***Proposal Draft-Do Not Cite, Quote or Release During the Review***
Dossier for Candidate Low-Priority Substance 2-Propanol, 1,1'-
oxybis-
(CASRN 110-98-5)
(l,l'-Dimethyldiethylene Glycol)
For Release at Proposal
August 9, 2019
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue
Washington, DC 20460

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***Proposal Draft-Do Not Cite, Quote or Release During the Review***
Contents
1.	Introduction	1
2.	Background on 1,1 -Dimethyldiethylene Glycol	3
3.	Physical-Chemical Properties	4
3.1 References	6
4.	Relevant Assessment History	8
5.	Conditions of Use	9
6.	Hazard Characterization	12
6.1	Human Health Hazard	15
6.1.1	Absorption, Distribution, Metabolism, and Excretion	16
6.1.2	Acute Toxicity	18
6.1.3	Repeated Dose Toxicity	18
6.1.4	Reproductive and Developmental Toxicity	19
6.1.5	Genotoxicity	19
6.1.6	Carcinogenicity	19
6.1.7	Neurotoxicity	20
6.1.8	Skin Sensitization	20
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	21
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
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7.	Exposure Characterization	24
7.1	Production Volume Information	24
7.2	Exposures to the Environment	24
7.3	Exposures to the General Population	25
7.4	Exposures to Potentially Exposed or Susceptible Subpopulations	25
7.4.1	Exposures to Workers	26
7.4.2	Exposures to Consumers	26
7.4.3	Exposures to Infants and Children	26
7.5	References	27
8.	Summary of Findings	28
8.1	Hazard and Exposure Potential of the Chemical Substance	28
8.2	Persistence and Bioaccumulation	29
8.3	Potentially Exposed or Susceptible Subpopulations	30
8.4	Storage near Significant Sources of Drinking Water	30
8.5	Conditions of Use or Significant Changes in Conditions of Use of the Chemical Substance	32
8.6	The Volume or Significant Changes in Volume of the Chemical Substance Manufactured or Processed.... 32
8.7	Other Considerations	33
9.	Proposed Designation	34
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 1,1 '-Dimethyldiethylene Glycol	V
A.3.	References	XX
Appendix B: Hazard Characterization	XXIII
B.1	References:	XLII
Appendix C: Literature Search Outcomes	XLVII
C.1	Literature Search and Review	XLVII
C.1.1 Search for Analog Data	XLVII
C.1.2 Search Terms and Results	XLVII I
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C.2 Excluded Studies and Rationale	LI
C.2.1 Human Health Hazard Excluded References	LI
C.2.2 Environmental Hazard	LIX
C.3 Fate	LXIV
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Tables
Table 1:1,1-Dimethyldiethylene Glycol at a	^
Glance	
Table 2: Physical-Chemical Properties for 1,1-Dimethyldiethylene Glycol		4
Table 3: Conditions of Use for 1,1-Dimethyldiethylene Glycol		11
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects		12
Table 5:1,1-Dimethyldiethylene Glycol and Analog ^
Structures	
Table A.1:1986-2015 National Production Volume Data for 1,1-Dimethyldiethylene Glycol (Non-
Confidential Production Volume in	I
Pounds)	
Table A.2: Sources Searched for Uses of 1,1-Dimethyldiethylene
Glycol	
Table A3: Uses of 1,1-Dimethyldiethylene Glycol		V
Table B.1: Human Health Hazard		XXIII
Table B.2: Environmental Hazard		XXXVII
Table B.3: Fate		XXXVIII
Table C.1: Search Terms Used in Peer-Reviewed Databases		XLIX
Table C.2: Search Terms Used in Grey Literature and Additional Sources		L
Table C.3: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard		LI
Table C.4: Screening Questions and Off-Topic References Excluded at Full-text Screening for Human
Health Hazard	
Table C.5: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Human Health Hazard - Animal	
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Human Health Hazard - In Vitro	
Table C.7: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard		LX
Table C.8: Screening Questions and Off-Topic References Excluded at Full-text Screening for
Environmental Hazard	 LXII
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Table C.9: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Environmental Hazard	
Table C.10: Off-Topic References Excluded at Initial Screening for Fate	 LXIV
Table C.11: Screening Questions and Off-Topic References Excluded at Full-text Screening for Fate	 LXVI
Table C.12: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
_ , LXVI
Fate	
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1. Introduction
In the Lautenberg amendments to the Toxic Substances Control Act (TSCA) (section 6(b)(1)(B)) and
implementing regulations (40 CFR 702.3), a low-priority substance is described as a chemical substance
that the Administrator concludes does not meet the statutory criteria for designation as a high-priority
substance, based on information sufficient to establish that conclusion, without consideration of costs or
other non-risk factors. A high-priority substance is defined as a chemical substance that the Administrator
concludes, without consideration of costs or other non-risk factors, may present an unreasonable risk of
injury to health or the environment because of a potential hazard and a potential route of exposure under
the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations
identified as relevant by the Administrator. 2-Propanol, l,l'-oxybis-, referenced as 1,1'-
dimethyldiethylene glycol for the remainder of this document, is one of the 40 chemical substances
initiated for prioritization as referenced in a March 21, 2019 notice (84 FR 10491).1
Before determining low or high prioritization status, under EPA's regulations at 40 CFR 702.92 and
pursuant to section 6(b)(1)(A) of the statute, EPA will generally use reasonably available information to
screen the candidate chemical substance under its conditions of use against the following criteria and
considerations:
•	the hazard and exposure potential of the chemical substance;
•	persistence and bioaccumulation;
•	potentially exposed or susceptible subpopulations;
•	storage near significant sources of drinking water;
•	conditions of use or significant changes in the conditions of use of the chemical substance;
•	the chemical substance's production volume or significant changes in production volume; and
•	other risk-based criteria that EPA determines to be relevant to the designation of the chemical
substance's priority.
Designation of a low-priority substance indicates that the chemical substance 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.
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2. Background on 1,1-Dimethyldiethylene Glycol
Table 1 below provides the CAS number, synonyms, and other information on l,r-dimethyldiethylene
glycol.
Table 1:1,1-Dimethyldiethylene Glycol at a Glance
Chemical Name
1,1 '-Dimethyldiethylene Glycol
CASRN
110-98-5
Synonyms
1,1 '-oxydi-2-propanol; 1,1 '-Oxydipropan-2-ol; 2-Propanol, 1,1 '-oxybis-; 1,1 '-Oxybis-2-
propanol; 2,2'-Dihydroxydipropyl ether; 2-Propanol, 1,1'-oxydi-
Trade Name(s)
NIAX Catalyst D-19
Molecular Formula
C6H14O3
Representative Structure
ch3 ch3
Source(s):
Kimetal. (2016); NLM (2018a)
l,l'-Dimethyldiethylene glycol is a P-series glycol ether, meaning that it is made from propylene oxide.
Glycol ethers are organic chemical compounds that contain both an alcohol functional group (R-OH) and
an ether functional group, which is an oxygen atom connected to two alkyl groups (R-O-R ). 1,1'-
Dimethyldiethylene glycol is an isomer of dipropylene glycol with two iso-propyl groups on either side of
the ether group. l,l'-Dimethyldiethylene glycol is produced as a byproduct of the manufacture of
propylene glycol. l,l'-Dimethyldiethylene glycol is an odorless solvent with a high boiling point and is
completely soluble in water while also maintaining the ability to dissolve oils. In addition, 1,1'-
dimethyldiethylene glycol is hygroscopic and acts as a humectant, which means it absorbs water and
increases hydration in products. l,l'-Dimethyldiethylene glycol also functions as a plasticizer and as a
plasticizer intermediate in the formation of polyurethane polyols to give improved flexibility and
resistance to cracking at low temperatures. A plasticizer is a substance that is added to a material to alter
its physical properties, mainly to increase flexibility or decrease viscosity. These properties make 1,1'-
dimethyldiethylene glycol a multifunctional ingredient used in a variety of applications and product
sectors. Section 5 includes conditions of use for this chemical.
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3. Physical-Chemical Properties
Table 2 lists physical-chemical properties for l,r-dimethyldiethylene glycol. A chemical's physical-chemical properties provide a basis for
understanding a chemical's behavior, including in the environment and in living organisms. These endpoints provide information generally needed
to assess potential environmental release, exposure, and partitioning as well as insight into the potential for adverse toxicological effects.
Table 2: Physical-Chemical Properties for 1,1 '-Dimethyldiethylene Glycol
Source/
Model
Data Type
Endpoint
Endpoint value
Notes
HSDB2019
Experimental
Physical state at
room temp
(based on melting
point)
Liquid (< -40°C)

HSDB2019; International
Chemical Safety Card, 2017;
OECDSIDS, 2001; Chadwick
1988
Experimental
Molecular weight
134 g/mol

EPISuite v.4.113
Calculated
Molecular weight
134.18 g/mol

Lyman 1990
Experimental
Molar volume
166 cm3/mol

HSDB
Experimental
Water solubility
1.00x105 mg/L
The PhysProp database reports a measured water solubility of 0.1 mg/L.
This appears to be in error, (1) because it is too low and (2) HSDB reports a
value of 100 g/L citing the same source (CITI, Japan).
International Chemical Safety
Card; OECD SIDS 2001
Experimental
Water solubility
1000000 mg/L
(miscible)

EPISuite v.4.11
Estimated
Water solubility
1.0x106 mg/L

International Chemical Safety
Card; OECD SIDS 2001
Experimental
Water solubility
7.45 mol/L

HSDB
Experimental
Water solubility
7.45x10-1 mol/L

ECHA
Experimental
Log Kow
-0.462 at21.7°C and
pH 6

3 EPI Suite Physical Property Inputs - Boiling Point = 232.8 deg C, Melting Point = -40 deg C, Vapor Pressure = 0.03 mm Hg, Water Solubility = 1000000 mg/L, Log P = -0.7,
SMILES: OC(C)COCC(C)0
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Table 2: Physical-Chemical Properties for 1,1 '-Dimethyldiethylene Glycol
Source/
Model
Data Type
Endpoint
Endpoint value
Notes
International Chemical Safety
Card 2019
Experimental
Log Kow
-0.7/-1.5

OECDSIDS 2001
Experimental
Log Kow
-1.486; -0.687

EPISuite v.4.11
Estimated
Log Kow
-0.64

EPISuite v.4.11
Estimated
Log Koa
6.14

EPISuite v.4.11
Estimated
Log Koc
0 (MCI); -0.38 (Kow)

HSDB; International Chemical
Safety Card 2019
Experimental
Vapor pressure
0.03 mm HG (4 Pa)
at 25°C

OECDSIDS 2001
Experimental
Vapor pressure
<0.075 at 20 °C;
<0.01 at 20 °C;
0.04 at 21 °C

Chadwick 1988
Experimental
Vapor pressure
<0.0075 (0.001 kPa)
at 20 °C

EPISuite v.4.11
Estimated
Vapor pressure
6.28x10-3 mm HG

EPISuite v.4.11
Estimated
Henry's Law
<1E-8 atm-m3/mole

EPISuite v.4.11
Estimated
Volatilization
5300 days (river)
58000 days (lake)

EPISuite v.4.11
Estimated
Photolysis
(Indirect)
4.1 hours (T1/2)
•	OH rate constant 3.31 E-11 cm3/molecules-second (12 hour day; 1.5E6
OH/cm3)
•	No ozone prediction
EPISuite v.4.11
Estimated
Hydrolysis
Rate constants
cannot be estimated
No reactive functional groups
EPISuite v.4.11
Estimated
Biodegradation
potential
Ready prediction:
Yes

EPISuite v.4.11
Estimated
BAF
0.9

EPISuite v.4.11
Estimated
BCF
3.16
Based on regression equation
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Based on its reported physical form and melting point, l,r-dimethyldiethylene glycol is a liquid
under ambient conditions (HSDB 2019). Exposure through direct dermal contact with the substance is
possible, but concern is lessened because this chemical is a slow skin penetrant (discussed in Section
6.1.1) and likely to be minimally absorbed through skin based on its molecular weight, water
solubility and log Kow. Because of its measured vapor pressure (OECD SIDS, 2001), 1,1'-
dimethyldiethylene glycol is expected to be volatile when in neat form at ambient temperatures. As a
result, exposure to 1,1'dimethyldiethylene glycol is possible through inhalation of vapors or aerosols
if they are generated. Based on measured solubility data (HSDB, 2019), l,r-dimethyldiethylene
glycol is considered water soluble, indicating the potential for this substance to dissolve in water and
form an aqueous solution. Water soluble substances have an increased potential for absorption
through the lungs; therefore, if inhalation of vapors or aerosols occurs, absorption through the lungs is
likely. Exposure potential changes if 1,1'dimethyldiethylene glycol is present in diluted form. The
estimated Henry's Law constant (EPI Suite, 2019) for l,l'-dimethyldiethylene glycol indicates
volatilization from water and aqueous solutions is not expected; therefore, exposure through breathing
vapor from a dilute form is expected to be minimal. Absorption and sequestration in fatty tissues are
unlikely, as reflected in the estimated bioconcentration (BCF) and bioaccumulation (BAF) values for
this compound (EPI Suite, 2019). The estimated log Koc (EPI Suite, 2019) indicates this substance is
highly mobile in soils, increasing its potential for leaching into groundwater, including ground water
sources of drinking water. If oral exposure occurs via ingestion of contaminated drinking water,
including well water, absorption through the gastrointestinal tract is likely based on experimental
evidence (discussed in Section 6.1.1). Concern for presence in drinking water is reduced in part by
1,1'dimethyldiethylene glycol's expected low persistence based on read-across from closely-related
analogs (discussed in Section 6.3.1) and low-hazard findings from toxicological studies of organisms
exposed to a closely-related analog in drinking water (discussed in Section 6.1).
3.1 References
Chadwick, Sharon S. (1988). "Ullmann's Encyclopedia of Industrial Chemistry", Reference Services
Review, Vol. 16 Issue: 4, pp.31-34, https://doi.org/10.1108/eb049034
Hazardous Substance Database (HSDB). (2016). 2,2'-Dihydroxydi-n-propyl ether. Retrieved from
http s: //toxnet .nlm.nih.gov/
European Chemicals Agency (ECHA). (2019). l,l'-oxydipropan-2-ol. Retrieved from
https://echa.europa.eu/substance-information/-/substanceinfo/100.003.475
International Chemical Safety Card (ICSC). (2019). Retrieved from
https://www.ilo.org/dvn/icsc/showcard.displav7p lang=en&p card id=1055&p version=2
Lyman, Warren J., Reehl, W. F., Rosenblatt, D. H. (1990). Handbook of chemical property estimation
methods: environmental behavior of organic compounds. American Chemical Society
OECD SIDS (2001). Dipropylene glycol (mixed isomers and dominant isomer Cas No: 25265-71-8
and 110-98-5 https://heronet.epa.gov/heronet/index.cfm/reference/download/reference id/4940388
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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 l,r-dimethyldiethylene glycol and added the chemical to
the Safer Choice Program's Safer Chemical Ingredients List (SCIL) in December 2012 under the
functional class of solvents. The SCIL4 is a continuously updated list of chemicals that meet low-
concern Safer Choice criteria. 5
EPA also reviewed international assessments of l,rdimethyldiethylene glycol. EPA identified
assessments by the Organisation for Economic Co-operation and Development (OECD), and
government agencies in Canada, Germany, and Japan.
The Organisation for Economic Co-operation and Development (OECD) Screening Information
Datasets (SIDS) Initial Assessment Meeting (SIAM) discussed the SIDS Initial Assessment Report
(SIAR) on l,r-dimethyldiethylene glycol (dipropylene glycol, mixed isomers and dominant isomer),
in January 2001. The SIAM determined this chemical to be "low priority for further work" for human
health and the environment.6
The Canadian Government, through an assessment of toxicity and exposure as part of its
categorization of the Domestic Substance List, found that l,r-dimethyldiethylene glycol did not meet
its criteria for further attention.7
Japan's National Institute of Technology and Evaluation (NITE) categorized l,l'-dimethyldiethylene
glycol as Exposure Class 4 in 2017, which is the lowest concern hazard ranking assigned.8
The German Environment Agency (UBA) designated l,l'-dimethyldiethylene glycol as "low hazard
to waters" in August 2017 based on an assessment of ecotoxicity and environmental fate.9
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://hpvchemicals.oecd.org/ui/handler.axd?id=40da06bl-a855-4c0c-bc21-bbc856dca725
7	https://canadachemicals.oecd. org/ChemicalDetails.aspx?ChemicalID=AD9A3337-870A-4CE5-8E04-DACE72B5D465
8	http://www.safe.nite.go.ip/icheck//direct.action?TYPE=DPAGE 1 &CAS= 110-98-5&MITI=2-413
9	https://webrigoletto.uba.de/rigoletto/public/searcliDetail.do7kennummeF2618
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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 l,r-dimethyldiethylene glycol (Appendix A) to inform which uses would be
determined conditions of use.1" One source of information that EPA used to help determine
conditions of use is 2016 Chemical Data Reporting (CDR). The CDR rule (previously known as the
Inventory Update Rule, or IUR), under TSCA section 8, requires manufacturers (including importers)
to report information on the chemical substances they produce domestically or import into the U.S.,
generally above a reporting threshold of 25,000 lb. per site per year. CDR includes information on the
manufacturing, processing, and use of chemical substances with information dating to the mid-1980s.
CDR may not provide information on other life-cycle phases such as the chemical substance's end-of-
life after use in products (i.e., disposal).
According to CDR, l,r-dimethyldiethylene glycol is manufactured domestically and imported. It is
used in processing (incorporation into formulation, mixture or reaction) for plastics product
manufacturing, soap, cleaning compound, and toilet preparation manufacturing; it is also used in
processing plastic material and resin. Examples of industrial uses include construction and building
materials and mining support activities. Consumer and commercial uses include air care products;
cleaning and furnishing care products; laundry and dishwashing products; plastic and rubber
products; arts and crafts; and toys, among others. Based on the known manufacturing, processing, and
uses of this chemical substance, EPA assumes distribution in commerce. In the 2016 CDR, two
facilities reported that l,rdimethyldiethylene glycol was not recycled (which could mean recycled,
reprocessed, or reused). For one facility, recycling information was withheld. No information on
disposal is found in CDR or through EPA's Toxics Release Inventory (TRI) Program11 because 1.1-
dimethyldiethylene glycol is not a TRI-reportable chemical. Although reasonably available
information did not specify additional types of disposal, for purposes of this proposed prioritization
designation, EPA assumed end-of-life pathways that include releases to air, wastewater, surface
water, and land via solid and liquid waste based on the conditions of use (e.g., incineration, landfill).
To supplement CDR, EPA conducted research through the publicly available databases listed in
Appendix A (Table A.2) and performed additional internet searches to clarify conditions of use or
find additional occupational12 and consumer uses. This research improved the Agency's
understanding of the conditions of use for l,l'-dimethyldiethylene glycol. Although EPA identified
uses of l,l'-dimethyldiethylene glycol 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 l,l'-dimethyldiethylene glycol
10	The prioritization process, including the definition of conditions of use, is explained in the Procedures for Prioritization
of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (82 FR 33753).
11	https://www.epa.gov/toxics-release-inventorv-tri-program
12	Occupational uses include industrial and/or commercial uses
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considered for chemical substance prioritization, per TSCA section 3(4). Table 3 reflects the TSCA
uses determined as conditions of use listed in Table A.3 (Appendix A).
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Table 3: Conditions of Use for 1,1'Dimethyldiethylene Glycol
Life Cycle Stage
Category
Subcategory of Use
Source
Manufacturing
Import
Import
EPA (2017b)
Processing
Processing- incorporation into
Plasticizers - plastics product manufacturing
EPA (2017b)

formulation, mixture or reaction
Odor agents - soap, cleaning compound, and toilet preparation
manufacturing; all other chemical product and preparation manufacturing


Processing—incorporation into article
Odor agents - plastic material and resin manufacturing


Industrial manufacturing
Automotive care, automotive fuel, automotive manufacturing; detergents
manufacturing; electronic equipment manufacturing; furniture manufacturing;
leather manufacturing; machinery and equipment manufacturing; paints,
varnishes, and coatings manufacturing; paper, pulp, and paper product
manufacturing; perfumes manufacturing; textile manufacturing; transport
equipment manufacturing
CPCat (2019); Synapse
Information Resources (2009)

Fabricated metal product manufacturing
Fabricated metal products; metal treatment and coating


Construction and building materials
covering large surface areas
Wood manufacturing
CPCat (2019)


Food-contact metallic manufacturing
Synapse Information
Resources (2009)

Recycling
Recycling
EPA (2017b)13
Distribution
Distribution
Distribution
EPA (2017b)

Construction and building materials
covering large surface areas
Boat and ship building; construction; floor and wall materials; glass building
materials
CPCat (2019); Synapse
Information Resources (2009)
Industrial



Mining (except oil and gas) support
activities
Mining (except oil and gas) support activities


Other
Industrial cleaning

Industrial/
commercial

Anti-foaming agents
CPCat (2019)
Commercial

Ostomy bag deodorizer
Medline.com (2017)
Commercial/
Air care products

EPA (2017b);
consumer
Cleaning and furnishing care products


13 In the 2016 CDR, two facilities reported that lj'-dimethy Methylene glycol was not recycled (which could mean recycled, reprocessed, or reused). For one facility, recycling
information was withheld. No further information about recycling or disposal was found.
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Table 3: Conditions of Use for 1,1'Dimethyldiethylene Glycol
Life Cycle Stage
Category
Subcategory of Use
Source

Laundry and dishwashing products

CPCat (2019)
Plastic and rubber products not covered
elsewhere

Consumer
Arts, crafts, and hobby materials;
Marker pens
CPCat (2019)
Furniture and furnishings not covered
elsewhere
Baby mattresses and pillows
Decor candle

