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Dossier for Candidate Low-Priority Substance Decanedioic
acid, 1,10-dibutyl ester
(CASRN 109-43-3)
(Dibutyl Sebacate)
For Release at Proposal
August 9, 2019
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue
Washington, DC 20460
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Contents
1. Introduction 1
2. Background on Dibutyl Sebacate 3
3. Physical-Chemical Properties 4
3.1 References 6
4. Relevant Assessment History 7
5. Conditions of Use 8
6. Hazard Characterization 12
6.1 Human Health Hazard 15
6.1.1 Absorption, Distribution, Metabolism, and Excretion 16
6.1.2 Acute Toxicity 17
6.1.3 Repeated Dose Toxicity 17
6.1.4 Reproductive and Developmental Toxicity 17
6.1.5 Genotoxicity 18
6.1.6 Carcinogenicity 18
6.1.7 Neurotoxicity 18
6.1.8 Skin Sensitization 19
6.1.9 Skin Irritation 19
6.1.10 Eye Irritation 19
6.1.11 Hazards to Potentially Exposed or Susceptible Subpopulations 20
6.2 Environmental Hazard 20
6.2.1 Acute Aquatic Toxicity 20
6.2.2 Chronic Aquatic Toxicity 20
6.2.3 Terrestrial Toxicity 21
6.3 Persistence and Bioaccumulation Potential 21
6.3.1 Persistence 21
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6.3.2 Bioaccumulation Potential 21
7. Exposure Characterization 12
7.1 Production Volume Information 12
7.2 Exposures to the Environment 12
7.3 Exposures to the General Population 13
7.4 Exposures to Potentially Exposed or Susceptible Subpopulations 13
7.4.1 Exposures to Workers 13
7.4.3 Exposures to Consumers 14
7.4.2 Exposures to Children 14
8. Summary of Findings 15
8.1. Hazard and Exposure Potential of the Chemical Substance 15
8.2. Persistence and Bioaccumulation 16
8.3. Potentially Exposed or Susceptible Subpopulations 16
8.4. Storage near Significant Sources of Drinking Water 17
8.5. Conditions of Use or Significant Changes in Conditions of Use of the Chemical Substance 18
8.6. The Volume or Significant Changes in Volume of the Chemical Substance Manufactured or Processed.... 19
8.7. Other Considerations 19
9. Proposed Designation 20
Appendix A: Conditions of Use Characterization I
A.1. CDR Manufacturers and Production Volume I
A.2. Uses II
A.2.1 Methods for Uses Products Table II
A.2.2 Uses of Dibutyl Sebacate IV
A.3 References XXVII
Appendix B: Hazard Characterization XXIX
B.1 References XXXVII
Appendix C: Literature Search Outcomes XXXIX
C.1 Literature Search and Review XXXIX
Figure C.1: Overview of the Literature Search and Review Process XXXIX
C.1.1 Search for Analog Data XXXIX
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C.1.2 Search Terms and Results XL
C.2 Excluded Studies and Rationale XLII
C.2.1 Human Health Hazard Excluded References XLII
C.2.2 Environmental Hazard XLVIII
C.2.3 Fate L
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Tables
3
Table 1: Dibutyl Sebacate at a Glance
Table 2: Physical-Chemical Properties for Dibutyl Sebacate 4
Table 3: Conditions of Use for Dibutyl Sebacate 12
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects 12
Table 5: Dibutyl Sebacate and Analog Structures 16
Table A.1:1986-2015 National Production Volume Data for Dibutyl Sebacate (Non-Confidential Production ^
Volume in Pounds)
Table A.2: Sources Searched for Uses of Dibutyl Sebacate II
Table A3: Uses of Dibutyl Sebacate 12
Table B.1: Human Health Hazard XXIX
Table B.2: Environmental Hazard XXXIV
Table B.3: Fate XXXV
Table C.1: Sources Used for Analog Search XL
Table C.2: Search Terms Used in Peer-Reviewed Databases XL
Table C.3: Search Terms Used in Grey Literature and Additional Sources XLII
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard XLIII
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human
Health Hazard
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Human Health Hazard - Animal
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Human Health Hazard - In Vitro
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard XLVIII
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for
Environmental Hazard XLVIII
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Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Environmental Hazard
Table C.11: Off-Topic References Excluded at Initial Screening for Fate L
Table C.12: Screening Questions and Off-Topic References Excluded at Full Text Screening for Fate LI
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Fate
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1. Introduction
In the Lautenberg amendments to the Toxic Substances Control Act (TSCA) (section 6(b)(1)(B)) and
implementing regulations (40 CFR 702.3), a low-priority substance is described as a chemical substance
that the Administrator concludes does not meet the statutory criteria for designation as a high-priority
substance, based on information sufficient to establish that conclusion, without consideration of costs or
other non-risk factors. A high-priority substance is defined as a chemical substance that the Administrator
concludes, without consideration of costs or other non-risk factors, may present an unreasonable risk of
injury to health or the environment because of a potential hazard and a potential route of exposure under
the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations
identified as relevant by the Administrator. Decanedioic acid, 1,10-dibutyl ester, referenced as dibutyl
sebacate for the remainder of this document, is one of the 40 chemical substances initiated for
prioritization as referenced in a March 21, 2019 notice (84 FR 10491).1
Before determining low or high prioritization status, under EPA's regulations at 40 CFR 702.92 and
pursuant to section 6(b)(1)(A) of the statute, EPA will generally use reasonably available information to
screen the candidate chemical substance under its conditions of use against the following criteria and
considerations:
• the hazard and exposure potential of the chemical substance;
• persistence and bioaccumulation;
• potentially exposed or susceptible subpopulations;
• storage near significant sources of drinking water;
• conditions of use or significant changes in the conditions of use of the chemical substance;
• the chemical substance's production volume or significant changes in production volume; and
• other risk-based criteria that EPA determines to be relevant to the designation of the chemical
substance's priority.
Designation of a low-priority substance indicates that the chemical does not meet the statutory criteria for
a high-priority substance and that a risk evaluation is not warranted at the time.
This screening-level review is organized as follows:
• Section 1 (Introduction): This section explains the requirements of the Lautenberg amendments to
the Toxic Substances Control Act (TSCA) and implementing regulations - including the criteria
and considerations ~ pertinent to prioritization and designation of low-priority substances.
• Section 2 (Background on the proposed Low Priority Substance): This section includes
information on attributes of the chemical substance, including its structure, and relates them to its
functionality.
1 https://www.federalregister.gov/documents/2019/03/21/2019-05404/imtiation-of-prioritization-under-tlie-toxic-substances-
control-act-tsca
2 The prioritization process is explained in the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic-
Substances Control Act (82 FR 33753).
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• Section 3 (Physical Chemical Properties) : This section includes a description of the physical-
chemical properties of the chemical substance and explains how these properties lead to the
chemical's fate, transport, and exposure potential.
• Section 4 (Relevant Assessment History): This section includes an overview of the outcomes of
other governing entities" assessments of the chemical substance.
• Section 5 (Conditions of Use): This section presents the chemical substance's known, intended,
and reasonably foreseen conditions of use under TSCA.
• Section 6 (Hazard Characterization): This section summarizes the reasonably available hazard
information and benchmarks the information against low-concern thresholds.
• Section 7 (Exposure Characterization): This section includes a qualitative summary of potential
exposures to the chemical substance.
• Section 8 (Summary of Findings): In this section, EPA presents information pertinent to
prioritization against each of the seven statutory and regulatory criteria and considerations, and
proposes a conclusion based on that evidence.
• Section 9 (Proposed Designation): In this section, EPA presents the proposed designation for this
chemical substance.
• Appendix A (Conditions of Use Characterization): This appendix contains a comprehensive list of
TSCA and non-TSCA uses for the chemical substance from publicly available databases.
• Appendix B (Hazard Characterization): This appendix contains information on each of the
studies used to support the hazard evaluation of the chemical substance.
• Appendix C (Literature Search Outcomes): This appendix includes literature search outcomes and
rationales for studies that were identified in initial literature screening but were found to be off-
topic or unacceptable for use in the screening-level review.
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2. Background on Dibutyl Sebacate
Table 1 below provides the CAS number, synonyms, and other information on dibutyl sebacate.
Table 1: Dibutyl Sebacate at a Glance
Chemical Name
Dibutyl Sebacate
CASRN
109-43-3
Synonyms
Dibutyl decanedioate; Butyl sebacate; Di-n-butyl sebacate, Decanedioic acid dibutyl ester,
Bis(n-butyl) sebacate, Di-n-butylsebacate, Sebacic acid dibutyl ester, Bis(n-butyl)sebacate;
Decanedioic acid, 1,10-dibutyl ester
Trade Name(s)
Polycizer DBS, Kodaflex DBS, Staflex DBS, Monoplex DBS
Molecular Formula
C18H34O4
Representative Structure
0
0^
Dibutyl sebacate is an ester of sebacic acid - a saturated, straight- 10-carbon-chain, naturally occurring
dicarboxylic acid that is derived from castor oil. An ester is an organic chemical compound derived from
an acid in which a hydroxyl (-OH) group is replaced by an alkoxy (-OR) group through the process of
esterification. Shorter chain aliphatic diesters, such as dibutyl sebacate, function as plasticizers to give
improved flexibility and resistance to cracking at low temperatures. A plasticizer is a substance that is
added to a material to alter its physical properties, mainly to increase flexibility or decrease viscosity.
These aliphatic diesters are also versatile solvents in that they are able to dissolve a wide range of organic
compounds. Section 5 includes conditions of use for this chemical.
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3. Physical-Chemical Properties
Table 2 lists physical-chemical properties for dibutyl sebacate. A chemical's physical-chemical properties provide a basis for understanding a
chemical's behavior, including in the environment and in living organisms. These endpoints provide information generally needed to assess
potential environmental release, exposure, and partitioning as well as insight into the potential for adverse toxicological effects.
Table 2: Physical-Chemical Properties for Dibutyl Sebacate
Source/Model
Data Type
Endpoint
Endpoint Value
Notes
Sigma Aldrich 2019
Experimental
Physical state at
room temp
Liquid
ATSDR 1995
Experimental
Molecular Weight
315 g/mol
HSDB2019
Experimental
Molecular Weight
314 g/mol
EPISuite v.4.113
Calculated
Molecular Weight
314 g/mol
ECHA 2018
Experimental
Molar Volume
436 cm3/mol
HSDB2019
Experimental
Melting Point
-10°C
HSDB2019
Experimental
Boiling Point
344.5°C
HSDB2019
Experimental
Water Solubility
40 mg/L at20°C
ECHA 2018
Experimental
Water Solubility
<0.05 mg/L at20°C
and pH 6.4
Column elution
EPISuite v.4.11
Estimated
Water Solubility
0.14 mg/L
Kow method
HSDB2018
Experimental
Water Solubility
1.27x10-4 mol/L
ECHA 2018
Experimental
Water Solubility
1.59x10"7 mol/L
EPISuite v.4.11
Estimated
Log Kow
6.3
EPISuite v.4.11
Estimated
Log Koa
12
EPISuite v.4.11
Estimated
Log Koc
3.59 (MCI); 4.28
(Kow)
ATSDR
Experimental
Vapor Pressure
3 mm Hg at180°C
HSDB2019; ECHA 2018
Experimental
Vapor Pressure
4.69x10"6 mm Hg at
25°C
ECHA source converted from 6.25x10 4 Pa
EPISuite v.4.11
Estimated
Vapor Pressure
1.78x10-4 mm Hg
3 EPI Suite Physical Property Inputs - Boiling Point = 344.5 deg C, Melting Point = -10 deg C, Vapor Pressure = 4.69E-06 mm Hg, Water Solubility = 40 mg/L, SMILES:
0=C(0CCCC)CCCCCCCCC(=0)0CCCC
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Table 2: Physical-Chemical Properties for Dibutyl Sebacate
Source/Model
Data Type
Endpoint
Endpoint Value
Notes
EPISuite v.4.11
Estimated
Henry's Law
4.85x10"8 atm-m3/mol
EPISuite v.4.11
Estimated
Volatilization
892 days (river)
9740 days (lake)
EPISuite v.4.11
Estimated
Photolysis
(Indirect)
7.0 hours (T1/2)
• OH rate constant 1.83E-11 cm3/molecules-second (12 hour day; 1.5E6
OH/cm3)
• No ozone reaction estimation
EPISuite v.4.11
Estimated
Hydrolysis
4.5 years at pH 7
166 days atpH 8
Aqueous Base/Acid-Catalyzed Hydrolysis (25 deg C)
EPISuite v.4.11
Estimated
Biodegradation
Ready prediction:
Yes
EPISuite v.4.11
Estimated
BAF
29
EPISuite v.4.11
Estimated
BCF
281
From regression-based method
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EPA's Sustainable Futures/P2 Framework Manual4 was used to interpret the physical-chemical
properties provided in Table 2. Based on its reported physical form and measured melting point
(ATSDR, 1995), dibutyl sebacate is a liquid under ambient conditions. Liquids have the potential for
exposure via direct dermal contact with the substance, ingestion, or by inhalation of aerosols if they
are generated. Based on its measured vapor pressure (ECHA, 2018), dibutyl sebacate in its pure form
is expected to have some volatility at ambient temperatures; however, if inhaled, absorption from the
lungs is expected to be minimal based on its water solubility. Though dibutyl sebacate has limited
solubility in water (ECHA, 2018), if it is present in aqueous products (e.g.., cleaning products), it is
not expected to volatilize from water and aqueous solutions based on its estimated Henry's Law
constant (EPI Suite, 2019). If orally ingested, limited absorption through the gastrointestinal tract is
expected based on its low water solubility. Further, the ester functional groups are expected to
undergo rapid metabolic transformation, which significantly decreases the potential for
bioconcentration or bioaccumulation. Based on its estimated log Koc (EPI Suite, 2019), dibutyl
sebacate is expected to adsorb onto soil and sediment rather than be transported through soil to
surface or ground water sources of drinking water. Estimated data indicate dibutyl sebacate is readily
biodegradable in aerobic and anaerobic environments (discussed further in Section 6.3.1), meaning
that it has the potential to break down in the environment into carbon dioxide and water.
3.1 References
ATSDR Toxicological Profile for Otto Fuel II and its Components, U.S. Dept. of Health and Human
Services, 1995
European Chemicals Agency (ECHA). (2019). Dibutyl sebacate. Retrieved from
https://echa.europa.eu/registration-dossier/7registered-dossier/16127
Hazardous Substance Database (HSDB). (2006). Dibutyl Sebacate. Retrieved from,
https: //toxnet .nlm .nih .gov
Sigma Aldrich (2019). Dibutyl sebacate. Retrieved from
https://www.sigmaaldrich.com/catalog/product/aldrich/84840?lang=en®ion=US
U.S. EPA. (2019). Estimation Programs Interface Suite, v 4.11. United States Environmental
Protection Agency, Washington, DC, USA
4 https://www.epa.gOv/sites/production/files/2015-05/documents/05.pdf
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4. Relevant Assessment History
EPA assessed the toxicological profile of dibutyl sebacate and added the chemical to the Safer Choice
Program's Safer Chemical Ingredients List (SCIL) in March 2017 under the functional classes
of solvent, emollient, and skin conditioning agent. The SCIL5 is a continuously updated list of
chemicals that meet low-concern Safer Choice criteria.6
EPA also reviewed international assessments of dibutyl sebacate. EPA identified assessments by New
Zealand's, Canada's and Germany's government agencies.
The Canadian Government, through an assessment of toxicity and exposure as part of its
categorization of the Domestic Substance List, found that dibutyl sebacate did not meet its criteria for
further attention.7
The German Environment Agency (UBA) designated dibutyl sebacate as "low hazard to waters" in
August 2017 based on an assessment of ecotoxicity and environmental fate.8
New Zealand's Environmental Protection Authority lists dibutyl sebacate in its Chemical
Classification and Information Database (CCID), which includes hazard and physical information
about single chemicals for use in hazard classifications and safety information. It has a classification
description of "suspected human reproductive or developmental toxicants"; "harmful to human target
organs or systems/'9 This description was used because, at the time of their determination, dibutyl
sebacate was classified based on limited information indicating some potential for
reproductive/developmental toxicity and target organ/systemic toxicity. U.S. EPA has identified a
sufficient data set for dibutyl sebacate or closely-related analogs to make a low-concern determination
for the areas of potential concern identified by New Zealand, as described in the remainder of this
screening review.
5 https://www.epa.gov/saferchoice/safer-ingredients
0 https://www.epa.gov/sites/production/files/2013-12/documents/dfe master criteria safer ingredients v2 l.pdf
7 https://canadachemicals.oecd. org/ChemicalDetails.aspx?ChemicalID=942696DD-DD93-445B-8E6D-943CD2270E55
8 https://webrigoletto.uba.de/rigoletto/public/searcliDetail.do7kennummeF2198
9 https://www.epa.govt.nz/database-search/chemical-classification-and-information-database-ccid/view/8231
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5. Conditions of Use
Per TSCA section 3(4), the term "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. EPA assembled information
on all uses of dibutyl sebacate (Appendix A) to inform which uses would be determined conditions of
use.1" One source of information that EPA used to help determine conditions of use is 2016 Chemical
Data Reporting (CDR). The CDR rule (previously known as the Inventory Update Rule, or IUR),
under TSCA section 8, requires manufacturers (including importers) to report information on the
chemical substances they produce domestically or import into the U.S., generally above a reporting
threshold of 25,000 lb. per site per year. CDR includes information on the manufacturing, processing,
and use of chemical substances with information dating to the mid-1980s. CDR may not provide
information on other life-cycle phases such as the chemical substance's end-of-life after use in
products (i.e., disposal).
According to CDR, dibutyl sebacate is manufactured domestically and imported. Based on CDR
reporting, it is used in processing (incorporation into formulation, mixture or reaction and
incorporation into article for plastic material and resin manufacturing, pharmaceutical and medicine
manufacturing, wholesale and retail trade, plastics product manufacturing, and rubber product
manufacturing); it is also used as a reactant in rubber product and synthetic rubber manufacturing.
Dibutyl sebacate is used in a variety of industrial applications, including water supply and sewage
treatment. Consumer and commercial uses include photographic supplies, film, and photo chemicals;
ink, toner, and colorant products; arts, crafts, and hobby materials; laundry and dishwashing products;
and cleaning and furnishing care products. Based on the known manufacturing, processing, and uses
of this chemical substance, EPA assumes distribution in commerce. According to CDR, dibutyl
sebacate was reported as recycled by at least one site. No information on disposal is found in
CDR or through EPA's Toxics Release Inventory (TRI) Program11 because dibutyl sebacate is not a
TRI-reportable chemical. Although reasonably available information did not specify additional types
of disposal, for purpose of this proposed prioritization designation, EPA assumed end-of-life
pathways that include releases to air, wastewater, surface water and land via solid and liquid waste
based on the conditions of use (e.g., incineration, landfill).
