EPA Document# EPA-740-D-20-018
April 2020
United States Office of Chemical Safety and
*7 EPA Environmental Protection Agency Pollution Prevention
Draft Scope of the Risk Evaluation for
Di-isobutyl Phthalate
(1,2-Benzenedicarboxylic acid, l,2-bis(2-methylpropyl) ester)
CASRN 84-69-5
¦CH
CH
April 2020
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TABLE OF CONTENTS
ACKNOWLEDGEMENTS 5
ABBREVIATIONS AND ACRONYMS 6
EXECUTIVE SUMMARY 9
1 INTRODUCTION 12
2 SCOPE OF THE EVALUATION 12
2.1 Reasonably Available Information 12
2.1.1 Search of Gray Literature 13
2.1.2 Search of Literature from Publicly Available Databases (Peer-Reviewed Literature) 14
2.1.3 Search of TSCA Submissions 19
2.2 Conditions of Use 20
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 20
2.2.2 Activities Excluded from the Scope of the Risk Evaluation 25
2.2.3 Production Volume 25
2.2.4 Overview of Conditions of Use and Lifecycle Diagram 25
2.3 Exposures 28
2.3.1 Physical and Chemical Properties 28
2.3.2 Environmental Fate and Transport 28
2.3.3 Releases to the Environment 28
2.3.4 Environmental Exposures 28
2.3.5 Occupational Exposures 29
2.3.6 Consumer Exposures 30
2.3.7 General Population Exposures 30
2.4 Hazards (Effects) 31
2.4.1 Environmental Hazards 31
2.4.2 Human Health Hazards 31
2.5 Potentially Exposed or Susceptible Subpopulations 31
2.6 Conceptual Models 32
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses 32
2.6.2 Conceptual Model for Consumer Activities and Uses 34
2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards 36
2.7 Analysis Plan 38
2.7.1 Physical and Chemical Properties and Environmental Fate 38
2.7.2 Exposure 38
2.7.2.1 Environmental Releases 39
2.7.2.2 Environmental Exposures 40
2.7.2.3 Occupational Exposures 42
2.7.2.4 Consumer Exposures 43
2.7.2.5 General Population 45
2.7.3 Hazards (Effects) 46
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2.7.3.1 Environmental Hazards 46
2.7.3.2 Human Health Hazards 48
2.7.4 Summary of Risk Approaches for Characterization 50
2.8 Peer Review 50
REFERENCES 51
APPENDICES 58
Appendix A LIST OF GRAY LITERATURE SOURCES 58
Appendix B PHYSICAL AND CHEMICAL PROPERTIES OF DI-ISOBUTYL PHTHALATE
61
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES 63
Appendix D REGULATORY HISTORY 64
D.l Federal Laws and Regulations ....64
D.2 State Laws and Regulations 66
D.3 International Laws and Regulations. .....67
Appendix E EXPOSURE INFORMATION 69
E.l Process Information ................69
E. 1.1 Manufacture (Including Import) 69
E. 1.1.1 Domestic Manufacturing 69
E.l. 1.2 Import 69
E. 1.2 Processing and Distribution 69
E. 1.2.1 Incorporated into a Formulation, Mixture or Reaction Product 69
E. 1.2.2 Incorporated into an Article 70
E. 1.2.3 Repackaging 70
E.l.2.4 Recycling 70
E.l.3 Uses 70
E.l.3.1 Adhesives, Sealants, Paints, and Coatings 70
E.l.3.2 Building/Construction Materials Not Covered Elsewhere 70
E.l.3.3 Ink, Toner, and Colorant Products 70
E.l.3.4 Plastic and Rubber Products 71
E.l.4 Other Uses 71
E.l.5 Disposal 71
E.2 Preliminary Occupational Exposure Data. .72
Appendix F SUPPORTING INFORMATION- CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES 73
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES 81
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES 88
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LIST OF TABLES
Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCA 20
Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation 21
Table 2-3. Categories and Sources of Environmental Release Data 39
LIST OF FIGURES
Figure 2-1. Gray Literature Search Results for Di-isobutyl Phthalate 14
Figure 2-2. Peer-reviewed Literature - Physical-Chemical Properties Search Results for Di-isobutyl
Phthalate 15
Figure 2-3. Peer-reviewed Literature - Fate and Transport Search Results for Di-isobutyl Phthalate 16
Figure 2-4. Peer-reviewed Literature - Engineering Search Results for Di-isobutyl Phthalate 17
Figure 2-5. Peer-reviewed Literature - Exposure Search Results for Di-isobutyl Phthalate 18
Figure 2-6. Peer-reviewed Literature - Hazard Search Results for Di-isobutyl Phthalate 19
Figure 2-7. Di-isobutyl Phthalate Life Cycle Diagram 27
Figure 2-8. Di-isobutyl Phthalate Conceptual Model for Industrial and Commercial Activities and Uses:
Worker and Occupational Non-User Exposures and Hazards 33
Figure 2-9. Di-isobutyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer
Exposures and Hazards 35
Figure 2-10. Di-isobutyl Phthalate Conceptual Model for Environmental Releases and Wastes:
Environmental and General Population Exposures and Hazards 37
LIST OF APPENDIX TABLES
TableApx A-l. Gray Literature Sources for Di-isobutyl Phthalate 58
TableApx B-l. Physical and Chemical Properties of Di-isobutyl Phthalate 61
TableApx C-l. Environmental Fate Characteristics of Di-isobutyl Phthalate 63
Table_Apx D-l. Federal Laws and Regulations 64
Table_Apx D-2. State Laws and Regulations 66
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements 67
Table Apx F-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table.. 73
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table 81
Table Apx H-l. General Population and Environmental Exposure Conceptual Model Supporting Table
88
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ACKNOWLEDGEMENTS
This report was developed by the United States Environmental Protection Agency (U.S. EPA), Office of
Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution Prevention and Toxics (OPPT).
Acknowledgements
The OPPT Assessment Team gratefully acknowledges participation or input from intra-agency
reviewers that included multiple offices within EPA, inter-agency reviewers that included multiple
federal agencies, and assistance from EPA contractors GDIT (Contract No. HHSN316201200013W),
ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF (Contract No.
68HERC19D0003), Abt Associates (Contract No. EP-W-16-009) and SRC (Contract No.
68HERH19F0213). EPA also acknowledges the contributions of technical experts from EPA's Office of
Research and Development.
Docket
Supporting information can be found in public docket: [Docket ID: EPA-HO-OPPT-2Q18-04341.
Disclaimer
Reference herein to any specific commercial products, process or service by trade name, trademark,
manufacturer or otherwise does not constitute or imply its endorsement, recommendation or favoring by
the United States Government.
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ABBREVIATIONS AND ACRONYMS
ACGIH
American Conference of Governmental Industrial Hygienists
ADME
Absorption, Distribution, Metabolism, and Excretion
BBP
Butylbenzyl Phthalate
BCF
Bioconcentration Factor
BMF
Biomagnification factor
BP
Boiling point
BW34
Body weight scaling to the 3/4 power
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CFR
Code of Federal Regulations
CHRIP
Chemical Risk Information Platform
ChemSTEER
Chemical Screening Tool for Exposure and Environmental R(
COC
Concentration of Concern
CPCat
Chemical and Product Categories
CPSC
Consumer Product Safety Commission
CPSIA
Consumer Product Safety Improvement Act
CSCL
Chemical Substances Control Law
CWA
Clean Water Act
DBP
Dibutyl Phthalate
DCHP
Dicyclohexyl Phthalate
DEHP
Di-ethylhexyl Phthalate
DHEXP
Di-n-hexyl Phthalate
DIBP
Di-isobutyl Phthalate
DINP
Di-isononyl Phthalate
DPENP
Di-n-pentyl Phthalate
DMR
Discharge Monitoring Report
EC
Engineering Controls
ECx
Effective Concentration
ECHA
European Chemicals Agency
EPA
Environmental Protection Agency
ERG
Eastern Research Group
ESD
Emission Scenario Document
EU
European Union
FDA
Food and Drug Administration
FR
Federal Register
FYI
For Your Information
GACT
Generally Available Control Technology
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GDIT General Dynamics Information Technology
GESTIS International Occupational Exposure Limit Database
GS Generic Scenario
HAP Hazardous Air Pollutant
Hg Mercury
HHE Health Hazard Evaluation
HSDB Hazardous Substances Data Bank
ICF ICF is a global consulting services company
IECCU Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned
Zones
ILO International Labor Organization
IMAP Inventory Multi-Tiered Assessment and Prioritisation (Australia)
IMIS Integrated Management Information System
KOECT Kirk-Othmer Encyclopedia of Chemical Technology
Koc Organic Carbon: Water Partition Coefficient
Kow Octanol: Water Partition Coefficient
LCx Lethal Concentration
LOAEL Lowest Observed Adverse Effect Level
LOEC Lowest Observed Effect Concentration
MACT Maximum Achievable Control Technology
MO A Mode of Action
MP Melting point
MRSA Maine Revised Statutes Annotated
NEI National Emissions Laboratory
NESHAP National Emission Standards for Hazardous Air Pollutants
NHANES National Health and Nutrition Examination Survey
NICNAS National Industrial Chemicals Notification and Assessment Scheme (Australia)
NIOSH National Institute for Occupational Safety and Health
NITE National Institute of Technology and Evaluation
NLM National Library of Medicine
NOAEL No Observed Adverse Effect Level
NOEC No Observed Effect Concentration
NPDES National Pollutant Discharge Elimination System
OCSPP Office of Chemical Safety and Pollution Prevention
OECD Organisation for Economic Co-operation and Development
OEL Occupational Exposure Limit
ONU Occupational Non-User
OPPT Office of Pollution Prevention and Toxics
OSHA Occupational Safety and Health Administration
PBPK Physiologically Based Pharmacokinetic
PBT Persistent, Bioaccumulative, Toxic
PECO Population, Exposure, Comparator and Outcome
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PESS
Potentially Exposed Susceptible Populations
POD
Point of Departure
POTW
Publicly Owned Treatment Works
PPE
Personal Protective Equipment
PVC
Polyvinyl chloride
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals (European Union)
RQ
Risk Quotient
SARA
Superfund Amendments and Reauthorization Act
SDS
Safety Data Sheet
SDWA
Safe Drinking Water Act
SMILES
Simplified molecular-input line-entry system
SRC
SRC Inc., formerly Syracuse Research Corporation
SVOC
Semi-volatile organic compound
T1/2
Half-Life
TBD
To be determined
TIAB
Title and Abstract
TMF
Trophic Magnification Factors
TRI
Toxic Release Inventory
TSCA
Toxic Substances Control Act
U.S.C.
United States Code
VP
Vapor Pressure
WHO
World Health Organization
WS
Water solubility
WWT
Wastewater Treatment
WWTP
Wastewater Treatment Plant
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EXECUTIVE SUMMARY
In December 2019, EPA designated di-isobutyl phthalate (CASRN 84-69-5) as a high-priority substance
for risk evaluation following the prioritization process as required by Section 6(b) of the Toxic
Substances Control Act (TSCA) and implementing regulations (40 CFR Part 702) (Docket ID: EPA-
HQ-OPPT-2018-0434). The first step of the risk evaluation process is the development of the scope
document and this document fulfills the TSCA regulatory requirement to issue a draft scope document
as described in 40 CFR 702.41(c)(7). The draft scope for di-isobutyl phthalate includes the following
information: the conditions of use, potentially exposed or susceptible subpopulations (PESS), hazards,
and exposures that EPA plans to consider in this risk evaluation, along with a description of the
reasonably available information, conceptual model, analysis plan and science approaches, and plan for
peer review for this chemical substance. EPA is providing a 45-day comment period on the draft scope.
Comments received on this draft scope document will help inform development of the final scope
document and the risk evaluation.
General Information. Di-isobutyl phthlate is a colorless liquid with a total production volume in the
United States up to 500,000 pounds (U.S. EPA 2019b).
Reasonably Available Information. EPA leveraged the data and information sources already described
in the document supporting the High-Priority Substance designation for di-isobutyl phthalate to inform
the development of this draft scope document. To further develop this draft scope document, EPA
conducted a comprehensive search to identify and screen multiple evidence streams (i.e., chemistry, fate,
release and engineering, exposure, hazard), and the search and screening results to date are provided in
Section 2.1. EPA is seeking public comment on this draft scope document and will consider additional
information identified following publication of this draft scope document, as appropriate, in developing
the final scope document. EPA is using the systematic review process described in the Application of
Systematic Review in TSCA Risk Evaluations document (U.S. EPA, 2018a) to guide the process of
searching for and screening reasonably available information, including information already in EPA's
possession, for use and inclusion in the risk evaluation. EPA is applying these systematic review
methods to collect reasonably available information regarding hazards, exposures, PESS, and conditions
of use that will help inform the risk evaluation for di-isobutyl phthalate.
Conditions of Use. EPA plans to evaluate manufacturing, including importing; processing; distribution
in commerce; industrial, commercial and consumer uses; and disposal of di-isobutyl phthalate in the risk
evaluation. Di-isobutyl phthalate is manufactured within, as well as imported into, the United States.
The chemical is incorporated into formulation, mixture, or reaction products and incorporated into
articles. The identified processing activities also include the recycling of di-isobutyl phthalate. Several
industrial and commercial uses were identified that ranged from use in plastic and rubber products to use
in adhesives and sealants. Consumer uses varied from inks, toner, and colorant products to adhesives
and sealants. EPA identified these conditions of use from information reported to EPA through
Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses
currently in production and uses whose production may have ceased. EPA is aware of information
reporting di-isobutyl phthalate used in personal care products such as perfume and nail polish as well as
in dentistry settings; however, they are not conditions of use as defined in TSCA § 3(4). Section 2.2
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provides details about the conditions of use within - and outside - the scope of the risk evaluation. In
addition, EPA plans to analyze distribution in commerce and disposal as part of the risk evaluation.
Conceptual Model. The conceptual models for di-isobutyl phthalate are presented in Section 2.6.
Conceptual models are graphical depictions of the actual or predicted relationships of conditions of use,
exposure pathways (e.g., media), exposure routes (e.g., inhalation, dermal, oral), hazards, and receptors
throughout the life cycle of the chemical substance—from manufacturing, processing, distribution in
commerce, storage, use, to release or disposal. EPA plans to focus the risk evaluation for di-isobutyl
phthalate on the following exposures, hazards and receptors, however, EPA also plans to consider
comments received on this draft scope and other reasonably available information when finalizing this
scope document, and to adjust the exposure pathways, exposure routes and hazards included in the scope
document as needed.
• Exposures (Pathways and Routes), Receptors and PESS. EPA plans to analyze both human and
environmental exposures resulting from the conditions of use of di-isobutyl phthalate that EPA
plans to consider in the risk evaluation. Exposures for di-isobutyl phthalate are discussed in
Section 2.3. Additional information gathered through systematic review searches will also
inform expected exposures.
In Section 2.6.3, EPA presents the conceptual models describing the identified exposures
(pathways and routes), receptors and hazards associated with the conditions of use of di-isobutyl
phthalate within the scope of the risk evaluation.
Preliminarily, EPA plans to evaluate the following human and environmental exposure
pathways, routes, receptors and PESS in the scope of the risk evaluation. However, EPA plans to
consider comments received on this draft scope and other reasonably available information when
finalizing this scope document, and to adjust the exposure pathways, exposure routes and
hazards included in the scope document as needed.
- Occupational exposures associated with industrial and commercial conditions of use:
EPA plans to evaluate exposures to workers and occupational non-users (ONUs) via the
inhalation route and exposures to workers via the dermal route associated with the
manufacturing, processing, use or disposal of di-isobutyl phthalate.
- Consumer and bystander exposures associated with consumer conditions of use: EPA
plans to evaluate the inhalation and dermal exposure to di-isobutyl phthalate for
consumers and bystanders from use of adhesives and sealants; air care products; cleaning
and furnishing care products; fabric, textile, and leather products; floor coverings; ink,
toner, and colorant products; paints and coatings; paper products; plastic and rubber
products not covered elsewhere; and toys, playground, and sporting equipment.
- General population exposures: EPA plans to evaluate exposure to di-isobutyl phthalate
via drinking water, surface water, groundwater, ambient air, soil, and fish ingestion for
the general population.
- Receptors and PESS: EPA plans to evaluate children, women of reproductive age (e.g.,
pregnant women), workers and consumers as receptors and PESS in the risk evaluation.
- Environmental exposures: EPA plans to evaluate exposure to di-isobutyl phthalate for
aquatic and terrestrial receptors.
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• Hazards. Hazards for di-isobutyl phthalate are discussed in Section 2.4. EPA completed
preliminary reviews of information from peer-reviewed assessments and databases to identify
potential environmental and human health hazards for di-isobutyl phthalate as part of the
prioritization process. Environmental hazard effects were identified EPA for aquatic and
terrestrial organisms. Information collected through systematic review methods and public
comments may identify additional environmental hazards that warrant inclusion in the
environmental hazard assessment of the risk evaluation.
EPA plans to use systematic review methods to evaluate the epidemiological and toxicological
literature for di-isobutyl phthalate. Relevant mechanistic evidence will also be considered, if
reasonably available, to inform the interpretation of findings related to potential human health
effects and the dose-response assessment. EPA plans to evaluate all the potential human health
hazards for di-isobutyl phthalate identified in Section 2.4.2. The broad health effect categories
include reproductive and developmental, immunological, nervous system, and irritation effects.
Analysis Plan. The analysis plan for di-isobutyl phthalate is presented in Section 2.7. The analysis plan
outlines the general science approaches that EPA plans to use for the various information streams (i.e.,
chemistry, fate, release and engineering, exposure, hazard) supporting the risk evaluation. The analysis
plan is based on EPA's knowledge of di-isobutyl phthalate to date which includes a partial, but ongoing,
review of identified information as described in Section 2.1. EPA plans to continue to consider new
information submitted by the public. Should additional data or approaches become reasonably available,
EPA may update its analysis plan in the final scope document.
