*** Proposal Draft - Do Not Cite, Quote or Release During the Review ***
Dossier for Candidate Low-Priority Substance 1-Docosanol
(CASRN 661-19-8)
For Release at Proposal
August 9, 2019
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue
Washington, DC 20460

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Contents
1.	Introduction	1
2.	Background on 1-Docosanol	3
3.	Physical-Chemical Properties	4
3.1 References	6
4.	Relevant Assessment History	7
5.	Conditions of Use	9
6.	Hazard Characterization	13
6.1	Human Health Hazard	16
6.1.1	Absorption, Distribution, Metabolism, and Excretion	17
6.1.2	Acute Toxicity	18
6.1.3	Repeated Dose Toxicity	19
6.1.4	Reproductive and Developmental Toxicity	19
6.1.5	Genotoxicity	19
6.1.6	Carcinogenicity	20
6.1.7	Neurotoxicity	20
6.1.8	Skin Sensitization	21
6.1.9	Skin Irritation	21
6.1.10	Eye Irritation	21
6.1.11	Hazards to Potentially Exposed or Susceptible Subpopulations	21
6.2	Environmental Hazard	21
6.2.1	Acute Aquatic Toxicity	21
6.2.2	Chronic Aquatic Toxicity	22
6.3	Persistence and Bioaccumulation Potential	22
6.3.1	Persistence	22
6.3.2	Bioaccumulation Potential	23
7.	Exposure Characterization	24
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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	25
7.4.2	Exposures to Consumers	26
8.	Summary of Findings	27
8.1	Hazard and Exposure Potential of the Chemical Substance	27
8.2	Persistence and Bioaccumulation	28
8.3	Potentially Exposed or Susceptible Subpopulations	28
8.4	Storage Near Significant Sources of Drinking Water	29
8.5	Conditions of Use or Changes in Conditions of Use of the Chemical Substance	30
8.6	The Volume or Significant Changes in Volume of the Chemical Substance Manufactured or Processed.... 31
8.7	Other Considerations	31
9.	Proposed Designation	32
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	II
A.2.2 Uses of 1-Docosanol	IV
A.3	References	XIII
Appendix B: Hazard Characterization	XVII
B.1	References	XXVII
Appendix C: Literature Search Outcomes	XXIX
C.1	Literature Search and Review	XXIX
C.1.1 Search for Analog Data	XXIX
C.2 Search Terms and Results	XXX
C.2 Excluded Studies and Rationale	XXXIX
C.2.1 Human Health Hazard Excluded References	XXXIX
C.2.2 Environmental Hazard	LI
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C.2.3 Fate.
.LIX
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Tables
Table 1:1-Docosanol at a Glance		3
Table 2: Physical-Chemical Properties for 1-Docosanol		4
Table 3: Conditions of Use for 1-Docosanol		11
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects		13
Table 5:1-Docosanol and Analog Structures		17
Table A.1:1986-2015 National Production Volume Data for 1-Docosanol (Non-Confidential Production	^
Volume in Pounds)	
Table A.2: Sources Searched for Uses of 1-Docosanol		II
Table A3: Uses of 1-Docosanol		IV
Table B.1: Human Health Hazard		XVII
Table B.2: Environmental Hazard		XXIV
Table B.3: Fate		XXV
Table C.1: Sources Used for Analog Search		XXX
Table C.2: Search Terms Used in Peer-Reviewed Databases		XXXI
Table C.3: Search Terms Used in Grey Literature and Additional Sources		XXXIX
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard		XLI
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human
Health Hazard	
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Human Health Hazard - Animal	
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Human Health Hazard - In Vitro	
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard	 LI
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for
Environmental Hazard	 LVII

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Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Environmental Hazard	
Table C.11: Off-Topic References Excluded at Initial Screening for Fate	 LIX
Table C.12: Screening Questions and Off-Topic References Excluded at Full Text Screening for Fate	 LXIII
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
_ , LXIII
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. 1-
Docosanol is one of the 40 chemical substances initiated for prioritization as referenced in a March
21, 2019 notice (84 FR 10491)1.
Before determining low or high prioritization status, under EPA's regulations at 40 CFR 702.92 and
pursuant to section 6(b)(1)(A) of the statute, EPA will generally use reasonably available information
to screen the candidate chemical substance under its conditions of use against the following criteria
and considerations:
•	the hazard and exposure potential of the chemical substance;
•	persistence and bioaccumulation;
•	potentially exposed or susceptible subpopulations;
•	storage near significant sources of drinking water;
•	conditions of use or significant changes in the conditions of use of the chemical substance;
•	the chemical substance's production volume or significant changes in production volume; and
•	other risk-based criteria that EPA determines to be relevant to the designation of the chemical
substance's priority.
Designation of a low-priority substance indicates that the chemical does not meet the statutory criteria
for a high-priority substance and that a risk evaluation is not warranted at the time.
This risk-based, screening-level review is organized as follows:
•	Section 1 (Introduction): This section explains the requirements of the Lautenberg
amendments to the Toxic Substances Control Act (TSCA) and implementing regulations -
including the criteria and considerations ~ pertinent to prioritization and designation of low-
priority substances.
1	https://www.federalregister.gov/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 2 (Background on the Proposed Low-Priority Substance): This section includes
information on attributes of the chemical substance, including its structure, and relates them
to its functionality.
Section 3 (Physical-Chemical Properties) : This section includes a description of the physical-
chemical properties of the chemical substance and explains how these properties lead to the
chemical's fate, transport, and exposure potential.
Section 4 (Relevant Assessment History): This section includes an overview of the outcomes
of other governing entities" assessments of the chemical substance.
Section 5 (Conditions of Use): This section presents the chemical substance's known,
intended, and reasonably foreseen conditions of use under TSCA.
Section 6 (Hazard Characterization): This section summarizes the reasonably available
hazard information and benchmarks the information against low-concern thresholds.
Section 7 (Exposure Characterization): This section includes a qualitative summary of
potential exposures to the chemical substance.
Section 8 (Summary of Findings): In this section, EPA presents information pertinent to
prioritization against each of the seven statutory and regulatory criteria and considerations,
and proposes a conclusion based on that evidence.
Section 9 (ProposedDesignation): 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-Docosanol
Table 1 below provides the CAS number, synonyms, and other information on 1-docosanol.
Table 1:1-Docosanol at a Glance
Chemical Name
1-Docosanol
CASRN
661-19-8
Synonyms
Docosan-1-ol; Behenyl alcohol; Docosanol; Behenic alcohol; Docosyl alcohol; n-
Docosanol; Brassica alcohol
Trade Name(s)
Abreva; Tadenan; Lidavol; Lanette22
Molecular Formula
C22H46O
Representative Structure
H 0
1-Docosanol is a long-chain, saturated fatty alcohol that is a water-insoluble, waxy solid. Fatty
alcohols are usually high-molecular-weight, straight-chain primary alcohols derived from natural fats
and oils. Saturated fatty alcohols have no carbon-carbon double bonds, and have the formula -
CH3(CH2)nOH - with variations in "n". Specifically, 1-docosanol is a saturated aliphatic alcohol
with a 22-carbon chain, known as docosane, with a hydroxy group (-OH) at the terminal carbon and
the formula CH3(CH2)210H. This chemical has uses in consumer and industrial products, as well as
in pharmaceutical products. 1-Docosanol functions as a thickener, emulsifier, emollient, and binder in
a variety of applications and product sectors. Section 5 inlcudes conditions of use for this chemical.
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3. Physical-Chemical Properties
Table 2 lists physical-chemical properties for 1-docosanol. 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-Docosanol
Source/Model
Data Type
Endpoint
Endpoint Value
Notes
PubChem 2004
Experimental
State at room
temperature
Solid

ECHA 2019; HSDB2006;
ChemSpider 2019;
EPISuitev.4.113
Experimental
Molecular weight
327 g/mol

EPISuitev.4.11
Experimental
Melting point
72.5°C

EPISuitev.4.11
Calculated
Molecular weight
326.61 g/mol

Lyman etal. 1990
Calculated
Molar volume
503 cm3/mol

ChemSpider 2019
Experimental
Water solubility
63600 at 30°C
This water solubility value seems unreasonably high considering the length
of the carbon chain in 1-docosanol.
ECHA 2019
Experimental
Water solubility
<1 mg/L
Based on detection limit of method used
EPISuitev.4.11
Estimated
Water solubility
7.50x10-5 mg/L

ChemSpider 2019
Experimental
Water solubility
1.95x10-1 mol/L
This water solubility value seems unreasonably high considering the length
of the carbon chain in 1-docosanol.
ECHA 2019
Experimental
Water solubility
3.06x10"6 mol/L

ECHA 2019
Experimental
Log Kow
8.3

EPISuitev.4.11
Estimated
Log Kow
9.68

EPISuitev.4.11
Estimated
Log Koa
10.854

EPISuitev.4.11
Estimated
Log Koc
5.32 (MCI); 5.87
(Kow)

HSDB2006; EPISuitev.4.11
Experimental
Vapor pressure
0.22 mm Hg at
180°C

3 EPI Suite Physical Property Inputs - Melting Point = 72.5 deg C, SMILES: OCCCCCCCCCCCCCCCCCCCCCC
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Table 2: Physical-Chemical Properties for 1-Docosanol
Source/Model
Data Type
Endpoint
Endpoint Value
Notes
ECHA 2019
Experimental
Vapor pressure
<7.5x10-4 mm Hg
(<0.001 mbar) at
38°C

EPISuitev.4.11
Estimated
Vapor pressure
6.13x10-8 mm Hg

EPISuitev.4.11
Estimated
Henry's Law
1.64x10"3 atm-m3/mol
(bond method)
4.88x10-3 (group
method)

EPISuitev.4.11
Estimated
Photolysis
(volatilization)
2.49 hours (river)
7.45 days (lake)

EPISuitev.4.11
Estimated
Photolysis
(indirect)
3.97 hours (T1/2)
OH rate constant 32.3 E-11 cm3/molecules-second (12 hours day; 1.5E6
OH/cm3)
EPISuitev.4.11
Estimated
Hydrolysis
Rate constants
cannot be estimated

EPISuitev.4.11
Estimated
Biodegradation
potential
Ready prediction:
Yes

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EPA's Sustainable Futures/P2 Framework Manual4 was used to interpret the physical-chemical
properties provided in Table 2. Based on its reported physical form (PubChem, 2019) and measured
melting point (EPISuite), 1-docosanol is a waxy solid under ambient conditions. In the solid form, 1-
docosanol has the potential for exposure via direct dermal contact with the substance, through
ingestion, and through inhalation of dust particles if they are generated. Based on its measured
(ECHA, 2019) and estimated vapor pressures (EPISuite), 1-docosanol is not likely to be volatile at
ambient temperatures. The estimated Henry's Law constant (EPISuite) for 1-docosanol reflects both
the low volatility and low aqueous solubility of this compound; volatilization from water and aqueous
solutions is expected to be minimal. Therefore, exposure via inhalation of vapors is expected to be
minimal. Based on measured solubility data (ECHA, 2019), 1-docosanol is not considered water
soluble, indicating that this substance is unlikely to dissolve in water and form an aqueous solution.
Water insoluble substances have decreased potential for absorption through the gastrointestinal tract
or lungs. Therefore, if exposed to the chemical in dust form, absorption through the lungs is unlikely.
Based on its estimated log Kow (EPISuite), 1-docosanol may cross lipid membranes; however, the
structure of this substance indicates it has the potential to be metabolized, leading to a decreased
likelihood of bioaccumulation. The estimated log Koc (EPISuite) indicates this substance is immobile
in soils and therefore unlikely to migrate into groundwater. 1-Docosanol is expected to have low
persistence. Experimental biodegradation data for 1-docosanol indicate it is inherently biodegradable
under aerobic conditions, and degradable under anaerobic conditions, indicating that this substance
has the potential to break down into carbon dioxide and water. In addition, intermediate
biodegradation products are expected to include fatty acids, which can be incorporated into biomass
via normal metabolic processes.
3.1 References
ChemSpider. (2019). Docosanol. Retrieved from http://www.chemspider.com/Chemical-
Structure. 12100 .html
European Chemicals Agency (ECHA). (2019). Docosan-l-ol. Retrieved from
https://echa.europa.eu/substance-information/-/substanceinfo/100.010.498
Hazardous Substance Database (HSDB). (2006). 1-Docosanol. Retrieved from
https: //toxnet .nlm .nih .gov
Lyman, Warren J., Reehl, W. F., Rosenblatt, D. H. (1990). Handbook of chemical property estimation
methods: environmental behavior of organic compounds. American Chemical Society
PubChem (2004). Docosanol. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/12620
U.S. EPA. (2019). Estimation Programs Interface Suite, v 4.11. United States Environmental
Protection Agency, Washington, DC, USA
4 https://www.epa.gOv/sites/production/files/2015-05/documents/05.pdf
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4. Relevant Assessment History
EPA assessed the toxicological profile of 1-docosanol and added the chemical to the Safer Choice
Program's Safer Chemical Ingredients List (SCIL) in September 2017 under the functional class of
emollients. The SCIL5 is a continuously updated list of chemicals that meet low-concern Safer Choice
criteria.6
EPA also reviewed international assessments of 1-docosanol. EPA identified assessments by the
Organisation for Economic Co-operation and Development (OECD) and government agencies of
Australia, Canada, Germany, and Japan.
The United Kingdom sponsored a long chain alcohol chemical category, which included 1-docosanol,
as an OECD SIDS Initial Assessment Report (SIAR). The OECD SIAM 227 reviewed the SIAR in
April 2006 and recommended 1-docosanol as low priority for further work based on the chemical's
low hazard profile. EPA also reviewed 1-docosanol as part of a long chain alcohol hazard
characterization in December 2009.8
The Australian Government's Department of Health National Industrial Chemicals Notification and
Assessment Scheme (NICNAS) determined 1-docosanol to not pose an unreasonable risk to the
health of workers and public health on the basis of the Tier I Inventory Multi-tiered Assessment and
Prioritisation (IMAP) assessment.9
The Canadian Government, through an assessment of toxicity and exposure as part of its
categorization of the Domestic Substance List, found that 1-docosanol did not meet its criteria for
further attention.1"
The German Environment Agency (UBA) designated 1-docosanol as "non-hazardous to water" in
August 2018 based on an assessment of ecotoxicity and environmental fate.11
Japan's National Institute of Technology and Evaluation (NITE) categorized 1-docosanol as hazard
class 4 for human health in 2017, the lowest-concern hazard ranking that NITE assigns.12
5 https://www.epa.gov/saferchoice/safer-ingredients
0 https://www.epa.gov/sites/production/files/2013-12/documents/dfe master criteria safer ingredients v2 l.pdf
7	https://hpvchemicals.oecd. org/UI/handler.axd?id=9802eİ2-2c9d-4f2 l-877e-90b6133efd73
8	https://cheniview.epa.gov/cheniview/proxy?filenanie=HC661198.pdf
9	The IMAP framework is a science and risk-based framework for the assessment and prioritisation of chemicals on
the Australian Inventory of Chemical Substances (AICS). It consists of 3 tiers of assessment, with the assessment effort
increasing with each tier, https://www.nicnas.gov.au/cheniical-infoniiation/iniap-assessnients/iniap-assessnients/liunian-
health-assessments
10	https://canadacheniicals.oecd.org/CheniicalDetails.aspx?CheniicalID=A2958A06-5755-450B-9E53-81C208212012
11	https://webrigoletto.uba.de/rigoletto/public/searcliDetail.do?kennummer=656
12	https://www.nite.go.jp/cheni/jcheck/detail.action?cno=661-19-8&nino=2-3704&request_locale=en
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These assessments from the international community support EPA's proposal of 1-docosanol as a
low-priority substance candidate.
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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 1-docosanol (Appendix A) to inform which uses would be determined conditions of
use.13 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).
Based on CDR, 1-docosanol is manufactured domestically and imported. It is an organic sodium salt
used in processing (incorporation into formulation, mixture or reaction and processing as a reactant
for plastic materials and resin manufacturing, soap, cleaning compound, and toilet preparation
manufacturing, paper manufacturing, paint and coating additives, products and other applications). 1-
Docosanol is used in a variety of industrial applications, including oil and gas drilling, extraction, and
support activities, as well as commercial products, including plastics and rubbers. Consumer uses
include paper products, paints and coatings, and laundry and dishwashing products, among others.
Based on the known manufacturing, processing, and uses of this chemical substance, EPA assumes
distribution in commerce. Based on CDR, five facilities reported that 1-docosanol was not recycled
(e.g., not recycled, remanufactured, reprocessed, or reused), and one facility reported recycling
information as confidential business information (CBI). No information on disposal is found in CDR
or through EPA's Toxics Release Inventory (TRI) Program14 because 1-docosanol 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 occupational15 and consumer uses. This research improved the Agency's
understanding of the conditions of use for 1-docosanol. Although EPA identified uses of 1-docosanol
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
13	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).
14	https://www.epa.gov/toxics-release-inventorv-tri-program
15	Occupational uses include industrial and/or commercial uses
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lists the conditions of use 1-docosanol 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-Docosanol
Life Cycle Stage
Category
Subcategory of Use
Source
Manufacturing
Domestic manufacture
Domestic manufacture- information on whether domestically manufactured was not
reported.
EPA (2017b)
Import
Import- manufacture
EPA (2017b)
Processing
Processing-
incorporation into
formulation, mixture or
reaction
Processing aids not otherwise listed- paper manufacturing; soap, cleaning compound, and
toilet preparation manufacturing, plastic materials and resin manufacturing
EPA (2017b)
Surface active agents- paper manufacturing
Surface active agents- soap, cleaning compound, and toilet preparation manufacturing
Paint additives and coating additives not described by other categories- paint and coating
manufacture
Lubricant and lubricant additives- petroleum lubricating oil and grease manufacturing
Other- all other chemical product and preparation manufacturing, paper manufacturing
Processing as a
reactant
Processing aids, not otherwise listed- paper manufacturing
Surface active agents- soap, cleaning compound, and toilet preparation manufacturing
Other
Agricultural additive manufacturing; textiles, apparel, and leather manufacturing
Synapse Information Resources
(n.d.), CPCat (2019)
Lubricants and
lubricant additives
Food-contact metallic manufacturing
Synapse Information Resources
(n.d.),CPCat (2019)
Recycling
Recycling
EPA (2017b)16
Distribution
Distribution
Distribution
EPA (2017b)
Industrial uses
Other
Oil and gas drilling, extraction, and support activities
Synapse Information Resources
(n.d.), CPCat (2019)
Processing aids, not
otherwise listed
Anti-foaming agent
CPCat (2019)
10 In the 2016 CDR, five facilities reported that 1-docosanol was not recycled (e.g., not recycled, remanufactured, reprocessed, or reused), and one facility reported recycling
information as CBI (EPA 2017b).
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Table 3: Conditions of Use for 1-Docosanol
Life Cycle Stage
Category
Subcategory of Use
Source

