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Dossier for Candidate Low-Priority Substance Propanol,
l(or 2)-(2-methoxymethylethoxy)-, acetate
(CASRN 88917-22-0)
(Dipropylene Glycol Methyl Ether Acetate (DPMA))
For Release at Proposal
August 9, 2019
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue
Washington, DC 20460
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Contents
1. Introduction 1
2. Background on Dipropylene Glycol Methyl Ether Acetate 3
3. Physical-Chemical Properties 4
3.1 References 7
4. Relevant Assessment History 9
5. Conditions of Use 10
6. Hazard Characterization 12
6.1 Human Health Hazard 15
6.1.1 Absorption, Distribution, Metabolism, and Excretion 17
6.1.2 Acute Toxicity 17
6.1.3 Repeated Dose Toxicity 18
6.1.4 Reproductive and Developmental Toxicity 19
6.1.5 Genotoxicity 19
6.1.6 Carcinogenicity 20
6.1.7 Neurotoxicity 20
6.1.8 Skin Sensitization 21
6.1.9 Skin Irritation 21
6.1.10 Eye Irritation 21
6.1.11 Hazards to Potentially Exposed or Susceptible Subpopulations 21
6.2 Environmental Hazard 22
6.2.1 Acute Aquatic Toxicity 22
6.2.2 Chronic Aquatic Toxicity 22
6.3 Persistence and Bioaccumulation Potential 22
6.3.1 Persistence 22
6.3.2 Bioaccumulation Potential 23
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 13
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 DPMA IV
A.3 References XIII
Appendix B: Hazard Characterization XVI
B.1 References XXIX
C.1 Literature Search and Review XXXIII
C.1.1 Search for Analog Data XXXIII
C.1.2 Search Terms and Results XXXIV
C.2 Excluded Studies and Rationale XXXVII
C.2.1 Human Health Hazard Excluded References XXXVII
C.2.2 Environmental Hazard XLIII
C.2.3 Fate XLV
Appendix D: Summary of Public Comments XLIX
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Tables
Table 1: DPMA at a Glance 3
Table 2: Physical-Chemical Properties for DPMA 4
Table 3: Conditions of Use for DPMA 11
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects 12
Table 5: DPMA and Analog Structures 16
Table A.1:1986-2015 National Production Volume Data for DPMA (Non-Confidential Production Volume in ^
Pounds)
Table A.2: Sources Searched for Uses of DPMA II
Table A3: Uses of DPMA IV
Table B.1: Human Health Hazard XVI
Table B.2: Environmental Hazard XXV
Table B.3: Fate XXVI
Table C.1: Sources Used for Analog Search XXXIV
Table C.2: Search Terms Used in Peer-Reviewed Databases XXXV
Table C.3: Search Terms Used in Grey Literature and Additional Sources XXXVII
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard XXXVII
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human
Health Hazard
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for ^
Human Health Hazard - Animal
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Human Health Hazard - In Vitro
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard XLIII
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for
Environmental Hazard XLIII
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ion for
XLIV
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 XLV
Table C.12: Screening Questions and Off-Topic References Excluded at Full Text Screening for Fate XLVI
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Fate
XLVI
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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, l(or 2)-(2-methoxymethylethoxy)-,
acetate, referenced as dipropylene glycol methyl ether acetate (DPMA), 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.
• Section 2 (Background on the Proposed Low-Priority Substance): This section includes
information on attributes of the chemical substance, including its structure, and relates them to its
functionality.
1 https://www.federalregister.gov/documents/2019/03/21/2019-05404/imtiation-of-prioritization-under-tlie-toxic-substances-
control-act-tsca
2 The prioritization process is explained in the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic-
Substances Control Act (82 FR 33753).
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• Section 3 (Physical-Chemical Properties): This section includes a description of the physical-
chemical properties of the chemical substance and explains how these properties lead to the
chemical's fate, transport, and exposure potential.
• Section 4 (Relevant Assessment History): This section includes an overview of the outcomes of
other governing entities" assessments of the chemical substance.
• Section 5 (Conditions of Use): This section presents the chemical substance's known, intended,
and reasonably foreseen conditions of use under TSCA.
• Section 6 (Hazard Characterization): This section summarizes the reasonably available hazard
information and benchmarks the information against low-concern thresholds.
• Section 7 (Exposure Characterization): This section includes a qualitative summary of potential
exposures to the chemical substance.
• Section 8 (Summary of Findings): In this section, EPA presents information pertinent to
prioritization against each of the seven statutory and regulatory criteria and considerations, and
proposes a conclusion based on that evidence.
• Section 9 (Proposed Designation): In this section, EPA presents the proposed designation for this
chemical substance.
• Appendix A (Conditions of Use Characterization): This appendix contains a comprehensive list of
TSCA and non-TSCA uses for the chemical substance from publicly available databases.
• Appendix B (Hazard Characterization): This appendix contains information on each of the
studies used to support the hazard evaluation of the chemical substance.
• Appendix C (Literature Search Outcomes): This appendix includes literature search outcomes and
rationales for studies that were identified in initial literature screening but were found to be off-
topic or unacceptable for use in the screening-level review.
• 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 Methyl Ether Acetate
Table 1 below provides the CAS number, synonyms, and other information on DPMA.
Table 1: DPMA at a Glance
Chemical Name
Dipropylene Glycol Methyl Ether Acetate
CASRN
88917-22-0
Synonyms
DPMA; 1-(3-Methoxypropoxy)propyl acetate; Glycol Ether DPM Acetate; 1(or2)-(2-
methoxymethylethoxy)-propanoacetate; propanol, 1 (or2)-(2-methoxymethylethoxy)-,acetate;
PPG-2 Methyl Ether Acetate
Trade Name(s)
DPMAc; Dowanol DPMA
Molecular Formula
C9H18O4
Representative Structure
O CH,
h3c 0 0
ch3
Source(s):
Kim et al. (2016); DeLima Associates (2018); Dow (2015)
DPMA is a propylene oxide-based, or P-series, glycol ether acetate. DPMA is an organic chemical
compound that contains an ester functional group comprised of two alkyl groups connected by a carbonyl
and a linking oxygen atom (RCOOR ) and two ether functional groups—an oxygen atom connected two
alkyl groups (R-O-R ). DPMA is commercially produced as a mixture of four isomeric components in
which the internal ether linkage may be adjacent to either a primary or secondary carbon atom. Shorter
chain ethers and esters, such as DPMA, are liquids capable of dissolving other substances and typically
function as solvents. DPMA is a colorless, water-soluble, sweet-smelling liquid with a moderate
evaporation rate, and it is miscible with organic solvents. These properties make DPMA useful as a
solvent, fragrance, film-forming agent, and coalescing agent 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 DPMA. 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 DPMA
Source/
Model
Data Type
Endpoint
Endpoint value
Notes
Sigma Aldrich 2019
Experimental
Physical state at
room temp
(based on melting
point)
Liquid
Staples and Davis 2002,
OECDSIDS 2003 (SIDS)
Experimental
Molecular weight
190 g/mol
EPISuite v.4.113
Calculated
Molecular weight
190.2 g/mol
Lyman 1990
Experimental
Molar volume
230.9 cm3/mol
Staples and Davies 2002;
OECDSIDS 2003
Experimental
Water solubility
1.60x105 mg/L
ECHA 2019
Experimental
Water solubility
183000 mg/L at 20°C
and pH 4.34;
160000 mg/L
ChemlDPIus 2019
Experimental
Water solubility
194000 mg/L at 25°C
EPISuite v.4.11
Estimated
Water solubility
40450 mg/L
(calculated from log
M; 173000 mg/L
(calculated by
fragment)
Staples and Davis 2002;
OECDSIDS 2003
Experimental
Water solubility
0.841 mol/L
ECHA 2019
Experimental
Water solubility
0.926 mol/L
3 EPI Suite Physical Property Inputs - Melting Point = -25.2 deg C, Boiling Point = 200 deg C, Vapor Pressure = 0.13 mm Hg, Water Solubility = 194000 mg/L, Log K0w = 0.803,
Henry's Law 2.0E-07 atm-m3/mole, SMILES: CC(=0)OC(C)COC(C)COC
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Table 2: Physical-Chemical Properties for DPMA
Source/
Model
Data Type
Endpoint
Endpoint value
Notes
ChemlDPIus 2019
Experimental
Water solubility
1.02 mol/L
Staples and Davis 2002;
OECDSIDS 2003
Experimental
Log Kow
0.803
ECHA 2019
Experimental
Log Kow
0.61
EPISuite v.4.11
Estimated
Log Kow
0.66
EPISuite v.4.11
Estimated
Log Koa
5.89
EPISuite v.4.11
Estimated
Log Koc
1 (MCI); 1.12 (Kow)
Staples and Davis 2002
Experimental
Vapor pressure
0.13 mm Hg (17 Pa)
ECHA 2019
Experimental
Vapor pressure
7.80x10-2 mm Hg
(10.4 Pa at 20°C);
1.93 mm Hg (2.57
mbar) at 20°C; 0.13
mm Hg (17 Pa)
OECDSIDS 2003
Experimental
Vapor pressure
0.13 mm Hg at 25°C
(17 Pa); <1 mm Hg at
20°C;
0.0836 mm Hg at
20°C
EPISuite v.4.11
Estimated
Vapor pressure
3.60x10"1 mm Hg
EPISuite v.4.11
Estimated
Henry's Law
2.0E-07 atm-m3/mol
Staples and Davis 2002
Experimental
Henry's Law
2.0E-07 (0.02 Pa-
m3/mole)
EPISuite v.4.11
Estimated
Volatilization
168 days (river)
1841 days (lake)
EPISuite v.4.11
Estimated
Photolysis
(Indirect)
3.82 hours (T1/2)
• OH rate constant 3.36 E-11 cm3/molecule-second (12 hour day; 1.5E6
OH/cm3)
• No ozone reaction estimation
EPISuite v.4.11
Estimated
Hydrolysis
Kb half-life 88 days at
pH 8; 2.4 years at pH
7
EPISuite v.4.11
Estimated
Biodegradation
potential
Ready prediction: No
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Table 2: Physical-Chemical Properties for DPMA
Source/
Model
Data Type
Endpoint
Endpoint value
Notes
EPISuite v.4.11
Estimated
BAF
1.1
EPISuite v.4.11
Estimated
BCF
3.2
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Based on its reported physical form and measured melting point, DPMA is a liquid under ambient
conditions (Sigma Aldrich, 2019). Liquids have the potential for exposure via direct dermal contact
with the substance, ingestion and by inhalation of aerosols, if they are generated. Exposure through
direct dermal contact with this substance is expected to result in poor to moderate dermal absorption.
Based on its measured vapor pressure, DPMA is expected to be volatile when in neat form at ambient
temperatures. As a result, exposure to DPMA is possible through inhalation of vapors or aerosols if
they are generated. Based on measured solubility data, DPMA is considered water soluble, indicating
the potential for this substance to dissolve in water and form an aqueous solution (ECHA, 2019).
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 DPMA is present in diluted form. The estimated Henry's Law constant (ECHA, 2019; EPI
Suite, 2019) for DPMA indicates volatilization from water and aqueous solutions is expected to be
minimal and therefore exposure through breathing vapor from a dilute form is expected to be
minimal. Based on its estimated log Kow, absorption and sequestration in fatty tissues are unlikely, as
reflected in the estimated BCF and BAF values for this compound (EPI Suite, 2019). The estimated
log Koc indicates this substance is highly mobile in soils, increasing its potential for leaching into and
transport in groundwater, including ground water sources of drinking water (EPI Suite, 2019). If oral
exposure occurs via ingestion of contaminated drinking water, including well water, absorption
through the gastrointestinal tract is expected to be moderate based on the log Kow (EPI Suite, 2019).
Concern for presence in drinking water is reduced in part by DPMA's expected low persistence.
Experimental biodegradation data indicate this substance is inherently biodegradable, meaning that it
has the potential to break down in the environment into carbon dioxide and water (ECHA, 1996,
4985142).
3.1 References
ChemlDplus. PPG-2 methyl ether acetate. Retrieved from
https: //chem .nlm .nih. go v/ch e m i dp l u s/rn/S 8917-22-0
European Chemicals Agency (ECHA). (2019). l-(3-methoxypropoxy)propyl acetate. Retrieved from
https://echa.europa.eu/substance-information/-/substanceinfo/100.133.736
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 (2003). Propylene glycol ethers: SIDS initial assessment report for SIAM 17: Arona, Italy, 11-
14
Sigma Aldrich (2019). Di(propylene glycol) methyl ether acetate, mixture of isomers. Retrieved from
https://\\\v\\ .sigmaaldrich.com/catalog/product/aldrich/406562?lang=cn&rcgion=US
Staples, CA; Davis, JW. (2002). An examination of the physical properties, fate, ecotoxicity and
potential environmental risks for a series of propylene glycol ethers. Chemosphere, Oct;49(l):61-73.
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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 DPMA 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, the Preliminary
Assessment Information Rule (PAIR) under TSCA required manufacturers and importers to submit a
standardized reporting form for each site at which they were manufacturing or importing a listed
chemical. The chemical substances chosen for this rule were those with possibly high exposure
potential or for which information about toxicity had been previously obtained. Also relevant to the
listing decision: 1) whether other Federal agencies had identified the chemical or mixture as
potentially posing a health risk, 2) the chemical's potentially high toxicity, 3) the chemical's high
production volumes, or 4) the lack of completed preliminary assessments for the chemical. Inclusion
of DPMA in the 1993 PAIR rule is not a concern because of EPA's high confidence in the chemical's
low hazard profile.
EPA also reviewed international assessments of DPMA. EPA identified assessments by the
Organisation for Economic Co-operation and Development (OECD), and government agencies in
Canada and Germany.
The OECD Screening Information Datasets (SIDS) Initial Assessment Meeting (SIAM) discussed the
SIDS Initial Assessment Report (SIAR) on propylene glycol ethers, including DPMA, in November
2003. 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 DPMA did not meet its criteria for further
attention.7
The German Environment Agency (UBA) designated DPMA as "low hazard to waters" in August
2017 based on an assessment of ecotoxicity and environmental fate.8
4 https://www.epa.gov/saferchoice/safer-ingredients
5 https://www.epa.gov/sites/production/files/2013-12/documents/dfe master criteria safer ingredients v2 l.pdf
0 https://lipvchemicals.oecd.Org/ui/handler.axd?id=fdbb6972-3dd4-4046-ba21-eeb6e28c05fb
7 https://www.ee.gc.ca/ese-ees/default.asp?lang=En&n=9F0069Fl-l
8 https://webrigoletto.uba.de/rigoletto/public/searcliDetail.do?keniiummer=8237
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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 DPMA (Appendix A) to inform which uses would be determined conditions of use.9
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, DPMA is manufactured domestically and imported. It is used in processing
(incorporation into formulation, mixture or reaction) for printing ink manufacturing, cleaning
compound and toilet preparation manufacturing, and paint and coating manufacturing; it is also used
as a reactant in wholesale and retail trade, and paint and coating manufacturing. Examples of
industrial, commercial, and consumer uses include ink, toner, and colorant products, paints and
coatings, and lubricants and greases. Based on the known manufacturing, processing, and uses of this
chemical substance, EPA assumes distribution in commerce. According to CDR, DPMA was recycled
by at least one facility. No information on disposal is found in CDR or through EPA's Toxics Release
Inventory (TRI) Program1" because DPMA 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 occupational11 and consumer uses. This research improved the Agency's
understanding of the conditions of use for DPMA. Although EPA identified uses of DPMA in
personal care products, this screening review covers TSCA conditions of use for the chemical
substance and personal care products are not considered further in EPA's assessment. Exclusions to
TSCA's regulatory scope regarding "chemical substance" can be found at TSCA section 3(2). Table 3
lists the conditions of use for DPMA 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).
