg at 145 °C
Toscano and Colmam (20.1.2)

<10 mm Hg at 25 °C
IPCS (.1.998)
Vapor Density
9.8 (relative vapor density to air = 1)
IPCS (2007)
Water Solubility
7,820 mg/L at 20 °C and pH 4.7-6. lb
(Directive 84/449/EEC A.6)
HSDB (20.1.5): OECD (2006): EC
(2000)

7,940 mg/L at 20 °C
PhvsProo Database (U.S. EPA,
20.1.2b): ECHA (20.1.8b)

7,000 mg/L temperature not specified
HSDB (20.1.5): ATSDR (20.1.2):
ECHA (20.1.8b) citins Muir (1984):
Mackay et al. (2006)
Log Kow
1.78 at 20 °Cb (directive 84/449/EEC
A.8)
OECD (2006): HSDB (20.1.5)
9

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Property or Endpoint
Value8
Reference

1.7 at 20 °C (shake-flask method)
ECHA (20.1.8b); PhysProp Database
(U.S. EPA. 20.1.2b)
1.47 (OECD 107)
EC (2000)
1.43; 1.48
HSDB (20.1.5): Mackay et al. (2006)
1.44
ATSDR (20.1.2); ECHA (20.1.8b):
MITI (1992)
Henry's Law Constant
<1 x io-8 atm-m3/mole (estimated)
U.S. EPA (20.1.2a)
Flash Point
216 °C (Cleveland open cup)
ATSDR (20.1.2): ECHA (20.1.8b):
Larranaga et al. (2016)
252 °C (open cup)
EC (2000)
232 °C
Toscano and Colman (20.1.2); ECHA
(20.1.8b)
225 °C (closed cup DIN 51758)
EC (2000)
202 °C (Pensky Martin closed cup)
IPCS (.1.998)
200 °C (ASTM D93)
EC (2000)
Auto Flammability
480 °C (autoignition temperature)
EC (2000): IPCS (.1.998)
Viscosity
1.4721 at 20 °C
IPCS (.1.998)
Refractive Index
34 cP at 25 °C
IPCS (.1.998)
Dielectric Constant
TBD
TBD
Notes:
aMeasured unless otherwise noted;
bSelected value
TBD = to be determined, if reasonably available. EPA is particularly interested in information from the
public on these properties or endpoints.
Table 6. Environmental Fate Characteristics of Tris(2-chloroethyl) Phosphate
Property or Endpoint
Value3
References
Direct Photodegradation
Not expected to be susceptible to direct photolysis
by sunlight because the chemical structure of TCEP
does not contain chromophores that absorb at
wavelengths >290 nm
HSDB (20.1.5)
Indirect Photodegradation
ti/2 = 5.8 hours (based on -OH rate constant of
2.2 x 1011 cm3/molecule-sec at 25 °C and 12-hour
day with 1.5 x 106 OH/cm3; estimated)13
U.S. EPA (20.1.2a)
Hydrolysis
ti/2 = stable at pH 3
ti/2 = 3,980 days at pH 7
ti/2 = 101 days at pH 10
EnvCanada (2009)
citing Brown et al.
(1975)
10

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Property or Endpoint
Value8
References
Biodegradation (Aerobic)
Water: 4%/28 days based on BOD
0%/28 days based on TOC
l%/28 days based on HPLC
Test substance concentration 100 ppm (MITI test)
NITE (2010); ECHA
(20.1.8b)

Water: 10%/27 days (OECD 302B)
15 %/21 days (OECD 302B) in activated non-
adapted industrial sludge
EnvCanada (2009); EC
(2000)

4 and 13%/28 days (OECD 301B) at 20 and 10
mg/L test substance concentration in activated
domestic sludge, adaption not specified


70-90%/48 days (OECD 30IB) at 20 mg/L test
substance concentration in activated domestic
sludge, adaption not specified


