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Dossier for Candidate Low-Priority Substance Propanol, Oxybis-
(CASRN 25265-71-8)
(Dipropylene Glycol)
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 3
2. Background on Dipropylene Glycol 5
3. Physical-Chemical Properties 6
3.1 References 8
4. Relevant Assessment History 10
5. Conditions of Use 12
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 18
6.1.4 Reproductive and Developmental Toxicity 18
6.1.5 Genotoxicity 19
6.1.6 Carcinogenicity 19
6.1.7 Neurotoxicity 19
6.1.8 Skin Sensitization 20
6.1.9 Skin Irritation 20
6.1.10 Eye Irritation 20
6.1.11 Hazards to Potentially Exposed or Susceptible Subpopulations 20
6.2 Environmental Hazard 20
6.2.1 Acute Aquatic Toxicity 21
6.2.2 Chronic Aquatic Toxicity 21
6.3 Persistence and Bioaccumulation Potential 21
6.3.1 Persistence 21
6.3.2 Bioaccumulation Potential 22
7. Exposure Characterization 12
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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
7.4.2 Exposures to Consumers 14
7.4.3 Exposures to Children 14
7.5 References 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 Table II
A.2.2 Uses of Dipropylene Glycol Ill
A.3 References XXXI
Appendix B: Human Hazard Characterization XXXVIII
B.1 References: Llll
Appendix C: Literature Search Outcomes LVIII
C.1 Literature Search and Review LVIII
Figure C.1: Overview of the Literature Search and Review Process LVIII
C.1.1 Search for Analog Data LVIII
C.1.2 Search Terms and Results LIX
II
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C.2 Excluded Studies and Rationale LXI
C.2.1 Human Health Hazard Excluded References LXI
C.2.2 Environmental Hazard LXVII
C.2.3 Fate LXXI
Appendix D: Summary of Public Comments LXXIV
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Tables
Table 1: Dipropylene Glycol at a Glance 5
Table 2: Physical-Chemical Properties for Dipropylene Glycol 6
Table 3: Conditions of Use for Dipropylene Glycol 14
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects 16
Table 5: Dipropylene Glycol and Analog Structures 16
Table A.1:1986-2015 National Production Volume Data for Dipropylene Glycol (Non-Confidential ^
Production Volume in Pounds)
Table A.2: Sources Searched for Uses of Dipropylene Glycol II
Table A.3: Uses of Dipropylene Glycol 14
Table B.1: Human Health Hazard XLVI
Table B.2: Environmental Hazard XLVIII
Table B.3: Fate XLIX
Table C.1: Sources Used for Analog Search LXVII
Table C.2: Search Terms Used in Peer-Reviewed Databases LIX
Table C.3: Search Terms Used in Grey Literature and Additional Sources LX
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard LXI
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
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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 LXVIII
Table C.9: Screening Questions and Off-Topic References Excluded at Full-Text Screening for
Environmental Hazard
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 LXXI
Table C.12: Screening Questions and Off-Topic References Excluded at Full-Text Screening for Fate .... LXXII
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
_ , LXXII
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.
Propanol, oxybis-, referenced as dipropylene glycol 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 risk-based, 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.
1 https://www.federalregister.gov/docimients/2019/03/21/2019-054Q4/initiation-of-prioritization-under-tlie-toxic-substances-
control-act-tsca
2 Hie prioritization process is explained in the Procedures for Prioritization of Chemicals for Risk Evaluation Under the
Toxic Substances Control Act (82 ER 33753).
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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.
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.
Appendix D (Summary of Public Comments): This appendix includes sources of information
for the chemical substance that the public recommended to EPA during a 90-day comment
period.
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2. Background on Dipropylene Glycol
Table 1 below provides the CAS number, synonyms, and other information on dipropylene glycol.
Table 1: Dipropylene Glycol at a Glance
Chemical Name
Dipropylene Glycol
CASRN
25265-71-8
Synonyms
Oxypropyl ether; 1-(1-hydroxypropoxy)propan-1-ol; Oxybispropanol; Propanol, oxybis-
Trade Name(s)
DPG; DPG LO+
Molecular Formula
C6H14O3
Representative Structure
CH, CH,
£
HO^
CHj CHj
e
mix
Source(s):
Kim etal. (2016); The Dow Chemical Company (2009a; 2009b); Synapse Information Resources (n.d); NLM (2018a)
Dipropylene glycol is a P-series glycol ether made from propylene oxide. Glycol ethers are organic
chemical compounds that contain both an alcohol functional group (R-OH) and an ether functional
group, which is an oxygen atom connected to two alkyl groups (R-O-R ). Dipropylene glycol is a
mixture of isomeric chemical compounds which include combinations of the linear and branched
forms of the propyl alcohol groups. Dipropylene glycol is produced as a byproduct of the
manufacture of propylene glycol. Dipropylene glycol is an odorless solvent with a high boiling point
and is completely soluble in water while also maintaining the ability to dissolve oils. In addition,
dipropylene glycol is hygroscopic and acts as a humectant, which means it absorbs water and
increases hydration in products. Dipropylene glycol also functions as a plasticizer and as a plasticizer
intermediate in the formation of polyurethane polyols to improve flexibility and increase 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 properties make
dipropylene glycol a multifunctional ingredient used in a variety of applications and product sectors.
Section 5 includes conditions of use for this chemical.
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3. Physical-Chemical Properties
Table 2 lists physical-chemical properties for dipropylene glycol. 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 Dipropylene Glycol
Source/Model
Data Type
Endpoint
Endpoint value
Notes
Sigma Aldrich 2019; SIDS
2001
Experimental
Physical state at
room temp
(based on melting
point)
Liquid (-20°C at 101.3 hPa
(76 mmHg))
Liquid (-39 °C)
Commercial mixture of CASRN 108-61-2; 110-98-5 and 106-62-7
ECHA 2019; HSDB, 2016;
Kirk-Othmer, 2006
Experimental
Molecular Weight
134 g/mol
EPISuite v.4.113
Calculated
Molecular Weight
134.18 g/mol
EPISuite was run for two isomers. The only difference in the
predicted values is in the atmospheric oxidation model.
Lyman 1990
Experimental
Molar Volume
166 cm3/mol
ECHA 2019
Experimental
Water Solubility
1000000 mg/L (100% vol) at
20 "CandpH 7.4
Value measured according to EU Method A.6, flask method.
HSDB 2016; SIDS 2001
Experimental
Water Solubility
1000000 mg/L (miscible)
EPISuite v.4.11
Estimated
Water Solubility
6.96x105 mg/L
ECHA 2019; HSDB 2016
Experimental
Water Solubility
7.45 mol/L
ECHA 2019
Experimental
Log P
-0.462 at 21.7°C andpH6
Value measured according to EU Method A.8, shake flask.
HSDB 2016
Experimental
Log Kow
-1.07
SIDS 2001
Experimental
Log Kow
-1.486; -0.687
EPISuite v.4.11
Estimated
Log Kow
-0.64
EPISuite v.4.11
Estimated
Log Koa
6.37
EPISuite v.4.11
Estimated
Log Koc
0 (MCI); -0.24 (Kow)
ECHA 2019
Experimental
Vapor Pressure
0.00975 mm Hg (1.3 Pa) at
25°C
Value measured according to EU Method A.4
HSDB 2016
Experimental
Vapor Pressure
0.0319 mm Hgat25°C
3 epi Suite Physical Property inputs - Boiling Point = 230.5 deg C, MP = 0 deg C, Vapor Pressure = 0.0319 mm Hg, Water Solubility = 1000000 mg/L, Log P = -0.46, SMILES:
OC(C)COC(C)CO
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Table 2: Physical-Chemical Properties for Dipropylene Glycol
Source/Model
Data Type
Endpoint
Endpoint value
Notes
Kirk-Othmer 2006
Experimental
Vapor Pressure
0.016 mm Hg (0.0021 kPa)
at 25°C
ChemID 2019
Experimental
Vapor Pressure
0.0319 mm Hg at25°C
SIDS 2001
Experimental
Vapor Pressure
< 0.075 mm Hg (0.01 hPa) at
20 °C;< 0.01 torr (0.013
hPa) at 20 °C; 0.04 torr (0.05
hPa) at 21 °C
Chadwick 1988
Experimental
Vapor Pressure
<0.0075 mm Hg (0.001 kPa)
at 20 °C
EPISuite v.4.11
Estimated
Vapor Pressure
7.30x10-3 mm Hg
ECHA 2019
Experimental
Vapor Pressure
34.6x10"12 cm3/molecule-sec
SIDS 2001
Experimental
Vapor Pressure
3.72 (half-life, hours)
EPISuite v.4.11
Estimated
Henry's Law
<1E-8 atm-m3/mol
EPISuite v.4.11
Estimated
Volatilization
5000 days (river)
55000 days (lake)
EPISuite v.4.11
Estimated
Photolysis
(Indirect)
4.1 hours (T1/2)
EPISuite v.4.11
Estimated
Photolysis
(Indirect)
3.72 hours
OH rate constant 3.46 E-11 cm3/molecule-second (12 hour day;
1.5E6 OH/cm3)
No ozone reaction
EPISuite v.4.11
Estimated
Hydrolysis
Rate constants cannot be
estimated
No hydrolyzable functional groups
EPISuite v.4.11
Estimated
Biodegradation
potential
Ready prediction: Yes
EPISuite v.4.11
Estimated
BAF
0.9
EPISuite v.4.11
Estimated
BCF
3.16
Based on regression equation
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Based on its reported physical form and measured melting point, dipropylene glycol is a liquid under
ambient conditions (Sigma Aldrich, 2019). Exposure through direct dermal contact with the substance
is possible, but concern is lessened because this chemical is a slow skin penetrant (discussed in
Section 6.1.1) and likely to be minimally absorbed through skin based on its molecular weight, water
solubility and log Kow. Because of its measured vapor pressure (ECHA, 2019), dipropylene glycol is
expected to be volatile when present in neat form or as an undiluted substance at ambient
temperatures. As a result, exposure to dipropylene glycol is possible through inhalation of vapors or
aerosols if they are generated. Based on measured solubility data (OECD SIDS, 2001), dipropylene
glycol is considered water soluble, indicating the potential for this substance to dissolve in water and
form an aqueous solution. Water soluble substances have an increased potential for absorption
through the lungs; therefore, if inhalation of vapors or aerosols occurs, absorption through the lungs is
likely. Exposure potential changes if dipropylene glycol is present in diluted form. The estimated
Henry's Law constant for dipropylene glycol (EPI Suite, 2019) indicates volatilization from water
and aqueous solutions would be minimal; therefore, exposure through breathing vapor from a dilute
form is expected to be minimal. Absorption and sequestration in fatty tissues are unlikely, as reflected
in the estimated BAF and BCF values for this compound (EPI Suite, 2019). The estimated log Koc
(EPI Suite, 2019) indicates this substance is highly mobile in soils, increasing its potential for
leaching into groundwater, including ground water sources of drinking water. If oral exposure occurs
via ingestion of contaminated drinking water, including well water, absorption through the
gastrointestinal tract is likely based on experimental evidence (discussed in Section 6.1.1). Concern
for presence in drinking water is reduced in part by dipropylene glycol's expected low persistence
(discussed in Section 6.3.1) and low-hazard findings from toxicological studies of organisms exposed
to dipropylene glycol in drinking water (discussed in Section 6.1). Experimental data indicate it is
readily biodegradable in aerobic environments, meaning that it has the potential to break down in the
environment into carbon dioxide and water (ECHA, 2007, 4940427).
3.1 References
Chadwick, Sharon S. (1988). "Ullmann's Encyclopedia of Industrial Chemistry", Reference Services
Review, Vol. 16 Issue: 4, pp.31-34, https://doi.org/10.1.108/eb049034
ChemlDplus. (2019). Dipropylene Glycol. Retrieved from
https://chem.nlm.nih.gov/chemidplus/rn/25265-71-8
European Chemicals Agency (ECHA). (2019). Oxydipropanol: biodegradation in water: screening
tests: 001 key | experimental result. Retrieved from
https://lieronet.epa.gov/lieronet/index.cfin/reference/download/reference id/4940427
European Chemicals Agency (ECHA). (2019). Oxydipropanol. Retrieved from
https://echa.europa.eu/registration-dossier/-/registered-dossier/14788
Hazardous Substance Database (HSDB). (2016). Dipropylene glycol. Retrieved from
https://toxnet.nlm.nih.gov/
Kirk-Othmer. (2006). Kirk-Othmer Encyclopedia of Chemical Technology.
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Lyman, Warren J., Reehl, W. F., Rosenblatt, D. H. (1990). Handbook of chemical property estimation
methods: environmental behavior of organic compounds. American Chemical Society
OECD SIDS (2001). Dipropylene glycol (mixed isomers and dominant isomer Cas No: 25265-71-8
and 110-98-5
https://heronet.epa.gov/heronet/index.cfm/reference/download/reference_id/4940388
Sigma Aldrich (2019). Tripropylene glycol. Retrieved from
https://www.sigmaaldrich.com/catalog/product/aldrich/d215554?lang=en®ion=US
U.S. EPA. (2019). Estimation Programs Interface Suite, v 4.11. United States Environmental
Protection Agency, Washington, DC, USA
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4. Relevant Assessment History
EPA assessed the toxicological profile of dipropylene glycol and added the chemical to the Safer
Choice Program's Safer Chemical Ingredients List (SCIL) in September 2012 under the functional
class of solvents. The SCIL4 is a continuously updated list of chemicals that meet low-concern Safer
Choice criteria.5
To better understand the hazard and exposure profile of certain chemical substances, EPA
promulgated the Preliminary Assessment Information Rule (PAIR) under TSCA in June 1992 to
require manufacturers and importers to submit a standardized reporting form for each site at which
they were manufacturing or importing a listed chemical substance to collect general volume, end use,
and exposure-related information. The chemical substances chosen for PAIR were those with possibly
high exposure potential or for which information about toxicity had been previously obtained. In
January 1994, EPA added dipropylene glycol to PAIR because of regulatory interest to the
Occupational Safety and Health Administration (OSHA) given the chemical's lack of dermal
absorption test data. Inclusion of dipropylene glycol in the PAIR rule is not indicative of current EPA
concern about this chemical because of data that is now available on dermal absorption (see Section
6.1.1), and EPA's high confidence in the chemical's low-hazard profile.
EPA also reviewed international assessments of dipropylene glycol. EPA identified assessments by
the Organisation for Economic Co-operation and Development (OECD), and government agencies in
Canada, Australia, Germany, New Zealand, and Japan.
The OECD Screening Information Datasets (SIDS) Initial Assessment Meeting (SIAM) discussed the
SIDS Initial Assessment Report (SIAR) on dipropylene glycol (mixed isomers and dominant isomer),
in January 2001. The SIAM determined this chemical to be "low priority for further work" for human
health and the environment.6
The Canadian Government, through an assessment of toxicity and exposure as part of its
categorization of the Domestic Substance List, found that dipropylene glycol did not meet its criteria
for further attention.7
The Australian Government's Department of Health National Industrial Chemicals Notification and
Assessment Scheme (NICNAS) determined dipropylene glycol to not pose an unreasonable risk to the
health of workers and public health on the basis of the Tier I Inventory Multi-tiered Assessment
and Prioritisation (IMAP) assessment.8
4 https://www.epa.gov/saferchoice/safer-iiigredients
5 https://www.epa.gov/sites/prodiiction/files/2013-12/dociiiiieiits/dfe master criteria safer ingredients v2 l.pdf
0 Iittps://hpvcliemicals.oecd.org/iii/handler.axd?id=40da06bl-a855-4c0c-bc21-bbc856dca725
7 https://canadachemicals.oecd. org/CliemicalDetails.aspx?ChemicalID=1044BC0C-01F2-4BC4-99B3-DEFF37D7B966
8 https://www.nicnas.gov.aii/cheniical-inforniation/iniap-assessnients/iniap-assessnients/liiinian-healtli-assessnients
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The German Environment Agency (UBA) designated dipropylene glycol as "low hazard to waters" in
August 2017 based on an assessment of ecotoxicity and environmental fate.9
New Zealand's Environmental Protection Authority lists dipropylene glycol 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 as "mildly irritating to the skin" and "irritating to the eye."10 Sections 6.1.9 and 6.1.10 of
this screening review contain a summary of the reasonably available information on these endpoints
and an explanation of why EPA does not believe irritation is a concern for this chemical.
Japan's National Institute of Technology and Evaluation (NITE) categorized dipropylene glycol as
hazard class 4 for ecological effect in 2017, which is the lowest concern hazard ranking assigned.11
9 https://webrigoletto.ute.de/rigoletto/public/searcliDetail.do7keiiiiuiiiiiieF341.9
-search/chemical-classification-and-information-database-ccid/view/2785
' https://www.nite.go.ip/chem/icheck/detail.action?cno=25265-71-8&miio=2-0413&requesttocale=eii
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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 dipropylene glycol (Appendix A) to inform which uses would be determined conditions
of use.12 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, dipropylene glycol is manufactured domestically and imported. It is used in
processing (incorporation into formulation, mixture or reaction and incorporation into article for
textiles, apparel, leather manufacturing, lubricants and lubricant additives, cleaning compounds, toilet
preparation manufacturing, and other applications); it is also used as a reactant in plastic material and
resin manufacturing; and for repackaging lubricant and lubricant additives, among other applications.
Examples of industrial uses include oil and gas drilling, extraction and support activities, and
construction and building materials covering large surface areas. Consumer and commercial uses
include cleaning and furnishing care products; ink, toner, and colorant products; laundry and
dishwashing products; paints and coatings, air care products; and finger paints and toys, among
others. Based on the known manufacturing, processing, and uses of this chemical substance, EPA
assumes distribution in commerce. According to CDR, dipropylene glycol 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) Program13 because dipropylene glycol is not a TRI-reportable chemical. Although
reasonably available information did not specify additional types of disposal, for purposes 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 occupational14 and consumer uses. This research improved the Agency's
understanding of the conditions of use for dipropylene glycol. Although EPA identified uses of
dipropylene glycol in personal care products, this screening review covers TSCA 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
12 Hie prioritization process, including the definition of conditions of me, is explained in the Procedures for Prioritization
of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (82 ER 33753).
13 https://www.epa.gov/toxics-release-inventorv-tri-program
14 Occupational uses include industrial and/or commercial uses
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section 3(2). Table 3 lists the conditions of use for dipropylene glycol 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 Dipropylene Glycol
Life Cycle Stage
Category
Subcategory of Use
Source
Manufacturing
Domestic manufacture
Domestic manufacture
EPA (2017b)
Import
Import
Processing
Processing- incorporation into
Finishing agents - textiles, apparel, and leather manufacturing
EPA (2017b), Sherlock (2019)
formulation, mixture or reaction
Lubricants and lubricant additives - all other chemical product and
preparation manufacturing
Pigments and dyes-paper manufacturing
Solvents (which become part of product formulation or mixture)- soap,
cleaning compound, and toilet preparation manufacturing;
All other basic organic chemical manufacturing;
Paint and coating manufacturing;
Plastics product manufacturing;
Printing ink manufacturing;
Rubber product manufacturing;
Odor agents- soap, cleaning compound, and toilet preparation manufacturing
Finishing agents-textiles, apparel, and leather manufacturing
Agricultural chemicals (non-pesticidal)- agriculture, forestry, fishing and
hunting
Process regulators- petrochemical manufacturing, petroleum refineries
Functional fluids (closed systems)- transportation equipment manufacturing
Intermediates- all other basic organic chemical manufacturing
Finishing agents- textiles, apparel, and leather manufacturing
Processingincorporation into article
Surface active agents- soap, cleaning compound, and toilet preparation
manufacturing
Intermediates- plastic material and resin manufacturing;
All other basic organic chemical manufacturing;
Petrochemical manufacturing;
Plastic material and resin manufacturing
Processing as a reactant
Catalyst- construction
Paint additives and coating additives not described by other categories- paint
and coating manufacturing
Accelerator- plastic material and resin manufacturing
Processing aids, not otherwise listed- carbon black manufacturing
Processing - repackaging
Lubricants and lubricant additives- lubricants and lubricant additives
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Industrial manufacturing
Automotive manufacturing; basic metal manufacturing; building material
manufacturing; communication equipment manufacturing; computer and
electronic manufacturing; fabricated metal products manufacturing; food
manufacturing; furniture manufacturing; iron metal manufacturing; leather
product manufacturing; metals manufacturing; non-metallic mineral product
manufacturing; perfume manufacturing; soap manufacturing; windmill
manufacturing; wood manufacturing
CPCat (2019); ECHA (2018b)
Pesticide, fertilizer, and other
agricultural chemical manufacturing
Crop and animal production; fertilizers
Recycling
Recycling
EPA (2017b)15
Distribution
Distribution
Distribution
EPA (2017b)
Industrial
Usenon-incorporative activities
Surface active agents- wholesale and retail trade
EPA (2017b)
Other
Mining; test drilling and boring; coloring agents; printing; sewage treatment;
CPCat (2019); ECHA (2018b)
Oil and gas drilling, extraction, and
support activities
Motor vehicle maintenance and repair; oil and gas exploration/production;
automotive fuel; crude petroleum and natural gas extraction; tracking, fuel
additive
Construction and building materials
covering large surface areas
Brick-layering; building construction; building glass; demolition; plumbing
installation; floor and wall covering; ship building
Industrial/
commercial/
consumer
Water treatments including softeners and lime deposit removers
CPCat (2019); ECHA (2018b)
Industrial/
commercial
Industrial cleaning
Paints and coatings
CPCat (2019)
15 According to CDR reports, at least one manufacturer indicates that the chemical substance is recycled onsite. No other information is available 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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Commercial/
consumer
Cleaning and furnishing care products;
laundry and dishwashing products;
Bathroom cleaner, boat cleaner; carpet and upholstery cleaner; drain cleaner;
floor cleaner; floor polish; furniture polish; general purpose cleaner; glass
cleaner; granite cleaner and polish, hard surface cleaner; kitchen cleaner;
oven/grill cleaner; shower cleaner; stain remover; toilet bowl cleaner;
dishwasher cleaner; dishwasher detergent; fabric freshener; fabric softener;
laundry detergent; laundry detergent scent additive; prewash stain remover
EPA (2017b); ECHA (2018b);
DeLima Associates (2013c);
CPCat (2019), DeLima
Associates (2015f); DeLima
Associates (2014c); DeLima
Associates (2015m);
GoodGuide (2011a); DeLima
Associates (2015o); DeLima
Associates (2015j); DeLima
Associates (2015d); DeLima
Associates (2015k); DeLima
Associates (2017a); DeLima
Associates (2015c);
DeLima Associates (2015b);
DeLima Associates (2015h);
DeLima Associates (2015e);
DeLima Associates (2015i);
DeLima Associates (2016b);
DeLima Associates (2014e);
Synapse Information
Resources (n.d.)
