vvEPA
United States	Office of Chemical Safety and
Environmental Protection Agency	Pollution Prevention
Proposed Designation of
Dibutyl Phthalate
(CASRN 84-74-2)
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	4
Approach	4
CDR and TRI Tables	4
CDR and TRI Summary and Additional Information on Conditions of Use	18
4.	Potentially exposed or susceptible subpopulations	20
Approach	20
Results and Discussion	20
5.	Persistence and bioaccumulation	21
Approach	21
Physical and Chemical Properties and Environmental Fate Tables	21
Persistence and Bioaccumulation Summary	23
6.	Storage near significant sources of drinking water	24
Approach	24
Results and Discussion	24
7.	Hazard potential	25
Approach	25
Potential Human Health and Environmental Hazard Tables	25
8.	Exposure potential	30
Approach	30
Results and Discussion	30
9.	Other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority	34
10.	Proposed designation and Rationale	34
11.	References	35
ii

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List of Tables
Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds)	3
Table 2. Dibutyl Phthalate (CASRN 84-74-2) Categories and Subcategories of Conditions of Use
(2016 CDR Reporting Cycle)	5
Table 3. Dibutyl Phthalate (CASRN 84-74-2) Categories and Subcategories of Conditions of Use
(2012 CDR Reporting Cycle)	7
Table 4. Activities and Uses Reported to TRI for Dibutyl Phthalate, Reporting Year 2011	8
Table 5. Activities and Uses Reported to TRI for Dibutyl Phthalate, Reporting Year 2015	12
Table 6. Activities and Uses Reported to TRI for Dibutyl Phthalate, Reporting Year 2017	16
Table 7. Physical and Chemical Properties of Dibutyl Phthalate	21
Table 8. Environmental Fate Characteristics of Dibutyl Phthalate	22
Table 9. Potential Human Health Hazards Identified for Dibutyl Phthalate	25
Table 10. Potential Environmental Hazards Identified for Dibutyl Phthalate	27
Table 11. The TRI Data on Dibutyl Phthalate from Reporting Years 2011, 2015, and 2017 Used
in this Document to Assess Exposure Potential	31
Table 12. Exposure Information for Consumers	32
Table 13. Exposure Information for the Environment and General Population	33
in

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Acronyms and Abbreviations
Term	Description
ACGIH	American Conference of Governmental Industrial Hygienists
AIA	Aerospace Industries Associated
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
iv

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MITI
Ministry of International Trade and Industry
MP
Melting point
NAICS
North American Industry Classification System
NKRA
Not Known or Reasonably Ascertainable
NICNAS
National Industrial Chemicals Notification and Assessment Scheme
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 (EPA) 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)). 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).
Dibutyl phthalate 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 dibutyl phthalate 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 information on dibutyl phthalate,
including relevant information received from the public and other information as appropriate.
1	NOTE: 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.re gulations. gov/document?D=EPA-HO-OPPT-2Q 16-0654-0108
2	https://www.federalregister.gOv/documents/2019/03/21/2019-05404/initiation-of-prioritization-under-the-toxic-
substances-co ntrol-act-tsca
1

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EPA will take comment on this proposed designation for 90 days before finalizing its designation
of dibutyl phthalate. The docket number for providing comments on dibutyl phthalate is EPA-
HQ-OPPT-2018-0503 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 potentially exposed or susceptible subpopulations,
including children, women of reproductive age, and workers, with respect to the chemical
substance.
•	Section 5 (Persistence and bioaccumidation): 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.
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 dibutyl phthalate reported
under the Inventory Update Reporting (IUR) rule and Chemical Data Reporting (CDR) rule3.
Results and Discussion
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.
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
Dibutyl
Phthalate
(84-74-2)
lOMto
50M
lOMto
50M
lOMto
50M
lOMto
50M
10M to
50M
10M to
50M
7,005,890
1M to
10M
lMto
10M
lMto
10M
lMto
10M
Note: M = million
Reference: U.S. EPA (20131 U.S. EPA (2017)
Production volume of dibutyl phthalate in 2015, as reported to EPA during the 2016 CDR
reporting period, was in the range of 1 million pound to 10 million pounds.
The range of production volume of dibutyl phthalate as reported to EPA has not changed from
2012 to 2015 from 1 million to 10 million pounds, having decreased from 10 million to 50
million pounds consistently reported from 1986 to 2006. The 2011 production volume is also
consistent with the 1 million to 10 million pound range reported from 2012 to 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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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 EPA 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 dibutyl phthalate 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 (Tables 4,5 and 6). 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.
In addition to the information disclosed in Part II Section 3 of the TRI Form R, the information
pertaining to waste management activities (i.e., disposal/releases, energy recovery, recycling, and
treatment) disclosed in other sections of the Form R was also used to supplement the CDR
information on conditions of use as shown in Tables 4, 5 and 6. 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 and TRI 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 (Tables 2 and 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. Dibutyl Phthalate (CASRN 84-74-2) Categories and Subcategories of Conditions of
Use5 (2016 CE
>R Reporting Cycle)
Life-Cycle
Stage
Category
Subcategory of Use
Reference
Manufacturing
Domestic manufacturing
Domestic manufacturing
U.S.EPA (2019a)
Import
Import
U.S.EPA (2019a)
Processing
Processing as a reactant
Intermediates in all other basic
organic chemical manufacturing
U.S.EPA (2019a)
Processing as a reactant
Plasticizers in wholesale and
retail trade
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Solvents (which become part of
product formulation or mixture)
in all other chemical product and
preparation manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Intermediates in asphalt paving,
roofing, and coating materials
manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Adhesives and sealant chemicals
in construction
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Plasticizers in paint and coating
manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Intermediates in petrochemical
manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Plasticizers in plastic material and
resin manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Plasticizers in plastic product
manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Functional fluids (closed systems)
in printing and related support
activities
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or reaction
product
Intermediates in rubber product
manufacturing
U.S.EPA (2019a)
5 Certain other uses that are excluded from TSCA are not captured in this table.
5

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Life-Cycle
Stage
Category
Subcategory of Use
Reference

Processing - incorporating into
formulation, mixture, or reaction
product
Plasticizers in soap, cleaning
compound, and toilet preparation
manufacturing
U.S.EPA (2019a)

Processing - incorporating into
formulation, mixture, or reaction
product
Solvents in soap, cleaning
compound, and toilet preparation
manufacturing
U.S.EPA (2019a)

Processing - incorporating into
formulation, mixture, or reaction
product
Plasticizers in textiles, apparel,
and leather manufacturing
U.S.EPA (2019a)

Processing - incorporating into
articles
Plasticizers in adhesive
manufacturing
U.S.EPA (2019a)

Processing - incorporating into
articles
Plasticizers in plastics product
manufacturing
U.S.EPA (2019a)

Processing - incorporating into
articles
Plasticizers in rubber product
manufacturing
U.S.EPA (2019a)

Repackaging
Laboratory chemicals in
wholesale and retail trade
U.S.EPA (2019a)