Soil: DT50 =167 days, DT90 »100 days based on
test substance concentration 5 mg/kg in standard soil
laboratory test
EnvCanada (2009)
Biodegradation (Anaerobic)
Soil: 0%/58 days at 80 mg/L test substance
concentration related to DOC (ISO DIS 11734)
EC (2000) citing
Noack (1993)
Wastewater Treatment
9.2% total removal (7.3% by biodegradation, 1.9 by
sludge and 0% by volatilization to air; estimated)b
U.S. EPA (20.1.2a)


Bioconcentration Factor
0.6-0.8 and <1.2-5.1 attest substance
concentrations of 0.1 and 1.0 ppm (w/v),
respectively (Cyprinus carpio)
NITE (20.1.0)
Bioaccumulation Factor
6.3 (estimated)13
U.S. EPA (20.1.2a)
Soil Organic Carbon:Water
Partition Coefficient (Log
Koc)
2.6 (Koc = 388; MCI method);
2 (Koc= 103; Kow method) (estimated)13
U.S. EPA (20.1.2a)

Notes: "Measured unless otherwise noted; bEPI Suite™physical property inputs: Log K0w = 1.78, BP = 330 °C, MP
= -55 °C, VP = 1.6 x 10"5 mmHg, WS = 7,820 mg/L, SMILES 0=P(0CCC1)(0CCC1)0CCC1
TOC = total organic carbon; HPLC = High-Performance Liquid Chromatography; DOC = dissolved organic carbon;
•OH = hydroxyl radical; OECD = Organization for Economic Cooperation and Development; TG = test guideline;
GC = gas chromatography; MITI = Ministry of International Trade and Industry; BOD = biochemical oxygen
demand
Persistence and Bioaccumulation Summary
TCEP is a liquid with low volatility and high water solubility (7,820 mg/L at 20 °C). Estimated
Henry's Law constant (<1 x 10-8 atm-m3/mol) and vapor pressure (1.6 x 10-5 mm Hg) data
indicate that this chemical will be moderately persistent in surface water and soil. In the air,
TCEP is expected to exist in the vapor phase where it may react with photochemically-produced
hydroxyl radicals at an estimated rate corresponding to a half-life of 5.8 hours.
In aerobic aquatic environments, TCEP is not readily biodegradable. It achieved only 4% of its
theoretical biological oxygen demand (BOD) over a 28-day incubation period using a sewage
sludge inoculum and the MITI test method. In a standard soil laboratory test, TCEP had a half-
11

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life of 167 days in aerobic soil; in anaerobic soil, it achieved 0% degradation after 58 days.
These data indicate that this chemical may persist in subsurface environments, groundwater, or
enclosed pipes when volatilization is not an option.
TCEP displayed low bioaccumulation potential with measured bioconcentration factor values of
0.6-0.8 and <1.2-5.1 in carp at concentrations of 0.1 and 1.0 ppm, respectively. The estimated
bioaccumulation factor (BAF) of 6.3 and log Kow of 1.78 also indicate low bioaccumulation
potential.
6. Storage near significant sources of drinking water
Approach
To support the proposed designation, EPA screened each chemical substance under its conditions
of use with respect to the seven criteria in TSCA section 6(b)(1)(A) and 40 CFR 702.9. The
statute specifically requires the Agency to consider the chemical substance's storage near
significant sources of drinking water, which EPA interprets as direction to focus on the chemical
substance's potential human health hazard and exposure.
EPA reviewed reasonably available information, specifically looking to identify certain types of
existing regulations or protections for the proposed chemical substances. EPA considered the
chemical substance's potential human health hazards, including to potentially exposed or
susceptible subpopulations, by identifying existing National Primary Drinking Water
Regulations under the Safe Drinking Water Act (40 CFR Part 141) and regulations under the
Clean Water Act (CWA; 40 CFR 401.15). In addition, EPA considered the consolidated list of
chemical substances subject to reporting requirements under the Emergency Planning and
Community Right-to-Know Act (EPCRA; Section 302 Extremely Hazardous Substances and
Section 313 Toxic Chemicals), the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA; Hazardous Substances), and the Clean Air Act (CAA) Section 112(r)
(Regulated Chemicals for Accidental Release Prevention). Regulation by one of these authorities
is an indication that the substance is a potential health or environmental hazard which, if released
near a significant source of drinking water, could present an unreasonable risk of injury to human
health or the environment.
Results and Discussion
TCEP is not subject to any of the regulations listed in the previous paragraph.
7. Hazard potential
Approach
EPA considered reasonably available information from peer-reviewed assessments and databases
to identify potential hazards for TCEP (Tables 7 and 8, respectively).
Because there are very few publicly available assessments for TCEP with cited environmental
hazard data. EPA used the infrastructure of ECOTOXicology knowledgebase (ECOTOX) to
identify single chemical toxicity data for aquatic and terrestrial life (U.S. EPA. 2018a). It uses a
comprehensive chemical-specific literature search of the open literature that is conducted
12