Paints and coatings
Paint and varnish remover; polishing agents
Automotive care
Car wax
CPCat (2019)
Anti-free and de-icing products
Lubricants and greases
Hydraulic fluids
ECHA (2018b)
Ink, toner, and colorant products
Ink and toner
CPCat (2019); Synapse
Information Resources (n.d.);
ECHA (2018b)
Adhesives and sealants
Non-structural caulking compounds and sealants; adhesives
GoodGuide (2011a)
Other
Degreasers; rust remover; pet litter; photographic
CPCat (2019); ECHA 2018b)
Commercial
Agricultural products (non-pesticidal)
EPA (2017b); CPCat (2019);
Other
Catalysts
Dow (2009b); Sherlock (2019)
Dry cleaning
Building/construction materials not
covered elsewhere
Golf and sports turf
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Lubricants and greases
Paper products;
plastic and rubber products not covered
elsewhere;
Urethane intermediate
Cleaning and furnishing care products
Other
Descaling agent
ECHA (2018b)
Consumer
Air care products
Air freshener; candle
DeLima Associates (2013a);
GoodGuide (2011a); CPCat
(2019); ECHA (2018b);
DeLima Associates (2015g)
Absorbents/adsorbents; casting and molding; welding and soldering;
whiteboard marker
DeLima Associates (2013b);
GoodGuide (2011a); CPCat
(2019); Descartes Datamyne
(2018), ECHA (2018b)
Toys, playground, and sporting
equipment
Finger paints; toys
ECHA (2018b); CPCat (2019)
Unknown
Food and beverage service activities; anti-foaming agent
CPCat (2019)
Disposal
Releases to air, wastewater, solid and
liquid wastes
EPA's assumptions based on
the identified uses16
16 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
on hazard for dipropylene glycol. This literature review approach17 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 dipropylene glycol against the endpoints listed below. EPA's New Chemicals
Program has used these endpoints for decades to evaluate chemical substances under TSCA18 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
Chemicals19 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
Toxicity20
Very High
High
Moderate
Low
Oral LD50 (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
17Discussed in the document "Approach Document for Screening Hazard Information for Low-Priority Substances Under
TSCA."
18 https://www.epa. gov/sustainable-futures/sustainable-futures-p2-framework-manual
19 https://www.unece.org/fileadmiri/DAM/trans/danger/publi/ghs/ghs rev07/English/ST SG AC10 30 Rev7e.pdf
20 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)21
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
Toxicity22
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
Toxicity22
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/
Genotoxicity23
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
in the germ cells of
humans.
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.
21 Values from GHS criteria for Specific Target Organ Toxicity Repeated Exposure (Chapter 3.9: Specific Target Organ
Toxicity' Repeated Exposure. 2009, United Nations).
22 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).
23 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
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.
Carcinogenicity24
Very High
High
Moderate
Low
Known or
presumed human
carcinogen (GHS
Category 1A and
1B)
Suspected human
carcinogen (GHS
Category 2)
Limited or marginal
evidence of
carcinogenicity in
animals (and
inadequate25 evidence
in humans)
Negative studies or
robust mechanism-
based structure
activity relationship
(SAR)
Neurotoxicity
(90-day study)21
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
Sensitization26
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
(equivalent to GHS
Category 1A or 1B)
Limited evidence
including the presence
of structural alerts
Adequate data
available indicating
lack of respiratory
sensitization
24 Criteria mirror classification approach used by the IARC (Preamble to the L4RC Monographs: B. Scientific Review and
Evaluation: 6. Evaluation and rationale. 2019J and incorporate GHS classification scheme (Chapter 3.6: Carcinogenicity.
2009, United Nations).
25 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.
20 From 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
Irritation/
Corrosivity27
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)28
Chronic Aquatic
Toxicity Value
(L/E/IC50)28
Persistence (Measured in terms of level of
biodegradation)29
Bioaccumulation
Potential30
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 dipropylene glycol. In many cases, EPA used analogous chemicals to make findings for
a given endpoint. Where this is the case, use of the analog is explained. If the chemical studied is not
named, the study is for dipropylene glycol. Appendix B contains more information on each study.
Dipropylene glycol is a mixture of dipropylene glycol isomers formed by the condensation of two
propylene oxide (methyl oxirane) units. The positions of the methyl substituents are unspecified. Both
analogs used to inform EPA's understanding of this chemical are oligomeric propylene glycols like
dipropylene glycol. The first analog, l,r-dimethyldiethylene glycol, is a specific isomer of
dipropylene glycol and is a component of dipropylene glycol. The second analog, tripropylene glycol,
is similar to dipropylene glycol, and has an additional propylene oxide unit. As shown in Table 5,
EPA used best professional judgement to select analogs for dipropylene glycol, based on similarity in
structure, physical-chemical properties, and functionality, with the assumption that these substances
will have similar environmental transport and persistence characteristics, and bioavailability and
27 Criteria derived from the Office of Pesticide Programs Acute Toxicity Categories (U.S. EPA. Label Review Manual.
2010).
28 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).
29 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).
30 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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toxicity profiles. Differences in the methyl group positions in these chemicals are not expected to
significantly affect their chemical and hazard profiles.
Table 5: Dipropylene Glycol and Analog Structures
CASRN
Name
Structure
25265-71-8
Dipropylene glycol
(mixed isomers)
CHi CHi
HO JL JL OH
O
i
ClHj CHj
c
mix
Representative structure
110-98-5
1,1 '-Dimethyldiethylene
glycol
ch3 ch3
Representative structure
24800-44-0
Tripropylene glycol
(mixed isomers)
CHa
CHa CHj
6.1.1 Absorption, Distribution, Metabolism, and Excretion
Absorption
To assess absorption, EPA relied on experimental studies on dipropylene glycol and tripropylene
glycol. In a dog study, dipropylene glycol was rapidly absorbed from the gastrointestinal tract and
was no longer detectable in blood 24 hours after an oral exposure (BUA. 1996). These data indicate
dipropylene glycol is rapidly absorbed after oral exposures.
In vitro studies were used to assess the potential for dermal absorption by dipropylene glycol. Excised
abdominal skin from human cadavers demonstrated dipropylene glycol is a slow penetrant, with the
results indicating a permeability coefficient of 3.85 x 10"5 cm/hour (Fasano et al.. 2011; ECHA.
2007b; Fasano. 2007).
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Based on its low molecular weight and high water solubility (discussed in Section 3), dipropylene
glycol is expected to be absorbed from the lungs if inhaled.
Distribution
Dipropylene glycol is considered water soluble based on its physical-chemical properties (Section 3)
and is likely to be distributed mainly in aqueous compartments in an organism. This prediction is
supported by experimental evidence on the analog tripropylene glycol. Rats exposed to tripropylene
glycol by oral gavage displayed radiolabeled tripropylene glycol in the tissues and the carcass 24
hours following exposure. Specifically, tripropylene glycol was reported in the liver at 0.20%,
kidneys at 0.09%, carcass at 0.06%, blood at 0.03%, and skin, brain, muscle, and fat at less than
0.03% (as percent of the administered dose per gram of tissue) (OECD., 2001; ECHA. 1995a). These
data indicate tissue distribution of tripropylene glycol was rapid, especially to the liver and kidney
after dosing and provide evidence that dipropylene glycol will be rapidly distributed following oral
absorption.
Metabolism
To assess the metabolism of dipropylene glycol, EPA relied on experimental evidence from
tripropylene glycol. Oral administration of tripropylene glycol to rats resulted in rapid metabolism to
dipropylene glycol, then to propylene glycol, which is converted to lactic and pyruvic acids or
excreted in the urine. Lactate and pyruvate may be further metabolized through the citric acid cycle to
yield carbon dioxide and water or may be stored as glycogen (OECD. 2001; EG >5a). Rats
exposed to 14C-tripropylene glycol by oral gavage excreted approximately 13% as free or conjugated
tripropylene glycol, approximately 8.4% as free and conjugated dipropylene glycol, and
approximately 3.9% as free and conjugated propylene glycol (OECD. 2001; EC] >5a). These
data indicate that dipropylene glycol will be metabolized.
Excretion
To assess excretion, EPA relied on experimental evidence from tripropylene glycol. Following the
oral administration of tripropylene glycol to rats, 52% was recovered in urine, 21% in exhaled CO 2,
and 5% in the feces after 24 hours ( P., 200.1.; ECHA. 1995a). These data indicate that
dipropylene glycol will be excreted from the body following exposure.
6.1.2 Acute Toxicity
EPA assessed the mammalian toxicity potential for acute exposure from dipropylene glycol using
results from oral, inhalation, and dermal studies. Rats exposed to dipropylene glycol by oral gavage
demonstrated no mortality at the single dose tested (5010 mg/kg), resulting in an LD50 greater than
5010 mg/kg in rats (ECHA. 1995dD. Another study in rats exposed by oral gavage reported a LD50 of
15,800 mg/kg (OECD. 2001; EC £0). These results indicate low concern for acute toxicity with
expected LD50S above the low-concern threshold of 2000 mg/kg for oral exposures.
A study on rabbits exposed to dipropylene glycol dermally reported no adverse effects at the single
dose tested (5010 mg/kg), resulting in an LD50 greater than 5010 mg/kg ("ECHA. 1995b). These
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results indicate low concern for acute toxicity with expected LD50S above the low-concern threshold
of 2000 mg/kg for dermal exposures.
A study on rats exposed to a dipropylene glycol aerosol reported no adverse effects at the single dose
tested, 2.34 mg/L (ECHA. 1995 c). Given that the single dose of the inhalation study indicated no
adverse effects at a dose below the low concern threshold of 5 mg/L for aerosols, EPA incorporated
experimental evidence on tripropylene glycol to inform a weight of the scientific evidence decision. A
study on rats exposed to a single concentration (0.083 mg/L) of tripropylene glycol in saturated vapor
for eight hours and then observed for two weeks reported no mortalities ("EC ). Based on
tripropylene glycol's vapor pressure of 0.00195 torr, the expected saturation concentration is around
0.02 mg/L at room temperature, which is below the study concentration of 0.083 mg/L, which
indicates the no effect concentration is occurring above complete saturation. Based on the chemical's
physical-chemical properties and available experimental data, this chemical poses low concern for
acute toxicity from inhalation exposures based on no adverse effects reported above the expected air
saturation concentration for tripropylene glycol and no effects observed at the highest dose of the
dipropylene glycol aerosol study.
6.1.3 Repeated Dose Toxicity
EPA assessed the potential for mammalian toxicity from repeated exposures to dipropylene glycol
using studies in mice and rats. Mice exposed to dipropylene glycol in drinking water for 13 weeks
demonstrated a no observed adverse effect level (NOAEL) of 2620 mg/kg-day and a lowest observed
adverse effect level (LOAEL) of 4790 mg/kg-day based on increased liver weight (ECHA. 2004g;
NTP. 2004). Rats exposed to dipropylene glycol in drinking water for 14 weeks demonstrated a
NOAEL of 435 mg/kg-day and a LOAEL of 890 mg/kg-day based on relative liver weight ("ECHA.
2Q04f; NTP. 2004). EPA also assessed the potential for toxicity from chronic exposures. A two-year
study on mice exposed to dipropylene glycol in drinking water demonstrated a NOAEL of 1040
mg/kg-day and a LOAEL of 1950 mg/kg-day based on decreased mean body weight (ECHA. 2004e:
NTP. 2004). Rats exposed to dipropylene glycol for two years in drinking water demonstrated a
NOAEL of 115 mg/kg-day and a LOAEL of 470 mg/kg-day based on incidence of nephropathy, focal
histiocytic and focal granulomatous inflammation in male livers (ECHA. 2004b. d; NTP. 2004).
These results indicate low concern for toxicity resulting from repeated exposures by exceeding the
low-concern threshold of 100 mg/kg-day for a 90-day study.
6.1.4 Reproductive and Developmental Toxicity
EPA assessed the potential for reproductive toxicity using read-across from an analog, tripropylene
glycol. In a combined repeated dose, reproductive, and developmental study, rats were exposed to
tripropylene glycol via oral gavage for 49 days, beginning 14 days prior to mating and through
lactation day 3 for females. The authors reported no reproductive (mating, fertility, and estrus cycle)
or developmental effects (external examinations of the pups and pup body weight gain) at the highest
dose tested (1000 mg/kg-day). The NOAEL for this study was 1000 mg/kg-day (OECD. .1.994;
ECHA. 1993 b). These analog results indicate low concern for reproductive toxicity in the target
chemical by exceeding the 250 mg/kg-day thresholds.
To further assess the potential for developmental toxicity, EPA evaluated two oral gavage studies on
dipropylene glycol. A study on pregnant rats exposed during gestational day (GD) 6-15 reported a
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developmental NOAEL of 2000 mg/kg-day and a LOAEL of 5000 mg/kg-day based on decreased
fetal weight (OECD. 2001; BUA. .1.996; Bates et ah. 1992b; ECI 0b). A study on rabbits
exposed to dipropylene glycol during GD 6-19 reported no adverse effects at the highest dose tested
(1200 mg/kg-day), resulting in a NOAEL of 1200 mg/kg-day ("OECD. 2001; Bates et ah. 1.992a;
ECU A. 1990a). These results indicate low concern for developmental toxicity by exceeding the 250
mg/kg-day threshold.
6.1.5 Genotoxicity
EPA assessed experimental studies on genotoxicity as a potential indicator of genotoxic
carcinogenicity. Three in vitro gene mutation studies resulted in negative findings from dipropylene
glycol exposure with and without metabolic activation in Salmonella typhimurium ("ECH.A. 2004c;
NTP. 2004; ECU A. 1992a) and in mouse lymphoma cells (ECHA. .1.988). Further, a mouse in vivo
study indicated negative results for chromosomal aberrations in the form of micronucleated
polychromatic erythrocytes ("OECD. 2001; ECHA. .1.999). These results indicate low concern for
genotoxicity.
6.1.6 Carcinogenicity
EPA assessed the potential for dipropylene glycol to cause carcinogenicity in mice and rats. Rats
exposed to dipropylene glycol in drinking water for 2 years demonstrated no dose-related increase in
cancer incidence and no cancer-related effects at the highest dose tested (3040 mg/kg-day in males,
2330 mg/kg-day in females), resulting in a negative finding for carcinogenicity (ECHA. 2004a. b;
NTP. 2004). Similarly, mice exposed to dipropylene glycol in drinking water for two years also found
no adverse effects at the highest dose tested (2390 mg/kg-day in males, 1950 mg/kg-day in females),
resulting in a negative finding for carcinogenicity (ECHA. 2004a; NTP. 2004). These negative results
indicate low concern for carcinogenicity.
6.1.7 Neurotoxicity
While no traditional neurotoxicity studies were available for dipropylene glycol or closely-related
analogs, EPA assessed the potential for neurotoxicity using relevant endpoints measured in acute and
repeated dose studies and using predictions made by U.S. EPA's ToxCast.31
Several repeated dose studies in rats and mice exposed to dipropylene glycol orally reported no
effects on the limited neurological endpoints that were evaluated (i.e., brain histopathology only).
Dipropylene glycol did not produce histopathological brain lesions in rats at oral doses up to 12,800
mg/kg-day for 3 months or up to 3,040 mg/kg-day for 2 years. Similarly, no brain lesions were
observed at oral doses up to 14,700 mg/kg-day for 3 months or up to 2,330 mg/kg-day for 2 years in
mice ("ECHA. 2004b. d; NTP. 2004). Rats acutely exposed to dipropylene glycol by oral gavage noted
decreased locomotor activity and ataxia for a few hours after exposure to the high dose of 5010
mg/kg, but the effects subsided by the first day of the observation period (E( >95d).
ToxCast results for dipropylene glycol included 27 assays related to neurological functions.
Bioactivity was not induced by dipropylene glycol in any assay.
31 fattps://actor, epa.gov/dashboard/ . Chemical specific assay list can be found at
https://actor.epa.gOv/dashboard/#chemical/55934-93-5.
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These data indicate there is low concern for neurotoxicity associated with dipropylene glycol. This
finding is also supported by the low-hazard findings for other human health hazard endpoints,
including, but not limited to, toxicity from acute exposures, reproductive toxicity, and developmental
toxicity.
6.1.8 Skin Sensitization
EPA assessed the potential for dipropylene glycol to cause skin sensitization using available
experimental studies. A study on guinea pigs (ECHA. 19950 and two studies on humans (ECHA.
1995g; Johansen etaL, .1.995; Leberco Labs, .1.994) reported negative results, indicating low concern
for skin sensitization by dipropylene glycol.
6.1.9 Skin Irritation
EPA assessed dermal irritation using experimental results on rabbits and humans. Three studies
demonstrated dipropylene glycol was negative for dermal irritation in rabbits ("ECHA. 1995 b. i;
Leberco Labs. 1994). Further, a study on skin-sensitive humans demonstrated negative results for
dermal irritation by dipropylene glycol (ECHA. 1997). while another study on humans indicated mild
erythema in 4 of the 33 subjects at the 24-hour scoring (ECHA. 1995e). The results of these studies
indicate that dipropylene glycol is of low concern for skin irritation.
6.1.10 Eye Irritation
To assess potential for eye irritation, EPA used the results of two studies on rabbits. Rabbits exposed
to dipropylene glycol displayed conjunctival redness and a subset displayed chemosis after one hour,
but these results were fully reversible by 24 hours, leading to a negative result for eye irritation
(ECHA. 1995f). These results are supported by another rabbit study with negative results (Leberco
6.1.11 Hazards to Potentially Exposed or Susceptible Subpopulations
The above information supports a low human health hazard finding for dipropylene glycol 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 dipropylene glycol.
6.2 Environmental Hazard
EPA assessed environmental hazard for dipropylene glycol based on available experimental data and
estimated toxicity values using the Ecological Structure Active (ECOSAR) Predictive Model.32
Appendix B contains a summary of the reasonably available environmental hazard data.
32https://www.epa.go v/tsca-screening-tools/ecological-structure-activity-relationships-ecosar-predictive-model
. These results indicate low concern for eye irritation.
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6.2.1 Acute Aquatic Toxicity
EPA assessed environmental hazard from acute exposures to dipropylene glycol using experimental
studies on dipropylene glycol and tripropylene glycol. No adverse effects were observed in aquatic
invertebrates exposed to dipropylene glycol at the highest dose tested (100 mg/L), resulting in a
NOAEL of 100 mg/L ("ECHA, 2002. 1995h). EPA used read-across from tripropylene glycol to assess
toxicity to aquatic vertebrates and algae. No effects were observed in aquatic vertebrates exposed to
tripropylene glycol, resulting in an LC50 greater than 1000 mg/L (ECHA. 1994a; QECD. .1.994).
Similarly, no effects were observed in algae exposed to tripropylene glycol, resulting in an LC50
greater than 1000 mg/L (QECD. .1.994). These aquatic toxicity studies indicate low concern for acute
aquatic exposure by exceeding the low-concern threshold of 100 mg/L.
6.2.2 Chronic Aquatic Toxicity
EPA estimated environmental hazard from chronic aquatic exposures using ECOSAR. Chronic
toxicity values estimated for aquatic vertebrates, aquatic invertebrates, and algae were 1,300 mg/L,
420 mg/L, and 370 mg/L, respectively. These toxicity values indicate that dipropylene glycol is
expected to have low environmental hazard based on the low-concern criteria chronic aquatic toxicity
threshold of 10 mg/L.
6.3 Persistence and Bioaccumulation Potential
6.3.1 Persistence
Varied results are observed in the experimental ready test data presented in Appendix B. Because of
the differences in the test conditions of the OECD ready test methods, some of this variability is
likely a result of performance under different test designs rather than an inherent limitation of the
biodegradability of the test substance. Given the varied results, EPA relied on studies on dipropylene
glycol and tripropylene glycol to make a weight of the scientific evidence conclusion. An explanation
of ready and inherent biodegradation tests is provided below.
Ready biodegradation tests are stringent test methods in which a high concentration of test substance
is evaluated using a non-adapted inoculum. Passing this type of test indicates that a chemical is likely
to biodegrade in the environment and have low potential for persistence. However, not passing the
ready criteria is not necessarily an indication that a chemical is recalcitrant or that it will be persistent
in the environment. In contrast, inherent biodegradability tests use more favorable conditions to
promote a high expected capacity for degradation, including the use of prolonged exposure periods
and a low ratio of test substance to inoculum biomass. Passing this type of test indicates that a
substance is inherently biodegradable but does not provide evidence for ready biodegradation. The
available data included tests for both ready biodegradation and inherent biodegradation.
An aerobic BOD5 test indicates dipropylene glycol is not rapidly biodegradable, with limited
biodegradation observed (as O; consumption) after 5 days (MeshakoetaL 1999). Additionally,
tripropylene glycol was tested in three ready tests (OECD Guidelines 301C, OECD 30 IB and OECD
30ID) that reported < 5% degradation over 28-day incubation periods, indicating that it is not readily
biodegradable (OECD. .1.994; EC 93a. 1991b). However, in another OECD Guideline 30ID
test, tripropylene glycol reached 69% O2 consumption after 28 days and just missed the 10-day
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window criterion at 59% in 11 days under aerobic conditions (ECHA. .1.99la). In addition, both
dipropylene glycol and tripropylene glycol reached > 81% O2 consumption after 28 days in the
OECD Guideline 301F test, meeting the criteria for ready biodegradation but not meeting the 10-day
window under aerobic conditions (ECHA. 2007a. c, 1994b). These data suggest that dipropylene
glycol is biodegradable and may be readily biodegradable under the right conditions. Results from
additional aerobic studies, including the inherent biodegradability test (OECD Guideline 3 02A) and a
seawater biodegradability test (OECD Guideline 306), provide further support that dipropylene glycol
has the capacity to biodegrade under environmental conditions (ECHA. 2007d. 1994b). Furthermore,
microbial inhibition tests indicate that these substances are non-toxic to microbial populations found
in sewage treatment plants (ECHA. 20.1.0. 1992b).
Based on the weight of the scientific evidence, the data suggest dipropylene glycol is expected to
biodegrade under aerobic conditions. Although under some test conditions this chemical may not
meet the benchmark for ready biodegradation, both primary and ultimate biodegradation of this
substance has been demonstrated using a variety of standard and non-standard test methods. No
quality experimental studies were available to assess anaerobic biodegradation. Though BIOWIN
modeling did not predict this chemical to anaerobically biodegrade quickly, these results do not
indicate this chemical would not anaerobically biodegrade. Dipropylene glycol's low-hazard results
for environmental and mammalian toxicity, and evidence of aerobic biodegradation, indicate low
concern for this chemical if present in anaerobic environments.