Repackaging
Plasticizers in wholesale and
retail trade
U.S.EPA (2019a)

Recycling
Recycling
U.S.EPA (2019a)
Distribution in
Commerce iLh
Distribution in commerce


Industrial
Uses
Non-incorporative activities
Solvent in Huntsman's maleic
anhydride manufacturing
technology
U.S.EPA (2019a)
Commercial
Adhesives and sealants
Adhesives and sealants
U.S.EPA (2019a)
Uses
Cleaning and furnishing care
products
Cleaning and furnishing care
products
U.S.EPA (2019a)

Floor coverings
Floor coverings
U.S.EPA (2019a)

Laboratory supply
Laboratory supply
U.S.EPA (2019a)

Paints and coatings
Paints and coatings
U.S.EPA (2019a)

Plastic and rubber products not
covered elsewhere
Plastic and rubber products not
covered elsewhere
U.S.EPA (2019a)

Personal care products
Personal care products
U.S.EPA (2019a)

Ink, toner, and colorant products
Ink, toner, and colorant products
U.S.EPA (2019a)
Consumer
Adhesives and sealants
Adhesives and sealants
U.S.EPA (2019a)
Uses
Floor coverings
Floor coverings
U.S.EPA (2019a)
6

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Life-Cycle
Stage
Category
Subcategory of Use
Reference
Disposala
Disposal


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.
Table 3. Dibutyl Phthalate (CASRN 84-74-2) Categories and Subcategories of Conditions of
Use6 (2012 CE
>R Reporting Cycle)
Life-Cycle
Stage
Category
Subcategory of Use
Reference
Manufacturing
Domestic manufacturing
Domestic manufacturing
U.S.EPA (2019a)
Import
Import
U.S.EPA (2019a)
Processing
Processing as a reactant
Intermediates in all other basic
organic chemical manufacturing
U.S.EPA (2019a)
Processing as a reactant
Plasticizers in wholesale and retail
trade
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or
reaction product
Plasticizers in all other chemical
product and preparation
manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or
reaction product
Plasticizers in plastics material and
resin manufacturing
U.S.EPA (2019a)
Processing - incorporating into
formulation, mixture, or
reaction product
Plasticizers in construction
U.S.EPA (2019a)
Processing - incorporating into
articles
Plasticizers in adhesive
manufacturing
U.S.EPA (2019a)
Processing - incorporating into
articles
Plasticizers in plastics product
manufacturing
U.S.EPA (2019a)
Recycling
Recycling
U.S.EPA (2019a)
Distribution in
Commerce iLh
Distribution in commerce


Industrial
Uses
Non-incorporative activities
Laboratory chemicals in services
U.S.EPA (2019a)
Non-incorporative activities
Plasticizers in plastics material and
resin manufacturing
U.S.EPA (2019a)
6 Certain other uses that are excluded from TSCA are not captured in this table.
7

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Life-Cycle
Stage
Category
Subcategory of Use
Reference

Non-incorporative activities
Plasticizers in plastics products
manufacturing
U.S.EPA (2019a)
Non-incorporative activities
Other in wholesale and retail trade
U.S.EPA (2019a)
Commercial
Uses
Explosive materials
Explosive materials
U.S.EPA (2019a)
Adhesives and sealants
Adhesives and sealants
U.S.EPA (2019a)
Floor coverings
Floor coverings
U.S.EPA (2019a)
Plastic and rubber products not
covered elsewhere
Plastic and rubber products not
covered elsewhere
U.S.EPA (2019a)
Ink, toner, and colorant
products
Ink, toner, and colorant products
U.S.EPA (2019a)
Consumer
Uses
Adhesives and sealants
Adhesives and sealants
U.S.EPA (2019a)
Floor coverings
Floor coverings
U.S.EPA (2019a)
Disposala
Disposal


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.
EPA used TRI data to identify additional conditions of use and to supplement CDR information
about conditions of use. In addition, TRI information from 2017 is useful for demonstrating that
a condition of use reported to CDR in 2015 is still ongoing.
Table 4. Activil
ties and Uses Reported to TRI for Dibutyl Phthalate, Reporting Year 2011
Activity Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Basic chemical manufacturing
3251


Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252

Import
Basic chemical manufacturing
3251


Plastics product manufacturing
3261


Rubber product manufacturing
3262

Produce or import
for on-site
use/processing
Basic chemical manufacturing
3251

Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252


Plastics product manufacturing
3261


Rubber product manufacturing
3262
8

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Activity Type
Activity
Industry Group
NAICS
Code

Produce or import
for sale/
distribution
Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252

Produce or import
as a byproduct
Basic chemical manufacturing
3251
Process
Process as a
reactant
Basic chemical manufacturing
3251

Plastics product manufacturing
3261

Process as an
article component
Paint, coating, and adhesive manufacturing
3255

Rubber product manufacturing
3262


Other fabricated metal product manufacturing
3329


National security and international affairs
9281

Process as a
formulation
component
Textile and fabric finishing and fabric coating mills
3133

Basic chemical manufacturing
3251


Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252


Paint, coating, and adhesive manufacturing
3255


Soap, cleaning compound, and toilet preparation
manufacturing
3256


Other chemical product and preparation manufacturing
3259


Plastics product manufacturing
3261


Rubber product manufacturing
3262


Other fabricated metal product manufacturing
3329


National security and international affairs
9281

Process -
repackaging
Basic chemical manufacturing
3251

Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252


Other chemical product and preparation manufacturing
3259


Other fabricated metal product manufacturing
3329


Chemical and allied products merchant wholesalers
4246


Waste treatment and disposal
5622
Otherwise Use

Basic chemical manufacturing
3251
9

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Activity Type
Activity
Industry Group
NAICS
Code

Otherwise use -
as a chemical
processing aid
Plastics product manufacturing
3261
Rubber product manufacturing
3262
Otherwise use -
as a
manufacturing aid
Plastics product manufacturing
3261
Otherwise use -
ancillary or other
use
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252
Plastics product manufacturing
3261
Cement and concrete product manufacturing
3273
Other nonmetallic mineral product manufacturing
3279
Waste treatment and disposal
5622
National security and international affairs
9281
Waste
Management
Disposal/releases
Textile and fabric finishing and fabric coating mills
3133
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation manufacturing
3259
Plastics product manufacturing
3261
Rubber product manufacturing
3262
Other nonmetallic mineral product manufacturing
3279
Other fabricated metal product manufacturing
3329
Chemical and allied products merchant wholesalers
4246
Waste treatment and disposal
5622
National security and international affairs
9281
Energy recovery
Textile and fabric finishing and fabric coating mills
3133
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252
10

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Activity Type
Activity
Industry Group
NAICS
Code