To supplement CDR, EPA conducted research through the publicly available databases listed in
Appendix A (Table A.2) and performed additional internet searches to clarify conditions of use or
find additional occupational12 and consumer uses. This research improved the Agency's
understanding of the conditions of use for dibutyl sebacate. In the course of this research, EPA
identified uses of dibutyl sebacate in various types of cleaning products, construction materials,
cosmetics, coatings, oils, adhesives, and food and beverage manufacturing, among others. Although
EPA identified uses of dibutyl sebacate in personal care products, this screening review covers TSCA
10 The prioritization process, including the definition of conditions of use, is explained in the Procedures for Prioritization
of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (82 FR 33753).
11 https://www.epa.gov/toxics-release-inventorv-tri-program
12 Occupational uses include industrial and/or commercial uses
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conditions of use for the chemical substance and personal care products are not considered in EPA's
assessment. Exclusions to TSCA's regulatory scope regarding "chemical substance" can be found at
TSCA section 3(2). Table 3 lists the conditions of use for dibutyl sebacate considered for chemical
substance prioritization, per TSCA section 3(4). Table 3 reflects the TSCA uses determined as
conditions of use listed in Table A.3 (Appendix A).
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Table 3: Conditions of Use for Dibutyl Sebacate
Life Cycle Stage
Category
Subcategory of Use
Source
Manufacturing
Domestic manufacture
Domestic manufacture not reported although some information is withheld and/or CBI
EPA (2017b)
Import
Import
Processing-
incorporation into
formulation, mixture or
Plasticizers- plastic material and resin manufacturing;
pharmaceutical and medicine manufacturing, Wholesale and retail trade, Plastics product
manufacturing, Rubber product manufacturing
EPA (2017b)
reaction
Solvents (which become part of product formulation or mixture)- photographic film paper,
plate, and chemical manufacturing, wholesale and retail trade
Pigments - printing ink manufacturing
Processing
Processing as a
reactant
Plasticizers - rubber product manufacturing, synthetic rubber manufacturing
Processing-
Incorporation into an
article
Plasticizer - plastic product manufacturing, rubber product manufacturing, wholesale and retail
trade
All other chemical
product and
preparation
manufacturing
Chemicals, cosmetics, electrical machinery, explosives, furniture, metals, textile and leather,
windmill, transportation equipment, and paint/varnish manufacturing
CPCat (2019); ECHA (2018)
Recycling
Recycling
EPA (2017b)13
Distribution
Distribution
Distribution
EPA (2017b)
Industrial uses
Other
Ceramic extrusion
Synapse Information
Resources (n.d.)
Photographic supplies,
film, and photo
chemicals
Printing and reproduction of recorded media
CPCat (2019)
Surfactant
Surface-active agent
CPCat (2019)
13 According to CDR reports, at least one manufacturer indicates that the chemical is recycled onsite. No other information is available information to indicate that other recycling
is taking place. Reasonably available information did not specify types of disposal, but EPA assumes these releases based on the conditions of use.
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Utilities
Water supply and sewage treatment
ECHA (2018)
Agriculture, forestry,
fishing and hunting14
ECHA (2018)
Industrial/
commercial uses
Lubricants and
greases
Lubricant additive, greases and lubricants
ECHA (2018)
Paints and coatings
Coatings, metal treatment coatings, polyvinyl butyral resins
Synapse Information
Resources (n.d.); ECHA
(2018)
Industrial/
commercial/
consumer uses
Photographic supplies,
film, and photo
chemicals
Photographic supplies, film, and photo chemicals
EPA (2017b)
Arts, crafts, and hobby
materials
Art and hobby supplies, finger paints, modelling clay
ECHA (2018)
Adhesives and sealant
chemicals
Adhesive manufacturing, sealants
CPCat (2019); ECHA (2018)
Fuels and related
products
Motor oil; oil and gas drilling, torpedo fuel
CPCat (2019); ECHA (2018),
ATSDR (1995)
Food and beverage15
Food and beverage manufacturing; food-contact metallic article manufacturing; food-contact
rubber articles; food packaging adhesives; food paper/paperboard packing
CPCat (2019); ECHA (2018),
Synapse Information
Resources (n.d.)
Ink, toner, and
colorant products
Ink, toner, and colorant products
EPA (2017b)
Automotive care
products
Cleaning
ECHA (2018)
Building/construction
materials not covered
elsewhere
Boat and ship construction, building construction materials, road construction, flooring
materials
CPCat (2019); ECHA (2018)
14 Assumed to be a mix of TSCA and non-TSCA products. More representative uses that fall into this category are provided in Table A.3.
15 TSCA use based on the assumption that the chemical is used in the manufacturing of products and not intended to be a component of food.
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Cleaning and
furnishing care
products
Boat cleaners, carpet cleaners, wipes, descaler, floor cleaner/polish, wood/leather/glass
cleaners, general cleaners, metal cleaners
ECHA (2018)
Laundry and
dishwashing products
Bleach products, dishwashing products, drain cleaner, fabric conditioner, detergents
ECHA (2018)
Deicing and anti-icing
products
Deicer
ECHA (2018)
Fabric, textile, and
leather products not
covered elsewhere
Leather treatment products
ECHA (2018)
Agricultural products
(non-pesticidal)
Plant protection products
ECHA (2018)
Adhesives, sealants
Adhesive
ECHA (2018)
Consumer
Odor agents
Fragrance16, air freshener
CPCat (2019), ECHA (2018)
Fabric, textile, and
leather products not
covered elsewhere
Dyes and finishes
CPCat (2019)
Disposal
Releases to air,
wastewater, solid and
liquid wastes
Though not explicitly
identified, releases from
disposal are assumed to be
reasonably foreseen17
10 Potentially a non-TSCA as category may contain both TSCA and non-TSCA uses; however, because information is insufficient to determine, it is assumed to be covered by
TSCA.
17 See Section 5 for a discussion on why releases are assumed to be reasonably foreseen for purposes of this proposed prioritization designation.
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6. Hazard Characterization
EPA reviewed primary literature and other data sources to identify reasonably available information.
This literature review approach18 is tailored to capture the reasonably available information associated
with low-hazard chemicals. EPA also used this process to verify the reasonably available information
for reliability, completeness, and consistency. EPA reviewed the reasonably available information to
identify relevant, quality studies to evaluate the hazard potential for dibutyl sebacate against the
endpoints listed below. EPA's New Chemicals Program has used these endpoints for decades to
evaluate chemical substances under TSCA19 and EPA toxicologists rely on these endpoints as key
indicators of potential human health and environmental effects. These endpoints also align with
internationally accepted hazard characterization criteria, such as the Globally Harmonized System of
Classification and Labelling of Chemicals2" as noted above in Section 4 and form the basis of the
comparative hazard assessment of chemicals.
Human health endpoints evaluated: Acute mammalian toxicity, repeated dose toxicity,
carcinogenicity, mutagenicity/genotoxicity, reproductive and developmental toxicity, neurotoxicity,
skin sensitization, and eye and skin irritation.
Environmental fate and effects endpoints evaluated: Aquatic toxicity, environmental persistence,
and bioaccumulation.
The low-concern criteria used to evaluate both human health and environmental fate and effects are
included in Table 4 below.
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
Human Health
Acute Mammalian
Toxicity21
Very High
High
Moderate
Low
Oral LDso (mg/kg)
<50
> 50 - 300
>300-2000
>2000
Dermal LD50 (mg/kg)
<200
> 200- 1000
> 1000-2000
>2000
Inhalation LC50
(vapor/gas) (mg/L)
<2
>2-10
>10-20
>20
Inhalation LC50
(dust/mist/fume)
(mg/L)
<0.5
>0.5-1.0
>1.0-5
>5
18This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
19 https://www.epa. gov/sustainable-futures/sustainable-futures-p2-framework-manual
20 https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs rev07/English/ST SG AC10 30 Rev7e.pdf
21 Values derived from GHS criteria (Chapter 3.1: Acute Toxicity. 2009, United Nations).
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
Repeated Dose
Toxicity (90-day
study)22
High
Moderate
Low
Oral (mg/kg-bw/day)
< 10
10-100
>100
Dermal (mg/kg-
bw/day)
<20
20 - 200
>200
Inhalation
(vapor/gas)
(mg/L/6h/day)
<0.2
0.2-1.0
>1.0
Inhalation
(dust/mist/fume)
(mg/L/6h/day)
<0.02
0.02-0.2
>0.2
Reproductive
Toxicity23
High
Moderate
Low
Oral (mg/kg/day)
<50
50 - 250
>250
Dermal (mg/kg/day)
< 100
100-500
>500
Inhalation (vapor,
gas, mg/L/day)
< 1
1-2.5
>2.5
Inhalation
(dust/mist/fume,
mg/L/day)
<0.1
0.1-0.5
>0.5
Developmental
Toxicity23
High
Moderate
Low
Oral (mg/kg/day)
<50
50 - 250
>250
Dermal (mg/kg/day)
< 100
100-500
>500
Inhalation (vapor,
gas, mg/L/day)
< 1
1-2.5
>2.5
Inhalation
(dust/mist/fume,
mg/L/day)
<0.1
0.1-0.5
>0.5
Mutagenicity/
Genotoxicity24
Very High
High
Moderate
Low
Germ cell
mutagenicity
GHS Category 1A
or 1B: Substances
known to induce
heritable mutations
or to be regarded
as if they induce
heritable mutations
GHS Category 2:
Substances which
cause concern for
humans owing to the
possibility that they
may induce heritable
mutations in the germ
cells of humans.
Evidence of
mutagenicity support by
positive results in vitro
OR in vivo somatic cells
of humans or animals
Negative for
chromosomal
aberrations and gene
mutations, or no
structural alerts.
11 Values from GHS criteria for Specific Target Organ Toxicity Repeated Exposure (Chapter 3.9: Specific Target Organ
Toxicity' Repeated Exposure. 2009, United Nations).
23 Values derived from the U.S. EPA's Office of Pollution Prevention & Toxics criteria for HPV chemical categorizations
(Methodology* for Risk-Based Prioritization Under ChM tP), and the EU REACH criteria for Annex IV (2007).
24 From GHS criteria (Chapter 3.5: Germ Cells Mutagenicity'. 2009, United Nations) and supplemented with considerations
for mutagenicity and genotoxicity in cells other than germs cells.
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
in the germ cells of
humans.
Mutagenicity and
genotoxicity in
somatic cells
OR
Evidence of
mutagenicity
supported by positive
results in in vitro AND
in vivo somatic cells
and/or germ cells of
humans or animals.
Carcinogenicity25
Very High
High
Moderate
Low
Known or
presumed human
carcinogen (GHS
Category 1Aand
1B)
Suspected human
carcinogen (GHS
Category 2)
Limited or marginal
evidence of
carcinogenicity in
animals (and
inadequate26 evidence
in humans)
Negative studies or
robust mechanism-
based structure
activity relationship
(SAR)
Neurotoxicity
(90-day study)22
High
Moderate
Low
Oral (mg/kg-bw/day)
< 10
10-100
>100
Dermal (mg/kg-
bw/day)
<20
20 - 200
>200
Inhalation
(vapor/gas)
(mg/L/6h/day)
<0.2
CD
CM
CD
>1.0
Inhalation
(dust/mist/fume)
(mg/L/6h/day)
<0.02
0.02-0.2
>0.2
Sensitization27
High
Moderate
Low
Skin sensitization
High frequency of
sensitization in
humans and/or high
potency in animals
(GHS Category 1A)
Low to moderate
frequency of
sensitization in human
and/or low to moderate
potency in animals
(GHS Category 1B)
Adequate data
available and not
GHS Category 1Aor
1B
Respiratory
sensitization
Occurrence in
humans or evidence
of sensitization in
humans based on
animal or other tests
Limited evidence
including the presence
of structural alerts
Adequate data
available indicating
lack of respiratory
sensitization
25 Criteria mirror classification approach used by the IARC (Preamble to the L4RC Monographs: B. Scientific Review and
Evaluation: 6. Evaluation and rationale. 2019) and incorporate GHS classification scheme (Chapter 3.6: Carcinogenicity.
2009, United Nations).
20 EPA's approach to determining the adequacy of information is discussed in the document "Approach Document for
Screening Hazard Information for Low-Priority Substances Under TSCA", also released at proposal.
27 Incorporates GHS criteria (Chapter 3.4: Respiratory or Skin Sensitization. 2009, United Nations).
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
(equivalent to GHS
Category 1A or 1B)
Irritation/
Corrosivity28
Very High
High
Moderate
Low
Eye irritation/
corrosivity
Irritation persists
for >21 days or
corrosive
Clearing in 8-21
days, severely
irritating
Clearing in 7 days or
less, moderately
irritating
Clearing in less than
24 hours, mildly
irritating
Skin irritation/
corrosivity
Corrosive
Severe irritation at 72
hours
Moderate irritation at 72
hours
Mild or slight irritation
at 72 hours
Environmental Fate and Effects
Acute Aquatic
Toxicity Value
(L/E/ICso)29
Chronic Aquatic
Toxicity Value
(L/E/ICso)29
Persistence (Measured in terms of level of
biodegradation)30
Bioaccumulation
Potential31
May be low concern
if <10 ppm...
...and <1 ppm...
...and the chemical meets the 10-day window as
measured in a ready biodegradation test...
Low concern if >10
ppm and <100
ppm...
...and >1 ppm and
<10 ppm...
...and the chemical reaches the pass level within
28 days as measured in a ready biodegradation
test
...and BCF/BAF <
1000.
Low concern if >100
ppm...
...and > 10 ppm...
... and the chemical has a half-life < 60 days...
6.1 Human Health Hazard
Below is a summary of the reasonably available information that EPA included in the hazard
evaluation of dibutyl sebacate. In many cases, EPA used analogous chemicals to make findings for a
given endpoint. Where this is case, use of the analog is explained. If the chemical studied is not
named, the study is for dibutyl sebacate. Appendix B contains more information on each study.
Dibutyl sebacate is an aliphatic diester. EPA used best professional judgement to select analogs for
dibutyl sebacate based on similarity in structure, physical-chemical properties and functionality, with
the assumption that these chemicals will have similar environmental transport and persistence
characteristics, and bioavailability and toxicity profiles. As shown in Table 5, the selected analogs
used to inform EPA's understanding of this chemical are aliphatic diesters like dibutyl sebacate.
Dibutyl adipate has a shorter aliphatic chain length separating the ester groups than dibutyl sebacate.
Diisopropyl sebacate has the same length aliphatic chain separating the ester groups as dibutyl
28 Criteria derived from the Office of Pesticide Programs Acute Toxicity Categories (U.S. EPA. Label Review Manual.
2010).
29 Derived from GHS criteria (Chapter 4.1: Hazards to the Aquatic Environment. 2009, United Nations), EPA OPPT New
Chemicals Program (Pollution Prevention (P2) Framework, 2005) and OPPT's criteria for HPV chemical categorization
(Methodology> for Risk Based Prioritization Under C1l4MP. 2009).
30 Derived from OPPT's New Chemicals Program and DIE Master Criteria and reflects OPPT policy on PBTs (Design for
the Environment Program Master Criteria for Safer Chemicals, 2010).
31 Derived from OPPT's New Chemicals Program and Arnot & Gobas (2006) [Arnote, J.A. and F,A. Gobas, A review of
bioconcentration factor (BCF) and bioaccimndation factor (B*4F) assessments for organic chemicals in aquatic organisms.
Environmental Reviews, 2006. 14: p. 257-297.]
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sebacate, but diisopropyl scbacatc's configuration of the ester groups are different than dibutyl
sebacatc's. Despite these subtle differences, the environmental and toxicological effects of dibutyl
adipate and diisopropyl sebacate are expected to be very similar to those of dibutyl sebacate.
Table 5: Dibutyl Sebacate and Analog Structures
CASRN
Name
Structure
109-43-3
Dibutyl sebacate
0
0
105-99-7
Dibutyl adipate
0
H,C^^^0
0
7491-02-3
Diisopropyl sebacate
CH3 0
HjC
0 ch3
6.1.1 Absorption, Distribution, Metabolism, and Excretion
Absorption
If ingested orally, dibutyl sebacate is expected to have low to moderate absorption from the
gastrointestinal tract based on its molecular weight and low water solubility (Section 3). If inhaled as
a vapor, aerosol, or dust, dibutyl sebacate is expected to have minimal absorption from the lungs
based on its low water solubility (Section 3). The potential for dermal absorption of dibutyl sebacate
is also predicted to be low based on the combination of its low water solubility and moderate log Kow
(Section 3).
Distribution
No quality experimental data32 on dibutyl scbacatc's distribution were available. Based on the
absorption, metabolism, and excretion information, it is expected that dibutyl sebacate will not be
distributed or retained throughout the body. If ingested, it is expected to be metabolized and excreted
(described further below).
32 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances under TSCA."
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Metabolism
Because quality experimental data on dibutyl sebacate metabolite formation were limited, the
Quantitative Structure-Activity Relationship (QSAR) toolbox33 was used to run the rat liver S9
metabolism simulator, the skin metabolism simulator, and the in vivo rat metabolism simulator. The
metabolism simulators predicted hydrolysis of dibutyl sebacate to the corresponding monoester
(sebacic acid monobutyl ester), releasing butanol. Butanol is further metabolized by alcohol
dehydrogenase to butyraldehyde and by aldehyde dehydrogenase to butyric acid, which is
subsequently metabolized via |3-oxidation to carbon dioxide and water. Other metabolites predicted
by the simulators include mono- and di- esters, carboxylic acids, and aldehydes.
Excretion
Based on the predicted metabolism of dibutyl sebacate and the excretion pathways observed with
butanol (discussed in Metabolism), metabolites of this substance are expected to be excreted via the
urine or further metabolized and exhaled as carbon dioxide.
6.1.2 Acute Toxicity
EPA assessed the potential for mammalian toxicity from acute exposure to dibutyl sebacate based on
two studies. Rats exposed to a single dose of dibutyl sebacate via oral gavage showed no mortality,
resulting in an LD50 greater than 4700 mg/kg (ECHA. 1976a). Rats exposed to dibutyl sebacate orally
resulted in mortality only at very high doses with an LD50 in between 16,000 mg/kg and 32,000
mg/kg (Smith. 1953). These studies indicate low concern for acute toxicity with LD50S above the low-
concern threshold of 2000 mg/kg for oral exposures.
6.1.3 Repeated Dose Toxicity
EPA assessed the potential for mammalian toxicity from repeated exposures to dibutyl sebacate using
experimental data. Rats exposed to dibutyl sebacate in their diet for one year identified no adverse
effects, resulting in a no observed adverse effect level (NOAEL) of 870 mg/kg-day (WHO. 2000;
Smith. 1953). A two year diet study in rats also reported no effects at the highest dose (4400 mg/kg-
day), resulting in a NOAEL of 4400 mg/kg-day (WHO. 2000; Smith. 1953). These results indicate
low concern for mammalian toxicity from repeated exposures to dibutyl sebacate by exceeding the
low-concern threshold of 100 mg/kg-day.