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according to the Standard Operating Procedures (SOPs)9. The environmental hazard information
was populated in ECOTOX and is available to the public. In comparison to the approach used to
survey human health hazard data, EPA also used a read-across approach to identify additional
environmental hazard data for isomers of TCEP, if available, to fill in potential data gaps when
there were no reported observed effects for specific taxa exposed to TCEP (Table 8).
Potential Human Health and Environmental Hazard Tables
EPA identified human health and environmental hazards based on a review of the reasonable
available information for TCEP (Tables 7 and 8, respectively).
9 The ECOTOX Standard Operating Procedures (SOPs) can be found at: https://cfpub.epa.gov/ecotox/
13

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Table 7. Potential Human Health Hazards Identified for Tris(2-chloroethyl) Phosphate

Tested
Effect
Observed

Human Health Hazards
for
Specific
Effect
Data Source
Acute Toxicity
X
X
ECHA (2018a). ECHA (2018b). U.S. EPA (2015a).
U.S. EPA (2015b). CPSC (2015). CPSC (2013).
U.S. EPA (2009). EC (2009). IPCS (1.998). NTP
Repeated Dose Toxicity
X
X
NICNAS (2016). U.S. EPA (2015a). U.S. EPA
(2015b). CPSC (20.1.5). CPSC (20.1.3). U.S. EPA
(2009). EnvCanada (2009). EC (2009). IPCS (.1.998)
Genetic Toxicity
X
X
ECHA (2018b). NICNAS (20.1.6). U.S. EPA
(2015b). CPSC (20.1.3). U.S. EPA (2009).
EnvCanada (2009). EC (2009). I ARC (1999}, IPCS
Reproductive Toxicity
X
X
ECHA (2018a). NICNAS (20.1.6). U.S. EPA
(2015a). U.S. EPA (2015b). CPSC (20.1.3). U.S.
i nvCanada (2009). EC (2009). IPCS
(.1.998)
Developmental Toxicity
X
X
(20.1.3). U.S. EPA (2009). EnvCanada (2009). EC
(2009)
Toxicokinetic
X
X
ECHA (2018a). U.S. EPA (2015a). U.S. EPA
(2015b). CPSC (20.1.5). CPSC (20.1.3). EC (2009).
IPCS (.1.998)
Irritation/Corrosion
X

ECHA (2018b). U.S. EPA (2015b). CPSC (20.1.3).
EC (2009). IPCS (.1.998)
Dermal Sensitization
X

U.S. EPA (2015b). EC (2009)
Respiratory Sensitization



Carcinogenicity
X
X
ECHA (2018a). NICNAS (20.1.6). U.S. EPA
(2015a). U.S. EPA (2015b). CPSC (20.1.3). U.S.
EPA (2009). EnvCanada (2009). EC (2009). IARC
(.1.999). IPCS (.1.998). NTP (.1.99.1.)
Immunotoxicity