Paint, coating, and adhesive manufacturing
3255


Other chemical product and preparation manufacturing
3259


Plastics product manufacturing
3261


Rubber product manufacturing
3262


Cement and concrete product manufacturing
3273


Other nonmetallic mineral product manufacturing
3279


Other fabricated metal product manufacturing
3329


Chemical and allied products merchant wholesalers
4246


Waste treatment and disposal
5622

Recycling
Textile and fabric finishing and fabric coating mills
3133


Basic chemical manufacturing
3251


Plastics product manufacturing
3261


Rubber product manufacturing
3262


Other nonmetallic mineral product manufacturing
3279


Other fabricated metal product manufacturing
3329

Treatment
Textile and fabric finishing and fabric coating mills
3133


Basic chemical manufacturing
3251


Resin, synthetic rubber, and artificial and synthetic fibers
and filaments manufacturing
3252


Paint, coating, and adhesive manufacturing
3255


Soap, cleaning compound, and toilet preparation
manufacturing
3256


Other chemical product and preparation manufacturing
3259


Rubber product manufacturing
3262


Other nonmetallic mineral product manufacturing
3279


Other fabricated metal product manufacturing
3329


Chemical and allied products merchant wholesalers
4246


Waste treatment and disposal
5622


National security and international affairs
9281
11

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Reference: U.S. EPA. 2019b
Table 5. Activil
ties and Uses Reported 1
o TRI for Dibutyl Phthalate, Reporting Year 2015
Activity Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Basic chemical manufacturing
3251
Import
Basic chemical manufacturing
3251
Chemical and allied products merchant
wholesalers
4246
Produce or import for on-
site use/processing
Basic chemical manufacturing
3251
Chemical and allied products merchant
wholesalers
4246
Produce or import for
sale/distribution
Chemical and allied products merchant
wholesalers
4246
Produce or import as a
byproduct
Basic chemical manufacturing
3251
Process
Process as a reactant
Basic chemical manufacturing
3251
Process as an article
component
Paint, coating, and adhesive manufacturing
3255
Rubber product manufacturing
3262
Other fabricated metal product manufacturing
3329
Waste treatment and disposal
5622
Process as an impurity
Basic chemical manufacturing
3251
Other fabricated metal product manufacturing
3329
Process as a formulation
component
Textile and fabric finishing and fabric coating
mills
3133
Basic chemical manufacturing
3251
Resin, synthetic rubber, and artificial and
synthetic fibers and filaments manufacturing
3252
Paint, coating, and adhesive manufacturing
3255
Soap, cleaning compound, and toilet preparation
manufacturing
3256
Other chemical product and preparation
manufacturing
3259
Rubber product manufacturing
3262
Other fabricated metal product manufacturing
3329
12

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Activity Type
Activity
Industry Group
NAICS
Code


Other miscellaneous manufacturing
3399


National security and international affairs
9281

Process - repackaging
Resin, synthetic rubber, and artificial and
synthetic fibers and filaments manufacturing
3252


Other fabricated metal product manufacturing
3329


Chemical and allied products merchant
wholesalers
4246


Waste treatment and disposal
5622
Otherwise Use
Otherwise use - as a
chemical processing aid
Basic chemical manufacturing
3251

Otherwise use - as a
manufacturing aid
Resin, synthetic rubber, and artificial and
synthetic fibers and filaments manufacturing
3252


Commercial and service industry machinery
manufacturing
3333

Otherwise use - ancillary
or other use
Basic chemical manufacturing
3251

Resin, synthetic rubber, and artificial and
synthetic fibers and filaments manufacturing
3252


Plastics product manufacturing
3261


Cement and concrete product manufacturing
3273


Other nonmetallic mineral product manufacturing
3279


Waste treatment and disposal
5622


National security and international affairs
9281
Waste
Management
Disposal/releases
Textile and fabric finishing and fabric coating
mills
3133


Basic chemical manufacturing
3251


Resin, synthetic rubber, and artificial and
synthetic fibers and filaments manufacturing
3252


Paint, coating, and adhesive manufacturing
3255


Other chemical product and preparation
manufacturing
3259


Plastics product manufacturing
3261


Rubber product manufacturing
3262


Other nonmetallic mineral product manufacturing
3279
13

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Activity Type
Activity
Industry Group
NAICS
Code


Other fabricated metal product manufacturing
3329


Commercial and service industry machinery
manufacturing
3333


Other miscellaneous manufacturing
3399


Chemical and allied products merchant
wholesalers
4246


Waste treatment and disposal
5622


National security and international affairs
9281

Energy recovery
Textile and fabric finishing and fabric coating
mills
3133


Basic chemical manufacturing
3251


Resin, synthetic rubber, and artificial and
synthetic fibers and filaments manufacturing
3252


Paint, coating, and adhesive manufacturing
3255


Rubber product manufacturing
3262


Cement and concrete product manufacturing
3273


Other nonmetallic mineral product manufacturing
3279


Other fabricated metal product manufacturing
3329


Chemical and allied products merchant
wholesalers
4246


Waste treatment and disposal
5622

Recycling
Textile and fabric finishing and fabric coating
mills
3133


Rubber product manufacturing
3262


Other nonmetallic mineral product manufacturing
3279


Other fabricated metal product manufacturing
3329


Waste treatment and disposal
5622

Treatment
Textile and fabric finishing and fabric coating
mills
3133


Basic chemical manufacturing
3251


Resin, synthetic rubber, and artificial and
synthetic fibers and filaments manufacturing
3252
14

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Activity Type
Activity
Industry Group
NAICS
Code