EPA plans to seek public comments on the systematic review methods supporting the risk evaluation for
di-isobutyl phthalate, including the methods for assessing the quality of data and information and the
approach for evidence synthesis and evidence integration supporting the exposure and hazard
assessments. The details will be provided in a supplemental document that EPA anticipates releasing
prior to the finalization of the scope document.
Peer Review. The draft risk evaluation for di-isobutyl phthalate will be peer reviewed. Peer review will
be conducted in accordance with relevant and applicable methods for chemical risk evaluations,
including using EPA's Peer Review Handbook and other methods consistent with Section 26 of TSCA
(See 40 CFR 702.45V
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1 INTRODUCTION
This document presents for comment the draft scope of the risk evaluation to be conducted for di-
isobutyl phthalate under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank
R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act
(TSCA) on June 22, 2016. The new law includes statutory requirements and deadlines for actions related
to conducting risk evaluations of existing chemicals.
TSCA § 6(b) and 40 CFR Part 702, Subpart A require the Environmental Protection Agency (EPA) to
designate chemical substances as high-priority substances for risk evaluation or low-priority substances
for which risk evaluations are not warranted at the time, and upon designating a chemical substance as a
high-priority substance, initiate a risk evaluation on the substance. TSCA § 6(b)(4) directs EPA, in
conducting risk evaluations for existing chemicals, to "determine whether a chemical substance presents
an unreasonable risk of injury to health or the environment, without consideration of costs or other non-
risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation by the Administrator, under the conditions of use."
TSCA § 6(b)(4)(D) and implementing regulations require that EPA publish the scope of the risk
evaluation to be conducted, including the hazards, exposures, conditions of use and potentially exposed
or susceptible subpopulations that the Administrator expects to consider within 6 months after the
initiation of a risk evaluation. In addition, a draft scope is to be published pursuant to 40 CFR 702.41. In
December 2019, EPA published a list of 20 chemical substances that have been designated high-priority
substances for risk evaluations (84 FR 71924). as required by TSCA § 6(b)(2)(B), which initiated the
risk evaluation process for those chemical substances. Di-isobutyl phthalate is one of the chemicals
designated as a high-priority substance for risk evaluation.
2 SCOPE OF THE EVALUATION
2.1 Reasonably Available Information
EPA conducted a comprehensive search for reasonably available information1 to support the
development of this draft scope document for di-isobutyl phthalate. EPA leveraged the data and
information sources already identified in the documents supporting the chemical substance's high-
priority substance designation. In addition, EPA searched for additional data and information on
physical and chemical properties, environmental fate, engineering, exposure, environmental and human
health hazards that could be obtained from the following general categories of sources:
1. Databases containing publicly available, peer-reviewed literature;
2. Gray literature, which is defined as the broad category of data/information sources not found in
standard, peer-reviewed literature databases.
3. Data and information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as "for your
information" (FYI) submissions.
1 Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize
for use in risk evaluations, considering the deadlines specified in TSCA Section 6(b)(4)(G) for completing such evaluation.
Information that meets the terms of the preceding sentence is reasonably available information whether or not the information
is confidential business information, that is protected from public disclosure under TSCA Section 14 (40 CFR 702.33).
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Following the comprehensive search, EPA performed a title and abstract screening to identify
information potentially relevant for the risk evaluation process. This step also classified the references
into useful categories or tags to facilitate the sorting of information through the systematic review
process. The search and screening processes were conducted based on EPA's general expectations for
the planning, execution and assessment activities outlined in the Application of Systematic Review in
TSCA Risk Evaluations document (U.S. EPA, 2018a). EPA plans to publish supplemental
documentation on the systematic review methods supporting the di-isobutyl phthalate risk evaluation to
explain the literature and screening process presented in this document in the form of literature
inventory trees. Please note that EPA focuses on the data collection phase (consisting of data search,
data screening, and data extraction) during the preparation of the TSCA scope document, whereas the
data evaluation and integration stages will occur during the development of the draft risk evaluation and
thus are not part of the scoping activities described in this document.
The subsequent sections summarize the data collection activities completed to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods. EPA plans to
seek public comments on the systematic review methods supporting the risk evaluation for di-isobutyl
phthalate upon publication of the supplemental documentation of those methods.
2.1.1 Search of Gray Literature
EPA surveyed the gray literature2 and identified 70 search results relevant to EPA's risk assessment
needs for di-isobutyl phthalate. Appendix A lists the gray literature sources that yielded 70 discrete data
or information sources relevant to di-isobutyl phthalate. EPA further categorized the data and
information into the various topic areas (or disciplines) supporting the risk evaluation (e.g., physical-
chemical (p-chem) properties, environmental fate, environmental hazard, human health hazard,
exposure, engineering) and the breakdown is shown in Figure 2-1. EPA is currently identifying
additional reasonably available information (e.g., public comments), and the reported numbers in Figure
2-1 may change.
2 Gray literature is defined as the broad category of data/information sources not found in standard, peer-reviewed literature
databases (e.g., PubMed and Web of Science). Gray literature includes data/information sources such as white papers,
conference proceedings, technical reports, reference books, dissertations, information on various stakeholder websites, and
other databases.
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Gray Literature l ags by Discipline
I'hysicaLChemical
Human.Hcalth.Hazard
Engineering
0 25 50 15 IOO
Percent Tagged (%)
Figure 2-1. Gray Literature Search Results for Di-isobutyl Phthalate
The percentages across disciplines do not add up to 100%, as each source may provide data or information for various topic
areas (or disciplines).
2.1.2 Search of Literature from Publicly Available Databases (Peer-Reviewed Literature)
EPA is currently conducting a systematic review of the reasonably available literature. This includes
performing a comprehensive search of the reasonably available peer review literature on p-chem
properties, environmental fate and transport, engineering (environmental release and occupational
exposure), exposure (environmental, general population and consumer) and environmental and human
health hazards of di-isobutyl phthalate. Eligibility criteria were applied in the form of PECO
(population, exposure, comparator, outcome) statements. Included references met the PECO criteria,
whereas excluded references did not meet the criteria (i.e., not relevant), and supplemental material was
considered as potentially relevant. EPA plans to analyze the reasonably available information identified
for each discipline during the development of the risk evaluation. The literature inventory trees depicting
the number of references that were captured and those that were included, excluded, or tagged as
supplemental material during the screening process for each discipline area are shown in Figure 2-2
through Figure 2-6. "TIAB" in these figures refers to title and abstract screening. Note that in some
figures the sum of the numbers for the various sub-categories may be larger than the broader category
because some studies may be included under multiple sub-categories. In other cases, the sum of the
various sub-categories may be smaller than the main category because some studies may not be depicted
in the sub-categories if their relevance to the risk evaluation was unclear.
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Boiling Point
Water Soluhlity
log KOW
Henry's Law Constant
Vapor Pressure
Vapor Density
Density
Retrieved for Fuil-text
Review
Included for Data
Extraction and Data
Evaluation
Dielectric Constant
134
Refractive Index
Total for TIAB:
P-Chem
126
Supplemental Information
Exclusion
Exclusion
Figure 2-2. Peer-reviewed Literature - Physical-Chemical Properties Search Results for Di-
isobutyl Phthalate
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©
Bioconcentration,
Biomagnification, etc.
Biodegradation
©
Hydrolysis
©
Photolysis
©
Sorption
©
Volatilization
@
Wastewater Treatment
G
Other
Figure 2-3. Peer-reviewed Literature - Fate and Transport Search Results for Di-isobutyl
Phthalate
Click here for interactive Health Assessment Workplace Collaborative (HAWC) Diagram.
16
Included
Excluded
TSCA Fate DIBP (2020)
Supplemental
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©
General Facility Estimate
39
Included
12
Environmental Release
546
TSCA Engineering DIBP
(2020)
507
Excluded
Occupational Exposure
®
Supplemental
Figure 2-4. Peer-reviewed Literature - Engineering Search Results for Di-isobutyl Phthalate
Click here for interactive HAWC Diagram.
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Include
351
TSCA Exposure DIBP (2020)
©
indoor air
©
ambient air
18
soil
©
sediment
14
biosolids/sludge
46:
surface water
©
ground water
©
drinking water
©
aquatic species
©
terrestrial species
115
C!y
epidemioiogical/human
biomonitoping study
consumeuj§es and/or
pro^cts
dietary
©
unclear
©
Supplemental
65
Exclude
0
foreign language
Figure 2-5. Peer-reviewed Literature - Exposure Search Results for Di-isobutyl Phthalate
Click here for interactive HAWC Diagram.
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Human
Retrieved for Full-text
Review
13
Animal
TSCA Hazard DIBP (2020)
3932
Exclusion
®
Plant
Supplemental Material
Figure 2-6. Peer-reviewed Literature - Hazard Search Results for Di-isobutyl Phthalate
Click here for interactive HAWC Diagram.
2.1.3 Search of TSCA Submissions
Table 2-1 presents the results of screening the titles of data sources and reports submitted to EPA
under criteria specific to individual disciplines (see Table 2-1 for the list of disciplines). The
details about the criteria are not part of this document but will be provided in a supplemental document
that EPA anticipates releasing prior to the finalization of the scope document. EPA identified eleven
submissions that met the inclusion criteria in these statements and identified zero submissions with
supplemental data. EPA excluded two submissions because the reports were identified as one of the
following:
• Record of telephone communication
• Letter with no data
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EPA plans to conduct additional deduplication at later stages of the systematic review process (e.g., full
text screening), when more information regarding the reports is available.
Table 2-1. Results of Title Screening of Submissions to EPA under Various Sections of TSCA
Discipline
Included
Supplemental
P-Chem Properties
0
0
Environmental Fate and Transport
0
0
Environmental and General Population Exposure
1
0
Occupational Exposure/Release Information
1
0
Environmental Hazard
1
0
Human Health Hazard
8
0
2.2 Conditions of Use
As described in the Proposed Designation of Di-isobutyl Phthalate (DIBP) (CASRN 84-69-5) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019b), EPA assembled information from the CDR
program to determine conditions of use3 or significant changes in conditions of use of the chemical
substance. EPA also consulted a variety of other sources to identify uses of di-isobutyl phthalate,
including published literature, company websites, and government and commercial trade databases and
publications. To identify formulated products containing di-isobutyl phthalate, EPA searched for safety
data sheets (SDS) using internet searches, EPA Chemical and Product Categories (CPCat) data, and
other resources in which SDSs could be found. SDSs were cross-checked with company websites to
make sure that each product SDS was current. In addition, EPA incorporated communications with
companies, industry groups, and public comments to supplement the use information.
EPA identified and described the categories and subcategories of conditions of use that will be included
in the scope of the risk evaluation (Section 2.2.1; Table 2-2). The conditions of use included in the scope
are those reflected in the life cycle diagrams and conceptual models.
After gathering the conditions of use, EPA identified those categories or subcategories of use activities
for di-isobutyl phthalate the Agency determined not to be conditions of use or will otherwise be
excluded during scoping. These categories and subcategories are described in Section 2.2.2.
2.2.1 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
Table 2-2 lists the conditions of use that are included in the scope of the risk evaluation.
3 Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is
intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of (15
U.S.C. § 2602(4)).
20
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Table 2-2. Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.il'e Cycle Stage
Category
Subcategory
References
Manufacturing
Domestic Manufacturing
Domestic Manufacturing
U.S. LP A (2019a)
Import
Import
U.S. EPA (2019a)
Processing
Incorporation into article
Plasticizers in:
-Construction; plastic
product manufacturing;
transportation equipment
manufacturing
U.S. EPA (2019a)
Processing -
incorporation into
formulation, mixture, or
reaction product
Plasticizers in:
- Adhesive
manufacturing; Plastic
product manufacturing
U.S. EPA (2019a)
Solvents (which become
part of product
formulations or mixture)
- Plastic material and
resin manufacturing
-Paints and Coatings
-Viscosity Adjusters
U.S. EPA (2019a)
CPSC (2015); Lanxess
Corporation (2015)
CPSC (2015)
Fuels and Related
Products (e.g., Fuel
additives)
CPSC (2015); Lanxess
Corporation (2015)
Processing aids, not
otherwise listed
Lanxess Corporation (2015)
Inks, Toner, and
Colorant Products (e.g.,
Toner/ printer cartridge)
CPSC (2015); Lanxess
Corporation (2015)
Repackaging (e.g.,
laboratory chemicals
EP A-HO-OPPT-2018-
0504-0019
Paper Products
CPSC (2015)
21
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l.il'e ( vole Shigo
CsiU'gorv
SuhcsiU'gorv
UcfciTIK'OS
Plastic and rubber
products not covered
elsewhere
Lanxess Corporation
C2015^; EPA-HO-OPPT-
2018-0434-0014
Fabric, textile, and
leather products not
covered elsewhere
Dow Chemical Companv
(2013"); CPSC C2015^
Recycling
Recycling
EP A-HO-OPPT-2018-
0434-0014
Distribution in
commerce
Distribution in
commerce
Industrial
Paints and Coatings
Paints and Coatings
CPSC C2015^; Lanxess
Corporation (2015)
Fuels and Related
Products
Fuels and Related
Products
(U.S. CPSC. 2015);
Lanxess Corporation (2015)
Plastic and rubber
products not covered
elsewhere
Plastic and rubber
products not covered
elsewhere
EP A-HO-OPPT-2018-
0434-0014
Adhesives and sealants
Adhesives and sealants
-Two-component glues
and adhesives
— Transportation
equipment
manufacturing
Azon USA Inc. (2015)
Glue 360 Inc. (2018)
EP A-HO-OPPT-2018-
0434-0007; EPA-HO-
OPPT-2019-0434-0015
Fabric, textile, and
leather products not
covered elsewhere
Fabric, textile, and
leather products not
covered elsewhere (e.g.,
Textile (fabric) dyes)
Dow Chemical Company
(2013); CPSC (2015)
Inks, Toner, and
Colorant Products
Inks, Toner, and
Colorant Products (e.g.,
Toner/printer cartridge)
CPSC (2015); Lanxess
Corporation (2015)
22
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l.il'e ( vole Shigo
CsiU'gorv
SuhcsiU'gorv
UcfciTIK'OS
Building/construction
materials not covered
elsewhere
Building/construction
materials not covered
elsewhere
CPSC (2015); Lanxess
Corporation (2015)
Floor coverings
Floor coverings
EP A-HO-OPPT-2018-
0434-0014; CPSC (2015)
Food packaging material
Food packaging material
CPSC (2015)
Paper Products
Paper Products
CPSC (2015)
Commercial
Adhesives and sealants
-Adhesives and sealants
-Two-component glues
and adhesives
U.S. EPA (2019a)
Glue 360 Inc. (2018)
Catalyst solvent
Catalyst solvent
U.S. EPA (2019a)
Paints and Coatings
Paints and Coatings
CPSC (2015); Lanxess
Corporation (2015)
Plastic and rubber
products not covered
elsewhere
Plastic and rubber
products not covered
elsewhere
U.S. EPA (2019a); Lanxess
Corporation (2015); EPA-
HO-OPPT-2018-0434-0014
Inks, Toner, and
Colorant Products
Inks, Toner, and
Colorant Products (e.g.,
Toner/printer cartridge)
CPSC (2015); Lanxess
Corporation (2015)
Laboratory chemicals
Laboratory chemicals
Sigma-Aldrich Inc. (2020)
Furnishing, Cleaning,
Treatment/Care Products
Furnishing, Cleaning,
Treatment/Care Products
(eg-,
Laundry and
dishwashing products)
CPSC (2015)
Explosive Materials
Explosive Materials
CPSC (2015)
Air Care Products
Air Care Products (e.g.,
Air Freshener)
CPSC (2015)
Floor coverings
Floor coverings
EP A-HO-OPPT-2018-
0434-0014); CPSC (2015)
Lubricants
Lubricants
CPSC (2015)
23
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l.il'e ( vole Shigo
CsiU'gorv
SuhcsiU'gorv
UcfciTIK'OS
Food packaging material
Food packaging material
CPSC (2015")
Consumer
Air Care Products
Air Care Products (e.g.,
Air Freshener)
CPSC (2015")
Floor coverings
Floor coverings
EP A-HO-OPPT-2018-
0434-0014"); CPSC (2015")
Toys, playground, and
sporting equipment
Toys, playground, and
sporting equipment
EP A-HO-OPPT-2018-
0434-0014"); CPSC (2015")
Paints and Coatings
Paints and Coatings
CPSC (2015"); Lanxess
Corporation (2015)
Fabric, textile, and
leather products not
covered elsewhere
Fabric, textile, and
leather products not
covered elsewhere (e.g.,
Textile (fabric) dyes)
Dow Chemical Company
(2013")
Inks, Toner, and
Colorant Products
Inks, Toner, and
Colorant Products (e.g.,
Toner/printer cartridge)
CPSC (2015"); Lanxess
Corporation (2015)
Furnishing, Cleaning,
Treatment/Care Products
Furnishing, Cleaning,
Treatment/Care Products
(eg-,
Laundry and
dishwashing products)
CPSC (2015)
Plastic and rubber
products not covered
elsewhere
Plastic and rubber
products not covered
elsewhere
Lanxess Corporation
(2015); EPA-HO-OPPT-
2018-0434-0014
Paper Products
Paper Products
CPSC (2015)
Adhesives and sealants
Adhesives and sealants
U.S. EPA (2019a); ITW
Performance Polymers
(2015)
Disposal
Disposal
Disposal
Life Cycle Stage Use Definitions
- "Industrial use" means use at a site at which one or more chemicals or mixtures are manufactured
(including imported) or processed.
- "Commercial use" means the use of a chemical or a mixture containing a chemical (including as part of
an article) in a commercial enterprise providing saleable goods or services.