Surface active agents
Surfactant
CPCat (2019)
Commercial
Plastic and rubber
products not
elsewhere classified

EPA (2017b)
Commercial/
consumer
Paper products

EPA (2017b)
Paints and coatings

EPA (2017b)
Consumer
Laundry and
dishwashing products

EPA (2017b)
Window and door
sealant

DeLima Associates (2016a)
Disposal
Releases to air,
wastewater, solid and
liquid wastes

Though not explicitly identified,
releases from disposal are
assumed to be reasonably
foreseen17
17 See Section 5 for a discussion on why releases are assumed to be reasonably foreseen for purposes of this proposed prioritization designation.
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6. Hazard Characterization
EPA reviewed primary literature and other data sources to identify reasonably available information.
This literature review approach18 is tailored to capture the reasonably available information associated
with low-hazard chemicals. EPA also used this process to verify the reasonably available information
for reliability, completeness, and consistency. EPA reviewed the reasonably available information to
identify relevant, quality studies to evaluate the hazard potential for 1-docosanol against the endpoints
listed below. EPA's New Chemicals Program has used these endpoints for decades to evaluate
chemical substances under TSCA19 and EPA toxicologists rely on these endpoints as key indicators of
potential human health and environmental effects. These endpoints also align with internationally
accepted hazard characterization criteria, such as the Globally Harmonized System of Classification
and Labelling of Chemicals2" as noted above in Section 4 and form the basis of the comparative
hazard assessment of chemicals.
Human health endpoints evaluated: Acute mammalian toxicity, repeated dose toxicity,
carcinogenicity, mutagenicity/genotoxicity, reproductive and developmental toxicity, neurotoxicity,
skin sensitization, and eye and skin irritation.
Environmental fate and effects endpoints evaluated: Aquatic toxicity, environmental persistence,
and bioaccumulation.
The low-concern criteria used to evaluate both human health and environmental fate and effects are
included in Table 4 below.
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
Human Health
Acute Mammalian
Toxicity21
Very High
High
Moderate
Low
Oral LDso (mg/kg)
<50
> 50 - 300
> 300 - 2000
>2000
Dermal LD50 (mg/kg)
<200
> 200- 1000
> 1000 -2000
>2000
Inhalation LC50
(vapor/gas) (mg/L)
<2
>2-10
>10-20
>20
Inhalation LC50
(dust/mist/fume)
(mg/L)
<0.5
>0.5-1.0
>1.0-5
>5
18This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
19	https://www.epa. gov/sustainable-futures/sustainable-futures-p2-framework-manual
20	https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs rev07/English/ST SG AC10 30 Rev7e.pdf
21	Values derived from GHS criteria (Chapter 3.1: Acute Toxicity. 2009, United Nations).
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
Repeated Dose
Toxicity (90-day
study)22

High
Moderate
Low
Oral (mg/kg-bw/day)

< 10
10-100
>100
Dermal (mg/kg-
bw/day)

<20
20 - 200
>200
Inhalation
(vapor/gas)
(mg/L/6h/day)

<0.2
0.2-1.0
>1.0
Inhalation
(dust/mist/fume)
(mg/L/6h/day)

<0.02
0.02-0.2
>0.2
Reproductive
Toxicity23

High
Moderate
Low
Oral (mg/kg/day)

<50
50 - 250
>250
Dermal (mg/kg/day)

< 100
100-500
>500
Inhalation (vapor,
gas, mg/L/day)

< 1
1-2.5
>2.5
Inhalation
(dust/mist/fume,
mg/L/day)

<0.1
0.1-0.5
>0.5
Developmental
Toxicity23

High
Moderate
Low
Oral (mg/kg/day)

<50
50 - 250
>250
Dermal (mg/kg/day)

< 100
100-500
>500
Inhalation (vapor,
gas, mg/L/day)

< 1
1-2.5
>2.5
Inhalation
(dust/mist/fume,
mg/L/day)

<0.1
0.1-0.5
>0.5
Mutagenicity/
Genotoxicity24
Very High
High
Moderate
Low
Germ cell
mutagenicity
GHS Category 1A
or 1B: Substances
known to induce
heritable mutations
or to be regarded
as if they induce
heritable mutations
GHS Category 2:
Substances which
cause concern for
humans owing to the
possibility that they
may induce heritable
mutations in the germ
cells of humans.
Evidence of
mutagenicity support by
positive results in vitro
OR in vivo somatic cells
of humans or animals
Negative for
chromosomal
aberrations and gene
mutations, or no
structural alerts.
22	Values from GHS criteria for Specific Target Organ Toxicity Repeated Exposure (Chapter 3.9: Specific Target Organ
Toxicity' Repeated Exposure. 2009, United Nations).
23	Values derived from the U.S. EPA's Office of Pollution Prevention & Toxics criteria for HPV chemical categorizations
(Methodology* for Risk-Based Prioritization Under ChM tP), and the EU REACH criteria for Annex IV (2007).
24	From GHS criteria (Chapter 3.5: Germ Cells Mutagenicity'. 2009, United Nations) and supplemented with considerations
for mutagenicity and genotoxicity in cells other than germs cells.
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects

in the germ cells of
humans.



Mutagenicity and
genotoxicity in
somatic cells

OR
Evidence of
mutagenicity
supported by positive
results in in vitro AND
in vivo somatic cells
and/or germ cells of
humans or animals.
Carcinogenicity25
Very High
High
Moderate
Low

Known or
presumed human
carcinogen (GHS
Category 1Aand
1B)
Suspected human
carcinogen (GHS
Category 2)
Limited or marginal
evidence of
carcinogenicity in
animals (and
inadequate26 evidence
in humans)
Negative studies or
robust mechanism-
based structure
activity relationship
(SAR)
Neurotoxicity
(90-day study)22

High
Moderate
Low
Oral (mg/kg-bw/day)

< 10
10-100
>100
Dermal (mg/kg-
bw/day)

<20
20 - 200
>200
Inhalation
(vapor/gas)
(mg/L/6h/day)

<0.2
CD
CM
CD
>1.0
Inhalation
(dust/mist/fume)
(mg/L/6h/day)

<0.02
0.02-0.2
>0.2
Sensitization27

High
Moderate
Low
Skin sensitization

High frequency of
sensitization in
humans and/or high
potency in animals
(GHS Category 1A)
Low to moderate
frequency of
sensitization in human
and/or low to moderate
potency in animals
(GHS Category 1B)
Adequate data
available and not
GHS Category 1Aor
1B
Respiratory
sensitization

Occurrence in
humans or evidence
of sensitization in
humans based on
animal or other tests
Limited evidence
including the presence
of structural alerts
Adequate data
available indicating
lack of respiratory
sensitization
25 Criteria mirror classification approach used by the IARC (Preamble to the L4RC Monographs: B. Scientific Review and
Evaluation: 6. Evaluation and rationale. 2019) and incorporate GHS classification scheme (Chapter 3.6: Carcinogenicity.
2009, United Nations).
20 EPA's approach to determining the adequacy of information is discussed in the document "Approach Document for
Screening Hazard Information for Low-Priority Substances Under TSCA", also released at proposal.
27 Incorporates GHS criteria (Chapter 3.4: Respiratory or Skin Sensitization. 2009, United Nations).
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Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects


(equivalent to GHS
Category 1A or 1B)


Irritation/
Corrosivity28
Very High
High
Moderate
Low
Eye irritation/
corrosivity
Irritation persists
for >21 days or
corrosive
Clearing in 8-21
days, severely
irritating
Clearing in 7 days or
less, moderately
irritating
Clearing in less than
24 hours, mildly
irritating
Skin irritation/
corrosivity
Corrosive
Severe irritation at 72
hours
Moderate irritation at 72
hours
Mild or slight irritation
at 72 hours
Environmental Fate and Effects
Acute Aquatic
Toxicity Value
(L/E/ICso)29
Chronic Aquatic
Toxicity Value
(L/E/ICso)29
Persistence (Measured in terms of level of
biodegradation)30
Bioaccumulation
Potential31
May be low concern
if <10 ppm...
...and <1 ppm...
...and the chemical meets the 10-day window as
measured in a ready biodegradation test...

Low concern if >10
ppm and <100
ppm...
...and >1 ppm and
<10 ppm...
...and the chemical reaches the pass level within
28 days as measured in a ready biodegradation
test
...and BCF/BAF <
1000.
Low concern if >100
ppm...
...and > 10 ppm...
... and the chemical has a half-life < 60 days...