Neurotoxicity
X
X
ECHA (2018a). U.S. EPA (2015a). U.S. EPA
(.1.999). IPCS (.1.998)
Epidemiological Studies or
Biomonitoring Studies
X
X
U.S. EPA (2015a). NICNAS (20.1.6). U.S. EPA
(2015b). CPSC (20.1.5). IPCS (.1.998)
Note: The X in the Effect Observed column indicates when a hazard effect was reported by one or more of the
referenced studies. Blank rows indicate when information was not identified during EPA's review of reasonably
available information to support the proposed designation.
14

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Table 8. Potential Environmental Hazards Identil
'ied for Tris(2-chloroethyl) P
losphate
Media
Study Duration
Taxa Groups
High Priority Chemical
Candidate
T ris(2-chloroethyl)
phosphate
(TCEP)
(CASRN 115-96-8)
Isomers of
T ris(2-chloroethyl)
phosphate (TCEP)
(CASRN 115-96-8)
NONE
Data Sources
Number of
Studies
Observed
Effects
Number
of Studies
Observed
Effects
Aquatic
Acute
exposure
Vegetation
-

-


Invertebrate
-

-


Fish
1
X
-

McGee et al. (2012)
Non-Fish Vertebrates
(i.e., amphibians,
reptiles, mammals)





Chronic
exposure
Vegetation
-

-


Invertebrate
-

-


Fish
-

-


Non-Fish Vertebrates
(i.e., amphibians,
reptiles, mammals)





Terrestrial
Acute
exposure
Vegetation
-

-


Invertebrate
1
X
-

Boyd et al. (2016)
Vertebrates
-

-


Chronic
exposure
Vegetation
-

-


Invertebrate
-

-


Vertebrates
3



Chapin et al. (1998);
Hardin et al. (1987);
Fernie et al. (2015)
The dash indicates that no studies relevant for environmental hazard were identified during this initial review and thus the "Observed Effects" column is left blank. The X in the
Observed Effects column indicates when a hazard effect was reported by one or more of the referenced studies. The N/A in the Observed Effects column indicates when a hazard
effect was not reported by one of the referenced studies' abstract (full reference review has not been conducted).
15

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8. Exposure potential
Approach
EPA considered reasonably available information to identify potential environmental,
worker/occupational, consumer exposures and general population to TCEP.
Release potential for environmental and human health exposure
TCEP is not included on the TRI chemical list. EPA considered conditions of use reported in
CDR and the physical and chemical properties to inform the release potential of TCEP.
Worker/occupational and consumer exposure
EPA's approach for assessing exposure potential was to review the physical and chemical
properties, conditions of use reported in CDR, and information from the National Institutes of
Health Consumer Product Database and the Chemical and Products Database (CPDat) for TCEP
to inform occupational and consumer exposure potential. The results of this review are detailed
in the following tables.
General population exposure
EPA identified environmental concentration data to inform TCEP's exposure potential to the
general population.
Results and Discussion
Release potential for environmental and human health exposure
TCEP's reported vapor pressure varies widely: 8.6 x 10"6 mm Hg at 20 °C and ranging between
1.6 x 10"5 mm Hg at 25 °C and <10 mm Hg at 25 °C. This chemical's vapor pressure indicates
potential for air releases from volatilization during manufacturing, processing and use.
When chemical substances are incorporated into formulations, mixtures, or reaction products, the
industrial releases may be a relatively low percentage of the production volume. Lower
percentage releases occur when a high percentage of the volume is incorporated without
significant process losses during its incorporation into a formulation, mixture, or product. The
actual percentages, quantities, and media of releases of the reported chemical associated with this
processing or use are not known.
Worker/occupational exposure
Worker exposures to this chemical may be affected by many factors, including but not limited to
volume produced, processed and used; physical form and concentration; processes of
manufacture, processing, and use; chemical properties such as vapor pressure, solubility, and
water partition coefficient; local temperature and humidity; and exposure controls such as
engineering controls, administrative controls, and the existence of a personal protective
equipment (PPE) program.
16

