PA
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Proposed Designation of
Butyl Benzyl Phthalate
(CASRN 85-68-7)
as 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 3
Approach 3
CDR Tables 4
CDR and TRI Summary and Additional Information on Conditions of Use 6
4. Potentially exposed or susceptible subpopulations 8
Approach 8
Results and Discussion 8
5. Persistence and bioaccumulation 9
Approach 9
Physical and Chemical Properties and Environmental Fate Tables 9
Results and Discussion 11
6. Storage near significant sources of drinking water 12
Approach 12
Results and Discussion 12
7. Hazard potential 13
Approach 13
Potential Human Health and Environmental Hazard Tables 13
8. Exposure potential 17
Approach 17
Results and Discussion 17
9. Other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority 21
10. Proposed designation and Rationale 21
11. References 22
ii
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List of Tables
Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds) 3
Table 2. Butyl Benzyl Phthalate (85-68-7) Categories and Subcategories of Conditions of Use
(2016 CDR Reporting Cycle) 5
Table 3. Butyl Benzyl Phthalate (85-68-7) Categories and Subcategories of Conditions of Use
(2012 CDR Reporting Cycle) 6
Table 4. Physical and Chemical Properties of Butyl Benzyl Phthalate 9
Table 5. Environmental Fate Characteristics of Butyl Benzyl Phthalate 10
Table 6. Potential Human Health Hazards Identified for Butyl Benzyl Phthalate 14
Table 7. Potential Environmental Hazards Identified for Butyl Benzyl Phthalate 15
Table 8. Exposure Information for Consumers 19
Table 9. Exposure Information for the Environment and General Population 20
in
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Acronyms and Abbreviations
Term Description
ACGIH American Conference of Governmental Industrial Hygienists
BBP Butyl benzyl phthalate
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
CWA Clean Water Act
EPCRA Emergency Planning and Community Right-to-Know Act
IUR Inventory Update Reporting
M Million
MITI Ministry of International Trade and Industry, Japan
MP Melting point
N/A Not applicable
NIH National Institutes of Health
NIOSH National Institute for Occupational Safety and Health
NOC Not otherwise categorized
NR Not reported
OECD Organisation for Economic Co-operation and Development
OSHA Occupational Safety and Health Administration
PEL Permissible Exposure Limit
PPE Personal protective equipment
RCRA Resource Conservation and Recovery Act
REL Recommended Exposure Limit
RY Reporting year
iv
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Term
Description
SMILES
Simplified molecular-input line-entry system
TBD
To be determined
TLV
Threshold Limit Value
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
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 (EPA'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 substances 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)). EPA uses scientific information that is consistent with the best available
science. 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).
Butyl benzyl phthalate (BBP) is one of the 40 chemical substances initiated for prioritization as
referenced in the March 21, 2019 notice (84 FR 1049)2. EPA has determined that BBP is a
suitable candidate for the proposed designation as a high-priority 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 information on BBP, including
relevant information received from the public and other information as appropriate.
1 For all 40 CFR 702 citations, please refer to:
https://www.govinfo.gov/content/pkg/CFR-2018-title40-vol33/xml/CFR-2018-title40-vol33-part702.xml and
https://www. regulations. gov/document?D=EPA~HQ~OPPT~2Q .1.6-0654-01.08
2 https://www.federalregister.gov/documents/2019/03/21/2019-05404/initiation-of-prioritization-under-the-toxic-
substances-co nt to 1-act-tsca
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EPA will take comment on this proposed designation for 90 days before finalizing its designation
of BBP. The docket number for providing comments on BBP is EPA-HQ-OPPT-2018-0501 and
is available at www.regulations.gov.
The information, analysis, and basis used 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 potentially exposed or susceptible subpopulations,
including children, women of reproductive age, and workers, with respect to 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 (Exposurepotential): 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.
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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 BBP 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 to protect individual site production
volumes that are confidential business information (CBI), is presented in Table 1.