9 The prioritization process, including the definition of conditions of use, is explained in the Procedures for Prioritization of
Chemicals for Risk Evaluation Under the Toxic Substances Control Act (82 FR 33753).
10 https://www.epa.gov/toxics-release-inventorv-tri-program
11 Occupational uses include industrial and/or commercial uses
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Table 3: Conditions of Use for DPMA
Life Cycle Stage
Category
Subcategory of Use
Source
Manufacturing
Domestic manufacture
Domestic manufacture
EPA (2017b)
Import
Import
Processing- incorporation into
formulation, mixture or reaction
Solvents (which become part of product formulation or
mixture) - printing ink manufacturing, soap, cleaning
compound, and toilet preparation manufacturing, paint and
coating manufacturing,
EPA (2017b)
Solvents (for cleaning and degreasing) - soap, cleaning
compound, and toilet preparation manufacturing
Odor agents - fragrances; soap, cleaning compound, and
toilet preparation manufacturing
Processing
Not known or reasonably ascertainable
(NKRA)
NKRA
Processing as a reactant
Solvents (which become part of product formulation or
mixture) - wholesale and retail trade, paint and coating
manufacturing
Transportation equipment manufacturing
Trade and repair of motor vehicles and motorcycles
SPIN (2018)
Chemical manufacturing
SPIN (2018)
Manufacture of rubber and plastic
products
Auto and tire care, tire protectant
SPIN (2018); NLM (2018b); Meguiars Inc.
(2008); CPCat (2019)
Recycling
Recycling
EPA (2017b)12
Industrial
Paint and coating manufacturing
Solvents (which become part of product formulation or
mixture)
EPA (2017b)
Distribution
Distribution
Distribution
EPA (2017b)
Industrial/Commercial
uses
Fuels and related products
Synapse Information Resources (n.d.)
12 In the 2016 CDR, one facility (CBI) reported that DPMA was recycled (recycled, remanufactured, reprocessed, or reused). Nineteen facilities reported that DPMA was not
recycled, while eight facilities withheld this information and three reported it as CBI.
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Industrial/commercial/
consumer uses
Ink, toner, and colorant products
Photochemical and reprographic agents, printing and
reproduction of recorded media, Screen wash
EPA (2017b); SPIN (2018); Chemical
Consultants Inc. (2018)
Paints and coatings
Coatings and paints; screen printing and roll coating
EPA (2017b); Monument Chemical (2018);
Synapse Information Resources (n.d.);
NLM (2018a); ECHA (2018); Dow (2015);
SPIN (2018)
Electronics
Synapse Information Resources (n.d.)
Lubricants and greases
Lubricants, greases, release products
ECHA (2018)
Mining
Synapse Information Resources (n.d.)
Metal products not covered elsewhere
Welding and soldering products
ECHA (2018)
Commercial/consumer
Cleaning and furnishing care products
Penetrating solvent/lubricant, floor polishes
EPA (2017b); DeLima Associates (2014);
CPCat (2019); Monument Chemical
(2018); Synapse Information Resources
(n.d.)
Laundry and dishwashing products
EPA (2017b)
Adhesives and sealants
Synapse Information Resources (n.d.);
ECHA (2018)
Consumer
Air Care Products
EPA (2017b); DeLima Associates (2015);
CPCat (2019); ECHA (2018)
Anti-freeze and de-icing products
ECHA (2018)
Surface treatment
Synapse Information Resources (n.d.);
ECHA (2018)
Textiles
ECHA (2018)
Disposal
Releases to air, wastewater, solid and
liquid wastes.
Though not explicitly identified, releases
from disposal are assumed to be
reasonably foreseen13
13 See Section 5 for a discussion on why releases are assumed to be reasonably foreseen for purposes of this proposed prioritization designation.
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6. Hazard Characterization
EPA reviewed primary literature and other data sources to identify reasonably available information.
This literature review approach14 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 DPMA against the endpoints
listed below. EPA's New Chemicals Program has used these endpoints for decades to evaluate
chemical substances under TSCA15 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 Chemicals16 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
Toxicity17
Very High
High
Moderate
Low
Oral LDso (mg/kg)
<50
> 50 - 300
> 300 - 2000
>2000
Dermal LD50 (mg/kg)
<200
> 200- 1000
> 1000 -2000
>2000
Inhalation LC50
(vapor/gas) (mg/L)
<2
>2-10
>10-20
>20
Inhalation LC50
(dust/mist/fume)
(mg/L)
<0.5
>0.5-1.0
>1.0-5
>5
14This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
15 https://www.epa. gov/sustainable-futures/sustainable-futures-p2-framework-manual
10 https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs rev07/English/ST SG AC10 30 Rev7e.pdf
17 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)18
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
Toxicity19
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
Toxicity19
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/
Genotoxicity20
Very High
High
Moderate
Low
Germ cell
mutagenicity
GHS Category 1A
or 1B: Substances
known to induce
heritable mutations
or to be regarded
as if they induce
heritable mutations
GHS Category 2:
Substances which
cause concern for
humans owing to the
possibility that they
may induce heritable
mutations in the germ
cells of humans.
Evidence of
mutagenicity support by
positive results in vitro
OR in vivo somatic cells
of humans or animals
Negative for
chromosomal
aberrations and gene
mutations, or no
structural alerts.
18 Values from GHS criteria for Specific Target Organ Toxicity Repeated Exposure (Chapter 3.9: Specific Target Organ
Toxicity' Repeated Exposure. 2009, United Nations).
19 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).
20 From GHS criteria (Chapter 3.5: Germ Cells Mutagenicity'. 2009, United Nations) and supplemented with considerations
for mutagenicity and genotoxicity in cells other than germs cells.
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
in the germ cells of
humans.
Mutagenicity and
genotoxicity in
somatic cells
OR
Evidence of
mutagenicity
supported by positive
results in in vitro AND
in vivo somatic cells
and/or germ cells of
humans or animals.
Carcinogenicity21
Very High
High
Moderate
Low
Known or
presumed human
carcinogen (GHS
Category 1Aand
1B)
Suspected human
carcinogen (GHS
Category 2)
Limited or marginal
evidence of
carcinogenicity in
animals (and
inadequate22 evidence
in humans)
Negative studies or
robust mechanism-
based structure
activity relationship
(SAR)
Neurotoxicity
(90-day study)18
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
Sensitization23
High
Moderate
Low
Skin sensitization
High frequency of
sensitization in
humans and/or high
potency in animals
(GHS Category 1A)
Low to moderate
frequency of
sensitization in human
and/or low to moderate
potency in animals
(GHS Category 1B)
Adequate data
available and not
GHS Category 1Aor
1B
Respiratory
sensitization
Occurrence in
humans or evidence
of sensitization in
humans based on
animal or other tests
Limited evidence
including the presence
of structural alerts
Adequate data
available indicating
lack of respiratory
sensitization
21 Criteria mirror classification approach used by the IARC (Preamble to the L4RC Monographs: B. Scientific Review and
Evaluation: 6. Evaluation and rationale. 2019) and incorporate GHS classification scheme (Chapter 3.6: Carcinogenicity.
2009, United Nations).
22 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."
23 Incorporates GHS criteria (Chapter 3.4: Respiratory or Skin Sensitization. 2009, United Nations).
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
(equivalent to GHS
Category 1A or 1B)
Irritation/
Corrosivity24
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)25
Chronic Aquatic
Toxicity Value
(L/E/ICso)25
Persistence (Measured in terms of level of
biodegradation)26
Bioaccumulation
Potential27
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 DPMA. 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 DPMA. Appendix B contains more information on each study.
DPMA is an acetic acid ester of a propylene glycol ether composed of two methylethoxy repeating
units with a methyl ether substitution on one of the terminal alcohols. It is a mixture of positional
isomers, in which the positions of the methyl groups are variable. EPA used best professional
judgement to select analogs for DPMA based on similarity in structure, physical-chemical properties,
and functionality, with the assumption that these chemicals will have similar environmental transport
and persistence characteristics, and bioavailability and toxicity profiles. All of the analogs presented
in Table 5 are either di- or tri-propylene glycol ethers that vary by the length of the aliphatic ether
chain length (methyl, ethyl, or butyl). Analogs are expected to metabolize via similar pathways in
14 Criteria derived from the Office of Pesticide Programs Acute Toxicity Categories (U.S. EPA. Label Review Manual.
2010).
25 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).
10 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).
11 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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vivo. The ester group in the target chemical is expected to rapidly hydrolyze in vivo to the
corresponding propylene glycol ether. Four of the analogs are isomeric mixtures that may contain
either the 1-methylethyl or 2-methylethyl substitution patterns in each propylene glycol unit.
However, for ethers of dipropylene glycol and tripropylene glycol, the structural differences among
the individual possible isomers are not expected to result in significant differences in the properties,
persistence or hazards of these chemicals. Based on these factors, the environmental and toxicological
effects of these analogs are expected to be very similar to those of DPMA.
Table 5: DPMA and Analog Structures
CASRN
Name
Structure
88917-22-0
Dipropylene glycol
methyl ether
acetate (DPMA)
(isomeric mixture)
O CH,
/CH3
H3C 0 0
ch3
30025-38-8
Dipropylene glycol
monoethyl ether
(isomeric mixture)
ch3
ho-^Y°\^o^ch3
CH,
Representative structure
34590-94-8
Dipropylene glycol,
methyl ether
(isomeric mixture)
CH,
h3c o
ch3
Representative structure
29911-28-2
Dipropylene glycol
monobutyl ether
ch3
ch3
25498-49-1
Tripropylene glycol
monomethyl ether
(isomeric mixture)
ch3
ho o ch3
Chfe ch3
Representative structure
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55934-93-5
Tripropylene glycol
n-butyl ether
ch3
(isomeric mixture)
HO 0 V
CH3 ch3
Dipropylene glycol, ethyl ether (CASRN 15764-24-6) and tripropylene glycol methyl ether (CASRN
20324-33-8) were also included in analog data searches; relevant, quality studies28 were only
identified for the CASRNs listed in Table 5.
6.1.1 Absorption, Distribution, Metabolism, and Excretion
Absorption
Based on the chemical's molecular weight, water solubility and log Kow (discussed in Section 3),
absorption through the lungs from inhalation exposure is likely, dermal absorption is expected to be
poor to moderate, and absorption though the gastrointestinal tract is expected to be moderate.
Distribution
Based on DPMA's log Kow, absorption and sequestration in fatty tissues is unlikely. Because DPMA
is water soluble, after an oral exposure it is expected to be widely distributed throughout the body to
various tissues including the liver, kidney and skin.
Metabolism
Because quality experimental data28 on DPMA's metabolite formation were limited, the Quantitative
Structure-Activity Relationship (QSAR) toolbox29 was used to run the rat liver S9 metabolism
simulator, the skin metabolism simulator, and the in vivo rat metabolism simulator. The QSAR
toolbox was used to identify putative DPMA metabolites. All three models predicted l-(2-methoxy-l-
methylethoxy)propan-2-ol, 3 -(3 -methoxypropoxy)-1 -Propanol, 1 -(3 -methoxypropoxy)propan-1 -ol
and acetic acid as metabolites of DPMA. Additional metabolites of DPMA identified by one or more
of the metabolism simulators included derivative esters, primary and secondary alcohols, carboxylic
acids, aldehydes, ketones and secondary diols.
Excretion
Based on DPMA's physical-chemical properties, it is expected that following exposure, DPMA will
be primarily excreted in the urine or exhaled as CO2. A minimal amount is expected to be excreted in
feces.
6.1.2 Acute Toxicity
EPA assessed the potential for mammalian toxicity from acute exposure to DPMA using results from
oral, dermal, and inhalation exposure studies.
28 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
29 https://www.oecd.org/chemicalsafetv/risk-assessment/oecd-qsar-toolbox.htm
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A study on rats dosed with a single exposure of DPMA by oral gavage indicated a LD50 of 5448
mg/kg in females and an LD50 greater than 5000 mg/kg in males (Robinson et al.. 2009; OECD. 2003;
ECHA. 1982c). These results indicate low concern for acute toxicity with LD50S above the low-
concern threshold of 2000 mg/kg for oral exposures.
A study on rabbits exposed to DPMA dermally reported no adverse effects at the single dose tested
(5000 mg/kg), resulting in an LD50 greater than 5000 mg/kg (OECD. 2003; ECHA. 1982a).
Additionally, a dermal study in rats reported an LD50 greater than 2000 mg/kg (ECHA. 1990c). These
results indicate low concern for acute, dermal toxicity with LD50 values above the low-concern
threshold of 2000 mg/kg for dermal exposures.
A study on rats exposed via inhalation to 5.7 mg/L (734 ppm) of DPMA vapor for four hours and
then observed for two weeks reported no mortalities (OECD. 2003; ECHA. 1982b). This
concentration exceeds the expected air saturation concentration of 135 ppm, indicating no effects at
complete air saturation (OECD. 2003). These results indicate low concern for acute, inhalation
toxicity based on no effects at air saturation.
6.1.3 Repeated Dose Toxicity
EPA assessed the potential for mammalian toxicity from repeated exposures to DPMA using
experimental data and read-across from analogs.
A study on rats exposed to DPMA by oral gavage for 28 days resulted in a no observed adverse effect
level (NOAEL) of 1000 mg/kg-day (ECHA. 1990e). These results indicate low concern for repeated
oral toxicity by exceeding the low-concern threshold of 100 mg/kg-day for 90-day studies or 300
mg/kg-day for approximately 30-day studies.
Two studies on rabbits dermally exposed to dipropylene glycol, methyl ether for 90-days reported a
lowest observed adverse effect level (LOAEL) of 9500 mg/kg-day (Dow Chemical. 2000b; Rowe et
al.. 1954) and a NOAEL of 4750 mg/kg-day (Dow Chemical. 2000a). Further, a study on rats
dermally exposed to dipropylene glycol, methyl ether for 28 days reported a NOAEL of 714 mg/kg-
day (Fairhurst et al.. 1989). EPA also considered a study on rabbits dermally exposed to another
analog, tripropylene glycol monomethyl ether, for 90 days. The study reported a NOAEL of 960
mg/kg-day and a LOAEL of 2900 mg/kg-day based on decreased body weight and increased kidney
weight (Dow Chemical. 2000c; Rowe et al.. 1954).These results indicate low concern for repeated
dermal toxicity by exceeding the low-concern threshold of 200 mg/kg-day for 90-day studies or 600
mg/kg-day for approximately 30-day studies.
A 13-week inhalation study in rats and rabbits exposed to dipropylene glycol, methyl ether vapor
reported no adverse effects at the highest tested concentration (1.212 mg/L), resulting in a no
observed adverse effect concentration (NOAEC) of 1.212 mg/L (Landry andYano. 1984). These
results indicate low concern for repeated inhalation toxicity by exceeding the low-concern threshold
of 1 mg/L for vapor inhalation exposures.
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6.1.4 Reproductive and Developmental Toxicity
EPA used read across from analogs to evaluate DPMA's potential to induce mammalian reproductive
and developmental toxicity.