6.1.4 Reproductive and Developmental Toxicity
EPA assessed the potential for mammalian reproductive toxicity using read-across from dibutyl
adipate. Rats exposed to dibutyl adipate by oral gavage beginning two weeks prior to mating and
through day 3 of lactation (for females) displayed no effects on reproductive parameters, resulting in
a NOAEL of 1000 mg/kg-day (OECD. 1996). This study also examined a subset of developmental
parameters, including pup number, pup sex ratio, live and dead pups, postnatal deaths, gross
abnormalities, pup weight gain, physical and behavioral abnormalities, reflexology and gross
necropsy. No adverse effects were noted at the highest dose tested (1000 mg/kg-day), resulting in a
33 https://www.oecd.org/chemicalsafetv/risk-assessment/oecd-qsar-toolbox.hlm
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NOAEL of 1000 mg/kg-day. These results indicate low concern for reproductive and developmental
toxicity by exceeding the low-concern thresholds of 250 mg/kg-day for oral exposures.
6.1.5 Genotoxicity
EPA assessed experimental data on genotoxicity as a potential indicator of genotoxic carcinogenicity.
An in vivo micronucleus study in mice exposed to dibutyl sebacate was negative for micronucleated
polychromatic erythrocytes (Wild et al.. 1983). A sex-linked recessive lethal mutation study on
Drosophila was also negative for dibutyl sebacate (Wild et al.. 1983). EPA also used read-across
from an analog, dibutyl adipate. Gene mutation studies in two bacteria species were negative with and
without activation when exposed to dibutyl adipate (ECHA. 1996; OECD. 1996). A chromosomal
aberration study in vivo in dibutyl adipate was negative for inducing damage without activation
(OECD. 1996). With metabolic activation, there was an increase in chromosomal damage; however,
these results were observed at cytotoxic concentrations. Weighing the negative results in several
species with the positive results occuring only at cytotoxic concentrations, EPA interprets these
results to indicate dibutyl sebacate has low concern for inducing genotoxicity.
6.1.6 Carcinogenicity
EPA assessed the potential for dibutyl sebacate to cause carcinogenicity using experimental data. Rats
exposed to dibutyl sebacate orally for two years demonstrated no cancer-related effects at the highest
dose tested of 4400 mg/kg-day, resulting in a negative finding for carcinogenicity (Smith. 1953).
These results indicate low concern for carcinogenicity by dibutyl sebacate.
6.1.7 Neurotoxicity
While no guideline neurotoxicity studies were available for dibutyl sebacate or closely related
analogs, EPA assessed the potential for neurotoxicity using relevant endpoints measured in repeated
dose studies, structural alerts, and predictions made by U.S. EPA's ToxCast.34
A one year, repeated dose study in rats exposed to dibutyl sebacate demonstrated dietary doses
corresponding to 870 mg/kg-day did not produce histopathological lesions in the brain (Smith. 1953).
ToxCast results for dibutyl sebacate included 27 in vitro high throughput biochemical- and cell-based
assays related to neurological functions.35 Dibutyl sebacate induced bioactivity in 1 of the 27 assays;
the active result was reported in the Novascreen Human Beta-site APP Cleaving Enzyme
(NVS_ENZ_hBACE) assay, but dibutyl sebacate was inactive in the NVS_ENZ_hBACE_Activator
assay. The protein used in this assay is the human Beta-secretase 1 protein, which targeted the beta-
site APP-cleaving enzyme 1 (BACE1) gene. The activity detected from exposure to dibutyl sebacate
indicates enzyme function and kinetic changes may occur in the BACE1 gene; however, an AC50
(concentration of 50% maximum activity) value could not be calculated for these data because the
34 https://actor.epa.gov/dashboard/. Chemical specific assay list can be found at
https://actor.epa.gOv/dashboard/#chemical/55934-93-5.
35 Identified by supplemental information in Chushak Y., Shows H., Gearhart J., Pangbum H. 2018. In silico identification
of protein targets for chemical neurotoxins using Toxcast in vitro data and read-across within the QSAR toolbox.
Toxicology Research issue 3. Supplemental files:
https://pubs.rsc.Org/en/content/articlelanding/2018/tx/c7tx00268h#idivAbstract.
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efficacy was below 50% at the highest concentration. Therefore, the results are only useful for a
qualitative determination of active vs. inactive in this assay and only represent a potential molecular
initiating event that does not appear to translate into adverse outcomes based on the low-hazard
findings for repeated dose exposures. Further, the analog di-n-butyl adipate (105-99-7) did not induce
activity in either the NVS_ENZ_hBACE or NVS_ENZ_hBACE_Activator assays (U.S. EPA
ToxCast, 2019).
This information indicates there is low concern for neurotoxicity associated with dibutyl sebacate.
This finding is also supported by the low-hazard findings for other human health hazard endpoints,
including, but not limited to, acute toxicity and reproductive toxicity.
6.1.8 Skin Sensitization
No quality experimental studies36 on dibutyl sebacate or closely related analogs were available to
assess the potential for dibutyl sebacate to cause skin sensitization. No structural alerts were identified
for protein binding potential of dibutyl sebacate for skin sensitization, using the QSAR Toolbox,
Version 4.2 models. These results indicate dibutyl sebacate is low concern for skin sensitization.
6.1.9 Skin Irritation
EPA assessed the potential of dibutyl sebacate to induce skin irritation using experimental data from
two analogs, dibutyl adipate and diisopropyl sebacate. Rabbits dermally exposed to diisopropyl
sebacate for 24 hours displayed slight erythema in two of six animals at 24 hours; however, these
results were fully reversible by 72 hours and were classified as non-irritating (ECHA. 1976b). Rabbits
exposed to dibutyl adipate for four hours showed slight to obvious erythema and very slight edema in
three of three animals one hour following exposure (ECHA. 1989). These effects were reversed by
day eight. Because results for the two analogs conflict, EPA investigated which analog is abetter
match for dibutyl sebacate for this endpoint. EPA determined diisopropyl sebacate is a stronger
analog than dibutyl adipate to assess the potential for skin irritation. EPA makes this finding based on
the following information. Diisopropyl sebacate is similar in size (Dibutyl sebacate: 314.47 g/mol;
diisopropyl sebacate: 286.42 g/mol; dibutyl adipate: 258.36 g/mol) and predicted to have similar
hydrophobicity and water solubility to dibutyl sebacate (Dibutyl sebacate: 0.14 mg/L, Log Kow of 6.3;
diisopropyl sebacate: 0.57 mg/L, Log Kow of 5.17; dibutyl adipate: 13.6 mg/L, Log Kow of 4.33). The
irritation study results for the stronger analog, diisopropyl sebacate, indicate that dibutyl sebacate is
of low concern for skin irritation.
6.1.10 Eye Irritation
EPA assessed available experimental data on eye irritation. A study in rabbits demonstrated dibutyl
sebacate induced slight eye irritation, but these effects were fully reversible within 48 hours (ECHA.
1991). These results indicate that dibutyl sebacate is of moderate concern for eye irritation.
30 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances under TSCA."
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6.1.11 Hazards to Potentially Exposed or Susceptible Subpopulations
The above information supports a low human health hazard finding for dibutyl sebacate based on
low-concern criteria. This finding includes considerations such as the potential for developmental
toxicity, reproductive toxicity, and acute or repeated dose toxicity that may impact potentially
exposed or susceptible subpopulations. Based on the hazard information discussed in Section 6, EPA
did not identify populations with greater susceptibility to dibutyl sebacate.
6.2 Environmental Hazard
EPA assessed environmental hazard for dibutyl sebacate based on estimated toxicity values using the
Ecological Structure Active (ECOSAR) Predictive Model37 and available experimental data from an
analog, dibutyl adipate. Appendix B contains a summary of the reasonably available environmental
hazard data.
6.2.1 Acute Aquatic Toxicity
EPA assessed aquatic toxicity from acute exposures using read-across on dibutyl adipate.
Invertebrates exposed to dibutyl adipate had a reported EC50 greater than 5.2 mg/L (ECHA. 2014b).
which exceeds the water solubility of dibutyl sebacate. Further, the predicted log Kow of 5.3 for
dibutyl sebacate exceeds the acute threshold for ECOSAR estimations (Log Kow of 5), indicating the
dissolved and bioavailable concentration of dibutyl sebacate in the water column required to cause
acute aquatic toxicity could not be reached due to the low water solubility and high log Kow. No
effects at saturation are expected for aquatic vertebrates, invertebrates, and algae acutely exposed to
dibutyl sebacate. Aerobic biodegradation is expected to further reduce the dissolved concentration in
the environment (see Section 6.3.1, below). These results indicate dibutyl sebacate is low concern for
acute aquatic exposures.
6.2.2 Chronic Aquatic Toxicity
EPA assessed toxicity from chronic exposures using read-across from dibutyl adipate. Invertebrates
exposed to dibutyl adipate had a reported range ofNOEC values, including greater than 1.5 mg/L and
greater than 1000 mg/L (ECHA. 2014a. 2013) A 21-day invertebrate study with dibutyl adipate
reported an LC50 of 4.3 mg/L (OECD. 1996).
EPA estimated the potential for dibutyl sebacate to cause chronic toxicity to aquatic vertebrates and
algae using ECOSAR. ECOSAR estimated a chronic effect to fish at 0.004 mg/L and to algae at 0.04
mg/L. These estimations indicate high concern for chronic aquatic toxicity, while the experimental
values for dibutyl adipate indicate moderate concern. For the purposes of this screening review, EPA
assumes high concern for aquatic toxicity, meaning that effects may be seen at values of less than 1
mg/L, which is equivalent to 1 ppm. For a chemical with chronic aquatic toxicity values <1 ppm to
be considered low concern for hazard, the chemical must reach 60% degradation within 10 days as
measured in an aerobic ready biodegradation test without degradation products of concern. Given the
expected low persistence of closely-related analogs for dibutyl sebacate (discussed in 6.3.1), these
aquatic toxicity studies indicate low concern for chronic aquatic exposure, because the aquatic
37https://www.epa.gov/tsca-screening-tools/ecological-striicture-activity-relationships-ecosar-predictive-model}
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toxicity data is accompanied by greater than 60% aerobic biodegradation within 10 days. Rapid
aerobic biodegradation of dibutyl sebacate (discussed in Section 6.3.1) is expected to reduce the
dissolved concentration in the environment, reducing the potential for chronic exposures and aquatic
toxicity. Therefore, dibutyl sebacate is low-concern for chronic aquatic toxicity.
6.2.3 Terrestrial Toxicity
EPA assessed the potential of dibutyl sebacate toxicity on a soil-dwelling organism, Eisenia fetida,
using experimental data from dibutyl adipate. An OECD Guideline 207 study reported a no observed
effect concentration (NOEC) of 1000 mg/kg following a 14-day exposure to dibutyl adipate (ECHA.
2013). These results demonstrate dibutyl sebacate is of low concern for sub-chronic exposures to soil
organisms.
6.3 Persistence and Bioaccumulation Potential
6.3.1 Persistence
EPA assessed the potential for dibutyl sebacate to be persistent using experimental data from two
analogs, dibutyl adipate and diisopropyl sebacate. A study following OECD Guideline 30IB reported
diisopropyl sebacate to be readily biodegradable under aerobic conditions, with greater than 60% of
the substance degraded in 10 days and 89.6% in 28 days based on CO2 evolution (ECHA. 1998). A
study following OECD Guideline 30IE reported dibutyl adipate to be readily biodegradable under
aerobic conditions, with 96% of the substance degraded within 28 days based on DOC (ECHA.
2000). Another study following OECD Guideline 301C, also known as the MITI test, reported dibutyl
adipate to be readily biodegradable under aerobic conditions, with 95% degrading in 28 days based
on BOD (OECD. 1996; ECHA. 1995). Further, an OECD Guideline 30ID study reported dibutyl
adipate degraded 60% in 28 days under aerobic conditions (ECHA. 1999). The available
biodegradation results on analogs meet the low-concern threshold of greater than 60% biodegradation
in 10 days (based on the aquatic toxicity criteria) and indicate dibutyl sebacate has low persistence.
EPA assessed the potential for anaerobic biodegradation using BIOWIN 7, a model within EPISuite.
This model predicted dibutyl sebacate would biodegrade quickly under anaerobic conditions, with a
probability of 0.7490. Predictions with a probability greater than 0.5 are considered reliable under this
model.
6.3.2 Bioaccumulation Potential
Based on the estimated bioaccumulation factor (BAF) value of 29 using the Estimation Programs
Interface (EPI) Suite models,38 dibutyl sebacate is expected to have low potential for bioaccumulation
in the environment based on the low-concern threshold of less than 1000.
38 https://www.epa.gov/tsca-screeni11g-tools/epi-suitelm-estimation-program-mterface
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7. Exposure Characterization
EPA considered reasonably available information on exposure for dibutyl sebacate. In general, there
is limited information on exposure for low-hazard chemicals. EPA consulted sources of exposure and
use information that include CDR and other databases and public sources (described in Table A.2). Of
these sources, EPA determined that the CDR database contained the primary source of information on
the conditions of use for this exposure characterization. EPA used these other databases and public
sources (described in Table A.2) only where they augmented information from the CDR database to
inform intended, known or reasonably foreseen uses (Section 5).
As shown in Tables 3 and A.3, dibutyl sebacate is a solvent used in processing (incorporation into an
article and into a formulation, mixture, or product) in the plastic, rubber, and pharmaceutical
manufacturing sectors. It is also used in a variety of industrial uses, such as water supply and sewage
treatment, and commercial and consumer uses, such as ink, toner, and colorant products; laundry and
dishwashing products; and cleaning and furnishing care products (Table 3). Non-TSCA uses are
beyond the scope of this assessment because of the exclusions under TSCA section 3(2) (See Table
A.3).
Under the conditions of use identified in Table 3, EPA assessed the potential exposure to the
following categories: the environment, the general population, and potentially exposed or susceptible
subpopulations including workers, consumers, and children.
7.1 Production Volume Information
Production volume information for dibutyl sebacate is based on an analysis of CDR data reported
from 1986 to 2015.39 In reporting years 1986 and 1998-2014, aggregate production volume for
dibutyl sebacate was between 1,000,000 lbs. and 10,000,000 lbs. In reporting years 1990, 1994 and
2015, aggregate product volume was comparatively less than other reporting years, at 500,000 lbs. to
1,000,000 lbs. In general, since 2011, production volume has remained relatively stable, with a slight
decrease from 2014-2015.
7.2 Exposures to the Environment
EPA expects most exposures to the environment to occur during the manufacture, import, processing,
and industrial, commercial, and consumer uses of dibutyl sebacate. Exposure is also reasonably
foreseeable from other uses, such as distribution and disposal. These activities could result in releases
of dibutyl sebacate to media including surface water, landfills, and air.
Given dibutyl sebacate's low water solubility, any releases to surface water are expected to result in
dibutyl sebacate adsorbing onto sediment based on the estimated log Koc (Table 2 of Section 3),
39 The CDR requires manufacturers (including importers) to report information on the chemicals they produce domestically
or import into the U.S above 25,000 lb. per site per year.
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potentially exposing benthic organisms. Further, EPA expects high levels of removal of dibutyl
sebacate during wastewater treatment (either directly from the facility or indirectly via discharge to a
municipal treatment facility or Publicly Owned Treatment Works (POTW)). Dibutyl sebacate is
expected to have low persistence aerobically and anaerobically (discussed in Section 6.3.1) and has
the potential to break down in the environment to carbon dioxide and water. Therefore, any releases
of the chemical to sediments or soils is expected to break down, reducing exposures to soil-dwelling
and benthic organisms.
If disposed of in a landfill, this chemical is expected to biodegrade under aerobic and anaerobic
conditions (aerobic and anaerobic biodegradation are discussed in Section 6.3.1).
If incineration releases during manufacturing and processing occur, EPA expects significant
degradation of dibutyl sebacate to the point that it will not be present in air.
7.3 Exposures to the General Population
EPA expects the general population is unlikely be exposed to dibutyl sebacate from the potential
environmental releases described above. Air exposure is unlikely from incineration. If dibutyl
sebacate is present in air from volatilization, it is expected to be reduced by its atmospheric half-life
of approximately 7 hours (Section 3). Dibutyl sebacate is unlikely to be present in surface water
because of its low water solubility (discussed in Section 3), biodegradability (discussed in Section
6.3.1), adsorption to sediment (based on the log Koc, discussed in Section 3), and removal through
wastewater treatment, thus reducing the potential for the general population to be exposed by oral
ingestion or dermal exposure. Further, given the predicted low concentration in the water column and
predicted bioaccumulation and bioconcentration potential of dibutyl sebacate, oral exposure to dibutyl
sebacate via fish ingestion is unlikely.
7.4 Exposures to Potentially Exposed or Susceptible Subpopulations
EPA identified workers, consumers, and children as potentially exposed or susceptible subpopulations
based on greater exposure to dibutyl sebacate than the general population during manufacturing,
processing, distribution, use, and disposal. EPA identified children (including any adults working
closely with children) as a population that may experience greater exposure to dibutyl sebacate than
the general population during use of art and hobby supplies, finger paints, and modelling clay. EPA
also identified consumers as a population that may experience greater exposure to dibutyl sebacate
than the general population through use of ink, toner, and colorant products; laundry and dishwashing
products; and cleaning and furnishing care products, for example.
7.4.1 Exposures to Workers
Based on its reported physical form and measured melting point (Table 2), dibutyl sebacate is a liquid
under ambient conditions. Based on dibutyl sebacate's conditions of use (Table 3), workers may be
exposed to liquids through direct dermal contact with the substance and inhalation of aerosols if they
are generated. Based on its measured vapor pressure, dibutyl sebacate is expected to have some
volatility at ambient temperatures, and therefore workers may be exposed through inhalation of
vapors. If inhaled, absorption through the lungs is expected to be minimal. However, if dibutyl
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sebacate is in a dilute form, the estimated Henry's Law constant for dibutyl sebacate indicates
volatilization from water and aqueous solutions is expected to be minimal. Workers may be exposed
to non-dilute dibutyl sebacate in manufacturing, processing, distribution, industrial use, and disposal.
7.4.3 Exposures to Consumers
Consumers may be exposed to dibutyl sebacate through the use of cleaning and furnishing care
products, laundry and dishwashing products, and ink, toner, and colorants products, for example. For
all these uses, if dermal contact does occur, dibutyl sebacate is expected to be minimally absorbed
through the skin. If the chemical is in an aerosol product and inhalation exposure occurs, dibutyl
sebacate"s absorption from the lungs is expected to be minimal. EPA does not include intentional
misuse, such as people drinking products containing this chemical, as part of the known, intended, or
likely conditions of use that could lead to an exposure (82 FR 33726). Thus, oral exposures will be
incidental (meaning inadvertent and low in volume). Dibutyl sebacate is expected to be rapidly
metabolized and excreted, further reducing the duration of exposure.
7.4.2 Exposures to Children
Children may be exposed to dibutyl sebacate through use of art and hobby supplies, finger paints, or
modelling clay. Given the molecular weight, water solubility, and partitioning coefficients in Table 2,
this chemical is expected to be poorly absorbed through the skin. For use in arts and crafts supplies,
dibutyl sebacate is assumed to only be present in aqueous solutions, such as finger paint solution.