Results and Discussion
Production volume of BBP in 2015, as reported to EPA during the 2016 CDR reporting period,
was between 10 and 50 million pounds. Production volume of BBP as reported to EPA has
decreased very substantially since 1990. It has decreased further since 2011 and has not changed
since 2012 consistently ranging from 10 to 50 million pounds per year (Table 1).
Table 1.1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds) i
Chemical
ID
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
Butyl
Benzyl
Phthalate
(85-68-7)
>50M
to
100M
>100M
to
500M
>50M
to
100M
>100M
to
500M
>50M
to
100M
50M to
<100M
50M to
100M
lOMto
50M
lOMto
50M
lOMto
50M
lOMto
50M
Note: M = million
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
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).
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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 BBP 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 pounds per site, except if certain TSCA actions apply (in which case
the reporting requirement is greater than 2,500 pounds 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. BBP is not included on
the TRI chemical list. For purposes of this proposed prioritization 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 available4 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 (Table 2 and Table 3
respectively).
4 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.
4
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Table 2. Butyl Benzyl Phthalate (85-68-7) Categories and Subcategories of Conditions of
Use5 (2016 CDR Reporting Cycle)
Life-Cycle Stage
Category
Subcategory of Use
Reference
Manufacturing
Domestic
manufacturing/Import
CBI
U.S. EPA
(.2019a)
Import
Import
U.S. EPA
Processing
Incorporation into
formulation, mixture, or
reaction product
Fillers in:
- Custom compounding of
purchased resin
U.S. EPA
Incorporation into article
Plasticizers in:
- Adhesive manufacturing
- Plastics product
manufacturing
U.S. EPA
(2019a)
Dislnlnilion in
( omnvicc
Dislnliulion in commerce
Commercial Uses
Adhesives and sealants
Adhesives and sealants
U.S. EPA
(2019a)
Floor coverings
Floor coverings
U.S. EPA
Paints and coatings
Paints and coatings
U.S. EPA
(2019a)
Consumer Uses
Adhesives and sealants
Adhesives and sealants
U.S. EPA
(2019a)
Floor coverings
Floor coverings
U.S. EPA
19a)
Disposal
Disposal
11 CDR includes information on the manufacturing, processing, and use of chemical substances. 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 Certain other uses that are excluded from TSCA are not captured in this table.
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Table 3. Butyl Benzyl Phthalate (85-68-7) Categories and Subcategories of Conditions of
Use6 (2012 CDR Reporting Cycle)
Life-Cycle Stage
Category
Subcategory of Use
Reference
Manufacturing
Domestic
manufacturing/Import
CBI
U.S. EPA
Import
Import
U.S. EPA
Processing
Processing - incorporating
into articles
Plasticizers in:
- Adhesive manufacturing
- Plastics product
manufacturing
U.S. EPA
(2019a)
Distribution in
( omnviix'
Dislnliulion in commerce
Commercial Uses
Adhesives and sealants
Adhesives and sealants
. EPA
Floor coverings
Floor coverings
U.S. EPA
Consumer Uses
Adhesives and sealants
Adhesives and sealants
U.S. EPA
(2019a)
Floor coverings
Floor coverings
U.S. EPA
(2019a)
Disposal
Disposal
eov/cdr/
a CDR includes information on the manufacturing, processing, and use of chemical substances. 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 and TRI Summary and Additional Information on Conditions of Use
BBP was removed from the TRI chemical list; reporting year (RY) 1993 was the last RY for this
chemical. In the 2016 CDR reporting cycle, BBP was reported as used in manufacturing
commercial and consumer products. Two sites reported use of BBP in adhesives and sealants.
One site reported use of BBP in floor coverings. Two sites reported use of BBP in commercial
paints and coatings. Three facilities reported that BBP was not recycled (e.g., not recycled,
remanufactured, reprocessed, or reused).
Industrial uses of BBP in adhesive and plastic product manufacturing were consistent between
the 2012 and 2016 CDR reporting cycles. In the 2012 CDR data, three sites reported non-specific
industrial processing, whereas in the 2016 CDR data, only one site reported non-specific
6 Certain other uses that are excluded from TSCA are not captured in this table.
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industrial processing and one site reported processing of BBP in the custom compounding of
resin.