No degradation products of concern were identified for this chemical substance. The available
biodegradation results meet the low-concern threshold and indicate this chemical has low persistence.
6.3.2 Bioaccumulation Potential
Based on the estimated bioaccumulation factor (BAF) value of 0.9 using the Estimation Programs
Interface (EPI) Suite models,33 dipropylene glycol is expected to have low potential for
bioaccumulation in the environment based on the low-concern threshold of less than 1000.
Because of dipropylene glycol's ability to biodegrade and its low BAF value, the chemical has low
concern for persistence and bioaccumulation.
33 https://www.epa.gov/tsca-screeiiiiig-tools/epi-suitetm-estimation-program-iiiterface
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7. Exposure Characterization
EPA considered reasonably available information on exposure for dipropylene glycol. 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. EPA used
these sources (described in Table A.2) to inform intended, known, or reasonably foreseen uses.
Dipropylene glycol is a solvent used in processing (incorporation into an article and into a
formulation, mixture, or product) in the industrial printing ink manufacturing sector and as a reactant
in plastic and resin manufacturing. It is used in a variety of industrial, consumer, and commercial
uses, as shown in Table 3. Non-TSCA uses, including those excluded under TSCA section 3(2), are
beyond the scope of this assessment (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 dipropylene glycol is based on an analysis of CDR data reported
from 1986-2015.34 In reporting years 1986, 1990, and 1994, aggregate production volume for
dipropylene glycol was between 50,000,000 and 100,000,000 lbs., and in reporting years 1998, 2002,
and 2006 aggregate production volume was between 100,000,000 and 500,000,000 lbs. Between
reporting years 2012 and 2015, aggregate production volume for dipropylene glycol was between
100,000,000 and 250,000,000 lbs. The exact amount is available for one year, 2011, in which
201,501,161 lbs. of dipropylene glycol was manufactured or imported. In general, since 2011,
production volume has remained relatively stable.
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 dipropylene glycol. Exposure is also possible from
other conditions of use, such as distribution and disposal. These activities could result in releases of
dipropylene glycol to media including surface water, landfills, and air.
EPA expects high levels of removal of dipropylene glycol during wastewater treatment (either
directly from the facility or indirectly via discharge to a municipal treatment facility or Publicly
Owned Treatment Works (POTW)). Further, dipropylene glycol is expected to have low persistence
(aerobic biodegradation is discussed in Section 6.3.1) and has the potential to break down in the
environment to carbon dioxide and water. Therefore, any release of this chemical is expected to break
down, reducing exposure to aquatic organisms in the water column and groundwater sources of
34 Hie CDR requires manufacturers (including importers) to report information on the chemical substances they produce
domestically or import into the U.S. above 25,000 lb. per site per year.
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drinking water, including well water. Based on the estimated log Koc (Table 2 of Section 3),
dipropylene glycol is expected to have negligible adsorption to sediment, reducing the potential for
toxicity to benthic organisms. Dipropylene glycol's biodegradability during treatment processes will
reduce the exposure potential to aquatic organisms.
If disposed of in a landfill, this chemical is expected to degrade under aerobic conditions (aerobic
biodegradation is discussed in Section 6.3.1).
If incineration releases during manufacturing and processing occur, EPA expects significant
degradation of dipropylene glycol 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 to be exposed to dipropylene glycol from the potential
environmental releases described above. Air exposure is unlikely from incineration. If dipropylene
glycol is present in the air from volatilization, it is expected to be reduced because of its short
atmospheric half-life of 4 hours (see Table 2 in Section 3). With the exception of time immediately
following a release, dipropylene glycol is unlikely to be present in surface water because it will
degrade (discussed in Section 6.3.1), reducing the potential for the general population to be exposed
by oral ingestion or dermal exposure. Given the low bioaccumulation or bioconcentration potential of
dipropylene glycol, oral exposure to dipropylene glycol via fish ingestion is unlikely.
7.4 Exposures to Potentially Exposed or Susceptible Subpopulations
EPA identified workers, children, and consumers as potentially exposed or susceptible subpopulations
based on greater exposure to dipropylene glycol 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 dipropylene glycol
than the general population during use of finger paints and toys. EPA also identified consumers as a
population that may experience greater exposure to dipropylene glycol 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), dipropylene glycol is a
liquid under ambient conditions. Based on dipropylene glycol'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 (Table 2), dipropylene glycol is expected
to be volatile at ambient temperatures, and therefore workers may be exposed through inhalation of
vapors. If dipropylene glycol is in a dilute form, the estimated Henry's Law constant for dipropylene
glycol suggests volatilization from water and aqueous solutions is expected to be minimal. Workers
may be exposed to dipropylene glycol in manufacturing, processing, distribution, use and disposal.
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7.4.2 Exposures to Consumers
Consumers may be exposed to dipropylene glycol 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, dipropylene glycol is expected to have minimal
absorption through the skin based on its molecular weight, water solubility and partitioning
coefficients (Section 3) and experimental data (Section 6.1.1). If the chemical is in an aerosol product
and inhalation exposure occurs, dipropylene glycol's absorption from the lungs is likely. EPA does
not include intentional misuse, such as people drinking products containing this chemical, as part of
the known, intended or reasonably foreseen conditions of use that could lead to an exposure (82 FR
33726). Thus, oral exposures will be incidental (meaning inadvertent and low in volume).
Dipropylene glycol is expected to be metabolized and excreted, further reducing the duration of
exposure.
7.4.3 Exposures to Children
Children may be exposed to dipropylene glycol through use of finger paints. Given the molecular
weight, water solubility, and partitioning coefficients in Table 2 and the absorption data in Section
6.1.1, this chemical is expected to be poorly absorbed through the skin. Dipropylene glycol is likely
to be present in a water-based solution in finger paints. Based on the predicted Henry's Law constant
(Section 3), dipropylene glycol's volatilization from water and aqueous solutions is expected to be
minimal from these products, reducing inhalation exposures from volatilization to children. While
using these products, children may rub their eyes or incidentally ingest the product.
Children may also be exposed to dipropylene glycol when playing with wooden toys. A 2005 survey
of chemical substances in consumer products conducted by the Danish Ministry of the Environment
detected the chemical in one of 15 wooden toys (Danish EPA, 2005). The study identified chemicals
in the wooden toys by soaking the toys in artificial saliva. While the study then estimated risk for a
subset of the chemicals detected in the wooden toys, such estimates were not calculated for
dipropylene glycol due to the chemicals low hazard profile. Additionally, based on the information in
Section 3 and Section 6.1.1, children's exposure via dermal pathways is expected to be minimal, and
ingestion is expected to result in metabolism and excretion.
7.5 References
Danish EPA. (2005). Migration and health assessment of chemical substances in surface treated
wooden toys. Retrieved from https://www2.mst.dk/Uclgiv/publications/2005 ^ ' VI \ \.
6Zpdff87-7614-713-4.pdf
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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 dipropylene glycol against each of the priority designation considerations in
40 CFR 702.9(a), listed below 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 rationales and reached conclusions.
8.1. Hazard and Exposure Potential of the Chemical Substance
Approach: EPA evaluated the hazard and exposure potential of dipropylene glycol. EPA used this
information to inform its proposed determination of whether dipropylene glycol would meet the
statutory criteria and considerations for proposed designation as a low-priority substance.
Hazard potential:
For dipropylene glycol'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 the low-concern thresholds. EPA found that dipropylene glycol is of low concern
for human health and environmental hazard across the range of endpoints in this 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,
consumers, and children (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, children and workers may be exposed to dipropylene glycol, exposure by the
dermal pathway is limited by dipropylene glycol's physical-chemical properties. If ingestion occurs,
dipropylene glycol is expected to be quickly metabolized and excreted, reducing the duration of
exposure. Inhalation of dipropylene glycol from dilute products is expected to be minimal; however,
workers may be exposed to vapors of neat dipropylene glycol. If dipropylene glycol is released into
the environment, its exposure potential will be reduced through biodegradation under aerobic
conditions.
Rationale: EPA determined that while workers, consumers, and children could be exposed to
dipropylene glycol during processing, manufacturing, distribution, use, or disposal, these exposures
do not pose a significant risk because of the chemical's low-hazard results across a range of endpoints
(discussed in Section 6). In summary, the concern for exposure is mitigated by the low-hazard profile
of this chemical.
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 dipropylene glycol 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 dipropylene
glycol 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 review of experimental data indicates dipropylene glycol is biodegradable under
aerobic conditions (discussed in Section 6.3.1). EPA's EPI Suite models indicate a low potential for
bioaccumulation and bioconcentration.
Proposed Conclusion: Based on an initial screen 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 dipropylene glycol 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,
such as infants, children, pregnant women, workers, or the elderly." EPA identified workers engaged
in the manufacturing, processing, distribution, use and disposal of dipropylene glycol as a potentially
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exposed or susceptible subpopulation (described in more detail in Section 7). EPA also identified
children as a population that may experience greater exposure to dipropylene glycol than the general
population during use of finger paints and toys. Consumers are also a potentially exposed
subpopulation because of their use of products such as ink, toner, and colorant products and laundry
and dishwashing products, as shown in Table 3.
Rationale: EPA did not identify hazard effects for this chemical that would make any population
susceptible. EPA expects workers, consumers, and children to have a higher exposure to dipropylene
glycol than the general population. Higher exposure to children (and adults working closely with
children) could result from use of finger paints containing dipropylene glycol, which might lead to
inadvertent eye contact. Children could also be exposed to dipropylene glycol via ingestion while
playing with wooden toys. 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 subpopulations, EPA proposes to conclude that the
screening-level review under 40 CFR 702.9(a)(3) does not support a finding that dipropylene glycol
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 dipropylene glycol
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, EPA explains its evaluation of the elements of risk relevant to the
storage of dipropylene glycol near significant sources of drinking water. For this criterion, 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. The 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, dipropylene glycol 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, dipropylene glycol is
expected to be water soluble (see Section 3) and not expected to persist (see Section 6) in the drinking
water supply. In the event of an accidental release to land, the estimated log Koc indicates this
substance is highly mobile in soils, increasing its potential for leaching into groundwater, including
well water. The fate and transport evaluation indicates dipropylene glycol is unlikely to partition into
sediment, predicted to biodegrade under aerobic conditions (see Section 3), and unlikely to
bioaccumulate (see Section 6), minimizing the likelihood that the chemical would be present in
sediment or groundwater to pose a longer-term drinking water contamination threat. Further, as
explained in section 6.1.3, repeated exposures of mice and rats to dipropylene glycol through the
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drinking water exposure pathway indicate low concern for exposure through drinking water to this
chemical.
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, dipropylene glycol would degrade in an aerobic
environment (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 dipropylene glycol 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 dipropylene glycol 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 dipropylene glycol and related potential
exposures.
Rationale: EPA evaluated the conditions of use of dipropylene glycol (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 reasonably foreseen, 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 dipropylene glycol'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
dipropylene glycol 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
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impacted by a change in conditions of use. Therefore, such changes would not support a finding that
dipropylene glycol 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 dipropylene glycol (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 reasonably foreseeable that designation of dipropylene glycol as a low-
priority substance could result in increased use and higher production volumes. EPA expects,
however, that any changes in dipropylene glycol's production volume would not alter the Agency's
assessment of low concern given the low-hazard profile of the chemical. EPA bases this expectation
on dipropylene glycol's consistently low-concern hazard characteristics across the spectrum of hazard
endpoints and regardless of 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
exposures, dipropylene glycol 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 review to support the proposed
designation of dipropylene glycol 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 dipropylene glycol 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, 55 companies manufactured or imported dipropylene glycol at 56 sites for reporting year
2015. Individual production volumes were withheld but may be available in later releases of the 2016
data.
Table presents the historic production volume of dipropylene glycol from the CDR (previously
known as the Inventory Update Rule, or IUR) from 1986-2015. In reporting years 1986, 1990, and
1994, aggregate production volume for dipropylene glycol was between 50,000,000 and 100,000,000
lbs., and in reporting years 1998, 2002, and 2006 aggregate production volume was between
100,000,000 and 500,000,000 lbs. Between reporting years 2012 and 2015, aggregate production
volume for dipropylene glycol was between 100,000,000 and 250,000,000 lbs. The exact amount is
available for one year, 2011, in which 201,501,161 lbs. of dipropylene glycol was manufactured or
imported. In general, since 2011, production volume has remained relatively stable without
significant increases or decreases.
Table A. 1
: 1986-2015 National Production Volume Data for Dipropylene glycol (Non-Confidential Production
Volume in Pounds
)
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
>50M -
>5M -
>50M -
>100M
>100M
100M-
201,501,161
100M-
100M-
100M-
100M-
100M
10M
100M
-500M
-500M
<500 M
250 M
250 M
250 M
250 M
Source(s):
EPA (2018a; 2017b; 2006; 2002)
Note(s):
M = Million
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A.2. Uses
A.2.1 Methods for Uses Table
Section A. 1 provides a list of known uses of dipropylene glycol, organized by category of use. To
compile the uses, EPA searched publicly available databases listed in Error! Reference source not
found, 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 Dipropylene Glycol
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)
25265-71-8
Yes
Canada Chemicals
Management Plan
information sheets
Government of Canada
(2018)
Dipropylene glycol;
DPG
No
Chemical and Product
Categories (CPCat)
CPCat (2019)
25265-71-8
Yes
ChemView2
EPA (2018a)
25265-71-8
Yes
Children's Safe Product
Act Reported Data
Washington State Dept. of
Ecology (2018)
25265-71-8
No
Consumer Product
Information Database
(CPID)
DeLima Associates (2018)
25265-71-8
Yes
Danish surveys on
chemicals in consumer
products
Danish EPA (2018)
N/A, there is no search
but report titles were
checked for possible
information on the
chemical
No
Datamyne
Descartes Datamyne
(2018)
Dipropylene glycol
Yes
DrugBank
DrugBank (2018b)
25265-71-8
Yes
European Chemicals
Agency (ECHA)
Registration Dossier
ECHA (2018a; 2018b)
25265-71-8
Yes
eChemPortal2
OECD (2018)
25265-71-8
Yes
Envirofacts2
EPA (2018b)
25265-71-8
No
Functional Use Database
(FUse)
EPA (2017a)
25265-71-8
Yes
Kirk-Othmer Encyclopedia
of Chemical Technology
Kirk-Othmer (2006)
Dipropylene glycol
No
Non-Confidential 2016
Chemical Data Reporting
(CDR)
EPA (2017b)
25265-71-8
Yes
PubChem Compound
Kimetal. (2016)
25265-71-8
Yes
Safer Chemical Ingredients
List (SCIL)
EPA (2018d)
25265-71-8
Yes
II
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Table A.2: Sources Searched for Uses of Dipropylene Glycol
Title
Author and Year
Search Term(s)
Found Use Information? 1
Synapse Information
Resources2
Synapse Information
Resources (2009)
Dipropylene glycol
Yes
Resource Conservation
and Recovery Act (RCRA)
EPA (2018c)
Dipropylene glycol
No
Scorecard: The Pollution
Information Site
GoodGuide (2011b)
25265-71-8
Yes
Skin Deep Cosmetics
Database
EWG (2018a, 2018b)
Uses for CAS RN 110-98-5, with the chemical name listed
as "Dipropylene Glycol." EWG did not have search results
for CAS RN 25265-71-8 or "1,1'dimethyldiethylene glycol."
Toxics Release Inventory
(TRI)
EPA (2018e)
25265-71-8
No
TOXNET2
NLM (2018a)
25265-71-8
Yes
Ullmann's Encyclopedia of
Industrial Chemistry
Ullmann's (2000)
Dipropylene glycol
No
Additional Sources Identified from Reasonably Available Information
Boscia
Boscia (2018)
Incidentally identified
while researching
details of this
chemical's uses and
products.
Yes
Cetaphil
Cetaphil (2018)
CVS
CVS (2018)
Dove
Dove (2018)
The Dow Chemical
Company
Dow (2009)
Medline
Medline.com (2009)
National Archives and
Records Information
National Archives and
Records Administration
(2018)
National Pesticide
Information Retrieval
System (NPIRS)
NPIRS (2018)
Neutrogena
Neutrogena (2018a)
Shiseido
Shiseido (2018)
Skinfood
Skinfood (2018)
Note(s):
1. If use information was found in the resource, it will appear in Table A.3 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 41,147 patents referencing
"dipropylene glycol" (USPTO 2018a). 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 dipropylene glycol 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.
A.2.2 Uses of Dipropylene Glycol
mi
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References |
TSCA Conditions of Use: Air Care Products
CDR reports use of liquid dipropylene glycol in consumer air care products at concentrations of less than 30 percent and at least 90 percent by weight (EPA 2017b).
DeLima Associates (2013a); GoodGuide (2011a); CPCat (2019); ECHA (2018b)
Air freshener
Consumer
Pollution Scorecard identifies use of dipropylene glycol in non-aerosol air fresheners. CPCat lists the use of dipropylene
glycol in air fresheners, deodorizers, air cleaners and anti-odor agents not including filters. CPID lists the use of dipropylene
glycol in air fresheners, including car air fresheners. The ECHA registration dossier indicates the use of dipropylene glycol in
air care products available for consumer use.
Expected users are consumer based on inclusion in CPID and GoodGuide's consumer uses.
DeLima Associates (2015g); CPCat (2019)
Candle
Consumer
CPCat lists the use of dipropylene glycol in decor candles and candle holders.
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
TSCA Conditions of Use: Cleaning and Furnishing Care Products
CDR reporting shows use of liquid dipropylene glycol in consumer and commercial cleaning and furnishing care products at concentrations of less than 30 percent by
weight (EPA 2017b).
CPCat (2019)
Automotive care
Consumer,
commercial
CPCat lists the use of dipropylene glycol in car care and cleaning products.
Expected users are not listed but are assumed to be consumer and commercial for automotive care.
Bathroom cleaner
Consumer
DeLima Associates (2015n)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
ECHA (2018b)
Boat cleaner
Commercial
The ECHA registration dossier indicates the use of dipropylene glycol in professional boat cleaners.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
IV
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
DeLima Associates (2013c); ECHA (2018b)
Carpet and
upholstery cleaner
Consumer,
commercial
The ECHA registration dossier indicates the use of dipropylene glycol in professional carpet cleaners.
CPID generally includes products for consumer use; therefore, the expected user is a consumer. Expected users are
commercial based on inclusion in ECHA's uses by professional workers.
CPCat (2019); ECHA (2018b)
Car wax
Commercial
CPCat lists the use of dipropylene glycol in car wax (polishing agents) for automotive care. The ECHA registration dossier
indicates the use of dipropylene glycol in professional car wash and dewaxing products.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
CPCat (2019)
Degreasers
Consumer,
commercial
CPCat lists the use of dipropylene glycol in degreasers, including cold-degreasing, de-waxing, and de-polishing.
Expected users are not listed but are expected to be consumer and commercial for degreasers.
ECHA (2018b)
Descaling agent
Commercial
The ECHA registration dossier indicates the use of dipropylene glycol in professional descaling agents.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
DeLima Associates (2015f); CPCat (2019); ECHA (2018b)
Drain cleaner
Commercial
CPCat lists the use of dipropylene glycol in drain cleaners. The ECHA registration dossier indicates the use of dipropylene
glycol in professional drain cleaners.
CPID lists this product for professional use; therefore, the expected users are commercial.
DeLima Associates (2014c); ECHA (2018b)
Floor cleaner
Consumer,
commercial
The ECHA registration dossier indicates the use of dipropylene glycol in professional floor cleaners and floor strippers.
CPID lists this product for professional and general use; therefore, the expected users are consumer and commercial.
V
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Floor polish
Consumer,
commercial
DeLima Associates (2015m); GoodGuide (2011a); CPCat (2019)
Pollution Scorecard identifies use of dipropylene glycol in floor polish. CPCat lists the use of wax and polishing agents for
floors.
Expected users are consumer based on inclusion in CPID and GoodGuide's consumer uses. Expected users are consumer
and commercial based on inclusion in ECHA's uses by professional workers.
Furniture polish
Consumer,
commercial
DeLima Associates (2008a)
CPID generally includes products for consumer use; therefore, the expected users are consumer and commercial.
General purpose
cleaner
Commercial
ECHA (2018b)
The ECHA registration dossier indicates the use of dipropylene glycol in general purpose cleaner.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
Glass cleaner
Consumer,
commercial
DeLima Associates (2015o); CPCat (2019); ECHA (2018b)
CPCat lists the use dipropylene glycol in glass and window cleaner/ polish. The ECHA registration dossier indicates the use
of dipropylene glycol in glass cleaner.
CPID generally includes products for consumer use; therefore, the expected user is a consumer. Expected users are also
commercial based on inclusion in ECHA's uses by professional workers.
Granite cleaner and
polish
Consumer
DeLima Associates (2015j)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
Hard surface cleaner
Consumer,
commercial
DeLima Associates (2015d)
CPID lists this product for professional and general use; therefore, the expected users are consumer and commercial.
VI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Industrial cleaning
Commercial,
industrial
CPCat lists the use dipropylene glycol in industrial, specialized cleaning and washing activities, including for commercial
clients.
Expected users are commercial and industrial based on CPCat's user classification.
ECHA (2018b)
Kitchen cleaner
Commercial
The ECHA registration dossier indicates the use of dipropylene glycol in kitchen cleaners.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
ECHA (2018b)
Oven/ grill cleaner
Commercial
The ECHA registration dossier indicates the use of dipropylene glycol in professional oven and grill cleaner.
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
CPCat (2019)
Rust removers
Consumer,
commercial
CPCat lists the use of dipropylene glycol in rust removers and corrosion inhibitors.
Expected users are not listed but are expected to be consumer and commercial for rust removers.
Shower cleaner
Consumer
DeLima Associates (2015k)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
Soap, cleaning
compound, and toilet
preparation
manufacturing
Industrial
EPA (2017b); Dow (2009)
CDR reports show use of dipropylene glycol as a solvent, surface active agent, and odor agent in the manufacture of soap,
cleaning compound, and toilet preparations. Dow identifies use in industrial soaps.
Expected users are industrial based on CDR's Industrial Processing and Use report.
VII
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Stain remover
DeLima Associates (2017a)
Consumer
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
DeLima Associates (2015c); CPCat (2019)
Toilet bowl cleaner
Consumer
CPCat lists the use of dipropylene glycol in sanitation agents for cleaning and washing of toilets.