Based on the predicted Henry's Law constant (provided in Section 3), dibutyl sebacate's
volatilization from aqueous solutions is expected to be minimal from these products, reducing
inhalation exposures to children. While using these products, children may rub their eyes or
incidentally ingest the product.
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8. Summary of Findings
EPA has used reasonably available information on the following statutory and regulatory criteria and
considerations to screen dibutyl sebacate against each of the priority designation considerations in 40
CFR 702.9(a), and discussed individually in this section, under its conditions of use:
• the hazard and exposure potential of the chemical substance (See Sections 6 and 7);
• persistence and bioaccumulation (See Section 6.3);
• potentially exposed or susceptible subpopulations (See Section 7.4);
• storage near significant sources of drinking water (See Section 8.4);
• conditions of use or significant changes in the conditions of use of the chemical
substance (See Section 5);
• the chemical substance's production volume or significant changes in production
volume (See Section 7.1); and
• other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority.
EPA conducted a risk-based, screening-level review based on the criteria and other considerations
above and other relevant information described in 40 CFR 702.9(c) to inform the determination of
whether the substance meets the standard of a high-priority substance. High-priority substance means
a chemical substance that EPA determines, without consideration of costs or other non-risk factors,
may present an unreasonable risk of injury to health or the environment because of a potential hazard
and a potential route of exposure under the conditions of use, including an unreasonable risk to
potentially exposed or susceptible subpopulations identified as relevant by EPA (40 CFR 702.3). This
section explains the basis for the proposed designation and how EPA applied statutory and regulatory
requirements, addressed issues, and reached conclusions.
8.1. Hazard and Exposure Potential of the Chemical Substance
Approach: EPA evaluated the hazard and exposure potential of dibutyl sebacate. EPA used this
information to inform its proposed determination of whether dibutyl sebacate would meet the
statutory criteria and considerations for proposed designation as a low-priority substance.
• Hazard potential:
For dibutyl sebacate's hazard potential, EPA gathered information for a broad set of human health
and environmental endpoints described in detail in Section 6 of this document. EPA benchmarked this
information against low-concern thresholds. EPA found that dibutyl sebacate is of low concern for
human health and environmental hazard across the range of endpoints in these low-concern criteria.
• Exposure potential:
To understand exposure potential, EPA gathered information on physical-chemical properties,
production volumes, and the types of exposures likely to be faced by workers, the general population,
children, and consumers (discussed in Sections 3 and 7). EPA also gathered information on
environmental releases. EPA identified workers, the general population, consumers, children, and the
environment as most likely to experience exposures. EPA determined that while the general
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population, consumers, and workers may be exposed to dibutyl sebacate, exposure by the dermal,
ingestion, and inhalation pathways are limited by dibutyl sebacate's physical-chemical properties. If
dibutyl sebacate is released into the environment, its exposure potential will be reduced through
biodegradation under aerobic and anaerobic conditions.
Rationale: Although dibutyl sebacate may cause moderate eye irritation, the effects are expected to
be relatively low-impact [minimal to moderate] and reversible, thereby reducing concern for longer-
term effects. Workers could be exposed during processing, manufacturing, distribution, use, and
disposal through handling and splashing or hand-to-face and eye contact. Other uses covered under
TSCA, especially consumer uses in cleaning and furnishing care products, potential use in finger
paints, and laundry and dishwashing products, would be unlikely to result in more than incidental eye
exposure. Eye irritation resulting from exposure in an occupational and consumer setting is mitigated
by the reversible nature of the effects and addressed by rinsing with water..
Proposed conclusion: Based on an initial analysis of reasonably available hazard and exposure
information, EPA proposes to conclude that the risk-based, screening-level review under 40 CFR
702.9(a)(1) does not support a finding that dibutyl sebacate meets the standard for a high-priority
substance. The reasonably available hazard and exposure information described above provides
sufficient information to support this proposed finding.
8.2. Persistence and Bioaccumulation
Approach: EPA has evaluated both the persistence and bioaccumulation potential of dibutyl sebacate
based on a set of EPA and internationally accepted measurement tools and thresholds that are
indicators of persistence and bioaccumulation potential (described in Section 6). These endpoints are
key components in evaluating a chemical's persistence and bioaccumulation potential.
Rationale: EPA's review of experimental data indicates dibutyl sebacate is readily biodegradable
under aerobic conditions, with greater than 60 percent biodegradation expected within 10 days, and
predicted to biodegrade under anaerobic conditions (Section 6.3.1). EPA's EPI Suite models indicate
a low potential for bioaccumulation and bioconcentration (Section 6.3.2).
Proposed conclusion: Based on an analysis of reasonably available information on persistence and
bioaccumulation, EPA proposes to conclude that the screening level review under 40 CFR 702.9(a)(2)
does not support a finding that dibutyl sebacate meets the standard for a high-priority substance. The
reasonably available persistence and bioaccumulation information described above provides sufficient
information to support this proposed finding.
8.3. Potentially Exposed or Susceptible Subpopulations
Approach: TSCA Section 3(12) states that the "term 'potentially exposed or susceptible
subpopulation' 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 of adverse health effects from exposure to a chemical substance or mixture,
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such as infants, children, pregnant women, workers, or the elderly." EPA identified workers engaged
in the manufacturing, processing, distribution, use, and disposal of dibutyl sebacate as a potentially
exposed or susceptible subpopulation (described in more detail in Section 7). EPA also identified
children as a population that may experience greater exposure to dibutyl sebacate than the general
population during use of art and hobby supplies, finger paints, or modelling clay. Consumers are also
a potentially exposed subpopulation because of their use of products such as cleaning and furnishing
care products, laundry and dishwashing products, and ink, toner, and colorants products, as shown in
Table 3.
Rationale: EPA expects workers and consumers to have a higher exposure to dibutyl sebacate than
the general population. Higher exposure to children (and adults working closely with children) could
result from use of art and hobby supplies, finger paints, or modelling clay containing dibutyl sebacate,
which might lead to inadvertent eye contact. Because of the chemical's low-concern hazard
properties, this exposure does not pose a significant increase in risk.
Proposed conclusion: Based on the Agency's understanding of the conditions of use and expected
users such as potentially exposed or susceptible populations, EPA proposes to conclude that the
screening-level review under 40 CFR 702.9(a)(3) does not support a finding that dibutyl sebacate
meets the standard for a high-priority substance. While the conditions of use will result in an
increase in exposures to certain populations, the consistently low-concern hazard profile of
dibutyl sebacate provides sufficient evidence to support a finding of low concern. The reasonably
available information on conditions of use, hazard, and exposure described above provides sufficient
information to support this proposed finding.
8.4. Storage near Significant Sources of Drinking Water
Approach: In Sections 6 and 7 of this document, EPA explains its evaluation of the elements of risk
relevant to the storage of dibutyl sebacate near significant sources of drinking water. EPA focused
primarily on the chemical's potential human health hazards, including to potentially exposed or
susceptible subpopulations, and environmental fate properties, and explored a scenario of a release to
a drinking water source. EPA also investigated whether the chemical was monitored for and detected
in a range of environmental media. This requirement to consider storage near significant sources of
drinking water is unique to prioritization under TSCA Section 6(b)(1)(A).
Rationale: In terms of health hazards, dibutyl sebacate is expected to present low concern to the
general population, including susceptible subpopulations, across a spectrum of health endpoints.
In the event of an accidental release into a surface drinking water source, dibutyl sebacate has limited
solubility in water, which decreases its potential for exposure via ingestion of contaminated drinking
water relative to more soluble substances. In the event of an accidental release to land, the estimated
log Koc indicates dibutyl sebacate is expected to adsorb onto soil and sediment rather than be
transported through soil to surface, ground or well water supplies. The fate and transport evaluation
indicates dibutyl sebacate is predicted to biodegrade under aerobic and anaerobic conditions and
unlikely to bioaccumulate (see Section 6.3).
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A sudden release of large quantities of the chemical near a drinking water source could have
immediate effects on the usability of a surface drinking water source. If such a release were to occur,
two primary factors would operate together to reduce concern. First, the chemical would be expected
to present low concern to the general population, including susceptible subpopulations, across a
spectrum of health endpoints (see Section 6). Second, dibutyl sebacate has low water solubility,
would likely bind to sediments, and would degrade in aerobic and anaerobic environments (see
Section 6). Together, these factors mean that any exposures to this chemical through drinking water
sources would be short-lived, and that if ingestion were to take place, concern for adverse health
effects would be low.
EPA also explored whether the chemical had been identified as a concern under U.S. environmental
statutes in the past. EPA searched lists of chemicals and confirmed that dibutyl sebacate does not
appear on these lists. The lists reviewed include EPA's List of Lists
(https://www.epa.gov/sites/production/files/2015-03/documents/list of lists.pdf). EPA also searched
the lists of chemicals included in the National Primary Drinking Water Regulations and the
Unregulated Contaminant Monitoring Rule (UCMR) under the Safe Drinking Water Act (SDWA).
Proposed conclusion: Based on a qualitative review of a potential release near a significant source of
drinking water, EPA proposes to conclude that the screening-level review under 40 CFR 702.9(a)(4)
does not support a finding that dibutyl sebacate meets the standard for a high-priority substance. The
reasonably available information on storage near significant sources of drinking water described
above provides sufficient information to support these proposed findings.
8.5. Conditions of Use or Significant Changes in Conditions of Use of the
Chemical Substance
Approach: EPA evaluated the conditions of use for dibutyl sebacate and related potential exposures.
Rationale: EPA evaluated the conditions of use of dibutyl sebacate (see Section 5 and Appendix A)
and found it to have a broad range of conditions of use. EPA expects that even if the conditions of use
were to expand beyond activities that are currently known, intended and likely, the outcome of the
screening review would likely not change and would not alter the Agency's conclusion of low
concern. EPA bases this expectation on dibutyl sebacate's consistently low-concern hazard
characteristics across the spectrum of hazard endpoints and regardless of a change in the nature or
extent of its use and resultant increased exposures.
Proposed conclusion: EPA's qualitative evaluation of potential risk does not support a finding that
dibutyl sebacate meets the standard for a high-priority substance, based on its low-hazard profile
under the current conditions of use. EPA proposes to find that even if conditions of use broaden,
resulting in an increase in the frequency or amount of exposures, the analysis conducted to support
the screening-level review under 40 CFR 702.9(a)(5) would not change significantly. In particular,
the analysis of concern for hazard, which forms an important basis for EPA's findings, would not be
impacted by a change in conditions of use. Therefore, such changes would not support a finding that
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dibutyl sebacate meets the standard for a high-priority substance. The reasonably available
information on conditions of use, or significant changes in conditions of use described above provides
sufficient information to support this proposed finding.
8.6. The Volume or Significant Changes in Volume of the Chemical Substance
Manufactured or Processed
Approach: EPA evaluated the current production volumes of dibutyl sebacate (Section 7.1) and
related potential exposures (Section 7.2 through 7.4).
Rationale: EPA used reasonably available information on production volume (see Appendix A) in
considering potential risk. It is possible that designation of dibutyl sebacate as a low-priority
substance could result in increased use and higher production volumes. EPA expects, however, that
any changes in dibutyl sebacate's production volume would not alter the Agency's assessment of low
concern given the chemical's low-hazard profile of the chemical. EPA bases this expectation on
dibutyl sebacate's consistently low-concern hazard characteristics across the spectrum of hazard
endpoints. This expectation would apply, even with a significant change in the volume of the
chemical manufactured or processed and resultant increased exposures.
Proposed conclusion: Based on this screening criteria under 40 CFR 702.9(a)(6), EPA proposes to
find that even if production volumes increase, resulting in an increase in the frequency or level of
exposure, dibutyl sebacate does not meet the standard for a high-priority substance. The reasonably
available information on production volume, or significant changes in production volume described
above provides sufficient information to support this proposed finding.
8.7. Other Considerations
EPA did not identify other considerations for the screening-level review to support the proposed
designation of dibutyl sebacate as a low-priority substance.
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9. Proposed Designation
Based on a risk-based- screening-level review of the chemical substance and, when applicable,
relevant information received from the public and other information as appropriate and consistent
with TSCA section 26(h) and (i), EPA is proposing to designate dibutyl sebacate as a low-priority
substance as it does not meet the statutory criteria for a high-priority substance.
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Appendix A: Conditions of Use Characterization
EPA gathered information on and related to conditions of use including uses of the chemical,
products in which the chemical is used, types of users, and status (e.g., known, regulated).
A.1. CDR Manufacturers and Production Volume
The Chemical Data Reporting (CDR) rule (previously known as the Inventory Update Rule, or IUR),
under TSCA section 8, requires manufacturers (including importers) to report information on the
chemical substances they produce domestically or import into the U.S., generally above a reporting
threshold of 25,000 lb. per site per year. According to the 2016 Chemical Data Reporting (CDR)
database, eight companies manufactured or imported dibutyl sebacate at eight sites for reporting year
2015.
Table A.l presents the historic production volume of dibutyl sebacate from the CDR (previously
known as the Inventory Update Rule, or IUR) from 1986-2015. In reporting years 1986, and 1998-
2014, aggregate production volume for dibutyl sebacate was between 1,000,000 lbs. and 10,000,000
lbs. In reporting years 1990, 1994 and 2015, aggregate product volume was comparatively less than
other reporting years, at 500,000 lbs. to 1,000,000 lbs. In general, since 2011, production volume has
remained relatively stable, with a slight decrease from 2014-2015.
Table A.1:1986-2015 National Production Volume Data for Dibutyl Sebacate (Non-Confidential Production
Volume in Pounds)
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
>1M -
10M
>500K -
1M
>500K-
1M
>1M -
10M
>1M -
10M
1M-
10M
1M-
10M
1M-
10M
1M-
10M
1M-
10M
500K-
1M
Source(s
EPA (20
Note(s):
K = Thoi
):
18a; 2017b; 2006; 2002, 2002)
jsand; M = Million
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A.2. Uses
A.2.1 Methods for Uses Products Table
Table A.2 provides a list of known uses of dibutyl sebacate, organized by category of use. To compile
the uses, EPA searched publicly available databases listed in Table A-2 and conducted additional
Google searches to clarify uses. Search terms differed among databases because of different search
term requirements for each database (i.e., some databases search by CASRN while others search by
chemical name).
Table A.2: Sources Searched for Uses of Dibutyl Sebacate
Title
Author and Year
Search Term(s)
Found Use
Information? 1
Sources searched for all use reports
California Links to
Pesticides Data
California Dept of Pesticide
Regulation (2013)
Dibutyl sebacate
No
Canada Chemicals
Management Plan
information sheets
Government of Canada (2018)
Dibutyl sebacate
No
Chemical and Product
Categories (CPCat)
CPCat (2019)
109-43-3
Yes
ChemView2
EPA (2018a)
109-43-3
Yes
Children's Safe Product Act
Reported Data
Washington State Dept. of
Ecology (2018)
109-43-3
No
Consumer Product
Information Database
(CPID)
DeLima Associates (2018)
109-43-3
No
Danish surveys on
chemicals in consumer
products
Danish EPA (2018)
Dibutyl sebacate
No
Datamyne
Descartes Datamyne (2018)
Dibutyl sebacate
No
DrugBank
DrugBank (2018)
109-43-3; Dibutyl sebacate
No
European Chemicals
Agency (ECHA)
Registration Dossier
EHCA (2018)
109-43-3
Yes
eChemPortal2
OECD (2018)
109-43-3
No
Envirofacts2
EPA (2018b)
109-43-3
No
Functional Use Database
(FUse)
EPA (2017a)
109-43-3
No
Kirk-Othmer Encyclopedia
of Chemical Technology
Kirk-Othmer (2006)
Dibutyl sebacate
No
Non-Confidential 2016
Chemical Data Reporting
(CDR)
EPA (2017b)
109-43-3
Yes
PubChem Compound
Kim etal. (2016)
109-43-3
Yes
Safer Chemical Ingredients
List (SCIL)
EPA (2018d)
109-43-3
Yes
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Table A.2: Sources Searched for Uses of Dibutyl Sebacate
Title
Author and Year
Search Term(s)
Found Use
Information? 1
Synapse Information
Resources2
Synapse Information
Resources (2009)
109-43-3
Yes
Resource Conservation
and Recovery Act (RCRA)
EPA (2018c)
109-43-3
No
Scorecard: The Pollution
Information Site
GoodGuide (2011)
109-43-3
No
Skin Deep Cosmetics
Database
EWG (2018)
109-43-3; Dibutyl sebacate
No
Toxics Release Inventory
(TRI)
EPA (2018e)
109-43-3
No
TOXNET2
NLM (2018)
109-43-3
Yes
Ullmann's Encyclopedia of
Industrial Chemistry
Ullmann's (2000)
Dibutyl sebacate
No
Additional sources identified from reasonably available information
Agency for Toxic
Substances and Disease
Registry (ATSDR)
ATSDR (1995)
Incidentally identified while
researching details of this
chemical's uses and
products.
Yes
Amazon
Amazon.com (2018)
Ceramic Industry
Ceramic Industry (2018)
Eastman Chemical
Company
Eastman Chemical Company
(2017)
Electronics Cooling
Mohapatra (2006)
Pfizer
Pfizer (2016)
Note(s):
1. If use information was found in the resource, it will appear in Table 3-2 unless otherwise noted.
2. This source is a group of databases; thus the exact resource(s) it led to will be cited instead of the database as whole.
The U.S. Patent and Trademark Office has an online database that shows 5,290 patents referencing
"dibutyl sebacate" (USPTO 2018). Although patents could be useful in determining reasonably
foreseen uses, it is difficult to confirm whether any of the patented technologies are currently in use.
Uses inferred from patents containing dibutyl sebacate were not included in Table A.3. Note that the
uses in Table A.3 that are covered under TSCA are included in Section 5, Table 3 of this document.
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A.2.2 Uses of Dibutyl Sebacate
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Cleaning Products
ECHA (2018)
Air freshener
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in aerosol and non-aerosol air freshener products, including
heated products including candles, diffusers. No further information about this specific use could be found and it is unknown
whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Automotive care
products
Consumer,
commercial,
industrial
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning automotive care products, in spray and
liquid forms, and in professional and industrial vehicle spray, rinse cleaning and wash products. No further information about this
specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer, commercial and industrial based on inclusion in ECHA's consumer uses, uses by professional
workers and uses at industrial sites.
ECHA (2018)
Bleach products
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning bleach products, in powder, liquid and
tablets forms. No further information about this specific use could be found and it is unknown whether this is an ongoing use in
the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Boat cleaners
Commercial,
industrial
The ECHA registration dossier reports use of dibutyl sebacate in professional boat cleaning and washing product, in spray and
wipe forms. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are commercial and industrial based on inclusion in ECHA's uses by professional workers and uses at industrial
sites.