A one-generation reproductive study in rats exposed to dipropylene glycol monobutyl ether by oral
gavage reported a reproductive NOAEL of 1000 mg/kg-day (ECHA. 1994). These results indicate
low concern for reproductive toxicity by exceeding the low-concern threshold of 250 mg/kg-day.
A developmental inhalation study in rats exposed to tripropylene glycol methyl ether aerosol from
gestation days (GD) 6-15 reported a NOAEC of 8.9 mg/L (Bio-Research Laboratories LTD. 1985a).
Another developmental inhalation study in rats exposed to tripropylene glycol monomethyl ether
aerosol from GD 6-15 reported a NOAEC of 1 mg/L-day (129 ppm) (Bio-Research Laboratories
LTD. 1985b). Two studies where rats were exposed from GD 6-15 and rabbits were exposed from
GD 7-19 to dipropylene glycol methyl ether vapor both reported NOAECs of 0.45 mg/L (53 ppm),
which is above dipropylene glycol methyl ether's theoretical air saturation vapor concentration of 26
ppm (ECHA. 1990a. b). These results indicate low concern for developmental toxicity from vapor
exposures based on no effects at air saturation and from aerosols by exceeding the low-concern
threshold of 0.5 mg/L for aerosol inhalation exposures.
6.1.5 Genotoxicity
EPA used experimental studies and read-across from analogs to assess DPMA's potential for
genotoxicity as a potential indicator of genotoxic carcinogenicity.
Two in vitro gene mutation studies in Salmonella typhimurium and E. coli exposed to DPMA resulted
in negative findings with and without metabolic activation (OECD. 2003).
EPA used read-across from analogs to assess genotoxicity through other mechanisms. Tripropylene
glycol monomethyl ether did not elicit unscheduled DNA synthesis in rat hepatocyte cells (Dow
Chemical. 1982). A study on mice injected with dipropylene glycol monobutyl ether demonstrated
negative results for significant increases in the presence of micronuclei (OECD. 2003). Several
studies on chromosomal aberrations in Chinese hamster ovary cells were available. Rat liver cells and
Chinese hamster lung cells exposed to dipropylene glycol, methyl ether indicated negative results for
chromosomal aberrations (ECHA. 2000b; Shell Chemical. 1983). Chinese hamster ovary cells
exposed to dipropylene glycol monoethyl ether were negative for chromosomal aberrations (ECHA.
1997). Chinese hamster ovary cells had mixed results for increases in chromosomal aberrations when
exposed to dipropylene glycol monobutyl ether. One study reported negative results for inducing
aberrations with and without activation (OECD. 2003). Two other studies reported dipropylene glycol
monobutyl ether as positive for inducing chromosomal aberrations with and without activation;
however, these results were observed at cytotoxic concentrations (OECD. 2003). Weighing the
negative results in several cell lines with the positive results occurring only at cytotoxic
concentrations, EPA interprets these results to indicate DPMA has low concern for inducing
genotoxicity.
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6.1.6 Carcinogenicity
Because quality experimental data on DPMA were limited, EPA relied on publicly available
quantitative structure activity relationship (QSAR) models and structural alerts (SA) to assess the
carcinogenic potential for DPMA. Structural alerts represent molecular functional groups or
substructures that are known to be linked to the carcinogenic activity of chemicals. The most common
structural alerts are those for electrophiles (either direct acting or following activation). Modulating
factors that will impact the carcinogenic potential of a given electrophile will include its relative
hardness or softness, its molecular flexibility or rigidity, and the balance between its reactivity and
stability.3" For this chemical, there is an absence of the types of reactive structural features that are
present in genotoxic carcinogens. DPMA is not an electrophile. ISS profiler, a QSAR model,31
identified an aldehyde metabolite alert; however, this aldehyde metabolite is expected to be short
lived and eliminated from the body. Further, the Virtual models for property Evaluation of chemicals
within a Global Architecture (VEGA) models"32 results indicate dipropylene glycol butyl ether has
low potential to be carcinogenic or mutagenic.
DPMA's metabolism and excretion, lack of structural alerts, and experimental genotoxicity studies
indicate that this chemical is unlikely to be carcinogenic or mutagenic.
6.1.7 Neurotoxicity
No guideline neurotoxicity studies on DPMA or closely related analogs were available to assess the
potential for DPMA to cause neurotoxicity. However, EPA reviewed supporting evidence from
repeated dose studies and ToxCast33 to inform EPA's assessment of neurotoxicity.
A repeated-dose study on rats exposed to dipropylene glycol monoethyl ether by oral gavage reported
minimal effects on the limited neurological endpoints that were evaluated. Effects to hindlimb grip
strength (magnitude of effect not reported) were observed in female rats at oral doses of dipropylene
glycol monoethyl ether at 1000 mg/kg-day in a 90-day oral gavage study. Hindlimb grip strength was
not affected by treatment in males from this study and no effects were noted in males or females
during a 2-week recovery period. Dipropylene glycol monoethyl ether did not produce
histopathological lesions in the brain, spinal cord and sciatic nerves or affect field or motor activity
measurements (ECHA. 2000a).
A 13-week inhalation study of dipropylene glycol methyl ether on rats and rabbits did not report
histopathological effects in the brain, peripheral nerve, or spinal cord at a concentration of 1.212
mg/L-day (Landry and Yano. 1984).
30 "Fundamental and Guiding Principles for (Q)SAR Analysis of Chemical Carcinogens with Mechanistic Considerations:
Series on Testing and Assessment, No. 229." 2015. Environment Directorate, Joint Meeting of the Chemicals Committee
and the Working Party on Chemicals, Pesticides and Bio techno logy.
31 Carcinogenicity alerts by ISS 2.4 profiler as encoded in the QSAR Toolbox 4.3 (qsartoolbox.org).
32 There are four carcinogenicity models housed within the VEGA 1.1.4 software tool available from
https://www.vegahub.eu. A summary of the results from these models is provided in Appendix B.
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ToxCast34 assays related to neurological functions were not identified for DPMA. Results for
tripropylene glycol n-butyl ether included 8 in vitro high throughput biochemical- and cell-based
assays related to neurological functions.35 Bioactivity was not induced in any assay by tripropylene
glycol n-butyl ether.
DPMA's low-concern findings for other human health hazard endpoints, including, but not limited to,
toxicity from acute and repeated exposures, and the lack of alerts through high-throughput assays,
indicate low concern for neurotoxicity.
6.1.8 Skin Sensitization
No quality experimental studies36 on DPMA or closely related analogs were available to assess the
potential for DPMA to cause skin sensitization. However, no structural alerts were identified for
protein binding potential of DPMA in regard to skin sensitization, using the QSAR Toolbox, Version
4.2. These results indicate DPMA is of low concern for skin sensitization.
6.1.9 Skin Irritation
EPA assessed dermal irritation effects using experimental data in rabbits. One study demonstrated
DPMA induced slight erythema in one of six animals at 24 hours, but these effects were fully
reversible by 72 hours (OECD. 2003; ECHA. 1982e). Another study reported DPMA as negative for
inducing skin irritation (ECHA. 1990f). These studies indicate DPMA 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 DPMA displayed erythema in three of six rabbits at 1 hour, but the effects were fully reversible by
24 hours (OECD. 2003; ECHA. 1982d). Another study reported negative results and indicated DPMA
was non-irritating (ECHA. 1990d). These studies indicate DPMA is of low concern for eye irritation.
6.1.11 Hazards to Potentially Exposed or Susceptible Subpopulations
The above information supports a low human health hazard finding for DPMA 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 DPMA.
34 https://actor.epa. go v/dashboard/. Chemical specific assay list can be found at
https://actor.epa.gOv/dashboard/#chemical/55934-93-5.
35 Identified by supplemental information in Chushak Y., Shows H., Gearhart J., Pangbum H. 2018. In silico identification
of protein targets for chemical neurotoxins using Toxcast in vitro data and read-across within the QSAR toolbox.
Toxicology Research issue 3. Supplemental files:
https://pubs.rsc.Org/en/content/articlelanding/2018/tx/c7tx00268h#idivAbstract.
30 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
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6.2 Environmental Hazard
EPA assessed environmental hazard for DPMA based on available acute toxicity experimental data
and estimated chronic toxicity values using the Ecological Structure Active (ECOSAR) Predictive
Model.37 Appendix B contains a summary of the reasonably available environmental hazard data.
6.2.1 Acute Aquatic Toxicity
EPA assessed environmental hazard from acute exposures to DPMA. Aquatic vertebrates exposed to
DPMA resulted in an LC50 of 161 mg/L (OECD. 2003 ). Invertebrates exposed to DPMA resulted in
an LC50 of 1090 mg/L (OECD. 2003; ECHA. 1983b). Algae exposed to DPMA resulted in an EC50
greater than 1000 mg/L (ECHA. 2000c). 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
Chronic toxicity values estimated using ECOSAR for aquatic vertebrates, invertebrates, and algae
were 15 mg/L, 370 mg/L, and 32 mg/L respectively. These toxicity values indicate that DPMA 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
EPA assessed the environmental persistence for DPMA using available experimental data on both
ready biodegradation and inherent biodegradation.
Varied results are observed in the ready test data available for DPMA. Due to the differences in
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. 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 rapidly in the environment and has 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.
In one stringent ready test similar to OECD 301C, using a test concentration of 100 mg/L, DPMA did
not pass the criteria based on O2 consumption and was considered not readily biodegradable under
aerobic conditions (OECD. 2003 ECHA. 2000. 4985139 ECHA. 2000. 4985139). However, 100%
primary degradation was observed in this test, indicating that the parent compound is not persistent
37https://www.epa.gov/tsca-screening-tools/ecological-striicture-activity-relationships-ecosar-predictive-model)
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under the conditions of this test. In addition, results from modified ready biodegradation tests using
adapted and acclimated inocula verify that DPMA is ultimately biodegradable under aerobic
conditions (OECD. 2003; ECHA. 1996). In addition, tripropylene glycol n-butyl ether, a closely
related analog, passed two OECD 301-series ready tests under aerobic conditions and was considered
readily biodegradable. Tripropylene glycol n-butyl ether met the 10-day window at a concentration of
90 mg/L in the OECD 301F test, but did not meet the 10-day window at 32 mg/L in the OECD 301F
test (Dow Chemical. 1998; ECHA. 1998) and 20 mg DOC/L in the OECD 301A test (ECHA. 2002).
Based on structural analysis, tripropylene glycol n-butyl ether is expected to degrade at a slower rate
compared to DPMA because it has more propylene glycol ether groups. Based on this analysis,
DPMA can be considered readily biodegradable by analogy to tripropylene glycol n-butyl ether. An
inherent biodegradability test OECD 302B (ECHA. 1993) for tripropylene glycol n-butyl ether and a
BOD5 test for DPMA (ECHA. 1983a) provide additional evidence that these substances are at least
inherently and ultimately biodegradable under aerobic conditions. Furthermore, the microbial
inhibition tests indicate that these substances are non-toxic to microbial populations found in sewage
treatment plants (ECHA. 2000d).
Anaerobic biodegradation data were not available for DPMA or closely related analogs. Though
BIOWIN modeling did not predict this chemical to anaerobically biodegrade quickly, these results do
not indicate this chemical would not anaerobically biodegrade. DPMA'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.
Based on the available information, the experimental data indicate that DPMA is readily
biodegradable under aerobic conditions, and complete mineralization of this chemical has been
reported using both standard and non-standard test methods. No degradation products of concern
were identified for this chemical substance. The available biodegradation results meet the low-
concern threshold and indicate this chemical will have low persistence.
6.3.2 Bioaccumulation Potential
Based on the estimated bioaccumulation factor (BAF) value of 1.1 using the Estimation Programs
Interface (EPI) Suite models,38 DPMA is expected to have low potential for bioaccumulation in the
environment based on the low-concern threshold of less than 1000.
38 https://www.epa.gov/tsca-screeniiig-tools/epi-suite1m-estimation-program-mterface
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7. Exposure Characterization
EPA considered reasonably available information on exposure for DPMA. In general, there is limited
information on exposure for low-hazard chemicals. EPA determined the CDR database and certain
other sources of DPMA use information are sources of information relevant to DPMA's exposure
potential. Of these sources, EPA determined that the CDR database contained the primary source of
information from other databases and public sources (listed in Table A.2). EPA used these sources
only where they augmented information from the CDR database to inform intended, known, or
reasonably foreseen uses (Section 5).
As shown in Tables 3 and A.3, DPMA is a solvent used in processing (incorporation into an article
and into a formulation, mixture, or product) in the paints, coatings, and industrial printing ink
manufacturing sectors. It is used in a variety of industrial, consumer, and commercial uses. Non-
TSCA uses are beyond the scope of this assessment because of the exclusions under TSCA section
3(2) (See Table A.3).
Under the conditions of use identified in Table 3, EPA assessed the potential exposure to the
following categories: the environment, the general population, and potentially exposed or susceptible
subpopulations including workers and consumers.
7.1 Production Volume Information
Production volume information for DPMA is based on an analysis of the CDR from 1986 to 2015.39
Prior to 2011, DPMA was not reported in the CDR. This does not mean it was not being produced or
imported, but more likely that no single entity site was producing above the reporting threshold of
generally 25,000 lb. per site per year. Between reporting years 2011 and 2013, aggregate production
volume for DPMA was between 1,000,000 and 10,000,000 lbs., and in reporting years 2014 and 2015
between 10,000,000 and 50,000,000 lbs. of DPMA was produced or imported.
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 DPMA. Exposure is also possible from other
activities, such as distribution and disposal. These activities could result in releases of DPMA to
media including surface water, landfills, and air.
EPA expects high levels of removal of DPMA during wastewater treatment (either directly from the
facility or indirectly via discharge to a municipal treatment facility or Publicly Owned Treatment
Works (POTW)). Further, DPMA 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 into carbon
dioxide and water. Therefore, any release of this chemical to surface water is expected to break down,
reducing exposure to aquatic organisms in the water column and groundwater sources of drinking
water, including well water. Based on the estimated log Koc (Section 3), DPMA is expected to have
39
The CDR requires manufacturers (including importers) to report information on the chemicals they produce domestically
or import into the U.S above 25,000 lb. per site per year.
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negligible adsorption to sediment, reducing the potential toxicity to benthic organisms. DPMA'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 and anaerobic
conditions (aerobic and anaerobic biodegradation are discussed in Section 6.3.1).
If incineration releases during manufacturing and processing occur, EPA expects significant
degradation of DPMA 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 DPMA from the potential
environmental releases described above. Air exposure is unlikely from incineration. If DPMA is
present in the air from volatilization, it is expected to be reduced because of its short atmospheric
half-life of less than 4 hours (see Table 2 in Section 3). DPMA 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. Further, given the low
bioaccumulation or bioconcentration potential of DPMA, oral exposure to DPMA via fish ingestion is
unlikely.
7.4 Exposures to Potentially Exposed or Susceptible Subpopulations
EPA identified workers as potentially exposed or susceptible subpopulations based on greater
exposure to DPMA than the general population during manufacturing, processing, distribution, use,
and disposal. EPA identified consumers as a population that may experience greater exposure to
DPMA 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), DPMA is a liquid under
ambient conditions. Based on DPMA'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, DPMA is expected to be volatile at ambient
temperatures, and therefore workers may be exposed through inhalation of vapors. However, if
DPMA is in a dilute form, the estimated Henry's Law constant for DPMA suggests volatilization
from water and aqueous solutions is expected to be minimal. Workers may be exposed to DPMA in
manufacturing, processing, distribution, use, and disposal.