Soap, cleaning compound, and toilet preparation
manufacturing
3256


Other chemical product and preparation
manufacturing
3259


Rubber product manufacturing
3262


Other nonmetallic mineral product manufacturing
3279


Other fabricated metal product manufacturing
3329


Chemical and allied products merchant
wholesalers
4246


Waste treatment and disposal
5622


National security and international affairs
9281
Reference: U.S. EPA. 2019b
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Table 6. Activities and Uses Reported t
o TRI for Dibutyl Phthalate, Reporting Year 2017
Activity Type
Activity
Industry Group
NAICS
Code
Manufacture
Produce
Basic chemical manufacturing
3251
Waste treatment and disposal
5622
Import
Basic chemical manufacturing
3251
Chemical and allied products merchant
wholesalers
4246
Produce or import for
on-site use/processing
Basic chemical manufacturing
3251
Chemical and allied products merchant
wholesalers
4246
Produce or import for
sale/distribution
Chemical and allied products merchant
wholesalers
4246
Produce or import as a
byproduct
Basic chemical manufacturing
3251
Waste treatment and disposal
5622
Process
Process as a reactant
Basic chemical manufacturing
3251
Process as an article
component
Rubber product manufacturing
3262
Other fabricated metal product manufacturing
3329
National security and international affairs
9281
Process as an impurity
Basic chemical manufacturing
3251
Other fabricated metal product manufacturing
3329
Process as a
formulation
component
Textile and fabric finishing and fabric coating
mills
3133
Paint, coating, and adhesive manufacturing
3255
Soap, cleaning compound, and toilet
preparation manufacturing
3256
Other chemical product and preparation
manufacturing
3259
Rubber product manufacturing
3262
Chemical and allied products merchant
wholesalers
4246
National security and international affairs
9281
Process - repackaging
Other fabricated metal product manufacturing
3329
Chemical and allied products merchant
wholesalers
4246
Waste treatment and disposal
5622
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Activity Type
Activity
Industry Group
NAICS
Code
Otherwise Use
Otherwise use - as a
chemical processing
aid
Basic chemical manufacturing
3251
Otherwise use - as a
manufacturing aid
Rubber product manufacturing
3262
Commercial and service industry machinery
manufacturing
3333
Otherwise use -
ancillary or other use
Basic chemical manufacturing
3251
Cement and concrete product manufacturing
3273
Other nonmetallic mineral product
manufacturing
3279
Waste treatment and disposal
5622
National security and international affairs
9281
Waste
Management
Disposal/Releases
Basic chemical manufacturing
3251
Paint, coating, and adhesive manufacturing
3255
Other chemical product and preparation
manufacturing
3259
Rubber product manufacturing
3262
Other fabricated metal product manufacturing
3329
Commercial and service industry machinery
manufacturing
3333
Chemical and allied products merchant
wholesalers
4246
Waste treatment and disposal
5622
National security and international affairs
9281
Energy recovery
Textile and fabric finishing and fabric coating
mills
3133
Basic chemical manufacturing
3251
Rubber product manufacturing
3262
Cement and concrete product manufacturing
3273
Other fabricated metal product manufacturing
3329
Chemical and allied products merchant
wholesalers
4246
Waste treatment and disposal
5622
Recycling
Rubber product manufacturing
3262
17

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Activity Type
Activity
Industry Group
NAICS
Code


Other fabricated metal product manufacturing
3329


Waste treatment and disposal
5622

Treatment
Basic chemical manufacturing
3251


Paint, coating, and adhesive manufacturing
3255


Soap, cleaning compound, and toilet
preparation manufacturing
3256


Other chemical product and preparation
manufacturing
3259


Other fabricated metal product manufacturing
3329


Chemical and allied products merchant
wholesalers
4246


Waste treatment and disposal
5622


National security and international affairs
9281
Reference: U.S. EPA. 2019b
CDR and TRI Summary and Additional Information on Conditions of Use
In the 2016 CDR data, dibutyl phthalate was reported as used in manufacturing, commercial and
consumer products. A total of 17 sites reported specific products manufactured, including
adhesives and sealants (4), paints and coatings (4), cleaning and furnishing care products (2),
floor coverings (2), other plastic and rubber products (2), ink, toner and colorants (1), laboratory
supplies (1) and personal care products (1). For industrial and commercial processing and use, a
total of 23 sites reported: processing as a reactant (2); processing - articles (3); processing -
formulation, mixture, or reaction product (16); processing - repackaging (1); and use - non-
incorporative activities (1).
Industrial use of dibutyl phthalate for all other basic organic chemical manufacturing (processing
as a reactant) and adhesive manufacturing (processing - incorporation into article) is consistent
between the 2012 and 2016 CDR reporting cycles, with one site reporting this use. Three sites
reported use in industrial plastics product manufacturing in 2012, but only one site reported this
use in 2016 under processing (incorporation into an articles); however, two sites reported use in
plastics product manufacturing under a different type of processing (incorporation into
formulation, mixture, or reaction product).
Textiles, apparel, and leather manufacturing, soap, cleaning compound, and toilet preparation
manufacturing, and printing and related activities are industrial uses of dibutyl phthalate that
were reported in 2016, but not 2012.
CDR data show that industrial use of dibutyl phthalate was consistent between 2012 and 2016.
Between 2012 and 2016, the number of sites reporting dibutyl phthalate use to CDR for
18

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consumer and commercial adhesives and sealants increased from one to four. Similarly, the
number of sites using dibutyl phthalate for floor coverings and plastic and rubber products both
increased from one to two. Only one site reported to CDR an unspecified consumer or
commercial use of dibutyl phthalate in 2012, but 11 sites did not report a specific use in 2016.
Use of dibutyl phthalate in consumer and commercial ink, toner, and colorant products is
consistent between the 2012 and 2016 CDR reporting cycles, as is the number of sites reporting
consumer/commercial use as NKRA (not known or reasonably ascertainable). One site reported
use of dibutyl phthalate for explosive materials in 2012, but the 2016 CDR data does not report
this use. Conversely, one site reported use of this chemical for laboratory supplies, four sites
reported use for commercial paint and coatings, and one site reported use in commercial personal
care products in the 2016 CDR reporting cycle, but not in 2012. CDR data show that consumer
and commercial uses are consistent between 2012 and 2016. Consumer uses were also identified
in additional databases, which are included in the Exposure Potential section (Section 8).
TRI data reported in Part II Section 3 of the TRI Form R ("Activities and Uses of the Toxic
Chemical at the Facility") were compiled for Reporting Year (RY) 2011, RY 2015, and RY
2017. RY 2011, RY 2015, and RY 2017 reflect the chemical activities at reporting facilities in
calendar years 2011, 2015, and 2017, respectively. Each facility filing a TRI Form R discloses
activities that apply to the TRI chemical at the facility. The TRI data presented above are from
the TRI dataset updated in April 2019. Tables 4, 5, and 6 present the activities and uses reported
to TRI by industry group for 2011, 2015, and 2017. Waste management activity type include all
industry groups that reported to TRI using each waste management activity for dibutyl phthalate.
The Aerospace Industries Associated (AIA) reported to EPA that the aerospace industry uses
dibutyl phthalate and products/formulations containing dibutyl phthalate in the manufacture,
operations and maintenance of aerospace products, and that dibutyl phthalate is used in
formulations for adhesives, conductive and interior coatings, potting compounds, putties, dye
penetrants, and sealants (EPA-HQ-OPPT-2018-0503-0004). The AIA reported that, as a
constituent of products, dibutyl phthalate was identified: within epoxy and other plastic
adhesives and in conductive and conformal coatings; in adhesives critical to electrical/circuit
boards due to its thermal properties and low outgassing properties (an important property for
space applications); as a processing aid for crosslinking in cement for acrylic processing; in
coatings that dissipate static charges on floor coatings and in fuel tanks, and as propellants within
pyrocartridges used in aircraft ejection seat safety systems; and as a plasticizer for rubber-based
formulations for fuel containment systems in both military and commercial aircraft (EPA-HQ-
OPPT-2018-0503-0004).
The American Coatings Association reported to EPA that dibutyl phthalate is used in plasticizers
as an additive in coatings and adhesives, and it is sometimes also found as an impurity in
coatings and adhesives (EPA-HQ-OPPT-2018-0503-0003).
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 or other susceptible subpopulations may
be potentially 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 dibutyl
phthalate assessment.
Children
EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles
intended for children over time for dibutyl phthalate. The 2012 and 2016 CDR did not report any
use of dibutyl phthalate in children's products. EPA also 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 dibutyl phthalate (Section 7, Table 9). Thus, women of reproductive age were identified as a
potentially exposed or susceptible subpopulation with respect to dibutyl phthalate.
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 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 dibutyl phthalate's persistence and
bioaccumulation.
Physical and Chemical Properties and Environmental Fate Tables
Tables 7 and 8 summarize the physical and chemical properties and the environmental fate
characteristics of dibutyl phthalate, respectively.
Table 7. Physical and Chemical Properties of Dibutyl Phthalate
Property or
Endpoint
Value3
Reference
Molecular Formula
C16H22O4
CRC Handbook
(Rumble, 2018)
Molecular Weight
278.344 g/mole
CRC Handbook
(Rumble, 2018)
Physical State
Liquid
CRC Handbook
(Rumble, 2018)
Physical Form
Oily liquid, colorless, faint yellow
HSDB (2015) citins NIOSH (2010)
Purity
Impurities include ca. 0.01% w/w butyl
benzoate and ca. 0.01% w/w butan-l-ol
HSDB (2015) citins ECB (2003)
Melting Point
-35 °C
PhvsProD Database (U.S. EPA. 2012b)
Boiling Point
340 °C
PhvsProD Database (U.S. EPA. 2012b)
Density
1.046 g/mL at 20 °C
HSDB (2015) citins O'Neil (2013)
Vapor Pressure
2.01 x 10"5 mm Hg at 25 °C
HSDB (2015) citins Donovan (1996)
Vapor Density
9.58 (relative vapor density to air = 1)
HSDB (2015) citins Lewis (2012)
Water Solubility
11.2 mg/L at 25 °C
Mackay et al. (2006) citing Howard et al.
(1985)'
4.45-4,500 mg/L
Mackay et al. (2006) citing several
sources
13.3, 14.6, and 5.50 mg/L at 10, 25, and
30 °C (shake flask surface tension
measurement)
Mackay et al. (2006) citing Thomsen et
al. (2001)
Log K0„
4.50
HSDB (2015) citins Ellinston and Flovd
(1996)
Henry's Law
Constant
1.81 x 10"6 (atm-m3/mol) at 23 °C
HSDB (2015) citins Atlas et al. (1983)
Flash Point
157 °C
ATSDR (2001) citins Weiss (1986)
21