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TCEP does not have an Occupational Safety and Health Administration (OSHA) Permissible
Exposure Limit (PEL)10, a National Institute for Occupational Safety and Health (NIOSH)
Recommended Exposure Limit (REL)11, or the Threshold Limit Value (TLV) set by American
Conference of Governmental Industrial Hygienists (ACGIH).
TCEP's reported vapor pressure varies widely: 8.6x 10"6 mm Hg at 20 °C and ranging between
1,6x 10"5 mm Hg at 25 °C and <10 mm Hg at 25 °C, and TCEP can exist as a liquid and a wet
solid. This indicates the potential for inhalation exposure to vapors generated by the liquid at
ambient room temperature conditions. The extent of inhalation exposure could vary from facility
to facility depending on many factors including but not limited to engineering control, type of
facility and design.
TCEP is indicated as being used in paints and coatings. Products used as paints and coatings may
be applied via spray or roll application methods. These methods may generate mists to which
workers may be exposed.
Consumer exposure
Based on CDR reporting information, TCEP appears to be used as a flame retardant in the paint
and coating manufacturing sector in 2012. In the 2016 CDR, all consumer and industrial use
information were either not reported or reported as not known or reasonably ascertainable. The
NIH Consumer Product Database and the Chemical and Products Database (CPDat) reported use
of TCEP in consumer products such as adhesives, automotive products, building materials,
fragrances, insulation, paint, textiles and toys (Table 9). In addition, TCEP was reported as used
in children's products in the Washington State Children's Safe Product Act Database (U.S. EPA
2015a). Existing assessments reported that TCEP may be present as an impurity in other
commercial flame retardants (ECHA 2018a. CPSC 20.1.5) or possibly in imported articles (ECHA
2018a). Despite the decline in production and use of TCEP, as of 2016, the chemical has been
measured in several consumer products including mattresses, furniture, automobile seating, and
in some infant and toddler products such as car seats, changing table pads, and nursing pillows
0MICNAS 20.1.6. U.S. EPA 2015aY
Table 9. Exposure Information for Consumers
Chemical Identity
Consumer Product Database
Consumer Uses (List)
Tris(2-chloroethyl) Phosphate
(115-96-8)
Adhesive, automotive, building material, electrical insulation,
fragrance, insulation, paint, textile, toys
Reference: CPDat
General population exposure
Releases of TCEP during certain conditions of use, such as industrial processing as a flame
retardant and consumer and commercial use, may result in general population exposures via
10 OSHA, 2009. Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs).
https://www.osha.gov/dsg/annotated-peis/tablez-l.htmi
11 NIOSH, 2005. NIOSH Pocket Guide to Chemical Hazards. https://www.cdc.gOv/n.iosIi/npg/npgdcas.html
17

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ingestion of indoor dust or through diet (via drinking water and fish ingestion), and dermal or
inhalation routes fNICNAS 20.1.6. U.S. EPA 2015a. CPSC 20.1.5. CPSC 20.1.31 TCEP was also
reported in water, soil, sediment, vegetation/diet, and other environmental media; it was not
reported in human or ecological biomonitoring matrices (Table 10).
18