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Carpet cleaners
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning carpet cleaner products, in spray and
liquid forms, and in professional carpet cleaning products. No further information about this specific use could be found and it is
unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Cleaning wipes
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning wipe products for use in the bathroom,
kitchen and floor. No further information about this specific use could be found and it is unknown whether this is an ongoing use
in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Descaler
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning descaler products and in professional
descaling agents. No further information about this specific use could be found and it is unknown whether this is an ongoing use
in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Dishwash
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning hand dishwashing products, in liquid
form, and professional dishwash product and rinse aid. No further information about this specific use could be found and it is
unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Drain cleaner/
unblocker
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning drain products, in powder and gel forms,
and in professional drain unblockers. No further information about this specific use could be found and it is unknown whether
this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Fabric
conditioners
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning fabric softener products, in liquid form
and professional laundry conditioner (softener). No further information about this specific use could be found and it is unknown
whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Floor cleaner,
polish, stripper
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional floor care products, in spray and wipe forms and
floor polish and stripper products. No further information about this specific use could be found and it is unknown whether this is
an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
VI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Furniture cleaner
(leather care)
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in "furniture floor and leather care" products, in spray and liquid
forms. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Furniture cleaner
(wooden)
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional wooden furniture care products, in spray and wipe
forms. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
ECHA (2018)
General purpose
cleaner
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional general purpose cleaners. No further information
about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
ECHA (2018)
Glass cleaner
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional glass cleaner, in spray and wipe forms. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
ECHA (2018)
Ironing aid
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in ironing aids. No further information about this specific use
could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
VII
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Kitchen cleaner
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional kitchen surface cleaners. No further information
about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
Dionisio etal. (2015); ECHA (2018)
Laundry
detergent
Consumer,
commercial,
industrial
CPCat lists the use of dibutyl sebacate in cleaning washing detergent, as a surfactant. The ECHA registration dossier reports
use of dibutyl sebacate in laundry cleaning and washing products both in powder and liquid forms, and in semi-automatic
processes. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are industrial based on inclusion in industrial sector categories and consumer and commercial based on
inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Leather treatment
products
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in leather treatment products; and professional leather care
products. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Machine
dishwasher
cleaner
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in washing and cleaning machine dishwashing products, in
powder, liquid and tablet forms and in professional dishwashing products intended for semi-automatic use. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
VIII
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Metal cleaner
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional metal cleaning agents, including silver and copper
polishes. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
ECHA (2018)
Oven and grill
cleaners
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in cleaning and washing over cleaners, in spray and trigger
forms, and in professional oven and grill cleaners. No further information about this specific use could be found and it is
unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Polishes and wax
blends
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in polishes and wax blends. No further information about this
specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Stain remover
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional laundry stain remover products. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
ECHA (2018)
Stainless steel
cleaner
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional stainless steel care. No further information about
this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
ECHA (2018)
Surface cleaner
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in surface cleaner products, in liquid, powder, gel and spray
forms. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Toilet cleaners
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in cleaning and washing toilet cleaner products, in powder, liquid,
gel and tablet forms. No further information about this specific use could be found and it is unknown whether this is an ongoing
use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Vehicle dewaxing
Commercial,
industrial
The ECHA registration dossier reports use of dibutyl sebacate in vehicle dewaxing product. No further information about this
specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial and industrial based on inclusion in ECHA's uses by professional workers and uses at industrial
sites.
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Construction
Boat and ship
construction
Industrial/
commercial/
consumer
CPCat (2019)
CPCat lists the use of dibutyl sebacate in the building and repairing of ships, floating structures, and pleasure and sporting
boats. No further information is available on its use in this industry.
The expected users are assumed to be industrial, commercial, and consumer.
CPCat (2019); ECHA (2018)
Building
construction
Consumer,
commercial,
industrial
CPCat lists the use of dibutyl sebacate in the construction of buildings and "complete constructions and part thereof civil." and in
construction materials. The ECHA registration dossier reports use of dibutyl sebacate in consumer and professional building
construction adhesives and chemicals. No further information about this specific use could be found and it is unknown whether
this is an ongoing use in the United States.
Expected users are commercial and industrial based on inclusion in ECHA's uses by professional workers and uses at industrial
sites.
CPCat (2019)
Building materials
Industrial
CPCat lists the use of dibutyl sebacate in construction materials and plastic construction materials. No further information is
available on its use in this industry.
Expected users are industrial based on inclusion in industrial sector categories.
Flooring materials
Industrial/
commercial/
consumer
CPCat (2019)
CPCat lists the use of dibutyl sebacate in flooring materials (joint-less floors). No further information is available on this use.
The expected users are assumed to be industrial, commercial, and consumer.
CPCat (2019)
Road
construction
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in road and construction applications. No further information
about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
XI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Cosmetics and Personal Care Products
CPCat (2019)
Fragrances1
Consumer
CPCat lists the use of dibutyl sebacate in consumer product fragrances available for consumer use.
Expected users are consumer based on its classification in product categories.
TSCA Conditions of Use: Fertilizer and Plant Products
ECHA (2018)
Agrochemicals
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in agrochemicals, fertilizers. No further information about this
specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Plant protection
products
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in plant protection products for outdoor and indoor spraying. No
further information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Pre-treated seeds
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in the application of pre-treated seeds for outdoor use, and in the
professional application of pre-treated seeds for indoor and outdoor use. No further information about this specific use could be
found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Seed treatment
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in seed treatment products for outdoor use. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
XII
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Food and Beverages
ECHA (2018)
Food and
beverage
manufacturing2
Industrial
The ECHA registration dossier reports use of dibutyl sebacate in industrial washing and cleaning and in food and beverage
processing. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
Synapse Information Resources (2009)
Food-contact
metallic article
manufacturing2
Industrial
Synapse Information Resources lists the use of dibutyl sebacate in food-contact coatings and as a surface lubricant for the
manufacturing of food-contact metallic articles. No further information could be found on this use.
Expected user is not stated, but it is most likely industrial for the manufacturing of food contact metallic articles.
Synapse Information Resources (2009)
Food-contact
rubber articles2
Industrial/
commercial/
consumer
Synapse Information Resources lists the use of dibutyl sebacate as a plasticizer in food-contact rubber articles for repeated use.
No further information could be found on this use.
The expected users are assumed to be industrial, commercial, and consumer.
Synapse Information Resources (2009)
Food packaging
adhesives2
Industrial/
commercial/
consumer
Synapse Information Resources lists the use of dibutyl sebacate in adhesives. No further information could be found on this
use.
The expected users are assumed to be industrial, commercial, and consumer.
Food
paper/paperboard
packing2
Industrial/
commercial/
consumer
Synapse Information Resources (2009)
Synapse Information Resources lists the use of dibutyl sebacate in "paper/paperboard in contact with aq./fatty foods."
The expected users are assumed to be industrial, commercial, and consumer.
XIII
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Fuel
Synapse Information Resources (2009)
Motor oil
Industrial/
commercial/
consumer
Synapse Information Resources lists dibutyl sebacate in motor oils. No further information about this specific use could be
found.
The expected users are assumed to be industrial, commercial, and consumer.
ECHA (2018)
Oil and gas
drilling
Commercial,
industrial
The ECHA registration dossier reports use of dibutyl sebacate in oil and gas field drilling and production operations. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial and industrial based on inclusion in ECHA's uses by professional workers and uses at industrial
sites.
ATSDR (1995); CPCat (2019)
Torpedo fuel
Industrial
CPCat lists the use of dibutyl sebacate in a product that is used as torpedo fuel by the United States military. The current use
and manufacturing of this product is unknown.
According to ATSDR, expected users of this chemical are industrial as the product is exclusively used by U.S. Navy personnel.
TSCA Conditions of Use: Manufacturing
CPCat (2019)
Adhesive
manufacturing
Industrial
CPCat lists the use of dibutyl sebacate in adhesive manufacturing. No further information is available on its function in industrial
adhesive manufacturing. However, other entries in this table show evidence of dibutyl sebacate in end-use adhesives, sealants,
paint adhesives, food packaging adhesives, and building construction adhesives.
Expected users are industrial based on inclusion in industrial sector categories.
XIV
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
CPCat (2019); ECHA (2018)
Chemicals
manufacturing
Industrial
CPCat lists the use of dibutyl sebacate in the manufacture of "chemicals and chemical products." The ECHA registration dossier
reports use of dibutyl sebacate in chemical production. No further information about this specific use could be found and it is
unknown whether this is an ongoing use in the United States.
Expected users are industrial based on inclusion in industrial sector categories and inclusion in ECHA's uses at industrial sites
CPCat (2019)
Electrical
machinery
manufacturing
Industrial
CPCat lists the use of dibutyl sebacate in the "manufacture of electrical machinery, equipment and apparatus." No further
information is available on its use in this industry.
Expected users are industrial based on inclusion in industrial sector categories.
ECHA (2018)
Explosives
manufacturing
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in explosives manufacturing. No further information about this
specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers
CPCat (2019)
Furniture
manufacturing
Industrial
CPCat lists the use of dibutyl sebacate in the manufacture of furniture. No further information is available on its use in this
industry.
Expected users are industrial based on inclusion in industrial sector categories.
CPCat (2019)
Machinery and
equipment
manufacturing
Industrial
CPCat lists the use of dibutyl sebacate in the manufacture of machinery and equipment. No further information is available on
its use in this industry.
Expected users are industrial based on inclusion in industrial sector categories.
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
CPCat (2019); Synapse Information Resources (2009)
Metals
manufacturing
Industrial
CPCat lists the use of dibutyl sebacate in the manufacturing of "fabricated metal products, except machinery." Synapse
Information Resources lists the use of dibutyl sebacate as a lubricant in metalworking. No further information is available on its
use in this industry.
Expected users are industrial based on inclusion in industrial sector categories.
CPCat (2019)
Paint and varnish
manufacturing
Industrial
CPCat lists the reported use of dibutyl sebacate in the manufacture of "paints, varnishes, and other similar coating, print."
Expected users are industrial based on inclusion in industrial sector categories.
Photographic film
paper, plate, and
chemical
manufacturing
Industrial
EPA (2017b)
CDR identified the use of dibutyl sebacate as a solvent in processing - incorporation into product formulation or mixture, in
photographic film paper, plate and chemical manufacturing.
Expected users are industrial based on identification in CDR's industrial processing and use report.
EPA (2017b); ECHA (2018)
Plastic product,
material and resin
manufacturing
Industrial
CDR identified the use of dibutyl sebacate as a plasticizer in processing - incorporation into formulation, mixture or reaction
product, and article, in plastics products, plastic material and resin manufacturing. The ECHA registration dossier reports use of
dibutyl sebacate as an additive in plastics.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
ECHA (2018)
Polymer
processing
Industrial
The ECHA registration dossier reports use of dibutyl sebacate in polymer processing. No further information about this specific
use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
XVI
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
EPA (2017b)
Printing ink
manufacturing
Industrial
CDR identified the use of dibutyl sebacate as a pigment in processing - incorporation into formulation, mixture or reaction
product, in printing ink manufacturing.
Expected users are industrial based on identification in CDR's industrial processing and use report.
EPA (2017b); CPCat (2019); Synapse Information Resources (2009); ECHA (2018)
Rubber product
manufacturing
Industrial
CDR identified the use of dibutyl sebacate as a plasticizer in processing - incorporation into article, and as a reactant, in rubber
product manufacturing. CPCat lists the use of dibutyl sebacate in the manufacture of rubber and plastics products. Synapse
Information Resources lists that dibutyl sebacate is used as a rubber softener. The ECHA registration dossier reports use of
dibutyl sebacate in rubber production and processing.
Expected users are industrial based on identification in CDR's industrial processing and use report.
EPA (2017b)
Synthetic rubber
manufacturing
Industrial
CDR identified the use of dibutyl sebacate as a plasticizer in processing as a reactant, in synthetic rubber manufacturing.
Expected users are industrial based on identification in CDR's industrial processing and use report.
Synapse Information Resources (2009); ECHA (2018)
Textile and
leather
manufacturing
Industrial
Synapse Information Resources lists the use of dibutyl sebacate as a fattening agent in textile and leather production. The
ECHA registration dossier reports use of dibutyl sebacate in textile applications as a reactive processing aid. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
CPCat (2019)
Transportation
equipment
manufacturing
Industrial
CPCat lists the reported use of dibutyl sebacate in the manufacture of "other transportation equipment." No further information is
available on its use in this industry.
Expected users are industrial based on inclusion in industrial sector categories.
XVII
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
EPA (2017b)
Wholesale and
retail trade
Industrial
CDR identified the use of dibutyl sebacate as a plasticizer and solvent in processing - incorporation into formulation, mixture or
reaction product, and article, in wholesale and retail trade.
Expected users are industrial based on identification in CDR's industrial processing and use report.
CPCat (2019)
Windmill
manufacturing
Industrial
CPCat lists the reported use of dibutyl sebacate in the manufacture of "windmills and parts of this." No further information is
available on its use in this industry.
Expected users are industrial based on inclusion in industrial sector categories.
XVIII
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Other Industrial Uses
CPCat (2019)
Agricultural crop,
agricultural
animal, hunting3
Industrial
CPCat lists the reported use of dibutyl sebacate as an agricultural crop, agricultural animals, and hunting. No further information
is provided on current use and manufacturing.
Expected users are industrial based on inclusion in industrial sector categories.
Ceramic Industry (2018); Synapse Information Resources (2009)
Ceramic
extrusion
Industrial
Synapse Information Resources lists the use of dibutyl sebacate in extrusion of ceramics. Ceramic extrusion is described as
"the act or process of shaping by forcing through a die."
Expected user is not stated, but it is most likely industrial for the cosmetics manufacturing.
ECHA (2018)
Coatings
Commercial,
industrial
The ECHA registration dossier reports use of dibutyl sebacate in coatings in various industrial and commercial processes. No
further information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial and industrial based on inclusion in ECHA's uses by professional workers and uses at industrial
sites.
Mohapatra (2006); Synapse Information Resources (2009)
Dielectric liquid
Industrial
Synapse Information Resources lists dibutyl sebacate as a dielectric liquid. Dielectric liquids are used as coolants for electronic.
Expected users are industrial as this is used in the manufacturing of electronics.
ECHA (2018)
Industrial cleaner
Industrial
The ECHA registration dossier reports use of dibutyl sebacate in industrial cleaners. No further information about this specific
use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
XIX
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Lubricant
Commercial,
industrial
The ECHA registration dossier reports use of dibutyl sebacate in lubricants for miscellaneous industrial and commercial
processes for vehicles or machinery. No further information about this specific use could be found and it is unknown whether
this is an ongoing use in the United States.
Expected users are commercial and industrial based on inclusion in ECHA's uses by professional workers and uses at industrial
sites.
ECHA (2018)
Metal treatment
Industrial
The ECHA registration dossier reports use of dibutyl sebacate in metal treatment coating product. No further information about
this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
Eastman Chemical Company (2017); Synapse Information Resources (2009)
Polyvinyl butyral
resins
Commercial,
industrial
Dibutyl sebacate is listed as an ingredient component in a polyvinyl resin that is currently available for use. Polyvinyl butyral
resin is a raw material that can be used in a variety of application including ceramic binders, inks/ dry toners, wood coatings,
etc. Synapse Information Resources lists dibutyl sebacate as a plasticizer in polyvinyl butyral.
Expected users are commercial and industrial, as the product information sheet lists that it can be used for commercial and
industrial applications.
Printing and
reproduction of
recorded media
Industrial
CPCat (2019)
CPCat lists the use of dibutyl sebacate in printing and reproduction of recorded media.
Expected users are industrial based on inclusion in industrial sector categories.
CPCat (2019)
Surfactant
Industrial
CPCat lists the reported use of dibutyl sebacate as a surface-active agent.
Expected users are industrial based on inclusion in industrial sector categories.
XX
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Water treatment
chemicals
Consumer,
commercial,
industrial
The ECHA registration dossier reports use of dibutyl sebacate in water treatment chemicals, and waste-water treatment, and in
consumer water softener products, in powder, liquid and tablet forms. No further information about this specific use could be
found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial and industrial based on inclusion in ECHA's uses by professional workers and uses at industrial
sites.
TSCA Conditions of Use: Miscellaneous
ECHA (2018)
Adhesives,
sealants
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in adhesives, sealants. No further information about this specific
use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Deicing and anti-
icing products
Consumer,
commercial
The ECHA registration dossier reports use of dibutyl sebacate in deicing and anti-icing application products. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers.
ECHA (2018)
Fillers, putties,
plasters,
modelling clay
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in fillers, putties, plasters, and modelling clay. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Finger paints
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in finger paints. No further information about this specific use
could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
XXI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
Synapse Information Resources (2009); ECHA (2018)
Greases and
lubricants
Consumer,
commercial
Synapse Information Resources lists dibutyl sebacate in greases. The ECHA registration dossier reports use of dibutyl sebacate
in lubricants and greases, in vehicles and machinery. No further information about this specific use could be found and it is
unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional workers
EPA (2017b); ECHA (2018)
Ink, toner, and
colorant products
Consumer,
commercial
CDR identified the use of ink, toner, and colorant products containing dibutyl sebacate. The ECHA registration dossier reports
use of dibutyl sebacate in ink and toners.
Expected users are based on CDR's consumer/commercial classification and inclusion in ECHA's consumer uses.
ECHA (2018)
Medical devices
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professionally used medical devices in spray and wipe
processes. No further information about this specific use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
Non-metal
surface treatment
products
Consumer
ECHA (2018)
The ECHA registration dossier reports use of dibutyl sebacate in non-metal surface treatment products. No further information
about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
XXII
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
CPCat (2019)
Paint adhesive
and binding agent
Unknown
CPCat lists the use of dibutyl sebacate as a paint adhesive, binding agent. No further information is provided on current use and
manufacturing.
Expected users are unknown, due to the limited availability of information.
CPCat (2019); ECHA (2018)
Paints, lacquers
and varnishes
Consumer
CPCat lists the use of dibutyl sebacate in paints, lacquers, varnishes. The ECHA registration dossier reports use dibutyl
sebacate in "coating and paints, thinners and paint removers." No further information about this specific use could be found and
it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
Photographic
supplies, film and
photo chemicals
Consumer,
Commercial
EPA (2017b); CPCat (2019)
CDR identified the use of dibutyl sebacate in photographic supplies, film and photo chemicals containing dibutyl sebacate.
CPCat lists the use of dibutyl sebacate as a photographic reprographic agent.
Expected users are based on CDR's consumer/commercial classification.
CPCat (2019)
Printing
Unknown
CPCat lists the use of dibutyl sebacate in printing inks. No further information is provided on current use and manufacturing.
Expected users are unknown, due to the limited availability of information.
CPCat (2019)
Surface treatment
of metal
Unknown
CPCat lists the use of dibutyl sebacate in "other surface treatment of metal." No further information is provided on current use
and manufacturing.
Expected users are unknown, due to the limited availability of information.
XXIII
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Textile dyes
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in "textile dyes, and impregnating products." No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
Non-TSCA Uses
ECHA (2018)
Biocidal products
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in biocidal products including for pest control. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
Synapse Information Resources (2009)
Cosmetics
manufacturing
Industrial
Synapse Information Resources lists the use of dibutyl sebacate as an emollient and film-former in cosmetics.