24
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l.il'e Cycle Slage
Category
Subcategory
References
- "Consumer use" means the use of a chemica
article, such as furniture or clothing) when sc
or a mixture containing a chemical (including as part of an
>ld to or made available to consumers for their use.
2.2.2 Activities Excluded from the Scope of the Risk Evaluation
As explained in the final rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act, TSCA Section 6(b)(4)(D) requires EPA to identify the hazards, exposures,
conditions of use, and the PESS the Administrator expects to consider in a risk evaluation, suggesting
that EPA may exclude certain activities that it determines to be conditions of use on a case-by-case
basis (82 FR 33726, 33729; July 20, 2017). As a result, EPA plans not to include in this scope or in the
risk evaluation the activities described below that the Agency has concluded do not constitute conditions
of use.
The U.S. Consumer Product Safety Commission lists use of Di-isobutyl phthalate in perfume, nail polish
and dentistry settings (U.S. CPSC. 2015). but these activities and releases associated with consumer uses
are not TSCA conditions of use and will not be evaluated during the risk evaluation. Perfume, nail
polish and dentistry settings uses are covered by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
321 and are therefore outside the scope of the definition of chemical substance4 as regulated by TSCA.
However, processing and industrial uses of these products are covered by TSCA and will be considered
a condition of use.
2.2.3 Production Volume
Production volume of di-isobutyl phthalate in 2011, as reported to EPA during the 2012 CDR reporting
period, was up to 500,000 pounds (U.S. EPA, 2017). Production volume reported to EPA during the
2016 CDR reporting period is CBI. EPA also uses pre-2011 CDR production volume information, as
detailed in the Proposed Designation of Di-isobutyl Phthalate (DIBP) (CASRN 84-69-5) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019b) and will include future production volume
information as it becomes available to support the exposure assessment.
2.2.4 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-8 depicts the conditions of use that are considered within
the scope of the risk evaluation for the various life cycle stages as presented in Section 2.2.1. This
4 Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination
of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or
uncombined radical. Chemical substance does not include (1) any mixture; (2) any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a
pesticide; (3) tobacco or any tobacco product; (4) any source material, special nuclear material, or byproduct material (as
such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act); (5) any article the sale of
which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954 (determined without regard to any
exemptions from such tax provided by section 4182 or 4221 or any other provision of such Code), and; (6) any food, food
additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act)
when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.
25
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section provides a brief overview of the industrial, commercial and consumer use categories included in
the life cycle diagram, which does not include the activities that EPA determined are out of scope. 0
contains more detailed descriptions (e.g., process descriptions, worker activities, process flow diagrams)
for each manufacture, processing, distribution in commerce, use and disposal category.
The information in the life cycle diagram is grouped according to the CDR processing codes and use
categories (including functional use codes for industrial uses and product categories for industrial,
commercial and consumer uses). The production volume of di-isobutyl phthalate in 2011 is included in
the lifecycle diagram, as reported to EPA during the 2016 CDR reporting period, as a range between 1
and 500,000 pounds (U.S. EPA. 2017) to protect production volumes that were claimed as CBI.
26
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MFG/IMPORT
Manufacture
(Including Import)
PROCESSING
K>
Incorporation into Formulation, Mixture, or Reaction
Product
(Plastici/.ers in: Adhesive manufacturing; Plastic product
manufacturing
Solvents (that become part of the formulation or mixture)
in: Plastic material and resin manufacturing: Paints and
coatings manufacturing: Viscosity adjusters
Additive in: Fuels and related products: Processing aids,
not otherwise listed: Inks, toner, and colorant products:
Laboratory chemicals: Paper products: Plastic and rubber
products not covered elsewhere: Fabric, textile, and leather
products not covered elsewhere)
Incorporation into Article
(Plastici/ers in: Construction; Plastics product
manufacturing: Transportation equipment manufacturing)
Repackaging
Recycling
-K>
INDUSTRIAL, COMMERCIAL, CONSUMER USES R ELEASES AND WASTE DISPOSAL
-K>
Adhesives and sealants 1,2
Building/construction materials not covered elsewhere 1
Fabric,textile,and leather products not covered elsewhere 1,2
Floor coverings 1,2
Ink, toner, and colorant products 1,2
Paints and coatings 1,2
Plastic and rubber products not covered elsewhere 1,2
Miscellaneous uses 1,2
e.g.. Fuels and related producLs; Paper Products; Catalyst Solvent;
Laboratory chemicals; Furnishing care products; Explosive materials; Air
carc products; Lubricants; Toys, playground, and sporting equipment...
Disposal
See Conceptual Model for
Environmental Releases and
Wastes
Manufacture
(including import)
Processing
Uses
1. Industrial and/or Commercial
2. Consumer
Figure 2-7. Di-isobutyl Phthalate Life Cycle Diagram
Volume is not depicted in the life cycle diagram for processing and industrial, commercial, and consumer uses as specific production volume is claimed as CBI or
withheld pursuant to TSCA Section § 14.
27
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2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze exposures and releases to the environment
resulting from the conditions of use within the scope of the risk evaluation for di-isobutyl phthalate.
Release pathways and routes will be described to characterize the relationship or connection between the
conditions of use of the chemical and the exposure to human receptors, including PESS, and
environmental receptors. EPA plans to consider, where relevant, the duration, intensity (concentration),
frequency, and number of exposures in characterizing exposures to di-isobutyl phthalate.
2.3.1 Physical and Chemical Properties
Consideration of p-chem properties are essential for a thorough understanding or prediction of
environmental fate (i.e., transport and transformation) and the eventual environmental concentrations.
They can also inform the hazard assessment. EPA plans to use the physical and chemical properties
described in the Proposed Designation of Di-isobutyl Phthalate (DIBP) (CASRN 84-69-5) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019b) to support the development of the risk
evaluation for di-isobutyl phthalate. The values for the physical and chemical properties (Appendix B)
may be updated as EPA collects additional information through systematic review methods.
2.3.2 Environmental Fate and Transport
Understanding of environmental fate and transport processes assists in the determination of the specific
exposure pathways and potential human and environmental receptors that need to be assessed in the risk
evaluation for di-isobutyl phthalate. EPA plans to use the environmental fate characteristics described in
the Proposed Designation of Di-isobutyl Phthalate (DIBP) (CASRN 84-69-5) as a High-Priority
Substance for Risk Evaluation (U.S. EPA, 2019b) to support the development of the risk evaluation for
di-isobutyl phthalate. The values for the environmental fate properties (Appendix C) may be updated as
EPA collects additional information through systematic review methods.
2.3.3 Releases to the Environment
Releases to the environment from conditions of use (e.g., manufacturing, industrial, and commercial
processes, commercial or consumer uses resulting in down-the-drain releases) are a component of
potential exposure and may be derived from reported data that are obtained through direct measurement,
calculations based on empirical data or assumptions and models.
Di-isobutyl phthalate is not reported to the Toxics Release Inventory (TRI). There may be releases of di-
isobutyl phthalate from industrial sites to wastewater treatment plants (WWTP), surface water, air and
landfill. Articles that contain di-isobutyl phthalate may release di-isobutyl phthalate to the environment
during use or through recycling and disposal.
2.3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of di-isobutyl phthalate can result in
releases to the environment and exposure to aquatic and terrestrial receptors (biota). Environmental
exposures to biota are informed by releases into the environment, overall persistence, degradation, and
bioaccumulation, and partitioning across different media. Concentrations of chemical substances in biota
provide evidence of exposure. EPA plans to review reasonably available environmental exposure data in
biota in the risk evaluation.
28
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There is some evidence of environmental concentration data present based on preliminary review of
reasonably available data (MDI (2002). Relevant and reliable monitoring studies provide information
that can be used in an exposure assessment. Monitoring studies that measure environmental
concentrations or concentrations of chemical substances in biota provide evidence of exposure. EPA
plans to review reasonably available information on environmental exposures in biota to inform the
development of the environmental exposure assessment for di-isobutyl phthalate.
2.3.5 Occupational Exposures
EPA plans to analyze worker activities where there is a potential for exposure under the various
conditions of use (manufacturing, processing, and industrial/commercial uses) described in Section 2.2.
In addition, EPA plans to analyze exposure to ONU's, workers who do not directly handle the chemical
but perform work in an area where the chemical is present. EPA also expects to consider the effect(s)
that engineering controls (EC) and/or personal protective equipment (PPE) have on occupational
exposure levels as part of the draft risk evaluation.
Worker activities associated with these conditions of use that will be analyzed include, but are not
limited to:
• Unloading and transferring di-isobutyl phthalate to and from storage containers to process
vessels;
• Handling, transporting and disposing of waste containing di-isobutyl phthalate;
• Cleaning and maintaining equipment;
• Sampling chemicals, formulations or products containing di-isobutyl phthalate for quality
control;
• Repackaging chemicals, formulations or products containing di-isobutyl phthalate;
Di-isobutyl phthalate is a liquid at room temperature and has a vapor pressure of 4.76x 10"5 mm Hg at
25 °C (NLM 2013) and inhalation exposure to vapor is expected to be low when working with di-
isobutyl phthalate at room temperature. However, EPA plans to analyze inhalation exposure in
occupational scenarios where di-isobutyl phthalate is applied via spray or roll application methods or is
handled as a dry powder or at elevated temperatures. Occupational exposure limits have not been
established for di-isobutyl phthalate by the Occupational Safety and Health Administration (OSHA), the
National Institute for Occupational Safety and Health (NIOSH), or the American Conference of
Governmental Industrial Hygienists (ACGIH).
Based on the conditions of use, EPA plans to analyze worker exposure to liquids and/or solids via the
dermal route. EPA does not plan to analyze dermal exposure for ONUs that do not directly handle di-
isobutyl phthalate.
EPA generally does not evaluate occupational exposures through the oral route. Workers may
inadvertently transfer chemicals from their hands to their mouths or ingest inhaled particles that deposit
in the upper respiratory tract. The frequency and significance of this exposure route are dependent on
several factors including the p-chem properties of the substance during expected worker activities,
workers' awareness of the chemical hazards, the visibility of the chemicals on the hands while working,
workplace practices, and personal hygiene that is difficult to predict (Cherrie et al., 2006). However,
EPA will consider oral exposure on a case-by-case basis for certain COUs and for worker activities
29
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where there is information and data on incidental ingestion of inhaled dust. EPA will consider ingestion
of inhaled dust as an inhalation exposure for di-isobutyl phthalate.
2.3.6 Consumer Exposures
CDR reporting and conversations with industry indicate the presence of di-isobutyl phthalate in a
number of consumer products and articles including: adhesives and sealants; air care products; cleaning
and furnishing care products; fabric, textile, and leather products not covered elsewhere; floor coverings;
ink, toner, and colorant products; paints and coatings; paper products; plastic and rubber products not
covered elsewhere; and toys, playground, and sporting equipment (See Section 2.6.2 and Figure 2-8).
These uses can result in exposures to consumers and bystanders (non-product users that are incidentally
exposed to the product).
Based on reasonably available information on consumer conditions of use, inhalation of di-isobutyl
phthalate is possible through either inhalation of vapor/mist during product usage or indoor air/dust.
Oral exposure of di-isobutyl phthalate is possible through either ingestion through product use via
transfer from hand to mouth or via through mouthing of articles containing di-isobutyl phthalate. Dermal
exposure may occur via contact with vapor or mist deposition onto the skin, via direct liquid contact
during use, or direct dermal contact of articles containing di-isobutyl phthalate. Based on these potential
sources and pathways of exposure, EPA plans to analyze oral, dermal and inhalation exposures to
consumers and inhalation exposures to bystanders that may result from the conditions of use of di-
isobutyl phthalate.
2.3.7 General Population Exposures
Releases of di-isobutyl phthalate from certain conditions of use, such as manufacturing, processing, or
disposal activities, may result in general population exposures via drinking water ingestion, dermal
contact, and inhalation from air releases (CPSC 2010b). Available assessments reviewed indicate that
diet has been reported the primary source of exposure to di-isobutyl phthalate with indoor air also
contributing to total di-isobutyl phthalate exposure (CPSC 2014). There is some evidence of
environmental concentration data present based on preliminary review of reasonably available data
(I 002)). EPA plans to review the reasonably available information for the presence of di-isobutyl
phthalate in environmental media relevant to general population exposure.
Available assessments reviewed indicate that diet has been reported the primary source of exposure to
di-isobutyl phthalate with indoor air also contributing to total di-isobutyl phthalate exposure (CPSC
2014). In the United States, urinary di-isobutyl phthalate levels have increased over the past four
National Health and Nutrition Examination Survey (NHANES) surveys (2001-2002; 2003-2004; 2005-
2006; 2007-2008) in all age groups, genders, and races, and in total (CPSC 2014).
The presence in environmental media and biomonitoring data suggest that general population exposures
are occuring. EPA plans to review reasonably available data related to general population exposures in
the risk evaluation.
30
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2.4 Hazards (Effects)
2.4.1 Environmental Hazards
As described in the Proposed Designation of Di-isobutyl Phthalate (DIBP) (CASRN 84-69-5) as a High-
Priority Substance for Risk Evaluation (TJ. S. EPA, 2019b), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential environmental hazards
for di-isobutyl phthalate. EPA considers all the potential environmental hazards for di-isobutyl phthalate
identified during prioritization (U.S. EPA 2019b) to be relevant for the risk evaluation and thus they
remain within the scope of the evaluation. EPA is in the process of identifying additional reasonably
available information through systematic review methods and public comments, which may update the
list of potential environmental hazards associated with di-isobutyl phthalate. If necessary, EPA plans to
update the list of potential hazards in the final scope document of di-isobutyl phthalate. Based on
information identified during prioritization, environmental hazard effects were identified for aquatic and
terrestrial organisms.
2.4.2 Human Health Hazards
As described in the Proposed Designation of Di-isobutyl Phthalate (DIBP) (CASRN 84-69-5) as a High-
Priority Substance for Risk Evaluation (U.S. EPA, 2019b), EPA considered reasonably available
information from peer-reviewed assessments and databases to identify potential human health hazards
for di-isobutyl phthalate. EPA plans to evaluate all the potential human health hazards for di-isobutyl
phthalate identified during prioritization. The health effect categories screened for during prioritization
included acute toxicity, irritation/corrosion, dermal sensitization, respiratory sensitization, genetic
toxicity, repeated dose toxicity, reproductive toxicity, developmental toxicity, immunotoxicity,
neurotoxicity, carcinogenicity, epidemiological or biomonitoring studies and ADME (absorption,
distribution, metabolism, and excretion).
The broad health effect categories included for further evaluation from designation are developmental
and reproductive effects. EPA is in the process of identifying additional reasonably available
information through systematic review methods and public input, which may update the list of potential
human health hazards under the scope of the risk evaluation. If necessary, EPA plans to update the list of
potential hazards in the final scope document of the di-isobutyl phthalate risk evaluation.
2.5 Potentially Exposed or Susceptible Subpopulations
TSCA § 6(b)(4) requires EPA to determine whether a chemical substance presents an unreasonable risk
to "a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation."
TSCA §3(12) states that "the term 'potentially exposed or susceptible subpopulation', or PESS, means a
group of individuals within the general population identified by the Administrator who, due to either
greater susceptibility or greater exposure, may be at greater risk than the general population for adverse
health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant
women, workers, or the elderly." General population is "the total of individuals inhabiting an area or
making up a whole group" and refers here to the U.S. general population (U.S. EPA. 2011).
During the Prioritization process, EPA identified the PESS based on CDR information and studies
reporting developmental and reproductive effects: children, women of reproductive age (e.g., pregnant
women), workers, and consumers (U.S. EPA 2019a). EPA plans to evaluate these PESS in the risk
evaluation.
31
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In developing exposure scenarios, EPA plans to analyze reasonably available data to ascertain whether
some human receptor groups may be exposed via exposure pathways that may be distinct to a particular
subpopulation or life stage (e.g., children's crawling, mouthing or hand-to-mouth behaviors) and
whether some human receptor groups may have higher exposure via identified pathways of exposure
due to unique characteristics (e.g., activities, duration or location of exposure) when compared with the
general population (U.S. EPA. 2006a). Likewise, EPA plans to evaluate reasonably available human
health hazard information to ascertain whether some human receptor groups may have greater
susceptibility than the general population to the chemical's hazard(s).
2.6 Conceptual Models
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of di-isobutyl phthalate. Pathways
and routes of exposure associated with workers and ONUs are described in Section 2.6.1, and pathways
and routes of exposure associated with consumers are described in Section 2.6.2. Pathways and routes of
exposure associated with environmental releases and wastes are discussed and depicted the conceptual
model shown in Section 2.6.3.
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses
Figure 2-8 illustrates the conceptual model for the pathways of exposure from industrial and commercial
activities and uses of di-isobutyl phthalate that EPA plans to include in the risk evaluation. There is
potential for exposures to workers and/or ONU's via inhalation routes and exposures to workers via
dermal routes. EPA plans to evaluate activities resulting in exposures associated with distribution in
commerce (e.g., loading, unloading) throughout the various lifecycle stages and conditions of use (e.g.,
manufacturing, processing, industrial use, commercial use, and disposal) rather than a single distribution
scenario. For each condition of use identified in Table 2-2, an initial determination was made as to
whether or not each unique combination of exposure pathway, route, and receptor will be analyzed in
the risk evaluation. The supporting rationale is presented in Appendix F.
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INDtSTR^AJTOi «>m\ii RCIAL EXPOSURE PATHWAY EXPOSURE ROUTE RECEPTORS HAZARDS
Workers
Dermal
Liquid Solid Contact
Processing
-Incorporation into formulation, mixture, or
reaction product
-Incorporation into article
-Repackaging
Adhesive* and sealants
Building/construction materials not
covered elsewhere
Fugitive Emissions
Fabric, textile, and leather products
not covered elsewhere
Inks, toner, and colorant products
Paints and coating;
Plastic and rubber products not
covered elsewhere
Miscellaneous uses
Figure 2-8. Di-isobutyl Phthalate Conceptual Model for Industrial and Commercial Activities and Uses: Worker and Occupational
Non-User Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human receptors from industrial and commercial activities and uses
of di-isobutyl phthalate.