Consumer and commercial uses of BBP in adhesives and sealants, as well as floor coverings
were consistent between 2012 and 2016; however, the product concentrations changed
significantly for adhesives and sealants. In 2012, there were two non-specific consumer or
commercial uses reported, whereas in 2016 two sites reported a use of BBP in commercial paints
and coatings.
CDR data show that consumer and commercial uses have not changed significantly between
2012 and 2016. Consumer uses were also identified in additional databases, which are included
in the Exposure Potential section (Section 8).
According to one public comment received, BBP is used in adhesives, lacquers, coatings, and
processing aids in the aerospace industry. BBP has been identified within lacquer compounds,
topcoats, spray paint and potting compounds. There are also very specific applications such as in
adhesives critical to electrical/circuit boards, in printed wire assemblies, and processing aids such
as parting lacquers, primer surfacer, and maskings used in the temporary protection of aircraft
parts. Other uses found were as a catalyst in composite air ducts, as a dielectric paste, or within
silicone rubber coated fiberglass (EPA-HQ-OPPT-2018-0501-0004 (Aerospace Industries
Association)).
According to another public comment, BBP is used in trace amounts as a plasticizer and additive
in clear coatings and industrial wood coatings, some of which are designed for spray application
and consumer use. BBP is also used in adhesives and sealants. It's also used in adhesives and
sealants. The amounts used in coatings manufacturing is extremely low (below 2,500 pounds per
year), if used at all. The amount of BBP in products are typically negligible, although some
specialty adhesives and sealants may contain amounts above 10%, but below 50% (EPA-HQ-
OPPT-2018-0501-0003 (American Coatings Association)).
According to an additional comment, BBP is used in coatings and construction materials (EPA-
HQ-OPPT-2018-0501-0008 (BASF)). Additionally, BASF reported importing this substance in
the 2016 CDR for the RY 2015 and 2018 and does not expect to report this chemical in their
2020 CDR. In their comments, BASF redacted specific amount of lbs imported in the 2016 CDR
and in 2018.
Should the Agency decide to make a final decision to designate this chemical substance as a
high-priority substance, further characterization of relevant TSCA conditions of use will be
undertaken as part of the process of developing the scope of the risk evaluation.
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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, workers, consumers
or the elderly. EPA analyzed processing and use information included on the CDR Form U.
These data provide an indication about whether children may be potentially exposed or other
susceptible subpopulations may be exposed. EPA also used human health hazard information to
identify potentially exposed or susceptible subpopulations.
Results and Discussion
At this stage, EPA identified children, women of reproductive age, consumers and workers as
subpopulations who may be potentially exposed or susceptible subpopulations for BBP.
Children
EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles
intended for children over time for BBP. The 2012 and 2016 CDR did not report any use in
children's products. In the existing assessments reviewed, there was no discussion on the
susceptibility of children to BBP. EPA identified potential developmental hazards that would
impact any stage of children's development.
Women of reproductive age (e.g., pregnant women per TSCA statute)
EPA identified studies that observed developmental and reproductive effects following exposure
to BBP (Section 7, Table 6). Pregnant women are therefore included as a susceptible
subpopulation with respect to BBP.
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 (Section 8) 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.
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5. Persistence and bioaccumulation
Approach
EPA reviewed reasonably available information, such as physical and chemical properties and
environmental fate characteristics, to understand BBP's persistence and bioaccumulation.
Physical and Chemical Properties and Environmental Fate Tables
Table 4 and Table 5 summarize the physical and chemical properties and environmental fate
characteristics of BBP, respectively.