6.1 Human Health Hazard
Below is a summary of the reasonably available information that EPA included in the hazard
evaluation of 1-docosanol. 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 1-docosanol. Appendix B contains more information on each study.
1-Docosanol is a linear C22 saturated aliphatic alcohol. EPA used best professional judgement to
select analogs for 1-docosanol based on similarity in structure, physical-chemical properties, and
functionality, with the assumption that these chemicals will have similar environmental transport and
persistence characteristics, bioavailability and toxicity profiles. All analogs presented in Table 5 are
long chain saturated aliphatic alcohols and have chain lengths from C16 to C20. Based on these
factors, the environmental and toxicological effects of these analogs are expected to be very similar to
each other and to 1-docosanol.
28	Criteria derived from the Office of Pesticide Programs Acute Toxicity Categories (U.S. EPA. Label Review Manual.
2010).
29	Derived from GHS criteria (Chapter 4.1: Hazards to the Aquatic Environment. 2009, United Nations), EPA OPPT New
Chemicals Program (Pollution Prevention (P2) Framework, 2005) and OPPT's criteria for HPV chemical categorization
(Methodology> for Risk Based Prioritization Under C1l4MP. 2009).
30	Derived from OPPT's New Chemicals Program and DIE Master Criteria and reflects OPPT policy on PBTs (Design for
the Environment Program Master Criteria for Safer Chemicals, 2010).
31	Derived from OPPT's New Chemicals Program and Arnot & Gobas (2006) [Arnote, J.A. and F,A. Gobas, A review of
bioconcentration factor (BCF) and bioaccimndation factor (B*4F) assessments for organic chemicals in aquatic organisms.
Environmental Reviews, 2006. 14: p. 257-297.]
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Table 5:1-Docosanol and Analog Structures
CASRN
Name
Structure
661-19-8
1-Docosanol
(C22)
629-96-9
1-Eicosanol (C20)
112-92-5
1-Octadecanol
(C18)
67762-27-0
Alcohols, C16-18
Representative structures
36653-82-4
Cetyl alcohol (C16)
Alcohols, CI6-18 and C18 unsaturated (CASRN 68002-94-8) was also included in analog data
searches; relevant, quality studies32 were only identified for the CASRNs listed in Table 5.
6.1.1 Absorption, Distribution, Metabolism, and Excretion
Absorption
Because of its low water solubility, 1-docosanol is not expected to be absorbed from dermal,
inhalation, or oral (from the gastrointestinal tract) exposures.
32 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
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Distribution
No quality experimental data33 on 1 -docosanol's distribution were available. Based on 1 -docosanol's
estimated log Kow, 1-docosanol will likely be distributed to fatty tissues in the body. However, it is
expected to be excreted through urine and feces (described below under Excretion).
Metabolism
Because quality experimental data on 1-docosanol metabolite formation were limited, the
Quantitative Structure-Activity Relationship (QSAR) toolbox34 was used to run the rat liver S9
metabolism simulator, the skin metabolism simulator, and the in vivo rat metabolism simulator. The
QSAR toolbox was used to identify putative 1-docosanol metabolites. All simulators reported
docosanoic acid as a putative metabolite. The rat liver S9 and skin metabolism simulators also
predicted the C22 aldehyde docosanal. The in vivo rat metabolism simulator predicted various ketone
metabolites and lower carbon (CIO - CI8) containing fatty acids.
Excretion
To assess 1 -docosanol's excretion pathways, EPA used read-across from 1-octadecanol. Chinchilla
rabbits were administered 1-octadecanol via oral gavage (OECD. 2006). Approximately 7.6% of the
administered dose was measured as the glucuronide metabolite in urine 24 hours after dosing. These
data indicate that 1-octadecanol is excreted as a glucuronide conjugate in small amounts (<10%) in
the urine. Due to its larger molecular weight, more of the transformed compound will likely be
excreted via feces. Due to its low vapor pressure, gas exchange is unlikely to be a major pathway of
excretion.
6.1.2 Acute Toxicity
EPA assessed the mammalian toxicity potential from acute oral exposures to 1-docosanol using
experimental data. A study following OECD 432 Guidelines exposed rats to 1-docosanol via oral
gavage. The study authors reported no mortality in the single tested dose (2000 mg/kg), resulting in
an LD50 greater than 2000 mg/kg (OECD. 2006; ECHA. 1997a). Another OECD 423 Guideline study
in rats exposed to 1-docosanol via oral gavage reported no mortality at the highest tested dose of
10,000 mg/kg (OECD. 2006). A study on mice exposed to 1-docosanol via oral gavage also reported
no mortality at the single tested dose of 1000 mg/kg, resulting in a LD50 greater than 1000 mg/kg
(Elder. 1988). Given the limited dosing of the oral gavage study and that no mortality was observed in
the other studies, these results indicate low concern for acute toxicity with LD50S greater than the low-
concern criteria threshold of 2000 mg/kg.
EPA assessed mammalian toxicity from acute dermal exposures using read-across from CI6-18
alcohols. Rabbits exposed to CI6-18 alcohols dermally for 24 hours resulted in an LD50 greater than
33 Discussed in the document "Approach Document for Screening Hazard Information for Low-Priority Substances
Under TSCA."
34 https://www.oecd.org/chemicalsafetv/risk-assessment/oecd-qsar-toolbox.htm
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8000 mg/kg (OECD. 2006). These results indicate low concern based on the dermal low-concern
threshold of 2000 mg/kg.
EPA assessed the mammalian toxicity potential from acute inhalation exposures using read-across
from CI6-18 alcohols. Rats exposed to alcohols, CI6-18 via vapor inhalation for six hours and
observed for 14 days resulted in no mortalities at the highest dose of 0.00014 mg/L (the saturated air
concentration) (ECHA. 1979). Since no effects were observed at saturated air concentration, these
results indicate low concern based on no effects at saturation.
6.1.3	Repeated Dose Toxicity
EPA assessed mammalian toxicity from repeated exposures to 1-docosanol using experimental data.
A study on rats exposed via oral gavage to 1-docosanol for 26 weeks resulted in a no observed
adverse effect level (NOAEL) of 1000 mg/kg-day (OECD. 2006; Iglesias et al.. 2002a). Similarly, a
26-week study in dogs via oral gavage resulted in a NOAEL of 2000 mg/kg-day (Iglesias et al..
2002a). These studies results indicated low-concern for toxicity from repeated exposures because the
NOAELs meet the low-concern criteria threshold of 100 mg/kg-day for a 90-day repeated dose study.
6.1.4	Reproductive and Developmental Toxicity
EPA assessed the potential for mammalian reproductive toxicity from 1-docosanol using
experimental data. Rats exposed to 1-docosanol by oral gavage for 71 days total, beginning during
premating and extending through mating for males and beginning 15 days premating and extending
through gestation day (GD) 20 for females (OECD. 2006; Iglesias et al.. 2002c; U.S. EPA. 2002d).
This study reported no adverse effects, resulting in a NOAEL of 1000 mg/kg-day. These results
indicate low concern because the NOAEL meets the low-concern criteria threshold of 250 mg/kg-day
for reproductive toxicity.
EPA also assessed the potential for mammalian developmental toxicity from 1-docosanol using
experimental data. A study on rabbits exposed to 1-docosanol by oral gavage during GD 6-19
reported a NOAEL of 2000 mg/kg-day (OECD. 2006; Iglesias et al.. 2002c). Rats exposed to 1-
docosanol by oral gavage for 71 days total, beginning during premating and extending through mating
for males and beginning 15 days during premating and extending through GD 20 for females (OECD.
2006; Iglesias et al.. 2002c; U.S. EPA. 2002d). This study reported no adverse developmental effects,
resulting in a NOAEL of 1000 mg/kg-day. These results indicate low-concern for developmental
toxicity by exceeding the low-concern criteria threshold of 250 mg/kg-day.
6.1.5	Genotoxicity
EPA assessed experimental gene mutation and chromosomal aberration studies as an indicator of 1-
docosanoFs potential to cause genotoxicity. An in vivo gene mutation study in mice reported 1-
docosansol as negative for inducing genotoxicity (OECD. 2006; Iglesias et al.. 2002a; U.S. EPA.
2002c). This result is further supported by negative findings in in vitro studies bacteria species and
Chinese hamster lung fibroblast cells exposed to 1-docosanol, with and without metabolic activation
(OECD. 2006; Iglesias et al.. 2002a. b; U.S. EPA. 2002b). Further, Chinese hamsterlung fibroblast
cells exposed to 1-docosanol were also negative for chromosomal aberrations with and without
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metabolic activation (Iglesias et al.. 2002a; U.S. EPA. 2002a). These results indicate a low concern
for genotoxicity.
6.1.6	Carcinogenicity
Because quality experimental data on 1-docosanol or closely-related analogs were limited, EPA relied
on predictive models to evaluate carcinogenicity. Based on Onco Logic15 estimations, high molecular
weight aliphatic alcohols like 1-docosanol (C > 20) are unlikely to be carcinogenic. In addition,
processing 1-docosanol through a selection of other models did not identify any specific concern for
carcinogenic potential. Structural alerts represent molecular functional groups or substructures that
are known to be linked to the carcinogenic activity of chemicals. The most common structural alerts
are those for electrophiles (either direct acting or following activation). Modulating factors that will
impact the carcinogenic potential of a given electrophile will include its relative hardness or softness,
its molecular flexibility or rigidity, and the balance between its reactivity and stability.36 For this
chemical, there is an absence of the types of reactive structural features that are present in genotoxic
carcinogens. 1-Docosansol is not an electrophile. Further, the Virtual models for property Evaluation
of chemicals within a Global Architecture (VEGA) models"37 results indicate 1-docosansol has low
potential to be carcinogenic or mutagenic.
Because of the chemical's predictive metabolism, absence of genotoxicity in experimental studies,
and low concern from predictive modeling, 1-docosanol has low concern for carcinogenicity.
6.1.7	Neurotoxicity
Though no guideline neurotoxicity studies were available for 1-docosanol or the identified analogs,
several repeated dose studies in rats and dogs for 1-octadecanol and 1-docosanol reported no effects
on the limited neurological endpoints that were evaluated (i.e., brain and spinal cord histopathology).
1-Octadecanol did not produce histopathological brain lesions in rats at an oral gavage dose of 1,000
mg/kg-day in a 28-day study (OECD. 2006). Additionally, 1-octadecanol did not produce
histopathological brain lesions in rats at an oral dietary dose of 2,000 mg/kg-day in a study when
males were exposed for 45 days and females were exposed for approximately 54 days (OECD. 2006).
1-Docosanol did not produce histopathological lesions in the brain or spinal cord of dogs at oral
gavage doses up to 2,000 mg/kg-day in a 26-week study (OECD. 2006). Similarly, in rats, no brain or
spinal cord lesions were observed at oral gavage doses up to 1,000 mg/kg-day in a 26-week study
(OECD. 2006; Iglesias et al.. 2002a).
Assays related to neurological functions were not identified for 1-docosanol or analogs in ToxCast.38
35 https://www.epa.gov/tsca-screeniiig-tools/oncologictm-computer-svstem-evalmte-carcinogemc-potential-chemicals
30 "Fundamental and Guiding Principles for (Q)SAR Analysis of Chemical Carcinogens with Mechanistic Considerations:
Series on Testing and Assessment, No. 229." 2015. Environment Directorate, Joint Meeting of the Chemicals Committee
and the Working Party on Chemicals, Pesticides and Bio techno logy.
37	There are four carcinogenicity models housed within the VEGA 1.1.4 software tool available from
https://www.vegahub.eu. A summary of the results from these models is provided in Appendix B.
38	Chemical specific assay list can be found at https://actor.epa.gOv/dashboard/#chemical/55934-93-5.
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Based on the neurological evidence from the repeated dose studies, and supporting evidence
indicating low concern for other endpoints, such as acute, reproductive, and developmental toxicity,
this information indicates low concern for neurotoxicity.
6.1.8	Skin Sensitization
Because quality experimental data on 1-docosanol or closely-related analogs were limited, the
potential for 1-docosanol to cause skin sensitization was assessed using structural alert predictions
from the QSAR Toolbox, Version 4.2. No structural alerts were identified for protein binding
potential by 1-docosanol, indicating low concern for skin sensitization by 1-docosanol.
6.1.9	Skin Irritation
EPA assessed the potential for skin irritation using a study following OECD 404 Guidelines (OECD.
2006; ECHA. 1997c). Rabbits exposed dermally to 1-docosanol demonstrated negative results,
indicating low concern for skin irritation from 1-docosanol.
6.1.10	Eye Irritation
EPA assessed l -docosanol's potential to act as an eye irritant using experimental studies. A study
following OECD 405 Guidelines exposed rabbits in their eyes to 1-docosanol (OECD. 2006; ECHA.
1997b. d). At one hour, all animals had slight conjunctival irritation. However, these results were
completely reversible by 72 hours. Another study exposing rabbits to 1-docosanol reported that 2
hours and 6 hours post exposure, all animals had conjunctival irritation (OECD. 2006; Elder. 1988).
All effects were completely reversible by 24 hours. These results indicate 1-docosanol is moderately
irritating to eyes.
6.1.11	Hazards to Potentially Exposed or Susceptible Subpopulations
The above information supports a low human health hazard finding for 1-docosanol based on low-
concern criteria. This finding considers the endogenous nature of 1-docosanol and 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 1-docosanol.
6.2 Environmental Hazard
EPA assessed environmental hazard for 1-docosanol based on available acute experimental data and
estimated chronic toxicity values using the Ecological Structure Active Relationships (ECOSAR)
Predictive Model.39 Appendix B contains a summary of the reasonably available environmental data.
6.2.1 Acute Aquatic Toxicity
EPA assessed environmental hazard from acute exposures using experimental data on 1-docosanol
and analogs. Aquatic vertebrates exposed to 1-docosanol for 96 hours displayed no effects at the
highest dose (1000 mg/L), resulting in an LC50 value greater than 1000 mg/L (OECD. 2006; ECHA.
39 https://www.epa.gov/tsca-screeniiig-tools/ecological-striictin'e-activity-relationships-ecosar-predictive-model)
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2000). Aquatic invertebrates exposed to 1-octadecanol for 48 hours resulted in an EC50 of 1700 mg/L.
Algae exposed to 1-octadecanol for 96 hours displayed no effects at the highest dose (250 mg/L
unfiltered, 10 mg/L filtered), resulting in an EC50 greater than 10 mg/L. The effect concentrations for
all three trophic levels exceed the water solubility of 1-docosanol, limiting the dissolved (and
bioavailable) concentration of the chemical in the water column to the point that acute toxicity is
unlikely to be exhibited. These results are also supported by ECOSAR estimations based on log Kow.
These results indicate that 1-docosanol is low concern for acute aquatic toxicity.
6.2.2 Chronic Aquatic Toxicity
Given the physical-chemical properties of these chemicals, specifically the low water solubility and
high log kow, The ECOSAR predictive model predicts limited dissolved (and bioavailable)
concentrations of the chemical in the water column to the extent that chronic toxicity is unlikely to be
exhibited. This conclusion is also supported by (OECD. 2006) and EPA's Hazard Characterization
(2009).8 Additionally, biodegradation (discussed below in Section 6.3.1) and sorption to sediments
(described in Section 3) are expected to further reduce the dissolved concentration in the
environment. Therefore, these results indicate 1-docosanol has low environmental hazard for aquatic
vertebrates, aquatic invertebrates and algae.
6.3 Persistence and Bioaccumulation Potential
6.3.1 Persistence
EPA assessed environmental persistence for 1-docosanol using an experimental study. An OECD
301B Guideline study reported that 1-docosanol degraded 37% in 28 days (OECD. 2006). While this
result indicates 1-docosanol is not readily biodegradable under aerobic conditions, this substance is
considered inherently biodegradable based on read-across from 1-octadecanol (OECD. 2006).
EPA assessed the potential for anaerobic biodegradation using read-across from cetyl alcohol. Cetyl
alcohol reached 97% total degradation after 28 days using activated sludge from a municipal sewage
treatment plant and an anaerobic sludge from a secondary digester of a municipal sewage treatment
plant (Steber and Wierich. 1987). In another study under similar conditions, cetyl alcohol reached
90% degradation after 28 days (Nuck and Federle. 1996). These results indicate 1-docosanol is
expected to biodegrade under anaerobic conditions based on read-across from cetyl alcohol.
No degradation products of concern were identified for this chemical substance. In addition, the
analog 1-octadecanol had a half-life of 5.7 hours in brown water in an indirect photolysis study
(Pittawav et al.. 2015). These results indicate 1-docosanol will degrade under aerobic and anaerobic
environments and has low persistence.
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6.3.2 Bioaccumulation Potential
Fatty alcohols are known to be absorbed and metabolized by fish to form molecules for energy,
growth and reproduction.4" Because the chemicals have a role in endogenous physiological processes,
they are not expected to bioconcentrate. Similar to its impact on aquatic toxicity, the low water
solubility and high Kow values of 1-docosonol will limit the dissolved and bioavailable concentration
of the chemical in the water column. This conclusion is supported by experimental evidence from an
aquatic vertebrate exposed to cetyl alcohol with a BAF of 56 (Frcitag et al.. 1982).
40
Douglas R. Tocher. {2003}. Metabolism and Functions of Lipids and Fatty Acids in Teleost Fish, Reviews in Fisheries
Science, 11:2, 107-184
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7. Exposure Characterization
EPA considered reasonably available information on exposure for 1-docosanol. In general, there is
limited information on exposure for low hazard chemicals. EPA consulted sources of use information
that include the CDR database and other databases and public sources. 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 these
other databases and public sources (listed in Table A.2). EPA used these sources only where they
augmented information from the CDR database and to inform intended, known, or reasonably
foreseeable uses (Section 5).
As shown in Tables 3 and A.3, 1-docosanol is used as a processing aid, additive and/or surfactant for
soap, cleaning compounds, and toilet preparation manufacturing, paper manufacturing, paint and
coating manufacturing and other applications, as well as in various industrial, consumer, and
commercial uses as shown in Table 3. Non-TSCA uses are beyond the scope of this assessment
because of the exclusions under TSCA section 3(2) (See Table A.3).
Under the conditions of use identified in Table 3, EPA assessed the potential exposure to the
following categories: the environment, the general population, and potentially exposed or susceptible
subpopulations including workers and consumers.
7.1	Production Volume Information
Production volume information for 1-docosanol is based on an analysis of CDR data reported from
1986 to 2015.41 The CDR database indicates that for reporting year 2015, six companies
manufactured or imported 1-docosanol at six sites. From 1986 to 1998 reporting years, aggregate
production volume for 1-docosanol was between 1,000,000 and 10,000,000 lbs., and in 2002
aggregate production volume was less at 10,000 to 500,000 lbs. From 2011 to 2015 reporting years,
aggregate production volume for 1-docosanol then increased to 1,000,000 to 10,000,000 lbs. In
general, since 1986, production volume has remained relatively stable, aside from a decrease in the
2002 reporting year.
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 1-docosanol. Exposure is also possible from other
uses, distribution and disposal. These activities could result in releases of 1-docosanol to media
including surface water, landfills, and air.
41 The CDR requires manufacturers (including importers) to report information on the chemicals they produce domestically
or import into the U.S above 25,000 lb. per site per year.
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EPA expects high levels of removal of 1-docosanol during wastewater treatment (either directly from
the facility or indirectly via discharge to a municipal treatment facility or Publicly Owned Treatment
Works (POTW)). Further, 1-docosanol is expected to have low persistence (aerobic and anaerobic
biodegradation are 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 the chemical to surface water is expected to
break down, reducing exposure to aquatic organisms in the water column, benthic organisms, and
groundwater sources of drinking water, including well water.
If disposed of in a landfill, this chemical is expected to degrade under aerobic and anaerobic
conditions (aerobic and anaerobic biodegradation are discussed in Section 6.3.1).
If incineration releases during manufacturing and processing occur, EPA expects significant
degradation of 1-docosanol 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 1-docosanol from the environmental
releases described above. The general population is unlikely to be exposed to 1-docosanol via
inhalation of ambient air because 1-docosanol is a solid, has a low vapor pressure, andwill break
down if incinerated. 1-Docosanol is also unlikely to be present in surface water because of low water
solubility and its ability to degrade (aerobic and anaerobic biodegradation are discussed in Section
6.3.1), reducing the potential for the general population to be exposed by oral ingestion or dermal
exposure. Given the limited bioavailability of 1-docosanol and its ability to be metabolized (discussed
further in Section 6.3.2), bioconcentration and bioaccumulation potential is low; therefore, oral
exposure to 1-docosanol via fish ingestion is unlikely.
7.4	Exposures to Potentially Exposed or Susceptible Subpopulations
EPA identified workers as potentially exposed or susceptible subpopulations based on greater
exposure to 1-docosanol than the general population during manufacturing, processing, distribution,
use and disposal. EPA also identified consumers as a population that may experience greater exposure
to 1-docosanol than the general population through use of paper products, paints and coatings, and
laundry and dishwashing products, for example. EPA did not identify populations with greater
susceptibility to 1-docosanol.
7.4.1 Exposures to Workers
Based on its reported physical form and measured melting point (Table 2), 1-docosanol is a solid
under ambient conditions. Based on 1 -docosanol's conditions of use (Table 3), workers may be
exposed to solids through direct dermal contact with the substance and inhalation of dust if it is
generated. 1-Docosanol is not expected to be a volatile substance, meaning workers are unlikely to be
exposed through inhalation of vapors. Workers may be exposed to 1-docosanol in manufacturing,
processing, distribution, use, and disposal.
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7.4.2 Exposures to Consumers
Consumers could be exposed to 1-docosanol through the use of paper products, paints and coatings,
laundry and dishwashing products, or others as specified in Table 3. For all these uses, if dermal
contact does occur, 1-docosanol is expected to be minimally absorbed through the skin. If the
chemical is in an aerosol product and inhalation exposure occurs, 1 -docosanol's absorption from the
lungs is unlikely. Consumer exposure through inhalation or incidental ingestion of dust if using
consumer products in a powdered form, such as powdered laundry and dishwashing products, is
expected to be limited by minimal absorption. 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). 1-Docosanol is expected to be metabolized and
excreted, further reducing the duration of exposure.
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8. Summary of Findings
EPA has used reasonably available information on the following statutory and regulatory criteria and
considerations to screen 1-docosanol against each of the priority designation considerations in 40
CFR 702.9(a), and discussed individually in this section, under its conditions of use:
•	the hazard and exposure potential of the chemical substance (See Sections 6 and 7);
•	persistence and bioaccumulation (See Section 6.3);
•	potentially exposed or susceptible subpopulations (See Section 7.4);
•	storage near significant sources of drinking water (See Section 8.4);
•	conditions of use or significant changes in the conditions of use of the chemical
substance (See Section 5);
•	the chemical substance's production volume or significant changes in production
volume (See Section 7.1); and
•	other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority.
EPA conducted a risk-based, screening-level review based on the criteria and other considerations
above and other relevant information described in 40 CFR 702.9(c) to inform the determination of
whether the substance meets the standard of a high-priority substance. High-priority substance means
a chemical substance that EPA determines, without consideration of costs or other non-risk factors,
may present an unreasonable risk of injury to health or the environment because of a potential hazard
and a potential route of exposure under the conditions of use, including an unreasonable risk to
potentially exposed or susceptible subpopulations identified as relevant by EPA (40 CFR 702.3). This
section explains the basis for the proposed designation and how EPA applied statutory and regulatory
requirements, addressed rationales, and reached conclusions.
8.1 Hazard and Exposure Potential of the Chemical Substance
Approach: EPA evaluated the hazard and exposure potential of 1-docosanol. EPA used this
information to inform its proposed determination of whether 1-docosanol would meet the statutory
criteria and considerations for proposed designation as a low-priority substance.
•	Hazard potential:
For 1-docosanol's hazard potential, EPA gathered information for a broad set of human health and
environmental endpoints described in detail in Section 6 of this document. EPA benchmarked this
information against low-concern thresholds. EPA found that 1-docosanol is of low concern for human
health and environmental hazard across the range of endpoints in these low-concern criteria.
•	Exposure potential:
To understand exposure potential, EPA gathered information on physical-chemical properties,
production volumes, and the types of exposures likely to be faced by workers, the general population,
children, and consumers (discussed in Sections 3 and 7). EPA also gathered information on
environmental releases. EPA identified workers, the general population, consumers, and the
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environment as most likely to experience exposures. EPA determined that while the general
population, consumers, and workers may be exposed to 1-docosanol, exposure by dermal, ingestion
and inhalation pathways are limited by 1 -docosanol's physical-chemical properties. If 1-docosanol is
released into the environment, its exposure potential will be minimal because of low water solubility,
and further reduced through biodegradation under aerobic and anaerobic conditions.
Rationale: Although 1-docosanol may cause moderate eye irritation, the effects are expected to be
reversible, thereby reducing concern for longer-term effects. Workers could be exposed during
processing, manufacturing, distribution, use, and disposal, through splashing of solutions or hand-to-
face and eye contact. Other uses covered under TSCA, especially consumer uses in laundry and
dishwashing products would be unlikely to result in more than incidental eye exposure. Eye irritation
resulting from exposure in an occupational and consumer setting is mitigated primarily by the
reversible nature of the effect and addressed by rinsing with water.
Proposed Conclusion: Based on an initial analysis of reasonably available hazard and exposure
information, EPA proposes to conclude that the risk-based, screening-level review under 40 CFR
702.9(a)(1) does not support a finding that 1-docosanol 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-docosanol
based on a set of EPA and internationally accepted measurement tools and thresholds that are sound
indicators of persistence and bioaccumulation potential (described in Section 6). These endpoints are
key components in evaluating a chemical's persistence and bioaccumulation potential.
Rationale: EPA review of experimental data indicates 1-docosanol is inherently biodegradable under
aerobic conditions and expected to degrade under anaerobic conditions (Section 6.3.1). Read-across
from a closely-related analog indicates low potential for bioaccumulation (discussed in Section 6.3.2).
Proposed Conclusion: Based on an initial screen of reasonably available information on persistence
and bioaccumulationEPA proposes to conclude that the screening-level review under 40 CFR
702.9(a)(2) does not support a finding that 1-docosanol meets the standard for a high-priority
substance. The reasonably available persistence and bioaccumulation information described above
provides sufficient information to support this proposed finding.
8.3	Potentially Exposed or Susceptible Subpopulations
Approach: TSCA Section 3(12) states that the "term 'potentially exposed or susceptible
subpopulation' means a group of individuals within the general population identified by the
Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than
the general population of adverse health effects from exposure to a chemical substance or mixture,
such as infants, children, pregnant women, workers, or the elderly." EPA considered potentially
exposed or susceptible subpopulations, such as infants, children, pregnant women, workers and the
elderly. EPA identified workers engaged in the manufacturing, processing, distribution, use and
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disposal of 1-docosanol as a potentially exposed or susceptible subpopulation (described in more
detail in Section 7). Consumers are also potentially exposed subpopulation because of their use of
paper products, paints and coatings, laundry and dishwashing products, and other products, as shown
in Table 3.
Rationale: EPA did not identify hazard effects for this chemical that would make any population
susceptible. EPA expects workers and consumers to have a higher exposure to 1-docosanol than the
general population. Because of the chemical's low-concern hazard properties and reversibility of the
effects, this exposure does not expose a significant increase in risk for consumers or workers.
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-docosanol 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 and reversible effects of
1-docosanol 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 1-docosanol near significant sources of drinking water. For this criterion, EPA focused
primarily on the chemical substance's potential human health hazards, including to potentially
exposed or susceptible subpopulations, and environmental fate properties, and explored a scenario of
a release to a drinking water source. EPA also investigated whether the chemical was monitored for
and detected in a range of environmental media. The requirement to consider storage near significant
sources of drinking water is unique to prioritization under TSCA Section 6(b)(1)(A).
Rationale: In terms of health hazards, 1-docosanol is expected to present low concern to the general
population, including susceptible subpopulations, across a spectrum of endpoints.
In the event of an accidental release into a surface drinking water source, 1-docosanol is not water
soluble (see Section 3) and it is not expected to persist (Section 6.3.1) in the drinking water supply. In
the event of an accidental release to land, its low water solubility and biodegradability (aerobic and
anaerobic biodegradation are discussed in Section 6.3.1) reduces its potential for transport to surface
drinking water sources and leaching into groundwater, including well water. Fate and transport
evaluations indicate 1-docosanol is likely to partition into sediment (see Section 3), predicted to
biodegrade under aerobic and anaerobic conditions (see Section 6.3), and unlikely to bioaccumulate
(see Section 6.3.2), minimizing the likelihood that the chemical would be present in sediment or
groundwater to pose a longer-term drinking water contamination threat.
A sudden release of large quantities of the chemical near a drinking water source could have
immediate effects on the usability of a surface drinking water source. If such a release were to occur,
two primary factors would operate together to reduce concern. First, the chemical would be expected
to present low concern to the general population, including susceptible subpopulations, across a
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spectrum of health endpoints (see Section 6). Second, 1-docosanol would degrade in aerobic and
anaerobic environments (see Section 6). Together, these factors mean that any exposures to this
chemical through drinking water sources would be short-lived, and that if ingestion were to take
place, concern for adverse health effects would be low.
EPA also explored whether the chemical had been identified as a concern under U.S. environmental
statutes in the past. EPA searched lists of chemicals and confirmed that 1-docosanol 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 1-docosanol meets the standard for a high-priority substance. The
reasonably available information on storage near significant sources of drinking water described
above provides sufficient information to support these proposed findings.
8.5 Conditions of Use or Changes in Conditions of Use of the Chemical
Substance
Approach: EPA evaluated the conditions of use for 1-docosanol and related potential exposures and
hazards.
Rationale: EPA assessed the conditions of use of 1-docosanol (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 -docosanol'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
1-docosanol 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 1-docosanol
meets the standard for a high-priority substance. The reasonably available information on conditions
of use, or significant changes in conditions of use, described above provides sufficient information to
support this proposed finding.
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8.6	The Volume or Significant Changes in Volume of the Chemical
Substance Manufactured or Processed
Approach: EPA evaluated the current production volumes of 1-docosanol (Section 7.1) and related
potential exposures (Section 7.2 through 7.4).
Rationale: EPA used reasonably available information on production volume (see Appendix A) in
considering potential risk. It is possible that designation of 1-docosanol as a low priority substance
could result in increased use and higher production volumes. EPA expects, however, that any changes
in 1 -docosanol's production volume would not alter the Agency's assessment of low concern given
the chemical's low-concern hazard profile. EPA bases this expectation on 1-docosanol'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, 1-docosanol does not meet the standard for a high-priority substance. The reasonably
available information on production volume, or significant changes in production volume described
above provides sufficient information to support this proposed finding.
8.7	Other Considerations
EPA does not believe that any other considerations for the screening review to support the proposed
designation of 1-docosanol 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 1-docosanol 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, 6 companies
manufactured or imported 1-docosanol at 6 sites for reporting year 2015. Individual production
volumes were withheld, but may be available in later releases of the 2016 CDR.
Table A.l presents the historic production volume of 1-docosanol from the CDR (previously known
as the Inventory Update Rule, or IUR) from 1986-2015. From 1986 to 1998 reporting years,
aggregate production volume for 1-docosanol was between 1,000,000 and 10,000,000 lbs., and in
2002 aggregate production volume was less at 10,000 to 500,000 lbs. From 2011 to 2015 reporting
years, aggregate production volume for 1-docosanol then increased to 1,000,000 to 10,000,000 lbs.
In general, since 1986, production volume has remained relatively stable without significant increases
or decreases, aside from a decrease in the 2002 reporting year.
Table A. 1
Pounds)
: 1986-2015 National Production Volume Data for 1-Docosanol (Non-Confidential Production Volume in
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
>1 M-
10M
>1 M-
10M
>1 M
-10M
>1 M-
10M
10 K —
500 K
1 M<
10 M
1 M-10M
1 M-
10 M
1 M-
10 M
1 M-
10 M
1 M-
10 M
Source(s
EPA (20
Note(s):
K = Thou?
):
18a; 2017b; 2006; 2002)
>and; M = Million; NDR = No data reported
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A.2. Uses
A.2.1 Methods for Uses
Section A.2 provides a list of known uses of 1-docosanol, 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-Docosanol
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)
629-96-9
No
Canada Chemicals
Management Plan
information sheets
Government of Canada
(2018)
629-96-9; 1-docosanol
No
Chemical and Product
Categories (CPCat)
CPCat (2019)
629-96-9
Yes
ChemView2
EPA (2018a)
629-96-9
Yes
Children's Safe Product
Act Reported Data
Washington State Dept. of
Ecology (2018)
629-96-9
No
Consumer Product
Information Database
(CPID)
DeLima Associates
(2018a)
661-19-8
Yes
Danish surveys on
chemicals in consumer
products
Danish EPA (2018)
1-docosanol; Behenyl alcohol
No
Datamyne
Descartes Datamyne
(2018)
1-docosanol
Yes
DrugBank
DrugBank (2018b)
661-19-8
Yes
European Chemicals
Agency (ECHA)
Registration Dossier
ECHA (2018)
661-19-8
Yes
eChemPortal2
OECD (2018)
661-19-8
No
Envirofacts2
EPA (2018b)
661-19-8
No
Functional Use Database
(FUse)
EPA (2017a)
661-19-8
Yes
Kirk-Othmer Encyclopedia
of Chemical Technology
Kirk-Othmer (2006)
1-docosanol; Behenyl alcohol
No
Non-Confidential 2016
Chemical Data Reporting
(CDR)
EPA (2017b)
661-19-8
Yes
PubChem Compound
Kim etal. (2016)
661-19-8
Yes
Safer Chemical Ingredients
List (SCIL)
EPA (2018d)
661-19-8
Yes
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Table A.2: Sources Searched for Uses of 1-Docosanol
Title
Author and Year
Search Term(s)
Found Use
Information? 1
Synapse Information
Resources2
Synapse Information
Resources (2009)
661-19-8
Yes
Resource Conservation
and Recovery Act (RCRA)
EPA (2018c)
661-19-8; 1-docosanol
No
Scorecard: The Pollution
Information Site
GoodGuide (2011)
661-19-8
No
Skin Deep Cosmetics
Database
EWG (2018)
661-19-8
Yes
Toxics Release Inventory
(TRI)
EPA (2018e)
661-19-8
No
TOXNET2
NLM (2018)
661-19-8
Yes
Ullmann's Encyclopedia of
Industrial Chemistry
Ullmann's (2000)
1-docosanol; Behenyl alcohol
No
Additional sources identified from reasonably available information
Manufacturer SDS
GlaxoSmithKline (2014)
Incidentally identified while
researching into details of this
chemical's uses and products.
Yes
Purdue University
Purdue University (2018)
Note(s):
1.	If use information was found in the resource, it will appear in Table 3-2 unless otherwise noted.
2.	This source is a group of databases; thus the exact resource(s) it led to will be cited instead of the database as whole.
The U.S. Patent and Trademark Office has an online database that shows 384 patents referencing "1-
docosanoF' (USPTO 2018). Although patents could be useful in determining reasonably foreseen
uses, it is difficult to confirm whether any of the patented technologies are currently in use. Uses
inferred from patents containing 1-docosanol 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-Docosanol
Table A.3: Uses of 1-Docosanol
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Manufacturing