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Property or
Endpoint
Value3
Reference
Auto Flammability
403 °C (autoignition temperature)
ATSDR (2001) citins NIOSH (1997)
Viscosity
0.203 poise at 20 °C
HSDB (2015) citins Lewis (2007)
Refractive Index
1.490 at 20 °C
HSDB (2015) citins (Weil (2013)
Dielectric Constant
TBD
TBD
Surface Tension
TBD
TBD
Notes:
"¦Measured unless otherwise noted; K0w = octanol-water partitioning coefficient
TBD = to be determined, if reasonably available. EPA is particularly interested in information from the public
on these properties or endpoints.
Table 8. Environmental Fate Characteristics of Dibutyl Phthalate
Property or
Endpoint
Value3
Reference
Direct
Photodegradation
ti/2 = 3 hours
Mackav et al. (2006) citing
Jin et al. (1999)
Indirect
Photodegradation
ti/2 = 18.4 hours with reaction with -OH radical
Mackay et al. (2006) citing
Howard (1989)
Hydrolysis
ti/2 = approximately 22 years
ATSDR (2001) citins U.S.
EPA (1989)
Biodegradation
(Aerobic)
Water: 69% by BOD, 100% by UV-VIS, 100% by GC
after 2 weeks at a concentration of 100 ppm unspecified
method (most likely Japanese MITI)
NITE (2019)
Soil: ti/2 = 1.8-53 days reported by multiple sources in
Mackay et al., 2006
3 days by microorganisms isolated from soil or
wastewater; 11-53 days depending on pH, soil type,
etc.; <5 days in garden soil; 48-552 hours based on
unacclimated aerobic soil grab sample data; 1.8 days at
30 degrees in garden soil; 6.7 days in soil; 11.2 days in
soil; 15.8 days in soil
Mackay et al. (2006)
Sediment: ti/2 = 1.0-23 days reported by multiple
sources in Mackay et al., 2006
Mackay et al. (2006)
Biodegradation
(Anaerobic)
Water: ti/2 = 1.19-27.2 days reported by multiple sources
in Mackay et al., 2006
Mackay et al. (2006)
Soil: ti/2 = 1-20 days reported by multiple sources in
Mackay et al., 2006
Mackay et al. (2006)
22

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Property or
Endpoint
Value3
Reference