Printing inks

Unknown

Hydraulic brake fluid; windshield washing agents; degreasers; lime deposit
(calcium) remover; textile detergent; food and beverage service activities;
food-contact coatings; food packaging; fuel additive; petroleum additive;
absorbents/adsorbents; adhesives and binding agents; colorant; corrosion
inhibitor; polishing agent; preservatives
Synapse Information
Resources (2009);
CPCat (2019)
Disposal
Releases to air, wastewater, solid and
liquid wastes

Though not explicitly
identified, releases from
disposal are assumed to be
reasonably foreseen14
14 See Section 5 for a discussion on why releases are assumed to be reasonably foreseen for purposes of this proposed prioritization designation.
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6. Hazard Characterization
EPA reviewed primary literature and other data sources to identify reasonably available information
on hazard for l,r-dimethyldiethylene glycol. This literature review approach15 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 l,r-dimethyldiethylene glycol against the endpoints listed below. EPA's
New Chemicals Program has used these endpoints for decades to evaluate chemical substances under
TSCA16 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
Chemicals17 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
Toxicity18
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
1'Discussed in the document "Approach Document for Screening Hazard Information for Low-Priority Substances Under
TSCA", also released at proposal.
10 https://www.epa. gov/sustainable-futures/sustainable-futures-p2-framework-manual
17	https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs rev07/English/ST SG AC10 30 Rev7e.pdf
18	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)19

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
Toxicity20

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
Toxicity20

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/
Genotoxicity21
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.
19	Values from GHS criteria for Specific Target Organ Toxicity Repeated Exposure (Chapter 3.9: Specific Target Organ
Toxicity' Repeated Exposure. 2009, United Nations).
20	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).
21	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.
Carcinogenicity22
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
inadequate23 evidence
in humans)
Negative studies or
robust mechanism-
based structure
activity relationship
(SAR)
Neurotoxicity
(90-day study)19

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
Sensitization24

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
Limited evidence
including the presence
of structural alerts
Adequate data
available indicating
lack of respiratory
sensitization
11 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).
23	This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
24	From GHS criteria (Chapter 3.4: Respiratory or Skin Sensitization. 2009, United Nations).
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects


animal or other tests
(equivalent to GHS
Category 1A or 1B)