Synapse Information Resources (2009)
Agricultural additive
manufacturing1
Industrial
Synapse Information Resources lists use of 1-docosanol in manufacturing of agricultural additives. No further information
on 1-docosanol use in this manufacturing process could be found.
Expected user is not stated, but it is most likely industrial for agricultural additive manufacturing,


EPA (2017b); CPCat (2019)
Basic organic
chemical
manufacturing
Industrial
CDR reported use of 1-docosanol as an intermediate in processing as a reactant in "all other basic organic chemical
manufacturing." CPCat list the use of 1-docosanol in "all other chemical product and preparation manufacturing." No
further information on 1-docosanol use in this manufacturing process could be found.
Expected users are industrial based on identification in CDR's industrial processing and use report.


Synapse Information Resources (2009)
Food-contact metallic
manufacturing2
Industrial
Synapse Information Resources lists use of 1-docosanol as a surface lubricant in manufacturing of food-contact metallic
articles. No further information on 1-docosanol use in this manufacturing process could be found.
Expected user is not stated, but it is most likely industrial for food-contact metallic manufacturing.


EPA (2017b)
Paint and coating
manufacturing
Industrial
CDR reported use of 1-docosanol in processing - incorporation into formulation, mixture, or reaction product, in paint
and coating manufacturing. No further information on 1-docosanol use in this manufacturing process could be found.
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-Docosanol
Use
Expected Users
Description of Use and References


EPA (2017b)
Paper manufacturing
Industrial
CDR reported use of 1-docosanol in processing - incorporation into formulation, mixture, or reaction product, or surface
active agent in paper manufacturing. No further information on 1-docosanol use in this manufacturing process could be
found.
Expected users are industrial based on identification in CDR's industrial processing and use report.