Table 4. Physical and Chemical Properties of Butyl Benzy
Phthalate
Property or
Endpoint
Value a
Reference
Molecular Formula
C19H20O4
CRC Handbook (Haynes, 2014)
Molecular Weight
312.360 g/mole
CRC Handbook (Haynes, 2014)
Physical State
Liquid
CRC Handbook (Haynes, 2014)
Physical Form
Clear, oil liquid
HSDB C citing Lewis (2012)
Purity
>98.5% w/w; impurities include <1.0%
dibenzyl phthalate, <0.5% benzyl
benzoate,
<0.5%) dibutyl phthalate, <2 ppm
a-clorotoluen and <2 ppm
a-a-diclorotoluen; additives include
<0.5 ppm pentaerythritol tetrakis (3-
(3,5-di-tert-butyl-4-
hydoxyphenyl)propionate
ECB (2007)
Melting Point
-35 °C
HSDB C ; Lewis (2012)
-40.5 °C
Phvsprop (2
Boiling Point
370 °C
CRC Handbook (Haynes, 2014);
HSDB f: citing Lewis (2012)
Density
1.12 g/cm3 at 25 °C
HSDB C citing CRC
Handbook (Haynes, 2014); Lewis
(2012)
Vapor Pressure
8.25 x 10"6 mm Hg at 25 °C
HSDB C citing Howard et
al. (1985)
Vapor Density
10.8 (relative vapor density to air = 1)
HSDB f: citing Lewis (2012)
Water Solubility
2.69 mg/L at 25 °C
HSDB f: citing Howard
(1985)
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Property or
Endpoint
Value a
Reference
Log Kow
4.73
HSDB C citing Ellington
and Floyd (1996)
Henry's Law
Constant
1.26 x 10"6 atm-m3/mole at 25 °C
(calculated from measured vapor
pressure and water solubility data)b
EPI Suite (2
Flash Point
199 °C (closed cup)
HSDB C citing NFPA
(2010)
Auto Flammability
425 °C (autoignition temperature)
ECB (2007) citing Baver AG
(1999)
Viscosity
42 mPa s at 25 °C
ECHA (2018) citing Ferro (2008)
Refractive Index
1.535-1.540 at 25 °C
HSDB ('. citing IARC 1982
Dielectric Constant
TBD
TBD
Surface Tension
34 dynes/cm (0.034 N/M) at 20 °C
HSDB C citing CHRIS
(1984)
Notes:
a Measured unless otherwise noted;
bEPI Suite™ physical property inputs: Log Kow = 4.73, BP = 370 °C, MP = -40.5 °C, VP = 8.25 x 10 6 mm Hg,
WS = 2.69 mg/L BioP = 4, BioA = 1 and BioS = 1 SMILES 0=C(0Cc(ccccl)cl)c(c(ccc2)C(=0)0CCCC)c2;
TBD = to be determined, if reasonably available. EPA is particularly interested in information from the
public on these properties or endpoints.
Table 5. Environmental Fate Characteristics of Butyl Benzyl Phthalate
Property or
Endpoint
Value a
Reference
Direct
0%/10 days; 43%/28 days
E <)7) citing Monsanto (1979)
Photodegradati on
<5%/28 days
E <07) citing Monsanto (1980)
ti/2 > 100 days
E '07) citing Gledhill et al. (1980)
Indirect
Photodegradati on
ti/2 =11.6 hours at 25 °C based on
OH rate constant of 1.1 x 10"11
cm3/molecule second and 1.5 x 106
OH/cm3; estimated)13
EPI Suite (2
Hydrolysis
ti/2 >100 days
ECHA C citing Gledhill et al.
(1980)
Biodegradation
(Aerobic)
74-79%/10-50 days at 25 °C
(activated sludge)
HSJW ^01 citing Desai (1992)
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Property or
Endpoint
Value a
Reference
ti/2 = 5 days (lake water/sediment
microcosm)
HSDB C citing Carson et al.
(1990)
81%/2 weeks based on BOD (MITI
test)
HSDBi: citing NITE (2015)
Biodegradation
(Anaerobic)
ti/2 =107 hours (sewage sludge)
HSDB C citing Zioaou et al.