Irritation/
Corrosivity25
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)26
Chronic Aquatic
Toxicity Value
(L/E/ICso)26
Persistence (Measured in terms of level of
biodegradation)27
Bioaccumulation
Potential28
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 l,r-dimethyldiethylene glycol. In many cases, EPA used analogous chemicals to make
findings for a given endpoint. Where this is the case, use of the analog is explained. If the chemical
studied is not named, the study is for l,r-dimethyldiethylene glycol. Appendix B contains more
information on each study.
l,r-Dimethyldiethylene glycol is an isomer of dipropylene glycol in which the methyl groups are
specified to be at the 1 and 1" positions. EPA used best professional judgement to select analogs for
l,r-dimethyldiethylene glycol 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. Both of the analogs listed in
25 Criteria derived from the Office of Pesticide Programs Acute Toxicity Categories (U.S. EPA. Label Review Manual.
2010).
20 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).
27	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).
28	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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Table 5 are oligomeric propylene glycols like the l,r-dimethyldiethylene glycol. The analog
dipropylene glycol is a condensation product of two propylene oxide (methyl oxirane) units and is a
mixture of isomers differing only in the placement of the methyl substituents. l,r-dimethyldiethylene
glycol is one of its components. The analog tripropylene glycol is a condensation product of three
propylene oxide units and does not have a specified placement of the methyl groups in each unit.
Differences in the methyl group positions in these chemicals are not expected to significantly affect
their chemical and hazard profiles. Based on these factors, the environmental and toxicological effects
of tripropylene glycol and dipropylene glycol are expected to be very similar to each other and to
l,r-dimethyldiethylene glycol.
Table 5:1,1'Dimethyldiethylene glycol and Analog Structures
CASRN
Name
Structure
110-98-5
1,1'-
Dimethyldiethylene
glycol
ch3 ch3
Representative structure
24800-44-0
Tripropylene glycol
(mixed isomers)
CH,
CH, CH,
Representative structure
25265-71-8
Dipropylene glycol
(mixed isomers)
CHj CHS
HO JL JL - OH
O N/
c
CHj CHj
t
mix
Representative structure
6.1.1 Absorption, Distribution, Metabolism, and Excretion
Absorption
To assess l,r-dimethyldiethylene glycol's absorption potential, EPA used experimental studies from
analogs. In a study on dogs, dipropylene glycol was rapidly absorbed from the gastrointestinal tract
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and was no longer detectable in the blood 24 hours after an oral exposure (BUA. 1996). Rats exposed
to 14C-tripropylene glycol by oral gavage also rapidly absorbed tripropylene glycol, as indicated by
recovery of 91.4% of the administered dose 24 hours following exposure (ECHA. 1995a). Based on
these data, l,r-dimethyldiethylene glycol is expected to be absorbed after oral exposures.
In vitro studies were used to assess the potential dermal absorption by l,r-dimethyldiethylene glycol
using read-across from dipropylene glycol. Excised abdominal skin from human cadavers
demonstrated dipropylene glycol is a slow penetrant, with the results demonstrating a permeability
coefficient of 3.85 x 10"5 cm/hour (Fasano et al.. 2011; ECHA. 2007b; Fasano. 2007). Based on these
data, potential for absorption of l,r-dimethyldiethylene glycol through the skin is low.
Based on its low molecular weight and high water solubility (discussed in Section 3), 1,1'-
dimethyldiethylene glycol is expected to be absorbed from the lungs if inhaled.
Distribution
l,l'-Dimethyldiethylene glycol is considered water soluble based on its physical-chemical properties
(Table 2) and is likely to be distributed mainly in aqueous compartments in an organism. This
prediction is supported by experimental evidence on the analog tripropylene glycol. Rats exposed to
tripropylene glycol by oral gavage displayed radiolabeled tripropylene glycol in the tissues and the
carcass 24 hours following exposure (OECD. 2001; ECHA. 1995a). Specifically, tripropylene glycol
was reported in the liver at 0.20%, kidneys at 0.09%, carcass at 0.06%, blood at 0.03%, and skin,
brain, muscle, and fat at less than 0.03% (as percent of the administered dose per gram of tissue).
These data indicate tissue distribution of tripropylene glycol to the liver and kidney and provide
evidence that l,l'-dimethyldiethylene glycol will be rapidly distributed following oral absorption.
Metabolism
To assess l,l'-dimethyldiethylene glycol's metabolism pathways, EPA used experimental studies
from analogs. Oral administration of tripropylene glycol to rats resulted in rapid metabolism to
dipropylene glycol, then to propylene glycol, which is converted to lactic and pyruvic acids or
excreted in the urine. Lactate and pyruvate may be further metabolized through the citric acid cycle to
yield carbon dioxide and water or may be stored as glycogen (OECD. 2001). Rats exposed to 14C-
tripropylene glycol by oral gavage excreted approximately 13% as free or conjugated tripropylene
glycol, approximately 8.4% as free and conjugated dipropylene glycol, and approximately 3.9% as
free and conjugated propylene glycol (OECD. 2001; ECHA. 1995a). These data indicate that 1,1'-
dimethyldiethylene glycol will be rapidly metabolized.
Excretion
To assess l,l'-dimethyldiethylene glycol's excretion pathways, EPA used experimental evidence
from tripropylene glycol. Following the oral administration of tripropylene glycol to rats, 52% was
recovered in urine, 21% in exhaled CO2, and 5% in the feces after 24 hours (ECHA. 1995a). These
data suggest that l,l'-dimethyldiethylene glycol will be excreted from the body following exposure.
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6.1.2	Acute Toxicity
EPA assessed the potential for mammalian toxicity from acute exposure by l,r-dimethyldiethylene
glycol using results from oral, inhalation, and dermal studies.
Two studies on rats exposed to l,r-dimethyldiethylene glycol by oral gavage reported LD50S at very
high doses, such as 12500 mg/kg and 16195 mg/kg respectively (Dow Chemical. 1994; Union
Carbide. 1994). Another study in guinea pigs exposed to l,r-dimethyldiethylene glycol by oral
gavage reported an LD50 of 10000 mg/kg (Union Carbide. 1994). These studies 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 dipropylene glycol dermally reported no adverse effects at the single
dose tested (5010 mg/kg), resulting in an LD50 greater than 5010 mg/kg (ECHA. 1995c). Another
study on rabbits exposed to tripropylene glycol dermally reported no adverse effects at the single dose
tested, resulting in an LD50 greater than 16320 mg/kg (ECHA. 1974a). These studies indicate low
concern for acute toxicity with LD50S above the low-concern threshold of 2000 mg/kg for dermal
exposures.
A study on rats exposed to a single concentration of tripropylene glycol in saturated vapor for eight
hours and then observed for two weeks reported no mortalities (ECHA. 1974b). Based on
tripropylene glycol's vapor pressure of 0.00195 torr, the expected air saturation concentration for
tripropylene glycol is around 0.02 mg/L at room temperature, which is below the study concentration
of 0.083 mg/L, indicating no adverse effects are expected at the complete air saturation concentration.
Another study on rats exposed to a dipropylene glycol aerosol reported no adverse effects at the
single dose tested, resulting in an LC50 greater than 2.34 mg/L (ECHA. 1995d). Considering the
chemical's physical chemical properties (see Section 3) and available experimental data, these results
indicate l,l'-dimethyldiethylene glycol is of low concern for acute toxicity from inhalation exposures
based on no adverse effects reported at the expected air saturation.
6.1.3	Repeated Dose Toxicity
EPA assessed the potential for mammalian toxicity from repeated exposures by 1,1'-
dimethyldiethylene glycol using read-across from tripropylene glycol. In a combined repeated dose,
reproductive, and developmental study (QECD. 1994: ECHA. 1993b). rats were exposed to
tripropylene glycol via oral gavage for 49 days, beginning 14 days prior to mating and through
lactation day 3 for females. The no observed adverse effect level (NOAEL) was 200 mg/kg-day and
the lowest observed adverse effect level (LOAEL) was 1000 mg/kg-day based on changes in organ
weight in parents.
EPA also assessed the potential for toxicity from repeated exposures to dipropylene glycol in drinking
water. A study on mice exposed to dipropylene glycol in drinking water for 13 weeks demonstrated a
NOAEL of 2620 mg/kg-day and a LOAEL of 4790 mg/kg-day based on increased liver weight
(ECHA. 2004g; NTP. 2004). A study on rats exposed to dipropylene glycol in drinking water for 14
weeks demonstrated a NOAEL of 425 mg/kg-day and a LOAEL of 890 mg/kg-day based on relative
liver weight (ECHA. 2004f; NTP. 2004). A 2-year study on mice exposed to dipropylene glycol in
drinking water demonstrated a NOAEL of 1040 mg/kg-day and a LOAEL of 1950 mg/kg-day based
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on decreased mean body weight (ECHA. 2004e; NTP. 2004). Another study on rats exposed to
dipropylene glycol for 2 years in drinking water demonstrated aNOAEL of 115 mg/kg-day and a
LOAEL of 470 mg/kg-day based on incidence of nephropathy, focal histiocytic and focal
granulomatous inflammation in male livers (ECHA. 2004b. d; NTP. 2004).
All of these analog results indicate low concern for toxicity resulting from repeated exposures by
exceeding the oral low-concern threshold of 100 mg/kg-day for a 90-day study.
6.1.4	Reproductive and Developmental Toxicity
EPA assessed the potential for reproductive toxicity using read-across from analog tripropylene
glycol. In a combined repeated dose, reproductive, and developmental study, rats were exposed to
tripropylene glycol via oral gavage for 49 days, beginning 14 days prior to mating and continuing
through lactation day 3 for females. The authors reported no reproductive (mating, fertility, and estrus
cycle) or developmental effects (external examinations of the pups and pup body weight gain) at the
highest dose tested (1000 mg/kg-day). EPA determined the NOAEL for this study was 1000 mg/kg-
day (OECD. 1994). These analog results indicate low concern for reproductive toxicity in the target
chemical by exceeding the 250 mg/kg-day threshold.
EPA further assessed the potential for developmental toxicity, using read-across from an analog,
dipropylene glycol. A study on pregnant rats orally exposed to dipropylene glycol during GD 6-15
reported a developmental NOAEL of 2000 mg/kg-day and a LOAEL of 5000 mg/kg-day based on
decreased fetal weight. A study on rabbits orally exposed to dipropylene glycol during GD 6-19
reported no adverse effects at the highest dose tested, resulting in aNOAEL of 1200 mg/kg-day
(OECD. 2001; Bates et al.. 1992a; ECHA. 1990a). These analog results indicate low concern for
developmental toxicity by exceeding the 250 mg/kg-day threshold.
6.1.5	Genotoxicity
EPA assessed experimental studies on genotoxicity as a potential indicator of genotoxic
carcinogenicity using read-across from dipropylene glycol. Three in vitro gene mutation studies
resulted in negative findings from dipropylene glycol exposure with and without metabolic activation
in Salmonella typhimiirium (ECHA. 2004c; NTP. 2004; ECHA. 1992a) and in mouse lymphoma cells
(ECHA. 1988). Further, a mouse in vivo study indicated negative results for chromosomal aberrations
in the form of micronucleated polychromatic erythrocytes from dipropylene glycol exposure (OECD.
2001; ECHA. 1999). These negative results in an analog indicate l,r-dimethyldiethylene glycol has
low concern for inducing genotoxicity.
6.1.6	Carcinogenicity
EPA assessed the potential for l,r-dimethyldiethylene glycol to cause carcinogenicity in mice and
rats using read-across from dipropylene glycol. Rats exposed to dipropylene glycol in drinking water
for 2 years demonstrated no dose-related effects on cancer incidence or cancer-related effects at the
highest dose tested (3040 mg/kg-day in males, 2330 mg/kg-day in females), resulting in a negative
finding for carcinogenicity (ECHA. 2004b; NTP. 2004). Similarly, mice exposed to dipropylene
glycol in drinking water for two years also demonstrated no adverse effects at the highest dose tested
(2390 mg/kg-day in males, 1950 mg/kg-day in females), resulting in a negative finding for
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carcinogenicity (ECHA. 2004a; NTP. 2004). Using read-across from this analog, these negative
results indicate low concern for carcinogenicity for l,r-dimethyldiethylene glycol.
6.1.7	Neurotoxicity
While no traditional neurotoxicity studies were available for l,r-dimethyldiethylene glycol or
closely-related analogs, EPA assessed the potential for neurotoxicity using relevant endpoints
measured in acute and repeated dose studies and using predictions made by U.S. EPA's ToxCast.29
Several repeat dose oral studies in rats and mice for analog tripropylene glycol reported no effects on
the limited neurological endpoints that were evaluated (i.e., brain histopathology only). Tripropylene
glycol did not produce histopathological lesions in the brain of rats at doses up to 1000 mg/kg-day
(highest dose tested) in a study when males were exposed for 49 days and females were exposed from
14 days prior to mating until day 3 of lactation (OECD. 1994; ECHA. 1993b). Dipropylene glycol did
not produce histopathological brain lesions in rats at oral doses up to 12,800 mg/kg-day for 3 months
or up to 3040 mg/kg-day for 2 years. Similarly, in mice, no brain lesions were observed at oral doses
up to 14700 mg/kg-day for 3 months or up to 2330 mg/kg-day for 2 years (ECHA. 2004b. d; NTP.
2004). A study on rats acutely exposed to dipropylene glycol by oral gavage noted decreased motor
activity and ataxia for a few hours after exposure to the high dose of 5010 mg/kg, but the effects
subsided by the first day of the observation period (ECHA. 1995e).
ToxCast results for l,r-dimethyldiethylene glycol included 15 in vitro high throughput biochemical-
and cell-based assays related to neurological functions.3" Bioactivity was not induced in any assay by
l,r-dimethyldiethylene glycol.
These data indicate there is low concern for neurotoxicity associated with l,r-dimethyldiethylene
glycol. This finding is also supported by the low-hazard findings for other human health hazard
endpoints, including, but not limited to, toxicity from acute exposures, reproductive toxicity, and
developmental toxicity.
6.1.8	Skin Sensitization
EPA assessed the potential for l,r-dimethyldiethylene glycol to cause skin sensitization using
available experimental studies in an analog, dipropylene glycol. Dipropylene glycol demonstrated
negative results in guinea pigs (ECHA. 1995k) and in two human studies (ECHA. 1995h; Johansen et
al.. 1995; Leberco Labs. 1994). These negative analog results indicate low concern for skin
sensitization for l,r-dimethyldiethylene glycol.
29 https://actor.epa.gov/dashboard/. Chemical specific assay list can be found at
https://actor.epa.gOv/dashboard/#chemical/55934-93-5.
M As identified by supplementary information from 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. https://pubs.rsc.org/en/content/articlepdf/2018/tx/c7tx00268h
Supplementary files: https://pubs.rsc.Org/en/content/articlelanding/2018/tx/c7tx00268h#idivAbstract
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6.1.9	Skin Irritation
EPA assessed the potential for dermal irritation using read-across from dipropylene glycol and
tripropylene glycol. Three studies in rabbits demonstrated negative results for dermal irritation by
dipropylene glycol (ECHA. 1995c. i; Leberco Labs. 1994). One study in rabbits demonstrated
tripropylene glycol was minimally irritating with mean irritation score of 2 out of 10 (ECHA. 1974d).
In another study, humans exposed to dipropylene glycol demonstrated mild erythema in 4 of the 33
subjects at the 24 hour scoring (ECHA. 1995f). However, humans exposed to tripropylene glycol for
24 hours reported negative results for skin irritation (ECHA. 1995b). A longer dermal patch study on
humans exposed to tripropylene glycol for 14 days also indicated negative results for skin irritation
(ECHA. 1997). Based on these results in analogs, l,r-dimethyldiethylene glycol is expected to be of
low concern for skin irritation.
6.1.10	Eye Irritation
To assess potential for eye irritation, EPA used read-across from two analogs, dipropylene glycol and
tripropylene glycol. Rabbits exposed to tripropylene glycol displayed mild conjunctival redness,
chemosis, and conjunctival discharge at the 1-hour scoring, but these results were fully reversible by
24 hours, leading to a negative result for eye irritation (ECHA. 2010a). Similarly, rabbits exposed to
dipropylene glycol displayed conjunctival redness and a subset displayed chemosis after one hour, but
again these results were fully reversible by 24 hours, leading to a negative result for eye irritation
(ECHA. 1995g). These results are supported by two studies with negative results in rabbits exposed
to dipropylene glycol (Leberco Labs. 1994) and tripropylene glycol (ECHA. 1974c). Additionally, an
in vitro human corneal epithelium model study (ECHA. 2010b) also reported tripropylene glycol as
negative for inducing ocular irritation. These in vivo and in vitro results in analogs indicate low
concern for eye irritation by l,r-dimethyldiethylene glycol.
6.1.11	Hazards to Potentially Exposed or Susceptible Subpopulations
The above information supports a low human health hazard finding for l,r-dimethyldiethylene
glycol based on low-concern criteria. This finding includes considerations such as the potential for
developmental toxicity, reproductive toxicity, and acute or repeated dose toxicity that may impact
potentially exposed or susceptible subpopulations. Based on the hazard information discussed in
Section 6, EPA did not identify populations with greater susceptibility to l,r-dimethyldiethylene
glycol.
6.2 Environmental Hazard
EPA assessed environmental hazard for l,r-dimethyldiethylene glycol based on estimated toxicity
values using the Ecological Structure Active (ECOSAR) Predictive Model31 and available
experimental data from two analogs, dipropylene glycol and tripropylene glycol. Appendix B
contains a summary of the reasonably available environmental hazard data.
31https://www.epa.gov/tsca-screeniiig-tools/ecological-striicture-activitv-relationships-ecosar-predictive-model
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6.2.1	Acute Aquatic Toxicity
EPA assessed environmental hazard from acute exposures using read-across from tripropylene glycol
and dipropylene glycol. No adverse effects were observed in aquatic invertebrates exposed to
dipropylene glycol (ECHA. 2002. 1995i) or tripropylene glycol (ECHA. 2010c. 1994a; OECD. 1994)
at the highest doses tested (100 mg/L and 1000 mg/L, respectively), resulting in LC50S greater than
100 mg/L and 1000 mg/L, respectively, for invertebrates. Similarly, no effects were observed in
aquatic vertebrate or algae exposed to tripropylene glycol resulting in LC50S greater than 1000 mg/L
for aquatic vertebrates (ECHA. 1994b; OECD. 1994) and algae (OECD. 1994). 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 by ECOSAR for aquatic vertebrates, aquatic invertebrates, and
algae were 1300 mg/L, 420 mg/L, and 370 mg/L, respectively. These toxicity values indicate that
l,r-dimethyldiethylene glycol is expected to have low environmental hazard based on the low-
concern criteria chronic aquatic toxicity threshold of 10 mg/L.
6.3 Persistence and Bioaccumulation Potential
6.3.1 Persistence
Varied results are observed in the experimental ready test data presented in Appendix B. Due to the
differences in the test conditions of the OECD ready test methods, some of this variability is likely a
result of performance under different test designs rather than an inherent limitation of the
biodegradability of the test substance. Given the varied results, EPA relied on studies from analogs
tripropylene glycol and dipropylene glycol to make a weight of the scientific evidence conclusion. An
explanation of ready and inherent biodegradation tests is provided below.
Ready biodegradation tests are stringent test methods in which a high concentration of test substance
is evaluated using a non-adapted inoculum. Passing this type of test indicates that a chemical is likely
to biodegrade 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. The available data included tests for both ready biodegradation and inherent
biodegradation.
Tripropylene glycol was tested in three aerobic ready tests (OECD 301C, OECD 301B and OECD
30ID) that reported <5% degradation over 28-day incubation periods, indicating that it is not readily
biodegradable (OECD. 1994; ECHA. 1993a. 1991b). However, in another OECD 30ID test,
tripropylene glycol reached 69% O2 consumption after 28 days and just missed the 10-day window
criterion at 59% in 11 days under aerobic conditions (ECHA. 1991a). In addition, both dipropylene
glycol and tripropylene glycol reached S81% O2 consumption after 28 days under aerobic conditions
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in the OECD 301F test, meeting the criteria for ready biodegradation but not meeting the 10-day
window (ECHA. 2007a. c, 1994c). These data suggest that tripropylene glycol is aerobically
biodegradable and may be readily biodegradable under the right conditions. Results from additional
aerobic studies, including the inherent biodegradability test OECD 302A and a seawater
biodegradability test (OECD 306) on dipropylene glycol provide further support that tripropylene
glycol has the capacity to biodegrade under environmental conditions (ECHA. 2007d. 1994c).
Furthermore, the microbial inhibition tests on tripropylene glycol and dipropylene glycol indicate that
these substances are non-toxic to microbial populations found in sewage treatment plants (ECHA.
2010c. 1992b).
Based on the weight of scientific evidence, the data suggest l,r-dimethyldiethylene glycol is
expected to biodegrade under aerobic conditions. Although under some test conditions this chemical
may not meet the benchmark for ready biodegradation, both ready and inherent biodegradation of
these substances has been demonstrated using a variety of standard and non-standard test methods.
No quality experimental studies were available to assess anaerobic biodegradation. Though BIOWIN
modeling did not predict this chemical to anaerobically biodegrade quickly, these results do not
indicate this chemical would not anaerobically biodegrade. ri-Dimethyldiethylene glycol's low-
hazard results for environmental and mammalian toxicity, and evidence of aerobic biodegradation,
indicate low concern for this chemical if present in anaerobic environments.
No degradation products of concern were identified for this chemical substance. The available
biodegradation results meet the low-concern threshold and indicate this chemical will have low
persistence.
6.3.2 Bioaccumulation Potential
Based on the estimated bioaccumulation factor (BAF) value of 0.9 using the Estimation Programs
Interface (EPI) Suite models,32 l,r-dimethyldiethylene glycol is expected to have low potential for
bioaccumulation in the environment based on the low concern threshold of less than 1000.
32 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 l,r-dimethyldiethylene glycol. In
general, there is limited information on exposure for low-hazard chemicals. EPA determined the CDR
database and certain other sources of l,r-dimethyldiethylene glycol use information are sources of
information relevant to l,r-dimethyldiethylene glycol's exposure potential. Of these sources, EPA
determined that the CDR database contained the primary source of information on the conditions of
use for this exposure characterization. EPA also consulted sources of use 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, l,r-dimethyldiethylene glycol is used in processing (incorporation
into formulation, mixture or reaction) for plastics product manufacturing, detergents, cleaning
compounds, and toilet preparation manufacturing. It is also used in industrial applications, such as
construction and building materials, and consumer and commercial applications including air care
products; cleaning and furnishing care products; laundry and dishwashing products; plastic and
rubber products; arts and crafts; and toys, among others. l,r-Dimethyldiethylene glycol may have
other uses, as shown in Table 3. Non-TSCA uses, including those because of the excluded under
TSCA section 3(2), are beyond the scope of this assessment (See Table A.3).
Under the conditions of use identified in Table 3, EPA assessed the potential exposure to the
following categories: the environment, the general population, and potentially exposed or susceptible
subpopulations including workers, consumers, and infants and children.
7.1	Production Volume Information
Production volume information for l,r-dimethyldiethylene glycol is based on an analysis of CDR
data reported from 1986 to 2015.33 In the 1986 reporting year, aggregate production volume for 1.1'-
dimethyldiethylene glycol was between 1,000,000 and 10,000,000 lbs. and in 1990, between
50,000,000 and 100,000,000 lbs. From the 1994 to 2002 reporting years, aggregate production
volume for l,r-dimethyldiethylene glycol was between 10,000 and 500,000 lbs., and for the 2011
reporting year, the exact amount is available, at 146,990 lbs. Production reached a high of 1,000,000
to <10,000,000 lbs. in 2012; however, it has remained stable within the range of 500,000 to
<1,000,000 lbs. from 2013-2015.
7.2	Exposures to the Environment
EPA expects most exposures to the environment to occur during the manufacture, import, processing,
and industrial, commercial, and consumer uses of l,r-dimethyldiethylene glycol. Exposure is also
reasonably foreseen from other conditions of use, such as distribution and disposal. These activities
33 The CDR requires manufacturers (including importers) to report information on the chemical substances they produce
domestically or import into the U.S above 25,000 lb. per site per year.
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could result in releases of l,r-dimethyldiethylene glycol to media including surface water, landfills,
and air.
EPA expects high levels of removal of l,r-dimethyldiethylene glycol during wastewater treatment
(either directly from the facility or indirectly via discharge to a municipal treatment facility or
Publicly Owned Treatment Works (POTW)). Further, l,r-dimethyldiethylene glycol is expected to
have low persistence (aerobic biodegradation is discussed in Section 6.3.1) and has the potential to
break down in the environment into carbon dioxide and water. Therefore, any release of this chemical
is expected to break down, reducing exposure to aquatic organisms in the water column and
groundwater sources of drinking water, including well water. Based on the estimated log Koc (Table 2
of Section 3), l,r-dimethyldiethylene glycol is expected to have negligible adsorption to sediment,
reducing the potential for toxicity to benthic organisms. Further, l,r-dimethyldiethylene glycol's
biodegradability during treatment processes will reduce the exposure potential to aquatic organisms.
If disposed of in a landfill, this chemical is expected to degrade under aerobic conditions (aerobic
biodegradation is discussed in Section 6.3.1).
If incineration releases during manufacturing and processing occur, EPA expects significant
degradation of l,r-dimethyldiethylene glycol to the point that it will not be present in air.
7.3	Exposures to the General Population
EPA expects the general population is unlikely to be exposed to l,r-dimethyldiethylene glycol from
the potential environmental releases described above. Air exposure is unlikely from incineration. If
l,rdiemthyldiethylene glycol is present in the air from volatilization, it is expected to be reduced
because of its short atmospheric half-life of about 4 hours (see Table 2 in Section 3). With the
exception of time immediately following a release, l,rdimethyldiethylene glycol is unlikely to be
present in surface water because it will degrade (discussed in Section 6.3.1), reducing the potential for
the general population to be exposed by oral ingestion or dermal exposure. Further, given the low
bioaccumulation or bioconcentration potential of l,r-dimethyldiethylene glycol, oral exposure to
l,r-dimethyldiethylene glycol via fish ingestion is unlikely.
7.4	Exposures to Potentially Exposed or Susceptible Subpopulations
EPA identified workers, consumers, and infants and children as potentially exposed or susceptible
subpopulations based on greater exposure to l,r-dimethyldiethylene glycol than the general
population during manufacturing, processing, distribution, use and disposal. EPA identified infants
and children (including any adults working closely with them) as a population that may experience
greater exposure to l,r-dimethyldiethylene glycol than the general population during use of hobby
products, toys, and baby mattresses and pillows. EPA also identified consumers as a population that
may experience greater exposure to l,r-dimethyldiethylene glycol than the general population
through use of printing inks, cleaning and furnishing care products, laundry and dishwashing
products, air care products, and decor candles, for example.
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7.4.1	Exposures to Workers
Based on its reported physical form and measured melting point (Table 2), l,r-dimethyldiethylene
glycol is a liquid under ambient conditions. Based on l,r-dimethyldiethylene glycol's conditions of
use, workers may be exposed to liquids through direct dermal contact with the substance and
inhalation of aerosols if they are generated. Based on its measured vapor pressure (Table 2), 1,1'-
dimethyldiethylene glycol is expected to be volatile at ambient temperatures, and therefore workers
may be exposed through inhalation of vapors. If l,l'-dimethyldiethylene glycol is in a dilute form,
the estimated Henry's Law constant for l,l'-dimethyldiethylene glycol suggests volatilization from
water and aqueous solutions is expected to be minimal. Workers may be exposed to 1,1'-
dimethyldiethylene glycol in manufacturing, processing, distribution, use, and disposal.
7.4.2	Exposures to Consumers
Consumers could be exposed to l,l'-dimethyldiethylene glycol through use of printing inks, cleaning
and furnishing care products, laundry and dishwashing products, air care products, decor candles, and
other products. For all these uses, if dermal contact does occur, l,l'-dimethyldiethylene glycol is
expected to have minimal absorption through the skin based on its molecular weight, water solubility
and partitioning coefficients (Section 3) and experimental data (Section 6.1.1). If the chemical is in an
aerosol product and inhalation exposure occurs, l,l'-dimethyldiethylene glycol's absorption from the
lungs is likely. EPA does not include intentional misuse, such as people drinking products containing
this chemical, as part of the known, intended or reasonably foreseen conditions of use that could lead
to an exposure (82 FR 33726). Thus, oral exposures will be incidental (meaning inadvertent and low
in volume). l,l'-Dimethyldiethylene glycol is expected to be rapidly metabolized and excreted,
further reducing the duration of exposure.
7.4.3	Exposures to Infants and Children
Children may be potentially exposed to l,l'-dimethyldiethylene glycol through the use of hobby
products, such as marker pens and toys, as noted in Table 3 (CPCat, 2019). In 2006, the Danish
Environmental Protection Agency conducted a survey of the following types of children's hobby
products: marker pens, glitter glue, acrylic paint, and shrink plastic. The initial screening detected
over 70 chemicals, with l,l'-dimethyldiethylene glycol detected in 3 of 26 marker pens; the chemical
was not found in the other types of hobby products. The Danish EPA prioritized quantifying
chemicals associated with hazardous effects, such as carcinogens, mutagens, and reproductive
toxicants and allergenic substances. The amount of l,l'-dimethyldiethylene glycol in the marker pens
was not quantitatively analyzed because of its low-concern for hazard (Danish EPA, 2008a). In a
survey conducted from 2013 to 2014 on children's toys by the Danish EPA, l,l'-dimethyldiethylene
glycol was detected in toy slime (at 5 mg/kg) but no other types of toys (Danish EPA, 2015)
As noted in Table 3 (CPCat, 2019), infants may also be exposed to l,l'-dimethyldiethylene glycol via
baby products. A 2008 survey by the Danish EPA investigated chemicals in the following types of
baby products: pillows for baby feeding; baby carriers; nursing pillows and cushions with different
covers and stuffing; baby mattresses with foam stuffing; aprons to perambulators; and disposable
foam washcloths. l,l'-Dimethyldiethylene glycol was detected in the foam of a baby mattress (at 56
|ig/g) and the outer cover (cotton with printing) of a pillow for baby feeding (at 19 jxg/g); the
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chemical was not detected in any of the other type of baby products investigated (Danish EPA,
2008b).
When children use marker pens and slime, skin contact is likely. When infants are placed on pillows
for baby feeding, skin contact with l,r-dimethyldiethylene glycol is possible if the chemical is
present in the outer cover. The same is true for baby mattresses if l,r-dimethyldiethylene glycol
migrates from the foam to the surface. However, l,r-dimethyldiethylene glycol is expected to be
poorly absorbed through the skin given its molecular weight, water solubility, and partitioning
coefficients (Section 3) and experimental evidence on analogs (6.1.1). Based on the predicted Henry's
Law constant (Section 3), l,r-dimethyldiethylene glycol's volatilization from water and aqueous
solutions is expected to be minimal, which is relevant for marker pens and toy slime, reducing
inhalation exposures to children. While using these products, children may rub their eyes or
incidentally ingest the product. Similarly, when infants are placed on baby mattresses or pillows for
feedings, they may orally ingest the chemical if mouthing these products or sucking their fingers. If
ingested, l,l'-dimethyldiethylene glycol is expected to be rapidly metabolized and excreted, further
reducing the duration of exposure. Therefore, EPA expects the exposures to l,l'-dimethyldiethylene
glycol through use of these products to be low.
EPA did not find information on the presence or concentration of l,l'-dimethyldiethylene glycol in
children's and baby products from sources beyond this Danish EPA study. EPA assumes that the
hobby products, toys, baby mattresses, and pillows used for feeding tested by the Danish EPA are
similar to products sold in the U.S., or that similar products and uses are reasonably foreseeable.
7.5 References
Danish EPA. (2008a). Survey and health assessment of chemical substances in hobby products for
children. Retrieved from https://www2.mst.dk/udgiv/publications/2008/978-87-7052-763-
7/pdf/978-87-7052-764-4.pdf
Danish EPA. (2008b). Survey, emission and health assessment of chemical substances in baby
products https://www2.mst.dk/udgiv/publications/2008/978-87-7052-717-0/pdf/978-87-7052-
718-7.pdf
Danish EPA. (2015). CMR Substances in Toys - Market Surveillance and Risk Assessment.
Retrieved from https://www2.mst.dk/Udgiv/publications/2015/10/978-87-93352-79-7.pdf
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8. Summary of Findings
EPA has used reasonably available information on the following statutory and regulatory criteria and
considerations to screen l,r-dimethyldiethylene glycol 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 l,l'-dimethyldiethylene glycol. EPA
used this information to inform its proposed determination of whether l,l'-dimethyldiethylene glycol
would meet the statutory criteria and considerations for proposed designation as a low-priority
substance.
•	Hazard potential:
For l,l'-dimethyldiethylene glycol's hazard profile, EPA gathered information for abroad 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 1,1'-
dimethyldiethylene glycol is of low concern for human health and environmental hazard across the
range of endpoints in this low-concern criteria.
•	Exposure potential:
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To understand exposure potential, EPA gathered information on physical-chemical properties,
production volumes, and the types of exposures likely to be faced by workers, the general population,
consumers, and infants and children (discussed in Sections 3 and 7). EPA also gathered information
on environmental releases. EPA identified workers, the general population, consumers, infants and
children, and the environment as most likely to experience exposures. EPA determined that while the
general population, consumers, children and workers may be exposed to l,r-dimethyldiethylene
glycol, exposure by the dermal pathway is limited by l,r-dimethyldiethylene glycol's physical-
chemical properties. If ingestion occurs, l,r-dimethyldiethylene glycol is expected to be metabolized
and excreted, reducing the duration of exposure. Inhalation of l,r-dimethyldiethylene glycol in dilute
products is expected to be minimal; however, workers may be exposed to vapors of neat
l,rdiemthyldiethylene glycol. If l,r-dimethyldiethylene glycol is released into the environment, its
exposure potential will be reduced through biodegradation under aerobic conditions. EPA found that
l,r-dimethyldiethylene glycol is of low concern for human and environmental exposure given the
low hazard nature of this chemical substance.
Rationale: EPA determined that while workers, consumers, and infants and children may be exposed
to l,r-dimethyldiethylene glycol during processing, manufacturing, distribution, use, or disposal,
these exposures do not pose a significant risk because of the chemical's low-hazard results across a
range of endpoints (discussed in Section 6). In summary, the concern for exposure is mitigated by the
low-hazard profile of this chemical.
Proposed conclusion: Based on an initial analysis of reasonably available hazard and exposure
information, EPA proposes to conclude that the risk-based screening level review under 40 CFR
702.9(a)(1) does not support a finding that l,l'-dimethyldiethylene glycol meets the standard for a
high-priority substance. The reasonably available hazard and exposure information described above
provides sufficient information to support this proposed finding.
8.2 Persistence and Bioaccumulation
Approach: EPA has evaluated both the persistence and bioaccumulation potential of 1,1'-
dimethyldiethylene glycol based on a set of EPA and internationally accepted measurement tools and
thresholds that are indicators of persistence and bioaccumulation potential (described in Section 6).
These endpoints are key components in evaluating a chemical's persistence and bioaccumulation
potential.
Rationale: As discussed in Section 6.3.1, EPA predicts l,l'-dimethyldiethylene glycol will have a
half-life less than 60 days. Given the low toxicity concern for this chemical, the low-concern criteria
require that the chemical not produce degradation products of concern and have a half-life less than
60 days (Section 6.3.1). The available biodegradation results meet the low concern threshold and
suggest this chemical has low potential for persistence. Additionally, EPA's EPI Suite models
indicate alow potential for bioaccumulation (Section 6.3.2).
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 l,l'-dimethyldiethylene glycol meets the standard for a
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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, and disposal of l,r-dimethyldiethylene glycol, as well
as consumers, infants and children, as potentially exposed or susceptible subpopulations (described in
more detail in Section 7). EPA also identified infants and children (and any adults working closely
with children) as a population that may experience greater exposure to l,r-dimethyldiethylene glycol
than the general population during use of hobby materials such as marker pens, toys such as toy
slime, and baby mattresses and pillows. Consumers are also a potentially exposed subpopulation
because of their use of products such as printing inks, cleaning and furnishing care products, laundry
and dishwashing products, air care products, decor candles, and other products.
Rationale: EPA did not identify hazard effects for this chemical that would make any population
susceptible. EPA expects workers, consumers, and infants and children to have a higher exposure to
l,r-dimethyldiethylene glycol than the general population. Higher exposure to children could result
from use of products such as marker pens and toy slime containing l,r-dimethyldiethylene glycol,
which might lead to inadvertent eye contact. Similarly, infants may have higher exposure to 1.1-
dimethyldiethylene glycol, and inadvertent eye contact with the chemical, from use of baby
mattresses and pillows. Children and infants could also be exposed to l,r-dimethyldiethylene glycol
via ingestion while using or teething these products. Because of the chemical's low-concern hazard
properties, this exposure does not pose a significant increase in risk for children and infants.
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 1,1'-
dimethyldiethylene 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 l,l'-dimethyldiethylene glycol provides sufficient evidence to support a finding of low concern.
The reasonably available information on conditions of use, hazard, and exposure described above
provides sufficient information to support this proposed finding.
8.4	Storage near Significant Sources of Drinking Water
Approach: In Sections 6 and 7, EPA explains its evaluation of the elements of risk relevant to the
storage of l,l'-dimethyldiethylene glycol near significant sources of drinking water. Forthis
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
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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, l,r-dimethyldiethylene glycol is expected to present low
concern to the general population, including susceptible subpopulations, across a spectrum of health
endpoints.
In the event of an accidental release into a surface drinking water source, l,r-dimethyldiethylene
glycol is expected to be water soluble (see Section 3) and not expected to persist (see Section 6) in the
drinking water supply. In the event of an accidental release to land, the estimated log Koc indicates
this substance is highly mobile in soils, increasing its potential for leaching into groundwater,
including well water. The fate and transport evaluation indicates l,r-dimethyldiethylene glycol is
unlikely to partition into sediment, predicted to biodegrade under aerobic conditions (see Section 3),
and unlikely to bioaccumulate (see Section 6), minimizing the likelihood that the chemical would be
present in sediment or groundwater to pose a longer-term drinking water contamination threat.
Further, as explained in Section 6.1.3, repeated exposures of mice and rats to dipropylene glycol, a
closely-related analog, through the drinking water exposure pathway indicate low concern for
exposure through drinking water to this chemical.
A sudden release of large quantities of the chemical near a drinking water source could have
immediate effects on the usability of a surface drinking water source. If such a release were to occur,
two primary factors would operate together to reduce concern. First, the chemical would be expected
to present low concern to the general population, including susceptible subpopulations, across a
spectrum of health endpoints (see Section 6). Second, l,r-dimethyldiethylene glycol would degrade
in aerobic environments (see Section 6). Together, these factors mean that any exposures to this
chemical through drinking water sources would be short-lived, and that if ingestion were to take
place, concern for adverse health effects would be low.
EPA also explored whether the chemical had been identified as a concern under U.S. environmental
statutes in the past. EPA searched lists of chemicals and confirmed that l,r-dimethyldiethylene
glycol does not appear on these lists. The lists reviewed include EPA's List of Lists
(https://www.epa.gov/sites/production/files/2015-03/documents/list of lists.pdf). EPA also searched
the lists of chemicals included in the National Primary Drinking Water Regulations and the
Unregulated Contaminant Monitoring Rule (UCMR) under the Safe Drinking Water Act (SDWA).
Proposed conclusion: Based on a qualitative review of a potential release near a significant source of
drinking water, EPA proposes to conclude that the screening-level review under 40 CFR 702.9(a)(4)
does not support a finding that l,r-dimethyldiethylene glycol meets the standard for a high-priority
substance. The reasonably available information on storage near significant sources of drinking water
described above provides sufficient information to support these proposed findings.
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8.5	Conditions of Use or Significant Changes in Conditions of Use of the
Chemical Substance
Approach: EPA evaluated the conditions of use for l,r-dimethyldiethylene glycol and related
potential exposures and hazards.
Rationale: EPA evaluated the conditions of use of l,r-dimethyldiethylene glycol (see Section 5 and
Appendix A) and found it to have a broad range of conditions of use.
EPA expects that even if the conditions of use were to expand beyond activities that are known,
intended, or 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 1,1'-
dimethyldiethylene glycol's consistently low-concern hazard characteristics across the spectrum of
hazard endpoints and regardless of a change in the nature or extent of its use and resultant increased
exposures.
Proposed conclusion: EPA's qualitative evaluation of potential risk does not support a finding that
l,l'-dimethyldiethylene glycol meets the standard for a high-priority substance, based on its low-
hazard profile under the current conditions of use. EPA proposes to find that even if conditions of use
broaden, resulting in an increase in the frequency or amount of exposures, the analysis conducted to
support the screening-level review under 40 CFR 702.9(a)(5) would not change significantly. In
particular, the analysis of concern for hazard, which forms an important basis for EPA's findings,
would not be impacted by a change in conditions of use. Therefore, such changes would not support a
finding that l,l'-dimethyldiethylene glycol meets the standard for a high-priority substance. The
reasonably available information on conditions of use or significant changes in conditions of use
described above provides sufficient information to support this proposed finding.
8.6	The Volume or Significant Changes in Volume of the Chemical
Substance Manufactured or Processed
Approach: EPA evaluated the current production volumes of l,l'-dimethyldiethylene glycol (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 l,l'-dimethyldiethylene glycol as a low-
priority substance could result in increased use and higher production volumes. EPA expects,
however, that any changes in l,l'-dimethyldiethylene glycol'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 l,l'-dimethyldiethylene glycol'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, l,l'-dimethyldiethylene glycol does not meet the standard for a high-priority substance.
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The reasonably available information on production volume or significant changes in production
volume described above provides sufficient information to support this proposed finding.
8.7 Other Considerations
EPA did not identify other considerations for the screening review to support the proposed
designation of l,r-dimethyldiethylene glycol as a low-priority substance.
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9. Proposed Designation
Based on a risk-based screening-level review of the chemical substance and, when applicable,
relevant information received from the public and other information as appropriate and consistent
with TSCA section 26(h) and (i), EPA is proposing to designate l,r-dimethyldiethylene glycol as a
low-priority substance as it does not meet the statutory criteria for a high-priority substance.
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Appendix A: Conditions of Use Characterization
EPA gathered information on and related to conditions of use including uses of the chemical,
products in which the chemical is used, types of users, and status (e.g., known, regulated).
A.1 CDR Manufacturers and Production Volume
The Chemical Data Reporting (CDR) rule (previously known as the Inventory Update Rule, or IUR),
under TSCA section 8, requires manufacturers (including importers) to report information on the
chemical substances they produce domestically or import into the U.S., generally above a reporting
threshold of 25,000 lb. per site per year. According to the 2016 CDR database, 2 companies
manufactured or imported l,r-dimethyldiethylene glycol at 3 sites for reporting year 2015.
Table A.l presents the historic production volume of l,r-dimethyldiethylene glycol from the CDR
from 1986-2015. In the 1986 reporting year, aggregate production volume for 1.1'-
dimethyldiethylene glycol was between 1,000,000 and 10,000,000 lbs. and in 1990, between
50,000,000 and 100,000,000 lbs. From the 1994 to 2002 reporting years, aggregate production
volume for l,rdimethyldiethylene glycol was between 10,000 and 500,000 lbs., and for the 2011
reporting year, the exact amount is available, at 146,990 lbs. Production reached a high of 1,000,000 -
<10,000,000 lbs. in 2012, however has remained stable within the range of 500,000 - <1,000,000 lbs.
from 2013-2015.
Table A.1:1986-2015 National Production Volume Data for 1,1'Dimethyldiethylene Glycol (Non-Confidential
Production Volume in Pounds)
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
1M-
10M
50M-
100M
10K-
500 K
10K-
500 K
10K-
500 K
1M-
10M
146,990
Withheld
500K-
<1M
500K-
<1M
500K-
<1M
Source(s):
EPA (2018a: 2017b: 2006: 2002): Sherlock (2019)