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2.6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-9 presents the exposure pathways, exposure routes and hazards to
human receptors from consumer activities and uses of di-isobutyl phthalate. EPA expects that consumers
may be exposed through product use or articles containing di-isobutyl phthalate through oral, dermal,
and inhalation routes. During use of articles, EPA expects that consumers may also be exposed via direct
dermal contact or mouthing. Bystanders are expected to be exposed through product use via inhalation.
It should be noted that some consumers may purchase and use products primarily intended for
commercial use. EPA plans to analyze pathways and routes of exposure that may occur during the
varied identified consumer activities and uses. The supporting rationale for consumer pathways
considered for di-isobutyl phthalate are included in Appendix G.
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CONSUMER ACTIVITIES £
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Figure 2-9. Di-isobutyl Phthalate Conceptual Model for Consumer Activities and Uses: Consumer Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes, and hazards to human receptors from consumer activities and uses of di-isobutyl
phthlate.
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2.6.3 Conceptual Model for Environmental Releases and Wastes: Potential
Exposures and Hazards
Figure 2-10 presents the potential exposure pathways, exposure routes and hazards to human and
environmental receptors from releases and waste streams associated with industrial, commercial and
consumer uses of di-isobutyl phthalate. EPA plans to evaluate exposures to receptors (e.g., general
population, aquatic, terrestrial species) that may occur from industrial and/or commercial and consumer
releases to air, water or land, including biosolids and soil, and other conditions of use. EPA expects
humans to be exposed to di-isobutyl phthalate from air emissions via inhalation as well as from water,
liquid, and solid waste releases; orally via drinking water, fish and soil ingestion; and dermally from
contact with groundwater and soil. The supporting rationale for general population and environmental
pathways considered for di-isobutyl phthalate are included in Appendix H.
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RELEASES AND WASTES FROM l\I)t STRIAL /
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Figure 2-10. Di-isobutyl Phthalate Conceptual Model for Environmental Releases and Wastes: Environmental and General
Population Exposures and Hazards.
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and wastes from industrial,
commercial and consumer uses of Di-isobutyl Phthalate that EPA plans to consider in the risk evaluation.
a) Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to Publicly Owned
Treatment Works (POTW) (indirect discharge). For consumer uses, such wastes may be released directly to POTW. Drinking water will undergo further
treatment in drinking water treatment plant. Ground water may also be a source of drinking water. Inhalation from drinking water may occur via showering.
b) Receptors include PESS (see Section 2.5).
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2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of di-isobutyl phthalate to date which includes a partial, but
not complete review of identified information as described in Section 2.1. EPA encourages submission of
additional data, such as full study reports or workplace monitoring from industry sources, that may be
relevant for EPA's evaluation of conditions of use, exposures, hazards and PESS during risk evaluation.
Further, EPA may consider any relevant CBI in a manner that protects the confidentiality of the information
from public disclosure. EPA plans to continue to consider new information submitted by the public. Should
additional data or approaches become reasonably available, EPA may update its analysis plan in the final
scope document.
2.7.1 Physical and Chemical Properties and Environmental Fate
EPA plans to analyze the p-chem properties and environmental fate and transport of di-isobutyl phthalate as
follows:
1) Review reasonably available measured or estimated p-chem and environmental fate endpoint
data collected using systematic review procedures and, where reasonably available,
environmental assessments conducted by other regulatory agencies. EPA plans to review data
and information collected through the systematic review methods and public comments about the p-
chem properties (Appendix B) and fate endpoints (Appendix C), some of which appeared in the
Substance for Risk Evaluation (U.S. EPA, 2019b). All sources cited in EPA's analysis will be
evaluated according to the procedures described in the systematic review documentation that EPA
plans to publish prior to finalizing the scope document. Where the systematic review process fails to
identify experimentally measured chemical property values of sufficiently high quality, these values
will be estimated using chemical parameter estimation models as appropriate. Model-estimated fate
properties will be reviewed for applicability and quality.
2) Using measured data and/or modeling, determine the influence of p-chem properties and
environmental fate endpoints (e.g., persistence, bioaccumulation, partitioning, transport) on
exposure pathways and routes of exposure to human and environmental receptors. Measured
data and, where necessary, model predictions of p-chem properties and environmental fate endpoints
will be used to characterize the persistence and movement of di-isobutyl phthalate within and across
environmental media. The fate endpoints of interest include volatilization, sorption to organic matter
in soil and sediments, water solubility, aqueous and atmospheric photolysis rates, aerobic and
anaerobic biodegradation rates, and potential bioconcentration and bioaccumulation. These
endpoints will be used in exposure calculations.
3) Conduct a weight of the scientific evidence evaluation of p-chem and environmental fate data,
including qualitative and quantitative sources of information. During risk evaluation, EPA plans
to evaluate and integrate the p-chem and environmental fate evidence identified in the literature
inventory using the methods described in the systematic review documentation that EPA plans to
publish prior to finalizing the scope document.
2.7.2 Exposure
EPA plans to analyze exposure levels for indoor air, surface water, drinking water, sediment, soil, aquatic
biota, and terrestrial biota associated with exposure to di-isobutyl phthalate. EPA has not yet determined the
exposure levels in these media or how they may be used in the risk evaluation. Exposure scenarios are
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sources (uses), exposure pathways, and exposed receptors. EPA plans to analyze scenario-specific
exposures. Based on their p-chem properties, expected sources, and transport and transformation within the
outdoor and indoor environment, chemical substances are more likely to be present in some media and less
likely to be present in others. Exposure level(s) can be characterized through a combination of reasonably
available monitoring data and modeling approaches.
2.7.2.1 Environmental Releases
EPA plans to analyze releases to environmental media as follows:
1) Review reasonably available published literature and other reasonably available information
on processes and activities associated with the conditions of use to analyze the types of releases
and wastes generated. EPA has reviewed some key data sources containing information on
processes and activities resulting in releases, and the information found is described in Appendix D.
EPA plans to continue to review data sources during risk evaluation using the evaluation strategy in
the systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Potential sources of environmental release data are summarized in Table 2-3 below:
Table 2-3. Categories and Sources of Environmental Release Data
U.S. EPA Generic Scenarios
OECD Emission Scenario Documents
2) Review reasonably available chemical-specific release data, including measured or estimated
release data (e.g., data from risk assessments by other environmental agencies). EPA plans to
match identified data to applicable conditions of use and identify data gaps where no data are found
for particular conditions of use. EPA plans to attempt to address data gaps identified as described in
steps 3 and 4 below by considering potential surrogate data and models.
Additionally, for conditions of use where no measured data on releases are reasonably available,
EPA may use a variety of methods including release estimation approaches and assumptions in the
Chemical Screening Tool for Occupational Exposures and Releases ChemSTEER (U.S. EPA.
2013).
3) Review reasonably available measured or estimated release data for surrogate chemicals that
have similar uses and physical properties. If surrogate data are identified, these data will be
matched with applicable conditions of use for potentially filling data gaps. Measured or estimated
release data for other phthalate esters may be considered as surrogates for di-isobutyl phthalate.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. This item will be performed after completion
of #2 and #3 above. EPA plans to evaluate relevant data to determine whether the data can be used
to develop, adapt or apply models for specific conditions of use (and corresponding release
scenarios). EPA has identified information from various EPA statutes (including, for example,
regulatory limits, reporting thresholds or disposal requirements) that may be relevant to release
estimation. EPA plans to consider relevant regulatory requirements in estimating releases during
risk evaluation.
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5) Review and determine applicability of OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios to estimation of environmental releases. EPA has identified potentially
relevant OECD Emission Scenario Documents (ESDs) and EPA Generic Scenarios (GS) that
correspond to some conditions of use; for example, the 2009 ESP on Adhesive Formulation, the
2011 ESP on Coating Application via Spray-Painting in the Automotive Refinishing Industry, the
2011 ESP on Chemical Industry, the 2011 ESP on Radiation Curable Coating. Inks and Adhesives.
the 2015 ESP on the Use of Adhesives. and the 2009 ESP on Plastic Additives may be useful to
assess potential releases. EPA plans to critically review these generic scenarios and ESPs to
determine their applicability to the conditions of use.
EPA Generic Scenarios are available at the following: https://www.epa.gov/tsca-screening-
tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases#genericscenarios
OECP Emission Scenario Pocuments are available at the following:
http://www.oecd.org/chemicalsafetv/risk-assessment/emissionscenariodocuments.htm
EPA may also need to perform targeted research for applicable models and associated parameters
that EPA may use to estimate releases for certain conditions of use. If ESPs and GSs are not
available, other methods may be considered. Additionally, for conditions of use where no measured
data on releases are available, EPA may use a variety of methods including the application of
default assumptions such as standard loss fractions associated with drum cleaning (3%) or single
process vessel cleanout (1%).
6) Map or group each condition of use to a release assessment scenario(s). EPA has identified
release scenarios and mapped (i.e., grouped) them to relevant conditions of use as shown in
Appendix F. EPA may refine the mapping of release scenarios based on factors (e.g., process
equipment and handling, magnitude of production volume used, and release sources and usage rates
of di-isobutyl phthalate and articles and formulations containing di-isobutyl phthalate, or
professional judgment) corresponding to conditions of use as additional information is identified
during risk evaluation.
7) Evaluate the weight of the scientific evidence of environmental release data. Puring risk
evaluation, EPA plans to evaluate and integrate the exposure evidence identified in the literature
inventory using the methods described in the systematic review documentation that EPA plans to
publish prior to finalizing the scope document. The data integration strategy will be designed to be fit-
for-purpose in which EPA plans to use systematic review methods to assemble the relevant data,
evaluate the data for quality and relevance, including strengths and limitations, followed by synthesis
and integration of the evidence.
2.7.2.2 Environmental Exposures
EPA plans to analyze the following in developing its environmental exposure assessment of di-isobutyl
phthalate:
1) Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure. For di-isobutyl phthalate, environmental media which will be
analyzed are sediment, soil, and water.
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2) Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with reasonably available monitoring
data.
Reasonably available environmental exposure models that meet the TSCA Science Standards and
that estimate water, sediment, and soil concentrations will be analyzed and considered alongside
reasonably available water, sediment, and soil monitoring data to characterize environmental
exposures. Modeling approaches to estimate surface water concentrations, sediment concentrations
and soil concentrations generally will include the following inputs: direct release into air,
groundwater, surface water, sediment, or soil, indirect release into air, groundwater, surface water,
sediment, or soil (i.e., air deposition), fate and transport (partitioning within media) and
characteristics of the environment (e.g., river flow, volume of lake, meteorological data).
3) Determine applicability of existing additional contextualizing information for any monitored
data or modeled estimates during risk evaluation. Any studies which relate levels of di-isobutyl
phthalate in the environment or biota with specific sources or groups of sources will be evaluated.
4) Group each condition(s) of use to environmental assessment scenario(s). Refine and finalize
exposure scenarios for environmental receptors by considering combinations of sources (use
descriptors), exposure pathways including routes, and populations exposed. For di-isobutyl
phthalate, the following are noteworthy considerations in constructing exposure scenarios for
environmental receptors:
Estimates of surface water concentrations, sediment concentrations and soil
concentrations near industrial point sources based on reasonably available monitoring
data.
Modeling inputs for release into the media of interest, fate and transport and
characteristics of the environment.
Reasonably available biomonitoring data. Monitoring data could be used to compare
with species or taxa-specific toxicological benchmarks.
Applicability of existing additional contextualizing information for any monitored data
or modeled estimates during risk evaluation. Review and characterize the spatial and
temporal variability, to the extent that data are reasonably available, and characterize
exposed aquatic and terrestrial populations.
Weight of the scientific evidence of environmental occurrence data and modeled
estimates.
5) Evaluate the weight of the scientific evidence of environmental occurrence data and modeled
estimates. During risk evaluation, EPA plans to evaluate and integrate the exposure evidence
identified in the literature inventory using the methods described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
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2.7.2.3 Occupational Exposures
EPA plans to analyze both worker and ONU exposures as follows:
1) Review reasonably available exposure monitoring data for specific condition(s) of use. EPA
plans to review exposure monitoring data found in published literature (including both personal
exposure monitoring data (direct exposures) and area monitoring data (indirect exposures)). EPA
has reviewed reasonably available monitoring data collected by OSHA and NIOSH and neither
collected data for di-isobutyl phthalate exposures. The most recent submissions to CDR for di-
isobutyl phthalate will be used to identify manufacturing and processing information for di-isobutyl
phthalate where occupational exposure may occur. CDR may also identify potential uses of di-
isobutyl phthalate that would indicate occupational exposure. Additionally, systematic review will
identify published reports containing worker exposure monitoring data that will inform the
occupational exposure assessment of di-isobutyl phthalate. EPA plans to continue to review data
sources identified in Appendix A for di-isobutyl phthalate using systematic review evaluation
strategies for environmental releases and occupational exposure data sources.
2) Review reasonably available exposure data for surrogate chemicals that have uses, volatility
and chemical and physical properties similar to di-isobutyl phthalate. EPA plans to review
literature sources identified and if surrogate data are found, these data will be matched to applicable
conditions of use for potentially filling data gaps. EPA believes other phthalate esters utilized in
similar ways to di-isobutyl phthalate may serve as surrogates for di-isobutyl phthalate.
3) For conditions of use where data are limited or not reasonably available, review existing
exposure models that may be applicable in estimating exposure levels. EPA has identified
potentially relevant OECD ESDs and EPA GS corresponding to some conditions of use. For
example, the 2015 ESP on the Use of Adhesives and the 2009 ESP on Plastic Additives, the are
some of the ESPs and GS's that EPA may use to estimate occupational exposures. EPA plans to
critically review these generic scenarios and ESPs to determine their applicability to the conditions
of use assessed. EPA plans to perform additional targeted research to understand those conditions of
use where ESPs or GS's were not identified, which may inform the exposure scenarios. EPA may
also need to perform targeted research to identify applicable models that EPA may use to estimate
exposures for certain conditions of use.
4) Review reasonably available data that may be used in developing, adapting or applying
exposure models to a particular risk evaluation scenario. This step will be performed after Steps
#2 and #3 are completed. Based on information developed from Steps #2 and #3, EPA plans to
evaluate relevant data to determine whether the data can be used to develop, adapt, or apply models
for specific conditions of use (and corresponding exposure scenarios). EPA may utilize existing,
peer-reviewed exposure models developed by EPA or other government agencies, or reasonably
available in the scientific literature, or EPA may elect to develop additional models to assess
specific condition(s) of use. Inhalation exposure models may be simple box models or two-zone
(near-field/far-field) models. In two-zone models, the near-field exposure represents potential
inhalation exposures to workers, and the far-field exposure represents potential inhalation exposures
to ONU's.
5) Consider and incorporate applicable EC and/or PPE into exposure scenarios. EPA plans to
review potentially relevant data sources on EC and PPE to determine their applicability and
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incorporation into exposure scenarios during risk evaluation. EPA plans to assess worker exposure
pre- and post-implementation of EC, using reasonably available information on available control
technologies and control effectiveness. For example, EPA may assess worker exposure in industrial
use scenarios before and after implementation of local exhaust ventilation.
6) Map or group each condition of use to occupational exposure assessment scenario(s). EPA has
identified occupational exposure scenarios and mapped them to relevant conditions of use (see
Appendix F). As presented in Table Apx F-l, EPA has grouped the scenarios into representative
release/exposure scenarios. EPA was not able to identify occupational scenarios corresponding to
some conditions of use. EPA plans to perform targeted research to understand those uses which may
inform identification of occupational exposure scenarios. EPA may refine the mapping of
occupational exposure scenarios based on factors (e.g., process equipment and handling, magnitude
of production volume used, and exposure/release sources) corresponding to conditions of use as
additional information is identified during risk evaluation.
7) Evaluate the weight of the scientific evidence of occupational exposure data, which may
include qualitative and quantitative sources of information. During risk evaluation, EPA plans to
evaluate and integrate the exposure evidence identified in the literature inventory using the methods
described in the systematic review documentation that EPA plans to publish prior to finalizing the
scope document. EPA plans to rely on the weight of the scientific evidence when evaluating and
integrating occupational data. The data integration strategy will be designed to be fit-for-purpose in
which EPA plans to use systematic review methods to assemble the relevant data, evaluate the data
for quality and relevance, including strengths and limitations, followed by synthesis and integration
of the evidence.
2.7.2.4 Consumer Exposures
EPA plans to analyze both consumers using a consumer product and bystanders associated with the
consumer using the product as follows:
1) Group each condition of use to consumer exposure assessment scenario(s). Refine and finalize
exposure scenarios for consumers by considering combinations of sources (ongoing consumer uses),
exposure pathways including routes, and exposed populations.
For di-isobutyl phthalate, the following are noteworthy considerations in constructing consumer
exposure scenarios:
Conditions of use and type of consumer product
Duration, frequency and magnitude of exposure
Weight fraction of chemical in products
Amount of chemical used
2) Evaluate the relative potential of indoor exposure pathways based on reasonably available
data. Indoor exposure pathways may include inhalation of indoor air during di-isobutyl phthalate
use and disposal, dermal contact to liquids or articles and mouthing of articles. The data sources
associated with these respective pathways have not yet been comprehensively evaluated, so
quantitative comparisons across exposure pathways or in relation to toxicity thresholds are not yet
available.
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3) Review existing indoor exposure models that may be applicable in estimating indoor air.
Indoor exposure models that estimate emission and migration of SVOCs into the indoor
environment are reasonably available. These models generally consider mass transfer as informed
by the gas-phase mass transfer coefficient, the solid-phase diffusion coefficient, and the material-air
partition coefficient. These properties vary based on p-chem properties and properties of the
material. The OPPT's Indoor Environmental Concentrations in Buildings with Conditioned and
Unconditioned Zones (IECCU) model and other similar models can be used to estimate indoor air
and dust exposures from indoor sources.