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
TSCA Conditions of Use: Construction
CPCat (2019)
Brick-layering
Industrial
CPCat lists the use of dipropylene glycol in bricklaying.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Building construction
Industrial
CPCat lists the use of dipropylene glycol in the construction of buildings and civil engineering works, and in construction
materials, including filling, padding and insulation materials (including to protect from noise, cold, electric)
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Building glass
Industrial
CPCat lists the use of dipropylene glycol in glass building material, with use as a colorant detected.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Demolition
Industrial
CPCat lists the use of dipropylene glycol in "demolition and wrecking of buildings."
Expected users are industrial based on CPCat's user classification.
VIII
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Floor and wall
covering
Industrial
CPCat lists the use of dipropylene glycol in floor and wall covering for building.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Plumbing installation
Industrial
CPCat lists the use of dipropylene glycol in plumbing, heat and air-conditioning installation.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Ship building
Industrial
CPCat lists the use of dipropylene glycol in the building and repairing of pleasure and sporting boats, ships and other
floating structures.
Expected users are industrial based on CPCat's user classification.
TSCA Conditions of Use: Energy and Resources
CPCat (2019)
Automotive fuel
Industrial
CPCat lists the use of dipropylene glycol in the retail sale of automotive fuel in specialized stores.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Crude petroleum and
natural gas extraction
Industrial
CPCat lists the use of dipropylene glycol in the extraction of crude petroleum and natural gas.
Expected users are not stated but expected to be industrial for tracking.
IX
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Fracking
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in resource extraction of gas through fracking.
Expected users are not stated but expected to be industrial for fracking.
Fuel additive
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol as a fuel additive.
Expected users are not stated but expected to be industrial for fuel additives.
Mining
Industrial
CPCat (2019); ECHA (2018b)
CPCat lists the use of dipropylene glycol in mining support service activities. The ECHA registration dossier indicates the
use of dipropylene glycol in mining.
Expected users are industrial based on CPCat's user classification.
Test drilling and
boring
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in test drilling and boring.
Expected users are industrial based on CPCat's user classification.
TSCA Conditions of Use: Food and Beverages
Food and beverage
service activities1
Unknown
CPCat (2019)
CPCat lists the use of dipropylene glycol in food and beverage service activities.
Expected users are industrial based on CPCat's user classification.
X
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References |
TSCA Conditions of Use: Industrial Uses
CPCat (2019)
Coloring agents
Industrial
CPCat lists the use of dipropylene glycol in industrial colorants, color agents, dyestuff, and color pigments.
Expected users are industrial, based on CPCat's user classification.
CPCat (2019)
Motor vehicle
maintenance and
repair
Industrial
CPCat lists the use of dipropylene glycol in the maintenance and repair of motor vehicles, including in bodywork repair and
painting.
Expected users are industrial based on CPCat's user classification.
Oil and gas
exploration/
production
Industrial
ECHA (2018b)
The ECHA registration dossier indicates the use of dipropylene glycol in oil and glass exploration or production products.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
CPCat (2019)
Printing
Industrial
CPCat lists the use of dipropylene glycol in printing and reproduction of recorded media, printing.
Expected users are industrial based on CPCat's user classification.
CPCat (2019); ECHA (2018b)
Sewage treatment
Industrial
CPCat lists the use of dipropylene glycol in "sewage and refuge disposal, sanitation and similar activities." The ECHA
registration dossier indicates the use of dipropylene glycol in sewage treatment.
Expected users are industrial based on CPCat's user classification.
XI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Surfactant
Industrial
EPA (2017b); CPCat(2019); ECHA (2018b)
CDR reports show use of dipropylene glycol as a surfactant in wholesale and retail trade. CPCat lists the use of dipropylene
glycol as a surfactant in detergents and cleaning and washing agents. The ECHA registration dossier indicates the use of
dipropylene glycol as a surfactant in industrial sites.
Expected users are industrial based on CDR's Industrial Processing and Use report.
TSCA Conditions of Use: Laundry and Dishwashing Products
CDR reports show use of liquid dipropylene glycol in consumer and commercial laundry and dishwashing products. CDR identifies concentrations (by weight) of less than
one percent in consumer products and at least one percent but less than 30 percent in consumer and commercial products (EPA 2017b).
Dishwasher cleaner
Consumer
DeLima Associates (2015b); CPCat (2019)
CPCat lists the use of dipropylene glycol in cleaning and washing agents for dishwashing machines.
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
Dishwasher
detergent
Consumer,
commercial
DeLima Associates (2015a); ECHA (2018b)
The ECHA registration dossier indicates the use of dipropylene glycol in dish wash and rinse products for commercial use.
CPID generally includes products for consumer use; therefore, the expected user is a consumer. Expected users are
commercial based on inclusion in ECHA's uses by professional workers.
Dry cleaning
Commercial
CPCat (2019)
CPCat lists the use of dipropylene glycol in washing and dry cleaning of textile and fur products.
Expected users are not listed but are expected to be commercial for dry cleaning.
Fabric freshener
Consumer
DeLima Associates (2015h)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
Fabric softener
Consumer
DeLima Associates (2015e)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
XII
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Laundry detergent
Consumer,
commercial
DeLima Associates (2015i); ECHA (2018b)
The ECHA registration dossier indicates the use of dipropylene glycol in laundry products including laundry detergents and
laundry aids for commercial use.
CPID generally includes products for consumer use; therefore, the expected user is a consumer. Expected users are
commercial based on inclusion in ECHA's uses by professional workers.
Laundry detergent
scent additive
Consumer
DeLima Associates (2016b)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
Prewash stain
remover
Consumer,
commercial
DeLima Associates (2014e); ECHA (2018b)
The ECHA registration dossier indicates the use of dipropylene glycol in pre-spotter/ stain remover.
CPID generally includes products for consumer use; therefore, the expected user is a consumer. Expected users are
commercial based on inclusion in ECHA's uses by professional workers.
TSCA Conditions of Use: Manufacturing
Synapse Information Resources (Synapse Information Resources (2009)) lists the use of dipropylene glycol in polyester and alkyd resins, reinforced plastics, plasticizers,
solvents and fragrance, which are used in the manufacturing sectors listed below.
Automotive
manufacturing
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in the manufacture of motor vehicles, trailers, and semi-trailers, and other transport
equipment.
Expected users are industrial based on CPCat's user classification.
Basic metal
manufacturing
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in the manufacture of basic metals.
Expected users are industrial based on CPCat's user classification.
XIII
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Building material
manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of "builders' carpentry and joinery."
Expected users are industrial based on CPCat's user classification.
EPA (2017b); CPCat (2019); ECHA (2018b)
Chemical
manufacturing
Industrial
CDR reports show use of dipropylene glycol as an intermediate and solvent (incorporated into the formulation, mixture, or
reaction product) in the manufacture of basic organic chemicals and other chemical products and preparations. CPCat lists
the use of dipropylene glycol in the manufacture of chemicals and chemical products. The ECHA registration dossier
indicates the use of dipropylene glycol in the manufacture of fine chemicals.
Expected users are industrial based on CDR's Industrial Processing and Use report.
Communication
equipment
manufacturing
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in the "manufacture of radio, television, and communication equipment."
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Computer and
electronic
manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of computer, electronic, optical products, and in electrical
equipment, machinery and components (including valves, tubes, electronic boards, etc.).
Expected users are industrial based on CPCat's user classification.
Fabricated metal
products
manufacturing
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in the manufacture of "fabricated metal products, except machinery."
Expected users are industrial based on CPCat's user classification.
XIV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Food manufacturing1
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of food products and beverages, and other food services.
Expected users are industrial based on CPCat's user classification.
CPCat (2019); ECHA (2018b)
Furniture
manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of furniture, including "office and shop furniture." The ECHA
registration dossier indicates that dipropylene glycol has been used in the manufacture of furniture.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Iron metal
manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of iron and metal products.
Expected users are industrial based on CPCat's user classification.
CPCat (2019); ECHA (2018b)
Leather product
manufacturing
Consumer,
commercial,
industrial
CPCat lists the use of dipropylene glycol in the manufacture of leather, leather apparel, bags, footwear and related products,
including use in leather tanneries and as an impregnation material. The ECHA registration dossier indicates that dipropylene
glycol has been used in leather treatment product.
Expected users are industrial based on CPCat's user classification, and consumer/ commercial due to inclusion in ECHA's
consumer uses and uses by professional workers.
CPCat (2019)
Metals manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of steel tubes, and structural metal products, including as
cooling agent for metal processing. CPCat also lists use in treatment and coating of metals.
Expected users are industrial based on CPCat's user classification.
XV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Non-metallic mineral
product
manufacturing
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in the manufacture of non-metallic mineral products.
Expected users are industrial based on CPCat's user classification.
EPA (2017b); CPCat (2019)
Paint manufacturing
Industrial
CDR reports show use of dipropylene glycol as a solvent and general paint/coating additive added during paint and coating
manufacturing. CPCat lists the use of dipropylene glycol in the "manufacture of paints, varnishes, and similar coatings,
print."
Expected users are industrial based on inclusion in CDR's Industrial Processing and Use report.
EPA (2017b); CPCat (2019); ECHA (2018b)
Paper manufacturing
Industrial
CDR reports show use of dipropylene glycol as a pigment and dye in paper manufacturing. CPCat lists the use of
dipropylene glycol in the manufacture of paper, pulp, paper products and paperboard, including use as a surface treatment
for paper, and cardboard and impregnation materials for paper. The ECHA registration dossier indicates the use of
dipropylene glycol, including as a solvent, in the manufacture of pulp, paper and paper products.
Expected users are industrial based on inclusion in CDR's Industrial Processing and Use report.
CPCat (2019)
Perfume
manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of perfumes.
Expected users are industrial based on CPCat's user classification.
EPA (2017b); CPCat (2019)
Petrochemical
manufacturing
Industrial
CDR reports show use of dipropylene glycol as an intermediate and process regulator in petrochemical manufacturing. CDR
also reports use as a processing aid in the manufacture of carbon black. CPCat lists the use of dipropylene glycol in the
manufacture of petrochemical manufacturing.
Expected users are industrial based on CDR's Industrial Processing and Use report.
XVI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
EPA (2017b); Dow (2009); CPCat (2019)
Plastic and rubber
manufacturing
Industrial
CDR reports show use of dipropylene glycol as a solvent in rubber product manufacturing and as an accelerator and
intermediate in the manufacture of plastic products, material and resin. Dow identifies use of dipropylene glycol as a high-
volume plasticizer, reactant in unsaturated polyurethane resins, initiator in urethane polyols, and reactive diluent in radiation-
cured resins and coatings.
CPCat lists the use of dipropylene glycol in the manufacture of plastics, rubber, plastic packing goods, plastics materials and
resins, with functions including as an intermediate, hardener, and softener.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Soap manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of soaps and detergents, cleaning compounds, and cleaning
and polishing.
Expected users are industrial based on CPCat's user classification.
EPA (2017b); CPCat (2019); ECHA (2018b)
Textiles, apparel, and
leather
manufacturing
Consumer,
commercial,
industrial
CDR reports show use of dipropylene glycol as a finishing agent in textile, apparel, and leather manufacturing. CPCat lists
the use of dipropylene glycol in the manufacture of textiles, including finishing of textiles, textile impregnation agents, and in
upholstery of chairs and seats. The ECHA registration dossier indicates the use of dipropylene glycol in consumer textile
dyes and impregnating products, manufacturing and industrial use of textile dyes and finishing products.
Expected users are industrial based on CDR's Industrial Processing and Use report, and consumer/ commercial based on
inclusion in ECHA's consumer uses and uses by professional workers.
Transportation
equipment
manufacturing
Industrial
EPA (2017b)
CDR reports show use of dipropylene glycol as a functional fluid in closed systems for transportation equipment
manufacturing.
Expected users are industrial based on CDR's Industrial Processing and Use report.
XVII
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Windmill
manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the "manufacture of windmills and parts of windmills."
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Wood manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the "manufacture of wood and products, of wood and cork" and wood building
material including for the impregnation of wood, sawmilling, and wood preserving agents.
Expected users are industrial based on CPCat's user classification.
TSCA Conditions of Use: Pesticides and Agriculture
CPCat (2019)
Crop and animal
production2
Industrial
CPCat lists the use of dipropylene glycol in "crop and animal production, hunting and related service activities," including in
the growing of perennial and non-perennial crops. Other uses in agricultural, including pesticides are listed elsewhere.
Expected users are industrial based on CPCat's user classification.
ECHA (2018b)
Fertilizers
Consumer,
commercial
The ECHA registration dossier indicates the use of dipropylene glycol in fertilizers and plant protection products.
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 Dipropylene Glycol
Use
Expected Users
Description of Use and References |
TSCA Conditions of Use: Miscellaneous
CPCat (2019); ECHA (2018b)
Absorbents and
adsorbents
Consumer
CPCat lists the use of dipropylene glycol in adsorbents and adsorbents. No further information could be found on this use.
The ECHA registration dossier indicates the use of dipropylene glycol in adsorbents.
Expected users are consumer based on inclusion in ECHA's consumer.
CPCat (2019); ECHA (2018b)
Adhesives
Consumer,
commercial
CPCat lists the use of dipropylene glycol in adhesives, binding agents, and glues, including in paints. The ECHA registration
dossier indicates that dipropylene glycol is used in adhesives and sealants.
Expected users are consumer and commercial due to inclusion in ECHA's consumer uses and uses by professional
workers.
EPA (2017b)
Agricultural products
Commercial,
industrial
CDR reports show use of liquid dipropylene glycol in commercial and industrial non-pesticide agricultural chemicals. CDR
identifies concentrations of less than one percent by weight in commercial agricultural products.
Expected users are commercial based on CDR's consumer/commercial classification and industrial based on CDR's
Industrial Processing and Use report.
CPCat (2019)
Anti-foaming agent
Unknown
CPCat lists the use of dipropylene glycol in anti-foaming agent, foam-reducing agents.
Expected users are unknown, due to the limited availability of information.
EPA (2017b); GoodGuide (2011a); CPCat (2019); ECHA (2018b)
Anti-freeze and
de-icing products
Consumer,
commercial
CDR reports show use of liquid dipropylene glycol in anti-freeze and de-icing products. Pollution Scorecard identifies use in
consumer de-icing agents. CPCat lists the use of dipropylene glycol in anti-freeze and de-icing products. The ECHA
registration dossier indicates the use of dipropylene glycol in anti-freeze and deicing products.
Expected users are consumer and commercial based on CDR's consumer/commercial classification.
XIX
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
EPA (2017b)
Building/construction
materials
Commercial,
industrial
CDR reports show use of liquid dipropylene glycol in commercial building and construction materials not covered elsewhere,
at concentrations of less than one percent by weight. CDR also reports use as a catalyst in industrial construction
applications.
Expected users are commercial based on CDR's consumer/commercial classification and industrial based on CDR's
Industrial Processing and Use report.
CPCat (2019)
Casting and molding
Consumer
CPCat lists the use of dipropylene glycol as a casting agent in casting materials and molding compounds.
Expected users are consumer.
ECHA (2018b)
Finger paints
Consumer,
commercial
The ECHA registration dossier indicates the use of dipropylene in finger paints. Uses in other paints is listed elsewhere. This
product is likely to be used by children.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional
workers.
EPA (2017b)
Golf and sports turf
Commercial
CDR reports show use of liquid dipropylene glycol in golf and sports turf at concentrations of at least 90 percent by weight.
Expected users are commercial based on CDR's consumer/commercial classification.
ECHA (2018b)
Hydraulic fluids
Consumer,
commercial
The ECHA registration dossier indicates the use of dipropylene glycol in hydraulic fluids.
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 Dipropylene Glycol
Use
Expected Users
Description of Use and References
EPA (2017b); CPCat (2019); Synapse Information Resources (2009); ECHA (2018b)
Ink and toner
Consumer,
commercial,
industrial
CDR reports show use of liquid dipropylene glycol in ink, toner, and colorant products. CDR identifies concentrations (by
weight) of at least one percent but less than 30 percent and at least 60 percent but less than 90 percent in reported
products. CDR also reports use as a solvent in the manufacture of printing ink. CPCat lists the use of dipropylene glycol in
print, inks, colorants, and toners. Synapse Information Resources lists the use of dipropylene glycol in printing inks. The
ECHA registration dossier indicates the use of dipropylene glycol in ink ands and toners for consumer, commercial and
industrial use.
Expected users are consumer and commercial based on CDR's consumer/commercial classification and industrial based on
CDR's Industrial Processing and Use report.
EPA (2017b); ECHA (2018b)
Intermediates
Commercial,
industrial
CDR reports show use of liquid dipropylene glycol in urethane intermediates at concentrations of at least 90 percent by
weight. The ECHA registration dossier indicates the use of dipropylene glycol as an intermediate at industrial sites, there is
no further information on current use as an intermediate for industrial users in the United States.
Expected users are commercial based on CDR's consumer/commercial classification, and industrial based on inclusion in
ECHA's uses at industrial sites.
EPA (2017b); Dow (2009); CPCat (2019); ECHA (2018b)
Lubricants and
greases
Consumer,
commercial,
industrial
CDR reports show use of liquid dipropylene glycol in commercial lubricants and greases at concentrations of less than one
percent by weight. CDR also reports use as a lubricant and lubricant additive in industrial non-oil and gas mining and
support activities. Dow identifies use of dipropylene glycol in cutting oils (often used in metalworking applications). CPCat
lists the use of dipropylene glycol in lubricants and greases. The ECHA registration dossier indicates the use of dipropylene
glycol in lubricants, greases and release products for consumer and industrial use.
Expected users are commercial based on CDR's consumer/commercial classification and industrial based on CDR's
Industrial Processing and Use report, and consumer based on inclusion in ECHA's consumer uses.
XXI
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
EPA (2017b); GoodGuide (2011a); CPCat (2019); Synapse Information Resources (2009); ECHA (2018b)
Paints and coatings
Consumer,
commercial
CDR reports show use of liquid dipropylene glycol in paints and coatings at concentrations of at least one percent but less
than 30 percent by weight. Pollution Scorecard identifies use in paints and primers for vehicles and machinery refinish as
well as interior water-thinned coatings. CPCat lists the use of dipropylene glycol in paint, lacquers, varnish, and primers,
including for decorative, protective, interior and exterior use. Synapse Information Resources lists the use of dipropylene
glycol in lacquer, paints and shellac varnishes. The ECHA registration dossier indicates the use of dipropylene glycol in
coatings, paints, and thinners.
Expected users are consumer and commercial based on CDR's consumer/commercial classification.
CPCat (2019); ECHA (2018b)
Paint and varnish
remover
Consumer
CPCat lists the use of dipropylene glycol as a solvent in paint and varnish removers. The ECHA registration dossier
indicates the use of dipropylene glycol in paint removers.
Expected users are consumer based on inclusion in ECHA's consumer uses.
EPA (2017b); ECHA (2018b)
Paper products
Consumer,
commercial
CDR reports show use of liquid dipropylene glycol in commercial paper products at concentrations of less than one percent
by weight. The ECHA registration dossier indicates that dipropylene glycol has been used in paper and board treatment
products.
Expected users are commercial based on CDR's consumer/commercial classification, and consumer based on ECHA's
consumer uses.
CPCat (2019)
Pet litter
Consumer
CPCat lists the use of dipropylene glycol in pet litter available for retail use.
Expected users are consumer based on CPCat's user classification.
XXII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019); ECHA (2018b)
Photographic
Consumer
CPCat lists the use dipropylene glycol in reprographic agents and photo-chemicals. The ECHA registration dossier indicates
the use of dipropylene glycol in photo-chemicals.
Expected users are consumer based on inclusion in ECHA's consumer uses.
EPA (2017b); CPCat (2019)
Plastic and rubber
products
Commercial
CDR reports show use of liquid, pellet, and large crystal dipropylene glycol in commercial plastic and rubber products not
covered elsewhere at concentrations of at least one percent but less than 60 percent by weight. CPCat lists the use of
dipropylene glycol in plastic and rubber products.
Expected users are commercial based on CDR's consumer/commercial classification.
CPCat (2019); ECHA (2018b)
Polishing agents
Consumer,
commercial
CPCat lists the use dipropylene glycol in polishing agents. The ECHA registration dossier indicates the use of dipropylene
glycol in polishes and wax blends
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional
workers.
GoodGuide (2011a)
Sealants
Consumer
Pollution Scorecard identifies use of dipropylene glycol in nonstructural caulking compounds and sealants.
Expected users are consumer based on inclusion in GoodGuide's consumer uses.
CPCat (2019)
Toys
Consumer
CPCat lists the use of dipropylene glycol in consumer toys, listed for child use, including fragrances and pool supplies.
Expected users are consumer based on CPCat's user classification.
XXIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019); ECHA (2018b)
Water treatments
Consumer,
commercial,
industrial
CPCat lists the use of dipropylene glycol in water treatment including softeners and lime deposit (calcium) remover. The
ECHA registration dossier indicates the use of dipropylene glycol in water treatment chemicals.
Expected users are based on inclusion in ECHA's consumer uses, uses by professional workers, and uses at industrial
sites.
CPCat (2019); ECHA (2018b)
Welding and
soldering
Consumer
CPCat lists the use of dipropylene glycol in welding and soldering agents, including soldering paste. The ECHA registration
dossier indicates the use of dipropylene glycol in welding and soldering products.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018b)
Whiteboard marker
Consumer
The ECHA registration dossier indicates the use of dipropylene glycol in whiteboard markers.
Expected users are consumer based on inclusion in ECHA's consumer uses.
Non-TSCA Uses
CPCat (2019)
Additive
Unknown
CPCat lists the use of dipropylene glycol in food additives, including in salt, spices and seasonings.
Expected users are unknown, due to the limited availability of information.
Animal insecticide
Consumer
DeLima Associates (2014a)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
XXIV
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Antiperspirant
Consumer
DeLima Associates (2013b); GoodGuide (2011a); CPCat (2019)
GoodGuide identifies use of dipropylene glycol in deodorants. CPCat lists the use of dipropylene glycol in deodorants and
antiperspirants.
Expected users are consumer based on inclusion in CPID and GoodGuide's consumer uses.
Bactericides
Unknown
CPCat (2019)
CPCat lists the use of dipropylene glycol in bactericides which function to kill bacteria, and bacteriostats, which function to
stop bacteria from reproducing.
Expected users are unknown, due to the limited availability of information.
Bath accessories
Consumer
CPCat (2019)
CPCat lists the use of dipropylene glycol in bath accessories for personal use and in bath products meant for use by babies.
Expected users are not listed but expected to be consumer for personal care bath accessories.
Body cleanser
Consumer
CPCat (2019)
CPCat lists the use of dipropylene glycol in body cleansers.
Expected users are not listed but expected to be consumer for body cleansers.
Body oil
Consumer
DeLima Associates (2011a);
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
Body wash
Consumer
DeLima Associates (20151)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
XXV
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
Cuticle treatment
DeLima Associates (2011a)
Consumer
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
CPCat (2019)
Disinfectants
Unknown
CPCat lists the use of dipropylene glycol in disinfecting agents and other sanitation agents.