Note(s):
K = Thousands; M =
: Million








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A.2 Uses
A.2.1 Methods for Uses Table
Section A.l provides a list of known uses of l,r-dimethyldiethylene glycol, 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 1,1'Dimethyldiethylene Glycol
Title Author and Year Search Term(s) Found Use Information?1
Sources searched for all use reports
California Links to
Pesticides Data
California Dept of
Pesticide Regulation
(2013)
110-98-5
No
Canada Chemicals
Management Plan
information sheets
Government of Canada
(2018)
1,1'dimethyldiethylene
glycol; 1,1'-oxydi-2-
propanol
No
Chemical and Product
Categories (CPCat)
CPCat (2019)
110-98-5
Yes
ChemView2
EPA (2018a)
110-98-5
Yes
Children's Safe Product
Act Reported Data
Washington State Dept. of
Ecology (2018)
110-98-5
No
Consumer Product
Information Database
(CPID)
DeLima Associates (2018)
110-98-5
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)
1,1'dimethyldiethylene
glycol; 1,1'-oxydi-2-
propanol
No
DrugBank
DrugBank (2018b)
110-98-5
No
European Chemicals
Agency (ECHA)
Registration Dossier
ECHA (2018a; 2018b)
110-98-5
No
eChemPortal2
OECD (2018)
110-98-5
No
Envirofacts2
EPA (2018b)
110-98-5
No
Functional Use Database
(FUse)
EPA (2017a)
110-98-5
Yes
Kirk-Othmer Encyclopedia
of Chemical Technology
Kirk-Othmer (2006)
1,1'dimethyldiethylene
glycol; 1,1'-oxydi-2-
propanol
No
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Table A.2: Sources Searched for Uses of 1,1'Dimethyldiethylene Glycol
Title
Author and Year
Search Term(s)
Found Use Information? 1
Non-Confidential 2016



Chemical Data Reporting
EPA (2017b)
110-98-5
Yes
(CDR)



PubChem Compound
Kimetal. (2016)
110-98-5
Yes
Safer Chemical
Ingredients List (SCIL)
EPA (2018d)
110-98-5
Yes
Synapse Information
Synapse Information
1,1'dimethyldiethylene
Yes
Resources2
Resources (2009)
glycol
Resource Conservation
and Recovery Act (RCRA)
EPA (2018c)
1,1'dimethyldiethylene
glycol; 1,1'-oxydi-2-
propanol
No
Scorecard: The Pollution
Information Site
GoodGuide (2011b)
110-98-5
No


Uses for CAS RN 110-98-5, with the chemical name listed


as "Dipropylene Glycol." EWG did not have search results
Skin Deep Cosmetics
EWG (2018a, 2018b)
for CAS RN 25265-71-8 or "1,1'dimethyldiethylene glycol."
Database
The uses are listed in Table 3-4 as they are unable to be
specifically listed as a use under dipropylene glycol or
1,1'dimethyldiethylene glycol.
Toxics Release Inventory
(TRI)
EPA (2018e)
110-98-5
No
TOXNET 2
NLM (2018a)
110-98-5
Yes
Ullmann's Encyclopedia of
Industrial Chemistry
Ullmann's (2000)
1,1'dimethyldiethylene
glycol; 1,1'-oxydi-2-
propanol
No
Additional Sources Identified from Reasonably Available Information
Boscia
Boscia (2018)


Cetaphil
Cetaphil (2018)


CVS
CVS (2018)


Dove
Dove (2018)


The Dow Chemical
Company
Dow (2009)
Incidentally identified
while researching
details of this

Medline
Medline.com (2009)

National Archives and
National Archives and
Records Administration
(2018)
Yes
Records Information
chemical's uses and
products.

National Pesticide


Information Retrieval
NPIRS (2018)


System (NPIRS)



Neutrogena
Neutrogena (2018a)


Shiseido
Shiseido (2018)


Skinfood
Skinfood (2018)


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Table A.2: Sources Searched for Uses of 1,1'Dimethyldiethylene Glycol
Title	| Author and Year	| Search Term(s)	| Found Use Information? 1
Note(s):
1.	If use information was found in the resource, it will appear in Table A.3 unless otherwise noted.
2.	This source is a group of databases; thus the exact resource(s) it led to will be cited instead of the database as whole.
The U.S. Patent and Trademark Office has an online database that shows no patents referencing
""I.I 'dimcthyldiethylenc glycol" (USPTO 2018b). 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 l,rdimethyldiethylene glycol were not
included in Table A.3. Note that the uses in Table A.3 that are covered under TSCA are included in
Section 5, Table 3 of this document.
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A.2.2 Uses of 1,1'-Dimethyldiethylene Glycol
Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Automotive and Engine


CPCat (2019)
Automotive care
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "maintenance and repairs of motor
vehicles" and in polishing agents for automotive lacquers (car wax). CPCat also lists use in
automotive care paints.
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Automotive fuel
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "retail sale of automotive fuel in
specialized stores."
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Automotive manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "manufacture of motor vehicles, trailers
and semi-trailers."
Expected users are industrial based on CPCat's user classification.


Synapse Information Resources (2009)
Hydraulic brake fluid
Unknown
Synapse Information Resources lists the use of 1,1'dimethyldiethylene glycol as a solvent in
hydraulic brake fluid.


CPCat (2019)
Windscreen washing agents
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in automotive windscreen and window care
washing agents.
Expected users are unknown, due to the limited availability of information.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Cleaning and Maintenance Products


EPA (2017b); CPCat (2019); Zep Inc (2015)
Air care products
Consumer, commercial
CDR shows the use of 1,1'dimethyldiethylene glycol in air care products at concentrations of at
least 90 percent by weight. CPCat lists the use of 1,1'dimethyldiethylene glycol in "air cleaners
and anti-odor agents (not filters)." 1,1'dimethyldiethylene glycol is listed as an ingredient in an air
sanitizer product currently available for consumer and commercial use.
Expected users are based on CDR's consumer/commercial classification.


EPA (2017b); CPCat (2019)
Cleaning and furnishing care
products
Consumer, commercial
CDR shows the use of 1,1'dimethyldiethylene glycol in cleaning and furnishing care products,
further information on exact uses were not reported to CDR. CDR reported concentrations in
these products of at least 1 percent but less than 30 percent by weight. CPCat lists the use of
1,1'dimethyldiethylene glycol in cleaning and washing agents, including industrial cleaning
activities.
Expected users are based on CDR's consumer/commercial classification.


CPCat (2019)
Degreasers
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in degreasers, including cold degreasing, de-
waxing, de-polishing.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Detergents manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "manufacture of soaps and detergents,
cleaning and polishing."
Expected users are industrial based on identification in CDR's industrial processing and use
report.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Floor wash agent
Consumer, commercial
CPCat lists the use of 1,1'dimethyldiethylene glycol in cleaning and washing agents for floors.
Expected users are not listed, but expected to be consumer and commercial.


CPCat (2019)
Furniture washing
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in "varnishing and acid washing of furniture."
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Industrial cleaning
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in industrial cleaning and washing, including
specialized cleaning activities.
Expected users are industrial based on CPCat's user classification.


EPA (2017b)
Laundry and dishwashing
products
Consumer, commercial
CDR shows the use of 1,1'dimethyldiethylene glycol in laundry and dishwashing products at
concentrations at less than 1 percent by weight.
Expected users are based on CDR's consumer/commercial classification.


CPCat (2019)
Lime deposit (calcium) remover
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in lime deposit (calcium) removers.
Expected users are unknown, due to the limited availability of information.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


EPA (2017b)
Soap, cleaning compound, and
toilet preparation manufacturing
Industrial
CDR shows the use of 1,1'dimethyldiethylene glycol in processing, as an odor agent in soap,
cleaning compound, and toilet preparation manufacturing
Expected users are industrial based on identification in CDR's industrial processing and use
report.


CPCat (2019)
Textile detergent
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in "washing agents for textiles (detergent)."
Expected users are unknown, due to the limited availability of information.
TSCA Conditions of Use: Construction and Building


CPCat (2019)
Boat and ship buildings
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the building and repairing of ships and
boats.
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Construction
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the construction of buildings, "general
construction of buildings and civil engineering works," and in construction materials.
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Floor and wall material
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in floor and wall covering use as building
materials.
Expected users are industrial based on CPCat's user classification.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Glass building materials
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in glass building materials.
Expected users are not stated but are assumed to be industrial for glass building materials.


CPCat (2019)
Wood manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "manufacture of builders carpentry," and
in the "manufacture of wood and of products of wood and cork" and "wooden goods to be used for
buildings." CPCat also lists the use of 1,1'dimethyldiethylene glycol as an impregnation material in
wood.
Expected users are industrial based on CPCat's user classification.
TSCA Conditions of Use: Food and Beverages


CPCat (2019)
Food and beverage service
activities1
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in food and beverage service activities.
Expected users are unknown, due to the limited availability of information.


Synapse Information Resources (2009)
Food-contact coatings1
Unknown
Synapse Information Resources lists the use of 1,1'dimethyldiethylene glycol as a defoamer in
food-contact coatings.
Expected users are unknown, due to the limited availability of information.


Synapse Information Resources (2009)
Food-contact metallic
manufacturing1
Industrial
Synapse Information Resources lists the use of 1,1'dimethyldiethylene glycol as a surface
lubricant for the manufacturing of food-contact metallic articles.
Expected users are unknown, due to the limited availability of information.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References
Food packaging1
Unknown
Synapse Information Resources (2009)
Synapse Information Resources lists the use of 1,1'dimethyldiethylene glycol in food packaging
adhesives and in paper/ paperboard in contact with fatty foods.
Expected users are unknown, due to the limited availability of information.
TSCA Conditions of Use: Fuel
Fuel additive
Unknown
CPCat (2019)
CPCat lists the use of 1,1'dimethyldiethylene glycol as a fuel additive. No further information is
available on the type of fuel in this use.
Expected users are unknown, due to the limited availability of information.
Petroleum additive
Industrial
Synapse Information Resources (2009)
Synapse Information Resources lists the use of 1,1'dimethyldiethylene glycol as a petroleum anti-
icing additive.
Expected users are not listed but expected to be industrial for petroleum additives.
TSCA Conditions of Use: Industrial Uses
Anti-foaming agents
Commercial, industrial
CPCat (2019)
CPCat lists the use of 1,1'dimethyldiethylene glycol in changing fluid properties as an "anti-
foaming agents, foam-reducing agents."
Expected users are not listed, but are expected to be commercial and industrial for the use of anti-
foaming agents.
Metal treatment and coating
Industrial
CPCat (2019)
CPCat lists the use of 1,1'dimethyldiethylene glycol in the treatment and coating of metals.
Expected users are industrial based on CPCat's user classification.	
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Mining (except oil and gas)
support activities
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in mining (except oil and gas) support
activities.
Expected users are not listed are assumed to be industrial for mining support activities.
TSCA Conditions of Use: Manufacturing


EPA (2017b); CPCat (2019)
Chemical manufacturing
Industrial
CDR shows the use of 1,1'dimethyldiethylene glycol in processing, as an odor agent in "all other
chemical product and preparation manufacturing." CPCat lists the use of 1,1'dimethyldiethylene
glycol in the "manufacture of chemicals and chemical products" and "other chemical products,"
including basic organic chemicals.
Expected users are industrial based on identification in CDR's industrial processing and use
report.


CPCat (2019)
Electronic equipment
manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of electronic equipment.
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Fabricated metal products
manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "manufacture of fabricated metal
products, except machinery."
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Furniture manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of furniture.
Expected users are industrial based on CPCat's user classification.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Leather manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "manufacture of leather and related
products" and in the tanneries industry for leather bags and footwear. CPCat lists the use of
1,1'dimethyldiethylene glycol in impregnation materials for leather. 1,1'dimethyldiethylene glycol
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Machinery and equipment
manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of machinery and
equipment.
Expected users are industrial based on CPCat's user classification.


CPCat (2019); Synapse Information Resources (2009)
Paints, varnishes and coatings
manufacturing
Consumer, commercial,
industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of paints, varnishes, and
similar coatings. CPCat also lists use in paints, lacquers and varnish products. Synapse
Information Resources lists the use of 1,1'dimethyldiethylene glycol as a surfactant in paints.
Expected users are industrial based on CPCat's user classification. Consumer and commercial
users are not listed but are assumed for uses of paints and varnish products.


CPCat (2019)
Paper, pulp and paper product
manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of pulp, paper, and paper
products. CPCat also lists the use of 1,1'dimethyldiethylene glycol in impregnation materials for
paper.
Expected users are industrial based on CPCat's user classification.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019); Synapse Information Resources (2009)
Perfumes manufacturing
Consumer, industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of perfumes and toilet
preparations, including perfumes. CPCat also lists use in fragrances as an odor agent, including
fragrances available for consumer use. Synapse Information Resources lists the use of
1,1'dimethyldiethylene glycol as a fragrance fixative/ diluent, and as an aromatics extraction
solvent.
Expected users are consumer and industrial based on CPCat's user classification.


EPA (2017b); CPCat (2019); Synapse Information Resources (2009)
Plastics manufacturing
Industrial
CDR shows the use of 1,1'dimethyldiethylene glycol in processing, as a plasticizer in "plastics
product manufacturing," and in processing, as an odor agent in "plastic material and resin
manufacturing." CPCat lists the use of 1,1'dimethyldiethylene glycol in the "manufacture of rubber
and plastic products." Synapse Information Resources lists the use of 1,1'dimethyldiethylene
glycol comonomer and surfactant for unsaturated polyester resins, and in reinforced plastics.
Expected users are industrial based on identification in CDR's industrial processing and use
report.


CPCat (2019); Synapse Information Resources (2009)
Textile manufacturing
Consumer, industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of textiles, in "textile
impregnation agents," and in textiles used in furniture including chair, seat upholstery and other
consumer products. Synapse Information Resources lists the use of 1,1'dimethyldiethylene glycol
as a solvent in textile lubricants used for industrial purposes.
Expected users are consumer and industrial based on CPCat's user classification.


CPCat (2019)
Transport equipment
manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the "manufacture of other transport
equipment."
Expected users are industrial based on CPCat's user classification.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Miscellaneous Products


CPCat (2019)
Arts and crafts toys
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in consumer arts and crafts toys for children.
Expected users are consumer based on CPCat's user classification.


CPCat (2019)
Baby products
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in consumer baby products. No further
information is provided on the specific baby products it is used in.
Expected users are consumer based on CPCat's user classification.


CPCat (2019)
Decor candle
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in consumer incense products, including a
decor candle.
Expected users are consumer based on CPCat's user classification.


EPA (2017b)
Plastic and rubber products
Consumer, commercial
CDR shows the use of 1,1'dimethyldiethylene glycol in "plastic and rubber products not covered
elsewhere" at concentrations of at least 30 percent but less than 60 percent by weight.
Expected users are based on CDR's consumer/commercial classification.


CPCat (2019); Synapse Information Resources (2009)
Printing inks
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in serigraphy printing ink, also known as
screen printing. Synapse Information Resources lists the use of 1,1'dimethyldiethylene glycol as a
solvent in printing inks.
Expected users are unknown, due to the limited availability of information.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References
Other Miscellaneous Uses


CPCat (2019)
Absorbents and adsorbents
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in absorbents and adsorbents.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Adhesive and binding agents
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in adhesives and binding agents.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Colorant
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in colorants and coloring agents including
dyestuff and pigments,
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Corrosion inhibitor
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in corrosion inhibitors and rust inhibitors as a
surface treatment.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Polishing agent
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in polishing agents.
Expected users are unknown, due to the limited availability of information.
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Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Preservatives
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in preservatives, conserving agents.
Preservatives in food products is listed elsewhere.
Expected users are unknown, due to the limited availability of information.
Non-TSCA Uses


CPCat (2019)
Agricultural pesticides
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in pesticides for agricultural use.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Bactericides
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in bactericides, which function to kill bacteria,
and bacteriostats, which aims to stop bacteria from reproducing.
Expected users are unknown, due to the limited availability of information.


CPCat (2019);
Biocides
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in biocides for non-agricultural uses.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Body wash
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in body wash and body cleansers.
Expected users are based on CPCat's user classification.


CPCat (2019)
Deodorants and antiperspirants
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in deodorants and antiperspirants.
Expected users are based on CPCat's user classification.
XVI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Disinfectants
Consumer, commercial
CPCat lists the use of 1,1'dimethyldiethylene glycol in disinfectants for cleaning and washing.
Expected users are not listed but are expected to be consumer and commercial as they are stated
for "public health area" use.


CPCat (2019)
Facial treatments
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in facial treatments.
Expected users are based on CPCat's user classification.


CPCat (2019)
Fungicides
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in fungicides.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Hair color
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in hair color and hair dye.
Expected users are based on CPCat's user classification.


CPCat (2019)
Hair shampoo
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in hair shampoos.
Expected users are based on CPCat's user classification.


CPCat (2019)
Hand soap and sanitizers
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in hand soap and sanitizers for personal care
use.
Expected users are based on CPCat's user classification.
XVII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Nail products
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in cosmetic nail products.
Expected users are not stated but are assumed to be consumer for nail products.
Permanent hair color
Consumer
DeLima Associates (2008, 2014)
CPID lists the product for professional use, therefore expected users are consumer.


CPCat (2019)
Pest control
Consumer
CPCat lists the use of 1,1'dimethyldiethylene glycol in consumer pest control products.
Expected users are consumer based on CPCat's user classification.


CPCat (2019)
Preservative
Unknown
CPCat lists the use of 1,1'dimethyldiethylene glycol in in-can preservatives.
Expected users are unknown, due to the limited availability of information.


CPCat (2019)
Shampoo manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of hair shampoo.
Expected users are industrial based on CPCat's user classification.


CPCat (2019); National Archives and Records Administration (2018)
Slimicide
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in slimicide. Slimicides are authorized for use
in the manufacturing of paper and paperboard in the U.S. as an anti-microbial against slime-
producing organisms.
Expected users are not listed, but expected to be industrial as the use of slimicides are only
permitted in manufacturing processes.
XVIII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1,1'-Dimethyldiethylene Glycol
Use
Expected Users
Description of Use and References


CPCat (2019)
Toothpaste manufacturing
Industrial
CPCat lists the use of 1,1'dimethyldiethylene glycol in the manufacture of toothpaste.
Expected users are industrial based on CPCat's user classification.