7.4.2 Exposures to Consumers
Consumers may be exposed to DPMA through the use of ink, toner, and colorant products, laundry
and dishwashing products; cleaning and furnishing care products; adhesives and sealants; and anti-
freeze and de-icing products, among others (Table 3). For all these uses, if dermal contact does occur,
DPMA is expected to have poor to moderate absorption through the skin based on its molecular
weight, water solubility and partitioning coefficient (Section 3) and experimental data (Section 6.1.1).
If the chemical is in an aerosol product and inhalation exposure occurs, DPMA's absorption from the
lungs is likely. EPA does not include intentional misuse, such as people drinking products containing
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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). DPMA is expected to be metabolized and excreted, further reducing the duration of
exposure.
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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 DPMA against each of the priority designation considerations in 40 CFR
702.9(a), 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 DPMA. EPA used this information to
inform its proposed determination of whether DPMA would meet the statutory criteria and
considerations for proposed designation as a low-priority substance.
• Hazard potential:
For DPMA'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 DPMA is of low concern for human
health and environmental hazard across the range of endpoints in these low-concern criteria.
• Exposure potential:
To understand exposure potential, EPA gathered information on physical-chemical properties,
production volumes, and the types of exposures likely to be faced by workers, the general population,
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children, and consumers (discussed in Sections 3 and 7). EPA also gathered information on
environmental releases. EPA identified workers, the general population, consumers, and the
environment as most likely to experience exposures. EPA determined that while the general
population, consumers, and workers may be exposed to DPMA, exposure by the dermal pathway is
limited by DPMA's physical-chemical properties. If ingestion occurs, DPMA is expected to be
metabolized and excreted, reducing the duration of exposure. Inhalation of DPMA in dilute products
is expected to be minimal; however, workers may be exposed to vapors of neat DPMA. If DPMA is
released into the environment, its exposure potential will be reduced through biodegradation.
Rationale: While workers, consumers, and children could be exposed to DPMA during processing,
manufacturing, distribution, use, or disposal, these exposures do not pose a significant risk because of
the chemicals 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 DPMA 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 DPMA 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 DPMA is readily and inherently 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 DPMA 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 DPMA as a potentially exposed or
susceptible subpopulation (described in more detail in Section 7). EPA also identified consumers as a
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potentially exposed subpopulation because of their use of ink, toner, and colorant products, cleaning
and furnishing care products, laundry and dishwashing products, and other types of products.
Rationale: EPA did not identify hazard effects for this chemical that would make any population
susceptible. EPA expects workers and consumers to have a higher exposure to DPMA than the
general population. Because of the chemical's low-concern hazard properties, this exposure does not
pose a significant increase in risk for workers or consumers.
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 DPMA 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 DPMA 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 DPMA near significant sources of drinking water. For this criterion, EPA focused
primarily on the chemical substance'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, DPMA 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, DPMA 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 DPMA 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.
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, DPMA would degrade in aerobic environments
(see Section 6.3.1). Together, these factors mean that any exposures to this chemical through drinking
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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 DPMA does not appear on
these lists. The lists reviewed include EPA's List of Lists
(https://www.epa.gov/sites/production/files/2015-Q3/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 DPMA 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 DPMA and related potential exposures and
hazards.
Rationale: EPA evaluated the conditions of use of DPMA (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
DPMA'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
DPMA meets the standard for a high-priority substance, based on its low-hazard profile under the
current conditions of use. EPA proposes to find that even if conditions of use broaden, resulting in an
increase in the frequency or amount of exposures, the analysis conducted to support the screening-
level review under 40 CFR 702.9(a)(5) would not change significantly. In particular, the analysis of
concern for hazard, which forms an important basis for EPA's findings, would not be impacted by a
change in conditions of use. Therefore, such changes would not support a finding that DPMA 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.
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8.6. The Volume or Significant Changes in Volume of the Chemical
Substance Manufactured or Processed
Approach: EPA evaluated the current production volumes of DPMA (Section 7.1) and related
potential exposures (Sections 7.2 through 7.4).
Rationale: EPA used reasonably available information on production volume (see Appendix A) in
considering potential risk. It is possible that designation of DPMA as a low-priority substance could
result in increased use and higher production volumes. EPA expects, however, that any changes in
DPMA's production volume would not alter the Agency's assessment of low concern given the
chemical's low-hazard profile. EPA bases this expectation on DPMA's consistently low-concern
hazard characteristics across the spectrum of hazard endpoints. This expectation would apply, even
with a significant change in the volume of the chemical manufactured or processed and resultant
increased exposures.
Proposed conclusion: Based on this screening criteria under 40 CFR 702.9(a)(6), EPA proposes to
find that even if production volumes increase, resulting in an increase in the frequency or level of
exposure, DPMA 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. EPA bases this expectation on
DPMA'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.
8.7. Other Considerations
EPA did not identify other considerations for the screening review to support the proposed
designation of DPMA 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 DPMA 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, 31 companies manufactured or imported DPMA at 31 sites for reporting year 2015.
Table A.l presents the historic production volume of DPMA from the CDR (previously known as the
Inventory Update Rule, or IUR) from 1986-2015. Prior to 2011, DPMA was not reported in the CDR.
This does not mean it was not being produced or imported, but more likely that no single entity site
was producing above the reporting threshold. Between reporting years 2011 and 2013, aggregate
production volume for DPMA was between 1,000,000 and 10,000,000 lbs., and in reporting years
2014 and 2015 between 10,000,000 and 50,000,000 lbs. of DPMA was produced or imported.
Table A.1:1986-2015 National Production Volume Data for DPMA (Non-Confidential Production Volume in
Pounds)
1986 1990 1994 1998 2002 2006
2011
2012
2013
2014
2015
Unknown1
1 M-
10 M
1 M-
10 M
1 M-
10 M
10 M -
50 M
10 M -
50 M
Source(s):
EPA (2018a; 2017b; 2006; 2002)
Note(s):
K = Thousand; M = Million; NDR = No data reported
1. The CAS RN 88917-22-0 could not be found in the 2006 or 1986-2002 IUR. It
is possible that no single entity triggered
| the reporting threshold in this year.
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A.2. Uses
A.2.1 Methods for Uses Table
Section A.2 provides a list of known uses of DPMA, organized by category of use. To compile the
uses, EPA searched publicly available databases listed in Table A.2 and conducted additional Google
searches to clarify uses. Search terms differed among databases because of different search term
requirements for each database (i.e., some databases search by CASRN while others search by
chemical name).
Table A.2: Sources Searched for Uses of DPMA
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)
88917-22-0
No
Canada Chemicals
Management Plan
information sheets
Government of Canada
(2018)
88917-22-0
No
Chemical and Product
Categories (CPCat)
CPCat etal. (2015)
88917-22-0
Yes
ChemView2
EPA (2018a)
88917-22-0
Yes
Children's Safe Product
Act Reported Data
Washington State Dept. of
Ecology (2018)
88917-22-0
No
Consumer Product
Information Database
(CPID)
DeLima Associates (2018)
88917-22-0
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
methyl ether acetate
Yes
DrugBank
DrugBank (2018)
Dipropylene glycol
methyl ether acetate;
88917-22-0
No
European Chemicals
Agency (ECHA)
Registration Dossier
ECHA (2018)
88917-22-0
Yes
eChemPortal2
OECD (2018)
88917-22-0
No
Envirofacts2
EPA (2018b)
88917-22-0
No
Functional Use Database
(FUse)
EPA (2017a)
88917-22-0
Yes
Kirk-Othmer Encyclopedia
of Chemical Technology
Kirk-Othmer (2006)
Dipropylene glycol
methyl ether acetate;
88917-22-0
No
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Table A.2: Sources Searched for Uses of DPMA
Title
Author and Year
Search Term(s)
Found Use Information?1
Non-Confidential 2016
Chemical Data Reporting
EPA (2017b)
88917-22-0
Yes
(CDR)
PubChem Compound
Kim etal. (2016)
88917-22-0
Yes
Safer Chemical Ingredients
List (SCIL)
EPA (2018d)
88917-22-0
Yes
Synapse Information
Synapse Information
Dipropylene glycol
Yes
Resources2
Resources (2009)
methyl ether acetate
Resource Conservation
and Recovery Act (RCRA)
EPA (2018c)
DPMA; dipropylene;
glycol ether
No
Scorecard: The Pollution
Information Site
GoodGuide (2011)
88917-22-0
No
Skin Deep Cosmetics
Database
EWG (2018)
88917-22-0
No
Toxics Release Inventory
(TRI)
EPA (2018e)
88917-22-0
No
TOXNET2
NLM (2018c)
88917-22-0
Yes
Ullmann's Encyclopedia of
Industrial Chemistry
Ullmann's (2000)
Dipropylene glycol
methyl ether acetate;
88917-22-0
No
Additional sources identified from reasonably available information
Chemical Consultants Inc.
Chemical Consultants Inc.
(2018)
Incidentally identified
while researching into
Dow Chemical Company
(Dow)
Dow (2015)
details of this
chemical's uses and
products.
Yes
Note(s):
1. If use information was found in the resource, it will appear in Table 3-2 unless otherwise noted.
2. This source is a group of databases; thus, the exact resource(s) it led to will be cited instead of the database as whole.
The U.S. Patent and Trademark Office has an online database that shows 398 patents referencing
"dipropylene glycol methyl ether acetate" (USPTO 2018). Although patents could be useful in
determining reasonably foreseen uses, it is difficult to confirm whether any of the patented
technologies are currently in use. Uses inferred from patents containing DPMA were not included in
Table A.3. Note that the uses in Table A.3 that are covered under TSCA are included in Section 5,
Table 3 of this document.
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A.2.2 Uses of DPMA
Table A3: Uses of DPMA
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Automotive and Transportation
CPCat (2019)
Auto and tire care
Industrial
CPCat reports use of DPMA in retail automotive care and cleaning products, repair, fluids and
lubricants, and tire accessories.
Expected users are industrial.
NLM (2018b); Meguiars Inc. (2008)
Tire protectant
Consumer
The Household Products Database identifies one tire protectant product that contains DPMA.
The Household Products Database generally includes consumer products; therefore, the
expected users are consumer.
SPIN (2018)
Trade and repair of motor vehicles and
motorcycles
Industrial
SPIN reports use of DPMA in the wholesale and retail trade and repair of motor vehicles and
motorcycles in Nordic countries. No further information about this use could be found, and it is
unknown whether this is an ongoing use in the United States.
Expected users are industrial based on inclusion in SPIN'S industrial uses database.
SPIN (2018)
Transport activities
Industrial
SPIN reports use of DPMA in supporting and auxiliary transport activities (including
warehousing), as well as activities of travel agencies, in Nordic countries. No further
information about this use could be found, and it is unknown whether this is an ongoing use in
the United States.
Expected users are industrial based on inclusion in SPIN'S industrial uses database.
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Table A.3: Uses of DPMA
Use
Expected Users
Description of Use and References
SPIN (2018)
Transportation equipment
manufacturing
Industrial
SPIN reports use of DPMA in the manufacture of other transport equipment in Nordic
countries. No further information about this use could be found, and it is unknown whether this
is an ongoing use in the United States.
Expected users are industrial based on inclusion in SPIN'S industrial uses database.
TSCA Conditions of Use: Cleaning
CDR reports use of liquid DPMA in consumer and commercial cleaning and furnishing care products. CDR reports concentrations (by weight) of less than one percent in
consumer products, at least 90 percent in commercial products, and at least one percent but less than 30 percent in consumer and commercial products (EPA 2017b).
ECHA identifies use of DPMA in commercial washing and cleaning products in European countries (ECHA 2018).
EPA (2017b); DeLima Associates (2015); CPCat (2019); ECHA (2018)
Air care products
Consumer
CDR reports use of liquid DPMA in consumer air care products at concentrations (by weight)
of less than 30 percent and at least 90 percent. CDR does not define what is included in air
care products, however this category generally includes air fresheners, candles, etc. CPID
lists multiple air fresheners that contain DPMA. ECHA identifies use of DPMA in air care
products in European countries.
Expected user is consumer based on CDR's consumer/commercial classification.
EPA (2017b)
Laundry and dishwashing products
Consumer
CDR reports use of DPMA in consumer laundry and dishwashing products at concentrations
of less than one percent by weight.
Expected users are consumer based on CDR's consumer/commercial classification.
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Table A.3: Uses of DPMA
Use
Expected Users
Description of Use and References
Penetrating solvent/lubricant
Consumer, commercial
DeLima Associates (2014); CPCat (2019); Monument Chemical (2018); Synapse Information
Resources (2009)
Monument Chemical identifies DPMA as a solvent used for dissolving resins in paints,
coatings, lacquers, and inks. Synapse Information Resources identifies use in cleaning
solvents and as a soil penetrant in cleaners. CPID lists one commercial penetrating solvent
that contains DPMA.
Expected user is consumer and commercial based on CDR's consumer/commercial
classification.
Soap, cleaning compound, and toilet
preparation manufacturing
Industrial
EPA (2017b)
CDR reports use of DPMA as a solvent and odor agent in processing during soap, cleaning
compound, and toilet preparation manufacturing.
Expected users are industrial based on inclusion in CDR's Industrial Processing and Use
report.
TSCA Conditions of Use: Media
Ink, toner, and colorant products
Consumer, commercial,
industrial
EPA (2017b); Monument Chemical (2018); Synapse Information Resources (2009); NLM
(2018a); ECHA (2018); Dow (2015); SPIN (2018); Dow (2017)
CDR reports use of liquid DPMA in ink, toner, and colorant products at concentrations of at
least one percent but less than 30 percent by weight. CDR also reports use of liquid DPMA as
a solvent in processing during printing ink manufacturing. Monument Chemical and Haz-Map
identify use of DPMA in silk screen inks, while Dow and Synapse Information Resources
identify use as a solvent for (silk screen) inks. ECHA identifies use of DPMA in consumer inks
and toners as well as ink mixing, transferring in European countries. SPIN reports use of
DPMA in printing inks, dyestuff, pigments, and coloring agents in Nordic countries.
Expected consumers are consumer and commercial based on CDR's consumer/commercial
classification and industrial based on CDR's Industrial Processing and Use report.
VI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table A.3: Uses of DPMA
Use
Expected Users
Description of Use and References
SPIN (2018)
Photo-chemicals and reprographic
agents
Consumer, commercial,
industrial
SPIN reports use of DPMA in photo-chemicals and reprographic agents in Nordic countries.
No further information about this use could be found, and it is unknown whether this is an
ongoing use in the United States.
Expected users are assumed to be consumer, commercial, and industrial.
SPIN (2018)
Printing and reproduction of recorded
media
Industrial
SPIN identifies use of DPMA by publishers and printers and for printing and reproduction of
recorded media in Nordic countries. No further information about this use could be found, and
it is unknown whether this is an ongoing use in the United States.
Expected users are industrial based on inclusion in SPIN'S industrial uses database.
ECHA (2018)
Screen printing and roll coating
Industrial
The ECHA registration dossier identifies use of DPMA in screen printing and roll coating
processes by industrial users in European countries.
Expected users are industrial based on inclusion in ECHA's uses at industrial sites.
Chemical Consultants Inc. (2018)
Screen wash
Consumer, commercial,
industrial
Chemical Consultants Inc. identifies use of DPMA in screen wash to dissolve UV-, Plastisol-,
and water-based inks.
Expected users are assumed to be consumer, commercial, and industrial.