(1989)
98.3%/120 days at 35 °C
HSDB C citing Parker et al. (1994)
Wastewater
Treatment
80% of sewage treatment plants had
a 90% removal of 1,2-
benzenedicarboxylic acid, 1-butyl 2-
(phenylmethyl) ester in secondary
sewage treatment plant, whereas
10% had less than 40% removal
E 07) citing U.S. EPA (1982)
100%) total removal (90%
biodegradation, 10% sludge, 0% air;
estimated)13
EPI Suite (2
Bioconcentration
Factor
663 and 772 (Lepomis macrochirus)
B 20
15) citing Carr et al. (1997)
0.13 to 45 (Ipomoea aquatica)
HSDB (20
15) citing Cai et al. (2006)
Soil Organic
Carbon:Water
Partition
Coefficient (Log
Koc)
3.3 at pH 4.8
HSDB (20
(1991)
15) citing Zurmuehl et al.
3.21
HSDB .G citing Sablijic et al.
(1995)
Notes:
a Measured unless otherwise noted
bEPI Suite™physical property inputs: Log Kow = 4.73, BP = 370 °C, MP = -40.5 °C, VP = 8.25 x 10~6 mmHg, WS
= 2.69 mg/L BioP = 4, BioA = 1 and BioS = 1 SMILES 0=C(0Cc(ccccl)cl)c(c(ccc2)C(=0)0CCCC)c2
•OH = hydroxyl radical; OECD: Organisation for Economic Co-operation and Development; SIDS = screening
information data sets; MITI = Ministry of International Trade and Industry, Japan; BOD = biochemical oxygen
demand; K0c = organic carbon-water partition coefficient
Results and Discussion
BBP is a clear, oily liquid with moderate water solubility (2.69 mg/L). Based on its calculated
Henry's Law constant (1.26 x 10"6 atm-m3/mole), BBP has moderate potential to volatilize from
water or moist soil surfaces; however, its measured vapor pressure (8.25 x 10"6 mm Hg) indicates
only low potential to volatilize from dry soil. BBP's measured soil adsorption coefficient (log
Koc 3.21-3.3) suggests moderate mobility in soil, which would increase the possibility of
migration of this chemical to groundwater. If released directly to air, BBP in the vapor phase will
be susceptible to both direct (measured half-life >100 days) and indirect (estimated half-life of
11.6 hours for reaction with photochemically-generated hydroxy radicals) photodegradation,
whereas particulate BBP may be removed via wet and dry precipitation.
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BBP reached 74-79 percent biodegradation in 10-50 days in aerobic activated sludge and 81
percent biodegradation in 14 days in a Japanese Ministry of International Trade and Industry
(MITI) test. Measured aerobic and anaerobic degradation half-lives of 5 and 4.5 days were
reported for BBP in lake water/sediment microcosm and sewage sludge, respectively. These data
suggest that BBP has low potential to persist in the environment. Based on the measured
bioconcentration factors of 663 and 772 in bluegill, BBP is expected to have low potential to
bioaccumulate.
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
BBP is a Priority Pollutant under the CWA. EPA has not established a Maximum Contaminant
Level Goal (MCLG) or Maximum Contaminant Level (MCL) for BBP.
BBP is not subject to reporting requirements under EPCRA. It was on the original TRI chemical
list in 1987 but delisted in calendar year 1994. EPA considers it as a hazardous substance under
CERCLA and releases of BBP in excess of 100 pounds are subject to reporting to the National
Response Center. It is also listed on the Superfund Amendments and Reauthorization Act of
1986, a list that includes substances most commonly found at facilities on the CERCLA National
Priorities List that have been deemed to pose the greatest threat to public health.
BBP is listed as a hazardous constituent under the Resource Conservation and Recovery Act
(RCRA). RCRA directs EPA to develop and promulgate criteria for identifying the
characteristics of hazardous waste, and for listing hazardous waste, taking into account toxicity,
12
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persistence, and degradability in nature, potential for accumulation in tissue and other related
factors such as flammability, corrosiveness, and other hazardous characteristics
7. Hazard potential
Approach
EPA considered reasonably available information from peer-reviewed assessments and databases
to identify potential human health and environmental hazards for BBP (Tables 6 and 7,
respectively).