Indoor exposure models that estimate emissions from consumer products are reasonably available.
These models generally consider p-chem properties (e.g., vapor pressure, molecular weight),
product specific properties (e.g., weight fraction of the chemical in the product), use patterns (e.g.,
duration and frequency of use), user environment (e.g., room of use, ventilation rates), and receptor
characteristics (e.g., exposure factors, activity patterns). The OPPT's Consumer Exposure Model
(CEM) and other similar models can be used to estimate indoor air exposures from consumer
products.
4) Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical assessment
if model parameter data are available. To the extent other organizations have already modeled a
di-isobutyl phthalate consumer exposure scenario that is relevant to the OPPT's assessment, EPA
plans to evaluate those modeled estimates. In addition, if other chemicals similar to di-isobutyl
phthalate have been modeled for similar uses, those modeled estimates will also be evaluated. The
underlying parameters and assumptions of the models will also be evaluated.
5) Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with indoor monitoring data reporting di-
isobutyl phthalate in specific media (e.g., indoor air). The availability of di-isobutyl phthalate
concentration for various ongoing uses will be evaluated. This data provides the source term for any
subsequent indoor modeling. Source attribution between overall indoor air levels and various indoor
sources will be analyzed.
6) Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if PESS need to be refined. During risk evaluation, EPA plans to
evaluate and integrate the exposure evidence identified in the literature inventory using the methods
described in the systematic review documentation that EPA plans to publish prior to finalizing the
scope document.
7) Evaluate the weight of the scientific evidence of consumer exposure estimates based on
different approaches. EPA plans to rely on the weight of the scientific evidence when evaluating
and integrating data related to consumer exposure. The weight of the scientific evidence may
include qualitative and quantitative sources of information. The data integration strategy will be
designed to be fit-for-purpose in which EPA plans to use systematic review methods to assemble the
relevant data, evaluate the data for quality and relevance, including strengths and limitations,
followed by synthesis and integration of the evidence.
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2.7.2.5 General Population
EPA plans to analyze general population exposures as follows:
1) Refine and finalize exposure scenarios for general population by considering combinations of
sources and uses, exposure pathways including routes, and exposed populations. For di-
isobutyl phthalate, the following are noteworthy considerations in constructing exposure scenarios
for the general population:
Review reasonably available environmental and biological monitoring data for media to
which general population exposures are expected.
For exposure pathways where data are not reasonably available, review existing exposure
models that may be applicable in estimating exposure levels.
Consider and incorporate applicable media-specific regulations into exposure scenarios or
modeling.
Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation. For example, existing models developed
for a chemical assessment may be applicable to another chemical assessment if model
parameter data are reasonably available.
Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with reasonably available monitoring
data.
Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if PESS need be further defined.
Evaluate the weight of the scientific evidence of general population exposure data.
Map or group each condition of use to general population exposure assessment scenario(s).
Environmental Exposure pathways regulated by non-TSCA EPA laws and regulations will
be excluded from analysis
EPA plans to evaluate a variety of data types to determine which types are most appropriate when
quantifying exposure scenarios. Environmental monitoring data, biomonitoring data, modeled
estimates, experimental data, epidemiological data, and survey-based data can all be used to
quantify exposure scenarios. In an effort to associate exposure estimates with sources of exposure
and/or conditions of use, EPA plans to consider source apportionment across exposure scenarios
during risk evaluation. EPA anticipates that there will be a wide range in the relative exposure
potential of the exposure scenarios identified in Appendix H. Source apportionment characterizes
the relative contribution of any of the following: a use/source toward a total media concentration, a
media concentration toward a total exposure route, or an exposure route toward a total external or
internal dose. This consideration may be qualitative, semi-quantitative, or quantitative, and is
dependent upon reasonably available data and approaches. For example, EPA may consider the co-
location of TSCA industrial facilities with reasonably available monitoring data or modeled
estimates. EPA may compare modeled estimates for discrete outdoor and indoor sources/uses that
apply to unique receptor groups.
After refining and finalizing exposure scenarios, EPA plans to quantify concentrations and/or doses
for these scenarios. The number of scenarios will depend on how combinations of uses, exposure
pathways, and receptors are characterized. The number of scenarios is also dependent upon the
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reasonably available data and approaches to quantify scenarios. When quantifying exposure
scenarios, EPA plans to use a tiered approach. First-tier analysis is based on data that is reasonably
available without a significant number of additional inputs or assumptions, and may be qualitative,
semi-quantitative, or quantitative. First-tier analyses were conducted during problem formulation
and are expected to continue during risk evaluation. The results of first tier analyses inform whether
scenarios require more refined analysis. Refined analyses will be iterative and require careful
consideration of variability and uncertainty. Should data become reasonably available that
summarily alters the overall conclusion of a scenario through iterative tiering, EPA can refine its
analysis during risk evaluation.
2) For exposure pathways where empirical data is not reasonably available, review existing
exposure models that may be applicable in estimating exposure levels. For di-isobutyl phthalate,
media where exposure models will be considered for general population exposure include models
that estimate, surface water concentrations, sediment concentrations, soil concentrations, and uptake
from aquatic and terrestrial environments into edible aquatic and terrestrial organisms.
3) Review reasonably available exposure modeled estimates. For example, existing models
developed for a previous di-isobutyl phthalate chemical assessment may be applicable to
EPA's assessment. In addition, another chemical's assessment may also be applicable if model
parameter data are reasonably available.
To the extent other organizations have already modeled di-isobutyl phthalate general population
exposure scenario that is relevant to this assessment, EPA plans to evaluate those modeled
estimates. In addition, if modeled estimates for other chemicals with similar physical chemical
properties and similar uses are reasonably available, those modeled estimates will also be evaluated.
The underlying parameters and assumptions of the models will also be evaluated.
4) Review reasonably available information on releases to determine how modeled estimates of
concentrations near industrial point sources compare with available monitoring data. The
expected releases from industrial facilities may change over time. Any modeled concentrations
based on recent release estimates will be compared with available monitoring data to determine
repre sentati venes s.
5) Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if PESS need to be further defined (e.g.,
early life and/or puberty as a potential critical window of exposure). For di-isobutyl phthalate,
exposure scenarios that involve PESS will consider age-specific behaviors, activity patterns, and
exposure factors unique to those subpopulations. For example, children will have different intake
rates for soil than adults.
6) Evaluate the weight of the scientific evidence of general population exposure estimates based
on different approaches. During risk evaluation, EPA plans to evaluate and integrate the exposure
evidence identified in the literature inventory using the methods described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
2.7.3 Hazards (Effects)
2.7.3.1 Environmental Hazards
EPA plans to conduct an environmental hazard assessment of di-isobutyl phthalate as follows:
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1) Review reasonably available environmental hazard data, including data from alternative test
methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies). EPA plans to analyze the hazards
of di-isobutyl phthalate to aquatic and/or terrestrial organisms, including plants, invertebrates (e.g.,
insects, arachnids, mollusks, crustaceans), and vertebrates (e.g., mammals, birds, amphibians, fish,
reptiles) across exposure durations and conditions if potential environmental hazards are identified
through systematic review results and public comments. Additional types of environmental hazard
information will also be considered (e.g., analogue and read-across data) when characterizing the
potential hazards of di-isobutyl phthalate to aquatic and/or terrestrial organisms.
Environmental hazard data will be evaluated using the environmental toxicity data quality criteria
outlined in the systematic review documentation that EPA plans to publish prior to finalizing the
scope document. The study evaluation results will be documented in the risk evaluation phase and
data from suitable studies will be extracted and integrated in the risk evaluation process.
Hazard endpoints (e.g., mortality, growth, immobility, reproduction) will be evaluated, while
considering data availability, relevance, and quality.
2) Derive hazard thresholds for aquatic and/or terrestrial organisms. Depending on the robustness
of the evaluated data for a particular organism or taxa (e.g., aquatic invertebrates), environmental
hazard values (e.g., ECx, LCx, NOEC, LOEC) may be derived and used to further understand the
hazard characteristics of di-isobutyl phthalate to aquatic and/or terrestrial species. Identified
environmental hazard thresholds may be used to derive concentrations of concern (COC), based on
endpoints that may affect populations of organisms or taxa analyzed.
3) Evaluate the weight of the scientific evidence of environmental hazard data. During risk
evaluation, EPA plans to evaluate and integrate the environmental hazard evidence identified in the
literature inventory using the methods described in the systematic review documentation that EPA
plans to publish prior to finalizing the scope document.
4) Consider the route(s) of exposure, based on reasonably available monitoring and modeling
data and other reasonably available approaches to integrate exposure and hazard
assessments. EPA plans to consider aquatic (e.g., water and sediment exposures) and terrestrial
pathways in the di-isobutyl phthalate conceptual model. These organisms may be exposed to di-
isobutyl phthalate via a number of environmental pathways (e.g., surface water, sediment, soil, diet).
5) Conduct an environmental risk characterization of di-isobutyl phthalate. EPA plans to conduct
a risk characterization of di-isobutyl phthalate to identify if there are risks to the aquatic and/or
terrestrial environments from the measured and/or predicted concentrations of di-isobutyl phthalate
in environmental media (i.e., water, sediment, soil). Risk quotients (RQs) may be derived by the
application of hazard and exposure benchmarks to characterize environmental risk (U.S. EPA. 1998;
Barnthouse et al.. 1982).
6) Consider a Persistent, Bioaccumulative, and Toxic (PBT) Assessment of di-isobutyl phthalate.
EPA plans to consider the persistence, bioaccumulation, and toxic (PBT) potential of di-isobutyl
phthalate after reviewing relevant p-chem properties and exposure pathways. EPA plans to assess
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the reasonably available studies collected from the systematic review process relating to
bioaccumulation and bioconcentration (e.g., BAF, BCF) of di-isobutyl phthalate. In addition, EPA
plans to integrate traditional environmental hazard endpoint values (e.g., LCso, LOEC) and exposure
concentrations (e.g., surface water concentrations, tissue concentrations) for di-isobutyl phthalate
with the fate parameters (e.g., BAF, BCF, BMF, TMF).
2.7.3.2 Human Health Hazards
EPA plans to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative test
methods (e.g., computational toxicology and bioinformatics; high-throughput screening
methods; data on categories and read-across; in vitro studies; systems biology). EPA plans to
use systematic review methods to evaluate the epidemiological and toxicological literature for di-
isobutyl phthalate. EPA plans to publish the systematic review documentation prior to finalizing the
scope document.
Relevant mechanistic evidence will also be considered, if reasonably available, to inform the
interpretation of findings related to potential human health effects and the dose-response
assessment. Mechanistic data may include analyses of alternative test data such as novel in vitro test
methods and high throughput screening. The association between acute and chronic exposure
scenarios to the agent and each health outcome will also be integrated. Study results will be
extracted and presented in evidence tables or another appropriate format by organ/system.
2) Conduct hazard identification (the qualitative process of identifying non-cancer and cancer
endpoints) and dose-response assessment (the quantitative relationship between hazard and
exposure) for identified human health hazard endpoints. Human health hazards from acute and
chronic exposures will be identified by evaluating the human and animal data that meet the
systematic review data quality criteria described in the systematic review documentation that EPA
plans to publish prior to finalizing the scope document. Hazards identified by studies meeting data
quality criteria will be grouped by routes of exposure relevant to humans (oral, dermal, inhalation)
and by cancer and noncancer endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA, 2012a,
2011, 1994). Dose-response analyses may be used if the data meet data quality criteria and if
additional information on the identified hazard endpoints are not reasonably available or would not
alter the analysis.
The cancer mode of action (MOA) determines how cancer risks can be quantitatively evaluated. If
cancer hazard is determined to be applicable to di-isobutyl phthalate, EPA plans to evaluate
information on genotoxicity and the mode of action for all cancer endpoints to determine the
appropriate approach for quantitative cancer assessment in accordance with the U.S. EPA
Guidelines for Carcinogen Risk Assessment (U.S. EPA. 2005).
3) In evaluating reasonably available data, determine whether particular human receptor groups
may have greater susceptibility to the chemical's hazard(s) than the general population.
Reasonably available human health hazard data will be evaluated to ascertain whether some human
receptor groups may have greater susceptibility than the general population to di-isobutyl phthalate
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hazard(s). Susceptibility of particular human receptor groups to di-isobutyl phthalate will be
determined by evaluating information on factors that influence susceptibility.
EPA has reviewed some sources containing hazard information associated with PESS and lifestages
such as pregnant women and infants. Pregnancy (i.e., gestation) and childhood are potential
susceptible lifestages for di-isobutyl phthalate exposure. EPA plans to review the current state of the
literature in order to potentially quantify these differences for risk evaluation purposes.
4) Derive points of departure (PODs) where appropriate; conduct benchmark dose modeling
depending on the reasonably available data. Adjust the PODs as appropriate to conform (e.g.,
adjust for duration of exposure) to the specific exposure scenarios evaluated. Hazard data will
be evaluated to determine the type of dose-response modeling that is applicable. Where modeling is
feasible, a set of dose-response models that are consistent with a variety of potentially underlying
biological processes will be applied to empirically model the dose-response relationships in the
range of the observed data consistent with EPA's Benchmark Dose Technical Guidance Document.
Where dose-response modeling is not feasible, NOAELs or LOAELs will be identified. Non-
quantitative data will also be evaluated for contribution to weight of the scientific evidence
or for evaluation of qualitative endpoints that are not appropriate for dose-response assessment.
EPA plans to evaluate whether the reasonably available PBPK and empirical kinetic models are
adequate for route-to-route and interspecies extrapolation of the POD, or for extrapolation of the
POD to standard exposure durations (e.g., lifetime continuous exposure). If application of the PBPK
model is not possible, oral PODs may be adjusted by BW3/4 scaling in accordance with U.S. EPA
(2011). and inhalation PODs may be adjusted by exposure duration and chemical properties in
accordance with U.S. EPA (1994).
5) Evaluate the weight of the scientific evidence of human health hazard data. During risk
evaluation, EPA plans to evaluate and integrate the human health hazard evidence identified in the
literature inventory under acute and chronic exposure conditions using the methods described in the
systematic review documentation that EPA plans to publish prior to finalizing the scope document.
6) Consider the route(s) of exposure (oral, inhalation, dermal), available route-to-route
extrapolation approaches, reasonably available biomonitoring data and available approaches
to correlate internal and external exposures to integrate exposure and hazard assessment. At
this stage of review, EPA believes there will be sufficient data to conduct dose-response analysis
and/or benchmark dose modeling for the oral route of exposure. EPA plans to also evaluate any
potential human health hazards following dermal and inhalation exposure to di-isobutyl phthalate,
which could be important for worker, consumer, and general population risk analysis. Reasonably
available data will be assessed to determine whether or not a point of departure can be identified for
the dermal and inhalation routes. This may include using route-to-route extrapolation methods
where appropriate and depending on the nature of reasonably available data.
If sufficient toxicity studies are not identified in the literature search to assess risks from dermal and
inhalation exposures, then a route-to-route extrapolation from oral toxicity studies would be needed
to assess systemic risks from dermal or inhalation exposures. Without an adequate PBPK model, the
approaches described in EPA guidance document Risk Assessment Guidance for Superfund Volume
I: Human Health Evaluation Manual (PartE, Supplemental Guidance for Dermal Risk Assessment)
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(U.S. EPA. 2004) could be applied to extrapolate from oral to dermal exposure. These approaches
may be able to further inform the relative importance of dermal exposures compared with other
routes of exposure. Similar methodology may also be used for assessing inhalation exposures
2.7.4 Summary of Risk Approaches for Characterization
Risk characterization is an integral component of the risk assessment process for both environmental and
human health risks. EPA plans to derive the risk characterization in accordance with EPA's Risk
Characterization Handbook (U.S. EPA. 2000). As defined in EPA's Risk Characterization Policy, "the risk
characterization integrates information from the preceding components of the risk evaluation and
synthesizes an overall conclusion about risk that is complete, informative and useful for decision makers."
Risk characterization is considered to be a conscious and deliberate process to bring all important
considerations about risk, not only the likelihood of the risk but also the strengths and limitations of the
assessment, and a description of how others have assessed the risk into an integrated picture.
The level of information contained in each risk characterization varies according to the type of assessment
for which the characterization is written. Regardless of the level of complexity or information, the risk
characterization for TSCA risk evaluations will be prepared in a manner that is transparent, clear,
consistent, and reasonable (U.S. EPA. 2000) and consistent with the requirements of the Procedures for
Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726). For instance,
in the risk characterization summary, EPA plans to further carry out the obligations under TSCA Section
26; for example, by identifying and assessing uncertainty and variability in each step of the risk evaluation,
discussing considerations of data quality such as the reliability, relevance and whether the methods utilized
were reasonable and consistent, explaining any assumptions used, and discussing information generated
from independent peer review.
EPA plans to also be guided by EPA's Information Quality Guidelines (U.S. 2002) as it provides guidance
for presenting risk information. Consistent with those guidelines, EPA plans to identify in the risk
characterization the following: (1) Each population addressed by an estimate of applicable risk effects; (2)
The expected risk or central estimate of risk for the PESS affected; (3) Each appropriate upper-bound or
lower-bound estimate of risk; (4) Each significant uncertainty identified in the process of the assessment of
risk effects and the studies that would assist in resolving the uncertainty; and (5) Peer reviewed studies
known to the Agency that support, are directly relevant to, or fail to support any estimate of risk effects and
the methodology used to reconcile inconsistencies in the scientific information.
2.8 Peer Review
Peer review will be conducted in accordance with EPA's regulatory procedures for chemical risk
evaluations, including using EPA's Peer Review Handbook and other methods consistent with Section 26
of TSCA (See 40 CFR 702.45). As explained in the Risk Evaluation Rule, the purpose of peer review is for
the independent review of the science underlying the risk assessment. Peer review will therefore address
aspects of the underlying science as outlined in the charge to the peer review panel such as hazard
assessment, assessment of dose-response, exposure assessment, and risk characterization.