Expected users are unknown, due to the limited availability of information.
Drugbank (2018a)
Facial masks
Consumer,
commercial
DrugBank lists the use of liquid dipropylene glycol in topical facial masks listed as currently available for over-the-counter
use in the United States.
Expected users are consumer and commercial, as the products is available for over-the-counter purchase.
First aid spray
Consumer
DeLima Associates (2014b)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
CPCat (2019); Descartes Datamyne (2018); ECHA (2018b)
Fragrance
Consumer
CPCat lists the use of dipropylene glycol as an odor agent in fragrances for cosmetic and personal care use. Datamyne
reports the export of "dipropylene glycol fragrance" from the U.S. to foreign countries. The specific products or use of the
exported fragrance is unknown. The ECHA registration dossier indicates the use of dipropylene glycol in perfumes and
fragrances.
Expected users are consumer based on inclusion in ECHA's consumer uses.
Hair conditioner
Consumer
DeLima Associates (2016c)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
XXVI
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Hair dye
Consumer
CPCat lists the use of dipropylene glycol in hair dye colorants.
Expected users are not listed but expected to be consumer for hair dyes.
DeLima Associates (2016a); P&G (2015)
Hair shampoo
Consumer,
commercial
Dipropylene glycol is listed as an ingredient in a hair shampoo product intended for professional use.
CPID generally includes products for consumer use; therefore, the expected user is a consumer. Expected users are
commercial as the product is listed for professional use.
Hair straightener
Consumer
DeLima Associates (2011b)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
DeLima Associates (2013b); CPCat (2019)
Hair styling
Consumer
CPCat lists the use of dipropylene glycol in hair styling products.
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
Hair toner
Consumer
DeLima Associates (2017b)
CPID generally includes products for consumer use; therefore, the expected user is a consumer.
CPCat (2019)
Hand cream and
lotion
Consumer
CPCat lists the use of dipropylene glycol in hand creams and lotions.
Expected users are not listed but expected to be consumer for hands creams and lotions.
XXVII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Hand sanitizers
Consumer
CPCat lists the use of dipropylene glycol in hand sanitizers.
Expected users are not listed but expected to be consumer for hand sanitizers.
CPCat (2019)
In-can preservatives
Unknown
CPCat lists the use of dipropylene glycol in in-can food preservatives.
Expected users are unknown, due to the limited availability of information.
CPCat (2019); ECHA (2018b)
Insecticide
Consumer,
commercial
CPCat lists the use of dipropylene glycol in insecticides which function specifically to kill insects. The ECHA registration
dossier indicates the use of dipropylene glycol in insecticides, repellents and other biocidal products.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional
workers.
ECHA (2018b)
Medical devices
Commercial
The ECHA registration dossier indicates the use of dipropylene glycol in professional medical devices,
Expected users are commercial based on inclusion in ECHA's uses by professional workers.
California Deptof Pesticide Regulation (2018); NPIRS (2018); GoodGuide (2011a); CPCat (2019); ECHA (2018b)
Pesticides
Commercial,
industrial
The California Department of Pesticide Regulation (Cal DPR) identifies four companies that use dipropylene glycol as an
active ingredient in pesticides. Cal DPR also reports 14 companies that use dipropylene glycol as an inactive ingredient in
pesticides. NPIRS identifies two companies that use dipropylene glycol in federally active pesticides. Pollution Scorecard
identifies use of dipropylene glycol in deodorizing and sanitizing pesticides. CPCat lists the use of dipropylene glycol in non-
agricultural and agricultural pesticides, including as an inert or active ingredient, antimicrobial, and some listings indicating
use in food. The ECHA registration dossier indicates the use of dipropylene glycol in biocidal products.
Expected users are consumer due to inclusion in ECHA's consumer uses, and industrial due to its use in pesticide
manufacturing.
XXVIII
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Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
ECHA (2018b)
Pharmaceutical uses
Consumer,
commercial
The ECHA registration dossier indicates the use of dipropylene glycol in pharmaceuticals.
Expected users are consumer and commercial based on inclusion in ECHA's consumer uses and uses by professional
workers.
CPCat (2019)
Razors
Consumer
CPCat lists the use of dipropylene glycol in razors as tools for hair removal.
Expected users are not listed but expected to be consumer for razors.
Shampoo
manufacturing
Industrial
CPCat (2019)
CPCat lists the use of dipropylene glycol in the manufacture of hair shampoo.
Expected users are industrial based on CPCat's user classification.
CPCat (2019)
Shaving cream
Consumer
CPCat lists the use of dipropylene glycol in shaving cream.
Expected users are not listed but expected to be consumer for shaving cream.
CPCat (2019)
Skin cleanser
Consumer
CPCat lists the use of dipropylene glycol in skin cleansers which broadly includes person care soaps, shower gels, and
hand cleansing creams.
Expected users are not listed but expected to be consumer for skin cleansers.
XXIX
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of Dipropylene Glycol
Use
Expected Users
Description of Use and References
CPCat (2019)
Toothpaste
manufacturing
Industrial
CPCat lists the use of dipropylene glycol in the manufacture of toothpaste.
Expected users are industrial based on CPCat's user classification.
Children's Products
CDR reports show use of liquid dipropylene glycol in consumer and commercial children's personal care products; further sources report use of dipropylene glycol in body
wash, toys, and finger paints intended for use by children.
Recycling and Disposal I
In the 2016 CDR, one facility, Proviron Inc., reported that dipropylene glycol was recycled (recycled, remanufactured, reprocessed, or reused). Thirty-eight facilities
reported that the chemical was not recycled, while ten facilities withheld this information and seven facilities reported this information as CBI (EPA 2017b).
I Note(s):
1. 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.
2. 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.
XXX
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
A.3 References
Boscia. (2018). Sake Hydrating and Brightening Serum. Retrieved from
https://www.boscia.com/shop/product detail.php?products id=278
California Dept of Pesticide Regulation. (2013). DPR Databases. Retrieved from
https://www.cdpr.ca.gov/dprdatabase.htm
California Dept of Pesticide Regulation. (2018). DIPROPYLENE GLYCOL. Retrieved from
https://apps.cdpr.ca.gov/cgi-bin/label/comp.pl
Cetaphil. (2018). Baby Daily Lotion. Retrieved from https://www.cetaphil .com/babv-1 otion/
CVS. (2018). Beauty 360 Pear And White Tea Anti-Bacterial Foaming Hand Soap, 7.5 OZ. Retrieved
from https://www.cvs.com/shop/beaiitv-36Q-pear-and-white-tea-anti-bacterial-foaming-hand-
soap-7~5~oz~prodid~ .1.02045 7
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. (2008a). Pledge Commercial Line, Lemon Clean, Aerosol, Professional Use-
08/22/2008. Retrieved from Pledge Commercial Line, Lemon Clean, Aerosol, Professional Use-
08/22/2008
DeLima Associates. (201 la). Avon Skin So Soft Original Gelled Body Oil. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1 /11175/standard/Avon%20Skin%20So%20
Soft%200riginal%20Gelled%20Bodv%200il/0.1. -022-1.05
DeLima Associates. (201 lb). Joico K-Pak Style Smoothing Hair Balm. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/ 1/standard/Joico%20K-
Pak%20Stvle%20Smoothing%20Hair%20Balm/l 0-0.1.3-003
DeLima Associates. (2013a). Air Wick Air Freshener with 100 Percent Natural Propellant, Vanilla
Indulgence. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/16298/standard/p%20class=%22p 1 %22%3
EAir%20Wick%20Air%20Freshener%20with%20100%20Percent%20Natural%20Propellant.%2
0Vanilla%20Indulgence.%20Aerosol-07/l8/2013/p?o 'i I y-001-977
DeLima Associates. (2013b). AXE Natural Look Hair Cream With Tea Tree Extract. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/13431/standard/AXE%20Natnral%20Look
%20Hair%20Cream%20With%20Tea%20Tree%20Exto 309
DeLima Associates. (2013c). Nilodor Natural Touch Paw TRAX Foaming Cleaner for Carpet &
Upholstery-06/27/2013. Retrieved from
xxxT
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
https://www.whatsinproclucts.com/tvpes/tvpe detail/1 I > ?%/standard/p%3ENilodor%20Natural
-06/27/2013/p%3E/14-013-053
DeLima Associates. (2014a). Absorbine Flys-X Ready to Use Insecticide Spray. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/14264/standard/Absorbine%20Flvs-
41014)01
DeLima Associates. (2014b). Lanacane First Aid Spray, Aerosol-12/29/2014. Retrieved from
https://www.whatsinproducts.com/types/tvpe detail/1/16327/standard/p%20class=%22pl%22%3
Espan%20class=%22sl%22%3ELanacane%20First%20Aid%20Sprav.%20 Aerosol-
12/29/2014/span%3E/p%'t IS 030-010
DeLima Associates. (2014c). Mop & Glo Professional Multi-Surface Floor Cleaner, Professional Use-
10/09/2014. Retrieved from
https://www.whatsinproducts.com/types/tvpe detail/ 1/standard/p%20class=%22p.1.%22%3
EMop%20&%20Glo%20Professional%20Multi-
Surface%20Floor%20Cleaner.%20Professional%20Use-l 0/09/2014/p%-U-' IK -001-793
DeLima Associates. (2014e). Resolve Max Power Laundry Pre-Treater Gel-11/26/2014. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/16019/standard/p%20class=%22pl%22%3
EResolve%20Max%20Power%20Laundrv%20Pre-Treater%20Gel-l 1/26/2014/p%3E/1.8-001-
705
DeLima Associates. (2015a). Cascade Actionpacs Dishwasher Detergent, Citrus Scent. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/17825/standard/p%20class=%22pl%22%3
ECascade%20Actionpacs%20Dishwasher%20Detergent%20Citrus%20Scent-
03/30/201.5/p 3-182
DeLima Associates. (2015b). Cascade Dishwasher Cleaner, Fresh Scent. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1 /17832/standard/p%20class=%22p 1 %22%3
ECascade%20Dishwasher%20Cleaner.%20Fresh%20Scent-03/26/2015/p%: 33-1.89
DeLima Associates. (2015c). Clorox Automatic Toilet Bowl Cleaner Bleach & Blue, Rain Clean.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/16398/standard/p%3EClorox%20Automati
c%20Toilet%20Bowl%20Cleaner%20Bleach%20&%20Blue.%20Rain%20Clean-
01/05/2015/p%3E/03-027-349
DeLima Associates. (2015d). Clorox Commercial Solutions Clorox 4 in One Disinfectant and Sanitizer.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/16487/standard/p%3EClorox%20Commer
cial%20Solutions%20Clorox%204%20in%20Qne%20Disinfectant%20and%20Sanitizer,%20Aer
osol.%20Professional%20Use-01/05/2015/p%3E/03-027-432
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
DeLima Associates. (2015e). Downy Ultra Infusions Fabric Softener, Amber Blossom. Retrieved from
https://www.whatsinproducts.com/types/tvpe detail/ 1/standard/p%20class=%22p 1 %22%3
EDownv%20Ultra%20Infiisions%20Fabric%20Softener.%20Amber%20Blossom-
03/03/2015/p 0-954
DeLima Associates. (2015f). Drano Max Build Up Remover, Commercial Line, Professional Use-
04/02/2015. Retrieved from
https://www.whatsinproducts.com/types/tvpe detail/1/1654l/standard/p%20class=%22pl%22%3
Espan.%20class=%22s.l.%22%3EDran.o%20Max%20Build%20Up%20Remover.%20Commercial
%20Line,%20ProfessionaI%20Use-
DeLima Associates. (2015g). Febreze Candle Hawaiian Aloha. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/18034/standard/p%2
EFebreze%20Candle%20Hawaiian%20Aloha-03/24/201 5/d( 5-394
DeLima Associates. (2015h). Febreze Fabric Refresher, Free. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/18050/standard/p%20class=%22pl%22%3
EFebreze%20Fabric%20Refresher.%20Free.%20Pump%20Sprav-02/23/2015/p 3-409
DeLima Associates. (2015i). Gain Ultra Laundry Detergent Powder, Original-04/17/2015. Retrieved
from
https://www.whatsinproducts.com/types/tvpe detail/ ^/standard/p%20class=%22p.1.%22%3
EGain%20Ultra%20Laundrv%20Detergent%20Powder.%20Qriginal -04/ .1.7/2015/p' h
944
DeLima Associates. (2015j). Method Daily Granite, Cleans + Polishes, Apple Orchard. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/19396/standard/p%3EMethod%20Dailv%2
QGranite.,%20Cleans%20+%20Polishes.%20Apple%200rchard.%20Pump%20Sprav-
05/11/2015/p 6-1.30
DeLima Associates. (2015k). Method Daily Shower, Eucalyptus Mint, Pump Spray-05/11/2015.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/19398/standard/p%3EMethod%20Dailv%2
0Shower..%20Eucalvptus%20Mint.%20Pump%20Sprav-05/l l/2015/p% )36-132
DeLima Associates. (20151). Old Spice Dry Skin Defense Body Wash, Live Wire-02/18/2015. Retrieved
from
https://www.whatsinproducts.com/tvpes/tvpe detail/ S/standard/p%20class=%22p.1.%22%3
E01d%20Spice%20Drv%20Skin%20Defense%20Bodv%20Wash.%20Live%20Wire-
02/ .1.8/2015/p 0-827
DeLima Associates. (2015m). Pledge FloorCare Multi-Surface Finish-02/25/2015. Retrieved from
https://www.whatsinproducts.com/tvpes/type detail/l/16567/standard/p%20class=%22pl%22%3
EPledge%20FloorCare%20Multi-Surface%20Finish-02/25/20.1.5/p%3E/.1.9-(HJ I
XXXiii
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
DeLima Associates. (2015n). Scrubbing Bubbles Bathroom Cleaner with Color Power Technology,
Aerosol-02/24/2015. Retrieved from
https://www.whatsinproclucts.com/tvpes/tYpe detail/1 /1660l/standard/p%20class=%22p 1 %22%3
ig%20Bubbles%20Bathroom%20Cleaner%20with%20Color%20Power%20Technolog
v.%20Aerosol-02/24/20 15/p°
DeLima Associates. (2015o). Windex Crystal Rain, Pump Spray-02/25/2015. Retrieved from
https://www.whatsinproducts.com/types/tvpe detail/l/16609/standard/p%20class=%22pl%22%3
EWindex%20Crvstal%20Rain.%20Pump%20Sprav-02/25/2015/p% >01-629
DeLima Associates. (2016a). Dove Advanced Hair Series Regenerative Nourishment Shampoo with Red
Algae Complex-04/27/2016. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/Li° I S0/standard/p%3EDove%20Advanced
%20Hair%20Series%20Regenerative%20Nourishment%20Shampoo%20with%20Red%20Algae
%20Complex-04/27/2016/p%3E/2.1. -0.1.0-423
DeLima Associates. (2016b). Febreze, Unstopables, In-Wash Scent Booster, Dreams-01/21/2016.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/18369/standard/p%20class=%22pl%22%3
EFebreze.%20Unstopables.%20In-Wash%20Scent%20Booster.%20Dreams-
01/21/201.6/p 3-488
DeLima Associates. (2016c). Herbal Essences, Bio Renew, Sheer Moisture Conditioner, Cucumber &
Green Tea-08/11/2016. Retrieved from
https://www.whatsinproducts.com/tvpes/type detail/1/21652/standard/p%20class=%22p 1 %22%3
EHerbal%20Essences.%20Bio%20Renew.%20Sheer%20Moisture%20Conditioner.%20Cucumbe
r%20&%20Green%20Tea-08 1 I ..>016/p%3E/16-033-569
DeLima Associates. (2017a). Carbona Stain Devils No. 2, Chocolate, Ketchup & Mustard. Retrieved
from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/19466/standard/p%20class=%22pl%22%3
ECarbona%20Stain%20Devils%20No.%202.%20Chocolate.%20Ketchup%20&%20Mustard-
02/10/201.7/p%3E/04-030-006
DeLima Associates. (2017b). Dove Advanced Hair Series, Quench Absolute Intense Restoration Mask for
Curly, Coarse Hair. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/19210/standard/p%3EDove%20Advanced
%20Hair%20Series.%20Quench%20Absolute%20Intense%20Restoration%20Mask%20for%20C
urlv.%20Coarse%20Hair-05/.1.0/201'/»>"; 1 'a
DeLima Associates. (2018). Consumer Product Information Database. Retrieved from
https://www.whatsinproducts.com/
Descartes Datamyne. (2018). Descartes Datamyne Import-Export Database.
XXXIV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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 101o/i.toxrep.2014..1.2.009
Dove. (2018). Nutritive Solutions Intensive Repair Conditioner. Retrieved from
https://www.dove.com/za/liair-care/conditioner/nutritive-soliitions-intensive-repair-
conditioner.html
Drugbank. (2018a). Dipropylene glycol. Retrieved from https://www.drugbank.ca/drugs/D
DrugBank. (2018b). DrugBank Database. Retrieved from https ://www. dru gbank. ca/
European Chemicals Agency (ECHA). (2018a). l,l'-oxydipropan-2-ol. Retrieved from
https://eeha.eiiropa.eii/siibstanee-infi3 rTOation./~/siibstaneeinfo/.l. 00.003.475
European Chemicals Agency (ECHA). (2018b). Oxydipropanol. Retrieved from
https://echa.europa.eii/registration-dossier/-/registered-dossier/ .1.601.6/1
EWG. (2018a). Dipropylene Glycol. Retrieved from
https://www.ewg.org/skindeep/ingredient/702123/DIPROPYLENE GLYCOL/
EWG. (2018b). Skin Deep Cosmetics Database. Retrieved from
https://www.ewg.Org/skindeep/#.W4RpIPlKiUk
GoodGuide. (201 la). Dipropylene glycol. Retrieved from http://seoreeard.goodguide.eom/ehemieal-
profiles/summarv.tcl?edf substance id=+25265-71-8#use profile
GoodGuide. (201 lb). Scorecard: The Pollution Information Site. Retrieved from
http://scorecard.goodgiiide.com/chemical-profiles/index.tcl
Government of Canada. (2018). Chemical Substances: Services and Information. Retrieved from
https://www.canada.ca/en/liealth-canada/services/chemical-siibstances.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, 7-/(Database issue),
D 1202-D 1213. doi: 10.1093/nar/gkv951
Kirk-Othmer. (2006). Kirk-Othmer Encyclopedia of Chemical Technology.
Medline.com. (2009). Material Safety Data Sheet. Retrieved from
https://www.medline.com/media/catalog/Docs/MSDS/MSD SD I8.pdf
Code of Federal Regulations, Title 21 Food and Drugs, (2018).
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
National Pesticide Information Retrieval System (NPIRS). (2018). Company Information. Retrieved
from http://npirspublic.ceris.purdue.edii/ppis/chemical2.aspx
Organisation for Economic Cooperation and Development (OECD). (2001). Dipropylene glycol, mixed
isomers and dominant isomer. Retrieved from:
http://www.inchem.org/documents/sids/sids/25265-71-8.pdf
Organisation for Economic Cooperation and Development (OECD). (2018). eChemPortal: Global Portal
to Information on Chemical Substances. Retrieved from
g/echemportal/index.action
P&G. (2015). Safety Data Sheet. Retrieved from
Sherlock. Scott. (2019). Email [Non-CBI redactedl. 25265-71-8 FW TSCA Low Priority Chemical
Review Processes CBI Review. July 9.
Shiseido. (2018). Benefiance WrinkleResist24 Protective Hand Revitalizer. Retrieved from
https://www.shiseido.com/benefiance-wrinkleresist24-protective-hand-revitalizer-
0730852118744.html
Skinfood. (2018). 0.9 Moist Toner. Retrieved from ^
Lus/products/0-9-moist-toner
Synapse Information Resources. (2009). Specialty Chemicals Source Book. Fourth Edition. Volume 1.
The Dow Chemical Company. (2009). Dipropylene Glycol Regular Grade (DPG). Retrieved from
https://web.archive.Org/web/20090714065203/littp://www.dow.com:80/propvleneglvcol/prod/dpg
.htm
U.S. Environmental Protection Agency (EPA). (2002). 1986-2002 Historical IUR Data. 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/fnnctional-iise-database-flise
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://chemview.epa.gov/chemview
U.S. Environmental Protection Agency (EPA). (2018b). Envirofacts Multisystem Search. Retrieved
from https://www3.epa.gov/enviro/facts/multisvstem.html
XXXVi
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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). (2018a). ChemlDplus, a TOXNET Database. Retrieved from
https ://che m. nl m. nih. gov/che midplus/
U.S. National Library of Medicine (NLM). (2018b). Haz-Map. Retrieved from
https://hazmap.nl m.nih.gov/categorv-details?id=5009&table=copvtblagents
U.S. Patent and Trademark Office (USPTO). (2018a). Dipropylene glycol. Retrieved from
http://patft.uspto.gov/netacgi/nph-
Parser?Sectl=PT02&Sect2=HIT0FF&p=l&u=%2Fnetahtml%2FPT0%2Fsearch-
bool.html&r=0&f=S&l=50&TERMl=Dipropvlene+glvcol&FIELDI=&cot=AND&TERM2=&F
IELD2=&d=PTXT
U.S. Patent and Trademark Office (USPTO). (2018b). USPTO Patent Full-Text and Image Database.
Retrieved from http://patft.uspto.gov/netacgi/nph-
Parser?S( fcSect2=HITOFF&p=l&u=%2Fnetahtml%2FPTO%2Fsearch-
bool .htm l&t=0&f=S&l=5 O&TERM 1=1 %2C 1 %27-oxvdi-2-
propanol &FIELD .1.=&co .1.=AND&TERM2=&FIELD2=&d=PTXT
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/
OCXVil
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Appendix B: Human Hazard Characterization
Table B.1:t
Human Health Hazard
ADME
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4940508,
4940301,
3039551
Dermal (in
vitro)
Human cadaver
skin
24 hours
Dose: 768 |iL
undiluted test
substance
Replicates: 7
samples from
4 cadavers
The test material was
considered a slow
penetrant
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity: 99.9%
OECD Guideline 428
GLP compliant
Results:
Steady state penetration was 39.3 pg/cm2-
hour and the permeability coefficient was
3.85x10"5 cm/hour
3041958
Intravenous
and oral
Dog
24 hours
Dose: 5000
mg/kg oral and
2000 mg/kg IV
Replicates: 2
dogs
The test material is no
longer detectable in
blood after 24 hours
Methods:
Test substance reported as CASRN 25265-71-
8
Purity not reported
GLP compliance not reported
4940456,
4940388
Oral (gavage)
Fischer 344 rats
Single exposure, 24
hour observation
Doses: 48.2
mg/kg
Replicates: 5
male rats
The test material is
rapidly absorbed and
distributed, and
primarily excreted
through urine. It is
also extensively
metabolized to
dipropylene and
monopropylene glycol
and further oxidized
to C02.