Because there are very few publicly available assessments for BBP with cited environmental
hazard data (Table 7). EPA used the infrastructure of ECOTOXicology knowledgebase
(ECOTOX) to identify single chemical toxicity data for aquatic and terrestrial life
2018). It uses a comprehensive chemical-specific literature search of the open literature that is
conducted according to the Standard Operating Procedures (SOPs)7. 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 BBP, if available, to fill in potential
data gaps when there were no reported observed effects for specific taxa exposed to BBP (Table
7).
Potential Human Health and Environmental Hazard Tables
EPA identified potential human health and environmental hazards based on a review of the
reasonable available information for BBP (Tables 6 and 7, respectively).
7 The ECOTOX Standard Operating Procedures (SOPs) can be found at:
https://cfpub.epa.gov/ecotox/help.cfm?helptabs=tab4
13
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Table 6. Potential Human Heall
h Hazards Identified for Butyl Benzyl Phthalate
Human Health
Hazards
Tested for
Specific
Effect
Effect
Observed
Reference
Acute Toxicity
X
(2003). RIVM (2001). Environment Canada (2000)
Repeated Dose
Toxicity
X
X
NICNAS (2015). CPSC (2014). CPSC (2010).
NICNAS (2008). ECB (2007). RIVM (2001). IRIS
Genetic Toxicity
X
X
ECB (2007). NTP (2003). U.S. EPA (2002). RIVM
(2001). Environment Canada (2000). IARC (1999).
NTP (1997). IRIS (1989)
Reproductive
Toxicity
X
X
UNEP (2016). CPSC (2014). CPSC (2010). ECHA
Developmental
Toxicity
X
X
UNEP (2016). CPSC (2014). OEHHA (2013).
OEHHA (1986). CPSC (2010). NICNAS (2008). ECB
(2007). NTP (2003). Environment Canada (2000).
IARC (1999)
Toxicokinetic
X
X
NICNAS (2015). OEi SUA i!°8o). CPSC (2010).
RIVM (2001). Environment Canada (2000). IARC
11
Irritation/ Corrosion
X
NICNAS (2008). ECB (2007). NTP (2003).
Environment Canada (2000)
Dermal Sensitization
X
(2003)
Respiratory
Sensitization
X
X
UNEP (2
Carcinogenicity
X
X
NICNAS (2015). OEHHA (2013). Lowell Center
U.S. EPA (2002). RIVM (2001). Environment Canada
(2000). IARC (1999). NTP (1997). IRIS (1989)
Immunotoxicity
Neurotoxicity
X
ECB (2007). Environment Canada (2000)
Epidemiological
Studies or
Biomonitoring
Studies
X
X
(2015). OEHHA (2013). ECHA (2010). OEHHA
I t<^6). ECB (2007). NTP (2003)
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 7. Potential Environmental Hazards Identified for Butyl Benzyl Phthalate
High-Priority
Chemical Candidate
Isomers of
Butyl Benzyl
Phthalate 1,2-
Butyl Benzyl
Phthalate 1,2-
Benzene-
Dicarboxylic Acid, 1-
Butyl
2(Phenylmethyl)
Ester
Benzene-
Dicarboxylic Acid, 1-
Butyl
2(Phenylmethyl)
Ester
(CASRN 85-68-7)
(CASRN 85-68-7)
NONE
Study
Number
Observed
Number
Observed
Media
Duration
Taxa Groups
of Studies
Effects
of Studies
Effects
Reference
Aquatic
Acute
exposure
Vegetation
3
X
-
Adams et al. (1995); Jonsson and Baun (2003);
Nendza and Wenzel (2006)
Invertebrate
20
X
Adams and Heidolph (1985); Adams et al.
(1995); Barera and Adams (1983); Herrero et al.