VII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table A3: Uses of DPMA
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Other Manufacturing
SPIN (2018)
Chemical manufacturing
Industrial
SPIN reports use of DPMA in the manufacture of chemicals and chemical products in Nordic
countries. No further information about this use could be found, and it is unknown whether this
is an ongoing use in the United States.
Expected users are industrial based on inclusion in SPIN'S industrial uses database.
SPIN (2018)
Manufacture of rubber and plastic
products
Industrial
SPIN reports use of DPMA in the manufacture of rubber and plastic products in Nordic
countries. No further information about this use could be found, and it is unknown whether this
is an ongoing use in the United States.
Expected users are industrial based on inclusion in SPIN'S industrial uses database.
TSCA Conditions of Use: Miscellaneous
Synapse Information Resources (2009); ECHA (2018)
Adhesives
Consumer
Synapse Information Resources identifies use of DPMA as a coupling agent and as a solvent
for adhesives. ECHA identifies use of DPMA in adhesives and sealants in European countries.
Expected users are consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Anti-freeze and de-icing products
Consumer
The ECHA registration dossier identifies use of DPMA in anti-freeze and de-icing products in
European countries.
Expected users are consumer based on inclusion in ECHA's consumer uses.
Synapse Information Resources (2009)
Electronics
Consumer, commercial,
industrial
Synapse Information Resources identifies use of DPMA as a solvent for electronic chemicals.
Expected users are assumed to be consumer, commercial, and industrial.
VIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table A.3: Uses of DPMA
Use
Expected Users
Description of Use and References
EPA (2017b); ECHA(2018)
Fragrance
Industrial
CDR reports use of liquid DPMA as an odor agent in the processing of fragrances, and ECHA
identifies use of DPMA in perfumes and fragrances in European countries. The International
Fragrance Association does not list DPMA as a current ingredient in its list of standards.
Expected users are industrial based on inclusion in CDR's Industrial Processing and Use
report.
ECHA (2018)
Lubricants, greases, and release
products
Consumer
ECHA identifies use of DPMA in lubricants, greases, and release products in European
countries.
Expected user is consumer based on inclusion in ECHA's consumer uses.
Mining
Consumer, commercial,
industrial
Synapse Information Resources (2009)
Synapse Information Resources identifies use of DPMA as a solvent for mining uses.
Expected users are assumed to be consumer, commercial, and industrial.
Synapse Information Resources (2009)
Oil field
Unknown
Synapse Information Resources identifies use of DPMA as a solvent for oil field uses. No
further information on this use could be found.
Expected users are unknown, due to the limited availability of information.
IX
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table A.3: Uses of DPMA
Use
Expected Users
Description of Use and References
EPA (2017b); Monument Chemical (2018); Synapse Information Resources (2009); NLM
(2018a); ECHA (2018); Dow (2015); SPIN (2018)
Paints and coatings
Consumer, commercial,
industrial
CDR reports use of liquid DPMA in paints and coatings at concentrations of at least 90 percent
by weight in commercial products and at least one percent but less than 30 percent by weight
in consumer and commercial products. CDR also reports use of DPMA as a solvent in paint
and coating manufacturing. Monument Chemical identifies use of DPMA as a solvent in paints
and coatings. Synapse Information Resources identifies use as a solvent for paints and epoxy
laminates and as a coalescent for architectural water-borne coatings. Haz-Map identifies use
of DPMA as an active and tailing solvent in coatings. ECHA identifies use of DPMA in coatings
and paints, thinners, and paint removers in European countries, and SPIN reports use in
paints, lacquers, and varnishes in Nordic countries. Dow identifies use of DPMA as an
industrial solvent for automotive paints and coatings (topcoats and refinishing), coil coatings
(protective finish), industrial maintenance coatings (corrosion control) and metal finishes.
Expected consumers are consumer and commercial based on CDR's consumer/commercial
classification and industrial based on CDR's Industrial Processing and Use report.
Synapse Information Resources (2009); ECHA (2018)
Polishes
Consumer
Synapse Information Resources identifies use of DPMA as a solvent for floor polishes. ECHA
identifies use of DPMA in polishes and wax blends in European countries.
Expected user is consumer based on inclusion in ECHA's consumer uses.
Synapse Information Resources (2009); ECHA (2018)
Surface treatment
Consumer
Synapse Information Resources identifies use of DPMA as a wetting agent. ECHA identifies
use of DPMA in non-metal surface treatment products in European countries.
Expected user is consumer based on inclusion in ECHA's consumer uses.
X
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table A3: Uses of DPMA
Use
Expected Users
Description of Use and References
ECHA (2018)
Textiles
Consumer
ECHA identifies use of DPMA in leather treatment products, textile dyes, and impregnation
products in European countries.
Expected user is consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Welding, soldering, and flux products
Consumer
ECHA identifies use of DPMA in welding, soldering, and flux products in European countries.
Expected user is consumer based on inclusion in ECHA's consumer uses.
EPA (2017b)
Wholesale and retail trade
Industrial
CDR reports use of liquid DPMA as a solvent in repackaging during wholesale and retail trade.
Expected users are industrial based on inclusion in CDR's Industrial Processing and Use
report.
Non-TSCA Uses
Synapse Information Resources (2009); ECHA (2018)
Agriculture
Consumer
Synapse Information Resources identifies use of DPMA as a solvent for agricultural uses.
ECHA identifies use of DPMA in biocidal products in European countries.
Expected users are consumer based on inclusion in ECHA's consumer uses.
EPA (2017b); DeLima Associates (2016)
Personal care products
Consumer, commercial
CDR reports use of liquid DPMA in commercial personal care products at concentrations of at
least 90% by weight. CPID identifies one consumer hair product that contains DPMA.
Expected users are commercial based on CDR's consumer/commercial classification, and
consumer based on CPID.
XI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table A.3: Uses of DPMA
Use | Expected Users | Description of Use and References
Children's Products
CDR reports did not include any uses in children's products; however, use in children's hair conditioner is found in this table.
Recycling and Disposal
In the 2016 CDR, one facility (CBI) reported that DPMA was recycled (recycled, remanufactured, reprocessed, or reused). Nineteen facilities reported that DPMA was not
recycled, while eight facilities withheld this information and three reported it as CBI.
XII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
A.3 References
California Dept of Pesticide Regulation. (2013). DPR Databases. Retrieved from
https: //www. cdpr. ca. gov/dprdatabase .htm
Chemical Consultants Inc. (2018). ECO-STRIP® PART A. Retrieved from
https://www.ccidom.com/us/en/products/enviroline/eco-strip-part-a/
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. (2014). CRC Knock'Er Loose Penetrating Solvent 03020, Aerosol, Professional Use.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/14009/standard/CRC%20Knock'Er%20Lo
ose%20Penetrating%20Solvent%2003020.%20Aerosol.%20Professional%20Use/03-003-063
DeLima Associates. (2015). Glade Pluglns Scented Oil Refills, Clean Linen. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/16699/standard/p%20class=%22pl%22%3
EGlade%20PlugIns%20Scented%200il%20Refills.%20Clean%20Linen-04/08/2015/p%3E/19-
001-722
DeLima Associates. (2016). Aussie Kids Bloomin Apple Detangler. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/18726/standard/p%20class=%22pl%22%3
EAussie%20Kids%20Bloomin%20Apple%20Detangler.%20Pump%20Sprav-
02/26/2016/p%3E/16-033-5 22
DeLima Associates. (2018). Consumer Product Information Database. Retrieved from
https: //www. whatsinproducts. com/
Descartes Datamyne. (2018). Descartes Datamyne Import-Export Database.
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. https://actor.epa.gov/cpcat/faces/home.xhtml
DrugBank. (2018). DrugBank Database. Retrieved from https://www.drugbank.ca/
European Chemicals Agency (ECHA). (2018). A mixture of RR and RS isomers. Retrieved from
https://echa.europa.eu/registration-dossier/-/registered-dossier/15979
EWG. (2018). Skin Deep Cosmetics Database. Retrieved from
https: //www.ewg. org/skindeep/#. W4RpIPlKiUk
GoodGuide. (2011). Scorecard: The Pollution Information Site. Retrieved from
http://scorecard.goodguide.com/chemical-profiles/index.tcl
Government of Canada. (2018). Chemical Substances: Services and Information. Retrieved from
https://www.canada.ca/en/health-canada/services/chemical-substances.html
XIII
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Kim, S., Thiessen, P. A., Bolton, E. E., Chen, J., Fu, G., Gindulyte, A., . . . Bryant, S. H. (2016).
PubChem Substance and Compound databases. Nucleic Acids Research, -/-/(Database issue),
D 1202-D 1213. doi: 10.1093/nar/gkv951
Kirk-Othmer. (2006). Kirk-Othmer Encyclopedia of Chemical Technology.
Meguiars Inc. (2008). Material Safety Data Sheet. Retrieved from
https: //www .msdsdigital. com/sv stem/file s/G7 4. PDF
Monument Chemical. (2018). Technical Product Information. Retrieved from
https://monumentchemical.com/uploads/files/TDS/DPMAc%20-%20TDS.pdf
Organisation for Economic Cooperation and Development (OECD). (2018). eChemPortal: Global Portal
to Information on Chemical Substances. Retrieved from
https: //www .echemportal. org/cchemportal/index.action
Substances in Preparations in Nordic Countries (SPIN). (2018).
DIPROPYLENGLYCOLMONOMETHYLETHERACETAT. Retrieved from
http://www.spin2000.net/spinmvphp/
Synapse Information Resources. (2009). Specialty Chemicals Source Book. Fourth Edition. Volume 1.
The Dow Chemical Company. (2015). Product Safety Assessment: DOWANOL DPMA Glycol Ether
Acetate. Retrieved from
http://msdssearch.dow.com/PublishedLiteratureDOWCQM/dh 096d/0901b8038096dbb5.pdf?file
path=productsafetv/pdfs/noreg/23 3 -00407 .pdf&fromPage=GetDoc
The Dow Chemical Company. (2017). Product Safety Assessment. Retrieved from
http://msdssearch.dow.com/PublishedLiteratureDOWCQM/dh 096d/0901b8038096dbb5.pdf?file
path=productsafetv/pdfs/noreg/23 3-00407.pdf&from Pagc=GctDoc
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/functional-use-database-fuse
U.S. Environmental Protection Agency (EPA). (2017b). Non-Confidential 2016 Chemical Data Reporting
(CDR). Retrieved from https://www.epa.gov/chemical-data-reporting
U.S. Environmental Protection Agency (EPA). (2018a). ChemView. Retrieved from
https: //chemvie w .epa. gov/chemview
U.S. Environmental Protection Agency (EPA). (2018b). Envirofacts Multisystem Search. Retrieved from
https://www3.epa.gov/enviro/facts/multisvstem.html
U.S. Environmental Protection Agency (EPA). (2018c). Look up table for BR Waste Code (National
Biennial RCRA Hazardous Waste Report). Retrieved from
https://iaspub.epa.gov/enviro/brs codes v2.waste lookup
XIV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
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). Haz-Map®: Information on Hazardous Chemicals
and Occupational Diseases. Retrieved from https://hazmap.nlm.nih.gov/categorv-
details?table=copvtblagents&id= 19021
U.S. National Library of Medicine (NLM). (2018b). Household Products Database. Retrieved from
https://hpd.nlm .nih.gov/cgi-bin/household/brands?tbl=brands&id=13006032
U.S. National Library of Medicine (NLM). (2018c). TOXNET Hazardous Substances Data Bank.
Retrieved from https://toxnet.nlm.nih.gov/cgi-bin/sis/search2
U.S. Patent and Trademark Office (USPTO). (2018). USPTO Patent Full-Text and Image Database.