EPA (2017b)
Petroleum lubricating
oil and grease
manufacturing
Industrial
CDR reported use of 1-docosanol in processing - incorporation into formulation, mixture, or reaction product, or additive,
in petroleum lubricating oil and grease manufacturing. No further information on 1-docosanol use in this manufacturing
process could be found.
Expected users are industrial based on identification in CDR's industrial processing and use report.


EPA (2017b)
Plastic material and
resin manufacturing
Industrial
CDR reported use of 1-docosanol in processing - incorporation into formulation, mixture, or reaction product in plastic
material and resin manufacturing. No further information on 1-docosanol use in this manufacturing process could be
found.
Expected users are industrial based on identification in CDR's industrial processing and use report.


EPA (2017b)
Soap, cleaning
compound, and toilet
preparation
manufacturing
Industrial
CDR reported use of 1-docosanol in processing - incorporation into formulation, mixture, or reaction product, or surface
active agent in soap, cleaning compound, and toilet preparation manufacturing. No further information on 1-docosanol
use in this manufacturing process could be found.
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-Docosanol
Use
Expected Users
Description of Use and References


CPCat (2019); Synapse Information Resources (2009)
Textiles, apparel, and
leather manufacturing
Industrial
CPCat list the use of 1-docosanol in textiles, apparel and leather manufacturing. Synapse Information Resources also list
1-docosanol use in manufacturing of textile and its use in synthetic fibers. No further information on 1-docosanol use in
this manufacturing process could be found.
Expected users are industrial based on CPCat's user classification.
TSCA Conditions of Use: Other Industrial Uses


CPCat (2019)
Anti-foaming agent
Industrial
CPCat lists the use of 1-docosanol as an anti-foaming agent.
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Lubricants, lubricant
additive
Industrial
CPCat lists the use of 1-docosanol as a lubricant, or lubricant additive.
Expected users are industrial based on CPCat's user classification.


CPCat (2019); Synapse Information Resources (2009)
Oil, resource
extraction
Industrial
Synapse Information Resources lists 1-docosanol use in oil well drilling. CPCat also lists the use of 1-docosanol in "oil
and gas drilling, extraction, and support activities."
Expected users are industrial based on CPCat's user classification.


CPCat (2019)
Surfactant
Industrial
CPCat lists the use of 1-docosanol as a surfactant in fluid property modulation.
Expected users are industrial based on CPCat's user classification.
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Table A.3: Uses of 1-Docosanol
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Home Care Products


EPA (2017b)
Laundry and
dishwashing products
Consumer
CDR identified the use of 1-docosanol in laundry and dishwashing products. No information of its use in specific products
could be found.
Expected users are based on CDR's consumer/commercial classification.


EPA (2017b)
Paints and coating
Consumer, commercial
CDR identified the use of 1-docosanol in paints and coatings. No information of its use in specific products could be
found.
The expected users are assumed to be consumer and commercial.
Window and door
sealant
Consumer
DeLima Associates (2016a)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
TSCA Conditions of Use: Pesticides


CPCat (2019); Purdue University (2018)
Pesticide ingredient3
Unknown
CPCat lists the use of 1-docosanol as an "inert pesticide ingredient." Further information on the use of 1-docosanol in
pesticides could not be found.
The expected users are unknown, due to the limited availability of information.
TSCA Conditions of Use: Miscellaneous


EPA (2017b)
Paper products
Consumer, commercial
CDR identified the use of 1-docosanol in consumer and commercial paper products. No further information could be
found on paper products containing 1-docosanol.
Expected users are consumer and commercial based on inclusion in CDR's consumer and commercial use report.
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Table A.3: Uses of 1-Docosanol
Use
Expected Users
Description of Use and References


EPA (2017b)
Plastics and rubber
products
Consumer
CDR identified the use of 1-docosanol in commercial "plastic and rubber products not covered elsewhere." No further
information could be found on plastic and rubber products containing 1-docosanol.
Expected users are based on CDR's consumer/commercial classification.
Non-TSCA Uses
Acne spot treatment
Consumer
DeLima Associates (2016d)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
After-shave
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Anti-aging cream
Consumer
DeLima Associates (2016f)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Anti-aging eye cream
Consumer
DeLima Associates (2016e)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Baby body lotion
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Baby body wash
Consumer
DeLima Associates (2018b)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Baby sunscreen
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Beauty or blemish
(BB) cream
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
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Table A.3: Uses of 1-Docosanol
Use
Expected Users
Description of Use and References
Body lotion
Consumer
DeLima Associates (2016g)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Body wash
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Color correcting (CC)
cream
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Concealer
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Cuticle treatment
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Deodorant/
antiperspirant
Consumer
DeLima Associates (2017)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Eye liner
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Face wash/ scrub
Consumer
DeLima Associates (2015)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Facial cleanser
Consumer
DeLima Associates (2016b)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Facial moisturizer
Consumer
DeLima Associates (2016e)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table A.3: Uses of 1-Docosanol
Use
Expected Users
Description of Use and References
Facial night cream
Consumer
DeLima Associates (2016c)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Hair conditioner
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Hair gel
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Hair relaxer
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Hair shampoo
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Hair spray
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Hair styling cream/
wax
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Hand cream/lotion
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Lip balm
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Lipstick
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table A.3: Uses of 1-Docosanol
Use
Expected Users
Description of Use and References
Makeup primer
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Mascara
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Pharmaceuticals
Unknown
Synapse Information Resources (2009)
Synapse Information Resources lists 1-docosanol as a "raw material, consistency agent, emollient for pharmaceuticals"
and its use in antihistamines.
The expected users are unknown, due to the limited availability of information.
Skin facial mask
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Skin firming treatment
Consumer
DeLima Associates (2016d)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Skin foundation
Consumer
CPCat (2019)
CPCat listed the use of 1-docosanol in two consumer available skin foundation products. Therefore the expected users is
consumer.
Skin lightener
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Skin moisturizer
Consumer
DeLima Associates (2008)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Skin redness and
pore reducer
Consumer
DeLima Associates (2016c)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table A.3: Uses of 1-Docosanol
Use
Expected Users
Description of Use and References
Skin toner
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Sun-less tanner
Consumer
DeLima Associates (2016h)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Sunscreen
Consumer
DeLima Associates (2013)
CPID generally includes products for consumer use; therefore the expected user is a consumer.


Drugbank (2018a); GlaxoSmithKline (2014)
Topical medications
Consumer
Drug Bank reports the use of 1-docosanol as a topical drug treatment for recurring herpes episodes of cold sores and
fever blisters. It is currently available for purchase in the United States in two over-the-counter cream medications.
Expected users are consumer, as the over-the-counter medications are currently available for consumer purchase.
Vapor rub
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the expected user is a consumer.
Wrinkle treatment
Consumer
DeLima Associates (2016h)
CPID generally includes products for consumer use; therefore the expected user is a consumer.
Children's Products
CDR reports did not include any uses in children's products; however, uses in baby lotion, baby wipes, wash and sunscreen product intended for babies are found in this table.
Recycling and Disposal
In the 2016 CDR, five facilities reported that 1-docosanol was not recycled (e.g., not recycled, remanufactured, reprocessed, or reused), and one facility reported recycling
information as CBI (EPA 2017b).
Note(s):
1.	Potentially a non-TSCA use, however, because information is insufficient to determine, it is assumed to be covered by TSCA.
2.	TSCA product based on the assumption that the chemical is used in the manufacturing of products and not intended to be a component of food.
3.	TSCA product based on assumption that it is a pesticide inert.
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A.3 References
California Dept of Pesticide Regulation. (2013). DPR Databases. Retrieved from
https: //www. cdpr. ca. gov/dprdatabase .htm
Danish EPA. (2018). Danish surveys on chemicals in consumer products. Retrieved from
https://cng.mst.dk/chcmicals/chcmicals-in-products/consumcrs-consumcr-products/danish-
survevs-on-consumer-products/
DeLima Associates. (2008). Aveeno Active Naturals Continuous Radiance Moisturizing Lotion, Medium
Skin Tones. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/8715/standard/Aveeno%20Active%20Natu
rals%20Continuous%20Radiance%20Moisturizing%20Lotion.%20Medium%20Skin%20Tones/l
0-001-071
DeLima Associates. (2013). LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Lotion. Retrieved
from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/13794/standard/LOreal%20Paris%20Subli
me%20Sun%20Advanced%20Sunscreen%20SPF%2030%20Lotion/12-006-050
DeLima Associates. (2015). Clearasil Ultra Rapid Action Face Scrub. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/16320/standard/p%20class=%22pl%22%3
Espan%20class=%22sl%22%3EClearasil%20Ultra%20Rapid%20Action%20Face%20Scrub-
05/29/2015/span%3E/p%3E/l 8-030-003
DeLima Associates. (2016a). DAPtex Plus Multi-Purpose Foam Sealant, Aerosol-11/20/2015. Retrieved
from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/18087/standard/p%20class=%22pl%22%3
EDAPtex%20Plus%20Multi-Purpose%20Foam%20Sealant.%20Aerosol-l 1/20/2015/p%3E/04-
008-130
DeLima Associates. (2016b). Olay Age Defying Classic Cleanser. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17732/standard/p%20class=%22pl%22%3
EQlav%20 Agc%20Dcfving%20Classic%20Clcanscr-02/16/2015/p%3E/16-033-088
DeLima Associates. (2016c). Olay Fresh Effects Clear Skin Redness & Pore Reducing Mattifier.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17748/standard/p%20class=%22pl%22%3
E01av%20Fresh%20Effects%20Clear%20Skin%20Redness%20&%20Pore%20Reducing%20Ma
ttifier-02/13/2015/p%3E/16-033-104
DeLima Associates. (2016d). Olay Fresh Effects Clear Skin Spot Zinger Acne Spot Treatment-
02/13/2015. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17750/standard/p%20class=%22pl%22%3
E01av%20Fresh%20Effects%20Clear%20Skin%20Spot%20Zinger%20Acne%20Spot%20Treat
ment-02/13/2015/p%3E/16-033-106
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DeLima Associates. (2016e). Olay Total Effects Anti-Aging Eye Treatment-02/13/2015.
DeLima Associates. (2016f). Olay Total Effects Anti-Aging Fragrance-Free Moisturizer SPF 15-
02/13/2015. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17800/standard/p%20class=%22pl%22%3
E01av%20Total%20Effccts%20Anti-Aging%20Fragrancc-Frcc%20Moisturizcr%20SPF%2015-
02/13/2015/p%3E/16-033-157
DeLima Associates. (2016g). Olay Total Effects Body Lotion. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17803/standard/p%20class=%22pl%22%3
E01av%20Total%20Effects%20Bodv%20Lotion-02/16/2015/p%3E/16-033 -160
DeLima Associates. (2016h). Olay Total Effects Moisturizer Plus Gradual Sunless Tanner-02/16/2015.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17807/standard/p%20class=%22pl%22%3
E01av%20Total%20Effects%20Moisturizer%20Plus%20Gradual%20Sunless%20Tanner-
02/16/2015/p%3E/16-033-164
DeLima Associates. (2017). Secret Original Invisible Solid Antiperspirant Deodorant, Berry Fresh-
03/18/2015. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17890/standard/p%20class=%22pl%22%3
ESecret%200riginal%20Invisible%20Solid%20Antiperspirant%20Deodorant.%20Berrv%20Fres
h-03/18/2015/p%3E/16-033-245
DeLima Associates. (2018a). Consumer Product Information Database. Retrieved from
https: //www. whatsinproducts. com/
DeLima Associates. (2018b). Seventh Generation Coconut Care, Creamy Body Wash. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/20423/standard/p%20class=%22pl%22%3
ESeventh%20Generation%20Coconut%20Care.%20Creamv%20Bodv%20Wash-
07/14/2017/p%3E/19-039-083
Descartes Datamyne. (2018). Descartes Datamyne Import-Export Database.
Dionisio, K. L., 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
Drugbank. (2018a). Docosanol. Retrieved from https://www.drugbank.ca/drugs/DB00632
DrugBank. (2018b). DrugBank Database. Retrieved from https://www.drugbank.ca/
European Chemicals Agency (ECHA). (2018). Docosan-l-ol.
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EWG. (2018). BEHENYL ALCOHOL. Retrieved from
https://www.ewg.org/skindeep/ingredient/70Q659/BEHENYL ALCOHOL/#.W5bipflKiUk
GlaxoSmithKline. (2014). Safety Data Sheet. Retrieved from
file:///C:/Users/antezanaA/Downloads/GSKSDS003132.pdf
GoodGuide. (2011). Scorecard: The Pollution Information Site. Retrieved from
http://scorecard.goodguide.com/chemical-profiles/index.tcl
Government of Canada. (2018). Chemical Substances: Services and Information. Retrieved from
https://www.canada.ca/en/health-canada/services/chemical-substances.html
Katz, D. H., Marcellettim, J. F., Khalil, M. H., Pope, L. E., & Katz, L. R. (1991). Antiviral activity of 1-
docosanol, an inhibitor of lipid-enve loped viruses including herpes simplex. Proceedings of the
National Academy of Sciences, 88(23), 10825-10829. doi:10.1073/pnas.88.23.10825
Kim, S., Thiessen, P. A., Bolton, E. E., Chen, J., Fu, G., Gindulyte, A., . . . Bryant, S. H. (2016).
PubChem Substance and Compound databases. Nucleic Acids Research, -/-/(Database issue),
D 1202-D 1213. doi: 10.1093/nar/gkv951
Kirk-Othmer. (2006). Kirk-Othmer Encyclopedia of Chemical Technology.
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
Purdue University. (2018). National Pesticide Information Retrieval System.
Synapse Information Resources. (2009). Specialty Chemicals Source Book. Fourth Edition. Volume 1.
U.S. Environmental Protection Agency (EPA). (2002). 1986-2002 Historical IUR Data. Retrieved from
Excel File
U.S. Environmental Protection Agency (EPA). (2006). 2006 IUR Public Database.
U.S. Environmental Protection Agency (EPA). (2017a). Functional Use Database (FUse). Retrieved
from: https://catalog.data.gov/dataset/functional-use-database-fuse
U.S. Environmental Protection Agency (EPA). (2017b). Non-Confidential 2016 Chemical Data Reporting
(CDR). Retrieved from https://www.epa.gov/chemical-data-reporting
U.S. Environmental Protection Agency (EPA). (2018a). ChemView. Retrieved from
https: //chemvie w .epa. gov/chemview
U.S. Environmental Protection Agency (EPA). (2018b). Envirofacts Multisystem Search. Retrieved
from https://www3.epa.gov/enviro/facts/multisvstem.html
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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). (2018). TOXNET Hazardous Substances Data Bank.
Retrieved from https://toxnet.nlm.nih.gov/cgi-bin/sis/search2
U.S. Patent and Trademark Office (USPTO). (2018). USPTO Patent Full-Text and Image Database.
Retrieved from: http://patft.uspto.gov/netacgi/nph-
Parser? Sect 1 =PTQ2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-
adv.htm&r=0&f=S&l=50&d=PTXT&RS=%221%2C2-
hexanediol%22&Refine=Refine+Search&Ouerv=l-docosanol
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/
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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
4949228
Oral (gavage)
Chinchilla
24 hours
Dose: 25 mmol
7.6% of the
Methods:


rabbits

Replicates: 3
administered
dose was
excreted by
glucuronide
•	Test substance reported as CAS RN 112-92-5
•	Purity not reported
•	GLP compliance data not reported
Acute Mammalian Toxicity
Source
Exposure Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
4949228,
Oral (gavage)
Sprague-
Single dose,
Dose: 2000 mg/kg
LDso > 2000
Methods:
4963011

Dawley rats
observed for 14
days
Replicates: 3 per sex
mg/kg
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported
•	OECD Guideline 423
•	GLP compliant
4949228
Oral (gavage)
Sprague-
Single dose,
Doses: 8250 and 10000
LDso > 10000
Methods:


Dawley rats
observed for 14
days
mg/kg
Replicates: 5 per sex per
dose
mg/kg
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported





•	OECD Guideline 423
•	GLP compliant
4934050
Oral
CF1 mice
Single dose,
Dose: 1000 mg/kg
LDso >1000
Methods:

(gavage)

observed for 8
days
Replicate: 10 mice
mg/kg
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported
•	GLP compliance data not reported
4949228
Dermal
New Zealand
24 hour
Dose: 8000 mg/kg
LDso > 8000
Methods:


white rabbit
exposure,
observed for 14
days
Replicates: 4 animals
mg/kg
•	Substance reported as CASRN 67762-27-0
•	Purity not reported
•	Not GLP compliant
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Table B.1: Human Health Hazard
5094502
Inhalation
Sprague-
6 hour
Dose: 0.00014 mg/L
LCso >
Methods:


Dawley rats
exposure,
observed for 14
days
Replicates: 6 animals
0.00014 mg/L
•	Substance reported as CASRN 67762-27-0
•	Purity not reported
•	Not GLP compliant
Repeated Dose Toxicity
Source
Exposure Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
4949228,
Oral (gavage)
CD rats
26 weeks
Doses: 0,10,100, and
NOAEL: 1000
Methods:
34905



1000 mg/kg-day
Replicates: 20 per sex
per dose
mg/kg-day
•	Test substance reported as CAS RN 661 -19-8
•	Purity: 98%
•	GLP compliant
Mortality Results:
•	1 male rat in 100 mg/kg group died from aspiration
34905
Oral (gavage)
Beagle dog
26 weeks
Doses: 0, 20, 200, and
2000 mg/kg-day
Replicates: 4 per sex per
group
NOAEL: 2000
mg/kg-day
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity: 98%
•	GLP compliant
4949228
Oral
Wistar rats
45 days
Doses: 0,100, 500, and
NOAEL: 2000
Methods:



(males), 54
2000 mg/kg-day
mg/kg-day
• Test substance reported as CAS RN 112-92-5



days (females)
Replicates: 12 per sex
per group

•	Purity: 99%
•	OECD Guideline 422
•	GLP compliant
4949228,
Oral (gavage)
Sprague-
28 days
Doses: 0,100, 500, and
NOAEL: 1000
Methods:
4934169

Dawley rats

1000 mg/kg-day
Replicates: 10 per sex
per group
mg/kg-day
•	Test substance reported as CAS RN 112-92-5
•	Purity not reported
•	OECD Guideline 407
•	GLP compliant
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Table B.1: Human Health Hazard
820061
Oral
Male Wistar
1 week- 3
Doses: 9400 - 28000
LOAEL: 28000
Methods:


rats
months
mg/kg-day
Replicates: 15 total, 3-4
per timepoint
mg/kg-day
based on
hepatic
structural
changes in
mitochondria
•	Test substance reported as CAS RN 112-92-5
•	Purity not reported
•	GLP compliance not reported
Reproductive Toxicity
Source
Exposure Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
4949228,
Oral (gavage)
Sprague-
Males: 71 days
Doses: 0,10,100, and
NOAEL: 1000
Methods:
4941207,

Dawley rats
premating,
1000 mg/kg-day
mg/kg-day
• Test substance reported as CAS RN 661 -19-8
34906


through mating
Females: 15
days premating
through GD17-
20
Replicates: 22 per sex
per group

•	Purity: 98%
•	ICH Harmonised Tripartite Guidelines for
Detection of Toxicity to Reproduction for Medicinal
Products
•	GLP compliant
Developmental Toxicity
Source
Exposure Route
Species &
Strain (if
available)
Duration
Doses and Replicate
Number
Effect
Study Details
4949228,
Oral (gavage)
New Zealand
GD 6-19
Doses: 0,125, 500, and
NOAEL: 2000
Methods
34906

white rabbits

2000 mg/kg-day
Replicates: 19-20
pregnant rabbits per
group
mg/kg-day
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported
•	ICH Harmonised Tripartite Guidelines for
Detection of Toxicity to Reproduction for Medicinal
Products
•	GLP compliant
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Table B.1: Human Health Hazard
4949228,
34906
Oral (gavage)
Sprague-
Dawley rats
Males: 71 days
premating,
through mating
Females: 15
days premating
through GD17-
20
Doses: 0,10,100, and
1000 mg/kg-day
Replicates: 22 per sex
per group
NOAEL: 1000
mg/kg-day
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity: 98%
•	ICH Harmonised Tripartite Guidelines for
Detection of Toxicity to Reproduction for Medicinal
Products
•	GLP compliant
Cancer
Source
Effect
Study Details
OncoLogic
v8.0
High molecular weight aliphatic alcohols (C>20) are expected to be of low concern
Methods: The concern level is based on structure-
activity relationships (SAR) analysis.
ISS v2.442
Negative (Estimated)
1-Docosanol does not contain any structural features indicative of electrophilic potential.
Methods:
Carcinogenicity alerts (genotoxic and non-genotoxic)
by ISS profiler as available within the OECD Toolbox
v4.3.
Results:
No alerts were identified for 1-docosanol






VEGA 1.1.443
1-Docosanol was processed through all 4 models. ISS 1.0.2 and IRFMN/ISSCAN-GX 1.0.0 predicted
the chemical to be non-carcinogenic with moderate reliability. IRFMN/Antares 1.0.0 predicted the
chemical to be non-carcinogenic with good reliability.
Overall, 1-Docosanol is expected not to be carcinogenic on the basis of the VEGA predictions.44
Methods:
VEGA 1.1.4 contains 4 models for carcinogenicity -
CAESAR 2.1.9, ISS 1.0.2, IRFMN/Antares 1.0.0,
IRFMN/ISSCAN-GX 1.0.0
Results:
•	CAESAR 2.1.9: Low reliability (1-Docosanol could
be outside of the applicability domain (AD) of the
model)
•	ISS 1.0.2: Predicted to be Non-carcinogenic with
moderate reliability
•	IRFMN/Antares 1.0.0: Possible non-carcinogen
with good reliability
•	IRFMN/ISSCAN-GX 1.0.0: Predicted to be
Possible Non-carcinogen with moderate reliability
Genotoxicity
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42	Carcinogenicity alerts by ISS profiler comprises 55 structural alerts for genotoxic and non-genotoxic carcinogenicity. The alerts have been compiled upon existing knowledge of
the mechanism of action of carcinogenic chemicals that have been published elsewhere (Benigni andBossa (2011) Chem Rev 111: 2507-2536 andBenigni R et al. (2013) Chew
Rev. 113: 2940-2957).
43	VEGA 1.1.4 contains 4 different models to facilitate an in silico assessment of carcinogenicity potential. The models are summarized in Golbamaki et al. (2016) J Environ Sci
and Health Part C http://dx.doi.org/10.1080/10590501.2Q16.1166879 as well as in documentation that is downloadable from within the VEGA tool itself
(https: //www. vegahub. eu/).
•	CAESAR 2.1.9 is a classification model for carcinogenicity based on a neural network.
•	ISS 1.0.2 is a classification model based on the ISS ruleset (as described above for the OECD Toolbox).
•	IRFMN/Antares 1.0.0 and IRFMN/ISSCAN-GX 1.0.0 are classification models based on a set of rules built with SARpy software (part of the same suite of VEGA tools
https://www.vegahub.eu/) extracted from the Antares and ISSCAN-CGX datasets respectively.
44	Each model is characterized by an applicability domain (AD) that depends on at least 5 components:
•	Similar substances with known experimental values within the underlying training set
•	Accuracy of prediction for similar substances
•	Concordance for similar substances,
•	Fragments similarity check on the basis of atom centered fragments,
•	Model descriptors range check.
A global AD index considers the other 5 components to provide an overall reliability score - low, moderate or high. EPA has not included low-reliability model results.
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Table B.1: Human Health Hazard
Source
Test Type &
Endpoint
Species &
Strain (if
available)
Metabolic
Activation
Doses
Results
Study Details
4941156,
34905,
4949228
Mammalian gene
mutation assay
(in vitro)
Chinese
Hamster Lung
Fibroblast Cells
With and
without
Doses: 2, 7.5,15, and 20
mg/mL
Negative
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity: 98%
•	GLP not reported
4941086,
34905
Mammalian
chromosomal
aberration assay
(in vitro)
Chinese
Hamster Lung
Fibroblast Cells
With and
without
Doses: Without metabolic
activation 0, 0.6, 10, 20
|jg/ml
With metabolic activation:
0,1.4,10, 20 |jg/ml
Negative
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity: 98%
•	GLP not reported
4941014,
34905
Gene mutation
assay (in vitro)
Salmonella
typhimurium
strains TA
1535, TA 1538,
TA98, TA 100,
TA 1537
With and
without
Doses: 10,100, 333.3,
666.6, and 1000 mg/plate
Negative
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity: 98%
•	GLP compliant
4949228
Gene mutation
assay (in vitro)
Salmonella
typhimurium
strains TA98
and TA100
Yes
Dose: 0, 50, 150, 500,
1,000,1,500 and 5,000
pg/plate
Negative
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported
•	GLP compliant
4940922,
4949228,
34905
Mammalian
gene mutation
assay (in vivo)
NMRI Mice
NA
Doses: 0, 50,150, and
500 mg/kg
Negative
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity: 98%
•	OECD Guideline 474
•	GLP compliant
Irritation
Source
Exposure Route
Species &
Strain (if
available)
Duration
Doses
Effect
Study Details
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Table B.1: Human Health Hazard
4949228,
4963040
Dermal
New Zealand
White Rabbits
4 hours under
semi-occlusive
conditions
Dose: 0.5 g of undiluted
test material
Replicates: 3 Females
Negative
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported
•	OECD Guideline 404
•	GLP compliant
4949228,
4963041,
4963002
Ocular
New Zealand
White Rabbits
Single
exposure,
examined for
72 hours
Dose: 0.1 mL of undiluted
test material
Replicates: 1 Female, 2
Males
Moderate
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported
•	OECD Guideline 405
•	GLP compliant
Results:
•	At 1 hour, all animals had slight conjunctival
irritation
•	All effects were completely reversible by 72 hours
4949228,
4934050
Ocular
New Zealand
White Rabbits
Single
exposure,
examined for
48 hours
Dose: 50 pL of undiluted
test material
Replicates: 5 Rabbits
Low
Methods:
•	Test substance reported as CAS RN 661 -19-8
•	Purity not reported
•	GLP compliance not specified
Results:
•	At 2 and 6 hours, there animals had conjunctival
irritation
•	All effects were completely reversible by 24 hours
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Table B.2: Environmental Hazard
Aquatic Toxicity: Experimental
Source
Species & Strain
(if available)
Duration
Doses and Replicate Number
Effect
Study Details
49449228,
4962973
Oncorhynchus
mykiss
96 hours
Doses: 0,10,100, and 1000 mg/L
(nominal)
Replicates: 7 organisms per vessel, 2
vessels per concentration
LCso > 1000 mg/L
Methods:
•	Test substance reported as CAS RN 661-19-
8
•	Purity not reported
•	OECD Guideline 203
•	GLP compliant
4962974,
4949228
Daphnia magna
48 hours
Doses: 0, 10, 30, 100, 300, 1000, 3000,
and 10,000 mg/L
ECso: 1700 mg/L
(NES)
Methods:
•	Test substance reported as CAS RN 112-92-
5
•	Purity not reported
•	OECD Guideline 202
•	GLP compliant
4949228,
4962964
Scenedesmus
subspicatus
96 hours
Doses: 10, 30,100, 300 mg/L unfiltered and
0.1,0.3,1.0, 3.0,10.0 mg/L filtrate
EC50: 250 mg/L
(unfiltered)
EC50 > 10 mg/L
(filtered) (NES)
Methods:
•	Test substance reported as CAS RN 112-92-
5
•	Purity not reported
•	OECD Guideline 201
•	GLP compliant
4949228
Daphnia magna
21 days
Doses: 0,1,3,10, 30, and 100 mg/L
NOEC: 0.98 mg/L
LOEC: 2.94 mg/L
(NES)
Methods:
•	Test substance reported as CAS RN 112-92-
5
•	Purity not reported
•	OECD Guideline 202
•	GLP compliant
Aquatic Toxicity: Estimated
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Model
Type
Duration
Species
Predicted Effect
Level
Notes
ECOSAR
v2.0 (Class:
Neutral
Organics)
Estimate
96 hours
Freshwater
fish
LCso: 0.0006
mg/L
NES. Freshwater fish 96 hours LC50 = 0.00059 mg/L; Chemical may not be soluble
enough to measure this predicted effect; the Log Kow of the chemical is greater
than the endpoint specific cut-offs presented (max log Kow = 5), then no effects at
saturation is expected.
ECOSAR
v2.0 (Class:
Neutral
Organics)
Estimate
48 hours
Daphnia
magna
LCso: 0.0006
mg/L
NES. Daphnia magna 48 hours LC50 = 0.00060 mg/L; Chemical may not be
soluble enough to measure this predicted effect; the Log Kow of the chemical is
greater than the endpoint specific cut-offs presented (max log Kow = 5), then no
effects at saturation is expected.
ECOSAR
v2.0 (Class:
Neutral
Organics)
Estimate
96 hours
Green algae
ECso: 0.005 mg/L
NES. Green Algae 96 hours EC50 = 0.0049 mg/L; Chemical may not be soluble
enough to measure this predicted effect; the Log Kow of the chemical is greater
than the endpoint specific cut-offs presented (max log Kow = 5), then no effects at
saturation is expected.
ECOSAR
v2.0 (Class:
Neutral
Organics)
Estimate
ChV
Freshwater
fish
ECso: 0.0001
mg/L
NES. Estimated ChV = 0.0001 mg/L. Chemical may not be soluble enough to
measure this predicted effect; the Log Kow of the chemical is greater than the
endpoint specific cut-offs presented (max log Kow = 8), then no effects at saturation
is expected.
ECOSAR
v2.0 (Class:
Neutral
Organics)
Estimate
ChV
Green algae
EC50: 0.005 mg/L
NES. Estimated ChV = 0.005 mg/L. Chemical may not be soluble enough to
measure this predicted effect; the Log Kow of the chemical is greater than the
endpoint specific cut-offs presented (max log Kow = 8), then no effects at saturation
is expected.
Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and number of replicates
Results
Study Details
4949228
CO biodegradation
28 days
Dose: 12.4 mg/L
Not
biodegradable
Methods:
•	Test substance reported as CASRN 661 -19-8
•	Purity not reported
•	OECD Guideline 301B
•	GLP compliant
Degradation during test:
•	16% in 8 days
•	23% in 10 days
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•	29% in 14 days
•	33% in 22 days
•	37% in 28 days
4949228
Aerobic biodegradation
28 days
Dose: 100 mg/L
Inherently
biodegradable
Methods:
•	Test substance reported as CASRN 36653-82-4
•	Purity not reported
•	OECD Guideline 301D
•	GLP compliance not reported
Degradation during test:
•	40% in 7 days
•	59% in 14 days
•	67% in 21 days
•	76% in 28 days
4944275
Aerobic biodegradation
28 days
Dose: 10 mg/L
Total
biodegradation
Methods:
•	Test substance reported as CASRN 36653-82-4
•	Purity: 98%
•	GLP compliance not reported
Degradation during test:
•	97.1% in 28 days
5094384
Aerobic biodegradation
28 days
Dose: 1 mg/L
Total
biodegradation
Methods:
•	Test substance reported as CASRN 36653-82-4
•	Purity > 98%
•	GLP compliance not reported
Degradation during test:
•	90.1% in 28 days
4335934
Photolysis (indirect)
Not
specified
Not specified
Readily
photolyzes
Methods:
•	Test substance reported as CASRN 112-92-5
•	Purity not reported
•	GLP compliance not reported
Results:
•	Half-life of 5.7 hours in Narda Lagoon (brown)
water
•	Half-life of 31.3 hours in distilled water
5094369
BAF
3 days
Dose: 50 |jg/L
Replicates: 5 Fish
56
Methods:
•	Test substance reported as CASRN 36653-82-4
•	Purity: 95%
•	GLP compliance not reported
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B.1 References
ECHA (European Chemicals Agency). (1979). Alcohols, C16-18: Acute toxicity: inhalation: 001 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/de/registration-dossier/-/registered-
dossier/16007/7/3/3
ECHA (European Chemicals Agency). (1997a). Docosan-l-ol: acute toxicity: oral: 001 key | experimental
result. https://echa.europa.eu/registration-dossier/-/registered-dossier/14378/7/3/2
ECHA (European Chemicals Agency). (1997b). Docosan-l-ol: eye irritation: in vivo: 001 key |
experimental result. https://echa.europa.eu/registration-dossier/-/registered-dossier/14378/7/4/3
ECHA (European Chemicals Agency). (1997c). Docosan-l-ol: skin irritation/corrosion: in vivo.
https://echa.europa.eu/registration-dossier/-/registered-dossier/14378/7/4/2
ECHA (European Chemicals Agency). (1997d). Icosan-l-ol: eye irritation: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/14380/7/4/3
ECHA (European Chemicals Agency). (2000). Docosan-l-ol: Short-term toxicity to fish: 001 key |
experimental result. Helsinki, Finland. https://echa.europa.eu/registration-dossier/-/registered-
dossier/143 78/6/2/2
Elder, RL. (1988). Final report on the safety assessment of cetearyl alcohol cetyl alcohol isostearyl
alcohol myristyl alcohol and behenyl alcohol [Review]. J Am Coll Toxicol 7: 359-413.
http://dx.doi.org/10.3109/10915818809023137
Freitag, D; Geyer, H; Kraus, A; Viswanathan, R; Kotzias, D; Attar, A; Klein, W; Korte, F. (1982).
Ecotoxicological profile analysis. VII. Screening chemicals for their environmental behavior by
comparative evaluation. Ecotoxicol Environ Saf 6: 60-81. http://dx.doi.org/10.1016/0147-
6513(82)90081-1
Iglesias, G; Hlywka, JJ; Berg, JE; Khalil, MH; Pope, LE; Tamarkin, D. (2002a). The toxicity of behenyl
alcohol I Genotoxicity and subchronic toxicity in rats and dogs. Regul Toxicol Pharmacol 36: 69-
79. http://dx.doi.org/10.1006/rtph.2002.1565
Iglesias, G; Hlywka, JJ; Berg, JE; Khalil, MH; Pope, LE; Tamarkin, D. (2002b). The toxicity of behenyl
alcohol. I. Genotoxicity and subchronic toxicity - Genetic Toxicity in vitro, (661-19-8) 1-
Docosanol. U.S. Environmental Protection Agency :: U.S. EPA.
https://ofmpub.epa.gov/oppthpv/Public_Search.PublicEndPointReport?robust_summary_id=2496
0394&WhichButton=PrintTab&ep_name=Genetic+Toxicity+in+vitro&selchemid=
Iglesias, G; Hlywka, JJ; Berg, JE; Khalil, MH; Pope, LE; Tamarkin, D. (2002c). The toxicity of behenyl
alcohol: II. Reproduction studies in rats and rabbits. Regul Toxicol Pharmacol 36: 80-85.
http://dx.doi.org/10.1006/rtph.2002.1566
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Nuck, BA; Federle, TW. (1996). Batch test for assessing the mineralization of C-14-radiolabeled
compounds under realistic anaerobic conditions. Environ Sci Technol 30: 3597-3603.
http://dx.doi.org/10.1021/es960302u
OECD (Organisation for Economic Co-operation and Development). (2006). SIDS initial assessment
report for SIAM 22. TOME 2: SIDS dossiers. Category name: long chain alcohols. Paris, France.
Pittaway, P; Herzig, M; Stuckey, N; Larsen, K. (2015). Biodegradation of artificial monolayers applied to
water storages to reduce evaporative loss. Water Sci Technol 72: 1334-1340.
http://dx.doi.org/10.2166/wst.2015.348
Steber, J; Wierich, P. (1987). The anaerobic degradation of detergent range fatty alcohol ethoxylates.
Studies with 14C-labelled model surfactants. Water Res 21: 661-667.
http://dx.doi.org/10.1016/0043-1354(87)90076-5
U.S. EPA (U.S. Environmental Protection Agency). (2002a). High production volume information system
(HPVIS). Endpoint details: genetic toxicity in vitro: study 2. 1-docosanol (661-19-8).
https://ofmpub.epa.gov/oppthpv/Public_Search.PublicEndPointReport?robust_summary_id=2496
0415&WhichButton=PrintTab&ep_name=Genetic+Toxicity+in+vitro&selchemid=
U.S. EPA (U.S. Environmental Protection Agency). (2002b). High production volume information system
(HPVIS). Endpoint details: genetic toxicity in vitro: study 3. 1-docosanol (661-19-8).
https://ofmpub.epa.gov/oppthpv/Public_Search.PublicEndPointReport?robust_summary_id=2496
0421&WhichButton=PrintTab&ep_name=Genetic+Toxicity+in+vitro&selchemid=
U.S. EPA (U.S. Environmental Protection Agency). (2002c). High production volume information system
(HPVIS). Endpoint details: genetic toxicity in vivo: behenyl alcohol (661-19-8).
https://ofmpub.epa.gov/oppthpv/Public_Search.PublicTabs?SECTION=l&epcount=l&v_rs_list=
24960518
U.S. EPA (U.S. Environmental Protection Agency). (2002d). High production volume information system
(HPVIS). Endpoint details: reproductive toxicity. 1-docosanol (661-19-8).
https://ofmpub.epa.gov/oppthpv/Public_Search.PublicTabs?SECTION=l&epcount=l&v_rs_list=
24960534
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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 1-docosanol. Search outcomes and reference details are provided 011
the candidate's HERO45 project page.
EPA created a fit-fbr-purpose process to transparently document the literature search and review46 of
available hazard and fate information for low-priority substance (LPS) candidates. References from peer-
reviewed primary sources, grey sources,4' and other sources were identified, screened at the title/abstract
and full text level, and evaluated for data quality based on discipline-specific criteria. An overview of the
literature search and review process is illustrated in Figure CI.
Figure C.l: Overview of the Literature Search and Review Process