Children's Products
CDR reports use in personal care products intended for children; CPID reports uses in baby products and arts and crafts.
Recycling and Disposal
In the 2016 CDR, two facilities reported that 1,1 '-dimethyldiethylene glycol was not recycled (which could mean recycled, reprocessed, or reused). For one facility, recycling
information was withheld. No further information about recycling or disposal was found.
Note(s):
1. TSCA use based on the assumption that the chemical is used in the manufacturing of products and not intended to be a component of food.
XIX

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A.3. References
Boscia. (2018). Sake Hydrating and Brightening Serum. Retrieved from
https://www.boscia.com/shop/product detail.php?products id=278
California Dept of Pesticide Regulation. (2013). DPR Databases. Retrieved from
https: //www. cdpr. ca. gov/dprdatabase .htm
Cetaphil. (2018). Baby Daily Lotion. Retrieved from https://www.cetaphil.com/babv-lotion/
CVS. (2018). Beauty 360 Pear And White Tea Anti-Bacterial Foaming Hand Soap, 7.5 OZ. Retrieved
from https://www.cvs.com/shop/beautv-360-pear-and-white-tea-anti-bacterial-foaming-hand-
soap-7-5 -oz-prodid-102045 7
Danish EPA. (2018). Danish surveys on chemicals in consumer products. Retrieved from
https://eng.mst.dk/chemicals/chemicals-in-products/consumers-consumer-products/danish-
survevs-on-consumer-products/
DeLima Associates. (2008). Revlon Colorist Expert Color and Glaze System, Black 20. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/8746/standard/Revlon%20Colorist%20Exp
ert%20Color%20and%20Glaze%20Svstem.%20Black%2020/l 8-002-065
DeLima Associates. (2014). PortionPac ScrubPac4 Concentrated Heavy Duty All Purpose Detergent,
Professional Use. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/14146/standard/PortionPac%20ScrubPac4
%20Concentrated%20Heavv%20Dutv%20All%20Purpose%20Detergent.%20Professional%20U
se/16-032-008
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.
doi :http ://dx.doi .org/10.1016/i .toxrep .2014.12.009
Dove. (2018). Nutritive Solutions Intensive Repair Conditioner. Retrieved from
https://www.dove.com/za/hair-care/conditioner/nutritive-solutions-intensive-repair-
conditioner.html
DrugBank. (2018b). DrugBank Database. Retrieved from https://www.drugbank.ca/
European Chemicals Agency (ECHA). (2018a). l,l'-oxydipropan-2-ol. Retrieved from
https://echa.europa.eu/substance-information/-/substanceinfo/100.003.475
European Chemicals Agency (ECHA). (2018b). Oxydipropanol. Retrieved from
https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/l
XX

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
EWG. (2018b). Skin Deep Cosmetics Database. Retrieved from
https: //www.ewg. org/skindeep/#. W4RpIPlKiUk
GoodGuide. (2011b). Scorecard: The Pollution Information Site. Retrieved from
http://scorecard.goodguide.com/chemical-profiles/index.tcl
Government of Canada. (2018). Chemical Substances: Services and Information. Retrieved from
https://www.canada.ca/en/health-canada/services/chemical-substances.html
Kim, S., Thiessen, P. A., Bolton, E. E., Chen, J., Fu, G., Gindulyte, A., . . . Bryant, S. H. (2016).
PubChem Substance and Compound databases. Nucleic Acids Research, 44 (Database issue),
D 1202-D 1213. doi: 10.1093/nar/gkv951
Kirk-Othmer. (2006). Kirk-Othmer Encyclopedia of Chemical Technology.
L'Oreal. (2018a). INFALLIBLE® Pro-Glow Foundation. Retrieved from
https://www.lorealparisusa.com/products/makeup/face/foundation-makeup/infallible-pro-glow-
foundation.aspx? shade=201 -classic-ivory
L'Oreal. (2018b). Root Rescue™. Retrieved from https://www.lorealparisusa.com/products/hair-
color/products/root-touch-up/root-rescue.aspx?shade=9-light-blonde
Medline.com. (2009). Material Safety Data Sheet. Retrieved from
https://www.medline.com/media/catalog/Docs/MSDS/MSD SDSD10918.pdf
Code of Federal Regulations, Title 21 Food and Drugs, (2018).
National Pesticide Information Retrieval System (NPIRS). (2018). Company Information. Retrieved from
http://npirspublic.ceris.purdue.edu/ppis/chemical2.aspx
Neutrogena. (2018a). Ageless Intensives® Anti-Wrinkle Deep Wrinkle Serum. Retrieved from
https://www.neutrogena.com/skin/skin-moisturizers/ageless-intensives-anti-wrinkle-deep-
wrinkle-serum/6806151 .html
Organisation for Economic Cooperation and Development (OECD). (2018). eChemPortal: Global Portal
to Information on Chemical Substances. Retrieved from
https: //www .echemportal. org/echemportal/index. action
P&G. (2015). Safety Data Sheet. Retrieved from
https://www.marlobeautv.com/images/graphics/pro2pro article image/7973 .pdf
Sherlock, Scott (2019). RE_ TSCA section 6~low priority chemical reviews—CASRN 110-98-5
(referenced in CDR-2016-00304 and 306). Email 25JUN19
Shiseido. (2018). Benefiance WrinkleResist24 Protective Hand Revitalizer. Retrieved from
https: //www. shiseido. com/benefiance -wrinklere sist24-protective-hand-revitalizer-
0730852118744.html
Skinfood. (2018). 0.9 Moist Toner. Retrieved from https://theskinfood.us/products/0-9-moist-toner
Synapse Information Resources. (2009). Specialty Chemicals Source Book. Fourth Edition. Volume 1.
XXI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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://chemview.epa.gov/chemview
U.S. Environmental Protection Agency (EPA). (2018b). Envirofacts Multisystem Search. Retrieved from
https://www3.epa.gov/enviro/facts/multisvstem.html
U.S. Environmental Protection Agency (EPA). (2018c). Look up table for BR Waste Code (National
Biennial RCRA Hazardous Waste Report). Retrieved from
https://iaspub.epa.gov/enviro/brs codes v2.waste lookup
U.S. Environmental Protection Agency (EPA). (2018d). Safer Chemical Ingredients List. Retrieved from
https://www.epa.gov/saferchoice/safer-ingredients
U.S. Environmental Protection Agency (EPA). (2018e). TRI-Listed Chemicals. Retrieved from
https://www.epa.gov/toxics-release-inventorv-tri-program/tri-listed-chemicals
U.S. National Library of Medicine (NLM). (2018a). ChemlDplus, a TOXNET Database. Retrieved from
https: //chem .nlm .nih. gov/chemidplus/
U.S. National Library of Medicine (NLM). (2018b). Haz-Map. Retrieved from
https://hazmap.nlm .nih. gov/categorv-details?id=5009&table=copvtblagents
U.S. Patent and Trademark Office (USPTO). (2018b). 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=1 %2C 1 %27-oxvdi-2-
propanol&FIELD 1=&co 1 =AND&TERM2=&FIELD2=&d=PTXT
Ullmann's. (2000). ULLMANN'S Encyclopedia of Industrial Chemistry.
Washington State Dept. of Ecology. (2018). Children's Safe Product Act Reported Data. Retrieved from
https://fortress.wa.gov/ecv/cspareporting/
Zep Inc. (2015). Safety Data Sheet Timemist(R) Air Sanitizer. Retrieved from
https://content.interlinebrands.com/product/document/10137/88Q923 SDS E.pdf
XXII

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Appendix B: Hazard Characterization
Table B.1: Human Health Hazard
ADME
Source
Exposure Route
Species & strain (if
available)
Duration
Doses and
replicate
number
Effect
Study Details
4940508, 4940301,
Dermal (in vitro)
Human cadaver skin
24 hours
Dose: 768
The test material
Methods:
3039551



undiluted test
substance
Replicates: 7
samples from 4
cadavers
was considered a
slow penetrant
•	Test substance reported as CASRN
25265-71-8
•	Purity: 99.9%
•	OECD Guideline 428
•	GLP compliant
Results:
•	Steady state penetration was 39.3
|jg/cm2-hour and the permeability
coefficient was 3.85x10 5 cm/hour
3041958
Intravenous and
Dog
24 hours
Doses: 5000
The test material
Methods:

oral


mg/kg oral and
2000 mg/kg IV
Replicates: 2
dogs
is no longer
detectable in
blood after 24
hours
•	Test substance reported as CASRN
25265-71-8
•	Purity not reported
•	GLP compliance not reported
4940456, 4940388
Oral (gavage)
Fischer 344 rats
Single
Dose: 48.2
The test material
Methods:



exposure, 24
hour
mg/kg
Replicates: 5
is rapidly
absorbed and
• Test substance reported as CASRN
24800-44-0



observation
male rats
distributed, and
primarily excreted
through urine. It is
also extensively
metabolized to
dipropylene and
monopropylene
glycol and further
oxidized to C02
•	Purity: 99.8%
•	GLP compliant
Results:
•	Absorption: 91.4 ± 2.07 % of the dose
administered was recovered indicating
tripropylene glycol is rapidly absorbed
•	Distribution: The liver and kidney had
the greatest amounts of tripropylene
glycol
•	Metabolism: Tripropylene glycol is
extensively metabolized. 5.8% of the
XXIII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard






dose was recovered as unmetabolized
parent compound. Tripropylene glycol
is metabolized to dipropylene
and monopropylene glycol and further
oxidized to CO2
• Excretion: Dipropylene glycol was
excreted primarily in the urine (52.3 ±
3.54%) and in exhaled breath
(20.7±0.59%)
Acute Mammalian Toxicity
Source
Exposure Route
Species & strain (if
available)
Duration
Doses and
replicate
number
Effect
Study Details
4951174
Oral (gavage)
Albino rats
Single
exposure, 14
day
observation
Doses: 10,000,
12,000, 14,000,
15,000, 16,000,
18,000, 20,000
and 25,000
mg/kg
Replicates: 4-
20 per group
Groups: young
male, male,
adolescents,
female
adolescents,
and male adults
LDso: 12500
mg/kg (most
conservative)
Methods:
•	Test substance reported as CASRN
110-98-5
•	Purity not reported
•	GLP compliance not reported
Mortality:
•	Young male rats: 10,000 mg/kg: 10%;
12,000 mg/kg: 10%; 14,000 mg/kg:
15%; 15,000 mg/kg: 60%; 16,000
mg/kg: (90%); LD50:14,8000 mg/kg
•	Adolescent male rats: 10,000 mg/kg:
10%; 12,000 mg/kg: 15%; 14,000
mg/kg: 75%; 15,000 mg/kg: 90%;
16,000 mg/kg: 100%; 18,000 mg/kg:
100%; 20,000 mg/kg: 90%; LD50:
12,500 mg/kg
•	Adult male rats: 12,000 mg/kg: 10%;
14,000 mg/kg: 40%; 15,000 mg/kg:
80% LD50:14,200 mg/kg
•	Adolescent female rats: 12,000 mg/kg:
0%; 14,000 mg/kg: 0%; 16,000 mg/kg:
40%; 18,000 mg/kg: 80%; 20,000
mg/kg: 80%; 25,000 mg/kg: 100% LD50:
16,500 mg/kg
XXIV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4951174
Oral (gavage)
Guinea pigs
Single
exposure, 14
day
observation
Doses: 3,000,
4,000, 5,000,
6,000, 8,000,
10,000, 12,000,
15,000 and
20,000 mg/kg
Replicates: 1-
10 per group
LDso: 10000
mg/kg
Methods:
•	Test substance reported as
CASRN110-98-5
•	Purity not reported
•	GLP compliance not reported
Morality:
•	3,000: 0%; 4,000: 20%; 5,000:10%;
6,000: 30%; 8,000:10%; 10,000: 50%;
12,000: 88%; 15,000: 100%; 20,000
mg/kg: 100%
4951207
Oral (gavage)
Albino rats
Single
exposure, 14
day
observation
Doses: 8815,
10,660, 12,710,
15,273, and
18,348 mg/kg
Replicates: 5
per sex per
dose
LDso: 16195
mg/kg
Methods:
•	Test substance reported as
CASRN 110-98-5
•	Purity not reported
•	GLP compliance not reported
Mortalities:
•	8815 mg/kg: 0/5 males, 0/5 females
•	10,660 mg/kg: 2/5 males, 0/5 females
•	12710 mg/kg: 0/5 males, 0/5 females
•	15273 mg/kg: 2/5 males, 2/5 females
•	18348 mg/kg: 4/5 males, 4/5 females
4940517
Inhalation
Rats
8 hour
exposure,
observed for
14 days
Dose: 0.083
mg/L
Replicates: 6
animals
LC5o> 0.083 mg/L
Methods:
•	Test substance CASRN 24800-44-0
•	Purity not reported
•	Pre-GLP compliance
4940443
Inhalation
(aerosol)
Sprague-Dawley rats
4 hour
exposure,
observed for
14 days
Dose: 2.34
mg/L
Replicates: 5
per sex
LCso > 2.34 mg/L
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 100%
•	EPA OPP 81-3
•	GLP compliant
4940519
Dermal
Albino rabbits
24 hour
exposure,
observed for
14 days
Dose: 16320
mg/kg
Replicates: 5
males
LDso > 16320
mg/kg
Methods:
•	Test substance reported as CASRN
24800-44-0
•	Purity not reported
•	Pre-GLP compliance

XXV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940453
Dermal
New Zealand White
24 hour
Dose: 5010
LDso >5010
Methods:


rabbits
exposure,
observed for
14 days
mg/kg
Replicates: 5
per sex
mg/kg
•	Test substance: CASRN 25265-71-8
•	Purity: 100%
•	EPA OPP 81-2
•	GLP compliant
Repeated Dose Toxicity
Source
Exposure Route
Species & strain (if
available)
Duration
Doses and
replicate
number
Effect
Study Details
4940389, 4940514
Oral (gavage)
Sprague-Dawley rats
Male: 2 weeks
Doses: 0, 8,
NOAEL: 200
Method:



prior to
40, 200, and
mg/kg-day
• Test substance reported as CASRN



mating, 49
1000 mg/kg-
LOAEL: 1000
24800-44-0



days total
Females: 2
weeks prior to
day
Replicates: 12
per sex per
mg/kg-day based
on organ weight
changes in
•	Purity > 98%
•	OECD Guideline 422
•	GLP compliant



mating up to
group
parents




day 3 of






lactation



4940384, 4940445
Oral (drinking
B6C3F1 mice
2 years
Doses:
NOAEL: 1040
Methods:

water)


Males: 0, 735,
1220, and 2390
mg/kg-day
Females: 0,
575,1040, and
1950 mg/kg-
day
Replicates: 50
per sex per
dose
mg/kg-day
LOAEL: 1950
mg/kg-day based
on decreased
mean body weight
•	Test substance reported as CASRN
25265-71-8
•	Purity: 99%
•	NTP Guideline
•	GLP compliant
XXVI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940466, 4940384
Oral (drinking
water)
B6C3F1 mice
13 weeks
Dose:
Males: 0, 715,
1350, 2620,
4790 and
11,000 mg/kg-
day
Females: 0,
1230, 2140,
4020, 7430 and
14700 mg/kg-
day
Replicates: 10
per sex per
dose
NOAEL: 2620
mg/kg-day (male)
LOAEL: 4790
mg/kg-day (male),
based on
increased liver
weight
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 99%
•	NTP Guideline
•	GLP compliant
Endpoints:
•	Mortality
o 7,430 mg/kg-day females:
(1/10) hypothermia
o 11,000 mg/kg-day males:
(3/10) dehydration
o 14,700 mg/kg-day females:
(1/10) dehydration
4940384, 4940465,
Oral (drinking
F344/N rats
2 years
Doses:
NOAEL: 115
Methods:
4940455
water)


Males: 0,115,
mg/kg-day
• Test substance reported as CASRN




470, and 3040
LOAEL: 470
25265-71-8




mg/kg-day
mg/kg-day based
• Purity: 99%




Females: 0,
on increased
• GLP compliance not reported




140, 530, and
incidence of





2330 mg/kg-
nephropathy, focal





day
histiocytic, and





Replicates: 50
focal





per sex per
granulomatous





dose
inflammation in






male livers

XXVII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940384, 4940462
Oral (drinking
F344/N rats
14 weeks (3
Doses:
NOAEL: 425
Methods:

water)

months)
Males: 0, 425,
890, 1840,
3890, and
12,800 mg/kg-
day
Females: 0,
460, 920, 1690,
3340, and 8950
mg/kg-day
Replicates: 10
per sex per
dose
mg/kg-day
LOAEL: 890
mg/kg-day based
on relative liver
weight
•	Test substance reported as CASRN
25265-71-8
•	Purity: 99%
•	GLP compliance not reported
Reproductive Toxicity
Source
Exposure Route
Species & Strain (if
available)
Duration
Doses and
replicate
number
Effect
Study Details
4940389,4940514
Oral (gavage)
Sprague-Dawley rats
Male: 2 weeks
Doses: 0, 8,
NOAEL: 200
Method:



prior to
mating, 49
days total;
Females: 2
weeks prior to
mating up to
40, 200, and
1000 mg/kg-
day
Replicates: 12
per sex per
group
mg/kg-day
LOAEL: 1000
mg/kg-day based
on organ weight
changes in
parents
•	Test substance reported as CASRN
24800-44-0
•	Purity > 98%
•	OECD Guideline 422
•	GLP compliant



day 3 of






lactation



Developmental Toxicity
Source
Exposure Route
Species & Strain (if
available)
Duration
Doses and
replicate
number
Effect
Study Details
XXVIII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940450, 4440869,
4940388, 3041958
Oral (gavage)
Pregnant Sprague-
Dawley rats
GD 6-15
Doses: 0, 800,
2000, and 5000
mg/kg-day
Replicates: 20-
27 per dose
NOAEL: 2000
mg/kg-day
LOAEL: 5000
mg/kg-day based
on decreased fetal
body weight
Methods:
•	Test substance reported as
CASRN 25265-71-8
•	Purity > 96%
•	NTP Guideline
•	GLP compliance
4440871, 4940459,
4940388
Oral (gavage)
New Zealand White rabbit
GD 6-19
Doses: 0, 200,
400, 800, and
1200 mg/kg-day
Replicates: 24
per group
NOAEL: 1200
mg/kg-day
Methods:
•	Test substance reported as
CASRN 25265-71-8
•	Purity > 96%
•	NTP protocol NTP-90-CTER-126
•	GLP compliant
Cancer
Source
Exposure Route
Species & Strain (if
available)
Duration
Doses and
replicate
number
Effect
Study Details
4940448,, 4940384
Oral (drinking
water)
Fischer 344 rats
2 years
Doses:
Males: 0,115,
470 and 3,040
mg/kg-day
Females: 0,
140, 530 and
2,330 mg/kg-
day
Replicates: 50
per sex per
dose
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 99%
•	NTP Guideline
•	GLP compliant
XXIX

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940384, 4940448
Oral (drinking
water)
B6C3F1 mice
2 years
Doses:
Males: 735,
1220, and 2390
mg/kg-day;
Females: 575,
1040, and 1950
mg/kg-day
Replicates: 50
per sex per
dose
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 99%
•	NTP Guideline
•	GLP compliant
Genotoxicity
Source
Test Type &
endpoint
Species & strain (if
available)
Metabolic
activation
Doses and
controls
Results
Study Details
4940446, 4940384
Gene mutation
(in vitro)
Salmonella typhimurium
strains TA 97, TA98,
TA100, TA 1535, TA
1538
With and
without
Doses: 0,100,
333, 1000,
3333 and
10000 |jg/plate
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity > 99%
•	NTP Guideline
•	GLP compliant
4940463
Gene mutation
(in vitro)
Mouse lymphoma
L5178Y dells
With and
without
Doses: 50,
100, 300, 500,
700, 1000,
2500 and 5000
[jg/mL
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity not reported
•	OECD Guideline 476
•	GLP compliant
4940467
Gene mutation
(in vitro)
Salmonella typhimurium
strains TA98, TA100, TA
1535, TA1537, TA 1538
With and
without
Doses: 0.100,
0.316,1.00,
3.16, 10.0,31.6
and 100
[jL/plate
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 99.9%
•	OECD Guideline 471
•	GLP compliant
XXX

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940451, 4940388
Chromosomal
Mouse
N/A
Doses: 0, 500,
Negative
Methods:

aberrations (in


1000, and 2000

• Test substance reported as CASRN

vivo)


mg/kg

25265-71-8




Replicates: 6

• Purity: 99.9%




per group

• OECD Guideline 474






• GLP Compliant
Sensitization
Source
Exposure Route
Species & Strain (if
Duration
Doses and
Effect
Study Details


available)

replicate






number


4940444,4946133
Dermal patch
Human
2 day
Study 1
Equivocal
Methods:



exposure,
Doses: 1%,

• Test substance reported as CASRN



observed 7
2%, 5%, and

25265-71-8



days
10% in

• Purity > 96%




Replicates: 34

• GLP compliance not reported




patients

Results:






• 1 person had positive reaction (only to




Study 2

standard grade dipropylene glycol)




Dose: 10% in

• 488 subjects showed no reaction and




Replicates:

13 subjects showed equivocal reaction




503 volunteers

to standard grade substance




212 Males

• 480 subjects showed no reaction and




291 Females

17 subjects showed equivocal reaction






to cosmetic grade substance






• Irritation was indicated in 2 analytical






grade and 5 cosmetic grade volunteers
XXXI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940460
Dermal
Guinea pigs
6 hour
exposure,
induction
repeated 3
times for 2
weeks
Dose: 0.5 mL
Replicates: 10
animals (7
Males
3 Females)
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 100%
•	EPA OPP 81-6
•	GLP compliant
Results:
•	1 animal displayed slight patchy
erythema 24 hours after
3118622
Dermal
patch
Humans
24 hour
exposure,
scored after
48 hours;
repeated for 9
applications
Dose: 0.4 mL
Replicates: 42
volunteers
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity not reported
•	Modified Draize Method
•	GLP compliance not reported
Irritation
Source
Exposure Route
Species & Strain (if
available)
Duration
Doses
Effect
Study Details
4940512
Dermal
Rabbits
24 hours
Dose: 0.01 mL
of undiluted
solution
Replicates: 5
animals
Minimally irritating
Methods
•	Test substance reported as CASRN
24800-44-0
•	Purity not reported
•	Pre-GLP compliance
Results:
•	Mean irritation score was 2 out of 10
(with 1 = no irritation). Moderate
capillary injection was observed on 4
rabbits
XXXII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940527
Dermal patch
Humans
24 hours
Dose: 0.2 mL
of 25% solution
Replicates: 33
volunteers
Negative
Methods
•	Test substance reported as CASRN
24800-44-0
•	Purity not reported
•	Non-GLP compliant
Results:
•	2 volunteers had mild erythema at 0.5
hours which resolved by 24 hours
4940526
Dermal patch
Humans
Daily for 14
days
Dose: 0.2mL of
50% solution
Replicates: 26
volunteers
Negative
Methods
•	Test substance reported as CASRN
24800-44-0
•	Purity not reported
•	Non-GLP compliant
•	1/26 subjects did not complete the due
to reasons unrelated to exposure
4940447
Dermal
Humans
Daily for 14
days
Doses: 0.2 mL
of 50% and
100% of test
substance
Replicates: 26
skin-sensitive
volunteers
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity not specified
•	GLP compliance not reported
Results:
•	One volunteer had a mildly irritating
response (erythema) to 100%
substance before day 4
4940461
Dermal
New Zealand White
rabbit
4 hour
exposure,
observed for
72 hours
Dose: 0.5 mL
Replicates: 3
per sex
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 100%
•	EPA OPP 81-5
•	GLP compliant
Results:
•	Very slight erythema observed in 1/6
animals within 45 min, but all test areas
were normal for the remaining
observation periods
XXXIII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940458
Dermal patch
Human
24 hour
exposure
Dose: 0.2 mL
of 25%
Replicates: 33
subjects
Mildly irritating
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity not reported
•	GLP compliance not reported
Results:
•	At the 24-hour scoring, 4/33 subjects
displayed mild erythema
3118622
Dermal
Albino rabbit
24 hour
exposure,
observed for
72 hour
Dose: 0.5 mL
Replicates: 3
rabbits per
group
Negative
Methods:
•	Test substance reported as CASRN
25265-71-8
•	Purity not reported
•	Draize Method
•	GLP compliance not reported
4940453
Dermal
New Zealand White
24 hour
Dose: 5010
Negative
Methods:


rabbit
exposure,
observed for
14 day
mg/kg
Replicates: 5
per sex

•	Test substance reported as CASRN
25265-71-8
•	Purity: 100%
•	EPA OPP 81-2
•	GLP compliant
Results:
•	Very slight irritation was observed in
5/10 animals 45 minutes after removal
of patch, but all effects were fully
reversible by 48 hours
XXXIV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940449
Ocular
New Zealand White
rabbit
Single
exposure, 72
hour exposure
Dose: 0.1 mL
Replicates: 3
per sex
Negative
Method:
•	Test substance reported as CASRN
25265-71-8
•	Purity: 100%
•	EPA OPP 81-4
•	GLP compliant
Results:
•	6/6 animals had conjunctival redness
and 2/6 animals displayed chemosis
after 1 hour, but these results were fully
reversible by 24 hours
3118622
Ocular
Rabbits
Single
exposure,
observed for 7
days
Dose: 0.1 mL
Replicates: 3
rabbits per
group
Negative
Method:
•	Test substance reported as CASRN
25265-71-8
•	Purity not reported
•	Draize Method
•	GLP compliance not reported
Results:
•	Eye irritation did not differ between
vehicle control and test material
4940520
Ocular
Rabbits
Single
exposure,
observed over
24 hours
Dose: 0.5 mL
of undiluted
solution
Replicates: 5
rabbits
Negative
Methods
•	Test substance reported as CASRN
24800-44-0
•	Purity not reported
•	Pre-GLP compliance
Results:
•	The overall irritation score was 1 (trace
or no injury) and was fully reversible.
The test material was considered non-
irritating
XXXV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4940518
Ocular
New Zealand White
Single
Dose: 0.1 mL
Negative
Methods


rabbits
exposure,
observed over
72 hours
of undiluted
solution
Replicates: 2
animals

•	Test substance reported as CASRN
24800-44-0
•	Purity=99.6%
•	OECD Guideline 405
•	GLP compliant
Results:
•	2/2 animals had mild conjunctival
redness, chemosis, and conjunctival
discharge at the 1-hour scoring
•	All effects were reversible by 24 hours
4940513
Ocular
SkinEthic Human
Corneal Epithelium
Model (in vitro)
10 minutes
Dose: 30 pL of
undiluted
solution
Replicates: 3
replicates
Negative
Methods
•	Test substance reported as CASRN
24800-44-0
•	Purity: 99.6%
•	GLP compliant
Other
Source
Exposure Route
Species & Strain (if
available)
Duration
Doses
Effect
Study Details
4088550
Cell viability
Human embryonic stem
NA
Doses: 0.0001
NOAEL:
Methods:


cells (hESCs) and

M to 0.1 M
0.00745M for
• Test substance reported as CASRN


human adult pulmonary
fibroblasts (hPF)


hESCs;
IC50: 0.04 M for
hESCs and hPF
25265-71-8
•	Purity not reported
•	GLP compliance not reported
Results:
•	In hESCs the estimated NOAEL was
0.00745M and the IC50 was 0.045M,
only the highest concentration tested
was significantly different from (vehicle)
controls
•	The IC50 in hPF cells was identical
(0.04M), but a reliable NOAEL could
not be determined
XXXVI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.2: Environmental Hazard
Aquatic Toxicity: Experimental
Source
Species &
strain (if
available)
Duration
Doses and replicate
number
Effect
Study Details
4940438
Daphnia
magna
48 hours
Dose: 100 mg/L
ECso > 100
mg/L
Methods:
•	Test substance reported as CAS RN 25265-71 -8
•	Purity: 100%
•	EPA 540/9-82-024, EPA-540/9-85-005 and ASTM Standards
E729-88a
•	GLP compliant
4940439
Daphnia
48 hours
Doses: 0, 12.5, 25, 50,
ECso > 100
Methods:

magna

and 100 mg/L
mg/L
•	Test substance reported as CAS RN 25265-71 -8
•	Purity: 99.6%
•	OECD Guideline 202
•	GLP compliant
4940389, 4940442
Oryzias
96 hours
Doses: 5 concentrations
LCso >
Methods:

latipes

between 95-1000 mg/L
(nominal)
Replicates: 10 per
group
1000 mg/L
•	Test substance reported as CASRN 24800-44-0
•	Purity: 97%
•	OECD Guideline 203
•	Not GLP compliant
4940389, 4940433
Daphnia
24 hours
Doses: 5 concentrations
EC50 >
Methods:

magna

between 10-1000 mg/L
Replicates: 4 replicates
per concentration, 5
organisms per replicates
1000 mg/L
•	Test substance reported as CASRN 24800-44-0
•	Purity: 97%
•	OECD Guideline 202
•	Not GLP compliant
4940389
Selenastrum
72 hours
Doses: 5 nominal
EC50 >
Methods:

capricornutum

concentrations 95-1000
mg/L
1000 mg/L
•	Test substance reported as CASRN 24800-44-0
•	Purity: 97%
•	OECD Guideline 201
•	Not GLP compliant
Aquatic Toxicity: Estimated
Model
Duration
Species
Predicted Effect Level
Notes
ECOSAR v2.0
96 hours
Freshwater fish
18000 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000
(Class: Neutral



mg/L; melting point -40°C SMILES: 0(CC(0)C)CC(0)C
Organics)





XXXVII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
ECOSAR v2.0
(Class: Neutral
48 hours
Daphnia magna
8100 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000
mg/L; melting point-40°C SMILES: 0(CC(0)C)CC(0)C
Organics)




ECOSAR v2.0
(Class: Neutral
72 hours
Green algae
2400 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000
mg/L; melting point -40°C SMILES: 0(CC(0)C)CC(0)C
Organics)




ECOSAR v2.0
(Class: Neutral
ChV
Freshwater fish
1300 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000
mg/L; melting point -40°C SMILES: 0(CC(0)C)CC(0)C
Organics)




ECOSAR v2.0
(Class: Neutral
ChV
Daphnia magna
420 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000
mg/L; melting point -40°C SMILES: 0(CC(0)C)CC(0)C
Organics)




ECOSAR v2.0
(Class: Neutral
ChV
Green algae
370 mg/L
Physical properties used for estimation Log K0w -0.46 (exp); water solubility 1000
mg/L; melting point -40°C SMILES: 0(CC(0)C)CC(0)C
Organics)




Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and
number of
replicates
Results
Study Details
4940389
BOD
28 days
Dose: 100
mg/L
Not readily
biodegradable
Method:
•	Test substance reported as CASRN 24800-44-0
•	Purity not reported
•	OECD Guideline 301C
•	GLP compliant
Results:
•	0% degradation by TOC and 0-3% by GC after 28 days
•	1 -2% BOD degradation after 28 days
4940425
CO2 evolution
28 days
NA
Not readily
biodegradable
Method:
•	Test substance reported as CASRN 24800-44-0
•	Purity: 95%
•	OECD Guideline 301B
•	GLP compliant
Results:
XXXVIII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***





• 0% degradation by DOC after 28 days
4-5% degradation by CO2 evolution after 28 days
4940426
O2 consumption
28 days
NA
69%
degradation
after 28 days
Method:
•	Test substance reported as CASRN 24800-44-0
•	Purity: 99.43%
•	OECD Guideline 301D
•	GLP compliant
Results:
•	59% in 11 days
69% degradation after 28 days
4940432
O2 consumption, CO2
consumption, DOC
removal
28 days
Dose: 100
mg/L
Readily
biodegradable
Method:
•	Test substance reported as CASRN 24800-44-0
•	Purity: 99.9%
•	OECD Guideline 301F
•	GLP compliant
Results:
•	81.9% O2 consumption, 61% CO2 consumption, 91.7%
DOC removal after 28 days
•	55.3% biodegradation within 10-day window
4940431
O2 consumption
28 days
NA
Not readily
biodegradable
Method:
•	Test substance reported as CASRN 24800-44-0
•	Purity: 99.43%
•	OECD Guideline 301D
•	GLP compliant
Results:
•	0% degradation by O2 consumption after 28day (below
detection limit of <2.5% ThOD)
4940428
Aerobic seawater
64 days
Dose: 51.2
mg/L
•	46.1%
DOC
removal
after 64
days
•	33.5%
CO2
evolution
after 62
days
Method:
•	Test substance reported as CASRN 24800-44-0
•	Purity 99.4%
•	OECD Guideline 306
•	GLP compliant
XXXIX

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
4946320
Sediment/Water
20 days
Doses: 5 and
10 mg/L
Inherently
Biodegradable
Method:
•	Test substance reported as CASRN 24800-44-0
•	Purity not reported
•	OECD Guideline 301E
•	GLP compliant
Endpoint:
•	<10% after 20 days with 10 mg/L dose
•	100% biodegradation by day 16 with 5 mg/L
•	Authors suggest that oxidation products may be toxic to
inoculum and TPG is inherently biodegradable
4940427
O2 consumption, CO2
evolution, DOC removal
28 days
Dose: 100
mg/L
Readily
biodegradable
Methods:
•	Test substance reported as CAS RN 25265-71 -8
•	Purity: 99.9%
•	OECD Guideline 301F
•	GLP compliant
Endpoints:
•	O2 consumption: 58.7% after 10 days, 84.4% after 28 days.
•	CO2 evolution: 64.5% after 28 days.
DOC removal: 93.4% after 28 days.
1763085
BOD

Doses: 14-
6816 mg/L
Insufficient O2
consumption
Methods:
•	Test substance reported as CAS RN 25265-71 -8
•	Purity not reported
•	Standard methods (APHA195)
•	GLP compliance not reported
Endpoints:
•	BOD < 0.001 g/g using microbial seed from supernatant of
settled raw sewage.
•	Insufficient O2 consumption
4940429
DOC removal using
activated sludge
inoculum
6 weeks
Dose: 18.5
mg/L
DOC removal
83.6% after 6
weeks
Methods:
•	Test substance reported as CAS RN 25265-71 -8
•	Purity > 99.9%
•	OECD Guideline 301F or OECD Guideline 302A
•	GLP compliant
Endpoints:
•	DOC removal 83.6% after 6 weeks
•	Biodegradation from days 10-42 of 82.5-84.7%
XL

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
4940424
CO2 evolution and BOD
64 days
Dose: 50.3
DOC removal
Methods:

removal

mg/L
showed
23.6+/-0.3%
degradation
after 64 days
CO2 evolution
showed
17.3+/-2.6%
degradation
after 62 days
•	Test substance reported as CAS RN 25265-71 -8
•	Purity: 99.4%
•	OECD Guideline 306
•	GLP compliance not reported
4940437
Toxicity to
3 hours
Doses: 10, 32,
NOEC: 1000
Methods:

microorganisms

100, 320 and
1000 mg/L
mg/L
•	Test substance reported as CASRN 24800-44-0
•	Purity: 99.9%






• OECD Guideline 209






• GLP compliant






Results:






• EC50 >1000 mg/L (nominal)
4940441
Toxicity to
18 hours
Doses:
EC10 > 1000
Methods:

microorganisms

Range Finding:
0.1,1,100, and
1000 mg/L
Main study:
1.95, 3.91,
mg/L
•	Test substance reported as CAS RN 25265-71 -8
•	Purity: 99.9%
•	GLP compliant



7.81, 15.63,






31.25, 62.5,






125, 250, 500,






and 1000 mg/L



Environmental Fate: Modelled
Model
Data Type
Endpoint
Predicted
Endpoint

Notes

EPISuite v.4.11
Estimated
BAF
0.9

EPISuite v.4.11
Estimated
BCF
3.16

EPISuite v.4.11 (BIOWIN
7)
Estimated
Anaerobic
biodegradation
Not predicted to
biodegrade quickly
Probability of 0.4055. Fragment representation is valid.
Fast degradation is defined as predicted probability >0.5.



under anaerobic






conditions



XLI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
B.1 References:
Bates. HK; Price. CJ; Marr. MC; Myers. CB; Heindel. JJ; Schwetz. BA. (1992a). Final report on the
developmental toxicity of dipropylene glycol (CAS #25265-71-8) in New Zealand white rabbits.
(NTP Study No. TER-90-14). Research Triangle Park, NC: National Toxicology Program.
Bates. HK; Price. CJ; Marr. MC; Myers. CB; Heindel. JJ; Schwetz. BA. (1992b). Final report on the
developmental toxicity of dipropylene glycol (CAS No. 25265-71-8) in Sprague-Dawley (CD
(trade name)) rats. Research Triangle Park, NC: National Toxicology Program.
BUA (GDCh Advisory Committee on Existing Chemicals). (1996). Dipropylene glycol. In GD BUA
(Ed.). Stuttgart, Germany: S. Hirzel.
Dow Chemical (Dow Chemical Company). (1994). Determination of the acute oral toxicity of
dipropylene glycol in rats with cover letter dated 03/28/94 (sanitized).
EC HA (European Chemicals Agency). (1974a). [(methylethylene)bis(oxy)]dipropanol: acute toxicity:
dermal. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/7/3/4
EC HA (European Chemicals Agency). (1974b). [(methylethylene)bis(oxy)]dipropanol: acute toxicity:
inhalation: 001 key | experimental result. Helsinki, Finland, https://ccha.curopa.cu/rcgistration-
dossicr/-/rcgistcrcd-dossicr/14788/7/3/3/'.)documcntUUID=b3324441 -49d4-432b-b4fc-
72047a3b05d2
EC HA (European Chemicals Agency). (1974c). [(methylethylene)bis(oxy)]dipropanol: eye irritation: 003
supporting | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/14788/7/4/3/?documentUUID=93b85621-2813-4cb3-be0f-c81034a5c6ee
EC HA (European Chemicals Agency). (1974d). [(methylethylene)bis(oxy)]dipropanol: skin
irritation/corrosion. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/7/4/2
EC HA (European Chemicals Agency). (1988). Oxydipropanol: genetic toxicity: in vitro: 002 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/7/2/?documentUUID=389098d4-4996-4c60-a762-d2b60df89dcc
EC HA (European Chemicals Agency). (1990a). Oxydipropanol: developmental toxicity/teratogencity:
002 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/7/9/3/?documentUUID=996f3dc0-f578-45ab-9a89-b92637f28c00
EC HA (European Chemicals Agency). (1990b). Oxydipropanol: developmental toxicity/teratogenicity:
001 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/7/9/3
EC HA (European Chemicals Agency). (1991a). [(methylethylene)bis(oxy)]dipropanol: biodegradation in
water: screening tests: 004 supporting | experimental result, https://echa.europa.eu/registration-
dossier/-/registered-dossier/14788/5/3/2/?documentUUID=caad96d0-3b36-4255-9bd2-
0e2da25ee91e
XLII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
EC HA (European Chemicals Agency). (1991b). [(methylethylene)bis(oxy)]dipropanol: biodegradation in
water: screening tests: 005 supporting | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/5/3/2/?documentUUID=00f8fa90-fc45-491e-b488-434e42981995
EC HA (European Chemicals Agency). (1992a). Oxydipropanol: genetic toxicity: in vitro: 003 supporting
| experimental result. Helsinki, Finland. https://ccha.ciiropa.cu/rcgistration-dossicr/-/registered-
dossier/16016/7/7/2/'MocumcntUUID=9d24f 12c-Ibffl-4481-8ac5-c7640975c049
EC HA (European Chemicals Agency). (1992b). Oxydipropanol: toxicity to microorganisms. Helsinki,
Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/6/2/8
EC HA (European Chemicals Agency). (1993a). [(methylethylene)bis(oxy)]dipropanol: biodegradation in
water: screening tests: 003 supporting | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/5/3/2/?documentUUID=10b66ef0-9fbb-4f6e-8371-693280a318dl
EC HA (European Chemicals Agency). (1993b). [(methylethylene)bis(oxy)]dipropanol: repeated dose
toxicity: oral: 002 key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/-/registered-dossier/14788/7/6/2/?documentUUID=814b4a8c-4620-4c5c-bf90-
b3f8622b63f6
EC HA (European Chemicals Agency). (1994a). [(methylethylene)bis(oxy)]dipropanol: short-term
toxicity to aquatic invertebrates: 001 key | experimental result, https://echa.europa.eu/registration-
dossier/-/registered-dossier/14788/6/2/4/?documentUUID=e7896c57-46b4-445a-ac8b-
2c4107d544fa
ECHA (European Chemicals Agency). (1994b). [(methylethylene)bis(oxy)]dipropanol: short-term
toxicity to fish: 001 key | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/6/2/2/?documentUUID=dd8cb796-a0f9-4d90-8fb2-57a6fe859ffa
ECHA (European Chemicals Agency). (1994c). Oxydipropanol: biodegradation in water: screening tests:
003 supporting | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-
dossier/-/registered-dossier/16016/5/3/2/?documentUUID=4dl6933c-e52a-4975-8416-
9c9534d5eal9
ECHA (European Chemicals Agency). (1995a). [(methylethylene)bis(oxy)]dipropanol: basic
toxicokinetics: in vivo. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/7/2/2
ECHA (European Chemicals Agency). (1995b). [(methylethylene)bis(oxy)]dipropanol: exposure related
observations in humans: other data: 001 key | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-dossier/14788/7/ll/6
ECHA (European Chemicals Agency). (1995c). Oxydipropanol: acute toxicity: dermal. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/7/3/4
ECHA (European Chemicals Agency). (1995d). Oxydipropanol: acute toxicity: inhalation. Helsinki,
Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/7/3/3
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EC HA (European Chemicals Agency). (1995e). Oxydipropanol: acute toxicity: oral: 001 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/3/2/?documentUUID=c8ac713 6-023 8-420c-bdcb-5 7a927cc6023
EC HA (European Chemicals Agency). (1995f). Oxydipropanol: exposure related observation in humans:
other data: 001 key | experimental result. Helsinki, Finland, https://ccha.curopa.cu/rcgistration-
dossier/-/registered-dossier/16016/7/11/6
EC HA (European Chemicals Agency). (1995g). Oxydipropanol: eye irritation: in vivo.
https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/7/4/3
EC HA (European Chemicals Agency). (1995h). Oxydipropanol: sensitisation data (human). Helsinki,
Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/7/11/5
EC HA (European Chemicals Agency). (1995i). Oxydipropanol: short-term toxicity to aquatic
invertebrates: 002 supporting | experimental result, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/6/2/4/?documentUUID=22a63c82-fala-4621-9cf5-2fb6efdfc6a3
EC HA (European Chemicals Agency). (1995j). Oxydipropanol: skin irritation/corrosion: in vivo.
Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/7/4/2
EC HA (European Chemicals Agency). (1995k). Oxydipropanol: skin sensitisation: in vivo (non-LLNA).
https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/7/5/2
EC HA (European Chemicals Agency). (1997). [(methylethylene)bis(oxy)]dipropanol: exposure related
observations in humans: other data: 002 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/7/1 l/6/?documentUUID=ca6dcade-09d9-479c-b79c-dccdc9d4493 7
EC HA (European Chemicals Agency). (1999). Oxydipropanol: genetic toxicity: in vivo.
https://echa.europa.eu/registration-dossier/-/registered-dossier/16016/7/7/3
EC HA (European Chemicals Agency). (2002). Oxydipropanol: short-term toxicity to aquatic
invertebrates: 001 key | experimental result, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/6/2/4
EC HA (European Chemicals Agency). (2004a). Oxydipropanol: carcinogenicity: oral. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/8/? documentUUID=22067ce9-4d3f-474a-a0eb-e0466eaa8a37
EC HA (European Chemicals Agency). (2004b). Oxydipropanol: carcinogenicity: oral: 001 key |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-dossier/l6016/7/8
EC HA (European Chemicals Agency). (2004c). Oxydipropanol: genetic toxicity: in vitro: 001 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/7/2/?documentUUID=74e59391-4529-4883-958e-083dla25594e
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EC HA (European Chemicals Agency). (2004d). Oxydipropanol: repeated dose toxicity: oral: 001 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/6/2
EC HA (European Chemicals Agency). (2004e). Oxydipropanol: repeated dose toxicity: oral: 002
supporting | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/7/6/2/?documentUUID=9b888e96-d05d-4451-9709-64fabae21fbc
EC HA (European Chemicals Agency). (2004f). Oxydipropanol: repeated dose toxicity: oral: 003
supporting | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/6/2/?documentUUID=9796c071 -d03 9-468a-b2f1 -0493 5 82fdc5 0
EC HA (European Chemicals Agency). (2004g). Oxydipropanol: repeated dose toxicity: oral: 004
supporting | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/7/6/2/?documentUUID=aeb50875-5f7d-41e6-802b-de9b618599ec
EC HA (European Chemicals Agency). (2007a). [(methylethylene)bis(oxy)]dipropanol: biodegradation in
water: screening tests: 001 key | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/5/3/2/?documentUUID=bf8b2f2f-7880-495b-adle-7a003f2c96c7
EC HA (European Chemicals Agency). (2007b). [(methylethylene)bis(oxy)]dipropanol: dermal absorption
in vitro/ex vivo. https://echa.europa.eu/registration-dossier/-/registered-dossier/14788/7/2/3
EC HA (European Chemicals Agency). (2007c). Oxydipropanol: biodegradation in water: screening tests:
001	key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/16016/5/3/2
EC HA (European Chemicals Agency). (2007d). Oxydipropanol: biodegradation in water: screening tests:
002	key | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/16016/5/3/2/?documentUUID=625 02e63 -7f7b-4797-aaba-87666cb5 7def
EC HA (European Chemicals Agency). (2010a). [(methylethylene)bis(oxy)]dipropanol: eye irritation: 001
key | experimental result. Helsinki, Finland, https://echa.europa.eu/registration-dossier/-
/registered-dossier/1478 8/7/4/3
EC HA (European Chemicals Agency). (2010b). [(methylethylene)bis(oxy)]dipropanol: eye irritation: 002
key | experimental result. https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/7/4/3/?documentUUID=6112967b-d401-4691-92fc-cl090a4e63c5
EC HA (European Chemicals Agency). (2010c). [(methylethylene)bis(oxy)]dipropanol: toxicity to
microorganisms: 001 key | experimental result. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-
dossier/14788/6/2/8/?documentUUID=95e7699a-lff8-4acc-a8f6-fba87bb72c52
Fasano. WJ. (2007). Dipropylene glycol: in vitro dermal absorption rate testing [TSCA Submission],
Fasano, WJ. https://chemview.epa.gov/chemview/proxv?filename=2008-l-8EHQ-08-
16930B 8ehq 0108 16930b.pdf
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Fasano. WJ; ten Bcrgc. W; Banton. MI; Heneweer. M; Moore. NP. (2011). Dermal penetration of
propylene glycols: Measured absorption across human abdominal skin in vitro and comparison
with a QSAR model. Toxicol In Vitro 25: 1664-1670. http://dx.doi.Org/10.1016/i.tiv.2011.07.003
Johansen. JD; Jemec. GBE; Rastogi. SC. (1995). Contact sensitization to dipropylene glycol in an eczema
population [Abstract]. Contact Derm 33: 211-212. http://dx.doi.org/10.1111/i.1600-
0536.1995 ,tb00560.x
Leberco Labs (Leberco Laboratories). (1994). Letter from [] to usepa submitting irritation toxicity studies
of 2-propanol, l,l'-oxybis- in the rabbit dated 03/24/94 (sanitized). (86940000234S).
NTP (National Toxicology Program). (2004). NTP technical report on the toxicology and carcinogenesis
studies of dipropylene glycol (CAS NO. 25265-71-8) in F344/N rats and B6C3F1 mice (pp. 6-
260). Research Triangle Park, NC: U.S Department of Health and Human Services. Public Health
Service. National Institutes of Health, https://ntp.niehs.nih.gov/ntp/htdocs/lt rpts/tr511 .pdf
OECD (Organisation for Economic Co-operation and Development). (1994). SIDS Initial Assessment
Report for SIAM 2 (Paris, 4-6 July 1994)Tripropylene glycol: CAS No: 24800-440.
https://hpvchemicals.oecd.org/UI/handler.axd?id=00205ec6-f694-448b-bbb2-be4121e9a7fe
OECD (Organisation for Economic Co-operation and Development). (2001). Dipropylene glycol (mixed
isomers and dominant isomer Cas No: 25265-71-8 and 110-98-5).
http://www.inchem.org/documents/sids/sids/25265-71-8.pdf
Union Carbide (Union Carbide Corporation). (1994). Letter from union carbide corp to usepa regarding
toxicity studies of various chemicals referenced in 40 cfr part 716, 58 fed reg 68311-68322
(12/27/93) w/attchmts dated 04/26/94. (TSCATS/442947 OTS0557477).
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Appendix C: Literature Search Outcomes
C.1 Literature Search and Review
This section briefly describes the literature search and review process, search terms, and search outcomes
for the hazard and fate screening of l,r-dimethyldiethylene glycol. Search outcomes and reference
details are provided on the candidate's HERO34 project page.
EPA created a fit-for-purpose process to transparently document the literature search and review35 of
available hazard and fate information for low-priority substance (LPS) candidates. References from peer-
reviewed primary sources, grey sources,36 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 C1.
Figure C.l: Overview of the Literature Search and Review Process
References available at
title/abstract screening
References available at data quality evaluation
References included in LPS screening reviews
References available at full text screening
References excluded at
full text screening
References excluded at
data quality evaluation
References excluded at
title/abstract screening
References available
from grey literature
and other sources
References available
from primary peer-
reviewed sources
C.1.1 Search for Analog Data
To supplement the information on the candidate chemical, l,r-dimethyldiethylene glycol, the following
LPS candidates were used as analogs for read-across: tripropylene glycol (CASRN 24800-44-0) and
dipropylene glycol (CASRN 25265-71-8). For more details and justification on analogs, see section 6.1.1.
Analogs were used to fill data gaps on endpoints for which l,r-dimethyldiethylene glycol lacked quality
data, such as repeated dose and developmental toxicity, and to add to the weight of the scientific
evidence. Analog references were searched, screened and evaluated using the same process as references
34	The HERO low-priority substance candidate project pages are accessible to the public at https://hero.epa. go v/hero/.
35	Discussed in the document "Approach Document for Screening Hazard Information for Low-Priority Substances Under
TSCA."
30 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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on l,r-dimethyldiethylene glycol described above.35 l,r-Dimethyldiethylene glycol and the two analogs
mentioned above fall under the glycol cluster in HERO.
C.1.2 Search Terms and Results
EPA began the literature review process for the hazard screening of l,r-dimethyldiethylene glycol by
developing search terms. To gather publicly available information, specific search terms were applied for
each discipline and across databases and grey literature sources. Table C.l lists the search terms used in
the database search of peer -reviewed literature for the glycol cluster including l,r-dimethyldiethylene
glycol. For grey literature and other secondary sources, Table C.2 lists the search terms used for the
glycols cluster.
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Table C.1: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms
Human Health
PubMed
25265-71-8[rn] OR 110-98-5[rn] OR 24800-44-0[rn] OR "((1 -methyl-1,2-ethanediyl)bis(oxy))bispropanol"[tw] OR
"((Methylethylene)bis(oxy))dipropanol"[tw] OR "1,1 '-Dimethyldiethylene glycol"[tw] OR "1,1'-Oxybis(2-propanol)"[tw] OR "1,1-
Oxybis-2-propanol"[tw] OR "1,1'-Oxydi-2-propanol"[tw] OR "1,1'-Oxydipropan-2-ol"[tw] OR "2,2'-Dihydroxydipropyl ether"[tw] OR
"2-(2-(2-Hydroxypropoxy)propoxy)-1-propanol"[tw] OR "2-Propanol, 1,1'-oxybis-"[tw] OR "2-Propanol, 1,1'-oxydi-"[tw] OR"4-Oxa-
2,6-heptandiol"[tw] OR "4-Oxaheptane-2,6-diol"[tw] OR "ADK DPG-RF"[tw] OR "Bis(2-hydroxypropyl) ether"[tw] OR "Bis(3-
hydroxypropyl)ether"[tw] OR "Diisopropylene glycol"[tw] OR "Dipropylene glycol"[tw] OR "DIPROPYLENEGLYCOL"[tw] OR
"DIPROPYLENGLYKOL"[tw] OR "Dowanol DPG"[tw] OR "DPG-FC"[tw] OR "DPG-RF"[tw] OR "NIAX catalyst D-19"[tw] OR
"oxidipropanol"[tw] OR "Oxybispropanol"[tw] OR "Oxydipropanol"[tw] OR "Propanol, ((1-methyl-1,2-ethanediyl)bis(oxy))bis-"[tw]
OR "Propanol, oxybis-"[tw] OR "Tripropylene glycol"[tw]