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=5 O&TERM 1 =dipropvlene+glvcol+methyl+ether+acetate&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/
XV
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Appendix B: Hazard Characterization
Table B.1: Human Health Hazard
Acute Mammalian Toxicity
Source
Exposure
Route
Species & strain
(if available)
Duration
Doses and replicate number
Effect
Study Details
5016019
Oral (gavage)
Sprague Dawley
rats
Single
exposure,
14 day
observatio
n
Dose: 5000 mg/kg
Replicates: 5 per sex
LDso > 5000 mg/kg
Methods:
• Test substance reported as CAS RN
88917-22-0
• Purity not reported
• OECD Guideline 401
• GLP compliant
5015995,
4956637,
2530089
Oral (gavage)
Fischer F344 rats
Single
exposure,
14 days
observatio
n
Doses: Male and female: 630,
1300, 2500, 5000 and
Female: 10000 mg/kg
Replicates: 6 per sex per
group
Female: LD50: 5448
mg/kg (95% CI
4071-7635)
Male: LD50 > 5000
mg/kg
Methods:
• Test substance reported as CAS RN
88917-22-0
• Purity not reported
• Equivalent to OECD Guideline 401
• GLP compliant
Mortalities:
• 5000 mg/kg: 2/6 females
• 100000 mg/kg: 6/6 females
4956637,
5016017
Dermal
New Zealand
White rabbits
24 hour
exposure,
14 day
observatio
n
Dose: 5000 mg/kg
Replicates: 2 per sex
LD50 > 5000 mg/kg
Methods:
• Test substance reported as CAS RN
88917-22-0
• Purity not reported
• Equivalent to OECD Guideline 402
• GLP compliant
5016008
Dermal
Sprague-Dawley
rats
24 hour
exposure,
14 day
observatio
n
Doses: 500,100,1500, and
2000 mg/kg
Replicates: 2 per sex per
group, additional 5 Rats
exposed to 2000 mg/kg
LD50 > 2000 mg/kg
Methods
• Test substance reported as CAS RN
88917-22-0
• Purity not reported
• OECD Guideline 402
• GLP compliance not reported
XVI
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Table B.1: Human Health Hazard
4956637,
Inhalation
Fischer 344 rats
4 hour
Doses: 0 and 5.7 mg/L
LCso > 5.7 mg/L
Methods
5015984
exposure,
Replicates: 6 males per
• Test substance reported as CAS RN
14 day
group
88917-22-0
observatio
• Purity not reported
n
• OECD Guideline 403
• GLP compliant
Repeated Dose Toxicity
Source
Exposure
Species & strain (if
Duration
Doses and replicate
Effect
Study Details
Route
available)
number
5016010
Oral (gavage)
Sprague Dawley rats
28 days
Doses: 0,100, 250 and
NOAEL: 1000 mg/kg-
Methods:
1000 mg/kg-day
day
• Test substance reported as
Replicates: 5 per sex per
CASRN 88917-22-0
dose
• Purity not reported
• Equivalent to OECD Guideline
407
• GLP compliant
5077990
Oral
CD-1 rats
90 days
Doses: 0, 50, 225, and
NOAEL: 1000 mg/kg-
Methods:
1000 mg/kg-day
day
• Test substance reported as
Replicates: 10 per group
CASRN 30025-38-8
per sex
• Purity > 98%
• OECD Guideline 408
• GLP compliant
4946620
Inhalation
Fisher 344 rats
13 weeks
Doses: 0, 0.091, 0.393,
NOAEC: 1.212 mg/L-
Methods:
and 1.212 mg/L-day
day
• Test substance reported as
Replicates: 10 per group
CASRN 34590-38-8
per sex
• Purity: 99%
• GLP compliance not reported
4946620
Inhalation
New Zealand White
13 weeks
Doses: 0, 0.091, 0.393,
I NOAEC: 1.212 mg/L-
Methods:
rabbits
and 1.212 mg/L-day
Replicates: 10 per group
day
• Test substance reported as
CASRN 34590-38-8
per sex
• Purity: 99%
• GLP compliance not reported
XVII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.1: Human Health Hazard
4146480
Dermal
Porton-Wistar rats
28 days
Doses: 0,100, and 1000
mg/kg-day
Replicates: 8 males per
group
NOAEL: 1000 mg/kg-
day
Methods:
• Test substance reported as
CASRN 34590-38-8
• Purity not reported
• GLP compliance not reported
4956637
Dermal
Wistar rats
13 weeks, 5
days per week
Doses: 0, 91, 273, and
910 mg/kg-day
Replicates: 10 per sex
per group
NOAEL: 91 mg/kg-day
LOAEL: 273 mg/kg-day
based on decreased
body weights in males
and increases in white
blood cell counts in both
sexes
Methods:
• Test substance reported as
CASRN 29911-28-2
• Purity > 95%
• GLP compliance not reported
5077871
Dermal
Rabbits
90 days
Doses: 0, 2850, and 4750
mg/kg-day
Replicates: 5 males per
group
NOAEL: 4750 mg/kg-
day
Methods:
• Test substance reported as
CASRN 34590-38-8
• Purity not reported
• GLP compliance not reported
3041622,
4944882
Dermal
Rabbits
90 days
Doses: 0,1, 3, 5, and 10
mL/kg-day
Replicates: 5 males per
group
NOAEL: 9500 mg/kg-
day
Methods:
• Test substance reported as
CASRN 34590-38-8
• Purity not reported
• GLP compliance not reported
4944882,
5077872,
4956637
Dermal
Rabbits
90 days
Doses: 0, 960, 2900,
4800, and 9600 mg/kg-
day
Replicates: 5-8 males per
group
NOAEL: 960 mg/kg-day
LOAEL: 2900 mg/kg-
day based on
decreased body weight
and increased kidney
weight
Methods:
• Test substance reported as
CASRN 25498-49-1
• Purity not reported
• Pre-dates GLP compliance
XVIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.1: Human Health Hazard
Reproductive Toxicity
Source
Exposure
Route
Species & Strain (if available)
Duration
Doses and replicate
number
Effect
Study Details
5077928
Oral (gavage)
Sprague-Dawley rats
1 generation
Doses: 0, 50, 225, and
1000 mg/kg-day
Replicates:
32 per sex per dose
NOAEL: 1000
mg/kg-day
Methods:
• Test substance reported as
CASRN 30025-38-8
• Purity > 90.15%
• OECD Guideline 415
• GLP compliant
Developmental Toxicity
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and replicate number
Effect
Study Details
4956637
Dermal
Wistar-derived
SPF-bred Albino
Rats
GD 6-15
Doses: 0, 273, and 910
mg/kg-day
Replicates: 21-25 per dose
NOAEL: 910 mg/kg-
day
Methods:
• Test substance reported as CAS RN 29911 -
28-2
• Purity > 95%
• OECD Guideline 414
• GLP compliant
5077932
Inhalation
Albino rat
GD 6-15
Doses: 0, 0.3, 0.9, 2.7, and
8.9 mg/L-day
Replicates:
7 per dose
NOAEC: 8.9 mg/L-
day
Methods:
• Test substance reported as CASRN 25498-
49-1
• Purity: 98.5%
• GLP compliance not reported
5077931
Inhalation
New Zealand
White rabbits
GD 7-19
Doses: 0.076, 0.23, and 0.45
mg/L for 6 hours per day
Replicates: 16 per dose
NOAEC: 0.45 mg/L-
day
Methods:
• Test substance reported as CASRN 34590-
94-8
• Purity 100%
• EPA OTS 798.4350
GLP compliant
XIX
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Table B.1: Human Health Hazard
5077930
Inhalation
Fisher 344 rats
GD 6-15
Doses: 0.076, 0.23, and 0.45
mg/L for 6 hours per day
Replicates: 32-37 per dose
NOAEC: 0.45 mg/L-
day
Methods:
• Test substance reported as CASRN 34590-
94-8
• Purity 100%
• EPA OTS 798.4350
• GLP compliant
5077934
Inhalation
Sprague Dawley
GD 6-15
Doses: 0, 0.1, 0.3, and 1.0
NOAEC: 1.0 mg/L-
Methods:
rats
mg/L for 6 hours per day
Replicates: 25 per dose
day
• Test substance reported as 25498-49-1
• Purity 98.5%
• GLP compliance not reported
Cancer
Source
Exposure
Route
Species & Strain
(if available)
Duration
Doses and
replicate
number
Effect
Study Details
OncoLogic
v8.0
OncoLogic currently
has no assessment
criteria regarding
methyl esters and/or
aliphatic ethers.
Structure could not be evaluated by Oncologic.
Genotoxicity
Source
Test Type &
Species & strain
Metabolic activation
Doses and
Results
Study Details
endpoint
(if available)
controls
4956637
Gene
Salmonella
With and without
Doses: 0,
Negative
Methods:
mutation (in
typhimurium
313, 635,
• Test substance reported as CAS RN 88917-
vitro)
strains TA98,
TA100, TA1535,
andTA1537
1250, 2500,
and 5000
pg/plate
22-0
• Purity > 99%
• KIHATSU Guidance 603
• GLP compliant
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.1: Human Health Hazard
4956637
Gene
mutation (in
vitro)
E. coli strain
WP2uvrA
With and without
Doses: 0,
313, 635,
1250, 2500,
and 5000
pg/plate
Negative
Methods:
• Test substance reported as CAS RN 88917-
22-0
• Purity > 99%
• KIHATSU Guidance 603
• GLP compliant
5077927
Chromosomal
aberrations
(in vitro)
Rat liver RL4
cells
Without
Doses: 0,
625, 1250,
2500, and
5000 pg/mL
Negative
Methods:
• Test substance reported as CASRN 34590-
94-8
• Purity not reported
• GLP compliance not reported
5077935
Chromosomal
aberrations
(in vitro)
CHL/IU cells
With and without
Doses: 0,
371,741,
and 1482
Ijg/mL
Negative
Methods:
• Test substance reported as CASRN 34590-
94-8
• Purity > 99%
• Japan Guidelines for Screening Mutagenicity
Testing of Chemicals
• GLP compliant
5077938
DNA damage
and repair
Rat hepatocyte
cells
Without
Doses: 0.1,
0.316, 1,
3.16, 10,
31.6, and
100 mM
Negative
Methods:
• Test substance reported as CASRN 25498-
49-1
• Purity: 98.7%
• GLP compliance not reported
5077989
Chromosomal
aberrations
(in vitro)
Chinese hamster
ovary cells
With and without
Doses: 0,
101,203,
405, 810
and 1620
Ijg/mL
Negative
Methods:
• Test substance reported as CASRN 30025-
38-8
• Purity not reported
• OECD Guideline 473
• GLP compliant
XXI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.1: Human Health Hazard
4956637
Chromosomal
aberrations
(in vivo)
Mouse
With
Doses: 0,
250, 833,
and 2500
mg/kg
Negative
Methods:
• Test substance reported as CAS RN 29911 -
28-2
• Purity: 99.5%
• GLP compliant
4956637
Chromosomal
Chinese hamster
With and without
Doses:
Positive at cytotoxic
Methods:
aberrations
ovary cells
• 0,333,
concentrations
• Test substance reported as CAS RN 29911 -
(in vitro)
1000,
(3332 [jg/mL with
28-2
and
3332
Ijg/mL
with
metabol
ic
activati
on
• 0,1000,
2000,
3000,
and
4000
Ijg/mL
without
activati
on
activation)
• Purity > 95%
• GLP compliant
Results:
• Cytotoxicity observed at 1000 and 3332
|jg/mL with metabolic activation and 3000 and
4000 [jg/mL without metabolic activation
XXII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.1: Human Health Hazard
4956637
Chromosomal
Aberrations
(in vitro)
Chinese hamster
ovary cells
With and without
Doses:
• 0,500,
1000,
2000,
and
3000
Ijg/mL
with
metaboli
c
activatio
n;
• 0,1000,
2000,
3500,
and
5000
Ijg/mL
without
activatio
n
Positive
Methods:
• Test substance reported as CAS RN 29911 -
28-2
• Purity not reported
• GLP compliant
Results:
• Significantly increased frequency of
aberrations was observed at 18-hour
incubation period for 500,1000 and 3000
|jg/mL with metabolic activation and 1000 and
5000 [jg/mL without metabolic activation
• Cytotoxicity observed at 3000 pg/mL with
metabolic activation and 5000 pg/mL without
metabolic activation
4956637
Chromosomal
aberrations
(in vitro)
Chinese hamster
ovary cells
With and without
Doses: 0,
500, 1667,
and 5000
Ijg/mL
Negative
Methods:
• Test substance reported as CAS RN 29911-
28-2
• Purity: 99.5%
• GLP compliant
4956637
Chromosomal
Aberrations
(in vitro)
Chinese hamster
ovary cells
With
Doses: 0,
500, 1667,
and 5000
Ijg/mL
Negative
Methods:
• Test substance reported as CAS RN 29911 -
28-2
• Purity: 99.5%
• GLP compliant
Irritation
Source
Exposure
Route
Species & Strain
(if available)
Duration Doses
Effect
Study Details
XXIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.1: Human Health Hazard
4956637,
5016018
Dermal
New Zealand
White rabbits
Exposure
for 24
hours,
observed
for 72
hours
Dose: 0.5 mL undiluted test
substance
Replicates: 6 females
Negative
Methods:
• Test substance reported as CAS RN 88917-
22-0
• Purity not reported
• OECD Guideline 404
• GLP compliant
Results:
• At 24 hours: 1/6 animals showed slight
erythema
• Effects fully reversible after 72 hours
5016007
Dermal
New Zealand
White rabbits
Exposure
for 4
hours,
observed
for 72
hours
Dose: 0.5 mL undiluted test
substance
Replicates: 3 total (2 males,
1 female)
Negative
Methods:
• Test substance reported as CAS RN 88917-
22-0
• Purity not reported
• OECD Guideline 404
• GLP not reported
4956637,
5016014
Ocular
New Zealand
White rabbits
7 day
observatio
n
Dose: 0.1 mL
Replicates:
Unwashed: 6 Females
Washed: 2 females & 1 male
Low potential for
eye irritation
Methods:
• Test substance reported as CAS RN 88917-
22-0
• Purity not reported
• OECD Guideline 405
• Not GLP compliant
Results:
• At 1 hour: 3/6 animals had erythema in
unwashed group
• Effects fully reversible after 24 hours
5016013
Ocular
New Zealand
White rabbits
72 hour
observatio
n
Dose: 0.1 mL
Replicates: 3 total (2 males,
1 female)
Negative
Methods:
• Test substance reported as CAS RN 88917-
22-0
• Purity not reported
• OECD Guideline 405
• GLP compliant
XXIV
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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
4956637, 4985129
Pimephales
promelas
96 hours
Doses: 0,100,
125, 160, 200, 250
and 320 mg/L
(nominal)
LCso: 151 mg/L
nominal
(calculated)
(95% C1139 -
161 mg/L)
Methods:
• Test substance CAS RN 88917-22-0
• Purity: 99.4%
• OECD Guideline 203
• GLP compliant
4956637, 4985124
Daphnia magna
48 hours
Doses: 0,160,
250, 400, 630,
1000,1600, and
2500 mg/L
(nominal)
LCso: 1090
mg/L (nominal)
Methods:
• Test substance CAS RN 88917-22-0
• Purity: 99.4%
• OECD Guideline 202
• GLP compliant
4985118
Pseudokirchneriella
subcapitata
72 hours
Doses: 0,1,10,
100 and 1000 ppm
(nominal)
ECso > 1000
mg/L (nominal)
Methods
• Test substance reported as CASRN 88917-22-0
• Purity not reported
• OECD Guideline 201
• GLP compliance not reported
Aquatic Toxicity: Estimated
Model
Endpoint
Species
Predicted Effect
Level
Notes
ECOSAR v2.0 (Class:
Esters)
Chronic value
Freshwater
fish
15 mg/L
SMILES Input: 0=C(C)OC(C)COC(C)COC. Experimental input value: WS = 1.94E+5
mg/L.
ECOSAR v2.0 (Class:
Esters)
Chronic value
Daphnia
magna
370 mg/L
SMILES Input: 0=C(C)OC(C)COC(C)COC. Experimental input value: WS = 1.94E+5
mg/L.
ECOSAR v2.0 (Class:
Esters)
Chronic value
Green
algae
32 mg/L
SMILES Input: 0=C(C)OC(C)COC(C)COC. Experimental input value: WS = 1.94E+5
mg/L.
XXV
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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
4985139,
Biodegradation
28 days
Dose: 100 mg/L
Not readily
Methods:
4956637
biodegradable
• Test substance reported as CASRN 88917-22-0
• Purity: 99%
• Japanese Guidelines "Biodegradation test of chemical
substance by microorganisms etc."
• GLP compliant
Results:
• Degradation: 16% biodegradation by 02 consumption after 28
days using an activated sludge inoculum
• Nearly 100% conversion of DPMA to DPM without further
degradation
4956637,
Biodegradation
28 days
Doses: 3.75 and
Readily
Methods:
4985142
7.5 mg/L
biodegradable
• Test substance reported as CASRN 88917-22-0
• Purity not reported
• Similar to OECD 301D but used pre-adapted sludge
• GLP compliant
• GLP compliant
Biodegradation results:
• 3.75 mg/L: 84.4% and 94.0% 02 consumption after 28 and 43
days, respectively
• 7.5 mg/L: 58% and 73.3% 02 consumption after 28 and 43
days
4985133
Biodegradation
28 days
Doses: 3.75 and
7.5 mg/L
Readily
biodegradable
Methods:
• Test substance reported as CAS RN 88917-22-0
• Purity: 99.4%
• BOD 5
• GLP compliant
Biodegradation results:
• Activated industrial sludge inoculum: 67% after 28 days
• Municipal sludge: 9% in 28 days
XXVI
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.3: Fate
• After 43 days with previously acclimated activated inoculum,
3.75 mg/L resulted in complete mineralization
4951403,
4985135
Biodegradation
28 days
Dose: 90 mg/L
Readily
biodegradable
Methods:
• Test substance identified as CASRN 55934-93-5
• Purity: 97.7%
• OECD Guideline 301F
• GLP compliant
Results:
• Degradation during test: 10% in 7.3 days; 60% in 10.5 days;
72% at 10-day window; 59% in 28 days by 02 consumption;
58% average removal by DOC at 28 days and 56%
mineralization to C02 after 28 days
4985134
Biodegradation
14 days
Doses: 20 and 32
mg DOC/L
Readily
biodegradable
Methods:
• Test substance identified as CASRN 55934-93-5
• Purity not reported
• OECD Guideline 301A
• GLP compliant
Results:
• Kinetic degradation results: 2% for 1 day, 9% for 3 days, 69% for
5 days, 88% for 7 days, and 96% 14 days
4985140
Biodegradation
28 days
Doses: 141.7 and
139 mg/L
Readily
biodegradable
Methods:
• Test substance identified as CASRN 55934-93-5
• Purity > 95%
• OECD Guideline 302B
• GLP compliant
4985126
Toxicity to microorganisms
3 hours
Doses: 0,10,
31.6, 100,316,
and 1000 mg/L
Negative
Methods:
• Test substance reported as CASRN 88917-22-0
• Purity: 99.7%
• OECD Guideline 209
• GLP compliant
Experimental Fate: Modelled
Model
Data Type
Endpoint
Predicted
Endpoint
Notes
XXVII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Table B.3: Fate
EPISuite
v.4.11
Estimated
BAF
1.1
EPI Suite (Physical Property Inputs - MP = -25.2 deg C, BP = 200 deg C, VP = 0.13
mm Hg, WS = 194000 mg/L, Log K0w = 0.803, Henry's Law2.0E-07 atm-m3/mole)
SMILES: CC(=0)0C(C)C0C(C)C0C
EPISuite
v.4.11
Estimated
BCF
3.2
EPISuite
v.4.11
(BIOWIN)
Estimated
Anaerobic
biodegradation
Not predicted to
biodegrade
quickly under
anaerobic
conditions
Predicted probability of -0.1046. Fragment representation is valid.