(2015); Home and Oblad (1983); Jonsson and
Baun (2003); LeBlanc (1980); Liu et al. (2009);
Martinez-Guitarte et al. (2012); Mayer (1987);
Monsanto Co. (1986); Morales et al. (2011);
Planello et al. (2011); Wang et al. (2011);
Zaroogian (1981)
Fish
12
X
Adams et al. (1995); Buccafusco et al. (1981);
Carr et al. (1997); E.G. and G. Bionomics
(1983) ; Heitmuller et al. (1981) ; Jarmolowicz et
al. (2010)
LeBlanc (1984) ; Ozretich et al. (1983)
Randall et al. (1983)
Non-fish vertebrate
—
—
(i.e., amphibians, reptiles,
mammals)
Vegetation
1
X
-
Chen etal. (2011)
15
-------
High-Priority
Chemical Candidate
Isomers of
Butyl Benzyl
Phthalate 1,2-
Butyl Benzyl
Phthalate 1,2-
Benzene-
Dicarboxylic Acid, 1-
Butyl
2(Phenylmethyl)
Ester
Benzene-
Dicarboxylic Acid, 1-
Butyl
2(Phenylmethyl)
Ester
(CASRN 85-68-7)
(CASRN 85-68-7)
NONE
Study
Number
Observed
Number
Observed
Media
Duration
Taxa Groups
of Studies
Effects
of Studies
Effects
Reference
Invertebrate
3
X
-
Adams and Heidolph (1985); E.G. and G.
Bionomics (1979); Rhodes et al. (1995)
Aquatic
Chronic
exposure
Fish
8
X
Barrows et al. (1978); Harries et al. (2000);
Hicks (2008); Kaplan et al. (2013); LeBlanc
(1984); Ozretich et al. (1983); Wibe et al. (2002);
Zhang et al. (2014)
Non-fish vertebrate
(i.e., amphibians, reptiles,
mammals)
1
X
Sugiyama et al. (2005)
Terrestrial
Acute
Vegetation
-
-
exposure
Invertebrate
3
X
-
Boyd et al. (2016); Lenoir et al. (2014); Valencia
et al. (1985)
Vertebrate
1
X
-
Wilson et al. (2004)
Chronic
Vegetation
-
-
exposure
Invertebrate
-
-
Vertebrate
1
X
-
Larsen et al. (2003)
The dash indicates that no studies relevant for environmental hazard were identified during the 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).
16
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8. Exposure potential
Approach
EPA considered reasonably available information to identify potential environmental,
worker/occupational, consumer, and general population exposures to BBP.
Release Potential for Environmental and Human Health Exposure
EPA considered conditions of use reported in CDR and the physical and chemical properties to
inform the release potential of BBP.
Worker/Occupational exposure 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 BBP
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 and ecological biomonitoring data to inform BBP's
exposure potential to the general population (Table 9).
Results and Discussion
Release Potential for Environmental and Human Health Exposure
BBP was removed from the TRI chemical list in 1994. RY 1993 was the last RY for this
chemical.
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.
When chemical substances have commercial or consumer use as adhesive and sealants, paints
and coatings can have variable release percentages. If the chemical is used as a solvent, it may
evaporate to the air during the drying or curing of the adhesive or sealant or paint or coating.
Other additives may be entrained in the dried or cured adhesive or sealant or paint or coating but
may be released to the environment due to abrasion of the adhesive or sealant or paint or coating.
The actual percentage and quantity of release of the reported chemical associated with this
category are not known but could be high.
Worker/Occupational exposure
Worker exposures to this chemical may be affected by many factors, including but not limited to
volume produced, processed, distributed, used, and disposed of; 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
17
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exposure controls such as engineering controls, administrative controls, and the existence of a
personal protective equipment (PPE) program.
BBP has a vapor pressure of 8.25 x 10"6 mm Hg at 25 °C/77 °F. EPA assumes negligible
inhalation exposure to vapors generated from liquids with vapor pressures below 0.001 mm Hg
at ambient room temperature conditions. BBP does not have an OSHA Permissible Exposure
Limit (PEL) (OSHA. 2009). a NIOSH Recommended Exposure Limit (REL) (NIOSH 2005). or
the TLV set by ACGIH.