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, 1-docosanol, the following analogs were used
for designation: alcohols, C16-18 (CASRN 67762-27-0); cetyl alcohol (CASRN 36653-82-4). Alcohols
€16-18 and C18 unsaturated (CASRN 68002-94-8) was also searched but not used for designation. For
45 The HERO low-priority substance candidate project pages are accessible to the public at https://hero.epa,gov/hero/.
Discussed in the document "Approach Document for Screening Hazard Infonnation for Low-Priority Substances Under
TSCA", also released at proposal.
Grey literature and additional sources are the broad category of studies not found in standard, peer-reviewed literature database
searches. Hiis includes U.S. and international government agency websites, non-government organization (NGO) websites, and
data sources that are difficult to find, or are not included, in the peer-reviewed databases, such as white papers, conference
proceedings, technical reports, reference books, dissertations, and infonnation on various stakeholder websites.
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more details and justification on analogs, see section 6.1.1. Analogs were used to fill data gaps on
endpoints for which 1-docosanol lacked quality data, such as aquatic toxicity, and to add to the weight of
the scientific evidence. EPA collected reasonably available information for these endpoints by searching
specific grey literature and other secondary sources, listed on Table C.l. If information related to the
identified analogs were available in these sources, the references were screened and evaluated using the
same process as references on 1-docosanol described above.46 EPA also used read-across from the LPS
candidates, 1-Octadecanol (CASRN 112-92-5) and 1-Eicosanol (CASRN 629-96-9). Although hazard
information was only available for 1-octadecaonl, conditions of use information for 1-eicosanol was used
for designation. The three LPS chemicals along with the analogs mentioned above fall under the fatty
alcohols cluster in HERO.
Table C.1: Sources Used for Analog Search
Resource
URL
ATSDR
http://www.atsdr.cdc.gov/toxprofiies/index.asp
ChemID (EPA - HPVIS via
ChemID)
http://chem.sis.nlm.nih.gov/chemidplus/
CIR
http://www.cir-safety.org/ingredients
ECHA
http://echa.europa.eu/web/guest/information-on-chemicais/registered-substances
ECOTOX
https://cfpub.epa.gov/ecotox/quick_query.htm
EPA - ChemView (incl. TSCATS,
RBP/HC, and HPV/HPVIS)
https://chemview.epa.gov/chemview
European Food Safety Authority
(EFSA)
http://www.efsa.europa.eu/
FDA
https://www.fda.gov/defauit.htm
HERA
http://www.heraproject.com/RiskAssessment.cfm
NICNAS
http://www.nicnas.gov.au/
NITE (J-CHECK)
http://www.safe.nite.go.jp/jcheck/search.action?request_locale=en
NTP
https://ntpsearch.niehs.nih.gov/home
OECD/SIDS
https://hpvchemicals.oecd.org/UI/Search.aspx;
http://webnet.oecd.org/hpv/ui/SponsoredChemicais.aspx
C.2 Search Terms and Results
EPA began the literature review process for the hazard screening of 1-docosanol by developing search
terms. To gather publicly available information, specific search terms were applied for each discipline and
across databases and grey literature sources. Table C.2 lists the search terms used in the database search
of peer -reviewed literature for the fatty alcohols cluster including 1-docosanol. For grey literature and
other secondary sources, Table C.3 lists the search terms used for the fatty alcohol LPS candidates and
analogs.
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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48
Human Health
PubMed
(112-92-5[rn] OR "1-Octadecanol" OR "Alcohol(C18)" OR "C18 alcohol" OR "n-Octadecanol" OR
"Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR "Octadecyl alcohol" OR "Stearic
alcohol" OR "Stearol" OR "Stearyl alcohol" OR "Stenol" OR 661-19-8[rn] OR 30303-65-2[rn] OR "1-
Docosanol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol" OR "n-Docosanol" OR "Abreva" OR "IK 2"
OR "IK.2" OR "Tadenan" OR 629-96-9[rn] OR "1-Eicosanol" OR "Arachidyl alcohol" OR "Eicosan-1-ol"
OR "Eicosanol" OR "Icosanol" OR "n-Eicosanol" OR 143-28-2[rn] OR 593-47-5[rn] OR "(Z)-9-
Octadecen-1-ol" OR "(Z)-Octadec-9-enol" OR "9-cis-Octadecenol" OR "9-Octadecen-1-ol" OR "9-
Octadecenol" OR "Adol 85" OR "cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl alcohol" OR
"Octadecenol" OR "Oleic alcohol" OR "Oleol" OR "Oleoyl alcohol" OR "Oleyl alcohol")
"1-Hydroxyoctadecane" OR "1-Stearyl alcohol" OR "Alcohol stearylicus" OR "Decyl octyl alcohol" OR
"Fatty alcohol(C18)" OR "n-1 -Octadecanol" OR "n-Octadecyl alcohol" OR "Octadecanol, 1-" OR
"Steraffine" OR "USP XIII stearyl alcohol" OR "Adol 62" OR "Adol 64" OR "Adol 68" OR "Aldol 62" OR
"Alfol 18" OR "Alfol 18NF" OR "Atalco S" OR "Cachalot S 43" OR "Cachalot S-43" OR "CO 1895" OR
"CO 1895F" OR "CO 1897" OR "CO-1895" OR "CO-1897" OR "Conol 1675" OR "Conol 30F" OR
"Conol 30S" OR "Conol 30SS" OR "Crodacol S" OR "Crodacol S 70" OR "Crodacol S 95" OR
"Crodacol S 95 NF" OR "Crodacol-S" OR "Dytol E-46" OR "Hainol 18 SS" OR "Hainol 18SS" OR
"Hyfatol 18-95" OR "Hyfatol 18-98" OR "Kalchol 8098" OR "Kalcohl 80" OR "Kalcohl 8098" OR "Kalcohl
8099" OR "Kalcol 8098" OR "Lanette 18" OR "Lanette 18DEO" OR "Lanol S" OR "Laurex 18" OR "Lorol
28" OR "Lorol C 18" OR "Polaax" OR "Rofamol" OR "Sipol S" OR "Siponol S" OR "Siponol SC" OR
"SSD AF" OR "Tego alkanol 18" OR "VLTN 6" OR "Conol 2265" OR "Hainol 22 S" OR "Hainol 22S" OR
"Kalcohl 22080" OR "Kalcol 22080" OR "Lanette 22" OR "Lidavol" OR "NAA 422" OR "Nacol 22-97" OR
"Nacol 22-98" OR "Stenol 1822" OR "Stenol 1822A" OR "Toho BH 65" OR "Arachic alcohol"
"Arachidic alcohol" OR "Eicosyl alcohol" OR "lcosan-1-ol" OR "icosane-1-ol" OR "n-1-Eicosanol" OR
"n-Eicosyl alcohol" OR "Pri-N-eicosyl alcohol" OR "Hainol 20 SS" OR "Hainol 20SS" OR "(Z)-9-
Octadecenol" OR "9-Octadecen-1-ol, (9Z)-" OR "9-Octadecen-1-ol, (Z)-" OR "cis-Octadecen-1-ol" OR
"cis-Delta9-Octadecenol" OR "HD oleyl alcohol 70/75" OR "HD oleyl alcohol 80/85" OR "HD oleyl
alcohol 90/95" OR "HD oleyl alcohol CG" OR "Octadec-9-en-1-ol, (Z)-" OR "Octadeca-9-cis-en-1-ol"
OR "Oleo alcohol" OR "Olive alcohol" OR "Adol 320" OR "Adol 330" OR "Adol 34" OR "Adol 340" OR
"Adol 80" OR "Adol 85NF" OR "Adol 90" OR "Atalco O" OR "Cachalot O 1" OR "Cachalot 0-1" OR
"Cachalot 0-15" OR "Cachalot 0-3" OR "Cachalot 0-8" OR "Crodacol A. 10" OR "Crodacol O" OR
"Crodacol-O" OR "Dermaffine" OR "H.D. eutanol" OR "HD-Eutanol" OR "HD-Ocenol 90/95" OR "HD-
Ocenol 92/96" OR "HD-Ocenol K" OR "Lancol" OR "Loxanol 95" OR "Loxanol M" OR "Ocenol" OR
"Ocenol 90/95" OR "Oceol" OR "Rikacol 90BHR" OR "Satol" OR "Sipol O" OR "Siponol OC" OR
"Unjecol 110" OR "Unjecol 50" OR "Unjecol 70" OR "Unjecol 70N" OR "Unjecol 90" OR "Unjecol
90BHR" OR "Unjecol 90N" OR "Unjecol 90NR" OR "Vegecol 90B" OR "Witcohol 85" OR "Witcohol
85NF" OR "Witcohol 90" OR "Witcohol 90NF"
Toxline
(112-92-5[rn] OR "1 -Octadecanol" OR "Alcohol(C18)" OR "C18 alcohol" OR "n-Octadecanol" OR
"Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR "Octadecyl alcohol" OR "Stearic
alcohol" OR "Stearol" OR "Stearyl alcohol" OR "Stenol" OR 661-19-8[rn] OR 30303-65-2[rn] OR "1-
Docosanol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol") AND (ANEUPL [org] OR BIOSIS [org] OR
48 Additional language or syntax such as [tw], [rn], [org], and [nm] were added to search terms. These are unique to individual
databases and must be applied to search terms so that the query can run properly.
XXXI