Sediment: ti/2 = 7-30 days reported by multiple sources
in Mackay et al., 2016
Mackay et al. (2006)
Wastewater
Treatment
56% total removal (0.52% by biodegradation, 55% by
sludge adsorption, and 0.04% by volatilization to air;
estimated)13
EPI Suite (U.S. EPA. 2012a)
Bioconcentration
Factor
3.1-21.2 and 5.2-176 attest substance concentrations of
0.05 and 0.015 ppm, respectively (Cyprinus cctrpio)
NITE (2019)
Bioaccumulation
Factor
Accumulation of 1,2-benzenedicarboxylic acid, 1,2-
dibutyl ester in the aquatic and terrestrial food chain is
limited by biotransformation, which progressively
increases with trophic level
ATSDR (2001) citins Staples
et al. (1997)
Soil Organic
Carbon:Water
Partition
Coefficient (Log
Koc)
2.17 (marine sediment/seawater);
0.3010-1.60 (clay and seawater);
4.54 (calculated, sediment-water);
3.14 (soil)
Mackay et al. (2006)
Notes: aMeasured unless otherwise noted; bEPI Suite™ physical property inputs: Log Kow = 4.50, BP = 340 °C, MP
= -35 °C, VP = 2.01 x 10"5 lninHg, WS = 11.2 mg/L, Henry's Law Constant = 1.81 x 10~6 atm-m3/mol. SMILES:
0=C(0CCCC)c(c(cccl)C(=0)0CCCC)cl; -OH = hydroxyl radical; GC = gas chromatography; MITI = Ministry of
International Trade and Industry, Japan; BOD = biochemical oxygen demand; K0c = organic carbon-water
partitioning coefficient
Persistence and Bioaccumulation Summary
Dibutyl phthalate, is a colorless to faint yellow, oily liquid. Based on its vapor pressure
(2.01 x 10"5 mm Hg) and Henry's Law Constant (1.81 x 10"6 atm-m3/mole), dibutyl phthalate is
expected to volatilize from water and moist soil surfaces, but not dry soils. It is expected to have
low mobility in soil (log Koc 3.14).
In aerobic water, dibutyl phthalate degraded by 69 percent over 2 weeks based on biochemical
oxygen demand. Aerobic degradation of dibutyl phthalate in soil occurs at a rate that corresponds
to half-lives between 1.8 and 3 days. Based on these results, dibutyl phthalate is expected to have
high biodegradability. Dibutyl phthalate in the air will be in the particulate form, which will be
removed by wet and dry precipitation. Direct photodegradation of dibutyl phthalate occurs at a
rate that corresponds to a half-life of 3 hours. In the vapor phase, dibutyl phthalate will react with
photochemically produced hydroxyl radicals at a rate that corresponds to a half-life of 18.4
hours. Bioconcentration factors of 3.1-176 indicate that dibutyl phthalate is not bioconcentrated.
Bioaccumulation factor data indicate that dibutyl phthalate will be metabolized more rapidly by
organisms the higher up the food chain it goes.
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6. Storage near significant sources of drinking water
Approach
To support the proposed designation, EPA analyzed 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)7 and regulations under the
CWA (40 CFR 401.15)8. In addition, EPA considered the consolidated list of chemical
substances subject to reporting requirements under EPCRA (Section 302 Extremely Hazardous
Substances and Section 313 Toxic Chemicals), CERCLA (Hazardous Substances), and 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 unreasonable risk of
injury to health or the environment.
Results and Discussion
Dibutyl phthalate is designated as a toxic pollutant under section 307(a)(1) of the CWA and as
such is subject to effluent limitations. Under the CWA section 304, dibutyl phthalate is included
in the list of total toxic organics (40 CFR 413.02(i))9 It is also designated as a hazardous
substance in accordance with Section 311(b)(2)(A) of the Federal Water Pollution Control Act.
Dibutyl phthalate is a hazardous substance under CERCLA. Releases of dibutyl phthalate in
excess of 10 pounds must be reported (40 CFR 302.4)10. Dibutyl phthalate is not subject to
CAA 112(r).
Dibutyl phthalate is included on the list of hazardous wastes pursuant to the Resource
Conservation and Recovery Act (RCRA) section 3001 (hazardous waste number U069)
identifying this commercial chemical product as a toxic waste when discarded (40 CFR
261.33)11. RCRA directs EPA to develop and promulgate criteria for identifying the
characteristics of hazardous waste, and for listing hazardous waste, taking into account toxicity,
persistence, and degradability in nature, potential for accumulation in tissue and other related
factors such as flammability, corrosiveness, and other hazardous characteristics.
7	https://www.govinfo.gov/app/details/CFR-2018-title40-vol25/CFR-2018-title40-vol25-partl41-subpartA/summarv
8	https://www.govinfo.gov/app/details/CFR-2018-title40-vol3 l/CFR-2018-title40-vol31 -sec401-15
9	https://www.govinfo.gov/app/details/CFR-1996-title40-vol 15/CFR-1996-title40-vol 15-sec413 -02
111 https://www.govinfo.gov/content/pkg/CFR-2004-title40-vol26/pdf/CFR-2004-title40-vol26-sec3Q2-4.pdf
11 https://www.govinfo.gov/app/details/CFR-2018-title40-vol28/CFR-2018-title40-vol28-sec261-33
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7. Hazard potential
Approach
EPA considered reasonably available information from peer-reviewed assessments and databases
to identify potential human health and environmental hazards for dibutyl phthalate (Tables 9 and
10, respectively).
There are very few publicly available assessments for dibutyl phthalate 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
according to the Standard Operating Procedures (SOPs)12. 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 dibutyl phthalate, if available, to fill in potential data
gaps when there were no reported observed effects for specific taxa exposed to the dibutyl
phthalate (Table 10).
Potential Human Health and Environmental Hazard Tables
EPA identified human health and environmental hazards based on a review of the reasonable
available information on dibutyl phthalate (Tables 9 and 10, respectively).
Table 9. Potential
luman Health Hazards Identified for Dibutyl Phthalate
Human Health
Hazards
Tested for
Specific Effect
Effect
Observed
Reference
Acute Toxicity
X
X
Environment Canada (1994). NTP (2000). RIVM
(2001). ATSDR (2001); NICNAS (2008). CPSC (2010).
NICNAS (2013). NICNAS (2016)
Repeated Dose
Toxicity
X
X
U.S. EPA (1987). Environment Canada (1994). NTP
(1995). NTP (2000). ATSDR (2001). ECB (2004).
NICNAS (2008). CPSC (2010). NICNAS (2013).
NICNAS (2016)
Genetic Toxicity
X
X
U.S. EPA (1987). Enviromnent Canada (1994). NTP
(1995). NTP (2000). ATSDR (2001). RIVM (2001).
NICNAS (2008). CPSC (2010). NICNAS (2013).
NICNAS (2016)
Reproductive
Toxicity
X
X
U.S. EPA (1987). Enviromnent Canada (1994). NTP
(1995). NTP (2000). ATSDR (2001). ECB (2004).
OEHHA (2007). NICNAS (2008). CPSC (2010). FDA
(2012); NICNAS (2013). CPSC (2014). NICNAS (2016)
Developmental
Toxicity
X
X
Enviromnent Canada (1994). NTP (1995). NTP (2000).
ATSDR (2001). OEHHA (2007). NICNAS (2008).
CPSC (2010). FDA (2012); FDA (2014); NICNAS
(2013). CPSC (2014). NICNAS (2016)
12 The ECOTOX Standard Operating Procedures (SOPs) can be found at: https://cfpub.epa. gov/ecotox/
25

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Human Health
Hazards
Tested for
Specific Effect
Effect
Observed
Reference
Toxicokinetic
X
X
NTP (1995). NTP (2000). ATSDR (2001). RIVM
(2001). NICNAS (2008). CPSC (2010). NICNAS
(2013). NICNAS (2016)
Irritation/Corrosion
X
X
NTP (2000). NICNAS (2008). NICNAS (2013).
NICNAS (2016)
Dermal
Sensitization
X
X
ATSDR (2001). ECB (2004). NICNAS (2008). CPSC
(2010). NICNAS (2013).
NICNAS (2016)
Respiratory
Sensitization
X
X
ATSDR (2001). NICNAS (2008). CPSC (2010)
Carcinogenicity
X

NTP (1995)
Immunotoxicity



Neurotoxicity
X
X
NTP (2000). ATSDR (2001). NICNAS (2013)
Epidemiological
Studies or
Biomonitoring
Studies
X
X
Enviromnent Canada (1994). ATSDR (2001). OEHHA
(2007). CPSC (2010). NICNAS (2013). CPSC (2014).
CPSC (2017)
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.
26

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Table 10. Potenl
ial Environmental I
azards Identified for Dibutyl Phthalate
Media
Study
Duration
Taxa Groups
High-Priority
Chemical
Candidate
Dibutyl Phthalate
(CASRN 84-74-2)
Isomers of
Dibutyl Phthalate
(CASRN 84-74-2)
NONE
Reference
Number
of Studies
Observed
Effects
Number
of Studies
Observed
Effects
Aquatic
Acute
exposure
Vegetation
10
X


Adams et al. (1995); Casserly et al. (1983); Chi et al.
(2006); Huang et al. (1999); Jonsson and Baun (2003);
Kuang et al. (2003); Kiihn and Pattard (1990); Li et al.
(2015); Nendza and Wenzel (2006); Scholz (1995)
Invertebrate
26
X