Fast degradation is defined as predicted probability >0.5.
XXVIII
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
B.1 References
Bio-Research Laboratories LTD. (1985). A teratological study of inhaled Dowanol TPM in the albino rat
with attached appendices. (OTS0521267).
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Dow Chemical (Dow Chemical Company). (2000b). Chronic skin absorption of propylene glycol methyl
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glycol ethers and its relevance to man (fourth edition). Volume II - Substance profiles. (Technical
report no. 95). Brussels. http://www.ecetoc.org/wp-content/uploads/2014/08/ECETQC-TR-095-
Vol-II.pdf
EC HA (European Chemicals Agency). (1982a). A mixture of RRand RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: acute toxicity: dermal: 002 supporting | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/15979/7/3/4/?documentUUID=da8cl8bb-53af-43dd-b669-4b9c49773625
EC HA (European Chemicals Agency). (1982b). A mixture of RR and RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: acute toxicity: inhalation: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15979/7/3/3
XXIX
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*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
EC HA (European Chemicals Agency). (1982c). A mixture of RRand RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: acute toxicity: oral: 002 supporting | experimental result.
https://ccha.curopa.cu/rcgistration-dossicr/-/registered-
dossier/ 15979/7/3/2/?documcntUUID=2f616d3 1 -fd0c-497c-a3 19-f 153Se6d55 19
EC HA (European Chemicals Agency). (1982d). A mixture of RR and RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: eye irritation: 002 supporting | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/15979/7/4/3/?documentUUID=fc778f4e-fa0e-4674-b4a9-d73ebcf4ea50
EC HA (European Chemicals Agency). (1982e). A mixture of RRand RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: skin irriation/corrosion: 002 supporting | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/15 979/7/4/2/?documentUUID=0af40c5 7-e446-44a3 -8476-2al f825df094
EC HA (European Chemicals Agency). (1983a). A mixture of RRand RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: biodegradation in water: screening tests: 005 supporting | experimental
result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/15979/5/3/2/?documentUUID=e3275479-34a4-4bbf-891b-lfbe6cldaeb8
EC HA (European Chemicals Agency). (1983b). A mixture of RR and RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: short-term toxicity to aquatic invertebrates: 002 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/15979/6/2/4/?documentUUID=7a894f2f-6bb4-4dc 1 -ac4d-1575b6283130
EC HA (European Chemicals Agency). (1990a). (2-methoxymethylethoxy)propanol: developmental
toxicity / teratogenicity: 001 key | experimental result.
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-
dossier/1475 l/7/9/3/?documentUUID=e 8135 7dc-b2 lb-48b5 -968 0-fa0c79cd3 610
EC HA (European Chemicals Agency). (1990b). (2-methoxymethylethoxy)propanol: developmental
toxicity / teratogenicity: 002 key | experimental result.
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-
dossier/14751/7/9/3/?documentUUID=358e7ca7-9d2b-4569-898d-f2d306664c34
EC HA (European Chemicals Agency). (1990c). A mixture of RRand RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: acute toxicity: dermal: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15979/7/3/4
XXX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
EC HA (European Chemicals Agency). (1990d). A mixture of RR and RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: eye irritation: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15979/7/4/3
EC HA (European Chemicals Agency). (1990e). A mixture of RRand RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: repeated dose toxicity: oral: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15979/7/6/2
EC HA (European Chemicals Agency). (1990f). A mixture of RR and RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: skin irritation/corrosion: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15979/7/4/2
EC HA (European Chemicals Agency). (1993). [(butoxymethylethoxy)methylethoxy]propan-l-ol:
Biodegradation in water: Screening tests: 003 Supporting | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/13383/5/3/2/?documentUUID=e94b3cla-e9d0-4a24-b980-673492312d8c
EC HA (European Chemicals Agency). (1994). l-(2-ethoxypropoxy)propan-2-ol; l-[(l-ethoxypropan-2-
yl)oxy]propan-2-ol: Toxicity to reproduction: 001 Weight of evidence | Experimental result.
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-
dossier/5800/7/9/2/?documentUUID=2ea91d99-9f68-442b-ae87-e84a0ade9051
EC HA (European Chemicals Agency). (1996). A mixture of RR and RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: biodegradation in water: screening tests: 002 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/15 979/5/3/2/?documentUUID=54bd7973 -0e02-420e-8eec-151 e31 d 1 d427
EC HA (European Chemicals Agency). (1997). l-(2-ethoxypropoxy)propan-2-ol; l-[(l-ethoxypropan-2-
yl)oxy]propan-2-ol: genetic toxicity: in vitro: 003 key | experimental result.
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-
dossier/5800/7/7/2/?documentUUID=7483f0e2-bada-420b-bcdd-f6259be2434b
EC HA (European Chemicals Agency). (1998). [(butoxymethylethoxy)methylethoxy]propan-l-ol:
biodegradation in water: screening tests: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/13383/5/3/2/?documentUUID=fl89898c-7bbb-4b00-8cle-c42269e8b080
EC HA (European Chemicals Agency). (2000a). l-(2-ethoxypropoxy)propan-2-ol; l-[(l-ethoxypropan-2-
yl)oxy]propan-2-ol: Repeated dose toxicity: oral: 001 key | experimental result.
https://www.echa.europa.eu/web/guest/registration-dossier/-/registered-
dossier/5800/7/6/2/?documentUUID=la294915-822a-4587-a7b4-3cl7051a96ac
XXXI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
EC HA (European Chemicals Agency). (2000b). (2-methoxymethylethoxy)propanol: genetic toxicity: in
vitro: 005 key| experimental result, https://www.echa.europa.eu/web/guest/registration-dossier/-
/registered-dossier/1475 l/7/7/2/?documentUUID=f 1 dO 1 db7-8b86-45 93 -a2fc-f8ec 1 cec6de7
EC HA (European Chemicals Agency). (2000c). A mixture of RRand RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: Toxicity to aquatic algae and cyanobacteria: 001 Key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/15 979/6/2/6/?documentUUID=e73 5 95 64-a5 68-4c2f-ae3 9-e6b 106bd7046
EC HA (European Chemicals Agency). (2000d). A mixture of RR and RS isomers of: (2-(2-methoxy-l-
methyl)ethoxy)-l-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-l-methylethyl acetate;
(2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1 -methyl)ethoxy)-2-
methylethyl acetate: toxicity to microorganisms: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/15979/6/2/8/?documentUUID=954229ee-b27c-424f-a6b5-08def6b94873
EC HA (European Chemicals Agency). (2002). [(butoxymethylethoxy)methylethoxy]propan-l-ol:
biodegradation in water: screening tests: 002 supporting | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/13 3 83/5/3/2/?documentUUID=63 71 f 16d-815 3 -4093 -aef3 -14f8 lb8624df
Fairhurst. S; Knight R; Marrs. TC; Scawin. JW; Spurlock. MS; Swanston. DW. (1989). Percutaneous
toxicity of ethylene glycol monomethyl ether and of dipropylene glycol monomethyl ether in the
rat. Toxicology 57: 209-215. http://dx.doi.org/10.1016/0300-483X(89)90166-2
Landry. TP; Yano. BL. (1984). Dipropylene glycol monomethyl ether: A 13-week inhalation toxicity
study in rats and rabbits. Fundam Appl Toxicol 4: 612-617. http://dx.doi.org/10.1016/Q272-
0590(84)90051-4
OECD (Organisation for Economic Co-operation and Development). (2003). Propylene glycol ethers:
SIDS initial assessment report for SIAM 17: Arona, Italy, 11-14 November 2003. (SIDS Initial
Assessment Meeting (SIAM) 17). UNEP Publications.
http://www.inchem.org/documents/sids/sids/pges.pdf
Robinson. V; Bergfeld. WF; Belsito. DV: Klaassen. CD: Marks. JG: Shank. RC: Slaga. TJ; Snyder. PW:
Panel. CIRE; Andersen. FA. (2009). Final report on the safety assessment of PPG-2 methyl ether,
PPG-3 methyl ether, and PPG-2 methyl ether acetate. Int J Toxicol 28: 162S-174S.
http://dx.doi.org/10.1177/1091581809350933
Rowe. VK; Mccollister. DP: Spencer. HC: Oven. F; Hollingsworth. RL: Drill. VA. (1954). Toxicology of
mono-, di-, and tri-propylene glycol methyl ethers. AMA Arch Ind Hyg Occup Med 9: 509-525.
Shell Chemical (Shell Chemical Company). (1983). Toxicity studies with Dowanol DPM: Tests for in
vitro genotoxicity with attachments, cover sheets and letter dated 060689. (OTS0520390. EPA
Doc No: 86-890000952).
https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/OTS052039Q.xhtml
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C.1 Literature Search and Review
This section briefly describes the literature search and review process, search terms, and search outcomes
for the hazard and fate screening of dipropylene glycol methyl ether acetate. Search outcomes and
reference details are provided on the candidate's HERO4" project page.
EPA created a fit-for-purpose process to transparently document the literature search and review41 of
available hazard and fate information for low-priority substance (LPS) candidates. References from peer-
reviewed primary sources, grey sources,42 and other sources were identified, screened at the title/abstract
and full text level, and evaluated for data quality based on discipline-specific criteria. An overview of the
literature search and review process is illustrated in Figure CI.
Figure C.l: Overview of the Literature Search and Review Process
&Q
References available at
title/abstract screening
References available at data quality evaluation
References included in LPS screening reviews
References available at full text screening
References excluded at
full text screening
References excluded at
data quality evaluation
References excluded at
title/abstract screening
References available
from grey literature
and other sources
References available
from primary peer-
reviewed sources
C.1.1 Search for Analog Data
To supplement the information on the candidate chemical, dipropylene glycol methyl ether acetate, the
following analogs were used for designation: dipropylene glycol, monoethyl ether (CASRN 30025-38-8);
dipropylene glycol, ethyl ether (CASRN 15764-24-6); dipropylene glycol, methyl ether (CASRN 34590-
94-8); dipropylene glycol, monobutyl ether (CASRN 29911-28-2); tripropylene glycol, monomethyl ether
(CASRN 25498-49-1); and tripropylene glycol methyl ether (CASRN 20324-33-8). Dipropylene glycol,
ethyl ether (15764-24-6) and tripropylene glycol, methyl ether (20324-33-8) were also considered. For
4() The HERO low-priority substance candidate project pages are accessible to the public at https://hero.epa.gov/liero/.
41 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-Priority
Substances Under TSCA."
42 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.
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more details and justification on analogs, see section 6.1.1. Analogs were used to fill data gaps on
endpoints for which dipropylene glycol methyl ether acetate lacked quality data, such as developmental
toxicity, or to add to the weight of the scientific evidence. EPA collected reasonably available information
for these endpoints by searching specific grey literature and other secondary sources, listed on Table C.l.
If information related to the identified analogs were available in these sources, the references were
screened and evaluated using the same process as references on dipropylene glycol methyl ether acetate
described above.41 EPA also used read-across from the LPS candidate, Tripropylene glycol n-butyl ether
(CASRN 55934-93-5). The two LPS chemicals along with the analogs mentioned above fall under the
propylene glycol ethers cluster in HERO.
Table C.1: Sources Used for Analog Search
Resource
URL
ATSDR
http://www.atsdr.cdc.gov/toxprofiies/index.asp
ChemID (EPA - HPVIS via
ChemID)
http://chem.sis.nlm.nih.gov/chemidplus/
CIR
http://www.cir-safety.org/ingredients
ECHA
http://echa.europa.eu/web/guest/information-on-chemicais/registered-substances
ECOTOX
https://cfpub.epa.gov/ecotox/quick_query.htm
EPA - ChemView (incl. TSCATS,
RBP/HC, and HPV/HPVIS)
https://chemview.epa.gov/chemview
European Food Safety Authority
(EFSA)
http://www.efsa.europa.eu/
FDA
https://www.fda.gov/defauit.htm
HERA
http://www.heraproject.com/RiskAssessment.cfm
NICNAS
http://www.nicnas.gov.au/
NITE (J-CHECK)
http://www.safe.nite.go.jp/jcheck/search.action?request_locale=en
NTP
https://ntpsearch.niehs.nih.gov/home
OECD/SIDS
https://hpvchemicals.oecd.org/UI/Search.aspx;
http://webnet.oecd.org/hpv/ui/SponsoredChemicais.aspx
C.1.2 Search Terms and Results
EPA began the literature review process for the hazard screening of dipropylene glycol methyl ether
acetate by developing search terms. To gather publicly available information, specific search terms were
applied for each discipline and across databases and grey literature sources. Table C.2 lists the search
terms used in the database search of peer -reviewed literature for the propylene glycol ethers cluster
including dipropylene glycol methyl ether acetate. For grey literature and other secondary sources, Table
C.3 lists the search terms used for the propylene glycol ethers LPS candidates and analogs.
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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms43
Human Health
PubMed
88917-22-0[rn] OR 55934-93-5[rn] OR "dipropylene glycol monomethyl ether acetate"[nm] OR
"((Butoxymethylethoxy)methylethoxy)propan-1-ol"[tw] OR "Dipropylene glycol monomethyl ether acetate"[tw] OR "Dowanol
TPnB"[tw] OR "PPG-2 methyl ether acetate"[tw] OR "PPG-3 BUTYL ETHER"[tw] OR "Propanol, (2-(2-
butoxymethylethoxy)methylethoxy)-"[tw] OR "Propanol, (2-methoxymethylethoxy)-, acetate"[tw] OR "Propanol, 1(or 2)-(2-
methoxymethylethoxy)-, acetate"[tw] OR "Tripropylene glycol butyl ether"[tw] OR "Tripropylene glycol n-butyl ether"[tw] OR
"(2-(2-butoxymethylethoxy)methylethoxy)propanol"[tw] OR "(2-methoxymethylethoxy)propanol acetate"[tw]
Toxline
(88917-22-0[rn] OR 55934-93-5[rn] OR "Dipropylene glycol monomethyl ether acetate" OR "PPG-2 methyl ether acetate")
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]
"((Butoxymethylethoxy)methylethoxy)propan-1-ol" OR "Dowanol TPnB" OR "PPG-3 BUTYL ETHER" OR "Propanol, (2-(2-
butoxymethylethoxy)methylethoxy)-" OR "Propanol, (2-methoxymethylethoxy)-, acetate" OR "Propanol, 1(or 2)-(2-
methoxymethylethoxy)-, acetate" OR "Tripropylene glycol butyl ether" OR "Tripropylene glycol n-butyl ether" OR "(2-(2-
butoxymethylethoxy)methylethoxy)propanol" OR "(2-methoxymethylethoxy)propanol acetate"
TSCATS1
(88917-22-0 [rn] OR 55934-93-5 [rn]) AND (TSCATS [org]) AND NOT PubMed [org] AND NOT pubdart [org]
WOS
TS=("88917-22-0" OR "55934-93-5" OR "((Butoxymethylethoxy)methylethoxy)propan-1-ol" OR "Dipropylene glycol
monomethyl ether acetate" OR "Dowanol TPnB" OR "PPG-2 methyl ether acetate" OR "PPG-3 BUTYL ETHER" OR
"Propanol, (2-(2-butoxymethylethoxy)methylethoxy)-" OR "Propanol, (2-methoxymethylethoxy)-, acetate" OR "Propanol, 1(or
2)-(2-methoxymethylethoxy)-, acetate" OR "Tripropylene glycol butyl ether" OR "Tripropylene glycol n-butyl ether" OR "(2-(2-
butoxymethylethoxy)methylethoxy)propanol" OR "(2-methoxymethylethoxy)propanol acetate")
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=("88917-22-0" OR "55934-93-5" OR "Butoxymethylethoxy methylethoxy propan-1-ol" OR "Dipropylene glycol
monomethyl ether acetate" OR "PPG-2 methyl ether acetate" OR "Tripropylene glycol butyl ether" OR "Tripropylene glycol
n-butyl ether")
2 hits manually added (+1 dupe within this query)
43 Additional language or syntax such as [tw], [rn], [org], and [nm] were added to search terms. These are unique to individual databases and must be applied to search terms so
that the query can run properly.