Expected user is not stated, but it is most likely industrial for the cosmetics manufacturing.
ECHA (2018)
Cosmetics
products
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in consumer end-use of cosmetics. No further information about
this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
CPCat (2019); Synapse Information Resources (2009)
Food additive/
flavoring
Unknown
CPCat lists the use of dibutyl sebacate as a food additive and flavoring. Synapse Information Resources lists dibutyl sebacate
as a synthetic flavoring agent in food.
The expected users are unknown, due to the limited availability of information.
XXIV
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
Synapse Information Resources (2009)
Perfumes
Consumer
Synapse Information Resources lists the use of dibutyl sebacate in perfumes.
Expected users are consumer based on its classification in product categories.
ECHA (2018)
Hand cleaner
(skin disinfectant)
Commercial
The ECHA registration dossier reports use of dibutyl sebacate in professional hand cleaners (skin disinfectants). No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
CPCat (2019)
Inactive drug
ingredient
Industrial
CPCat lists the use of dibutyl sebacate as an inactive ingredient in a pharmaceutical drug and use in pharmaceutical medicine
manufacturing.
Expected users are industrial based on inclusion in industrial sector categories.
ECHA (2018)
Insecticides
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in insecticide and repellent products, in liquid and spray forms.
No further information about this specific use could be found and it is unknown whether this is an ongoing use in the United
States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
Pfizer (2016)
Pain medication
Consumer
Dibutyl sebacate is listed as ingredient in a Troxyca ER, a medication currently available for use in the United States. The drug
is used to treat severe pain.
Expected users are consumer as the medication is a prescription pain medication that would be prescribed to consumers.
XXV
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Table A.3: Uses of Dibutyl Sebacate
Use
Expected Users
Description of Use and References
ECHA (2018)
Pest control
products
Consumer
The ECHA registration dossier reports use of dibutyl sebacate in pest control products, insecticides and repellents. No further
information about this specific use could be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on inclusion in ECHA's consumer uses.
EPA (2017b); Synapse Information Resources (2009)
Pharmaceutical
and medicine
manufacturing
Industrial
CDR identified the use of dibutyl sebacate as a plasticizer in processing - incorporation into formulation, mixture or reaction
product, in pharmaceutical and medicine manufacturing. Synapse Information Resources lists the use of dibutyl sebacate in oral
pharmaceuticals.
Expected users are industrial based on identification in CDR's industrial processing and use report.
Amazon.com (2018)
Skin cleansing oil
Consumer
Dibutyl sebacate is listed as an ingredient for a skin cleansing oil product currently available for use and purchase.
Expected users are consumer as the product is available for consumer purchase.
Children's Products
CDR reports did not include any uses in children's products. However, the ECHA registration dossier includes use in finger paints, which are likely to be used by children.
Recycling and Disposal
In the 2016 CDR, one facility reported recycling dibutyl sebacate (e.g., recycled, remanufactured, reprocessed, or reused). Two facilities reported not recycling dibutyl
sebacate, two facilities withheld recycling information, and three facilities reported this information as CBI (EPA 2017b).
Note(s):
1. Potentially a non-TSCA use as category may contain both TSCA and non-TSCA uses; however, because information is insufficient to determine, it is assumed to be
covered by TSCA.
2. TSCA product based on the assumption that the chemical is used in the manufacturing of products and not intended to be a component of food.
3. Assumed to be a mix of TSCA and non-TSCA products. It is expected that more specifically defined uses in the table are representative of the uses that fall into this
category.
XXVI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
A.3 References
Agency for Toxic Substances and Disease Registry (ATSDR). (1995). Toxicological Profile for Otto Fuel
II and its Components.
Amazon.com. (2018). Bb Laboratories Deep Clear Cleansing Oil 150ml. Retrieved from
https://www.amazon.eom/Laboratories-Deep-Clear-Cleansing-150ml/dp/B004M801KA
California Dept of Pesticide Regulation. (2013). DPR Databases. Retrieved from
https: //www. cdpr. ca. gov/dprdatabase .htm
Ceramic Industry. (2018). Extrusion Basics. Retrieved from
https: //www. ceramicindustrv. com/articles/87808-extrusion-basics
Danish EPA. (2018). Danish surveys on chemicals in consumer products. Retrieved from
https://eng.mst.dk/chemicals/chemicals-in-products/consumers-consumer-products/danish-
survevs-on-consumer-products/
DeLima Associates. (2018). Consumer Product Information Database. Retrieved from
https: //www. whatsinproducts. com/
Dionisio, K. L. (CPCat), Frame, A. M., Goldsmith, M.-R., Wambaugh, J. F., Liddell, A., Cathey, T., . . .
Judson, R. S. (2015). Exploring consumer exposure pathways and patterns of use for chemicals in
the environment. Toxicology Reports, 2, 228-237.
doi :http ://dx.doi .org/10.1016/i .toxrep .2014.12.009
Eastman Chemical Company. (2017). Butvar Polyvinyl Resins Properties and Uses. Retrieved from
https://www.eastman.com/Literature Center/A/ADDBVR3 978 .pdf
European Chemicals Agency (ECHA). (2018). Dibutyl Sebacate. Retrieved from
https://echa.europa.eu/registration-dossier/-/registered-dossier/16127/1
GoodGuide. (2011). Scorecard: The Pollution Information Site. Retrieved from
http://scorecard.goodguide.com/chemical-profiles/index.tcl
Government of Canada. (2018). Chemical Substances: Services and Information. Retrieved from
https://www.canada.ca/en/health-canada/services/chemical-substances.html
Kim, S., Thiessen, P. A., Bolton, E. E., Chen, J., Fu, G., Gindulyte, A., . . . Bryant, S. H. (2016).
PubChem Substance and Compound databases. Nucleic Acids Research, -/-/(Database issue),
D 1202-D 1213. doi: 10.1093/nar/gkv951
Kirk-Othmer. (2006). Kirk-Othmer Encyclopedia of Chemical Technology.
Mohapatra, S. C. (2006). An Overview of Liquid Coolants for Electronics Cooling. Retrieved from
https://www.electronics-cooling.eom/2006/05/an-overview-of-liquid-coolants-for-electronics-
cooling/#
Organisation for Economic Cooperation and Development (OECD). (2018). eChemPortal: Global Portal
to Information on Chemical Substances. Retrieved from
https: //www .echemportal. org/echemportal/index. action
XXVII
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Pfizer. (2016). SAFETY DATA SHEET. Retrieved from
https://www.pfizer.com/sites/default/files/products/material safety data/Oxvcodone HC1 Naltre
xone HCL ER tablets 26-Aug-2016.pdf
Synapse Information Resources. (2009). Specialty Chemicals Source Book. Fourth Edition. Volume 1.
U.S. Environmental Protection Agency (EPA). (2002). 1986-2002 Historical IURData. Retrieved from
Excel File
U.S. Environmental Protection Agency (EPA). (2006). 2006 IUR Public Database.
U.S. Environmental Protection Agency (EPA). (2017a). Functional Use Database (FUse). Retrieved
from https://catalog.data.gov/dataset/functional-use-database-fuse
U.S. Environmental Protection Agency (EPA). (2017b). Non-Confidential 2016 Chemical Data Reporting
(CDR). Retrieved from https://www.epa.gov/chemical-data-reporting
U.S. Environmental Protection Agency (EPA). (2018a). ChemView. Retrieved from
https: //chemvie w .epa. gov/chemview
U.S. Environmental Protection Agency (EPA). (2018b). Envirofacts Multisystem Search. Retrieved from
https://www3.epa.gov/enviro/facts/multisvstem.html
U.S. Environmental Protection Agency (EPA). (2018c). Look up table for BR Waste Code (National
Biennial RCRA Hazardous Waste Report). Retrieved from
https://iaspub.epa.gov/enviro/brs codes v2.waste lookup
U.S. Environmental Protection Agency (EPA). (2018d). Safer Chemical Ingredients List. Retrieved from
https://www.epa.gov/saferchoice/safer-ingredients
U.S. Environmental Protection Agency (EPA). (2018e). TRI-Listed Chemicals. Retrieved from
https://www.epa.gov/toxics-release-inventorv-tri-program/tri-listed-chemicals
U.S. National Library of Medicine (NLM). (2017). Haz-Map. Retrieved from
https://hazmap.nlm .nih.gov/categorv-details?id=4753&table=copvtblagents
U.S. National Library of Medicine (NLM). (2018). TOXNET® (TOXicology DataNETwork). Retrieved
from https://toxnet.nlm.nih.gov/
U.S. Patent and Trademark Office (USPTO). (2018). USPTO Patent Full-Text and Image Database.
Retrieved from http: //patft .uspto. gov/netahtml/PTO/search-adv .htm
Ullmann's. (2000). ULLMANN'S Encyclopedia of Industrial Chemistry.
Washington State Dept. of Ecology. (2018). Children's Safe Product Act Reported Data. Retrieved from
https://fortress.wa.gov/ecv/cspareporting/
XXVIII
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Appendix B: Hazard Characterization
Table B.1: Human Health Hazard
Acute Mammalian Toxicity
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
4867875
Oral (gavage)
Albino rat
Single
exposure
Dose: 4,700 mg/kg
Replicates: 5 per sex
LD50 > 4700 mg/kg
Methods:
• Test substance reported as CASRN 109-43-3
• Purity not reported
• Equivalent to OECD Guideline 401
• Predates GLP compliance
61578
Oral
Sprague-
Dawley rat
Single
exposure
observed for 7
days
Doses and
replicates:
• 1,000 mg/kg (3
males)
• 5,000 mg/kg (9
males)
• 16,000 mg/kg (6
males)
• 32,000 mg/kg (6
males)
LD50 estimated to be
between 16000 mg/kg-
32000 mg/kg
Methods:
• Test substance reported as CASRN 109-43-3
• Purity not reported
• Predates GLP compliance
Mortality Results:
• 1000 mg/kg: 0/3 males
• 5000 mg/kg: 0/9 males
• 16000 mg/kg: 0/6 males
• 32000 mg/kg: 6/6 males
Repeated Dose Toxicity
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
4829109, 61578
Oral
Sprague-
Dawley rat
1 year
Doses: 0, 7, 35,170,
and 870 mg/kg-day
Replicates: 10 males
per group
NOAEL: 870 mg/kg-
day
Methods:
• Test substance reported as CASRN 109-43-3
• Purity not reported
XXIX
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Table B.1: Human Health Hazard
• Doses reported in percent diet and mg/kg-day
but no basis for conversion was provided;
these doses are based on percent diet and
EPA reference values for body weight and
food consumption
• Predates GLP compliance
4829109, 61578
Oral
Sprague-
Dawley rat
2 year
Doses: 0, 7, 35,170,
870, and 4400 mg/kg-
day
Replicates: 16 males
per group
NOAEL: 4400 mg/kg-
day
Methods:
• Test substance reported as CASRN 109-43-3
• Purity not reported
• Doses reported in percent diet and mg/kg-day
but no basis for conversion was provided;
these doses are based on percent diet and
EPA reference values for body weight and
food consumption
• Predates GLP compliance
Reproductive Toxicity
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
5077960
Oral (gavage)
Sprague-
Dawley rats
2 weeks prior
to mating
through day 3
of lactation (for
females) or 42
days (for
males)
Doses: 0,100, 300,
and 1000 mg/kg-day
Replicates: 13 per
sex per group
NOAEL: 1000 mg/kg-
day
• Test substance reported as CASRN 105-99-7
• Purity > 99%
• GLP compliant
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
Developmental Toxicity
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
No data available.
Cancer
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
61578
Oral
Sprague-
2 year
Doses: 0, 7, 35,170,
Negative
Methods: I
Dawley rat
870, 4400 mg/kg-day
Replicates: 16 males
per group
•
•
•
•
Test substance reported as CASRN 109-43-3
Purity not reported
Doses reported in percent diet and mg/kg-day
but no basis for conversion was provided;
these doses are based on percent diet and
EPA reference values for body weight and
food consumption
Predates GLP compliance
Genotoxicity
Source
Test Type &
endpoint
Species &
Strain (if
available)
Metabolic
Activation
Doses and Controls
Results
Study Details
2207709
Base test on
Drosophila
N/A
Dose: 19 mM
Negative
Methods: I
Drosophila,
•
Test substance reported as CASRN 109-43-3
Sex linked
•
Purity not reported
recessive
lethal mutation
•
GLP compliance not reported
2207709
Chromosomal
NMRI Mice
N/A
Doses: 0, 943, 1886,
Negative
Methods: I
aberration (in
or 2829 mg/kg
•
Test substance reported as CASRN 109-43-3
vivo)
Replicates: 4 per
group
•
•
Purity not reported
GLP compliance not reported
XXXI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
5077960
Gene
Salmonella
With and
Doses: 0, 312.5, 625,
Negative
Methods:
mutation (in
typhimurium
without
1250, 2500, and 5000
• Test substance reported as CASRN 105-99-7
vitro)
TA98, TA 100,
TA1535 and
TA 1537
|jg/plate
• Purity > 99%
• Equivalent to OECD Guideline 471
• GLP compliant
5077960
Gene
E. Coli strain
With and
Doses: 0, 312.5, 625,
Negative
Methods:
mutation (in
WP2
without
1250, 2500, and 5000
• Test substance reported as CASRN 105-99-7
vitro)
|jg/plate
• Purity > 99%
• Equivalent to OECD Guideline 472
• GLP compliant
5077960
Gene
Salmonella
With and
Doses:
Negative
Methods:
mutation (in
typhimurium
without
Experiment 1: 8, 40,
• Test substance reported as CASRN 105-99-7
vitro)
TA98, TA 100,
TA 1535, TA
1537, andTA
1538
200,1000 and 5000
|jg/plate
Experiment 2: 50,
125, 250, 500 and
1000 pg/plate
• Purity > 99%
• Equivalent to OECD Guideline 471
• GLP compliant
5077960
Chromosomal
Chinese
With and
Doses:
Without metabolic
Methods:
aberration (in
Hamster lung
without
Without metabolic
activation: negative
• Test substance reported as CASRN 105-99-7
vitro)
cells
activation: 0, 0.012,
0.023, and 0.046
mg/mL
With metabolic
activation: 0, 0.7,1.3,
and 2.6 mg/mL
With metabolic
activation, positive at
cytotoxic
concentrations
• Purity > 99%
• Equivalent to OECD Guideline 471
• GLP compliant
Results:
• With metabolic activation, cytotoxic at 0.7
mg/L
Sensitization
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
No data available.
Irritation
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses
Effect
Study Details
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Table B.1: Human Health Hazard
5077950
Skin
Small White
Russian
rabbits
4 hour
exposure,
observed for 8
days
Doses: 0.5 mL of
undiluted test material
Replicates: 3 male
rabbits
Irritating
Methods:
• Test substance reported as CASRN 105-99-7
• Purity approximately 99.7%
• OECD Guideline 404
• GLP compliance not reported
Results:
• Slight to obvious erythema and very slight
edema observed in 3/3 animals 1 hour
following exposure
• Observed effects were fully reversed 8 days
following exposure
5077953
Skin
Rabbits
24 hour
exposure,
observed for 3
days
Doses: 0.5 mL of
undiluted test material
Replicates: 3 rabbits
per sex
Non-irritating
Methods:
• Test substance reported as CAS RN 7491-02-
3
• Purity not reported
• Equivalent to OECD Guideline 404
• Not GLP compliant
Results:
• Slight erythema was observed in 2/6 animals
24 hours following the exposure period
• Observed effects were fully reversed 3 days
following exposure
4867885
Ocular
Kleinrussen,
Chbb:HM
rabbits
72 hours
Doses: Undiluted test
material
Replicates: 3 male
rabbits
Non-irritating
Methods:
• Test substance reported as CASRN 109-43-3
• Purity not reported
• OECD Guideline 405
• GLP compliant
Results:
• 2/3 animals had slight conjunctiva prior to 48
hours
• 1/3 animals had slight chemosis prior to 48
hours
• All effects fully reversible by 48 hours
XXXIII
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.2: Environmental Hazard
Aquatic Toxicity: Experimental
Source
Species & Strain (if
available)
Duration
Doses and Replicate Number
Effect
Study Details
5077961
Daphnia magna
5 days
Doses: 0.045, 0.16, 0.48, 1.5
and 5.2 mg/L (measured)
EC50 > 5.2 mg/L
• Test substance reported as CAS RN 105-
99-7
• Purity: 99.7%
• OECD Guideline 211
• GLP compliant
5077960
Daphnia magna
21 days
Doses: 5 nominal concentrations
(0.18-18 mg/L) Replicates: 10
organisms per group
LC50: 4.3 mg/L
• Test substance reported as CAS RN 105-
99-7
• Purity: 99%
• OECD Guideline 202
• Not GLP compliant
5077962
Daphnia magna
21 days
Doses: 0.045, 0.16, 0.48, 1.5
and 5.2 mg/L (measured)
Replicates: 1 organism per
vessel, 10 vessels per test
concentration, 20 vessels per
control
NOEC: 1.5 mg/L
• Test substance reported as CAS RN 105-
99-7
• Purity: 99.7%
• OECD Guideline 211
• GLP compliant
5077963
Eisenia fetida
14 days
Doses: 1000 mg/kg soil
NOEC > 1000 mg/kg soil
• Test substance reported as CAS RN 105-
99-7
• Purity: 100%
• OECD Guideline 207
• GLP compliant
Aquatic Toxicity: Estimated
Model
Endpoint
Species
Predicted Effect Level
Notes
ECOSAR v2.0
(Class: Esters)
Acute
Freshwater
fish
LC50 = 0.1 mg/L
NES. Estimated Log K0w exceeds the endpoint specific cutoff.
ECOSAR v2.0
(Class: Esters)
Acute
Daphnia
magna
LC50 = 0.2 mg/L
NES. Estimated Log K0w exceeds the endpoint specific cutoff.
ECOSAR v2.0
(Class: Esters)
Acute
Green algae
EC50 = 0.04 mg/L
NES. Estimated Log K0w exceeds the endpoint specific cutoff.
ECOSAR v2.0
(Class: Esters)
Chronic
Freshwater
fish
ChV = 0.004 mg/L
XXXIV
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
ECOSAR v2.0
(Class: Esters)
Chronic
Daphnia
magna
ChV = 0.03 mg/L
ECOSAR v2.0
(Class: Esters)
Chronic
Green algae
ChV = 0.04 mg/L
Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and number of replicates
Results
Study Details
5077969
C02
evolution
28 days
Doses: 20 mg/L
Biodegradable
Methods:
• Test substance reported as CAS RN 7491 -02-3
• Purity not reported
• OECD Guideline 301B
• GLP compliance not reported
Biodegradation kinetics:
• 89.6% in 28 days; met the 10-day window
5077966
DOC
28 days
Doses: 20 mg/L
Biodegradable
Methods:
• Test substance reported as CASRN 105-99-7
• Purity not reported
• OECD Guideline 301E
• Not GLP compliant
Biodegradation kinetics:
• 96% in 28 days
5077960,
5077964
BOD
28 days
Doses: 100 mg/L
Biodegradable
Methods:
• Test substance reported as CASRN 105-99-7
• Purity not reported
• OECD Guideline 301C
• GLP compliant
Biodegradation kinetics:
• 86-95% in 28 days
5077965
Sludge
inoculum
28 days
Doses: 2.62 mg/L
Biodegradable
• Test substance reported as CASRN 105-99-7
• Purity: 99.6%
• OECD Guideline 301D
• GLP compliant
Biodegradation kinetics:
XXXV
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
• 60% in 28 days
Environmental Fate: Modelled
Model
Data
Type
Endpoint
Predicted Endpoint
Notes
EPISuite v.4.11
Estimated
BAF
29
From Arnot-Gobas method
EPISuite v.4.11
Estimated
BCF
281
From regression-based method
EPISuite v.4.11
Estimated
Anaerobic
Predicted to biodegrade under
Predicted probability of 0.7490. Fragment representation is valid.