BBP is indicated as being used in adhesives and sealants and paints and coatings. Products used
as adhesive and sealants, and 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
CDR reporting and information from the National Institutes of Health (NIH) Household Products
Database and the Chemical and Products Database (CFDat) indicate that BBP is used in a
number of consumer products (Table 8) and exposure can occur following the use of these
products ( , NTP 2.003). Once incorporated into products intended for consumer
use, BBP is not bound within the matrix and can migrate from the polymeric material and be
released (ECB 2007). Consumer exposure can come from food and food packaging, fragrances,
baby products, children's toys, and indoor dust (OEHHA. 2013).
18
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Table 8. Exposure Information for Consumers
Chemical
Identity
Consumer Product Database
Consumer Uses (List)
Butyl Benzyl
Phthalate
(85-68-7)
Adhesive, apparel bags, arts crafts paint, arts crafts products, automotive, automotive
care, binding, building material, carpet, caulk/sealant, casting agent, cleaner, clothing,
colorant, decor, electronics, filler, filler building material, finish spray, fixative, flooring,
fluid property modulator, footwear, grout sealer, hardener, insulation, lubricant, metal
surface treatment, paint, paint automotive, paint binding, paint exterior, paper surface
treatment, photographic, plastic building material, plastic, plastic softener, polish, primer,
printing, printing ink, putty or filler, rubber, seal material, softener, surface treatment,
toothbrush, toys, viscous liquid building material, wall building material, writing ink
Reference: CPDat
General population exposure
Releases of BBP from certain conditions of use, such as manufacturing, disposal, or waste
treatment activities, may result in general population exposures via ingestion, dermal contact,
and inhalation from air releases. Based on a review of the available literature, there is ecological
aquatic, non-mammalian biomonitoring data available; however, no human biomonitoring was
identified (Table 9).
BBP has been identified in air, water, sediment, and soil samples (ECB 2007. Environment
Canada 20001 as well as in food stuffs (i.e., carcass meat, poultry, eggs, and milk) (NTP 2003.
CPSC 2010). The general population is primarily exposed via ingestion (NTP 20^' , i \ >\ ! 9,
CPSC 2010V
19
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Table 9. 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
yes
no
no
MDI (2002)
EPA Ambient Monitoring Technology
Information Center - Air Toxics Data
no
no
no
\(1990)
EPA Discharge Monitoring Report Data
yes
no
no
\ (2007)
EPA Unregulated Contaminant Monitoring
Rule
no
no
no
\ (1996)
FDA Total Diet Study
no
no
no
FDA (1991)
Great Lakes Environmental Database
yes
no
no
(2018b)
Information Platform for Chemical
Monitoring Data
yes
no
no
EC (2018)
International Council for the Exploration of
the Sea
no
no
no
ICES (2018)
OECD Monitoring Database
no
no
no
OECD (2018)
Targeted National Sewage Sludge Survey
no
no
no
\ (2006)
The National Health and Nutrition
Examination Survey
no
no
no
CDC (2013)
USGS Monitoring Data -National Water
Quality Monitoring Council
yes
no
no
rS(1991a)
USGS Monitoring Data -National Water
Quality Monitoring Council, Air
no
no
no
rS (1991b)
USGS Monitoring Data -National Water
Quality Monitoring Council, Ground Water
yes
no
no
rS(1991c)
USGS Monitoring Data -National Water
Quality Monitoring Council, Sediment
yes
no
no
S(199Id)
USGS Monitoring Data -National Water
Quality Monitoring Council, Soil
yes
no
no
rS(1991e)
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
yes
USGS (199Is)
1 Conccn.= concentration
bBiomon.= biomonitoring
20
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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 BBP 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 BBP 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 BBP 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, exposure to consumers, 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., repeated dose toxicity, genetic toxicity,
reproductive toxicity, developmental toxicity, respiratory sensitization, carcinogenicity, and
observations in epidemiologic and/or biomonitoring studies).
21
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