Toxline
(25265-71-8[rn] OR 110-98-5[rn] OR 24800-44-0[rn] OR "((1-methyl-1,2-ethanediyl)bis(oxy))bispropanol" OR
"((Methylethylene)bis(oxy))dipropanol" OR "1,1 '-Dimethyldiethylene glycol" OR "1,1'-Oxybis(2-propanol)" OR "1,1 '-Oxybis-2-
propanol" OR "1,1'-Oxydi-2-propanol" OR "1,1'-Oxydipropan-2-ol" OR "2,2-Dihydroxydipropyl ether" OR "2-(2-(2-
Hydroxypropoxy)propoxy)-1-propanol" OR "2-Propanol, 1,1-oxybis-" OR "2-Propanol, 1,1-oxydi-" OR "4-Oxa-2,6-heptandiol" OR
"4-Oxaheptane-2,6-diol" OR "ADK DPG-RF" OR "Bis(2-hydroxypropyl) ether" OR "Bis(3-hydroxypropyl)ether" OR
"Diisopropylene glycol" OR "Dipropylene glycol" OR "DIPROPYLENEGLYCOL" OR "DIPROPYLENGLYKOL" OR "Dowanol
DPG" OR "DPG-FC" OR "DPG-RF" OR "NIAX catalyst D-19" OR "oxidipropanol" OR "Oxybispropanol" OR "Oxydipropanol" OR
"Propanol, ((1-methyl-1,2-ethanediyl)bis(oxy))bis-" OR "Propanol, oxybis-" OR "Tripropylene glycol") AND (ANEUPL [org] OR
BIOSIS [org] OR CIS [org] OR DART [org] OR EMIC [org] OR EPIDEM [org] OR FEDRIP [org] OR HEEP [org] OR HMTC [org]
OR I PA [org] OR RISKLINE [org] OR MTGABS [org] OR NIOSH [org] OR NTIS [org] OR PESTAB [org] OR PPBIB [org]) AND
NOT PubMed [org] AND NOT pubdart [org]

TSCATS1
(25265-71-8 [rn] OR 110-98-5 [rn] OR 24800-44-0 [rn]) AND (TSCATS [org]) AND NOT PubMed [org] AND NOT pubdart [org]

WOS
TS=("25265-71-8" OR "110-98-5" OR "24800-44-0" OR "((1-methyl-1,2-ethanediyl)bis(oxy))bispropanol" OR
"((Methylethylene)bis(oxy))dipropanol" OR "1,1 '-Dimethyldiethylene glycol" OR "1,1'-Oxybis(2-propanol)" OR "1,1 '-Oxybis-2-
propanol" OR "1,1 '-Oxydi-2-propanol" OR "1,1 '-Oxydipropan-2-ol" OR "2,2- Di hydroxydipropyl ether" OR "2-(2-(2-
Hydroxypropoxy)propoxy)-1-propanol" OR "2-Propanol, 1,1-oxybis-" OR "2-Propanol, 1,1 -oxydi-" OR "4-Oxa-2,6-heptandiol" OR
"4-Oxaheptane-2,6-diol" OR "ADK DPG-RF" OR "Bis(2-hydroxypropyl) ether" OR "Bis(3-hydroxypropyl)ether" OR
"Diisopropylene glycol" OR "Dipropylene glycol" OR "DIPROPYLENEGLYCOL" OR "DIPROPYLENGLYKOL" OR "Dowanol
DPG" OR "DPG-FC" OR "DPG-RF" OR "NIAX catalyst D-19" OR "oxidipropanol" OR "Oxybispropanol" OR "Oxydipropanol" OR
"Propanol, ((1 - methyl-1,2-ethanediy l)bis(oxy) )bi s-" OR "Propanol, oxybis-" OR "Tripropylene glycol")
lndexes=SCI-EXPANDED, CPCI-S, CPCI-SSH, BKCI-S, BKCI-SSH, CCR-EXPANDED, IC Timespan=AII years
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Table C.1: Search Terms Used in Peer-Reviewed Databases
Environmental
Hazard
WOS
Same as human health strategy synonyms only
Toxline
Same as human health strategy synonyms only

TSCATS1
Same as human health strategy CASRN only

Proquest
TITLE=("25265-71-8" OR "1,1'-Oxybis 2-propanol" OR "1,1 '-Oxybis-2-propanol" OR "1,1 '-Oxydi-2-propanol" OR "1,1'-
Oxydipropan-2-ol" OR "2-Propanol, 1,1-oxybis-" OR "Bis 2-hydroxypropyl ether" OR "Dipropylene glycol" OR
"DIPROPYLENEGLYCOL" OR "Propanol, oxybis-" OR "Tripropylene glycol")
ABSTRACT=("25265-71 -8" OR "1,1'-Oxybis 2-propanol" OR "1,1 '-Oxybis-2-propanol" OR "1,1 '-Oxydi-2-propanol" OR "1,1'-
Oxydipropan-2-ol" OR "2-Propanol, 1,1-oxybis-" OR "Bis 2-hydroxypropyl ether" OR "Dipropylene glycol" OR
"DIPROPYLENEGLYCOL" OR "Propanol, oxybis-" OR "Tripropylene glycol")
SUBJECT=("25265-71 -8" OR "1,1'-Oxybis 2-propanol" OR "1,1 '-Oxybis-2-propanol" OR "1,1 '-Oxydi-2-propanol" OR "1,1'-
Oxydipropan-2-ol" OR "2-Propanol, 1,1-oxybis-" OR "Bis 2-hydroxypropyl ether" OR "Dipropylene glycol" OR
"DIPROPYLENEGLYCOL" OR "Propanol, oxybis-" OR "Tripropylene glycol")
("110-98-5" OR "24800-44-0" OR" 1 -methyl-1,2-ethanediyl bis oxy bispropanol" OR "Methylethylene bis oxy dipropanol" OR "1,1'-
Dimethyldiethylene glycol" OR "2,2'-Dihydroxydipropyl ether" OR "2- 2- 2-Hydroxypropoxy propoxy -1-propanol" OR "2-Propanol,
1,1 '-oxydi-" OR "4-Oxa-2,6-heptandiol" OR "4-Oxaheptane-2,6-diol" OR "ADK DPG-RF" OR "Bis 3-hydroxypropyl ether" OR
"Diisopropylene glycol" OR "DIPROPYLENGLYKOL" OR "Dowanol DPG" OR "DPG-FC" OR "DPG-RF" OR "NIAX catalyst D-19"
OR "oxidipropanol" OR "Oxybispropanol" OR "Oxydipropanol" OR "Propanol, 1 -methyl-1,2-ethanediyl bis oxy bis-")
Fate
WOS
Same as human health strategy synonyms only
Table C.2: Search Terms Used in Grey Literature and Additional Sources
Chemical
Search terms
Glycol cluster
(1,1'-
Dimethyldiethylene
glycol; dipropylene
glycol, tripropylene
glycol)
Searched asastring or individually depending on resource: "25265-71-8" OR "110-98-5" OR "24800-44-0"
OR "Dipropylene glycol" OR "Dipropyleneglycol" OR "Propanol, oxybis-" OR "Tripropylene glycol"
After the search terms were applied, more than 620 references 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.35 Of these, 71 references were included for data evaluation and
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used to support the designation of l,r-dimethyldiethylene glycol as LPS. The included hazard and fate references are listed in the bibliography of
Appendix B.
C.2 Excluded Studies and Rationale
This section lists the excluded references, by HERO ID, found to be off-topic or unacceptable for use in the hazard screening of 1.1
dimethyldiethylene glycol. The excluded references are organized by discipline (human health hazard, environmental hazard, and fate), presented
along with a rationale based on exclusion criteria. The criteria35 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 1,1"-dimethyldiethylene glycol, EPA excluded a total of 539 references when assessing human health hazard. Off-
topic references (e.g., studies that did not contain information relevant to human health) were excluded at either title/abstract screening (see Table
C.3), or full-text screening (see Table C.4). Unacceptable references (e.g., studies that did not meet data quality metrics) were excluded at full-text
screening (see Tables C.5 and C.6). Off-topic and unacceptable references are displayed next to the corresponding exclusion criteria.
Table C.3: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs37 relevant to human health hazard
33975
4949055
4948960
4947155
4705492
1201178
4949084
4948984
4948886
4946188
44187
4949056
4948961
4947156
4706833
1204953
4949085
4948985
4948887
4946189
404898
4949058
4948962
4947159
4738360
1249186
4949086
4948986
4948890
4946190
628230
4949060
4948963
4947160
4738993
1254062
4949087
4948988
4948891
4946193
628727
4949061
4948964
4947161
4742957
1314113
4949089
4948989
4948892
4946194
635083
4949063
4948965
4947175
4828940
1316100
4949090
4948990
4948893
4946210
744085
4949064
4948966
4947177
4828943
1321888
4949092
4948991
4948894
4946247
789593
4949065
4948967
4947178
4847997
1458307
4949094
4948992
4948895
4946257
37 The information needs for human health hazard includes a list of study characteristics pertaining to the study population/test organism, types of exposures and routes, use of
controls, type and level of effects. A complete list of the information needs is provided in Table A1 of the "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA." These information needs helped guide the development of questions for title/abstract and full-text screening.
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Table C.3: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard
789651
4949066
4948968
4947179
4853443
1496934
4949095
4948993
4948896
4946258
926985
4949067
4948969
4947182
4909646
1549118
4949096
4948994
4948898
4946259
992939
4949068
4948970
4947185
4940595
1580047
4949098
4948995
4948899
4946263
1058389
4949070
4948971
4947187
4940694
1611582
4949099
4948996
4948900
4946320
1058433
4949071
4948972
4947189
4940855
1612753
4949100
4948997
4948902
4946322
1112905
4949072
4948974
4947194
4941419
1615034
4949102
4948998
4948904
4946324
1124442
4949074
4948975
4947200
4945941
1689217
4949103
4948999
4948905
4946329
1124901
4949075
4948977
4947201
4946008
1763085
4949104
4949000
4948906
4946359
1142139
4949076
4948978
4947202
4946061
1763087
4949105
4949001
4948909
4946360
1153582
4949078
4948979
4947203
4946132
1763125
4949106
4949002
4948911
4946361
1156301
4949080
4948980
4947204
4946147
1763137
4949108
4949003
4948912
4946374
1167387
4949081
4948981
4947223
4946178
1763157
4949109
4949004
4948913
4946375
1201159
4949082
4948982
4947224
4946179
1781960
4949110
4949005
4948914
4946376
1201176
4949083
4948983
4948885
4946180
1808388
4949111
4949006
4948915
4946380
3036899
4949156
4949040
4948950
4947131
1808755
4949112
4949007
4948916
4946387
3037885
4949157
4949042
4948951
4947132
1865871
4949113
4949009
4948918
4946408
3038973
4949158
4949044
4948952
4947135
1955931
4949116
4949010
4948919
4946410
3039406
4949159
4949045
4948953
4947136
1967450
4949117
4949011
4948920
4946411
3039791
4951048
4949046
4948954
4947137
1970619
4949118
4949012
4948921
4946419
3041527
4951050
4949047
4948955
4947138
2231679
4949119
4949013
4948922
4946423
3041622
4951055
4949049
4948956
4947140
2232056
4949120
4949015
4948923
4946506
3041638
4951170
4949051
4948958
4947141
2232422
4949121
4949016
4948925
4946513
3041935
4951176
4949052
4948959
4947154
2232425
4949122
4949017
4948926
4946538
3047394
4951181
4949053
4339757
4576534
2232427
4949123
4949018
4948927
4946547
Lll

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.3: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard
3051635
4951206
4949054
4376725
4579583
2232444
4949126
4949020
4948928
4946614
3051709
4951208
3753956
4388064
4583202
2232562
4949128
4949021
4948930
4946615
3103598
4951228
3823035
4391261
4656492
2273142
4949129
4949022
4948931
4946617
3114932
4428638
3830342
4395587
4660346
2292715
4949130
4949023
4948932
4946619
3115961
4428838
3830898
4398518
4704876
2302957
4949131
4949024
4948933
4946620
3119596
4433785
3846566
4399866
3577212
2530089
4949132
4949026
4948934
4946621
3225794
4436364
3847436
4400649
3577235
2563138
4949134
4949027
4948935
4946623
3374286
4436864
3874693
4404349
3590105
2692340
4949135
4949028
4948936
4947105
3402924
4438060
4146480
4408404
3619406
2745927
4949138
4949029
4948938
4947106
3445046
4438415
4148076
4420372
3625221
2824290
4949140
4949030
4948940
4947107
3476490
4425601
4148079
4420932
4275583
2875983
4949141
4949031
4948942
4947108
3477473
4426820
4168926
4420947
4276472
2883990
4949142
4949032
4948943
4947109
3491334
3559324
4173202
4421954
4423539
2887419
4949149
4949033
4948944
4947110
3539276
3562800
4222683
4948949
4947130
2892020
4949150
4949034
4948946
4947111
3009070
4949153
4949037
4948948
4947115
2978028
4949152
4949035
4948947
4947113
3036268
4949154
4949039







Reference excluded (HERO ID) because the reference primarily contained in silico data
N/A.
Table C.4: Screening Questions and Off-Topic References Excluded at Full-text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain information pertaining
No
1322754
to a low- priority substance candidate?