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CDR database) [Database], Washington, DC: U.S. Environmental Protection Agency, Office of Pollution
Prevention and Toxics. Retrieved from ChemView: June 2019. https://chemview.epa.gov/chemview HERO
ID: 6275311
U.S. EPA (U.S. Environmental Protection Agency). (2018). Application of systematic review in TSCA risk
evaluations. (740-P1-8001). Washington, DC: U.S. Environmental Protection Agency, Office of Chemical
Safety and Pollution Prevention, https://www.epa.gov/sites/production/files/2018-
06/documents/final application of sr in tsca 05-31-18.pdf. HERO ID: 4532281
U.S. EPA (U.S. Environmental Protection Agency) (2019a). Chemical Data Reporting (2012 and 2016 CBI
CDR database). Washington, DC. U.S. Environmental Protection Agency, Office of Pollution Prevention
and Toxics, (accessed April 25, 2019). HERO ID: 6301193
U.S. EPA (U.S. Environmental Protection Agency). (2019b). Proposed Designation of Di-isobutyl
Phthalate (DIBP) (CASRN 84-69-5) as High-Priority Substance for Risk Evaluation.
https://www.epa.gov/sites/production/files/2019-08/documents/di-isobutvlphthalate 84-69-5 high-
priority proposeddesignation 082319 O.pdf. HERO ID: 6311814
U.S. EPA (U.S. Environmental Protection Agency). (2020). Generic scenarios documents for occupational
exposure and release assessment, https://www.epa.gov/tsca-screening-tools/chemsteer-chemical-screening-
tool-exposures-and-environmental-releases#genericscenarios. HERO ID: 6311552
56
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U.S. EPA (U.S. Environmental Protection Agency) (2020). Using Predictive Methods to Assess Exposure
and Fate under TSCA. https://www.epa.gov/tsca-screening-tools/using-predictive-methods-assess-
exposure-and-fate-under-tsca#fate.
Wolfe, NL; Steen, WC; Burns, LA. (1980). Phthalate ester hydrolysis: Linear free energy relationships.
Chemosphere 9: 403-408. HERO ID: 5335927
57
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APPENDICES
Appendix A LIST OF GRAY LITERATURE SOURCES
Table Apx A-1. Grav Literature Sources for Di-isobutvl Pht
lalate
Source/Agency
Source Name
Source Type
Source Category
Australian
Government,
Department of
Health
\ 1C\ \S Assessments (ccoj
International
Resources
Assessment or
Related Document
Australian
Government,
Department of
Health
N1CNAS Assessments (human health.
Tier 1, 11 or 111)
International
Resources
Assessment or
Related Document
CPSC
Chronic Hazard Advisory Panel Reports
Other US
Agency
Resources
Assessment or
Related Document
CPSC
Technical Reports: Exposure/Risk
Assessment
Other US
Agency
Resources
Assessment or
Related Document
CPSC
Technical Reports: Toxicity Review
Other US
Agency
Resources
Assessment or
Related Document
ECHA
ECHA Documents
International
Resources
Assessment or
Related Document
ECHA
Annex XVII To REACH - Conditions of
Use
International
Resources
Assessment or
Related Document
ECHA
European Union Risk Assessment Report
International
Resources
Assessment or
Related Document
Env Canada
Canada Substance Grouping Pages
International
Resources
Assessment or
Related Document
Env Canada
Priority Substances List Assessment
Report; State of Science Report,
Environment Canada Assessment
International
Resources
Assessment or
Related Document
58
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Sou roe/Agency
Source Nit file
Source Type
Source Category
Env Canada
Guidelines, Risk Management,
Regulations
International
Resources
Assessment or
Related Document
EPA
Other EPA: Misc sources
US EPA
Resources
General Search
EPA
EPA: AP-42
US EPA
Resources
Regulatory Document
or List
EPA
TRI: Envirofacts Toxics Release
Inventory 2017 Updated Dataset
US EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and 2016
non-CBI CDR database)
US EPA
Resources
Database
EPA
Chemical Data Reporting (2012 and 2016
CBI CDR database)
US EPA
Resources
Database
EPA
EPA: Generic Scenario
US EPA
Resources
Assessment or
Related Document
EPA
EPA Discharge Monitoring Report Data
US EPA
Resources
Database
EPA
IRIS Tox Review
US EPA
Resources
Assessment or
Related Document
EPA
Office of Water: CFRs
US EPA
Resources
Regulatory Document
or List
EPA
Office of Air: National Emissions
Inventory (NE1) - National Emissions
Inventory (NE1) Data (2014, 201 1, 2008)
US EPA
Resources
Database
EPA
Office of Air: CFRs and Dockets
US EPA
Resources
Regulatory Document
or List
FDA
FDA technical support documents for
regulations
Other US
Agency
Resources
Assessment or
Related Document
KOECT
Kirk-Othmer Encyclopedia of Chemical
Technology Journal Article
Other Resource
Encyclopedia
NIOSH
CDC NIOSH - Publications and Products
Other US
Agency
Resources
Assessment or
Related Document
59
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Sou roe/Agency
Source N si me
Source Type
Source Category
NLM
National Library of Medicine's Hazardous
Substance Databank
Other US
Agency
Resources
Database
NLM
National Library of Medicine's HazMap
Other US
Agency
Resources
Database
OECD
OECD Emission Scenario Documents
International
Resources
Assessment or
Related Document
OECD
OECD: General Site
International
Resources
General Search
OSHA
U.S. OSHA Chemical Exposure Health
Data (CEHD) program data [ERG]
Other US
Agency
Resources
Database
60
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Appendix B PHYSICAL AND CHEMICAL PROPERTIES OF DI-
ISOBUTYL PHTHALATE
This appendix provides p-chem information and data found in preliminary data gathering for di-isobutyl
phthalate. Table Apx B-l summarizes the p-chem property values preliminarily selected for use in the risk
evaluation from among the range of reported values collected as of March 2020. This table differs from that
presented in the Promised Designation of Di-isobutyl Phthalate (CASRN 84-69-5) as a Hieh-Priority
Substance for Risk Evaluation (U.S. EPA, 2019b) and may be updated as EPA collects additional
information through systematic review methods. All p-chem property values that were extracted and
evaluated as of March 2020 are presented in the supplemental filq Data Extraction and Data Evaluation
Tables for Physical Chemical Property Studies (EP A-HQ-OPPT-2018-0434).
Table Apx B-l. Physical and Chemical Properties of Di-isobutyl Phthalate
Properly or Knripoinl
Value*
Reference
Data Quality
Rating
Molecular formula
C16H22O4
NA
NA
Molecular weight
278.35 g/mol
NA
NA
Physical state
Liquid
NLM, 2013
High
Physical properties
Colorless
Elsevier, 2019
High
Melting point
-64 C
NLM, 2013
High
Boiling point
296.5°C
NLM, 2013
High
Density
1.036-1.0412 g/crn3 at
20°C
Elsevier, 2019
High
Vapor pressure
4.76xl0"5 mm Hg at
25°C
NLM, 2013
High
Vapor density
Not available
Water solubility
6.2 rng/L at 24°C
NLM, 2013
High
Log Octanol/water partition
coefficient (Log Kow)
4.34
Ishak, 2016
High
Henry's Law constant
1.83 x 10"7 atm-m Vmol
Elsevier, 2019
High
Flash point
169°C
RSG, 2019
Medium
61
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Propcrlv or Kndpoinl
Ysiliic"
Uol'omuT
l>:il:i Qusililv
Killing
Auto flammability
Not available
Viscosity
41 cP at 20°C
NLM, 2013
High
Refractive index
1.4900
NLM, 2013
High
Dielectric constant
6.56
Elsevier, 2019
High
5|<
Measured unless otherwise noted.
NA = Not applicable
62
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Appendix C ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES
Table Apx C-l provides the environmental fate characteristics that EPA identified and considered in
developing the scope for di-isobutyl phthalate.
Table Apx C-l. Environmental Fate Characteristics of Di-isobutyl Phthalate
Properly or Kmlpoinl
Value"
Reference
Direct Photodegradation
May be susceptible due to
potential absorption
HSDB (2013)
Indirect Photodegradation
ti/2 = 1.2 days (12-hour day at 1.5
x 106 OH/cm3) based on OH rate
constant of 9.3 x 10"12
cm3/molecule-second at 25 °C;
estimated)
U.S. EPA (2012b)
Hydrolysis
ti/2 = 5,730 days (at pH = 8, based
on a rate constant of 0.0014 M"1
second"1)
Wolfe (1980)
Biodegradation (Aerobic)
98%/4 weeks (OECD 302C)
HSDB (2013) citing Sedykh and
Klopman (2007)
100%/6 days (die-away tests)
HSDB (2013) citing Hattori
(1975)
40%/28 days OECD 301B (C02
evolution)
ECHA (2019)
Biodegradation (Anaerobic)
0-30%/96 days (sewage
sludge and swamp water)
0-30%/56 days (marine
sediment)
HSDB (2013) citing Madsen
(1995)
Wastewater Treatment
99.5% total removal (92% by
biodegradation, 7.5% by sludge
adsorption, and 0% by
volatilization to air; estimated)
U.S. EPA (2012b)
Bioconcentration Factor
240 (log BCF = 2.4; estimated)"
U.S. EPA (2012b)
26 (log BAF = 1.4; estimated)"
U.S. EPA (2012b)
Soil Organic Carbon:Water
Partition Coefficient (Log Koc)
3.14
HSDB (2013) citing Sabljic
(1995)
* Measured unless otherwise noted
A EPI Suite™ physical property inputs: Log Kow = 4.11, BP = 296.5 °C, MP = -64 °C, VP = 4.76 x 10~5 mm Hg, WS
= 6.2 mg/L, BioP = 4, BioA = 1, Bio S = 1 SMILES 0=C(0CC(C)C)c(c(cccl)C(=0)0CC(C)C)cl
Bioconcentration factor = BCF; Bioaccumulation factor = BAF
63
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Appendix D REGULATORY HISTORY
The chemical substance, di-isobutyl phthalate, is subject to federal and state laws and regulations in the
United States (TableApx D-l and TableApx D-2). Regulatory actions by other governments, tribes and
international agreements applicable to di-isobutyl phthalate are listed in Table Apx_D-3.
D.l Federal Laws and Regulations
Table Apx D-l. Federal Laws and Regulations
Slat utes/Ucgulal ions
Description of Description ol' Regulation
Authority/Regulation
EPA Regulations
Toxic Substances
Control Act (TSCA)
- Section 6(b)
EPA is directed to identify high-
priority chemical substances for risk
evaluation; and conduct risk
evaluations on at least 20 high priority
substances no later than three and one-
half years after the date of enactment
of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act.
Di-isobutyl phthalate is one of the 20
chemicals EPA designated as a High-
Priority Substance for risk evaluation
under TSCA (84 FR 71924. December 30.
2019). Designation of di-isobutyl
phthalate as high-priority substance
constitutes the initiation of the risk
evaluation on the chemical.
Toxic Substances
Control Act (TSCA)
- Section 8(a)
The TSCA Section 8(a) CDR Rule
requires manufacturers (including
importers) to give EPA basic
exposure-related information on the
types, quantities and uses of chemical
substances produced domestically and
imported into the United States.
Di-isobutyl phthalate manufacturing
(including importing), processing and use
information is reported under the CDR
rule (76 FR 50816. August 16. 20111
Toxic Substances
Control Act (TSCA)
- Section 8(b)
EPA must compile, keep current and
publish a list (the TSCA Inventory) of
each chemical substance manufactured
(including imported) or processed in
the United States.
Di-isobutyl phthalate was on the initial
TSCA Inventory and therefore was not
subject to EPA's new chemicals review
process under TSCA Section 5 (60 FR
16309. March 29. 1995V
Toxic Substances
Control Act (TSCA)
- Section 8(d)
Provides EPA with authority to issue
rules requiring producers, importers,
and (if specified) processors of a
chemical substance or mixture to
submit lists and/or copies of ongoing
and completed, unpublished health and
safety studies.
Zero health and safety studies received for
di-isobutyl phthalate (1982-1992) (U.S.
EPA, ChemView. Accessed April 25,
2019). Di-isobutyl phthalate is listed under
the category "Alkyl phthalates — all alkyl
esters of 1, 2-benzenedicarboxylic
acid fort ho -phthalic acid)" (40 CFR
716.120V
Toxic Substances
Control Act (TSCA)
- Section 8(e)
Manufacturers (including importers),
processors, and distributors must
immediately notify EPA if they obtain
information that supports the
Two risk reports received for di-isobutyl
phthalate (2003: 88030000106; 2010:
88100000438) (U.S. EPA, ChemView.
Accessed April 9, 2019).
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Slat utes/Ucgulal ions
Description of Description ol' Regulation
Authority/Regulation
conclusion that a chemical substance
or mixture presents a substantial risk
of injury to health or the environment.
Clean Water Act
(CWA) - Sections
301, 304, 306, 307,
and 402
Clean Water Act Section 307(a)
establishes a list of toxic pollutants or
combination of pollutants under the
CWA. The statue specifies a list of
families of toxic pollutants also listed
in the Code of Federal Regulations at
40 CFRPart 401.15. The "priority
pollutants" specified by those families
are listed in 40 CFR Part 423
Appendix A. These are pollutants for
which best available technology
effluent limitations must be established
on either a national basis through rules
(Sections 301(b), 304(b), 307(b), 306)
or on a case-by-case best professional
judgement basis in NPDES permits,
see Section 402(a)(1)(B). EPA
identifies the best available technology
that is economically achievable for
that industry after considering
statutorily prescribed factors and sets
regulatory requirements based on the
performance of that technology.
As a phthalate ester, di-isobutyl phthalate
is designated as a toxic pollutant under
Section 307(a)(1) of the CWA, and as
such is subject to effluent limitations.
Specifically, di-isobutyl phthalate is
categorized as an "aromatic organic
chemical," as applicable to the process
wastewater discharges resulting from the
manufacture of bulk organic chemicals
(40 CFR 414.701
Clean Air Act (CAA) -
Section 112(d)
Directs EPA to establish, by rule,
NESHAPs for each category or
subcategory of listed major sources
and area sources of HAPs (listed
pursuant to Section 112(c)). For major
sources, the standards must require the
maximum degree of emission
reduction that EPA determines is
achievable by each particular source
category. This is generally referred to
as maximum achievable control
technology (MACT). For area sources,
the standards must require generally
achievable control technology (GACT)
though may require MACT.
EPA has established NESHAPs for a
number of source categories that emit di-
isobutyl phthalate to air. (See
https://www.epa.gov/stationary-sources-
air-pollution/national-emission-standards-
hazardous-air-pollutants-neshap-9)
Other Federal Regulations
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Statutes/Regulations
Description of Description ol' Regulation
Authority/Regulation
Federal Food, Drug,
and Cosmetic Act
(FFDCA)
Provides the FDA with authority to
oversee the safety of food, drugs and
cosmetics.
Di-isobutyl phthalate is listed as an
optional substance to be used in:
adhesives to be used as components of
articles intended for use in packaging,
transporting, or holding food (21 CFR §
175.105); the base sheet and coating of
cellophane. (21 CFR § 177.1200).
Consumer Product
Safety Improvement
Act of 2008 (CPSIA)
Under Section 108 of the Consumer
Product Safety Improvement Act of
2008 (CPSIA), CPSC prohibits the
manufacture for sale, offer for sale,
distribution in commerce or
importation of eight phthalates in toys
and child care articles at
concentrations greater than 0.1
percent: di-ethylhexyl phthalate,
dibutyl phthalate, butyl benzyl
phthalate, diisononyl phthalate,
diisobutyl phthalate, di-n-pentyl
phthalate, di-n-hexyl phthalate and
dicyclohexyl phthalate.
The use of di-isobutyl phthalate at
concentrations greater than 0.1 percent is
banned in toys and child care articles (16
CFR part 1307.3). Di-isobutvl phthalate is
considered "toxic" under the FHSA.
(CPSC Toxicity Review of di-isobutyl
ohthalate, Oct. 24, 2010). See also CPSC,
Exposure Assessment: Potential for the
Presence of Phthalates in Selected
Plastics, October 1, 2015.
D.2 State Laws and Regulations
Table Apx D-2. State Laws and Regulations
State Actions
Description of Action
State W ater Pollution
Discharge Programs
Several states ha\e adopted water pollution discharge programs which categorize
di-isobutyl phthalate as an "aromatic organic chemical," as applicable to the
process wastewater discharges resulting from the manufacture of bulk organic
chemicals, including Illinois (35 111. Adm. Code 307-2406); and Wisconsin (Wis.
Adm. Code § NR 235.601
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's products
containing di-isobutyl phthalate, including: Maine which lists di-isobutyl phthalate
as a "chemical of concern" (38 MRS A Chapter 16-D); Minnesota which lists di-
isobutyl phthalate as a "chemical of high concern" (Toxic Free Kids Act Minn.
Stat. 116.9401 to 116.9407); and Washington State which lists di-isobutyl
phthalate as a "chemical of high concern to children" (Wash. Admin. Code 173-
334-130).
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State Actions
Description of Action
Other
Di-isobutyl phthalate is listed as a Candidate Chemical under California's Safer
Consumer Products Program established under Health and Safety Code § 25252
and 25253 (California, Candidate Chemicals List. Accessed April 17, 2019).
Di-isobutyl phthalate is listed as a "nonfunctional constituent" under California's
Cleaning Product Right to Know Act of 2017 (California Health & Safety Code §
1089521
California lists di-isobutyl phthalate as a designated priority chemical for
biomonitoring under criteria established by California SB 1379 (Biomonitoring
California, Priority Chemicals, February 2019).