Methods:
Test substance reported as CASRN 24800-44-
0
Purity: 99.8%
GLP compliant
Results:
Absorption: 91.4 ± 2.07 % of the dose
administered was recovered indicating
tripropylene glycol is rapidly absorbed
Distribution: The liver and kidney had the
greatest amounts of tripropylene glycol
Metabolism: Tripropylene glycol is extensively
metabolized. 5.8% of the dose was recovered
XXXVIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
as unmetabolized parent compound.
Tripropylene glycol is metabolized to
dipropylene and monopropylene glycol and
further oxidized to CO2
Excretion: Dipropylene glycol was excreted
primarily in the urine (52.3 ± 3.54%) and in
exhaled breath (20.7±0.59%)
Acute Mammalian Toxicity
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4940443
Inhalation
Sprague-Dawley
4 hours, observed for
Dose: 2.34
LCso > 2.34 mg/L
Methods:
(aerosol)
rats
14 days
mg/L
Replicates: 5
per sex
Test substance reported as CASRN 25265-71 -
8
Purity: 100%
EPA OPP 81-3
GLP compliant
4940457
Oral (gavage)
Sprague-Dawley
Single exposure,
Dose: 5010
LD50 >5010 mg/kg
Methods:
rats
observed for 14 days
mg/kg
Replicates: 5
per sex
Test substance reported as CASRN 25265-71 -
8
Purity: 100%
EPA OPP 81-1
GLP compliant
Results:
No mortality
Decreased locomotor activity reported in 2/5
males, the remaining 3 males and 5 females
were ataxic
4 males and 1 female had yellow perineal
staining after 5 hours
4940464,
Oral (gavage)
Wister rats
Single exposure,
Doses: 8.6,
LD5o:15.8 mL/kg (or
Methods:
4940388
observed for 14 days
10.4, 12.4,
14.9, and 17.9
16,000 mg/kg)
Test substance reported as CASRN 25265-71 -
8
ml/kg
Replicates: 5
per sex per
dose
Purity: 100%
Similar to OECD 401 (acute oral toxicity)
Not GLP compliant
Results:
XXXIX
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
8.6 mL/kg: 0/5 males or females
10.4 mL/kg: 2/5 males and 0/5 females
12.4 mL/kg: 0/5 males or females
14.9 mL/kg: 2/5 males and females
17.9 mL/kg 4/5 males and females
4940453
Dermal
New Zealand
white rabbits
24 hour exposure,
observed for 14 days
Dose: 5010
mg/kg
Replicates: 5
per sex
LDso >5010 mg/kg
Methods:
Test substance: CASRN 25265-71-8
Purity: 100%
EPA OPP 81-2
GLP compliant
Repeated Dose Toxicity
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4940384,
4940445
Oral (drinking
water)
B6C3F1 mice
2 years
Doses:
Males: 0, 735,
1220, 2390
mg/kg-day
Females: 0,
575,1040,
and 1950
mg/kg-day
Replicates:
50 per sex per
dose
NOAEL: 1040 mg/kg-
day
LOAEL: 1950 mg/kg-
day based on
decreased mean
body weight
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity: 99%
NTP Guideline
GLP compliant
4940466,
4940384
Oral (drinking
water)
B6C3F1 mice
13 weeks
Doses:
Males: 0, 715,
1350, 2620,
4790 and
11,000 mg/kg-
day
Females: 0,
1230,2140,
4020, 7430
and 14700
mg/kg-day
NOAEL: 2620 mg/kg-
day (male)
LOAEL: 4790 mg/kg-
day (male), based on
increased liver weight
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity: 99%
NTP guideline
GLP compliant
Results:
Mortality
0 7,430 mg/kg-day females: (1/10)
hypothermia
XL
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Replicates:
o 11,000 mg/kg-day males: (3/10)
10 per sex per
dehydration
dose
o 14,700 mg/kg-day females: (1/10)
dehydration
4940384,
Oral (drinking
F344/N rats
2 years
Doses:
NOAEL: 115 mg/kg-
Methods:
4940465,
water)
Males: 0,115,
day
Test substance: CASRN 25265-71-8
4940455
470, and 3040
mg/kg-day
Females: 0,
140, 530, and
2330 mg/kg-
day
Replicates:
50 per sex per
dose
LOAEL: 470 mg/kg-
day based on
increased incidence
of nephropathy, focal
histiocytic, and focal
granulomatous
inflammation in male
livers
Purity: 99%
GLP compliance not reported
4940384,
Oral (drinking
F344/N rats
14 weeks (3 months)
Doses:
NOAEL: 425 mg/kg-
Methods:
4940462
water)
Males: 0, 425,
890, 1840,
3890, and
12,800 mg/kg-
day
Females: 0,
460, 920,
1690, 3340,
and 8950
mg/kg-day
Replicates:
10 per sex per
dose
day
LOAEL: 890 mg/kg-
day based on relative
liver weight
Test substance reported as CASRN 25265-71 -
8
Purity: 99%
GLP compliance not reported
Reproductive Toxicity
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4940389,
Oral (gavage)
Sprague-Dawley
Male: 2 weeks prior to
Doses: 0, 8,
NOAEL: 1000 mg/kg-
Method:
4940514
rats
mating, 49 days total
40, 200, and
1000 mg/kg-
day
day
Test substance reported as CASRN 24800-
44-0
XLI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Females: 2 weeks prior
to mating up to day 3
of lactation
Replicates:
12 per sex per
group
Purity > 98%
OECD Guideline 422
GLP compliant
Developmental Toxicity
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4940450,
4440869,
4940388,
3041958
Oral (gavage)
Pregnant
Sprague-Dawley
rats
GD6-15
Doses: 0,
800, 2000,
and 5000
mg/kg-day
Replicates:
20-27 per
dose
NOAEL: 2000 mg/kg-
day
LOAEL: 5000 mg/kg-
day based on
decreased fetal body
weight
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity > 96%
NTP
GLP compliance
4440871,
4940459,
4940388
Oral (gavage)
New Zealand
white rabbit
GD6-19
Doses: 0,
200, 400, 800,
and 1200
mg/kg-day
Replicates:
24 per group
NOAEL: 1200 mg/kg-
day
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity > 96%
NTP protocol NTP-90-CTER-126
GLP compliant
Cancer
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4940448,
4940455,
4940384
Oral (drinking
water)
Fischer 344 rats
2 years
Doses:
Males: 0,115,
470 and 3,040
mg/kg-day
Females: 0,
140, 530 and
2,330 mg/kg-
day
Negative
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity: 99%
NTP Guideline
GLP compliant
XLII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Replicates:
50 per sex per
dose
4940384,
Oral (drinking
B6C3F1 mice
2 years
Doses:
Negative
Methods:
4940448
water)
Males: 735,
1220, 2390
mg/kg-day
Females: 575,
1040,1950
mg/kg-day
Replicates:
50 per sex per
dose
Test substance reported as CASRN 25265-71 -
8
Purity: 99%
NTP Guideline
GLP compliant
Genotoxicity
Source
Test Type &
Endpoint
Species & Strain
(if available)
Metabolic Activation
Doses and
Controls
Results
Study Details
4940446,
Gene mutation
Salmonella
With and without
Doses: 0,
Negative
Methods:
4940384
(in vitro)
typhimurium
strains TA 97,
TA98, TA100, TA
1535, TA 1538
100, 333,
1000, 3333
and 10000
pg/plate
Test substance reported as CASRN 25265-71 -
8
Purity >99%.
NTP Guideline
GLP compliant
4940463
Gene mutation
Mouse lymphoma
With and without
Doses: 50,
Negative
Methods:
(in vitro)
L5178Y vtaells
100, 300, 500,
700, 1000,
2500 and
5000 [jg/mL
Test substance reported as CASRN 25265-71 -
8
Purity not reported
OECD Guideline 476
GLP compliant
4940467
Gene mutation
Salmonella
With and without
Doses: 0.100,
Negative
Methods:
(in vitro)
typhimurium
strains TA98,
TA100, TA 1535,
TA1537, TA 1538
0.316, 1.00,
3.16, 10.0,
31.6 and 100
[jL/plate
Test substance reported as CASRN 25265-71 -
8
Purity: 99.9%
OECD Guideline 471
GLP compliant
XLIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
4940451,
Chromosomal
Mouse
N/A
Doses: 0,
Negative
Methods:
4940388
aberrations (in
vivo)
500, 1000,
and 2000
mg/kg
Replicates: 6
per group
Test substance reported as CASRN 25265-71 -
8
Purity: 99.9%
OECD Guideline 474
GLP Compliant
Sensitization
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4940444,
Dermal patch
Human
2 day exposure,
Study 1
Equivocal
Methods:
4946133
observed 7 days
Doses: 1%,
2%, 5%, and
10%
Test substance reported as CASRN 25265-71 -
8
Purity > 96%
Replicates:
34 patients
GLP compliance not reported
Results:
Study 2
1 person had positive reaction (only to
standard grade dipropylene glycol)
Dose: 10%
488 subjects showed no reaction and 13
Replicates:
503 volunteers
subjects showed equivocal reaction to
standard grade substance
212 Males
480 subjects showed no reaction and 17
291 Females
subjects showed equivocal reaction to
cosmetic grade substance
Irritation was indicated in 2 analytical grade
and 5 cosmetic grade volunteers
4940460
Dermal
Guinea pigs
6 hour exposure,
Dose: 0.5 mL
Negative
Methods:
induction repeated 3
Replicates:
Test substance reported as CASRN 25265-71 -
times during 2 weeks
10 animals
(7 Males
8
Purity: 100%
3 Females)
EPA OPP 81-6
GLP compliant
Results:
1 animal displayed slight patchy erythema 24
hours after
XLIV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
3118622
Dermal
patch
Humans
24 hour exposure,
scored after 48 hours;
repeated for 9
applications
Dose: 0.4 mL
Replicates:
42 volunteers
Negative
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity not reported
Modified Draize Method
GLP compliance not reported
Irritation
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses
Effect
Study Details
4940447
Dermal
Humans
Daily for 14 days
Doses: 0.2
mL of 50% or
100%
Replicates:
26 skin-
sensitive
volunteers
Negative
Methods:
Test substance: CASRN 25265-71-8
Purity not reported
GLP compliance not reported
Results:
One volunteer had a mildly irritating response
(erythema) to 100% substance before day 4
4940461
Dermal
New Zealand
white rabbit
4 hour exposure,
observed for 72 hours
Dose: 0.5 mL
Replicates: 3
per sex
Negative
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity: 100%
EPA OPP 81-5
GLP compliant
Results:
Very slight erythema observed in 1/6 animals
within 45 minutes, but all test areas were
normal for the remaining observation periods
4940458
Dermal patch
Human
24 hour exposure
Dose: 0.2 mL
of 25%
Replicates:
33 subjects
Mildly irritating
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity not reported
GLP compliance not reported
Results:
At the 24-hour scoring, 4/33 subjects displayed
mild erythema
XLV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
3118622
Dermal
Albino rabbit
24 hour exposure,
observed for 72 hour
Dose: 0.5 mL
Replicates: 3
rabbits per
group
Negative
Methods:
Test substance reported as CASRN 25265-71 -
8
Purity not reported
Draize Method
GLP compliance not reported
4940453
Dermal
New Zealand
white rabbit
24 hour exposure,
observed for 14 day
Dose: 5010
mg/kg
Replicates: 5
per sex
Negative
Methods:
Test substance: CASRN 25265-71-8
Purity: 100%
EPA OPP 81-2
GLP compliant
Endpoints:
Very slight irritation was observed in 5/10
animals 45 minutes after removal of patch, but
all effects were fully reversible by 48 hours
4940449
Ocular
New Zealand
white rabbit
Single exposure, 72
hour observation
Dose: 0.1 mL
Replicates: 3
per sex
Negative
Method:
Test substance reported as CASRN 25265-71 -
8
Purity: 100%
EPA OPP 81-4
GLP compliant
Endpoint:
6/6 animals had conjunctival redness and 2/6
animals displayed chemosis after 1 hour, but
these results were fully reversible by 24 hours
3118622
Ocular
Rabbits
Single exposure,
observed for 7 days
Dose: 0.1 mL
Replicates: 3
rabbits per
group
Negative
Method:
Test substance: CASRN 25265-71-8
Purity not reported
Draize Method
GLP compliance not reported
Results:
Eye irritation did not differ between vehicle
control and test material
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
Other
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses
Effect
Study Details
4088550
Cell
Human embryonic
NA
Doses:
NOAEL:
Methods:
viability
stem cells
0.0001
0.00745M
Test substance reported as CASRN 25265-71-8
(hESCs) and
M to 0.1
for
hESCs;
IC50:
0.04 M
for
hESCs
and hPF
Purity not reported
human adult
M
GLP compliance not reported
pulmonary
Results:
fibroblasts (hPF)
In hESCs the estimated NOAEL was 0.00745M and the IC50 was 0.045M, only the
highest concentration tested was significantly different from (vehicle) controls.
The IC50 in hPF cells was identical (0.04M), but a reliable NOAEL could not be
determined
XLVII
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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
4940438
Daphnia magna
48 hours
Dose: 100 mg/L
ECso >100
mg/L
Methods:
Test substance reported as CASRN 25265-71-8
Purity: 100%
EPA 540/9-82-024, EPA-540/9-85-005 and ASTM Standards
E729-88a
GLP compliant
4940439
Daphnia magna
48 hours
Doses: 0,12.5,25,
50, and 100 mg/L
ECso >100
mg/L
Methods:
Test substance reported as CASRN 25265-71-8
Purity: 99.6%
OECD Guideline 202
GLP compliant
4940389, 4940442
Oryzias latipes
96 hours
Doses: 5
concentrations
between 95 mg/L
and 1000 mg/L
(nominal)
LCso >1000
mg/L
Methods:
Test substance reported as CASRN 24800-44-0
Purity: 97%
OECD Guideline 203
Not GLP compliant
4940389
Selenastrum
capricornutum
72 hours
Doses: 5
concentrations
between 95 mg/L
and 1000 mg/L
(nominal)
ECso >1000
mg/L
Methods:
Test substance reported as CASRN 24800-44-0
Purity: 97%
OECD Guideline 201
Not GLP compliant
Aquatic Toxicity: Estimated
Model
Duration
Species
Predicted Effect
Level
Notes
ECOSARv2.0 (Class:
Neutral Organics)
96 hours
Aquatic
Vertebrates
ECso: 18000 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000 mg/L;
melting point-40°C (exp) SMILES: 0(CC(0)C)CC(0)C
ECOSARv2.0 (Class:
Neutral Organics)
72 hours
Green
Algae
ECso: 2400
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000 mg/L;
melting point-40°C (exp) SMILES: 0(CC(0)C)CC(0)C
ECOSARv2.0 (Class:
Neutral Organics)
ChV
Aquatic
Vertebrates
1300 mg/L
Physical properties used for estimation Log Kow -0.46 (exp); water solubility 1000 mg/L;
melting point-40°C (exp) SMILES: 0(CC(0)C)CC(0)C
XLVIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
ECOSARv2.0 (Class:
Neutral Organics)
ChV
Daphnia
420 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000 mg/L;
melting point-40°C (exp) SMILES: 0(CC(0)C)CC(0)C
ECOSARv2.0 (Class:
Neutral Organics)
ChV
Green
Algae
370 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000 mg/L;
melting point-40°C (exp) SMILES: 0(CC(0)C)CC(0)C
Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and Number of
Replicates
Results
Study Details
4940427
O2 consumption,
CO2 evolution,
DOC removal
28 days
Dose: 100 mg/L
Readily
biodegradable
Methods:
Test substance reported as CASRN 25265-71-8
Purity: 99.9%
OECD Guideline 301F
GLP compliant
Endpoints:
O2 consumption: 58.7% after 10 days, 84.4% after 28 days.
CO2 evolution: 64.5% after 28 days.
DOC removal: 93.4% after 28 days.
1763085
BOD
N/A
Doses: 14-6816 mg/L
Insufficient O2
consumption
Methods:
Test substance reported as CASRN 25265-71-8
Purity not reported
Standard methods (APHA195)
GLP compliance not reported
Endpoints:
BOD < 0.001 g/g using microbial seed from supernatant of
settled raw sewage. Insufficient O2 consumption
4940429
DOC removal
using activated
sludge inoculum
6 weeks
Dose: 18.5 mg/L
DOC removal
83.6% after 6
weeks
Methods:
Test substance reported as CASRN 25265-71-8
Purity > 99.9%
OECD Guideline 301F or OECD Guideline 302A
GLP compliant
Endpoints:
DOC removal 83.6% after 6 weeks
Biodegradation from days 10-42 of 82.5-84.7%
4940432
O2 consumption,
CO2
28 days
Dose: 100 mg/L
Readily
biodegradable
Method:
XLIX
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and Number of
Replicates
Results
Study Details
consumption,
DOC removal
Test substance CASRN 24800-44-0
Purity: 99.9%
OECD Guideline 301F
GLP compliant
Results:
81.9% O2 consumption, 61% CO2 consumption, 91.7% DOC
removal after 28 days
55.3% biodegradation within 10-day window
4940424
CO2 evolution
and BOD
removal
64 days
Dose: 50.3 mg/L
DOC removal
showed 23.6+/-
0.3% degradation
after 64 days
CO2 evolution
showed 17.3+/-
2.6% degradation
after 62 days
Methods:
Test substance reported as CASRN 25265-71-8
Purity: 99.4%
OECD Guideline 306
GLP compliance not reported
4940389
BOD
28 days
Dose: 100 mg/L
Not readily
biodegradable
Method:
Test substance reported as CASRN 24800-44-0
Purity not reported
OECD Guideline 301C
GLP compliant
Results:
0% degradation by TOC and 0-3% by GC after 28 days
1 -2% BOD degradation after 28 days
4940425
CO2 evolution
28 days
NA
Not readily
biodegradable
Method:
Test substance reported as CASRN 24800-44-0
Purity: 95%
OECD Guideline 301B
GLP compliant
Results:
0% degradation by DOC after 28 days
4-5% degradation by CO2 evolution after 28 days
4940426
O2 consumption
28 days
NA
69% degradation
after 28 days
Method:
L
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and Number of
Replicates
Results
Study Details
Test substance reported as CASRN 24800-44-0
Purity: 99.43%
OECD Guideline 301D
GLP compliant
Results:
59% in 11 days
69% degradation after 28 days
4940431
O2 consumption
28 days
NA
Not readily
biodegradable
Method:
Test substance reported as CASRN 24800-44-0
Purity: 99.43%
OECD Guideline 301D
GLP compliant
Results:
0% degradation by O2 consumption after 28day (below detection
limit of <2.5% ThOD)
4940437
Toxicity to
microorganisms
3 hours
Doses: 10, 32,100,
320 and 1000 mg/L
NOEOIOOO
mg/L
Methods:
Test substance reported as CASRN 24800-44-0
Purity: 99.9%
OECD Guideline 209
GLP compliant
Results:
EC50 >1000 mg/L (nominal)
4940441
Toxicity to
microorganisms
18 hours
Doses:
Range Finding: 0.1,1,
100, and 1000 mg/L
Main study: 1.95, 3.91,
7.81, 15.63, 31.25,
62.5, 125, 250, 500,
and 1000 mg/L
EC10 > 1000 mg/L
Methods:
Test substance reported as CASRN 25265-71-8
Purity: 99.9%
GLP compliant
Environmental Fate: Modelled
Model
Data Type
Endpoint
Predicted Endpoint
Notes
LI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and Number of
Replicates
Results
Study Details
EPISuite
Estimated
BAF
0.9
v.4.11
EPISuite
Estimated
BCF
3.16
v.4.11
EPISuite
v.4.11
Estimated
Anaerobic
biodegradation
Not predicted to
biodegrade quickly
Probability of 0.4055. Fragment representation is valid.
Fast degradation is defined as predicted probability >0.5.
(BIOWIN 7)
under anaerobic
conditions
EPI Suite
For purposes of the EPI
EPI Suite (Physical Property Inputs - BP = 232.8 deg C, MP = -40 deg C, VP = 0.03 mm Hg,
Reference
estimates, the melting
WS = 1000000 mg/L, Log P = -0.7 SMILES: OC(C)COCC(C)Q
point was entered as -
40 °C and the Log K0w
was taken from the
I CSC entry.
Lll
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
B.1 References:
Bates., HK; Price. CJ; Marr., M; Myers, CB; Heindel. II; Schwetz. BA. (1992a). Final report on the
developmental toxicity of dipropylene glycol (CAS #25265-71-8) in New Zealand white rabbits.
(NTP Study No. TER-90-14). Research Triangle Park, NC: National Toxicology Program.
Bates. HK; Price. CJ; Marr. M; Myers. CB; Heindel JJ; Schwetz. BA. (1992b). Final report on the
developmental toxicity of dipropylene glycol (CAS No. 25265-71-8) in Sprague-Dawley (CD
(trade name)) rats. Research Triangle Park, NC: National Toxicology Program.
BUA (GDCh Advisory Committee on Existing Chemicals). (1996). Dipropylene glycol. In GD BUA
(Ed.). Stuttgart, Germany: S. Hirzel.