(BIOWIN 7)
biodegradation
anaerobic conditions
Fast degradation is defined as predicted probability >0.5.
Note: the prediction for this chemical is outside of the estimation domain
XXXVI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
B.1 References
ECHA (European Chemicals Agency). (1976a). Dibutyl sebacate: acute toxicity: oral 001 key |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-dossier/16127/7/3/2
ECHA (European Chemicals Agency). (1976b). Diisopropyl sebacate: skin irritation/corrosion: 001 key |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/10094/7/4/2/?documentUUID=73ffea54-2c63-4fd4-9828-dlclb3bbe883
ECHA (European Chemicals Agency). (1989). Dibutyl adipate: skin irritation/corrosion: 001 key |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-dossier/5939/7/4/2
ECHA (European Chemicals Agency). (1991). Dibutyl sebacate: eye irritation: in vivo: 001 key |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16127/7/4/3/?documentUUID=ce4ed65c-e5bc-47f6-ac52-9dd56ac25091
ECHA (European Chemicals Agency). (1995). Dibutyl adipate: biodegradation in water: screening tests:
001 key | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/5939/5/3/2/?documentUUID=641f54ba-5881-4a20-882a-050195db28c6
ECHA (European Chemicals Agency). (1996). Dibutyl adipate: genetic toxicity: in vitro. 003 supporting |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/5939/7/7/2/?documentUUID=6cab85c9-7d5e-4d3a-83fe-9f060a93c915
ECHA (European Chemicals Agency). (1998). Diisopropyl sebacate: biodegradation in water: screening
tests: 001 key | Experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/10094/5/3/2/?documentUUID=c6b2ff26-0a23-4757-85e9-e807fe353faa
ECHA (European Chemicals Agency). (1999). Dibutyl adipate: biodegradation in water: screening tests:
002 other | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/5939/5/3/2/?documentUUID=45cbla62-2c54-4ela-a73d-55c0350325b8
ECHA (European Chemicals Agency). (2000). Dibutyl adipate: biodegradation in water: screening tests:
003 other | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/5939/5/3/2/?documentUUID=f298b3f7-59al-452b-a0d2-4a27dd712afa
ECHA (European Chemicals Agency). (2013). Dibutyl adipate: Toxicity to soil macroorganisms except
arthropods: 001 key | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/5939/6/4/2/?documentUUID=el6a9cl2-49c2-4809-82c8-claa947eb7ac
ECHA (European Chemicals Agency). (2014a). Dibutyl adipate: long-term toxicity to aquatic
invertebrates: 001 key | experimental result, https://echa.europa.eu/registration-dossier/-
/registered-dossier/5939/6/2/5/?documentUUID=514a687a-f8c7-4060-98b9-fecd7a40529c
ECHA (European Chemicals Agency). (2014b). Dibutyl adipate: short-term toxicity to aquatic
invertebrates: 001 weight of evidence | experimental result, https://echa.europa.eu/registration-
dossier/-/registered-dossier/5939/6/2/4/?documentUUID=01907b80-5be6-4d6e-9e56-
b7729dd20c20
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OECD (Organisation for Economic Co-operation and Development). (1996). Dibutyl adipate: CAS
No: 105-99-7. Geneva: UNEP Publications,
http ://www.inchem.org/documents/sids/sids/105 997 .pdf
Smith, CC. (1953). Toxicity of butyl stearate, dibutyl sebacate, dibutyl phthalate, and methoxyethyl
oleate. AMA Arch Ind Hyg Occup Med 7: 310-318.
WHO (World Health Organization). (2000). Safety evaluation of certain food additives and contaminants.
Aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional
oxygenated functional groups. In WHO Food Additives Series (pp. 229-260). Geneva,
Switzerland.
Wild, D; King, MT; Gocke, E; Eckhardt, K. (1983). Study of artificial flavoring substances for
mutagenicity in the salmonella/microsome, base and micronucleus tests. Food Chem Toxicol 21:
707-719. http://dx.doi.Org/https://doi.org/10.1016/0278-6915(83)90202-8
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Appendix C: Literature Search Outcomes
C.1 Literature Search and Review
This section briefly describes the literature search and review process, search terms, and search outcomes
for the hazard and fate screening of dibutyl sebacate. Search outcomes and reference details are provided
on the candidate's HERO4" project page.
EPA created a fit-for-purpose process to transparently document the literature search and review41 of
available hazard and fate information for low-priority substance (LPS) candidates. References from peer-
reviewed primary sources, grey sources,42 and other sources were identified, screened at the title/abstract
and full-text level, and evaluated for data quality based on discipline-specific criteria. An overview of the
literature search and review process is illustrated in Figure CI.
Figure C.1: Overview of the Literature Search and Review Process
References available at
title/abstract screening
References available at data quality evaluation
References included in LPS screening reviews
References available at full text screening
References excluded at
full text screening
References excluded at
data quality evaluation
References excluded at
title/abstract screening
References available
from grey literature
and other sources
References available
from primary peer-
reviewed sources
C.1.1 Search for Analog Data
To supplement the information on the candidate chemical, dibutyl sebacate, the following analogs were
used for designation: dibutyl adipate (CASRN 105-99-7) and diisopropyl sebacate (CASRN 7491-02-3).
For more details and justification on analogs, see section 6.1.1. Analogs were used to fill data gaps on
40 The HERO low-priority substance candidate project pages are accessible to the public at https://hero.epa,gov/hero/.
41 Discussed in the document "Approach Document for Screening Hazard Information for Low-Priority Substances Under
TSCA", also released at proposal.
42 Grey literature and additional sources are the broad category of studies not found in standard, peer-reviewed literature database
searches. Hiis includes U.S. and international government agency websites, non-government organization (NGO) websites, and
data sources that are difficult to find, or are not included, in the peer-reviewed databases, such as white papers, conference
proceedings, technical reports, reference books, dissertations, and information on various stakeholder websites.
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endpoints for which dibutyl sebacate lacked quality data, such as developmental toxicity, or to add to the
weight of the scientific evidence. EPA collected reasonably available information for these endpoints by
searching specific grey literature and other secondary sources, listed on Table C.l. If information related
to the identified analogs were available in these sources, the references were screened and evaluated using
the same process as references on dibutyl sebacate described above.41
Table C.1: Sources Used for Analog Search
Resource
URL
ATSDR
http://www.atsdr.cdc.gov/toxprofiies/index.asp
ChemID (EPA - HPVIS via
ChemID)
http://chem.sis.nlm.nih.gov/chemidplus/
CIR
http://www.cir-safety.org/ingredients
ECHA
http://echa.europa.eu/web/guest/information-on-chemicais/registered-substances
ECOTOX
https://cfpub.epa.gov/ecotox/quick_query.htm
EPA - ChemView (incl. TSCATS,
RBP/HC, and HPV/HPVIS)
https://chemview.epa.gov/chemview
European Food Safety Authority
(EFSA)
http://www.efsa.europa.eu/
FDA
https://www.fda.gov/defauit.htm
HERA
http://www.heraproject.com/RiskAssessment.cfm
NICNAS
http://www.nicnas.gov.au/
NITE (J-CHECK)
http://www.safe.nite.go.jp/jcheck/search.action?request_locale=en
NTP
https://ntpsearch.niehs.nih.gov/home
OECD/SIDS
https://hpvchemicals.oecd.org/UI/Search.aspx;
http://webnet.oecd.org/hpv/ui/SponsoredChemicais.aspx
C.1.2 Search Terms and Results
EPA began the literature review process for the hazard screening of dibutyl sebacate by developing search
terms. To gather publicly available information, specific search terms were applied for each discipline and
across databases and grey literature sources. Table C.2 lists the search terms used in the database search
of peer -reviewed literature for dibutyl sebacate. For grey literature and other secondary sources, Table
C.3 lists the search terms used for dibutyl sebacate and analogs.
Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms
Human Health
PubMed
109-43-3[rn] OR "Bis(n-butyl) sebacate"[tw] OR "Bis(n-butyl)sebacate"[tw] OR "Butyl
sebacate"[tw] OR "DECANEDIOATE, DIBUTYL"[tw] OR "Decanedioic acid dibutyl
ester"[tw] OR "Decanedioic acid, 1,10-dibutyl ester"[tw] OR "Decanedioic acid, dibutyl
ester"[tw] OR "Decanedioic acid, dibutyl ester"[tw] OR "Decanodioic acid, dibutyl
ester"[tw] OR "Di-n-Butyl sebacate"[tw] OR "Di-n-butylsebacate"[tw] OR "Dibutyl 1,8-
octanedicarboxylate"[tw] OR "Dibutyl decanedioate"[tw] OR "Dibutyl sebacate"[tw] OR
"Dibutyl sebacinate"[tw] OR"Dibutylsebacat"[tw] OR "Ergoplast SDB"[tw] OR "Kodaflex
DBS"[tw] OR "Monoplex DBS"[tw] OR "Otto Fuel N"[tw] OR "Polycizer DBS"[tw] OR
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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms
"Reomol DBS"[tw] OR "Sebacic acid di-n-butyl ester"[tw] OR "Sebacic acid, dibutyl
ester"[tw] OR "Staflex DBS"[tw] OR "Uniflex DBS"[tw] OR "PX 404"[tw]
Toxline
(( 109-43-3 [rn] OR "bis n-butyl sebacate" OR "butyl sebacate" OR "decanedioate
dibutyl" OR "decanedioic acid dibutyl ester" OR "decanedioic acid 1 10-dibutyl ester"
OR "decanedioic acid dibutyl ester" OR "decanedioic acid dibutyl ester" OR
"decanodioic acid dibutyl ester" OR "di-n-butyl sebacate" OR "di-n-butylsebacate" OR
"dibutyl 1 8-octanedicarboxylate" OR "dibutyl decanedioate" OR "dibutyl sebacate" OR
"dibutyl sebacinate" OR "dibutylsebacat" OR "ergoplast sdb" OR "kodaflex dbs" OR
"monoplex dbs" OR "otto fuel ii" OR "polycizer dbs" OR "reomol dbs" OR "sebacic acid
di-n-butyl ester" OR "sebacic acid dibutyl ester" OR "staflex dbs" OR "uniflex dbs" OR
"px 404") AND (aneupl [org] OR biosis [org] OR cis [org] OR dart [org] OR emic [org]
OR epidem [org] OR fedrip [org] OR heep [org] OR hmtc [org] OR ipa [org] OR riskline
[org] OR mtgabs [org] OR niosh [org] OR ntis [org] OR pestab [org] OR ppbib [org]))
AND NOT PubMed [org] AND NOT pubdart [org]
TSCATS1
109-43-3[rn] AND tscats[org]
WOS
TS=(" 109-43-3" OR "Bis(n-butyl) sebacate" OR "Bis(n-butyl)sebacate" OR "Butyl
sebacate" OR "DECANEDIOATE, DIBUTYL" OR "Decanedioic acid dibutyl ester" OR
"Decanedioic acid, 1,10-dibutyl ester" OR "Decanedioic acid, dibutyl ester" OR
"Decanedioic acid, dibutyl ester" OR "Decanodioic acid, dibutyl ester" OR "Di-n-Butyl
sebacate" OR "Di-n-butylsebacate" OR "Dibutyl 1,8-octanedicarboxylate" OR "Dibutyl
decanedioate" OR "Dibutyl sebacate" OR "Dibutyl sebacinate" OR "Dibutylsebacat" OR
"Ergoplast SDB" OR "Kodaflex DBS" OR "Monoplex DBS" OR "Otto Fuel II" OR
"Polycizer DBS" OR "Reomol DBS" OR "Sebacic acid di-n-butyl ester" OR "Sebacic
acid, dibutyl ester" OR "Staflex DBS" OR "Uniflex DBS" OR "PX 404")
Environmental
Hazard
WOS
Same as human health strategy synonyms only
Toxline
Same as human health strategy synonyms only
TSCATS1
Same as human health strategy CASRN only
Proquest
Title=(" 109-43-3" OR "Bis n-butyl sebacate" OR "Butyl sebacate" OR
"DECANEDIOATE, DIBUTYL" OR "Decanedioic acid dibutyl ester" OR "Decanedioic
acid, 1,10-dibutyl ester" OR "Decanedioic acid, dibutyl ester" OR "Decanedioic acid,
dibutyl ester" OR "Decanodioic acid, dibutyl ester" OR "Di-n-Butyl sebacate" OR "Di-n-
butylsebacate" OR "Dibutyl 1,8-octanedicarboxylate" OR "Dibutyl decanedioate" OR
"Dibutyl sebacate" OR "Dibutyl sebacinate" OR "Dibutylsebacat" OR "Otto Fuel II" OR
"Sebacic acid di-n-butyl ester" OR "Sebacic acid, dibutyl ester")
Abstract=(" 109-43-3" OR "Bis n-butyl sebacate" OR "Butyl sebacate" OR
"DECANEDIOATE, DIBUTYL" OR "Decanedioic acid dibutyl ester" OR "Decanedioic
acid, 1,10-dibutyl ester" OR "Decanedioic acid, dibutyl ester" OR "Decanedioic acid,
dibutyl ester" OR "Decanodioic acid, dibutyl ester" OR "Di-n-Butyl sebacate" OR "Di-n-
butylsebacate" OR "Dibutyl 1,8-octanedicarboxylate" OR "Dibutyl decanedioate" OR
"Dibutyl sebacate" OR "Dibutyl sebacinate" OR "Dibutylsebacat" OR "Otto Fuel II" OR
"Sebacic acid di-n-butyl ester" OR "Sebacic acid, dibutyl ester")
Subject=("109-43-3" OR "Bis n-butyl sebacate" OR "Butyl sebacate" OR
"DECANEDIOATE, DIBUTYL" OR "Decanedioic acid dibutyl ester" OR "Decanedioic
acid, 1,10-dibutyl ester" OR "Decanedioic acid, dibutyl ester" OR "Decanedioic acid,
dibutyl ester" OR "Decanodioic acid, dibutyl ester" OR "Di-n-Butyl sebacate" OR "Di-n-
butylsebacate" OR "Dibutyl 1,8-octanedicarboxylate" OR "Dibutyl decanedioate" OR
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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms
"Dibutyl sebacate" OR "Dibutyl sebacinate" OR "Dibutylsebacat" OR "Otto Fuel II" OR
"Sebacic acid di-n-butyl ester" OR "Sebacic acid, dibutyl ester")
Title=("Ergoplast SDB" OR "Kodaflex DBS" OR "Monoplex DBS" OR "Polycizer DBS"
OR "Reomol DBS" OR "Staflex DBS" OR "Uniflex DBS") OR Abstract=("Ergoplast
SDB" OR "Kodaflex DBS" OR "Monoplex DBS" OR "Polycizer DBS" OR "Reomol DBS"
OR "Staflex DBS" OR "Uniflex DBS") OR Subject=("Ergoplast SDB" OR "Kodaflex
DBS" OR "Monoplex DBS" OR "Polycizer DBS" OR "Reomol DBS" OR "Staflex DBS"
OR "Uniflex DBS")
Fate
wos
Same as human health strategy synonyms only
Table C.3: Search Terms Used in Grey Literature and Additional Sources
Chemical
Search terms
Dibutyl
Sebacate
Searched as a string or individually depending on resource: "109-43-3" OR "Bis(n-butyl) sebacate" OR "Bis(n-
butyl)sebacate" OR "Butyl sebacate" OR "DECANEDIOATE, DIBUTYL" OR "Decanedioic acid dibutyl ester"
OR "Decanedioic acid, 1,10-dibutyl ester" OR "Decanedioic acid, dibutyl ester" OR "Decanedioic acid, dibutyl
ester" OR "Decanodioic acid, dibutyl ester" OR "Di-n-Butyl sebacate" OR "Di-n-butylsebacate" OR "Dibutyl
1,8-octanedicarboxylate" OR "Dibutyl decanedioate" OR "Dibutyl sebacate" OR "Dibutyl sebacinate" OR
"Dibutylsebacat" OR "Ergoplast SDB" OR "Kodaflex DBS" OR "Monoplex DBS" OR "Otto Fuel II" OR
"Polycizer DBS" OR "Reomol DBS" OR "Sebacic acid di-n-butyl ester" OR "Sebacic acid, dibutyl ester" OR
"SEBACINSAEURE-DIBUTYLESTER" OR "Staflex DBS" OR "Uniflex DBS"
Analogs
searched
di-n-butyl adipate (105-99-7); diisopropyl sebacate (7491-02-3)
After the search terms were applied, more than 290 references were returned by all search efforts across
peer-reviewed databases and grey literature sources. The total number of references include database
results, additional strategies, and analog searches. All references from the search efforts were screened
and evaluated through the LPS literature search and review process.41 Of these, 7 references were
included for data evaluation and used to support the designation of dibutyl sebacate as LPS. The included
hazard and fate references are listed in the bibliography of Appendix B.
C.2 Excluded Studies and Rationale
This section lists the excluded references, by HERO ID, found to be off-topic or unacceptable for use in
the hazard screening of dibutyl sebacate. The excluded references are organized by discipline (human
health hazard, environmental hazard, and fate), presented along with a rationale based on exclusion
criteria. The criteria41 was used to determine off-topic references in the title/abstract or full text screening
and to determine unacceptable references in the data quality evaluation are provided in the form of
questions.
C.2.1 Human Health Hazard Excluded References
For the screening review of dibutyl sebacate, EPA excluded a total of 231 references when assessing
human health hazard. Off-topic references (e.g., studies that did not contain information relevant to
human health) were excluded at either title/abstract screening (see Table C.4), or full-text screening (see
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Table C.5). Unacceptable references (e.g., studies that did not meet data quality metrics) were excluded at
full-text screening (see Tables C.6 and C.7). Off-topic and unacceptable references are displayed next to
the corresponding exclusion criteria.