D.3 International Laws and Regulations
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements
Country/Tribe/
Organization
Requirements and Restrictions
Canada
Di-isobutyl phthalate is on the Domestic Substances List (Government of
Canada. Managing substances in the environment. Substances search.
Database accessed April 17, 2019).
European Union
In February 2012, di-isobutyl phthalate was added to Annex XIV of REACH
(Authorisation List) with a sunset date of February 21, 2015. After the sunset
date, only persons with approved authorization applications may continue to
use the chemical. No requests for authorization were submitted by any user.
There is a recommendation for amending the authorization list under review,
with a deadline for commenting on December 3, 2019, which would revise the
allowable concentration of the chemical for use in mixtures from 0.3% to
0.1%. (European Chemicals Agency (ECHA) database. Accessed April 26,
2019).
In March 2015, di-isobutyl phthalate was added to Annex II of Directive
2011/65/EU on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (EEE) (RoHS 2). The Directive sets a
maximum concentration value tolerated by weight in homogenous materials
for di-isobutyl phthalate of 0.1%. The restriction applies to medical devices,
including in vitro medical devices, and monitoring and control instruments,
including industrial monitoring and control instruments, from 22 July 2021.
The restriction does not apply to cables or spare parts for the repair, the reuse,
the updating of functionalities or upgrading of capacity of EEE placed on the
market before 22 July 2019, and of medical devices, including in vitro medical
devices, and monitoring and control instruments, including industrial
67
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Coiintrv/Trihc/
Orgiini/silion
Requirements sinri Restrictions
monitoring and control instruments, placed on the market before 22 July 2021
(Commission Delegated Directive (EU) 2015/863).
Di-isobutyl phthalate is subject to the Restriction of Hazardous Substances
Directive (RoHS), EU/2015/863, which restricts the use of hazardous
substances at more than 0.1% by weight at the 'homogeneous material' level in
electrical and electronic equipment, beginning July 22, 2019. (European
Commission RoHS).
Australia
Di-isobutyl phthalate was assessed under Human Health Tier II of the
Inventory Multi-Tiered Assessment and Prioritisation (IMAP) as part of the
C4-6 side chain transitional phthalates. Uses reported include as a plasticizer
for rubber and PVC, and in adhesives (NICNAS, 2016, Human Health Tier II
assessment for C4-6 side chain transitional phthalates). In addition, di-isobutyl
phthalate was assessed under Environment Tier II of IMAP as part of the
phthalate esters. In 2015, di-isobutyl phthalate was also assessed as a Priority
Existing Chemical (Assessment Report No. 40) (National Industrial Chemicals
Notification and Assessment Scheme (NICNAS). Chemical inventory.
Database accessed April 3, 2019).
Japan
Di-isobutyl phthalate is regulated in Japan under the following legislation:
• Act on the Evaluation of Chemical Substances and Regulation of Their
Manufacture, etc. (Chemical Substances Control Law; CSCL)
(National Institute of Technology and Evaluation (NITE) Chemical Risk
Information Platform (CHRIP). Accessed April 17, 2019).
World Health
Organization (WHO)
WHO International Programme on Chemical Safety identified an acute hazard
for di-isobutyl phthalate as combustible and recommended prevention and fire-
fishting techniaues (ICSC: 0829, October 2006).
Denmark, Ireland, Latvia,
New Zealand, United
Kingdom
Occupational exposure limits for di-isobutyl phthalate (GESTIS International
limit values for chemical agents (Occupational exposure limits, OELs)
database. Accessed April 17, 2019). Ireland, New Zealand and the United
Kingdom have an eight-hours limit of 5 mg/m3. Latvia has an eight-hours limit
of 1 mg/m3. Denmark has an eight-hours limit of 3 mg/m3 and a short-term
limit of 6 mg/m3.
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Appendix E EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for di-isobutyl phthalate.
E.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker exposure
activities. EPA plans to consider this information in combination with available monitoring data and
estimation methods and models, as appropriate, to quantify occupational exposure and releases for the
various conditions of use in the risk evaluation.
E.l.l Manufacture (Including Import)
The 2016 CDR reports two facilities that submitted activity data for 2015. One of these facilities stated that
they imported di-isobutyl phthalate in 2015 and the other stated that they manufactured di-isobutyl
phthalate in 2015 (U.S. EPA, 2019a). According to 2016 public CDR data, di-isobutyl phthalate is imported
into the United States in solid form and manufactured in liquid form (U.S. EPA, 2019a).
E.l.1.1 Domestic Manufacturing
Di-isobutyl phthalate is classified as part of the phthalate ester grouping of compounds predominantly used
as plasticizers in the production of varied plastic products. Di-isobutyl phthalate is typically termed a
"specialty" plasticizer, as it is a fast-fusing, low-carbon-number phthalate that can be used for varying
applications (Cadogan & Howick, 2000). Di-isobutyl phthalate is typically manufactured through catalytic
esterification of phthalic anhydride with isobutanol. Manufacturing operations take place in closed systems
either via batch or more automated continuous operations and will typically involve the purification of di-
isobutyl phthalate product streams via either vacuum distillation or by passing over activated charcoal as a
means of recovering unreacted alcohols (CPSC, 2010).
E.l.1.2 Import
In general, chemicals may be imported into the United States in bulk via water, air, land, and intermodal
shipments (Tomer and Kane, 2015). These shipments take the form of oceangoing chemical tankers,
railcars, tank trucks, and intermodal tank containers. Di-isobutyl phthalate is shipped in solid form
according to 2016 CDR. The facility in 2016 CDR that imported di-isobutyl phthalate in 2015 imported di-
isobutyl phthalate directly to their site for on-site processing or use (U.S. EPA, 2019a).
E.1.2 Processing and Distribution
E.l.2.1 Incorporated into a Formulation, Mixture or Reaction Product
Incorporation into a formulation, mixture or reaction product refers to the process of mixing or blending of
several raw materials to obtain a single product or preparation. Exact process operations involved in the
incorporation of di-isobutyl phthalate into a chemical formulation, mixture, or reaction product are
dependent on the specific manufacturing process or processes involved. One company reported to 2016
CDR that di-isobutyl phthalate is used as a plasticizer in the formulation of adhesives and one company
reported that di-isobutyl phthalate is used as a plasticizer in plastic products (U.S. EPA, 2019a). Di-isobutyl
phthalate is also used as an additive to ink, toner, and colorant products, automotive care products, and
other miscellaneous products (U.S. EPA, 2019a; U.S. CPSC, 2015; UNIPLEX, 155). The exact processes
used to formulate products containing di-isobutyl phthalate are not known at this time; however, several
ESDs published by the OECD and Generic Scenarios published by EPA have been identified that provide
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general process descriptions for these types of products. EPA plans to evaluate processing uses of di-
isobutyl phthalate during risk evaluation.
E.l.2.2 Incorporated into an Article
Incorporation into an article typically refers to a process in which a chemical becomes an integral
component of an article (as defined at 40 CFR 704.3) for distribution in commerce. Exact process
operations involved in the incorporation of di-isobutyl phthalate-containing formulations or reaction
products are dependent on the article. One company reported to 2016 CDR that di-isobutyl phthalate is used
as a plasticizer in plastic products and another company reported that di-isobutyl phthalate is used as a
plasticizer in construction and transportation equipment manufacturing (U.S. EPA, 2019a). EPA plans to
evaluate processing uses of di-isobutyl phthalate during risk evaluation.
E.l.2.3 Repackaging
Repackaging refers to preparation of a chemical substance for distribution into commerce in a different
form, state, or quantity than originally received/stored, where such activities include transferring a chemical
substance form a bulk storage container into smaller containers.
E.l.2.4 Recycling
The 2016 CDR reports that no companies reported recycling (U.S. EPA, 2019a). A public commenter
indicated that di-isobutyl phthalate may be recycled (Earth Justice 2019). EPA plans to evaluate the
potential for recycling of di-isobutyl phthalate during risk evaluation.
E.1.3 Uses
E.l.3.1 Adhesives, Sealants, Paints, and Coatings
Di-isobutyl phthalate is used in a variety of adhesive, sealant, paint, and coating products. Specifically, di-
isobutyl phthalate is used in adhesives and sealants used in transportation equipment manufacturing,
adhesives and sealants used in construction, food packaging adhesives, two-component high-strength
anchoring adhesive, surface adhesives and seam adhesive for solid surfacing, motor vehicle paints, paints,
lacquers, and varnishes (U.S. EPA, 2019a; Auto Alliance 2019; Aerospace Industries Association 2019;
U.S. CPSC, 2015; Lanxess 2015; Azon USA 2015; Glue 360 Inc. 2018; ITW Performance Polymers 2015).
The application procedure depends on the type of adhesive, sealant, paint, or coating formulation and the
type of substrate. The formulation is loaded into the application reservoir or apparatus and applied to the
substrate via brush, spray, roll, dip, curtain, or syringe or bead application. Application may be manual or
automated. After application, the adhesive, sealant, paint, or coating is allowed to dry or cure (OECD,
2015). The drying/curing process may be promoted through the use of heat or radiation (radiation can
include ultraviolet (UV) and electron beam radiation (OECD, 2010).
E.l.3.2 Building/Construction Materials Not Covered Elsewhere
Di-isobutyl phthalate is a constituent of building and construction materials used for brick laying (U.S.
EPA, 2019a), concrete (Lanxess 2015), and construction adhesives (U.S. EPA, 2019a), and other materials
(U.S. CPSC, 2015; Lanxess 2015). EPA plans to evaluate these uses of di-isobutyl phthalate during risk
evaluation.
E.l.3.3 Ink, Toner, and Colorant Products
Di-isobutyl phthalate is used in coloring agents, dyes, pigments (as a dispersing agent), and printing inks
(U.S. CPSC, 2015; Lanxess 2015). Printing inks are comprised of colorants (e.g., pigments, dyes and
toners) dispersed in a formulation to form a paste, liquid or solid which can be applied to a substrate surface
70
-------
and dried (U.S. EPA, 2010). Industrial printing processes can be categorized as lithographic, flexographic,
gravure, letterpress, screen printing or digital printing. Commercial printing may involve lithographic,
flexographic, gravure and letterpress printing - all of which involve the transfer of images from printing
plates to a substrate. Screen printing requires a mesh screen to transfer the ink to a substrate, whereas digital
printing allows for the transfer of a digital image directly onto a substrate. Inkjet printing is the most
common form of digital printing. It involves the application of small drops of ink onto a substrate, with
direct contact between the ink nozzle and the substrate (U.S. EPA, 2010).
E.l.3.4 Plastic and Rubber Products
As described in Section E. 1.2.2, di-isobutyl phthalate is used to increase the flexibility of plastic and rubber
products, which may be used industrially, commercially, and by consumers. Di-isobutyl phthalate is used in
plastics used in the building and construction industry, floor coverings, toys, and food packaging (Earth
Justice 2019; U.S. CPSC, 2015; Lanxess 2015). Di-isobutyl phthalate is likely entrained in the products;
however, DIHP may be available for exposure depending on the application of the end use products, such
as if building and construction materials are cut prior to installation. EPA plans to evaluate these uses of di-
isobutyl phthalate during risk evaluation.
E.1.4 Other Uses
Di-isobutyl phthalate is also used in fuels and related products (U.S. CPSC, 2015; Lanxess 2015), paper
products (U.S. CPSC, 2015), catalyst solvent (US EPA, 2019a), explosive materials (U.S. CPSC, 2015), air
care products (U.S. CPSC, 2015), and lubricants (U.S. CPSC, 2015). Di-isobutyl phthalate is also used in
laboratory settings (Sigma Aldrich 2020). Laboratory procedures are generally done within a fume hood, on
a bench with local exhaust ventilation or under general ventilation.
EPA plans to evaluate these uses of di-isobutyl phthalate during risk evaluation.
E.1.5 Disposal
Each of the conditions of use of di-isobutyl phthalate may generate waste streams of the chemical that are
collected and transported to third-party sites for disposal, treatment, or recycling. Industrial sites that treat
or dispose onsite wastes that they themselves generate are assessed in each condition of use assessment.
Similarly, point source discharges of di-isobutyl phthalate to surface water are assessed in each condition of
use assessment (point source discharges are exempt as solid wastes under RCRA). Wastes of di-isobutyl
phthalate that are generated during a condition of use and sent to a third-party site for treatment, disposal, or
recycling may include the following:
• Wastewater: di-isobutyl phthalate may be contained in wastewater discharged to POTW or other,
non-public treatment works for treatment. Industrial wastewater containing di-isobutyl phthalate
discharged to a POTW may be subject to EPA or authorized NPDES state pretreatment programs.
The assessment of wastewater discharges to POTWs and non-public treatment works of di-isobutyl
phthalate is included in each of the condition of use assessments.
• Solid Wastes: Solid wastes are defined under RCRA as any material that is discarded by being:
abandoned; inherently waste-like; a discarded military munition; or recycled in certain ways (certain
instances of the generation and legitimate reclamation of secondary materials are exempted as solid
wastes under RCRA). Solid wastes may subsequently meet RCRA's definition of hazardous waste
by either being listed as a waste at 40 CFR §§ 261.30 to 261.35 or by meeting waste-like
characteristics as defined at 40 CFR §§ 261.20 to 261.24. Solid wastes that are hazardous wastes are
71
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regulated under the more stringent requirements of Subtitle C of RCRA, whereas non-hazardous
solid wastes are regulated under the less stringent requirements of Subtitle D of RCRA.
Di-isobutyl phthalate is not a listed hazardous waste under RCRA.
• Wastes Exempted as Solid Wastes under RCRA: Certain conditions of use of di-isobutyl phthalate
may generate wastes of di-isobutyl phthalate that are exempted as solid wastes under 40 CFR §
261.4(a). For example, the generation and legitimate reclamation of hazardous secondary materials
of di-isobutyl phthalate may be exempt as a solid waste.
E.2 Preliminary Occupational Exposure Data
NIOSH HHEs have not been conducted with a focus on di-isobutyl phthalate monitoring and/or workplace
exposure to date. Di-isobutyl phthalate does not have an OSHAIMIS code. As such, OSHA has not
collected monitoring data for this chemical.
72
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Appendix F SUPPORTING INFORMATION- CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES
Table Apx
M. Worker and Occupational Non-User Exposure Concepl
tual Model Supporting Table
l.ik ( \ik-
C;iU-»iir\
Ri'k'sisi- / l.\|)iisuiv
I'ApilMIIV
P;illl\\;i\
l".\|)IISUIV
Run It/
Ki-ivplnr /
Piipuhiliiiii
PlilllS III
I'.Nillllilll'
K;iliim;ik-
Manufacture
Domestic
Manufacture
Domestic
Manufacture
Manufacture and
Packaging
Liquid
Contact
Dermal
Workers
Yes
2016 CDR references manufacture in
liquid form. Thus, the potential for
exposures to workers exists during
manufacturing.
Solid Contact
1 )ermal
Workers
No
2016 CDR does not reference manufacture
in solid lorni.
Vapor
Inhalation
Workers.
ONI J
No
Due to di-isobutyl phthalate's vapor
pressure (VP) (VP = 4.76 x 10-5 mm 1 Ig)
at room temperature, potential for vapor
generation is low.
Mist
Inhalation/
1 )ermal
Workers.
ONU
No
Mist generation is not expected during
manufacturing.
Dust
Inhalation/
1 )ermal
Workers.
ONLJ
No
2016 CDR does not reference manufacture
in solid form.
Liquid/Solid
Contact
1 )ermal
ONU
No
1 )ermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Import
Import
Repackaging of
import containers
I .iquid
Contact
1 )ermal
Workers
No
2016 CDR does not reference import in
liquid form.
Solid Contact
Dermal
Workers
Yes
2016 CDR references import in solid form.
The potential for exposures to workers
exists during import, but exposure will
only occur in the event the imported
material is repackaged.
73
-------
l.ili-( \ill-
Slum-
(;ili-»iir\
Slll)i;ili-»H|'\
ki-li-;isi- / l.\|)iisuiv
Sii-iiiiriu
l".\|)osuri-
l".\|)iisiin-
kuuli-
ki-ii-plnr /
Pupiihiliiiii
PlilllS III
l;.\:illl;ili-
kiiiiiuiiili-
Vapor
Inhalation
Workers,
ONI J
No
])ue to di-isobutyl phthalate's vapor
pressure (VP) (VP = 4.76 x 10-5 mm I Ig)
at room temperature, potential lor vapor
generation is low.
Mist
Inhalation/
I )ermal
Workers,
ONI J
No
Mist generation is not expected during
repackaging of import containers.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
2016 CDR references solid form, which
may create dust. The potential for dust
exposures to workers and ONUs exists
during import, but exposure will only
occur in the event the imported material is
repackaged.
Liquid/Solid
Contact
Dermal
ONI J
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Processing
Incorporated
into
formulation,
mixture or
reaction
product
Plasticizers in:
Adhesive
manufacturing;
Plastic product
manufacturing
Processing into
formulations,
mixtures, or reaction
product
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during processing (incorporation
into formulation, mixture, or reaction
product), as di-isobutyl phthalate may be
in liquid form.
Solvents (which
become part of
product
formulations or
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during processing (incorporation
into formulation, mixture, or reaction
product), as di-isobutyl phthalate may be
in solid form.
mixture): Plastic
material and resin
manufacturing;
Paints and
Coatings; Viscosity
Adjusters
Vapor
Inhalation
Workers,
ONU
Yes
Due to di-isobutyl phthalate's vapor
pressure (VP) (VP = 4.76 x 10-5 mm Hg)
at room temperature, potential for vapor
generation is low. However, some of these
operations may occur at elevated
temperatures, which increase the potential
for vapor generation.