1629162


1776453


1875316


2301122


2301139
LIN

-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.4: Screening Questions and Off-Topic References Excluded at Full-text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)


3041082


4219489


4862648


4940454


4941418


4946053


4947114


4951209


61412


824457


1744616


1744618


3039593


4441664


4442235


4862648


4940287


4940288


4940320


4940383


4940385


4940387


4940395


4940392


4946053


4948456


4949088


4951173


4951178
What type of source is this reference?
Review article or book chapter that contains only
1004739

citations to primary literature sources
3038211


4940386


4946377


628176
LIV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.4: Screening Questions and Off-Topic References Excluded at Full-text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)


3036785
What kind of evidence does this reference
primarily contain?
In silico studies that DO NOT contain experimental
verification
N/A.
The following question apply to HUMAN evidence only
Does the reference report an exposure route that
is or is presumed to be by an inhalation, oral, or
dermal route?
No
N/A.
Does the reference report both test substance
exposure(s) AND related health outcome(s)?
No
N/A.
If the reference reports an exposure to a chemical
mixture, are measures of the test substance or
related metabolite(s) reported independently of
other chemicals?
Note: If the paper does not pertain to mixtures,
choose "Not Applicable".
No
4951213
The following question apply to ANIMAL evidence only
Does the reference report an exposure route that
is by inhalation, oral, or dermal route?
No
N/A.
Does the reference report both test substance-
related exposure(s) AND related health
outcome(s)?
No
N/A.
Does the reference report the duration of
exposure?
No
N/A.
Does the reference report an exposure to the test
substance only (i.e. no mixtures with the exception
of aqueous solutions and reasonable impurities
and byproducts)?
No
4951261
4951218
4951185
1230541
Does the paper report a negative control that is a
vehicle control or no treatment control?
No38
4951261
38 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).
LV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.4: Screening Questions and Off-Topic References Excluded at Full-text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
The following questions apply to MECHANISTIC/ALTERNATIVE TEST METHODS evidence only
Does the reference report a negative control that is
a vehicle control or no treatment control?
No
3036587
Does the reference report an exposure to the test
substance only (i.e. no mixtures with the exception
of aqueous solutions and reasonable impurities
and byproducts)?
No
N/A.
For genotoxicity studies only: Does the study use a
positive control?
No
3036587

Table C.5: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test substance identity
•	The test substance identity cannot be
determined from the information provided
(e.g., nomenclature was unclear and
CASRN or structure were not reported).
OR
•	For mixtures, the components and ratios were
not characterized or did not include information that
could result in a reasonable approximation of
components.
N/A.


Metric 2:
Negative and vehicle controls
A concurrent negative control group was not
included or reported.
OR
The reported negative control group was not
appropriate (e.g., age/weight of animals differed
between control and treated groups).
N/A.


Metric 3:
Positive controls
When applicable, an appropriate concurrent positive
control (i.e., inducing a positive response) was not
used.
N/A.
LVI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Metric 4:
Reporting of doses/concentrations
Doses/concentrations were not reported and could
not be calculated using default or reported
estimates of body weight and diet/water intake (e.g.,
default intake values are not available for pregnant
animals).
1763148
3041958
4940388
4940524
4940510
Metric 5:
Exposure duration
The duration of exposure was not reported.
OR
The reported exposure duration was not suited to
the study type and/or outcome(s) of interest (e.g.,
<28 days for repeat dose).
4940388
4940389
4941420
4946133
Metric 6:
Test animal characteristics
The test animal species was not reported.
OR
The test animal (species, strain, sex, life-stage,
source) was not appropriate for the evaluation of
the specific outcome(s) of interest (e.g., genetically
modified animals, strain was uniquely susceptible or
resistant to one or more outcome of interest).
4941420
1763148
4940389
4940388
3041958
4946133
Metric 7:
Number of animals per group
The number of animals per study group was not
reported.
OR
The number of animals per study group was
insufficient to characterize toxicological effects (e.g.,
1-2 animals in each group).
N/A.


Metric 8:
Outcome assessment methodology
The outcome assessment methodology was not
sensitive for the outcome(s) of interest (e.g.,
evaluation of endpoints outside the critical window
of development, a systemic toxicity study that
evaluated only grossly observable endpoints, such
as clinical signs and mortality, etc.).
1763148
2282271
4940388
4940389
4941420
4946133
Metric 9:
Reporting of data
Data presentation was inadequate (e.g., the
report does not differentiate among findings in
multiple exposure groups).
OR
Major inconsistencies were present in reporting of
4940388
4940524
4941420
2282271
LVII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***

results.
4442235
4940303
4940394
4946044
4940452

Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test Substance identity
The test substance identity or description cannot be
determined from the information provided (e.g.,
nomenclature was unclear and CASRN or structure
were not reported).
OR
For mixtures, the components and ratios were not
characterized or did not include information that
could result in a reasonable approximation of
components.
3039551
Metric 2:
Negative controls
A concurrent negative control group was not
included or reported.
OR
The reported negative control group was not
appropriate (e.g., different cell lines used for
controls and test substance exposure).
N/A.
Metric 3:
Positive controls
A concurrent positive control or proficiency group
was not used.
N/A.
Metric 4:
Assay type
The assay type was not reported.
OR
The assay type was not appropriate for the study
type or outcome of interest (e.g., in vitro skin
corrosion protocol used for in vitro skin irritation
assay).
N/A.
Metric 5:
Reporting of concentration
The exposure doses/concentrations or amounts of
test substance were not reported.
N/A.
Metric 6:
Exposure duration
No information on exposure duration(s) was
reported.
4940521
4940522
LVIII

-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***

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).
4940389
2282271
Metric 7:
Metabolic activation
No information on the characterization and use of a
metabolic activation system was reported.
OR
The exposure duration was not appropriate
for the study type and/or outcome of interest
(e.g., 24 hours exposure for bacterial reverse
mutation test).
N/A.
Metric 8:
Test model
The test model was not reported
OR
The test model was not routinely used for
evaluation of the specific outcome of interest.
N/A.
Metric 9:
Outcome assessment methodology
The outcome assessment methodology was not
reported.
OR
The assessment methodology was not appropriate
for the outcome(s) of interest (e.g., cells were
evaluated for chromosomal aberrations immediately
after exposure to the test substance instead of after
post-exposure incubation period).
4940451
4940388
C.2.2 Environmental Hazard
For the screening review of LPS candidate l,r-dimethyldiethylene glycol, EPA excluded a total of 547 references when assessing environmental
hazard. Off-topic environmental hazard references excluded at title/abstract screening are listed in Table C.7, and those excluded at full-text
screening are listed in Table C.8. References in Table C.9 represent unacceptable studies based on specific data quality metrics for environmental
hazard. Off-topic and unacceptable references are displayed next to the corresponding exclusion criteria.
LIX

-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.7: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs39 relevant to environmental hazard
44187
4440871
4949112
4948988
4946374
2892020
4738993
1744618
4949052
4948891
404898
4441664
4949113
4948989
4946375
2978028
4742957
1763125
4949053
4948892
635083
4442235
4949116
4948990
4946376
3009070
4828940
1763137
4949054
4948893
744085
4940392
4949117
4948991
4946377
3036268
4828943
1763148
4949055
4948894
789593
4940395
4949118
4948992
4946380
3036587
4847997
1763157
4949056
4948895
789651
4941420
4949119
4948993
4946387
3036785
4853443
1776453
4949058
4948896
824457
4944882
4949120
4948994
4946408
3036899
4862648
1808755
4949060
4948898
926985
4946008
4949121
4948995
4946419
3037885
4909646
2112816
4949061
4948899
1058389
4946016
4949122
4948996
4946513
3038211
4940595
2301122
4949063
4948900
1058433
4946044
4949123
4948997
4946538
3038973
4940694
2301139
4949064
4948902
1112905
4946053
4949126
4948998
4946547
3039406
4940855
2745927
4949065
4948904
1124442
4946054
4949128
4948999
4946614
3039551
4941418
3041082
4949066
4948905
1124901
4946055
4949129
4949001
4946615
3039791
4941419
3041527
4949067
4948906
1142139
4946135
4949130
4949002
4946617
3041935
4945941
3041622
4949068
4948909
1153582
4946142
4949132
4949003
4946619
3114932
4946061
3041638
4949070
4948911
1156301
4946194
4949134
4949004
4946620
3115961
4946132
3103598
4949071
4948912
1167387
4946244
4949135
4949005
4946623
3225794
4946133
3118622
4949072
4948913
1201159
4946247
4949138
4949006
4947105
3374286
4946147
4222683
4949074
4948914
1201176
4946261
4949140
4949007
4947107
3402924
4946178
4259576
4949075
4948915
1201178
4946314
4949141
4949009
4947108
3445046
4946179
4440869
4949076
4948916
1204953
4946316
4949142
4949010
4947109
3476490
4946180
4948954
4949078
4948918
1249186
4946333
4949149
4949011
4947110
3477473
4946188
4948955
4949080
4948919
1321888
4946334
4949150
4949012
4947111
3491334
4946189
4948956
4949081
4948920
1458307
4946361
4949152
4949013
4947113
3539276
4946190
4948958
4949082
4948921
1496934
4946362
4949153
4949015
4947114
3559324
4946191
4948959
4949083
4948922
39 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.
LX

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
1549118
4946363
4949154
4949016
4947115
3562800
4946193
4948960
4949084
4948923
1611582
4946410
4949156
4949017
4947130
3577212
4946210
4948961
4949085
4948925
1612753
4946411
4949157
4949018
4947131
3577235
4946257
4948962
4949086
4948926
1615034
4946412
4949158
4949020
4947132
3590105
4946258
4948963
4949087
4948927
1689217
4946414
4949159
4949021
4947135
3619406
4946259
4948964
4949088
4948928
1781960
4946416
4951181
4949022
4947136
3625221
4946263
4948965
4949089
4948930
1808388
4946420
1763085
4949023
4947137
3753956
4946322
4948966
4949090
4948931
1865871
4946423
1763087
4949024
4947138
3830342
4946324
4948967
4949092
4948932
1875316
4946424
4946320
4949026
4947140
3830898
4946329
4948968
4949094
4948933
1955931
4946506
4949131
4949027
4947141
3846566
4946359
4948969
4949095
4948934
1967450
4946511
992939
4949028
4947155
3847436
4946360
4948970
4949096
4948935
1970619
4946541
3051635
4949029
4947156
3874693
4420932
4948971
4949098
4948936
2231679
4946621
3051709
4949030
4947159
4088550
4420947
4948972
4949099
4948938
2232056
4947224
4951048
4949031
4947160
4146480
4421954
4948974
4949100
4948940
2232422
4948456
2282271
4949032
4947161
4148076
4423539
4948975
4949102
4948942
2232425
4949000
33975
4949033
4947175
4148079
4425601
4948977
4949103
4948943
2232427
4951050
61412
4949034
4947177
4168926
4426820
4948978
4949104
4948944
2232444
4951055
628176
4949035
4947182
4173202
4428638
4948979
4949105
4948946
2232562
4951170
628230
4949037
4947185
4275583
4428838
4948980
4949106
4948947
2273142
4951173
628727
4949039
4947189
4276472
4433785
4948981
4949108
4948948
2292715
4951176
1004739
4949040
4947201
4339757
4436364
4948982
4949109
4948949
2302957
4951185
1230541
4949042
4947202
4376725
4436864
4948983
4949110
4948950
2563138
4951207
1254062
4949044
4947203
4388064
4438060
4948984
4949111
4948951
2692340
4951209
1314113
4949045
4947204
4391261
4438415
4948985
4579583
4948952
2824290
4951213
1316100
4949046
4948885
4395587
4576534
4948986
4583202
4948953
2875983
4951218
1322754
4949047
4948886
4398518
4404349
4705492
4660346
4420372
2883990
4951261
1580047
4949049
4948887
4399866
4408404
4706833
4704876
4400649
2887419
4738360
1629162
4949051
4948890





Reference excluded (HERO ID) because the reference c
id NOT presenl
quantitative environmental hazard data
N/A.
LXI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.9: Screening Questions and Off-Topic References Excluded at Full-text Screening for Environmental Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain information pertaining
to a low- priority substance candidate?
No
1580138
4731313
4851358
4951178
1744616
4940286
4951206
4951228
4940436
4947106
4951208
What type of source is this reference?
Review article or book chapter that contains only
citations to primary literature sources
4219489
Is quantitative environmental hazard data
presented?
No
N/A.
Is this primarily a modeling/simulation study?
[Note: select "No" if experimental verification was
included in the study]
Yes
N/A.
Is environmental hazard data presented for
standard or non-standard aquatic or terrestrial
species (fish, invertebrates, microorganisms, non-
mammalian terrestrial species)?
No
N/A.
Is exposure measured for the target substance or
is the test substance a mixture (except for
reasonable impurities, byproducts, and aqueous
solutions) or formulated product?
Mixture
N/A.
Formulated Product
N/A.
Does the reference report a duration of exposure?
No
N/A.
Does the reference report a negative control that is
a vehicle control or no treatment control?
No
7504
4940435
4940366
4940397
LXII

-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.9: Screening Questions and Off-Topic References Excluded at Full-text Screening for Environmental Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference include endpoints in the
information needs?
No
N/A.

Table C.9: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Environmental Hazard
Question
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test Substance Identity
The test substance identity or description cannot
be determined from the information provided
(e.g., nomenclature was unclear, CASRN or
structure were not reported, substance name/
description does not match CASRN).
OR
For mixtures, the components and ratios were not
characterized or did not include information that
could result in a reasonable approximation of
components.
N/A.


Metric 2:
Negative Controls
A concurrent negative control group was not
included or reported.
4951174
4951208
Metric 3:
Experimental System
The experimental system (e.g., static, semi-static,
or flow-through regime) was not described.
4940436
4940440
4951174
4940388
3041958
Metric 4:
Reporting of Concentrations
Test concentrations were not reported.
4951174
4951208
Metric 5:
Exposure Duration
The duration of exposure was not reported.
OR
The reported exposure duration was not suited to
the study type and/or outcome(s) of interest (e.g.,
study intended to assess effects on reproduction did
not expose organisms for an acceptable period of
time prior to mating).
4951208
4951174
Metric 6:
Test Organism Characteristics
The test species was not reported.
OR
The test species, life stage, or age was not
appropriate for the outcome(s) of interest.
N/A.
LXIII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.9: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Environmental Hazard
Question
Unacceptable if:
References excluded (HERO ID)



Metric 7:
Outcome Assessment Methodology
The outcome assessment methodology was not
reported.
N/A.
Metric 8:
Reporting of Data
Data presentation was inadequate.
OR
Major inconsistencies were present in reporting of
results.
4940388
3041958
C.3 Fate
For the screening review of LPS candidate l,r-dimethyldiethylene glycol, EPA excluded a total of 453 references when assessing environmental
fate. Off-topic fate references excluded at title/abstract screening are listed in Table C. 10, and those excluded at full-text screening are listed in
Table C. 11. References in Table C. 12 represent unacceptable studies based on specific data quality metrics for fate. Off-topic and unacceptable
references are displayed next to the corresponding exclusion criteria.
Table C.10: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID'
) because the reference did NOT contain information needs40 relevant to environmental fate
44187
4949033
4948959
4946621
4146480
2232444
4949089
4949005
4948895
4847997
404898
4949034
4948960
4946623
4148076
2232562
4949090
4949006
4948896
4853443
635083
4949035
4948961
4947105
4148079
2273142
4949092
4949007
4948898
4862648
744085
4949037
4948962
4947107
4168926
2292715
4949094
4949009
4948899
4909646
789593
4949039
4948963
4947108
4173202
2302957
4949095
4949010
4948900
4940595
789651
4949040
4948964
4947109
4275583
2563138
4949096
4949011
4948902
4940694
824457
4949042
4948965
4947110
4276472
2692340
4949098
4949012
4948904
4940855
926985
4949044
4948966
4947111
4339757
2824290
4949099
4949013
4948905
4941418
992939
4949045
4948967
4947113
4376725
2875983
4949100
4949015
4948906
4941419
1058389
4949046
4948968
4947114
4388064
2883990
4949102
4949016
4948909
4941420
1058433
4949047
4948969
4947115
4391261
2887419
4949103
4949017
4948911
4945941
40 The information needs for fate includes a list of study characteristics pertaining to the associated media and exposure pathways, associated processes, and use of controls. A
complete list of the information needs is provided in Table A3 of the "Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA." These
information needs helped guide the development of questions for title/abstract and full-text screening.
LXIV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.10: Off-Topic References Excluded at Initial Screening for Fate
1112905
4949049
4948970
4947130
4395587
2892020
4949104
4949018
4948912
4946061
1124442
4949051
4948971
4947131
4398518
2978028
4949105
4949020
4948913
4946132
1124901
4949052
4948972
4947132
4399866
3009070
4949106
4949021
4948914
4946133
1142139
4949053
4948974
4947135
4400649
3036268
4949108
4949022
4948915
4946147
1153582
4949054
4948975
4947136
4404349
3036587
4949109
4949023
4948916
4946178
1156301
4949055
4948977
4947137
4408404
3036785
4949110
4949024
4948918
4946179
1167387
4949056
4948978
4947138
4420372
3036899
4949111
4949026
4948919
4946180
1201159
4949058
4948979
4947140
4420932
3037885
4949112
4949027
4948920
4946188
1201176
4949060
4948980
4947141
4420947
3038211
4949113
4949028
4948921
4946189
1201178
4949061
4948981
4947155
4421954
3038973
4949116
4949029
4948922
4946190
1204953
4949063
4948982
4947156
4423539
3039406
4949117
4949030
4948923
4946191
1249186
4949064
4948983
4947159
4425601
3039551
4949118
4949031
4948925
4946193
1321888
4949065
4948984
4947160
4426820
3039791
4949119
4949032
4948926
4946194
1458307
4949066
4948985
4947161
4428638
3041935
4949120
4946380
4948927
4946210
1496934
4949067
4948986
4947175
4428838
3114932
4949121
4946387
4948928
4946247
1549118
4949068
4948988
4947177
4433785
3115961
4949122
4946408
4948930
4946257
1611582
4949070
4948989
4947182
4436364
3225794
4949123
4946410
4948931
4946258
1612753
4949071
4948990
4947185
4436864
3374286
4949126
4946419
4948932
4946259
1615034
4949072
4948991
4947189
4438060
3402924
4949128
4946506
4948933
4946263
1689217
4949074
4948992
4947201
4438415
3445046
4949129
4946513
4948934
4946322
1781960
4949075
4948993
4947202
4576534
3476490
4949130
4946538
4948935
4946324
1808388
4949076
4948994
4947203
4579583
3477473
4949132
4946547
4948936
4946329
1865871
4949078
4948995
4947204
4583202
3491334
4949134
4946614
4948938
4946359
1875316
4949080
4948996
4947224
4660346
3539276
4949135
4946615
4948940
4946360
1955931
4949081
4948997
4948885
4704876
3559324
4949138
4946617
4948942
4946361
1967450
4949082
4948998
4948886
4705492
3562800
4949140
4946619
4948943
4946374
1970619
4949083
4948999
4948887
4706833
3577212
4949141
4946620
4948944
4946375
2231679
4949084
4949000
4948890
4738360
3577235
4949142
4948952
4948946
4946376
2232056
4949085
4949001
4948891
4738993
3590105
4949149
4948953
4948947
4946377
2232422
4949086
4949002
4948892
4742957
3619406
4949150
4948954
4948948
4949157
2232425
4949087
4949003
4948893
4828940
3625221
4949152
4948955
4948949
4949158
2232427
4949088
4949004
4948894
4828943
3753956
4949153
4948956
4948950
4949159
3830898
4949156
3847436
3874693
4088550
3830342
4949154
4948958
4948951
4951181
3846566









LXV

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.10: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT present quantitative environmental fate data
m.
Table C.11: Screening Questions and Off-Topic References Excluded at Full-text Screening for Fate
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain information pertaining
to a low- priority substance candidate?
No
4940397
4940399
4949131
1763087
4940401
What type of source is this reference?
Review article or book chapter that contains only
citations to primary literature sources
N/A.
Is quantitative fate data presented?
No
N/A.
Is this primarily a modeling/simulation study?
[Note: Select "Yes" only if there is no experimental
verification]
Yes
N/A.

Table C.12: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test substance identity
The test substance identity or description cannot be
determined from the information provided (e.g.,
nomenclature was unclear and CASRN or structure
were not reported).
OR
For mixtures, the components and ratios were not
characterized or did not include information that
could result in a reasonable approximation of
components.
N/A.
Metric 2:
Study controls
The study did not include or report crucial control
groups that consequently made the study unusable
(e.g., no positive control for a biodegradation study
reporting 0% removal).
OR
4940366
4940402
4940404
LXVI

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.12: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)

The vehicle used in the study was likely to unduly
influence the study results.

Metric 3:
Test substance stability
There were problems with test substance stability,
homogeneity, or preparation that had an impact on
concentration or dose estimates and interfered with
interpretation of study results.
4940404
4940430
Metric 4:
Test method suitability
The test method was not reported or not suitable
for the test substance.
OR
The test concentrations were not reported.
OR
The reported test concentrations were not
measured, and the nominal concentrations reported
greatly exceeded the substances water solubility,
which would greatly inhibit meaningful interpretation
of the outcomes.
4940402
4940404




Metric 5:
Testing conditions
Testing conditions were not reported, and the
omission would likely have a substantial impact on
study results.
OR
Testing conditions were not appropriate for the
method (e.g., a biodegradation study at
temperatures that inhibit the microorganisms).
4940366
4940402
4940404
Metric 6:
System type and design- partitioning
Equilibrium was not established or reported,
preventing meaningful interpretation of study
results.
OR
The system type and design (e.g. static, semi-static,
and flow-through; sealed, open) were not capable of
appropriately maintaining substance concentrations,
preventing meaningful interpretation of study
results.
N/A.
LXVII

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*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.12: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
Metric 7: Test organism-degradation
The test organism, species, or inoculum source
were not reported, preventing meaningful
interpretation of the study results.
4940402
4940430
Metric 8:
Test organism-partitioning
The test organism information was not reported.
OR
The test organism is not routinely used and would
likely prevent meaningful interpretation of the study
results.
N/A.
Metric 9:
Outcome assessment methodology
The assessment methodology did not address or
report the outcome(s) of interest.
1763085
4940402
4940404
4940388
4940389
Metric 10:
Data reporting
Insufficient data were reported to evaluate the
outcome of interest or to reasonably infer an
outcome of interest.
OR
The analytical method used was not suitable for
detection or quantification of the test substance.
OR
Data indicate that disappearance or transformation
of the parent compound was likely due to some
other process.
N/A.


Metric 11:
Confounding Variables
There were sources of variability and uncertainty in
the measurements and statistical techniques or
between study groups.
4940402
4940404
4940430
Metric 12:
Verification or plausibility of results
Reported value was completely inconsistent with
reference substance data, related physical chemical
properties, or otherwise implausible, suggesting that
a serious study deficiency exists (identified or not).
1763085
4940366
4940402
4940404
LXVIII

-------