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs43 relevant to human health
hazard
470461
4828910
4829077
1940287
4829005
1332794
4828991
4829102
3539768
4829025
675047
4828911
4829078
1955077
4829006
1332863
4828992
4829103
4725770
4829026
788806
4828913
4829079
1955671
4829007
1332864
4828995
4829104
4828873
4829030
789457
4828914
4829081
1964710
4829008
1332951
4828996
4829105
4828874
4829031
789500
4828915
4829082
1964712
4829009
1338440
4828997
4829107
4828875
4829032
789607
4828917
4829083
2035549
4829011
1341409
4828998
4829108
4828876
4829035
789865
4828918
4829084
2219907
4829012
1341532
4828999
4829110
4828877
4829036
1035976
4828919
4829085
2303476
4829013
1342285
4829000
4829111
4828878
4829037
1048860
4828920
4829088
2309930
4829015
1342303
4829001
4829114
4828879
4829038
1049870
4828921
4829090
2749721
4829016
1585256
4829002
4829116
4828880
4829040
1197952
4828922
4829091
2952365
4829017
1764374
4829004
4829185
4828881
4829041
1249977
4828923
4829092
3039434
4829018
4828898
4829063
4828892
4828882
4829042
1312288
4828924
4829093
3040068
4829019
4828899
4829064
4828893
4828883
4829043
1315808
4828925
4829095
3040761
4829020
4828900
4829065
4828894
4828884
4829044
1323131
4828926
4829096
3046807
4829021
4828901
4829066
4828895
4828885
4829045
1325374
4828927
4829097
3046989
4829022
4828902
4829067
4828896
4828886
4829046
1325731
4828929
4829100
3363559
4829023
4828903
4829068
4828897
4828887
4829049
1325814
4828930
4829101
3493667
4829024
4828904
4829069
4829056
4828888
4829051
4828908
4829074
4829061
4829054
4828890
4828905
4829070
4829058
4828889
4829053
4828909
4829076
4829062
4829055
4828891
4828906
4829072
4829059
4829073
4829060
4828907
Reference excluded (HERO ID) because the reference primarily contained in silico data
N/A.
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain
information pertaining to a low-
priority substance candidate?
No
789535
4861538
4867872
4829099
What type of source is this
reference?
Review article or book chapter that
contains only citations to primary
literature sources
3042030
4860775
4861081
43 The information needs for human health hazard includes a list of study characteristics pertaining to the study population/test
organism, types of exposures and routes, use of controls, type and level of effects. A complete list of the information needs is
provided in Table A1 of the "Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA".
These information needs helped guide the development of questions for title/abstract and full-text screening.
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Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
4862652
What kind of evidence does this
reference primarily contain?
In silico studies that DO NOT
contain experimental verification
N/A
The following question apply to HUMAN evidence only
Does the reference report an
exposure route that is or is
presumed to be by an inhalation,
oral, or dermal route?
No
N/A
Does the reference report both test
substance exposure(s) AND related
health outcome(s)?
No
N/A
If the reference reports an exposure
to a chemical mixture, are
measures of the test substance or
related metabolite(s) reported
independently of other chemicals?
Note: If the paper does not pertain
to mixtures, choose "Not
Applicable".
No
N/A
The following question apply to ANIMAL evidence only
Does the reference report an
exposure route that is by inhalation,
oral, or dermal route?
No
N/A
Does the reference report both test
substance-related exposure(s) AND
related health outcome(s)?
No
4867876
4867877
4867886
4867892
Does the reference report the
duration of exposure?
No
N/A
Does the reference report an
exposure to the test substance only
(i.e. no mixtures with the exception
of aqueous solutions and
reasonable impurities and
byproducts)?
No
4829192
Does the paper report a negative
control that is a vehicle control or
no treatment control?
No44
4867877
4867886
4867876
4867892
4861922
The following questions apply to MECHANISTIC/ALTERNATIVE TEST METHODS evidence only
Does the reference report a
negative control that is a vehicle
control or no treatment control?
No
4862652
1335403
4828912
4829112
44 Except for acute mammalian toxicity and skin and eye irritation studies, where the use of a negative control may not be
required (e.g., OECD 403 Acute Inhalation Toxicity Guidelines).
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Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
4867878
Does the reference report an
No
1335403
exposure to the test substance only
(i.e. no mixtures with the exception
of aqueous solutions and
reasonable impurities and
byproducts)?
For genotoxicity studies only: Does
No
4862652
the study use a positive control?
4828912
4829112
1335403
4867879
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test Substance
Identity
• The test substance identity cannot be
determined from the information provided
(e.g., nomenclature was unclear and CASRN
or structure were not reported).
OR
• For mixtures, the components and ratios were not
characterized or did not include information that could
result in a reasonable approximation of components.
N/A
Metric 2:
Negative and Vehicle
Controls
A concurrent negative control group was not included
or reported.
OR
The reported negative control group was not
appropriate (e.g., age/weight of animals differed
between control and treated groups).
2207709
4829115
Metric 3:
Positive
Controls
When applicable, an appropriate concurrent positive
control (i.e., inducing a positive response) was not
used.
N/A
Metric 4:
Reporting of
Doses/Concentrations
Doses/concentrations were not reported and could
not be calculated using default or reported estimates
of body weight and diet/water intake (e.g., default
intake values are not available for pregnant animals).
4829115
4867862
4867874
4867889
Metric 5:
Exposure Duration
The duration of exposure was not reported.
OR
The reported exposure duration was not suited to the
study type and/or outcome(s) of interest (e.g., <28
days for repeat dose).
2207709
61578
4829071
4867861
Metric 6:
Test Animal
Characteristics
The test animal species was not reported.
OR
N/A
XLV
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
The test animal (species, strain, sex, life-stage,
source) was not appropriate for the evaluation of the
specific outcome(s) of interest (e.g., genetically
modified animals, strain was uniquely susceptible or
resistant to one or more outcome of interest).
Metric 7:
Number of Animals
Per Group
The number of animals per study group was not
reported.
OR
The number of animals per study group was
insufficient to characterize toxicological effects (e.g.,
1-2 animals in each group).
2207709
4867861
4867889
30540
Metric 8:
Outcome Assessment
Methodology
The outcome assessment methodology was not
sensitive for the outcome(s) of interest (e.g.,
evaluation of endpoints outside the critical window of
development, a systemic toxicity study that evaluated
only grossly observable endpoints, such as clinical
signs and mortality, etc.).
2207709
4867889
61578
4829071
4829115
4867862
2303428
Metric 9:
Reporting of Data
Data presentation was inadequate (e.g., the
report does not differentiate among findings in
multiple exposure groups).
OR
Major inconsistencies were present in reporting of
results.
4829115
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test Substance Identity
The test substance identity or
description cannot be determined
from the information provided (e.g.,
nomenclature was unclear and
CASRN or structure were not
reported).
OR
For mixtures, the components and
ratios were not characterized or did
not include information that could
result in a reasonable approximation
of components.
N/A
Metric 2:
Negative Controls
A concurrent negative control group
was not included or reported.
OR
The reported negative control
group was not appropriate (e.g.,
different cell lines used for
controls and test substance
exposure).
2303428
XLVI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 3:
Positive Controls
A concurrent positive control or
proficiency group was not used.
N/A
Metric 4:
Assay Type
The assay type was not reported.
OR
The assay type was not appropriate
for the study type or outcome of
interest (e.g., in vitro skin corrosion
protocol used for in vitro skin
irritation assay).
N/A
Metric 5:
Reporting of Concentration
The exposure doses/concentrations
or amounts of test substance were
not reported.
2303428
Metric 6:
Exposure Duration
No information on exposure
duration(s) was reported.
OR
The exposure duration was not
appropriate for the study type and/or
outcome of interest (e.g., 24 hours
exposure for bacterial reverse
mutation test).
1335402
2303428
Metric 7:
Metabolic Activation
No information on the
characterization and use of a
metabolic activation system was
reported.
OR
The exposure duration was
not appropriate for the study
type and/or outcome of
interest (e.g., 24 hours
exposure for bacterial reverse
mutation test).
2303428
Metric 8:
Test Model
The test model was not reported
OR
The test model was not routinely
used for evaluation of the specific
outcome of interest.
1335402
Metric 9:
Outcome Assessment Methodology
The outcome assessment
methodology was not reported.
OR
The assessment methodology was
not appropriate for the outcome(s) of
interest (e.g., cells were evaluated
for chromosomal aberrations
immediately after exposure to the
test substance instead of after post-
exposure incubation period).
1335402
XLVII
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
C.2.2 Environmental Hazard
For the screening review of LPS candidate dibutyl sebacate, EPA excluded a total of 223 references when
assessing environmental hazard. Off-topic environmental hazard references excluded at title/abstract
screening are listed in Table C.8, and those excluded at full-text screening are listed in Table C.9.
References in Table C.10 represent unacceptable studies based on specific data quality metrics for
environmental hazard. Off-topic and unacceptable references are displayed next to the corresponding
exclusion criteria.
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs45 relevant to environmental 1
hazard
470461
4829004
4828908
4829102
4829043
1342303
4829036
4828999
4829193
4829073
675047
4829005
4828909
4829103
4829044
1598314
4829037
4829000
4829196
4829074
788806
4829006
4828911
4829104
4829045
1764374
4829038
4829001
4829197
4829076
789457
4829007
4828912
4829105
4829046
1940287
4829040
4829002
4829201
4829077
789500
4829008
4828913
4829107
4829049
1955671
4829041
4828893
4828877
4829078
789535
4829009
4828914
4829108
4829051
1964710
4829042
4828895
4828878
4829079
789865
4829011
4828915
4829110
4829053
1964712
3493667
4828896
4828879
4829081
1035976
4829012
4828917
4829111
4829054
1965786
3539768
4828897
4828881
4829082
1049870
4829013
4828918
4829112
4829055
2035549
4455565
4828898
4828882
4829083
1197952
4829015
4828919
4829113
4829056
2219907
4725770
4828899
4828883
4829084
1249977
4829016
4828920
4829114
4829058
2303476
4828874
4828901
4828884
4829085
1312288
4829017
4828921
4829116
4829059
2309930
4828875
4828902
4828885
4829088
1315808
4829018
4828922
4829128
4829060
2749721
4828876
4828903
4828886
4829090
1323131
4829019
4828923
4829130
4829061
2952365
4829097
4828904
4828887
4829091
1325374
4829020
4828925
4829131
4829062
3039434
4829098
4828905
4828888
4829092
1325731
4829021
4828926
4829135
4829063
3040068
4829099
4828906
4828889
4829093
1325814
4829022
4828927
4829138
4829064
3040761
4829100
4828907
4828890
4829094
1332794
4829023
4828929
4829139
4829065
3046807
4829101
1341409
4828891
4829095
1332863
4829024
4828930
4829143
4829066
3046989
4829175
4829070
4828892
4829096
1332864
4829025
4828991
4829150
4829067
3363559
4829031
4828996
4829185
4829072
1332951
4829026
4828992
4829165
4829068
1341532
4829032
4828997
4829180
4829071
1338440
4829030
4828995
4829173
4829069
1342285
4829035
4828998
Reference excluded (HERO ID) because the reference did NOT present quantitative environmental hazard data
N/A.
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for Environmental Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain
information pertaining to a low-
priority substance candidate?
No
61578
1335403
3042030
4829109
45 The information needs for environmental hazard includes a list of study characteristics pertaining to the test organism/species,
type and level of effects, and use of controls. A complete list of the information needs is provided in Table A2 of the "Approach
Document for Screening Hazard Information for Low-Priority Substances Under TSCA". These information needs helped guide
the development of questions for title/abstract and full-text screening.
XLVIII
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for Environmental Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
What type of source is this
reference?
Review article or book chapter that
contains only citations to primary
literature sources
N/A
Is quantitative environmental
No
N/A
hazard data presented?
Is this primarily a
Yes
N/A
modeling/simulation study?
[Note: select "No" if experimental
verification was included in the
study]
Is environmental hazard data
No
N/A
presented for standard or non-
standard aquatic or terrestrial
species (fish, invertebrates,
microorganisms, non-mammalian
terrestrial species)?
Is exposure measured for the target
Mixture
N/A
substance or is the test substance
Formulated Product
N/A
a mixture (except for reasonable
impurities, byproducts, and
aqueous solutions) or formulated
product?
Does the reference report a
No
N/A
duration of exposure?
Does the reference report a
No
N/A
negative control that is a vehicle
control or no treatment control?
Does the reference include
No
N/A
endpoints in the information needs?
Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Environmental Hazard
Question
Unacceptable if:
References excluded (HERO ID)
Metric 1:
The test substance identity or
N/A
Test Substance Identity
description cannot be
determined from the information
provided (e.g., nomenclature
was unclear, CASRN or structure
were not reported, substance
name/ description does not
match CASRN).
OR
For mixtures, the components and
ratios were not characterized or did
not include information that could
result in a reasonable approximation
of components.
Metric 2:
A concurrent negative control group
N/A
Negative Controls
was not included or reported.
XLIX
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Environmental Hazard
Question
Unacceptable if:
References excluded (HERO ID)
Metric 3:
Experimental System
The experimental system (e.g.,
static, semi-static, or flow-through
regime) was not described.
N/A
Metric 4:
Reporting of Concentrations
Test concentrations were not
reported.
N/A
Metric 5:
Exposure Duration
The duration of exposure was not
reported.
OR
The reported exposure duration was
not suited to the study type and/or
outcome(s) of interest (e.g., study
intended to assess effects on
reproduction did not expose
organisms for an acceptable period
of time prior to mating).
N/A
Metric 6:
Test Organism Characteristics
The test species was not reported.
OR
The test species, life stage, or age
was not appropriate for the
outcome(s) of interest.
N/A
Metric 7:
Outcome Assessment Methodology
The outcome assessment
methodology was not reported.
4867859
Metric 8:
Reporting of Data
Data presentation was
inadequate.
OR
Major inconsistencies were present
in reporting of results.
N/A
C.2.3 Fate
For the screening review of LPS candidate dibutyl sebacate, EPA excluded atotal of 175 references when
assessing environmental fate. Off-topic fate references excluded at title/abstract screening are listed in
Table C. 11, and those excluded at full-text screening are listed in Table C. 12. References in Table C. 13
represent unacceptable studies based on specific data quality metrics for fate. Off-topic and unacceptable
references are displayed next to the corresponding exclusion criteria.
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs46 relevant to environmental
fate
470461
4829063
4829030
4828921
3539768
1332794
4829079
4829054
4829000
4828888
675047
4829064
4829031
4828922
4725770
1332863
4829081
4829055
4829001
4828890
788806
4829065
4829032
4828923
4828874
1332864
4829082
4829056
4829002
4828892
789457
4829066
4829035
4828925
4828875
1338440
4829083
4829058
4829004
4828893
40 The information needs for fate includes a list of study characteristics pertaining to the associated media and exposure
pathway s, associated processes, and use of controls. A complete list of the information needs is provided in Table A3 of the
"Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA". These information needs
helped guide the development of questions for title/abstract and full-text screening.
L
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
789500
4829067
4829036
4828926
4828876
1341409
4829084
4829059
4829005
4828895
789535
4829068
4829037
4828927
4828877
1341532
4829085
4829060
4829006
4828896
789865
4829069
4829038
4828929
4828878
1342285
4829088
4829061
4829007
4828897
1035976
4829070
4829040
4828930
4828879
1342303
4828920
4829062
4829008
4828899
1197952
4829071
4829041
4828991
4828881
1598314
4829019
4828911
4829009
4828901
1249977
4829072
4829043
4828992
4828882
1764374
4829020
4828912
4829011
4828902
1315808
4829073
4829044
4828995
4828883
1940287
4829021
4828913
4829012
4828903
1323131
4829074
4829045
4828996
4828884
1955671
4829022
4828914
4829013
4828904
1325374
4829076
4829046
4828997
4828885
1964710
4829023
4828915
4829015
4828905
1325731
4829077
4829051
4828998
4828886
1964712
4829025
4828917
4829016
4828907
1325814
4829078
4829053
4828999
4828887
2035549
4829026
4828918
4829017
4828908
2303476
3040068
2309930
3046807
2952365
2219907
3039434
4828919
4829018
4828909
2749721
3493667
Reference excluded (HERO ID
) because the reference did NOT present quantitative environmental fate data
N/A.
Table C.12: Screening Questions and Off-Topic References Excluded at Full Text Screening for Fate
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain
No
3042030
information pertaining to a low-
1049870
priority substance candidate?
2218126
3363559
4829042
4829049
4860842
4861922
4884530
4829143
4829173
4860893
What type of source is this
Review article or book chapter that
4861922
reference?
contains only citations to primary
literature sources
Is quantitative fate data presented?
No
2218126
Is this primarily a
Yes
N/A
modeling/simulation study? [Note:
Select "Yes" only if there is no
experimental verification]
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test Substance Identity
The test substance identity or description cannot be
determined from the information provided (e.g.,
nomenclature was unclear and CASRN or structure were
not reported).
OR
N/A
LI
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
For mixtures, the components and ratios were not
characterized or did not include information that could
result in a reasonable approximation of components.
Metric 2:
Study Controls
The study did not include or report crucial control groups
that consequently made the study unusable (e.g., no
positive control for a biodegradation study reporting 0%
removal).
OR
The vehicle used in the study was likely to unduly
influence the study results.
N/A
Metric 3:
Test Substance
Stability
There were problems with test substance stability,
homogeneity, or preparation that had an impact on
concentration or dose estimates and interfered with
interpretation of study results.
N/A
Metric 4:
Test Method Suitability
The test method was not reported or not suitable for the
test substance.
OR
The test concentrations were not reported.
OR
The reported test concentrations were not measured, and
the nominal concentrations reported greatly exceeded the
substances water solubility, which would greatly inhibit
meaningful interpretation of the outcomes.
N/A
Metric 5:
Testing Conditions
Testing conditions were not reported, and the omission
would likely have a substantial impact on study results.
OR
Testing conditions were not appropriate for the method
(e.g., a biodegradation study at temperatures that inhibit
the microorganisms).
N/A
Metric 6:
System Type and
Design- Partitioning
Equilibrium was not established or reported, preventing
meaningful interpretation of study results.
OR
The system type and design (e.g. static, semi-static, and
flow-through; sealed, open) were not capable of
appropriately maintaining substance concentrations,
preventing meaningful interpretation of study results.
N/A
Metric 7: Test
Organism-Degradation
The test organism, species, or inoculum source were not
reported, preventing meaningful interpretation of the
study results.
N/A
Metric 8:
Test Organism-
Partitioning
The test organism information was not reported.
OR
The test organism is not routinely used and would likely
prevent meaningful interpretation of the study results.
N/A
Metric 9:
Outcome Assessment
Methodology
The assessment methodology did not address or report
the outcome(s) of interest.
4829024
Lll
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***Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
Metric 10:
Data Reporting
Insufficient data were reported to evaluate the outcome of
interest or to reasonably infer an outcome of interest.
OR
The analytical method used was not suitable for detection
or quantification of the test substance.
OR
Data indicate that disappearance or transformation of the
parent compound was likely due to some other process.
N/A
Metric 11:
Confounding Variables
There were sources of variability and uncertainty in the
measurements and statistical techniques or between
study groups.
4829024
Metric 12:
Verification or
Plausibility of Results
Reported value was completely inconsistent with
reference substance data, related physical chemical
properties, or otherwise implausible, suggesting that a
serious study deficiency exists (identified or not).
N/A
LIN
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