ECHA (European Chemicals Agency). (1974). [(methylethylene)bis(oxy)]dipropanol: acute toxicity:
inhalation: 001 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/-/registered-dossier/14788/7/3/3/?documentUUID=b b~b4fe~
72047a3b05d2
ECHA (European Chemicals Agency). (1980). Oxydipropanol: acute toxicity: oral: 002 supporting |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/.1.60.1.6/7/3/2/?documentl j88a-8c76-433b-993f-acc62594e680
ECHA (European Chemicals Agency). (1988). Oxydipropanol: genetic toxicity: in vitro: 002 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/1 ?documentUUID=389098d4-4996-4c60-a762-d2b60df89dcc
ECHA (European Chemicals Agency). (1990a). Oxydipropanol: developmental toxicity/teratogencity:
002 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/?/9/3/?doeumentU ?6f3dc0-f578-45ab-9a89-b92637f28c00
ECHA (European Chemicals Agency). (1990b). Oxydipropanol: developmental toxicity/teratogenicity:
001 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/7/9/3
ECHA (European Chemicals Agency). (1991a). |(methylethylene)bis(oxy)|dipropanol: biodegradation in
water: screening tests: 004 supporting | experimental result, https://echa.europa.eu/registration-
dossier/-/registered-dossier/14788/5/3/2/?documentUUID=caad96d0-3b36-4255-9bd2-
0e2da25ee91e
ECHA (European Chemicals Agency). (1991b). |(methylethylene)bis(oxy)|dipropanol: biodegradation in
water: screening tests: 005 supporting | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration~dossier/~/registered~
dossier/.1.4788/5/3/2/?documentL 0f8fe90-fc45-491e-b488-434e42981995
' till '
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
ECH.A (European Chemicals Agency). (1992a). Oxydipropanol: genetic toxicity: in vitro: 003 supporting
| experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/16016/7/7/2/?documentUUID=9d24fl2e-lbf0-4481-8ae5-e7640975e049
ECHA (European Chemicals Agency). (1992b). Oxydipropanol: toxicity to microorganisms. Helsinki,
Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/.1.60.1.6/6/2/8
ECHA (European Chemicals Agency). (1993a). [(methylethylene)bis(oxy)]dipropanol: biodegradation in
water: screening tests: 003 supporting | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/.1.4788/5/3/2/?documentl I II) 10b66ef0-9fbb-4f6e-8371-693280a318dl
ECHA (European Chemicals Agency). (1993b). [(methylethylene)bis(oxy)]dipropanol: repeated dose
toxicity: oral: 002 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/-/registered-dossier/14788/7/6/2/?documentUUID=814b4a8c-4620-4c5c-bf90-
b3f8622b63f6
ECHA (European Chemicals Agency). (1994a). |(methylethylene)bis(oxy)|dipropanol: short-term
toxicity to fish: 001 key | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/6/2/2/?documentL d8cb796-a0f9-4d90-8fb2-57a6fe859ffe
ECHA (European Chemicals Agency). (1994b). Oxydipropanol: biodegradation in water: screening tests:
003 supporting | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/-/registe red-dossier/ .1.6016/5/3/2/?documentUUID=4d.l.6933c-e52a-4975-84.1.6-
9c9534d5eal9
ECHA (European Chemicals Agency). (1995a). |(methylethylene)bis(oxy)|dipropanol: basic
toxicokinetics: in vivo. Helsinki, Finland. https://echa.europa.eu/registration~dossier/~/registered~
dossier/.1.4788/7/2/2
ECHA (European Chemicals Agency). (1995b). Oxydipropanol: acute toxicity: dermal. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-dossier/ .1.60.1.6/7/3/4
ECHA (European Chemicals Agency). (1995c). Oxydipropanol: acute toxicity: inhalation. Helsinki,
Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/.1.60.1.6/7/3/3
ECHA (European Chemicals Agency). (1995d). Oxydipropanol: acute toxicity: oral: 001 key |
experimental result. Helsinki, Finland. https://eeha.eiiropa.eii/registration~dossier/--/registered~
dossier/.1.60.1.6/7/3/2/?documentUUID=c8ac7136-0238-420c-bdcb-57a927cc6023
ECHA (European Chemicals Agency). (1995e). Oxydipropanol: exposure related observation in humans:
other data: 001 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/-/registe red-dossier/1 >
LIV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
ECH.A (European Chemicals Agency). (19950. Oxydipropanol: eye irritation: in vivo.
https://echa.europa.eu/registration-dossier/-/registered-dossier/ .1.60.1.6/7/4/3
ECH.A (European Chemicals Agency). (1995g). Oxydipropanol: sensitisation data (human). Helsinki,
Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/. 5
ECHA (European Chemicals Agency). (1995h). Oxydipropanol: short-term toxicity to aquatic
invertebrates: 002 supporting | experimental result, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/6/2/4/?documentU >a63c82-fala-4621-9cf5-2fb6efdfc6a3
ECHA (European Chemicals Agency). (1995i). Oxydipropanol: skin irritation/corrosion: in vivo.
Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/160.1.6/7/4/2
ECHA (European Chemicals Agency). (1995j). Oxydipropanol: skin sensitisation: in vivo (non-LLNA).
https://echa.europa.eu/registration-dossier/-/registered-dossier/ .1.60.1.6/7/5/2
ECHA (European Chemicals Agency). (1997). Oxydipropanol: exposure related observations in humans:
other data: 002 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/-/registe red-dossier/ .1.60.1.6/7/1l/6/?documentUUID=d0571cec-5afe-40b6-86f9-
d57dlef9c2£2
ECHA (European Chemicals Agency). (1999). Oxydipropanol: genetic toxicity: in vivo.
https://eeha.europa.eu/registration~dossier/~/registered~dossi(
ECHA (European Chemicals Agency). (2002). Oxydipropanol: short-term toxicity to aquatic
invertebrates: 001 key | experimental result, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/6/2/4
ECHA (European Chemicals Agency). (2004a). Oxydipropanol: carcinogenicity: oral. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/8/?documenLI I iP . 2067ce9-4d3f-474a-a0eb-e0466eaa8a37
ECHA (European Chemicals Agency). (2004b). Oxydipropanol: carcinogenicity: oral: 001 key |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-dossier/.1.60.1.6/7/8
ECHA (European Chemicals Agency). (2004c). Oxydipropanol: genetic toxicity: in vitro: 001 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration~dossier/--/registered--
dossier/leOle/ V/J/?documentUUID=74e5S\'° ( -l:29-4883-958e-083dla25594e
ECHA (European Chemicals Agency). (2004d). Oxydipropanol: repeated dose toxicity: oral: 001 key |
experimental result. Helsinki, Finland, https://eeha.europa.eu/registratk)n.~dossier/~/registered~
dossier/16016/7/6/2
ECHA (European Chemicals Agency). (2004e). Oxydipropanol: repeated dose toxicity: oral: 002
supporting | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registe red-dossier/.1.60.1.6/7/6/2/?docume ?8 8 8e96-d05 d-445.1. -9709-64fabae2.1. fbc
LV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
ECH.A (European Chemicals Agency). (2004f). Oxydipropanol: repeated dose toxicity: oral: 003
supporting | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/6/2/?documentUUID=9796c071-d039-468a-b2fl-0493582fdc50
ECHA (European Chemicals Agency). (2004g). Oxydipropanol: repeated dose toxicity: oral: 004
supporting | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/.1.60.1.6/7/6/2/?documentl sb50875-5f7d-4 Ie6-802b-de9b6.1.8599ec
ECHA (European Chemicals Agency). (2007a). [(methylethylene)bis(oxy)]dipropanol: biodegradation in
water: screening tests: 001 key | experimental result. Helsinki, Finland.
https://eeha.eiiropa.eii/registration~dosgier/--/registered~
dossier/.1.4788/5/3/2/?documentl f8b2£2f-7880-495b-adle-7a003£2c96c7
ECHA (European Chemicals Agency). (2007b). [(methylethylene)bis(oxy)]dipropanol: dermal absorption
in vitro/ex vivo. https://echa.europa.eu/registration-dossier/-/registered-dossier/14788/7/2/3
ECHA (European Chemicals Agency). (2007c). Oxydipropanol: biodegradation in water: screening tests:
001 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/5/3/2
ECHA (European Chemicals Agency). (2007d). Oxydipropanol: biodegradation in water: screening tests:
002 key | experimental result. https://echa.europa.eu/registratk)n~dossier/~/registered~
dossier/.1.60.1.6/5/3/2/?documentl 2502e63-7f7b-4797-aaba-87666cb57def
ECHA (European Chemicals Agency). (2010). [(methylethylene)bis(oxy)]dipropanol: toxicity to
microorganisms: 001 key | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/6/2/8/?documentl 5e7699a-lff8-4aee-a8fl5-fba87bb72e52
Fasano., W'J. (2007). Dipropylene glycol: in vitro dermal absorption rate testing [TSCA Submission|.
Fasano, WJ. https://ehemyiew.epa.goy/ehemyiew/proxy?ftleriaroe=2008~l~8EHO~08~
.1.6930B 8eho 01 OS 16930b.pdf
Fasano. WJ; ten Berge. W; Banton. MI; Heneweer. M; Moore. NP. (2011). Dermal penetration of
propylene glycols: Measured absorption across human abdominal skin in vitro and comparison
with a QSAR model. Toxicol In Vitro 25: 1664-1670. http://dx.doi.org/.' /i.tiv.2011.07.003
Johansen. ID; Jemec. G6E; Rastogi. SC. (1995). Contact sensitization to dipropylene glycol in an eczema
population [Abstract]. Contact Derm 33: 211-212. http://dx.doi.org/10.1111/i..1.600-
0536.1995 .tb00560.x
Leberco Labs (Lcberco Laboratories). (1994). Letter from [] to usepa submitting irritation toxicity studies
of 2-propanol, l,l'-oxybis- in the rabbit dated 03/24/94 (sanitized). (86940000234S).
LVI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Meshako, E; Bleekroanti, CA; Goltz. MN. (1999). Biodegradability and microbial toxicity of aircraft
fuel system icing inhibitors. Environ Toxicol 14: 383-390. http://dx.doi.org/10.1002/(SICI) 1522-
7278(1999)14:4<383::AID-TOX2>3.0.CO:2-M
NTP (National Toxicology Program). (2004). NTP technical report on the toxicology and carcinogenesis
studies of dipropylene glycol (CAS NO. 25265-71-8) in F344/N rats and B6C3F1 mice (pp. 6-
260). Research Triangle Park, NC: U.S Department of Health and Human Services. Public Health
Service. National Institutes of Health, https://ntp.niehs.nih.gov/ntp/htdocs/lt rpts/tr511 .pdf
QECD (Organisation for Economic Co-operation and Development). (1994). SIDS Initial Assessment
Report for SIAM 2 (Paris, 4-6 July 1994)Tripropylene glycol: CAS No: 24800-440.
https://lipvchemicals.oecd.Org/U I/handler.axd?id=00205ee6~f694~448b~bbb2~be4.1.2.1.e9a7fe
QECD (Organisation for Economic Co-operation and Development). (2001). Dipropylene glycol (mixed
isomers and dominant isomer Cas No: 25265-71-8 and 110-98-5).
http://www.inchem.org/documents/sids/sids/25265-71-8.pdf
iVIl'
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* * * Proposal Draft Do Not Cite, Quote or Release During the Review * * *
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 screening of dipropylene glycol. Search outcomes and reference details are provided on the
candidate's HERO35 project page.
EPA created a fit-for-purpose process to transparently document the literature search and review36 of
available hazard and fate information for low-priority substance (LPS) candidates. References from peer-
reviewed primary sources, grey sources,37 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 C I.
Figure C.1: Overview of the Literature Search and Review Process
yf\
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
title/abstract screening
References excluded at
data quality evaluation
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, dipropylene glycol, the following LPS
candidates were used as analogs for read-across: I. r-dimcthyldiethylcnc glycol (CASRN 110-98-5) and
tripropylene glycol (CASRN 24800-44-0). For more details and justification on analogs, see section 6.1.1.
Analogs were used to fill data gaps on endpoints for which dipropylene glycol lacked quality data, such as
35 The HERO low-priority substance candidate project pages are accessible to the public at littus://hero. epa. go v/hero/.
* Discussed in the document "Approach Document for Screening Hazard Information for Low-Priority Substances Under
TSCA", also released at proposal.
Grey literature and additional sources are the broad category of studies not found in standard, peer-reviewed literature database
searches. This 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.
LVIII
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reproductive toxicity, and to add to the weight of the scientific evidence. Analog references were
searched, screened and evaluated using the same process as references on dipropylene glycol described
above.36 Dipropylene glycol and the two analogs mentioned above fall under the glycol cluster in HERO.
C.1.2 Search Terms and Results
EPA began the literature review process for the hazard screening of dipropylene glycol 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. 1.1 lists the search terms used in the
database search of peer -reviewed literature for the glycol cluster including dipropylene glycol. For grey
literature and other secondary sources, Table C.1.2 lists the search terms used for the glycol cluster.
Table C.1: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms
Human Health
PubMed
25265-71-8[rn] OR 110-98-5[rn] OR 24800-44-0[rn] OR "((1-methyl-1,2-
ethanediyl)bis(oxy))bispropanol"[tw] OR "((Methylethylene)bis(oxy))dipropanol"[tw] OR
"1,1 '-Dimethyldiethylene glycol"[tw] OR "1,1'-Oxybis(2-propanol)"[tw] OR "1,1'-Oxybis-2-
propanol"[tw] OR "1,1 -Oxydi-2-propanol"[tw] OR "1,1 -Oxydipropan-2-ol"[tw] OR "2,2'-
Dihydroxydipropyl ether"[tw] OR "2-(2-(2-Hydroxypropoxy)propoxy)-1-propanol"[tw] OR
"2-Propanol, 1,1'-oxybis-"[tw] OR "2-Propanol, 1,1'-oxydi-"[tw] OR "4-Oxa-2,6-
heptandiol"[tw] OR "4-Oxaheptane-2,6-diol"[tw] OR "ADK DPG-RF"[tw] OR "Bis(2-
hydroxypropyl) ether"[tw] OR "Bis(3-hydroxypropyl)ether"[tw] OR "Diisopropylene
glycol"[tw] OR "Dipropylene glycol"[tw] OR "DIPROPYLENEGLYCOL"[tw] OR
"DIPROPYLENGLYKOL"[tw] OR "Dowanol DPG"[tw] OR "DPG-FC"[tw] OR "DPG-
RF"[tw] OR "NIAX catalyst D-19"[tw] OR "oxidipropanol"[tw] OR "Oxybispropanol"[tw]
OR"Oxydipropanol"[tw] OR"Propanol, ((1-methyl-1,2-ethanediyl)bis(oxy))bis-"[tw] OR
"Propanol, oxybis-"[tw] OR "Tripropylene glycol"[tw]
Toxline
(25265-71-8[rn] OR 110-98-5[rn] OR 24800-44-0[rn] OR "((1-methyl-1,2-
ethanediyl)bis(oxy))bispropanol" OR"((Methylethylene)bis(oxy))dipropanol" OR "1,1'-
Dimethyldiethylene glycol" OR "1,1'-Oxybis(2-propanol)" OR "1,1 '-Oxybis-2-propanol"
OR "1,1 '-Oxydi-2-propanol" OR "1,1 '-Oxydipropan-2-ol" OR "2,2'-Dihydroxydipropyl
ether" OR "2-(2-(2-Hydroxypropoxy)propoxy)-1-propanol" OR "2-Propanol, 1,1 '-oxybis-"
OR "2-Propanol, 1,1'-oxydi-" OR "4-Oxa-2,6-heptandiol" OR "4-Oxaheptane-2,6-diol"
OR "ADK DPG-RF" OR"Bis(2-hydroxypropyl) ether" OR "Bis(3-hydroxypropyl)ether" OR
"Diisopropylene glycol" OR "Dipropylene glycol" OR "DIPROPYLENEGLYCOL" OR
"DIPROPYLENGLYKOL" OR "Dowanol DPG" OR "DPG-FC" OR "DPG-RF" OR "NIAX
catalyst D-19" OR "oxidipropanol" OR "Oxybispropanol" OR "Oxydipropanol" OR
"Propanol, ((1 -methyl-1,2-ethanediyl)bis(oxy))bis-" OR "Propanol, oxybis-" OR
"Tripropylene glycol") 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
(25265-71-8 [rn] OR 110-98-5 [rn] OR24800-44-0 [rn]) AND (TSCATS [org]) AND
NOT PubMed [org] AND NOT pubdart [org]
WOS
TS=("25265-71 -8" OR "110-98-5" OR "24800-44-0" OR "((1-methyl-1,2-
ethanediyl)bis(oxy))bispropanol" OR"((Methylethylene)bis(oxy))dipropanol" OR "1,1'-
Dimethyldiethylene glycol" OR "1,1'-Oxybis(2-propanol)" OR "1,1 '-Oxybis-2-propanol"
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Table C.1: Search Terms Used in Peer-Reviewed Databases
OR "1,1 '-Oxydi-2-propanol" OR "1,1 "-Oxydipropan-2-ol" OR "2,2'-Dihydroxydipropyl
ether" OR"2-(2-(2-Hydroxypropoxy)propoxy)-1-propanol" OR "2-Propanol, 1,1-oxybis-"
OR "2-Propanol, 1,1'-oxydi-" OR "4-Oxa-2,6-heptandiol" OR "4-Oxaheptane-2,6-diol"
OR "ADK DPG-RF" OR"Bis(2-hydroxypropyl) ether" OR "Bis(3-hydroxypropyl)ether" OR
"Diisopropylene glycol" OR "Dipropylene glycol" OR "DIPROPYLENEGLYCOL" OR
"DIPROPYLENGLYKOL" OR "Dowanol DPG" OR "DPG-FC" OR "DPG-RF" OR "NIAX
catalyst D-19" OR "oxidipropanol" OR "Oxybispropanol" OR "Oxydipropanol" OR
"Propanol, ((1 -methyl-1,2-ethanediyl)bis(oxy))bis-" OR "Propanol, oxybis-" OR
"Tripropylene glycol")
lndexes=SCI-EXPANDED, CPCI-S, CPCI-SSH, BKCI-S, BKCI-SSH, CCR-EXPANDED,
IC Timespan=AII years
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=("25265-71 -8" OR "1,1'-Oxybis 2-propanol" OR "1,1 '-Oxybis-2-propanol" OR
"1,1 "-Oxydi-2-propanol" OR"1,1'-Oxydipropan-2-ol" OR "2-Propanol, 1,1-oxybis-" OR
"Bis 2-hydroxypropyl ether" OR "Dipropylene glycol" OR "DIPROPYLENEGLYCOL" OR
"Propanol, oxybis-" OR "Tripropylene glycol")
ABSTRACT=("25265-71 -8" OR "1,1'-Oxybis 2-propanol" OR "1,1 '-Oxybis-2-propanol"
OR"1,1'-Oxydi-2-propanol" OR"1,1'-Oxydipropan-2-ol" OR "2-Propanol, 1,1 -oxybis-"
OR "Bis 2-hydroxypropyl ether" OR "Dipropylene glycol" OR "DIPROPYLENEGLYCOL"
OR "Propanol, oxybis-" OR "Tripropylene glycol")
SUBJECT=("25265-71 -8" OR "1,1'-Oxybis 2-propanol" OR "1,1 '-Oxybis-2-propanol" OR
"1,1'-Oxydi-2-propanol" OR"1,1'-Oxydipropan-2-ol" OR "2-Propanol, 1,1'-oxybis-" OR
"Bis 2-hydroxypropyl ether" OR "Dipropylene glycol" OR "DIPROPYLENEGLYCOL" OR
"Propanol, oxybis-" OR "Tripropylene glycol")
("110-98-5" OR "24800-44-0" OR" 1 -methyl-1,2-ethanediyl bis oxy bispropanol" OR
"Methylethylene bis oxydipropanol" OR "1,1 '-Dimethyldiethylene glycol" OR "2,2'-
Dihydroxydipropyl ether" OR "2- 2- 2-Hydroxypropoxy propoxy -1-propanol" OR "2-
Propanol, 1,1'-oxydi-" OR "4-Oxa-2,6-heptandiol" OR "4-Oxaheptane-2,6-diol" OR "ADK
DPG-RF" OR "Bis 3-hydroxypropyl ether" OR "Diisopropylene glycol" OR
"DIPROPYLENGLYKOL" OR "Dowanol DPG" OR "DPG-FC" OR "DPG-RF" OR "NIAX
catalyst D-19" OR "oxidipropanol" OR "Oxybispropanol" OR "Oxydipropanol" OR
"Propanol, 1-methyl-1,2-ethanediyl bis oxy bis-")
Fate
WOS
Same as human health strategy synonyms only
Table C.2: Search Terms Used in Grey Literature and Additional Sources
Chemical
Search terms
Glycol cluster
(1,1'-
Dimethyldiethylene
glycol; dipropylene
glycol, tripropylene
glycol)
Searched as a string or individually depending on resource: "25265-71-8" OR "110-98-5" OR "24800-44-0"
OR "Dipropylene glycol" OR"Dipropyleneglycol" OR "Propanol, oxybis-" OR "Tripropylene glycol"
After the search terms were applied, more than 620 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
LX
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and evaluated through the LPS literature search and review process.36 Of these, 71 references were
included for data evaluation and used to support the designation of dipropylene glycol 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 dipropylene glycol. The excluded references are organized by discipline (human
health hazard, environmental hazard, and fate), presented along with a rationale based on exclusion
criteria. The criteria36 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 dipropylene glycol, EPA excluded a total of 539 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.3), or full-text screening (see
Table C.4). Unacceptable references (e.g., studies that did not meet data quality metrics) were excluded at
full-text screening (see Tables C.5 and C.6). Off-topic and unacceptable references are displayed next to
the corresponding exclusion criteria.
Table C.3: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs38 relevant to human health
hazard
33975
4949055
4948960
4947155
4705492
1201178
4949084
4948984
4948886
4946188
44187
4949056
4948961
4947156
4706833
1204953
4949085
4948985
4948887
4946189
404898
4949058
4948962
4947159
4738360
1249186
4949086
4948986
4948890
4946190
628230
4949060
4948963
4947160
4738993
1254062
4949087
4948988
4948891
4946193
628727
4949061
4948964
4947161
4742957
1314113
4949089
4948989
4948892
4946194
635083
4949063
4948965
4947175
4828940
1316100
4949090
4948990
4948893
4946210
744085
4949064
4948966
4947177
4828943
1321888
4949092
4948991
4948894
4946247
789593
4949065
4948967
4947178
4847997
1458307
4949094
4948992
4948895
4946257
789651
4949066
4948968
4947179
4853443
1496934
4949095
4948993
4948896
4946258
926985
4949067
4948969
4947182
4909646
1549118
4949096
4948994
4948898
4946259
992939
4949068
4948970
4947185
4940595
1580047
4949098
4948995
4948899
4946263
1058389
4949070
4948971
4947187
4940694
1611582
4949099
4948996
4948900
4946320
1058433
4949071
4948972
4947189
4940855
1612753
4949100
4948997
4948902
4946322
1112905
4949072
4948974
4947194
4941419
1615034
4949102
4948998
4948904
4946324
38 Hie information needs for human health hazard includes a list of study characteristics pertaining to the study population/test
organism, types of exposures and routes, me 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.