Adams et al. (1995); Call et al. (1979); Call et al.
(1983);Dixon et al. (1999); Huang et al. (1999);
Jonsson and Baun (2003); Kiihn et al. (1989);
Laughlin et al. (1978); Linden et al. (1979); Liu et al.
(2009); Mayer and Ellersieck (1986); Rao and Conklin
(1986); Scholz (1994b); Streufert (1977); Tagatz and
Stanley (1987); Walker (1984); Yang et al. (2009);
Yoshioka et al. (1985)
Fish
22
X


Adams et al. (1995); Buccafusco et al. (1981); Cravedi
and Perdu-Durand (2002); E.G. and G. Bionomics
(1983);
Geiger et al. (1985); Jarmolowicz et al. (2010); Jee et
al. (2009); Mayer and Ellersieck (1986); Mayer et al.
(1972); Ortiz-Zarragoitia et al. (2006); Scholz (1994a);
Xu et al. (2013a); Xu et al. (2013b)
Non-fish vertebrate
(i.e., amphibians,
reptiles, mammals)
4
X


Gardner et al. (2016); Higuchi (2002); Lee et al.
(2005); Pickford and Morris (1999)
27

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Media
Study
Duration
Taxa Groups
High-Priority
Chemical
Candidate
Dibutyl Phthalate
(CASRN 84-74-2)
Isomers of
Dibutyl Phthalate
(CASRN 84-74-2)
NONE
Reference
Number
of Studies
Observed
Effects
Number
of Studies
Observed
Effects






Chronic
exposure
Vegetation
6
X
-

Chi et al. (2006); Huang et al. (2006); Li et al. (2006)
Invertebrate
6
X


Huang et al. (1999); Kashian and Dodson (2002);
Kuhn et al. (1989); Rao and Conklin (1986); Rhodes et
al. (1995); Yoshioka et al. (1986)
Fish
16
X


Aoki et al. (2011); Bhatia et al. (2013); Bhatia et al.
(2014)
Call et al. (1980); Call et al. (1983); Chen et al. (2015);
E.G. and G. Bionomics (1983); Jee et al. (2009); Ortiz-
Zarragoitia and Cajaraville (2005); Ortiz-Zarragoitia et
al. (2006); Padilla et al. (2012); Rhodes et al. (1995);
Van den Belt et al. (2003); Weston et al. (2009); Xu et
al. (2014)
Non-fish vertebrate
(i.e., amphibians,
reptiles, mammals)
4
X


Higuchi (2002); Ohtani et al. (2000); Shen et al.
(2011); Sugiyama et al. (2005)
28

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Media
Study
Duration
Taxa Groups
High-Priority
Chemical
Candidate
Dibutyl Phthalate
(CASRN 84-74-2)
Isomers of
Dibutyl Phthalate
(CASRN 84-74-2)
NONE
Reference
Number
of Studies
Observed
Effects
Number
of Studies
Observed
Effects






Terrestrial
Acute
exposure
Vegetation
-

-

none
Invertebrate
8
X


Boyd et al. (2016); Do Nascimento Filho et al. (2013);
Jensen et al. (2001);
Kim et al. (2008); Lenoir et al. (2014); Neuhauser et al.
(1985); Samoiloff et al. (1980)
Vertebrate
2
X
-

Cater et al. (1977); Wilson et al. (2004)
Chronic
exposure
Vegetation
6
X
-

Cai et al. (2008); Hulzebos et al. (1993); Liao et al.
(2009); Sun et al. (2015)
Invertebrate
2
X
-

Du et al. (2015); Jensen et al. (2001)
Vertebrate
9
X


Cater et al. (1977); Chapin et al. (1998); Hardin et al.
(1987); Higuchi et al. (2003); Higuchi (2002);
Hill et al. (1975); Nishijima et al. (2003); Oishi and
Hiraga (1980); Peakall (1974)
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).
29

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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 dibutyl phthalate.
Release Potential for Environmental and Human Health Exposure
In addition to other required information, a submission of a TRI Form R report must include the
quantities of a TRI chemical the facility released on-site to air, water, or land, and the quantities
it transferred off-site to another facility for further waste management. On-site release quantities
are reported in Part II Section 5 of the TRI Form R, and off-site transfers are reported in Part II
Section 6. Waste management activities include: transfers of a TRI chemical in wastewater to a
publicly owned treatment works (POTWs) facility or to a non-POTW wastewater treatment
facility for the purpose of treatment for destruction or removal; combustion for energy recovery;
treatment (treatment includes treatment via incineration for destruction and waste stabilization);
recycling; and release, including disposal. During treatment, combustion for energy recovery, or
recycling activities, it is possible that some of the quantities of the TRI chemical will be released
to the environment.
Worker Occupational and consumer exposure
EPA 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 dibutyl
phthalate 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, human and environmental biomonitoring data to
inform dibutyl phthalate's exposure potential to the general population (Table 13).
Results and Discussion
Release potential for environmental and human health exposure
Aggregated quantities of dibutyl phthalate released on-site to air, water, and land, and aggregated
quantities of dibutyl phthalate transferred off-site to POTW and other wastewater treatment
facilities (non-POTW) are presented in Table 11 for RY 2011, 2015, and 2017. The table does
not include any of the reported quantities pertaining to other waste management activities (e.g.,
recycling, combustion for destruction) that occurred on-site or off-site during RY 2011, 2015,
and 2017. The "Number of Facilities" is the count of unique facilities that filed a TRI Form R
report for dibutyl phthalate for RY 2011, 2015, and 2017. The TRI data presented were obtained
from the TRI dataset following its update in April 2019.
30

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Table 11. The TRI Data on Dibutyl Phthalate from Reporting Years 2011, 2015, and 2017
Used in this Document to Assess Exposure Potential			
Year
Number of
Facilities
That
Reported
Total
Quantities
Released
On-Site to
Air (lbs.)
Total
Quantities
Released On-
Site to Water
(lbs.)
Total
Quantities
Released
(Disposed
of) On-Site
to Land
(lbs.)
Total
Quantities
Transferred
to POTWs
(lbs.)
Total Quantities
Transferred to
Other (Non-
POTWs)
Wastewater
Treatment
Facilities (lbs.)
2011
92
14,982
118
155,374
7,783
382
2015
72
7,157
2
165,351
2,213
0
2017
63
5,628
0
326,942
8,008
0
Note: POTW = publicly owned treatment works
Reference: U.S. EPA. 2019b
For RY 2017, 63 facilities submitted TRI reports for dibutyl phthalate. The total quantities of
dibutyl phthalate these facilities released on-site to air (as fugitive and stack emissions), surface
water and land are: 5,628 pounds; 0 pounds; and 326,942 pounds, respectively. These facilities
reported 8,008 pounds of the chemical transferred to POTWs and zero pounds transferred off-site
to other non-POTW wastewater treatment facilities for the purpose of wastewater treatment.
These transfer categories represent two types of off-site transfers for wastewater treatment that
may lead to releases from the receiving facilities. They do not include quantities sent off-site for
other types of waste management activities that include, or may lead to, releases of the chemical.
Quantities transferred off-site represent the amount of a toxic chemical a facility sent off-site
prior to any waste management (e.g., treatment) at a receiving facility. Some of the quantities of
dibutyl phthalate received by the non-POTW wastewater treatment facilities may have been
released to surface waters or to air during treatment processes at the facilities.
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
exposure controls such as engineering controls, administrative controls, and the existence of a
personal protective equipment (PPE) program.
Dibutyl phthalate has an Occupational Safety and Health Administration (OSHA) permissible
exposure limit (PEL) (OSHA. 2019). The PEL is 5 milligrams (mg)/cubic meter (m3) over an 8-
hour work day, time weighted average (TWA). This chemical also has a National Institute for
Occupational Safety and Health (NIOSH) Recommended Exposure Limit (REL) (NIQSH. 2010)
of 5 mg/m3 TWA. The American Conference of Governmental Industrial Hygienists (ACGIH)
set the threshold limit value (TLV) at 5 mg/m3 TWA.
Dibutyl phthalate has a vapor pressure of 2.01 x 10"5 mm Hg at 25 °C/77 °F. Experience has
shown that inhalation exposure to vapors generated from liquids with vapor pressures below
31