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Table 10. Exposure Information for the
Environment and General Population
Database Name
Env.
Concen.
Data
Present?
Human
Biomon.
Data
Present?
Ecological
Biomon.
Data
Present?
Reference
California Air Resources Board
no
no
no
CARB (2005)
Comparative Toxicogenomics Database
no
no
no
MDI (2002)
EPA Ambient Monitoring Technology
Information Center - Air Toxics Data
no
no
no
U.S. EPA (1990)
EPA Discharge Monitoring Report Data
yes
no
no
U.S. EPA (2007)
EPA Unregulated Contaminant Monitoring
Rule
no
no
no
U.S. EPA (.1.996)
FDA Total Diet Study
yes
no
no
FDA (.1.99.1.)
Great Lakes Environmental Database
no
no
no
U.S. EPA (20.1.8b)
Information Platform for Chemical
Monitoring Data
no
no
no
EC (20.1.8)
International Council for the Exploration of
the Sea
no
no
no
ICES (20.1.8)
OECD Monitoring Database
no
no
no
OECD (20.1.8)
Targeted National Sewage Sludge Survey
no
no
no
U.S. EPA (2006)
The National Health and Nutrition
Examination Survey
no
no
no
emmm
USGS Monitoring Data -National Water
Quality Monitoring Council
yes
no
no
USGS (1991a)
USGS Monitoring Data -National Water
Quality Monitoring Council, Air
no
no
no
USGS (1991b)
USGS Monitoring Data -National Water
Quality Monitoring Council, Ground Water
yes
no
no
USGS (1.991c)
USGS Monitoring Data -National Water
Quality Monitoring Council, Sediment
yes
no
no
USGS (.1.99.1.(1)
USGS Monitoring Data -National Water
Quality Monitoring Council, Soil
no
no
no
USGS {.1.99.1.e)
USGS Monitoring Data -National Water
Quality Monitoring Council, Surface Water
yes
no
no
USGS (199If)
USGS Monitoring Data -National Water
Quality Monitoring Council, Tissue
no
no
no
USGS (.1.99.1.g)
11 Concen.= concentration
b Biomon.= biomonitoring
19

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Existing assessments also indicated TCEP was detected in ambient air, indoor air, indoor dust,
landfill sludge, sewage sludge, drinking water, groundwater, surface water, and wastewater
(NICNAS 20.1.6. U.S. EPA 2015a. U.S. EPA 2015b. CPSC 20.1.5. CPSC 20.1.3. EnvCanada 2009. EC
2009.1ARC .1.999. IPCS 1998). as well as in human breast milk, hair, and nails (U.S. EPA 2015a.
NICNAS 20.1.6. CPSC 20.1.5) and in the following biota: avian, fish, aquatic animals (including
shellfish), mammalian species (U.S. EPA 2015a. U.S. EPA 2015b. IPCS .1.998). Metabolites of
TCEP were detected in human urine (NICNAS 20.1.6. U.S. EPA 2015a. CPSC 20.1.5). Based on fate
properties, such as water solubility, Henry's Law constant, and soil organic carbon-water
partition coefficient, EPA anticipates possible presence of TCEP in water and soil (EnvCanada
2009. EC 2009. IPCS 19PS. < ,_S U A 2015a). The primary route of exposure for very young
children is via ingestion of indoor dust; mouthing of articles, and hand-to-mouth behavior (ECHA
2018a. NICNAS 20.1.6. CPSC 20.1.5. CPSC 20.1.3. EC 2009).
9. Other risk-based criteria that EPA determines to be relevant to the designation of
the chemical substance's priority
EPA did not identify other risk-based criteria relevant to the designation of the chemical
substance's priority.
10. Proposed designation and Rationale
Proposed designation: High-priority substance
Rationale: EPA identified and analyzed reasonably available information for exposure and
hazard and is proposing to find that TCEP may present an unreasonable risk of injury to health
and/or the environment, including potentially exposed or susceptible subpopulations, (e.g.,
workers, consumers, women of reproductive age, children). This is based on the potential hazard
and potential exposure of TCEP under the conditions of use described in this document to
support the prioritization designation. Specifically, EPA expects that the manufacturing,
processing, distribution, use, and disposal of TCEP may result in presence of the chemical in
surface water and groundwater, ingestion of the chemical in drinking water, inhalation of the
chemical from air releases, exposure to workers, and exposure to the general population,
including children. In addition, EPA identified potential environmental (e.g., aquatic toxicity,
terrestrial toxicity) and human health hazards (e.g., acute toxicity, repeated dose toxicity, genetic
toxicity, reproductive toxicity, developmental toxicity, toxicokinetics, carcinogenicity,
neurotoxicity, and observations in epidemiological studies and biomonitoring studies).
20

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