LXI
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1124442
4949074
4948975
4947200
4945941
1689217
4949103
4948999
4948905
4946329
1124901
4949075
4948977
4947201
4946008
1763085
4949104
4949000
4948906
4946359
1142139
4949076
4948978
4947202
4946061
1763087
4949105
4949001
4948909
4946360
1153582
4949078
4948979
4947203
4946132
1763125
4949106
4949002
4948911
4946361
1156301
4949080
4948980
4947204
4946147
1763137
4949108
4949003
4948912
4946374
1167387
4949081
4948981
4947223
4946178
1763157
4949109
4949004
4948913
4946375
1201159
4949082
4948982
4947224
4946179
1781960
4949110
4949005
4948914
4946376
1201176
4949083
4948983
4948885
4946180
1808388
4949111
4949006
4948915
4946380
3036899
4949156
4949040
4948950
4947131
1808755
4949112
4949007
4948916
4946387
3037885
4949157
4949042
4948951
4947132
1865871
4949113
4949009
4948918
4946408
3038973
4949158
4949044
4948952
4947135
1955931
4949116
4949010
4948919
4946410
3039406
4949159
4949045
4948953
4947136
1967450
4949117
4949011
4948920
4946411
3039791
4951048
4949046
4948954
4947137
1970619
4949118
4949012
4948921
4946419
3041527
4951050
4949047
4948955
4947138
2231679
4949119
4949013
4948922
4946423
3041622
4951055
4949049
4948956
4947140
2232056
4949120
4949015
4948923
4946506
3041638
4951170
4949051
4948958
4947141
2232422
4949121
4949016
4948925
4946513
3041935
4951176
4949052
4948959
4947154
2232425
4949122
4949017
4948926
4946538
3047394
4951181
4949053
4339757
4576534
2232427
4949123
4949018
4948927
4946547
3051635
4951206
4949054
4376725
4579583
2232444
4949126
4949020
4948928
4946614
3051709
4951208
3753956
4388064
4583202
2232562
4949128
4949021
4948930
4946615
3103598
4951228
3823035
4391261
4656492
2273142
4949129
4949022
4948931
4946617
3114932
4428638
3830342
4395587
4660346
2292715
4949130
4949023
4948932
4946619
3115961
4428838
3830898
4398518
4704876
2302957
4949131
4949024
4948933
4946620
3119596
4433785
3846566
4399866
3577212
2530089
4949132
4949026
4948934
4946621
3225794
4436364
3847436
4400649
3577235
2563138
4949134
4949027
4948935
4946623
3374286
4436864
3874693
4404349
3590105
2692340
4949135
4949028
4948936
4947105
3402924
4438060
4146480
4408404
3619406
2745927
4949138
4949029
4948938
4947106
3445046
4438415
4148076
4420372
3625221
2824290
4949140
4949030
4948940
4947107
3476490
4425601
4148079
4420932
4275583
2875983
4949141
4949031
4948942
4947108
3477473
4426820
4168926
4420947
4276472
2883990
4949142
4949032
4948943
4947109
3491334
3559324
4173202
4421954
4423539
2887419
4949149
4949033
4948944
4947110
3539276
3562800
4222683
4948949
4947130
2892020
4949150
4949034
4948946
4947111
3009070
4949153
4949037
4948948
4947115
2978028
4949152
4949035
4948947
4947113
3036268
4949154
4949039
Reference excluded (HERO ID
because the reference primarily contained in silico data
N/A.
K XII '
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Table C.4: 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
No
1322754
information pertaining to a low-
1629162
priority substance candidate?
1776453
1875316
2301122
2301139
3041082
4219489
4862648
4940454
4941418
4946053
4947114
4951209
61412
824457
1744616
1744618
3039593
4441664
4442235
4862648
4940287
4940288
4940320
4940383
4940385
4940387
4940395
4940392
4946053
4948456
4949088
4951173
4951178
What type of source is this
Review article or book chapter that
1004739
reference?
contains only citations to primary
3038211
literature sources
4940386
4946377
628176
3036785
What kind of evidence does this
In silico studies that DO NOT
N/A.
reference primarily contain?
contain experimental verification
The following question apply to HUMAN evidence only
Does the reference report an
No
N/A.
exposure route that is or is
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presumed to be by an inhalation,
oral, or dermal route?
Does the reference report both test
No
N/A.
substance exposure(s) AND related
health outcome(s)?
If the reference reports an exposure
No
4951213
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".
The following question apply to ANIMAL evidence only
Does the reference report an
No
N/A.
exposure route that is by inhalation,
oral, or dermal route?
Does the reference report both test
No
N/A.
substance-related exposure(s) AND
related health outcome(s)?
Does the reference report the
No
N/A.
duration of exposure?
Does the reference report an
No
4951261
exposure to the test substance only
4951218
(i.e. no mixtures with the exception
4951185
of aqueous solutions and
1230541
reasonable impurities and
byproducts)?
Does the paper report a negative
No39
4951261
control that is a vehicle control or
no treatment control?
The following questions apply to MECHANISTIC/ALTERNATIVE TEST METHODS evidence only
Does the reference report a
No
3036587
negative control that is a vehicle
control or no treatment control?
Does the reference report an
No
N/A.
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
3036587
the study use a positive control?
39 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: 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).
N/A.
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).
1763148
3041958
4940388
4940524
4940510
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).
4940388
4940389
4941420
4946133
Metric 6:
Test Animal Characteristics
The test animal species was not
reported.
OR
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).
4941420
1763148
4940389
4940388
3041958
4946133
Metric 7:
Number of Animals Per Group
The number of animals per study
group was not reported.
OR
N/A.
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The number of animals per study
group was insufficient to
characterize toxicological effects
(e.g., 1-2 animals in each group).
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.).
1763148
2282271
4940388
4940389
4941420
4946133
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.
4940388
4940524
4941420
2282271
4442235
4940303
4940394
4946044
4940452
Table C.6: 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.
3039551
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).
N/A.
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
N/A.
LXVI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
protocol used for in vitro skin
irritation assay).
Metric 5:
Reporting of Concentration
The exposure doses/concentrations
or amounts of test substance were
not reported.
N/A.
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).
4940521
4940522
4940389
2282271
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).
N/A.
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.
N/A.
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).
4940451
4940388
C.2.2 Environmental Hazard
For the screening review of LPS candidate dipropylene glycol, EPA excluded a total of 547 references
when assessing environmental hazard. Off-topic environmental hazard references excluded at
title/abstract screening are listed in Table C.7, and those excluded at full-text screening are listed in Table
C.8. References in Table C.9 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.
Xv I
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.7: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs40 relevant to
environmental hazard
44187
4440871
4949112
4948988
4946374
2892020
4738993
1744618
4949052
4948891
404898
4441664
4949113
4948989
4946375
2978028
4742957
1763125
4949053
4948892
635083
4442235
4949116
4948990
4946376
3009070
4828940
1763137
4949054
4948893
744085
4940392
4949117
4948991
4946377
3036268
4828943
1763148
4949055
4948894
789593
4940395
4949118
4948992
4946380
3036587
4847997
1763157
4949056
4948895
789651
4941420
4949119
4948993
4946387
3036785
4853443
1776453
4949058
4948896
824457
4944882
4949120
4948994
4946408
3036899
4862648
1808755
4949060
4948898
926985
4946008
4949121
4948995
4946419
3037885
4909646
2112816
4949061
4948899
1058389
4946016
4949122
4948996
4946513
3038211
4940595
2301122
4949063
4948900
1058433
4946044
4949123
4948997
4946538
3038973
4940694
2301139
4949064
4948902
1112905
4946053
4949126
4948998
4946547
3039406
4940855
2745927
4949065
4948904
1124442
4946054
4949128
4948999
4946614
3039551
4941418
3041082
4949066
4948905
1124901
4946055
4949129
4949001
4946615
3039791
4941419
3041527
4949067
4948906
1142139
4946135
4949130
4949002
4946617
3041935
4945941
3041622
4949068
4948909
1153582
4946142
4949132
4949003
4946619
3114932
4946061
3041638
4949070
4948911
1156301
4946194
4949134
4949004
4946620
3115961
4946132
3103598
4949071
4948912
1167387
4946244
4949135
4949005
4946623
3225794
4946133
3118622
4949072
4948913
1201159
4946247
4949138
4949006
4947105
3374286
4946147
4222683
4949074
4948914
1201176
4946261
4949140
4949007
4947107
3402924
4946178
4259576
4949075
4948915
1201178
4946314
4949141
4949009
4947108
3445046
4946179
4440869
4949076
4948916
1204953
4946316
4949142
4949010
4947109
3476490
4946180
4948954
4949078
4948918
1249186
4946333
4949149
4949011
4947110
3477473
4946188
4948955
4949080
4948919
1321888
4946334
4949150
4949012
4947111
3491334
4946189
4948956
4949081
4948920
1458307
4946361
4949152
4949013
4947113
3539276
4946190
4948958
4949082
4948921
1496934
4946362
4949153
4949015
4947114
3559324
4946191
4948959
4949083
4948922
1549118
4946363
4949154
4949016
4947115
3562800
4946193
4948960
4949084
4948923
1611582
4946410
4949156
4949017
4947130
3577212
4946210
4948961
4949085
4948925
1612753
4946411
4949157
4949018
4947131
3577235
4946257
4948962
4949086
4948926
1615034
4946412
4949158
4949020
4947132
3590105
4946258
4948963
4949087
4948927
1689217
4946414
4949159
4949021
4947135
3619406
4946259
4948964
4949088
4948928
1781960
4946416
4951181
4949022
4947136
3625221
4946263
4948965
4949089
4948930
1808388
4946420
1763085
4949023
4947137
3753956
4946322
4948966
4949090
4948931
1865871
4946423
1763087
4949024
4947138
3830342
4946324
4948967
4949092
4948932
1875316
4946424
4946320
4949026
4947140
3830898
4946329
4948968
4949094
4948933
1955931
4946506
4949131
4949027
4947141
3846566
4946359
4948969
4949095
4948934
1967450
4946511
992939
4949028
4947155
3847436
4946360
4948970
4949096
4948935
1970619
4946541
3051635
4949029
4947156
3874693
4420932
4948971
4949098
4948936
2231679
4946621
3051709
4949030
4947159
4088550
4420947
4948972
4949099
4948938
2232056
4947224
4951048
4949031
4947160
4146480
4421954
4948974
4949100
4948940
2232422
4948456
2282271
4949032
4947161
4148076
4423539
4948975
4949102
4948942
2232425
4949000
33975
4949033
4947175
4148079
4425601
4948977
4949103
4948943
2232427
4951050
61412
4949034
4947177
4168926
4426820
4948978
4949104
4948944
2232444
4951055
628176
4949035
4947182
4173202
4428638
4948979
4949105
4948946
2232562
4951170
628230
4949037
4947185
4275583
4428838
4948980
4949106
4948947
2273142
4951173
628727
4949039
4947189
4276472
4433785
4948981
4949108
4948948
2292715
4951176
1004739
4949040
4947201
4339757
4436364
4948982
4949109
4948949
2302957
4951185
1230541
4949042
4947202
4376725
4436864
4948983
4949110
4948950
LXVIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
2563138
4951207
1254062
4949044
4947203
4388064
4438060
4948984
4949111
4948951
2692340
4951209
1314113
4949045
4947204
4391261
4438415
4948985
4579583
4948952
2824290
4951213
1316100
4949046
4948885
4395587
4576534
4948986
4583202
4948953
2875983
4951218
1322754
4949047
4948886
4398518
4404349
4705492
4660346
4420372
2883990
4951261
1580047
4949049
4948887
4399866
4408404
4706833
4704876
4400649
2887419
4738360
1629162
4949051
4948890
Reference excluded (HERO ID) because the reference did NOT present quantitative environmental hazard data
N/A.
Table C.8: 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
1580138
4731313
4851358
4951178
1744616
4940286
4951206
4951228
4940436
4947106
4951208
What type of source is this
reference?
Review article or book chapter that
contains only citations to primary
literature sources
4219489
Is quantitative environmental
hazard data presented?
No
N/A.
Is this primarily a
modeling/simulation study?
[Note: select "No" if experimental
verification was included in the
study]
Yes
N/A.
Is environmental hazard data
presented for standard or non-
standard aquatic or terrestrial
species (fish, invertebrates,
microorganisms, non-mammalian
terrestrial species)?
No
N/A.
Is exposure measured for the target
substance or is the test substance
a mixture (except for reasonable
impurities, byproducts, and
aqueous solutions) or formulated
product?
Mixture
N/A.
Formulated Product
N/A.
40 Hie information needs for environmental hazard includes a list of study characteristics pertaining to the test organism/species,
type and level of effects, and me 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.
LXIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Does the reference report a
duration of exposure?
No
N/A.
Does the reference report a
No
7504
negative control that is a vehicle
4940435
control or no treatment control?
4940366
4940397
Does the reference include
endpoints in the information needs?
No
N/A.
Table C.9: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Environmental
Hazard
Question
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,
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.
N/A.
Metric 2:
Negative
Controls
A concurrent negative control group was not included or reported.
4951174
4951208
Metric 3:
Experimental
System
The experimental system (e.g., static, semi-static, or flow-through
regime) was not described.
4940436
4940440
4951174
4940388
3041958
Metric 4:
Reporting of
Concentrations
Test concentrations were not reported.
4951174
4951208
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).
4951208
4951174
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.
N/A.
Metric 8:
Reporting of
Data
Data presentation was inadequate.
OR
Major inconsistencies were present in reporting of results.
4940388
3041958
LXX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
C.2.3 Fate
For the screening review of LPS candidate dipropylene glycol, EPA excluded a total of 453 references
when assessing environmental fate. Off-topic fate references excluded at title/abstract screening are listed
in Table C. 10, and those excluded at full-text screening are listed in Table C. 11. References in Table C. 12
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.10: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs41 relevant to environmental
fate
44187
4949033
4948959
4946621
4146480
2232444
4949089
4949005
4948895
4847997
404898
4949034
4948960
4946623
4148076
2232562
4949090
4949006
4948896
4853443
635083
4949035
4948961
4947105
4148079
2273142
4949092
4949007
4948898
4862648
744085
4949037
4948962
4947107
4168926
2292715
4949094
4949009
4948899
4909646
789593
4949039
4948963
4947108
4173202
2302957
4949095
4949010
4948900
4940595
789651
4949040
4948964
4947109
4275583
2563138
4949096
4949011
4948902
4940694
824457
4949042
4948965
4947110
4276472
2692340
4949098
4949012
4948904
4940855
926985
4949044
4948966
4947111
4339757
2824290
4949099
4949013
4948905
4941418
992939
4949045
4948967
4947113
4376725
2875983
4949100
4949015
4948906
4941419
1058389
4949046
4948968
4947114
4388064
2883990
4949102
4949016
4948909
4941420
1058433
4949047
4948969
4947115
4391261
2887419
4949103
4949017
4948911
4945941
1112905
4949049
4948970
4947130
4395587
2892020
4949104
4949018
4948912
4946061
1124442
4949051
4948971
4947131
4398518
2978028
4949105
4949020
4948913
4946132
1124901
4949052
4948972
4947132
4399866
3009070
4949106
4949021
4948914
4946133
1142139
4949053
4948974
4947135
4400649
3036268
4949108
4949022
4948915
4946147
1153582
4949054
4948975
4947136
4404349
3036587
4949109
4949023
4948916
4946178
1156301
4949055
4948977
4947137
4408404
3036785
4949110
4949024
4948918
4946179
1167387
4949056
4948978
4947138
4420372
3036899
4949111
4949026
4948919
4946180
1201159
4949058
4948979
4947140
4420932
3037885
4949112
4949027
4948920
4946188
1201176
4949060
4948980
4947141
4420947
3038211
4949113
4949028
4948921
4946189
1201178
4949061
4948981
4947155
4421954
3038973
4949116
4949029
4948922
4946190
1204953
4949063
4948982
4947156
4423539
3039406
4949117
4949030
4948923
4946191
1249186
4949064
4948983
4947159
4425601
3039551
4949118
4949031
4948925
4946193
1321888
4949065
4948984
4947160
4426820
3039791
4949119
4949032
4948926
4946194
1458307
4949066
4948985
4947161
4428638
3041935
4949120
4946380
4948927
4946210
1496934
4949067
4948986
4947175
4428838
3114932
4949121
4946387
4948928
4946247
1549118
4949068
4948988
4947177
4433785
3115961
4949122
4946408
4948930
4946257
1611582
4949070
4948989
4947182
4436364
3225794
4949123
4946410
4948931
4946258
1612753
4949071
4948990
4947185
4436864
3374286
4949126
4946419
4948932
4946259
1615034
4949072
4948991
4947189
4438060
3402924
4949128
4946506
4948933
4946263
1689217
4949074
4948992
4947201
4438415
3445046
4949129
4946513
4948934
4946322
1781960
4949075
4948993
4947202
4576534
3476490
4949130
4946538
4948935
4946324
1808388
4949076
4948994
4947203
4579583
3477473
4949132
4946547
4948936
4946329
1865871
4949078
4948995
4947204
4583202
3491334
4949134
4946614
4948938
4946359
1875316
4949080
4948996
4947224
4660346
3539276
4949135
4946615
4948940
4946360
41 Hie information needs for fate includes a list of study characteristics pertaining to the associated media and exposure
pathways, 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.
LXXI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
1955931
4949081
4948997
4948885
4704876
3559324
4949138
4946617
4948942
4946361
1967450
4949082
4948998
4948886
4705492
3562800
4949140
4946619
4948943
4946374
1970619
4949083
4948999
4948887
4706833
3577212
4949141
4946620
4948944
4946375
2231679
4949084
4949000
4948890
4738360
3577235
4949142
4948952
4948946
4946376
2232056
4949085
4949001
4948891
4738993
3590105
4949149
4948953
4948947
4946377
2232422
4949086
4949002
4948892
4742957
3619406
4949150
4948954
4948948
4949157
2232425
4949087
4949003
4948893
4828940
3625221
4949152
4948955
4948949
4949158
2232427
4949088
4949004
4948894
4828943
3753956
4949153
4948956
4948950
4949159
3830898
4949156
3847436
3874693
4088550
3830342
4949154
4948958
4948951
4951181
3846566
Reference excluded (HERO ID) because the reference did NOT present quantitative environmental fate data
N/A.
Table C.11: 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 information
No
4940397
pertaining to a low- priority substance
4940399
candidate?
4949131
1763087
4940401
What type of source is this reference?
Review article or book chapter that
N/A.
contains only citations to primary
literature sources
Is quantitative fate data presented?
No
N/A.
Is this primarily a modeling/simulation study?
Yes
N/A.
[Note: Select "Yes" only if there is no
experimental verification]
Table C.12: 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
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:
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.
4940366
4940402
4940404
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.
4940404
4940430
LXXII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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.
4940402
4940404
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).
4940366
4940402
4940404
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.
4940402
4940430
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.
1763085
4940402
4940404
4940388
4940389
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.
4940402
4940404
4940430
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).
1763085
4940366
4940402
4940404
_xx7ii
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Appendix D: Summary of Public Comments
On March 21, 2019, EPA initiated the prioritization process for 20 chemical substances as candidates for
designation as Low-Priority Substances. EPA published a document in the Federal Register providing the
identity of the chemical substances being initiated for prioritization and a general explanation of why the
Agency chose these chemical substances. EPA provided a 90-day comment period during which
interested persons could submit relevant information on these chemical substances.42
For dipropylene glycol, EPA received public comment recommending that the Agency consider specific
publicly available data sources. EPA reviewed all of these sources as part of its screening review of the
chemical. Table 1 below lists these recommended sources, the HERO ID (if applicable), and notes about
each source. EPA used the Health & Environmental Research Online (HERO) database to search,
retrieve, and/or store data sources supporting scientific assessments. For references with HERO IDs, more
information on the references can be found by searching the HERO ID at
https://hero.epa.gov/hero/index.cfm/search/index.
Table D.1: Recommended Sources for Dipropylene Glycol based on Public Comment
Source
HERO ID
Notes
The Dow Chemical Company. (2013). Product Safety
Assessment: Dipropylene Glycol.
NA
EPA captured this information from other
sources in Section 3: Physical-Chemical
Properties.
CIR (2006). Annual Review of Cosmetic Ingredient Safety
Assessments- 2004/2005. International Journal of
Toxicology, 25(Suppl 2), 1-89.
5021883
This article was part of EPA's literature review
process. It includes concentrations of
dipropylene glycol and other chemicals in
cosmetics and other products, which are not in
TSCA's regulatory scope.
CIR (1985). Final Report on the Safety Assessment of
Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and
Dipropylene Glycol. Journal of the American College of
Toxicology, 4(5), 223- 248
4941420
This article was part of EPA's literature review
process but was excluded due to limited data
reported in the summaries.
Fowles, J. R., Banton, M. I., & Pottenger, L. H. (2013). A
toxicological review of propylene glycols. Critical reviews in
toxicology, 43(4), 363-390.
3038211
This is a review article that contains citations to
other literature sources, which EPA consulted
but excluded because it only contains citations to
primary literature sources.
West, R., Banton, M., Hu, J., & Klapacz, J. (2014). The
Distribution, Fate, and Effects of Propylene Glycol
Substances in the Environment. Reviews of Environmental
Contamination and Toxicology Volume 232. Springer,
Cham, 2014. 107-138.
2537482
This is a review article that contains citations to
other literature sources, which EPA consulted.
Haque T, Rahman KM, Thurston DE, Hadgraft J, Lane ME.
(2017). Topical delivery of anthramycin I. Influence of neat
solvents. European journal of pharmaceutical sciences.
104:188-195.
4947114
This article was part of EPA's literature review
process but was excluded because the reference
did not contain information pertaining to the low-
priority substance candidate
42 Docket number EPA-HQ-OPPT-2019-0131 includes the list of 20 chemical substances that are candidates for designation as
Low-Priority Substances for risk evaluation ("https://www.federalregister.gOv/documents/2019/03/21/2019-05404/initiation-of-
prioritization-under-the-toxic-substances-control-act-tsca). Individual dockets were established for each of the 20 low-priority
candidates. Docket number EPA-HQ-OPPT-2019-0124 addresses dipropylene glycol.
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table D.1: Recommended Sources for Dipropylene Glycol based on Public Comment
Source
HERO ID
Notes
US EPA Exposure Predictions (mg/kg bw/day) for
Dipropylene glycol (CAS No. 25265-71-8) /
DTXSID0027856 from EPA CompTox Chemicals
Dashboard.
NA
This source was not used because it contains
predicted exposure data.
High Throughput Heuristics for Prioritizing Human
Exposure to Environmental Chemicals" Environ. Sci.
Technol. 2014, 48(21):12760-12767.
3841221
This article was part of EPA's literature review
process. It was excluded because it includes
predicted exposure data.
EU REACH and ECHAdatasets
NA
EPA reviewed and included information in
Section 4: Relevant Assessment History.
Environment Canada
NA
EPA reviewed and included information in
Section 4: Relevant Assessment History.
OECD SIDS Initial Assessment
NA
EPA reviewed and included information in
Section 4: Relevant Assessment History.
Safer Choice Chemical List (SCIL)
NA
EPA reviewed and included information in
Section 4: Relevant Assessment History.
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