-------
0.001 mmHg at ambient room temperature conditions may be negligible. Some handling
activities of dibutyl phthalate may generate dust, particularly when handled as a dry powder.
Workers may be exposed to aerosolized particles.
Dibutyl phthalate 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
Dibutyl phthalate is widely used in consumer products, like cosmetics, adhesives, regenerated
cellulose, and cellophane (ECB. 2004). It is present in some home furnishings, paints, vinyl
flooring, and floor wax (ATSDR. 2001). The National Institutes of Health Consumer Product
Database and the Chemical and Products Database (CPDat) reported dibutyl phthalate in many
products ranging from adhesives and arts and crafts products to floor polish, paints, and solvents
(Table 12). Consumers are likely exposed to dibutyl phthalate in fragrant products containing
this chemical, such as household cleaners and auto products (NICNAS. 2016). The European
Chemicals Agency (ECHA) conducted exposure modeling for cosmetics, food, and toys for
children and concluded that there is no need for further information or testing or risk reduction
measures beyond those which are being applied already (ECB. 2004 ). Chronic use of medication
with dibutyl phthalate increased the urinary metabolite monobutyl phthalate in patients (CPSC.
2010).
Table 12. Exposure Information for Consumers
Chemical
Identity
Consumer Product Database
Consumer Uses (List)
Dibutyl
Phthalate
(84-74-2)
Adhesive, apparel bags, arts crafts products, automotive, automotive care, automotive
component, binding, building material, body repair, carpet, carpet cleaner, casting
agent, catalyst, cleaner, clipper lubricant/cleaner, clothing, colorant, decor, electrical,
electrical insulation, electronics, filler, filler building material, floor cleaner, floor
polish, flooring, fluid property modulator, footwear care, footwear, fragrance, grills,
hardener, ink colorant, insulation, leather impregnation, lubricant, metal surface
treatment, paint, paint binding, paint filler, paint hardener, paint spray, paper
impregnation, paper surface treatment, paving, photographic, plastic, plastic filler,
plastic hardener, plastic softener, polish, printing, printing ink, rubber, rubber
processing, seal material, softener, solvent, sports equipment, stain remover, surface
treatment, textile, textile impregnation, toys, viscous liquid building material, wall
building material, wood impregnation
Reference: CPDat
General population exposure
The general population may be exposed to dibutyl phthalate from contaminated air, water, and
some foods (ATSDR. 2001; CPSC. 2010). Air is likely the main source of exposure for the general
population, but some exposure may come from consumption of dairy products, fish, and seafood
32

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(ATSDR. 2001). The major source of dietary dibutyl phthalate intake is from consumption of fish
(ECB. 2004). A summary of the studies from peer-reviewed databases is presented in Table 9.
Table 13. 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
yes
no
MDI (2002)
EPA Ambient Monitoring Technology
Information Center - Air Toxics Data
yes
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 (1996)
FDA Total Diet Study
no
no
no
FDA (1991)
Great Lakes Environmental Database
yes
no
no
U.S. EPA (2018b)
Information Platform for Chemical
Monitoring Data
no
no
no
EC (2018)
International Council for the Exploration of
the Sea
yes
no
yes
ICES (2018)
OECD Monitoring Database
no
no
no
OECD (2018)
Targeted National Sewage Sludge Survey
no
no
no
U.S. EPA (2006)
The National Health and Nutrition
Examination Survey
no
no
no
CDC (2013)
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 (1991c)
USGS Monitoring Data -National Water
Quality Monitoring Council, Sediment
yes
no
no
USGS (1991d)
USGS Monitoring Data -National Water
Quality Monitoring Council, Soil
yes
no
no
USGS (1991e)
USGS Monitoring Data -National Water
Quality Monitoring Council, Surface Water
yes
no
no
USGS (199 If)
USGS Monitoring Data -National Water
Quality Monitoring Council, Tissue
no
no
yes
USGS (1991e)
a Concen.= concentration
b Biomon.= biomonitoring
33

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Dibutyl phthalate has been detected in air, surface water and groundwater, sediment, biota,
sewage sludge and waste effluents (Environment Canada. 1994; ECB. 20041 as well as in human
breastmilk (ECB. 2004). The general population's daily exposure to dibutyl phthalate is estimated
to be less than 10 [j,g/kg/d (CPSC. 2010). Biomonitoring studies measuring dibutyl phthalate from
the urine of children, school teachers, and parents indicate that the primary metabolite for dibutyl
phthalate was higher in the children when compared with the adults (CPSC. 2010). The Australian
National Industrial Chemicals Notification and Assessment Scheme (NICNAS) provides
modeling for estimation of dermal and inhalation exposure of the general population, including
children, from cosmetics (NICNAS 2013). Modeling for estimated exposures in women, infants,
toddlers, and children is also available (CPSC. 2014) as are models using the NHANES
2005/2006 exposure estimates (CPSC. 2015). Susceptible subpopulations will respond differently
to dibutyl phthalate exposure compared with the general population (see Section 4).
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 dibutyl phthalate may present an unreasonable risk of injury
to health and/or the environment, including potentially exposed or susceptible subpopulations,
(e.g., workers, women of reproductive age, consumers, children). This is based on the potential
hazard and potential exposure of dibutyl phthalate 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 dibutyl phthalate 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 exposure to children. In addition, EPA expects
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, irritation/corrosion, dermal sensitization, respiratory sensitization, neurotoxicity, and
observations in epidemiological studies and/or biomonitoring studies).
34

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Du, L; Li, G; Liu, M; Li, Y; Yin, S; Zhao, J; Zhang, X. (2015). Evaluation of DNA damage and
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dfab7ac53e37
EG; Bionomics, G. (1983). Acute toxicity of thirteen phthalate esters to fathead minnow
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