74
-------
l.ili-( \ill-
Slum-
(;ili-»iir\
Slll)i;ili-»H|'\
ki-li-;isi- / r.\|>iiMin-
Sii-iiiiriii
l".\|)osuri-
l".\|)iisiin-
kuuli-
ki-ii-plnr /
Pupiihiliiiii
PlilllS III
l;.\:illl;ili-
kiiiiiuiiili-
Fuels and Related
Products (e.g., Fuel
Mist
Inhalalion/
Dermal
Workers.
ONU
No
Mist generation is not expected during
processing (incorporation into formulation,
mixture, or reaction product).
additives)
Processing aids, not
otherwise listed
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for dust exposures to
workers and ONUs exists during
processing as di-isobutyl phthalate may be
in solid form.
Inks, Toner, and
Colorant Products
(e.g., Toner/ printer
cartridge)
Paper Products
Liquid/Solid
Contact
I )ermal
ONU
No
Dermal exposure by ()NW is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Plastic and rubber
products not
covered elsewhere
Fabric, textile, and
leather products not
covered elsewhere
Incorporated
into articles
Plasticizers in:
Construction;
plastic product
manufacturing;
Plastics and Rubber
product
manufacturing
(Plastic Converting)
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during incorporation into articles, as
di-isobutyl phthalate may be in liquid
form.
75
-------
l.ili-( \ill-
Slum-
C';ili-»iir\
Slll>iali-»iir\
ki-li-asi- / l.\|)iisuiv
Sii-iiariu
l".\|)osuri-
l".\|)iisiin-
kuuli-
ki-ii-plnr /
Population
PlilllS III
l;.\:illl;ili-
kiiiiiuiiili-
transportation
equipment
manufacturing
Other article
manufacturing
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during processing (incorporation
into articles), as di-isobutyl phthalate may
be in solid form, such as for resins.
Vapor
Inhalation
Workers,
ONU
Yes
Due to di-isobutyl phthalate's vapor
pressure (VP) (VP = 4.76 x 10-5 mm Hg)
at room temperature, potential for vapor
generation is low. However, some of these
operations may occur at elevated
temperatures, which increase the potential
for vapor generation.
Mist
Inhalation/
I )ermal
Workers.
ONU
No
Mist generation is not expected during
incorporation into article.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for exposures to workers
exists during processing (incorporation
into articles), as di-isobutyl phthalate may
be in solid form, such as for resins.
I.iquid/Solid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Repackaging
Repackaging
Repackaging into
large and small
containers
I. i quid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during repackaging, as di-isobutyl
phthalate may be in liquid form.
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during repackaging, as di-isobutyl
phthalate may be incorporated into
products in solid form.
Vapor
Inhalation
Workers.
ONU
No
Due to di-isobulyl phthalate's vapor
pressure (VP) (VP = 4.76 * 10-5 mm I Ig)
at room temperature, potential for vapor
generation is low.
76
-------
l.ili-( \ill-
Slum-
(;ili-»iir\
Slll)i;ili-»H|'\
ki-li-;isi- / l.\|)iisuiv
Sii-iiiiriu
l".\|)osuri-
P;illi\\;i\
l".\|)iisiin-
kuuli-
ki-ii-plnr /
Pupiihiliiiii
PlilllS III
l;.\:illl;ili-
kiiiiiuiiili-
Mist
Inhalation/
I )ermal
Workers.
ONIJ
No
Mist generation is not expected during
repackaging.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
The potential for dust exposures to
workers and ONUs exists during
processing (repackaging), as di-isobutyl
phthalate may be incorporated into
products in solid form.
Liquid/Solid
Contact
I )ermal
ONIJ
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Recycling
Recycling
Recycling of di-
isobutyl phthalate
and products
containing di-
isobutyl phthalate
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use as liquid
formulations may be recycled.
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use as solid formulations
may be recycled.
Vapor
Inhalation
Workers.
ONU
No
Due to di-isobutyl phthalate's vapor
pressure (VP) (VP = 4.76 * 10-5 mm I Ig)
at room temperature, potential for vapor
generation is low.
Mist
Inhalation/
1 )ermal
Workers.
ONU
No
Mist generation is not expected during
recycling of liquid wastes.
Dust
Inlialation/
Dermal
Workers,
ONU
Yes
Dust generation is possible during
recycling of solid wastes.
Liquid/Solid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Paints and
coatings;
Paints and coatings;
adhesives and
Liquid
Contact
Dermal
Workers
Yes
These products are in liquid form;
therefore, exposures to workers exists for
77
-------
l.ili ( \ill-
Slum-
(;ili-»iir\
Slll)i;ili-»H|'\
ki-li-;isi- / r.\|>iiMin-
Sii-iiiiriii
l".\|)osuri-
l".\|)iisiin-
kuuli-
ki-ii-plnr /
Pupiihiliiiii
PlilllS III
l;.\:illl;ili-
kiiiiiuiiili-
Industrial/
Commercial
Use
adhesives and
sealants;
Furnishing,
Cleaning,
Treatment/Care
Products; Air
Care Products
(e.g., Air
Freshener)
sealants;
Furnishing,
Cleaning,
Treatment/Care
Products; Air Care
Products (e.g., Air
Freshener)
Spray, brush, roll,
dip, and other forms
of application
di-isobutyl phthalate used in these
products.
Solid Contact
Dermal
Workers
No
The potential for exposures to solid di-
isobulyl phthalate is not expected during
the use of these products because they are
in liquid form.
Vapor
Inhalation
Workers.
ONI J
No
Due to di-isobulyl phlhalale's vapor
pressure (VP) (VP = 4.76 x 10-5 mm I Ig)
at room temperature, potential for vapor
generation is low.
Mist
Inhalation/
Dermal
Workers,
ONU
Yes
Mist generation is possible during
application of these products.
Dust
Inhalation/
1 )ermal
Workers.
ONU
No
I'he potential for exposures to solid di-
isobulyl phthalate is not expected during
the use of these products because they are
in liquid form.
Liquid/Solid
Contact
1 )ermal
ONU
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Fuels and
related
products;
Fabric, textile,
and leather
Fuels and related
products; Fabric,
textile, and leather
products not
covered elsewhere
Use of fuels and
related products
Liquid
Contact
Dermal
Workers
Yes
These products are in liquid form;
therefore, exposures to workers exists for
di-isobutyl phthalate used in these
products.
products not
covered
elsewhere (e.g.,
Textile (fabric)
dyes); Inks,
Toner, and
Colorant
(e.g., Textile
(fabric) dyes); Inks,
Toner, and Colorant
Products (e.g.,
Toner/printer
Use of fabric dyes
Use of inks, toner,
and colorant products
(e.g., printing)
Solid Contact
1 )ermal
Workers
No
I'he potential for exposures to solid di-
isobulyl phthalate is not expected during
the use of these products because they are
in liquid form.
Vapor
Inhalation
Workers.
ONU
No
Due to di-isobulyl phlhalale's vapor
pressure (VP) (VP = 4.76 x 10-5 mm I Ig)
78
-------
l.ili-( \ill-
Slum-
C';ili-»iir\
Slll>iali-»iir\
ki-li-asi- / r.\|>iiMin-
Sii-iiiiriii
l".\|)osuri-
l".\|)iisiin-
kuuli-
ki-ii-plnr /
Population
I'lilllS III
l;.\:illl;ili-
kiiiiiuiiili-
Products (e.g.,
Toner/printer
cartridge);
catalyst
solvent;
lubricants
cartridge); catalyst
solvent; lubricants
Use of catalyst
at room temperature, potential lor vapor
generation is low.
solvents
Mi si
Inhalation/
I )ermal
Workers.
ONI I
No
Mist generation is not expected during use
of these products.
Use of lubricants
Dust
Inhalation/
Dermal
Workers.
ONI J
No
The potential for exposures to solid di-
isobutyl phthalate does not exist during the
use of these products because they are in
liquid form.
Liquid/Solid
Contact
I )ermal
ONIJ
No
Dermal exposure by ()NIJ is not expected
for this condition of use as they arc not
expected to directly handle the chemical.
Plastic and
rubber
products not
covered
elsewhere;
Building/
construction
materials not
covered
elsewhere;
floor
coverings; food
packaging
material; paper
products;
explosive
Plastic and rubber
products not
covered elsewhere;
Building/
construction
Use of articles made
using di-isobutyl
phthalate
Liquid
Contact
Dermal
Workers
No
The potential for exposures to liquid di-
isobutyl phthalate is not expected during
the use of these products because they are
solid articles.
materials not
covered elsewhere;
floor coverings;
food packaging
material; paper
products; explosive
materials
Solid Contact
Dermal
Workers
Yes
These products may include solid articles
in which di-isobutyl phthalate is entrained;
therefore, di-isobutyl phthalate exposures
to workers is unlikely but may occur if
cutting /sawing / other machining
operations occur.
Vapor
Inhalation
Workers.
ONIJ
No
Due to di-isobutyl phthalate's vapor
pressure (VP) (VP = 4.76 * 10-5 mm I Ig)
at room temperature, potential for vapor
generation is low.
materials
Mist
Inhalation/
1 )ermal
Workers,
ONIJ
No
Mist generation is not expected during use
of these products.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
These products may include solid articles
in which di-isobutyl phthalate is entrained:
therefore, di-isobutyl phthalate exposures
to workers and ONUs is unlikely but may
79
-------
l.ili-( \ill-
Slum-
(;ili-»iir\
Slll)i;ili-»H|'\
ki-li-;isi- / l.\|)iisuiv
Sii-iiiiriu
l".\|)osuri-
l".\|)iisiin-
kuuli-
ki-ii-plnr /
Pupiihiliiiii
I'lilllS III
l;.\:illl;ili-
kiiiiiuiiili-
occur if cutting /sawing / other machining
operations occur.
Liquid/Solid
Contact
Dermal
ONI J
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
Disposal
Disposal
Disposal of di-
isobutyl phthalate
wastes
Worker handling of
wastes
Liquid
Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use as liquid
formulations may be disposed.
Solid Contact
Dermal
Workers
Yes
The potential for exposures to workers
exists during this use as solid formulations
may be disposed
Vapor
Inhalation
Workers.
ONI J
No
Due to di-isobulyl phthalate's vapor
pressure (VP) (VP = 4.76 * 10-5 mm I la)
at room temperature, potential for vapor
generation is low.
Mist
Inhalation/
1 )ermal
Workers,
ONU
No
Mist generation is not expected during
disposal ofliquid wastes.
Dust
Inhalation/
Dermal
Workers,
ONU
Yes
Dust generation is possible during disposal
of solid wastes.
Liquid/Solid
Contact
1 )ermal
ONIJ
No
Dermal exposure by ONU is not expected
for this condition of use as they are not
expected to directly handle the chemical.
80
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Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table
l.il'c Cu'le
S(;i»e
C;iK'lior\
Siil)c;iU'}ior\
Kcloiiso from
sou IVO
l'A|)OMIIV
Pillliw ;¦>
Koulc
Receptor
I'liins In
l-'.\;ilii;ilc
Kiilioiiiile
Fabric, Textile
and Leather
Products no
Covered
Elsewhere
(Article)
Direct contact
through handling
of articles
containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Direct contact
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition of
use and will be analyzed.
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Floor Coverings
(Article)
Direct contact
through handling
of articles
containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Direct contact
through
mouthing of
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition of
use and will be analyzed.
81
-------
l.ilo ( >cle
StiliiO
( iilciion
Siihc.ik'iion
Kcloiiso from
sou ive
l'A|)OMIIV
PiUliNin
Koulo
Km*|)lor
I'lilllS In
Kiilioiiiilc
articles
containing
chemical
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Packaging,
Paper, Plastic,
Hobby Products
Paper Products
(Article)
Direct contact
through handling
of articles
containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Direct contact
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition of
use and will be analyzed.
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Plastic and
Rubber Products
not Covered
Elsewhere
Direct contact
through handling
of articles
containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
82
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l.ilo ( >cle
StiliiO
( iilciion
Siihc.ik'iion
Kcloiiso from
sou ive
l'A|)OMIIV
PiUliNin
Koulo
Km*|)lor
I'lilllS In
Kiilioiiiilc
(Article)
Direct contact
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition of
use and will be analyzed
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Toys,
Playground, and
Sporting
Equipment
(Article)
Direct contact
through handling
of articles
containing
chemical
Direct
Contact
Dermal
Consumers
Yes
Dermal exposure may occur for this
condition of use, dermal exposure will be
analyzed.
Direct contact
through
mouthing of
articles
containing
chemical
Mouthing
Oral
Consumers
Yes
Oral exposure may occur for this condition of
use and will be analyzed
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
83
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l.ilo ( >cle
StiliiO
( iilciion
Siihc.ik'iion
Kcloiiso from
sou ive
l'A|)OMIIV
PiUliNin
Koulo
Km*|)lor
I'lilllS In
Kiilioiiiilc
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Adhesives and
Sealants
(Product)
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed
Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation and
dermal exposures would be expected and
analyzed
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Air Care
Products
(Product)
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
84
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l.ilo ( >cle
StiliiO
( iilciion
Siihc.ik'iion
Kcloiiso from
sou ive
l'A|)OMIIV
PiUliNin
Roulc
Km*|)lor
I'lilllS lo
Kiilioiiiilc
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed
Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation and
dermal exposures would be expected and
analyzed
Consumer
Use
Furnishing,
Cleaning,
Treatment/Care
Products
Cleaning and
Furnishing Care
Products
(Product)
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed
Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation and
dermal exposures would be expected and
evaluated
85
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l.ilo ( >cle
StiliiO
( iilciion
Siihc.ik'iion
Kcloiiso from
sou ive
l'A|)OMIIV
PiUliNin
Koulo
Km*|)lor
I'lilllS In
Kiilioiiiilc
Consumer
Use
Packaging,
Paper, Plastic,
Hobby Products
Ink, Toner and
Colorant
Products
(Product)
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed
Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation and
dermal exposures would be expected and
analyzed
Consumer
Use
Construction,
Paint, Electrical,
and Metal
Products
Paints and
Coatings
(Product)
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dermal, oral and inhalation exposure from
this condition of use may occur and will be
analyzed
Direct contact
through
application or
use of products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in using the chemical.
86
-------
l.ilo ( >cle
StiliiO
( iilciion
Siihc.ik'iion
Kcloiiso from
sou ive
l'A|)OMIIV
PiUliNin
Koulo
Km*|)lor
I'lilllS In
Kiilioiiiilc
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed
Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
Yes
If product is applied as a mist, inhalation and
dermal exposures would be expected and
analyzed
Consumer
Handling of
Disposal and
Waste
Wastewater,
Liquid wastes
and solid wastes
Wastewater,
Liquid wastes
and solid wastes
Long-term
emission/mass-
transfer,
Abrasion,
Transfer to Dust
Dust
Dermal,
Inhalation,
Oral
Consumers,
Bystanders
Yes
Dust generation is possible during the
handling of solid waste
Direct contact
through handling
or disposal of
products
Liquid
Contact
Dermal
Consumers
Yes
Exposure is expected to be primarily
restricted to consumers who are directly
involved in handling and disposal of the
chemical.
Long-term
emission/mass-
transfer through
application or
use of products
Vapor
Inhalation
Consumers
and
Bystanders
Yes
Inhalation is possible and will be analyzed
Direct contact
through
application or
use of products
Mist
Inhalation
and
Dermal
Consumers
and
Bystanders
No
Mist generation is not expected during
handling or disposal
87
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Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table A
)x H-l. General Population and Environmental Exposure Conceptual Model Supporting Table
I _i IV
( \cle
( ;i(eiion
Kok'iisc
I'1\|)osiiiv
Pillliw :¦> /
Modiii
I'lxposuro
Koii ics
Kcccplor /
I'opuliilion
Phins In
r.\;iliiiili*
Kiilimiiilo
Near facility
ambient air
concentrations
Inhalation
General
Population
Yes
Emissions to Air
Emissions to Air
Indirect
deposition to
nearby bodies
of water and
soil catchments
Oral
Dermal
General
Population
Yes
TBD
Aquatic and
Terrestrial
Receptors
Di-isobutyl phthalate deposition
to nearby bodies of water and
soil are expected exposure
pathways, not covered under
other EPA regulations, and,
therefore in scope.
Yes
All
TBD
Wastewater or
Liquid Wastes
Industrial pre-
treatment and
wastewater
treatment, or POTW
Direct release
into surface
water and
indirect
partitioning to
sediment
Aquatic and
Terrestrial
Receptors
Yes
Release of di-isobutyl phthalate
into surface water and indirect
partitioning to sediment exposure
pathways to aquatic and
terrestrial receptors will be
analyzed
Oral
Dermal
General
Population
Yes
Release of di-isobutyl phthalate
into surface water and indirect
partitioning to sediment and
bioaccumulation exposure
pathways to the general
population will be analyzed.
88
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1 -i IV
( \cle
Csilcfion
Kok'iisc
I'lxposiiiv
Pillliw :¦> /
Modiii
I'lxpoMirc
Koii Ics
Kcccplor /
Population
Pliins In
l''.\;iliiiili'
Kiilioiiiilo
Drinking Water
via Surface or
Ground Water
Oral
Dermal and
Inhalation
(e.g.
showering)
General
Population
Yes
Release of di-isobutyl phthalate
into surface water and indirect
partitioning to drinking water is
an expected exposure pathway.
Biosolids:
application to
soil and/or
migration to
groundwater
Oral (e.g.
ingestion of
soil)
Inhalation
General
Population
Yes
EPA plans to analyze the
pathway from biosolids to the
general population and terrestrial
species.
and/or surface
water
TBD
Terrestrial
receptors
Yes
Disposal
Solid and Liquid
Municipal landfill
and other land
disposal
Leachate to
soil, ground
water and/or
mitigation to
surface water
Oral
Dermal
General
Population
Yes
EPA plans to analyze the
pathway from municipal landfills
and other land disposal to the
general population, aquatic and
terrestrial receptors.
Wastes
TBD
Aquatic and
Terrestrial
Receptors
89
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