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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms43
SUBJECT=("88917-22-0" OR "55934-93-5" OR "Butoxymethylethoxy methylethoxy propan-1-ol" OR "Dipropylene glycol
monomethyl ether acetate" OR "PPG-2 methyl ether acetate" OR "Tripropylene glycol butyl ether" OR "Tripropylene glycol
n-butyl ether")
3 hits manually added
ABSTRACT=("88917-22-0" OR "55934-93-5" OR "Butoxymethylethoxy methylethoxy propan-1-ol" OR "Dipropylene glycol
monomethyl ether acetate" OR "PPG-2 methyl ether acetate" OR "Tripropylene glycol butyl ether" OR "Tripropylene glycol
n-butyl ether")
"Dowanol TPnB" OR "PPG-3 BUTYL ETHER" OR "Propanol, 2- 2-butoxymethylethoxy methylethoxy OR "Propanol, 2-
methoxymethylethoxy -, acetate" OR "2- 2-butoxymethylethoxy methylethoxy propanol" OR "2-methoxymethylethoxy
propanol acetate"
Fate
wos
Same as human health strategy synonyms only
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Table C.3: Search Terms Used in Grey Literature and Additional Sources
Chemical
Search terms
Propylene glycol
ether cluster
(DPMA;
tripropylene
glycol n-butyl
ether)
Query string searched as a string or individually depending on resource: "5131-66-8" OR "107-98-2" OR "108-
65-6" OR "88917-22-0" OR "55934-93-5" OR "1-Butoxy-2-propanol" OR "1-methoxy 2-propyl acetate" OR "1-
methoxy-2-propanol" OR "1-methoxy-2-propyl acetate" OR "1-Methoxypropan-2-ol" OR "2-acetoxy-1-
methoxypropane" OR "2-methoxypropyl acetate" OR "2-methoxy-1-methylethyl acetate" OR "3-Methoxy-2-
propanol" OR "Butoxypropanol" OR "Dipropylene glycol monomethyl ether acetate" OR "methoxyisopropanol"
OR "Methoxyisopropyl acetate" OR "n-Butoxy-2-propanol" OR "PGMEA" OR "PPG-2 methyl ether acetate"
OR "Propylene glycol methyl ether" OR "Propylene glycol monobutyl ether" OR "Propylene glycol monomethyl
ether" OR "propylene glycol n-butyl ether" OR "1-Butoxypropan-2-ol" OR "1-methoxy-2-acetoxypropane" OR
"propylene glycol 1-methyl ether" OR "Propyleneglycol monomethyl ether acetate" OR "Tripropylene glycol
butyl ether" OR "Tripropylene glycol n-butyl ether"
Analog
searched
Dipropylene glycol, ethyl ether (15764-24-6); dipropylene glycol, monoethyl ether (30025-38-8); dipropylene
glycol, methyl ether (34590-94-8); dipropylene glycol, monobutyl ether (29911-28-2); tripropylene glycol,
monomethyl ether (25498-49-1); tripropylene glycol, methyl ether (20324-33-8)
After the search terms were applied, more than 100 references were returned by all search efforts across
peer-reviewed databases and grey literature sources. The total number of references include database
results, additional strategies, and analog searches. All references from the search efforts were screened
and evaluated through the LPS literature search and review process.41 Of these, 48 references were
included for data evaluation and used to support the designation of dipropylene glycol methyl ether
acetate 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 methyl ether acetate. The excluded references are organized
by discipline (human health hazard, environmental hazard, and fate), presented along with a rationale
based on exclusion criteria. The criteria41 was used to determine off-topic references in the title/abstract or
full text screening and to determine unacceptable references in the data quality evaluation are provided in
the form of questions.
C.2.1 Human Health Hazard Excluded References
For the screening review of dipropylene glycol methyl ether acetate, EPA excluded a total of 46
references when assessing human health hazard. Off-topic references (e.g., studies that did not contain
information relevant to human health) were excluded at either title/abstract screening (see Table C.4), or
full-text screening (see Table C.5). Unacceptable references (e.g., studies that did not meet data quality
metrics) were excluded at full-text screening (see Tables C.6 and C.7). Off-topic and unacceptable
references are displayed next to the corresponding exclusion criteria.
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs44 relevant to human health
hazard
44 The information needs for human health hazard includes a list of study characteristics pertaining to the study population/test
organism, types of exposures and routes, use of controls, type and level of effects. A complete list of the information needs is
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1549118
4742957
2292715
4951403
Reference excluded (HERO ID) because the reference primarily contained in silico data
4946621
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain
No
58939
information pertaining to a low-
95230
priority substance candidate?
655409
3114932
5015980
5015981
5015982
5015983
5015985
5015986
5015987
5015988
5015989
5015990
5015992
5015993
5015994
5015996
5015997
5015998
5015999
5016000
5016001
5016002
5016003
5016004
5016005
5016006
5016009
5016011
5016015
5016016
5016020
5015992
5015994
What type of source is this
Review article or book chapter that
4851358
reference?
contains only citations to primary
5015978
literature sources
provided in Table A1 of the "Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA".
These information needs helped guide the development of questions for title/abstract and full-text screening.
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Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
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
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
3114932
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
5015178
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
5015178
duration of exposure?
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)?
Does the paper report a negative
No45
5015178
control that is a vehicle control or
5015978
no treatment control?
The following questions apply to MECHANISTIC/ALTERNATIVE TEST METHODS evidence only
Does the reference report a
No
N/A.
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
45 Except for acute mammalian toxicity and skin and eye irritation studies, where the use of a negative control may not be
required (e.g., OECD 403 Acute Inhalation Toxicity Guidelines).
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Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
reasonable impurities and
byproducts)?
For genotoxicity studies only: Does
the study use a positive control?
No
N/A.
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test substance identity
• The test substance identity
cannot be determined from
the information provided
(e.g., nomenclature was
unclear and CASRN or
structure were not reported).
OR
• For mixtures, the components
and ratios were not characterized or
did not include information that could
result in a reasonable approximation
of components.
4956637
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).
4956637
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).
2530089
4956637
5016012
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).
2530089
XL
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Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 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).
5015171
2530089
5015991
Metric 7:
Number of animals per group
The number of animals per study
group was not reported.
OR
The number of animals per study
group was insufficient to
characterize toxicological effects
(e.g., 1-2 animals in each group).
2530089
4956637
5015171
5015991
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.).
2530089
4956637
5015171
5015991
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.
2530089
4956637
5014494
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test substance identity
The test substance identity or
description cannot be determined
from the information provided (e.g.,
nomenclature was unclear and
CASRN or structure were not
reported).
OR
For mixtures, the components and
ratios were not characterized or did
not include information that could
4956637
XLI
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Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
result in a reasonable approximation
of components.
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
protocol used for in vitro skin
irritation assay).
4956637
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).
2530089
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
4956637
XLII
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Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health
Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
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).
C.2.2 Environmental Hazard
For the screening review of LPS candidate dipropylene glycol methyl ether acetate, EPA excluded a total
of 21 references when assessing environmental hazard. Off-topic environmental hazard references
excluded at title/abstract screening are listed in Table C.8, and those excluded at full-text screening are
listed in Table C.9. References in Table C.10 represent unacceptable studies based on specific data quality
metrics for environmental hazard. Off-topic and unacceptable references are displayed next to the
corresponding exclusion criteria.
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
1 Reference excluded (HERO ID) because the reference did NOT contain information needs46 relevant to 1
environmental hazard
4742957
2563138
2530089
2292715
1549118
44187
3114932
4951403
4946621
3114932
4946621
4742957
Reference excludec
I (HERO ID) because the reference did NOT present quantitative environmental hazard data
N/A.
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for Environmental Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain
No
3827368
information pertaining to a low-
4985113
priority substance candidate?
4985115
4985117
4985121
4985125
4985127
4985130
4985131
4985132
What type of source is this
Review article or book chapter that
N/A.
reference?
contains only citations to primary
literature sources
Is quantitative environmental
No
N/A.
hazard data presented?
40 The information needs for environmental hazard includes a list of study characteristics pertaining to the test organism/species,
type and level of effects, and use of controls. A complete list of the information needs is provided in Table A2 of the "Approach
Document for Screening Hazard Information for Low-Priority Substances Under TSCA". These information needs helped guide
the development of questions for title/abstract and full-text screening.
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Is this primarily a
Yes
N/A.
modeling/simulation study?
[Note: select "No" if experimental
verification was included in the
study]
Is environmental hazard data
No
N/A.
presented for standard or non-
standard aquatic or terrestrial
species (fish, invertebrates,
microorganisms, non-mammalian
terrestrial species)?
Is exposure measured for the target
Mixture
N/A.
substance or is the test substance
Formulated Product
N/A.
a mixture (except for reasonable
impurities, byproducts, and
aqueous solutions) or formulated
product?
Does the reference report a
No
N/A.
duration of exposure?
Does the reference report a
No
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negative control that is a vehicle
4985116
control or no treatment control?
4985125
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Does the reference include
No
N/A.
endpoints in the information needs?
Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Environmental Hazard
Question
Unacceptable if:
References excluded (HERO ID)
Metric 1:
The test substance identity or
4956637
Test substance identity
description cannot be
determined from the information
provided (e.g., nomenclature
was unclear, CASRN or structure
were not reported, substance
name/ description does not
match CASRN).
OR
For mixtures, the components and
ratios were not characterized or did
not include information that could
result in a reasonable approximation
of components.
Metric 2:
A concurrent negative control group
N/A.
Negative controls
was not included or reported.
Metric 3:
The experimental system (e.g.,
N/A.
Experimental system
static, semi-static, or flow-through
regime) was not described.
Metric 4:
Test concentrations were not
N/A.
Reporting of concentrations
reported.
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Metric 5:
Exposure duration
The duration of exposure was not
reported.
OR
The reported exposure duration was
not suited to the study type and/or
outcome(s) of interest (e.g., study
intended to assess effects on
reproduction did not expose
organisms for an acceptable period
of time prior to mating).
N/A.
Metric 6:
Test organism characteristics
The test species was not reported.
OR
The test species, life stage, or age
was not appropriate for the
outcome(s) of interest.
N/A.
Metric 7:
Outcome assessment methodology
The outcome assessment
methodology was not reported.
N/A.
Metric 8:
Reporting of data
Data presentation was
inadequate.
OR
Major inconsistencies were present
in reporting of results.
N/A.
C.2.3 Fate
For the screening review of LPS candidate dipropylene glycol methyl ether acetate, EPA excluded a total
of 9 references when assessing environmental fate. Off-topic fate references excluded at title/abstract
screening are listed in Table C.l 1, and those excluded at full-text screening are listed in Table C.12.
References in Table C.13 represent unacceptable studies based on specific data quality metrics for fate.
Off-topic and unacceptable references are displayed next to the corresponding exclusion criteria.
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs47 relevant to environmental I
fate
1549118
2292715
2530089
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4742957
Reference excluded (HERO ID) because the reference did NOT present quantitative environmental fate data
N/A.
47 The information needs for fate includes a list of study characteristics pertaining to the associated media and exposure
pathway s, associated processes, and use of controls. A complete list of the information needs is provided in Table A3 of the
"Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA". These information needs
helped guide the development of questions for title/abstract and full-text screening.
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Table C.12: Screening Questions and Off-Topic References Excluded at Full Text Screening for Fate
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain
No
4985137
information pertaining to a low-
4985138
priority substance candidate?
4985141
What type of source is this
Review article or book chapter that
N/A.
reference?
contains only citations to primary
literature sources
Is quantitative fate data presented?
No
N/A.
Is this primarily a
Yes
N/A.
modeling/simulation study? [Note:
Select "Yes" only if there is no
experimental verification]
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
The test substance identity or
N/A.
Test substance identity
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.
Metric 2:
The study did not include or report
4956637
Study controls
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.
Metric 3:
There were problems with test
4956637
Test substance stability
substance stability, homogeneity, or
preparation that had an impact on
concentration or dose estimates and
interfered with interpretation of study
results.
Metric 4:
The test method was not reported
4956637
Test method suitability
or not suitable for the test
substance.
OR
The test concentrations were not
reported.
XLVI
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Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
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.
Metric 5:
Testing conditions
Testing conditions were not
reported, and the omission would
likely have a substantial impact on
study results.
OR
Testing conditions were not
appropriate for the method (e.g., a
biodegradation study at
temperatures that inhibit the
microorganisms).
N/A.
Metric 6:
System type and design-
partitioning
Equilibrium was not established or
reported, preventing meaningful
interpretation of study results.
OR
The system type and design (e.g.
static, semi-static, and flow-through;
sealed, open) were not capable of
appropriately maintaining substance
concentrations, preventing
meaningful interpretation of study
results.
N/A.
Metric 7:
Test organism-degradation
The test organism, species, or
inoculum source were not reported,
preventing meaningful interpretation
of the study results.
4956637
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.
N/A.
Metric 10:
Data reporting
Insufficient data were reported to
evaluate the outcome of interest or
to reasonably infer an outcome of
interest.
OR
N/A.
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Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
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.
Metric 11:
Confounding variables
There were sources of variability
and uncertainty in the
measurements and statistical
techniques or between study
groups.
4956637
Metric 12:
Verification or plausibility of results
Reported value was completely
inconsistent with reference
substance data, related physical
chemical properties, or otherwise
implausible, suggesting that a
serious study deficiency exists
(identified or not).
N/A.
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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.48
For dipropylene glycol methyl ether acetate, 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 Tripropylene Glycol N-Butyl Ether based on Public Comment
Source
HERO ID
Notes
Cosmetic Ingredient Review's (CIR's) 2009 publication
titled: "Final Report on the Safety Assessment of PPG-2
Methyl Ether, PPG-3 Methyl Ether, and PPG-2 Methyl Ether
Acetate
2530089
This review article was part of EPA's literature
review process. Each study was evaluated
based on the literature search and review
process described in Appendix C.
48 Docket number EPA-HQ-OPPT-2019-0131 includes the list of 20 chemical substances that are candidates for
designation as Low-Priority Substances (https://www.federalregister.gov/documents/2019/03/21/2Q19-
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-2019-0121 addresses dipropylene glycol
methyl ether acetate.
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