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48


CIS [org] OR DART [org] OR EMIC [org] OR EPIDEM [org] OR HAPAB [org] OR HEEP [org] OR HMTC
[org] OR IPA [org] OR RISKLINE [org] OR MTGABS [org] OR NIOSH [org] OR NTIS [org] OR PESTAB
[org] OR PPBIB [org]) AND NOT PubMed [org] AND NOT pubdart [org]
("n-Docosanol" OR "Abreva" OR "IK 2" OR "IK.2" OR "Tadenan" OR 629-96-9[rn] OR "1-Eicosanol" OR
"Arachidyl alcohol" OR "Eicosan-1-ol" OR "Eicosanol" OR "Icosanol" OR "n-Eicosanol" OR 143-28-2[rn]
OR 593-47-5[rn] OR "(Z)-9-Octadecen-1-ol" OR "(Z)-Octadec-9-enol" OR "9-cis-Octadecenol" OR "9-
Octadecen-1-ol" OR "9-Octadecenol" OR "Adol 85" OR "cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl
alcohol" OR "Octadecenol" OR "Oleic alcohol" OR "Oleol" OR "Oleoyl alcohol" OR "Oleyl alcohol")
AND (ANEUPL [org] OR BIOSIS [org] OR CIS [org] OR DART [org] OR EMIC [org] OR EPIDEM [org]
OR HAPAB [org] OR HEEP [org] OR HMTC [org] OR IPA [org] OR RISKLINE [org] OR MTGABS [org]
OR NIOSH [org] OR NTIS [org] OR PESTAB [org] OR PPBIB [org]) AND NOT PubMed [org] AND
NOT pubdart [org]
("1-Hydroxyoctadecane" OR" 1 -Stearyl alcohol" OR "Alcohol stearylicus" OR "Decyl octyl alcohol" OR
"Fatty alcohol(C18)" OR "n-1-Octadecanol" OR "n-Octadecyl alcohol" OR "Octadecanol, 1-" OR
"Steraffine" OR "USP XIII stearyl alcohol" OR "Adol 62" OR "Adol 64" OR "Adol 68" OR "Aldol 62" OR
"Alfol 18" OR "Alfol 18NF" OR "Atalco S" OR "Cachalot S 43" OR "Cachalot S-43" OR "CO 1895" OR
"CO 1895F" OR "CO 1897" OR "CO-1895" OR "CO-1897" OR "Conol 1675" OR "Conol 30F" OR
"Conol 30S" OR "Conol 30SS" OR "Crodacol S" OR "Crodacol S 70" OR "Crodacol S 95" OR
"Crodacol S 95 NF" OR "Crodacol-S" OR "Dytol E-46" OR "Hainol 18 SS" OR "Hainol 18SS" OR
"Hyfatol 18-95" OR "Hyfatol 18-98" OR "Kalchol 8098" OR "Kalcohl 80" OR "Kalcohl 8098" OR "Kalcohl
8099" OR "Kalcol 8098" OR "Lanette 18" OR "Lanette 18DEO" OR "Lanol S" OR "Laurex 18" OR "Lorol
28" OR "Lorol C 18" OR "Polaax" OR "Rofamol" OR "Sipol S" OR "Siponol S" OR "Siponol SC" OR
"SSD AF" OR "Tego alkanol 18" OR "VLTN 6" OR "Conol 2265" OR "Hainol 22 S" OR "Hainol 22S" OR
"Kalcohl 22080" OR "Kalcol 22080" OR "Lanette 22" OR "Lidavol" OR "NAA 422" OR "Nacol 22-97" OR
"Nacol 22-98" OR "Stenol 1822" OR "Stenol 1822A" OR "Toho BH 65" OR "Arachic alcohol" OR
"Arachidic alcohol" OR "Eicosyl alcohol" OR "lcosan-1-ol" OR "icosane-1-ol" OR "n-1 -Eicosanol" OR
"n-Eicosyl alcohol" OR "Pri-N-eicosyl alcohol" OR "Hainol 20 SS" OR "Hainol 20SS" OR "(Z)-9-
Octadecenol" OR "9-Octadecen-1-ol, (9Z)-" OR "9-Octadecen-1-ol, (Z)-" OR "cis-Octadecen-1-ol" OR
"cis-Delta9-Octadecenol" OR "HD oleyl alcohol 70/75" OR "HD oleyl alcohol 80/85" OR "HD oleyl
alcohol 90/95" OR "HD oleyl alcohol CG" OR "Octadec-9-en-1-ol, (Z)-" OR "Octadeca-9-cis-en-1-ol"
OR "Oleo alcohol" OR "Olive alcohol" OR "Adol 320" OR "Adol 330" OR "Adol 34" OR "Adol 340" OR
"Adol 80" OR "Adol 85NF" OR "Adol 90" OR "Atalco O" OR "Cachalot O 1" OR "Cachalot 0-1" OR
"Cachalot 0-15" OR "Cachalot 0-3" OR "Cachalot 0-8" OR "Crodacol A. 10" OR "Crodacol O" OR
"Crodacol-O" OR "Dermaffine" OR "H.D. eutanol" OR "HD-Eutanol" OR "HD-Ocenol 90/95" OR "HD-
Ocenol 92/96" OR "HD-Ocenol K" OR "Lancol" OR "Loxanol 95" OR "Loxanol M" OR "Ocenol" OR
"Ocenol 90/95" OR "Oceol" OR "Rikacol 90BHR" OR "Satol" OR "Sipol O" OR "Siponol OC" OR
"Unjecol 110" OR "Unjecol 50" OR "Unjecol 70" OR "Unjecol 70N" OR "Unjecol 90" OR "Unjecol
90BHR" OR "Unjecol 90N" OR "Unjecol 90NR" OR "Vegecol 90B" OR "Witcohol 85" OR "Witcohol
85NF" OR "Witcohol 90" OR "Witcohol 90NF") AND (ANEUPL [org] OR BIOSIS [org] OR CIS [org] OR
DART [org] OR EMIC [org] OR EPIDEM [org] OR HAPAB [org] OR HEEP [org] OR HMTC [org] OR IPA
[org] OR RISKLINE [org] OR MTGABS [org] OR NIOSH [org] OR NTIS [org] OR PESTAB [org] OR
PPBIB [org]) AND NOT PubMed [org] AND NOT pubdart [org]
TSCATS1
(112-92-5 [rn] OR 661-19-8 [rn] OR 30303-65-2 [rn] OR 629-96-9 [rn] OR 143-28-2 [rn] OR 593-47-5
[rn]) AND (TSCATS [org]) AND NOT PubMed [org] AND NOT pubdart [org]
XXXII

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48

wos
TS=("112-92-5" OR "1-Octadecanol" OR "Alcohol(C18)" OR "C18 alcohol" OR "n-Octadecanol" OR
"Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR "Octadecyl alcohol" OR "Stearic
alcohol" OR "Stearol" OR "Stearyl alcohol" OR "Stenol" OR "661-19-8" OR "30303-65-2" OR "1-
Docosanol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol" OR "n-Docosanol" OR "Abreva" OR "IK 2"
OR "IK.2" OR "Tadenan" OR "629-96-9" OR "1-Eicosanol" OR "Arachidyl alcohol" OR "Eicosan-1-ol"
OR "Eicosanol" OR "Icosanol" OR "n-Eicosanol" OR "143-28-2" OR "593-47-5" OR "(Z)-9-Octadecen-
1-ol" OR "(Z)-Octadec-9-enol" OR "9-cis-Octadecenol" OR "9-Octadecen-1-ol" OR "9-Octadecenol" OR
"Adol 85" OR "cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl alcohol" OR "Octadecenol" OR "Oleic
alcohol" OR "Oleol" OR "Oleoyl alcohol" OR "Oleyl alcohol" OR "Adol 85NF" OR "Arachic alcohol" OR
"Decyl octyl alcohol" OR "Eicosyl alcohol" OR "lcosan-1-ol" OR "Ocenol" OR "Satol" OR "Witcohol 85")
AND ((WC=("Toxicology" OR "Endocrinology & Metabolism" OR "Gastroenterology & Hepatology" OR
"Gastroenterology & Hepatology" OR "Hematology" OR "Neurosciences" OR "Obstetrics &
Gynecology" OR "Pharmacology & Pharmacy" OR "Physiology" OR "Respiratory System" OR "Urology
& Nephrology" OR "Anatomy & Morphology" OR "Andrology" OR "Pathology" OR
"Otorhinolaryngology" OR "Ophthalmology" OR "Pediatrics" OR "Oncology" OR "Reproductive Biology"
OR "Developmental Biology" OR "Biology" OR "Dermatology" OR "Allergy" OR "Public, Environmental
& Occupational Health") OR SU=("Anatomy & Morphology" OR "Cardiovascular System & Cardiology"
OR "Developmental Biology" OR "Endocrinology & Metabolism" OR "Gastroenterology & Hepatology"
OR "Hematology" OR "Immunology" OR "Neurosciences & Neurology" OR "Obstetrics & Gynecology"
OR "Oncology" OR "Ophthalmology" OR "Pathology" OR "Pediatrics" OR "Pharmacology & Pharmacy"
OR "Physiology" OR "Public, Environmental & Occupational Health" OR "Respiratory System" OR
"Toxicology" OR "Urology & Nephrology" OR "Reproductive Biology" OR "Dermatology" OR "Allergy"))
OR (WC="veterinary sciences" AND (TS="rat" OR TS="rats" OR TS="mouse" OR TS="murine" OR
TS="mice" OR TS="guinea" OR TS="muridae" OR TS=rabbit* OR TS=lagomorph* OR TS=hamster*
OR TS=ferret* OR TS=gerbil* OR TS=rodent* OR TS="dog" OR TS="dogs" OR TS=beagle* OR
TS="canine" ORTS="cats" OR TS="feline" ORTS="pig" ORTS="pigs" ORTS="swine" OR
TS="porcine" OR TS=monkey* OR TS=macaque* OR TS=baboon* OR TS=marmoset*)) OR
(TS=toxic* AND (TS="rat" OR TS="rats" OR TS="mouse" OR TS="murine" OR TS="mice" OR
TS="guinea" OR TS="muridae" OR TS=rabbit* OR TS=lagomorph* OR TS=hamster* OR TS=ferret*
OR TS=gerbil* OR TS=rodent* OR TS="dog" OR TS="dogs" OR TS=beagle* OR TS="canine" OR
TS="cats" OR TS="feline" OR TS="pig" OR TS="pigs" OR TS="swine" OR TS="porcine" OR
TS=monkey* OR TS=macaque* OR TS=baboon* OR TS=marmoset* OR TS="child" OR TS="children"
OR TS=adolescen* OR TS=infant* OR TS="WORKER" OR TS="WORKERS" OR TS="HUMAN" OR
TS=patient* OR TS=mother OR TS=fetal OR TS=fetus OR TS=citizens OR TS=milk OR TS=formula
OR TS=epidemio* OR TS=population* OR TS=exposure* OR TS=questionnaire OR SO=epidemio*))
OR TI=toxic* OR TS=metaboli* OR TS=biotransform* OR ((TS="breakdown" OR TS="break-down")
AND (TS=product OR TS=products)))
lndexes=SCI-EXPANDED, CPCI-S, CPCI-SSH, BKCI-S, BKCI-SSH, CCR-EXPANDED, IC
Timespan=AII years
TS=("1-Hydroxyoctadecane" OR" 1 -Stearyl alcohol" OR "Alcohol stearylicus" OR "Fatty alcohol(C18)"
OR "Steraffine" OR "USP XIII stearyl alcohol" OR "Adol 62" OR "Adol 64" OR "Adol 68" OR "Aldol 62"
OR "Alfol 18" OR "Alfol 18NF" OR "Atalco S" OR "Cachalot S 43" OR "Cachalot S-43" OR "CO 1895"
OR "CO 1895F" OR "CO 1897" OR "CO-1895" OR "CO-1897" OR "Conol 1675" OR "Conol 30F" OR
"Conol 30S" OR "Conol 30SS" OR "Crodacol S" OR "Crodacol S 70" OR "Crodacol S 95" OR
"Crodacol S 95 NF" OR "Crodacol-S" OR "Dytol E-46" OR "Hainol 18 SS" OR "Hainol 18SS" OR
"Hyfatol 18-95" OR "Hyfatol 18-98" OR "Kalchol 8098" OR "Kalcohl 80" OR "Kalcohl 8098" OR "Kalcohl
XXXIII

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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48


8099" OR "Kalcol 8098" OR "Lanette 18" OR "Lanette 18DEO" OR "Lanol S" OR "Laurex 18" OR "Lorol
28" OR "Lorol C 18" OR "Polaax" OR "Rofamol" OR "Sipol S" OR "Siponol S" OR "Siponol SC" OR
"SSD AF" OR "Tego alkanol 18" OR "VLTN 6" OR "Conol 2265" OR "Hainol 22 S" OR "Hainol 22S" OR
"Kalcohl 22080" OR "Kalcol 22080" OR "Lanette 22" OR "Lidavol" OR "NAA 422" OR "Nacol 22-97" OR
"Nacol 22-98" OR "Stenol 1822" OR "Stenol 1822A" OR "Toho BH 65" OR "Arachidic alcohol" OR
"icosane-1-ol" OR "n-1-Eicosanol" OR "Hainol 20 SS" OR "Hainol 20SS" OR "(Z)-9-Octadecenol" OR
"cis-Octadecen-1-ol" OR "cis-Delta9-Octadecenol" OR "HD oleyl alcohol 70/75" OR "HD oleyl alcohol
80/85" OR "HD oleyl alcohol 90/95" OR "HD oleyl alcohol CG" OR "Octadec-9-en-1-ol, (Z)-" OR
"Octadeca-9-cis-en-1 -ol" OR "Oleo alcohol" OR "Olive alcohol" OR "Adol 320" OR "Adol 330" OR "Adol
34" OR "Adol 340" OR "Adol 80" OR "Adol 90" OR "Atalco O" OR "Cachalot O 1" OR "Cachalot 0-1"
OR "Cachalot 0-15" OR "Cachalot 0-3" OR "Cachalot 0-8" OR "Crodacol A.10" OR "Crodacol O" OR
"Crodacol-O" OR "Dermaffine" OR "H.D. eutanol" OR "HD-Eutanol" OR "Lancol" OR "Loxanol 95" OR
"Loxanol M" OR "Oceol" OR "Rikacol 90BHR" OR "Sipol O" OR "Siponol OC" OR "Unjecol 110" OR
"Unjecol 50" OR "Unjecol 70" OR "Unjecol 70N" OR "Unjecol 90" OR "Unjecol 90BHR" OR "Unjecol
90N" OR "Unjecol 90NR" OR "Vegecol 90B" OR "Witcohol 85NF" OR "Witcohol 90" OR "Witcohol
90NF")
lndexes=SCI-EXPANDED, CPCI-S, CPCI-SSH, BKCI-S, BKCI-SSH, CCR-EXPANDED, IC
Timespan=AII years


Environmental
Hazard
wos
TS=("112-92-5" OR "1-Octadecanol" OR "Alcohol(C18)" OR "C18 alcohol" OR "n-Octadecanol" OR
"Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR "Octadecyl alcohol" OR "Stearic
alcohol" OR "Stearol" OR "Stearyl alcohol" OR "Stenol" OR "661-19-8" OR "30303-65-2" OR "1-
Docosanol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol" OR "n-Docosanol" OR "Abreva" OR "IK 2"
OR "IK.2" OR "Tadenan" OR "629-96-9" OR "1-Eicosanol" OR "Arachidyl alcohol" OR "Eicosan-1-ol"
OR "Eicosanol" OR "Icosanol" OR "n-Eicosanol" OR "143-28-2" OR "593-47-5" OR "(Z)-9-Octadecen-
1-ol" OR "(Z)-Octadec-9-enol" OR "9-cis-Octadecenol" OR "9-Octadecen-1-ol" OR "9-Octadecenol" OR
"Adol 85" OR "cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl alcohol" OR "Octadecenol" OR "Oleic
alcohol" OR "Oleol" OR "Oleoyl alcohol" OR "Oleyl alcohol" OR "Adol 85NF" OR "Arachic alcohol" OR
"Decyl octyl alcohol" OR "Eicosyl alcohol" OR "lcosan-1-ol" OR "Ocenol" OR "Satol" OR "Witcohol 85")
AND ((WC=("Agriculture, Dairy & Animal Science" OR "Biodiversity Conservation" OR "Biology" OR
"Developmental Biology" OR "Ecology" OR "Entomology" OR "Environmental Sciences" OR
"Environmental Studies" OR "Fisheries" OR "Forestry" OR "Limnology" OR "Marine & Freshwater
Biology" OR "Microbiology" OR "Mycology" OR "Oceanography" OR "Ornithology" OR "Plant Sciences"
OR "Reproductive Biology" OR "Zoology")) OR (SU=("Agriculture" OR "Biodiversity & Conservation"
OR "Developmental Biology" OR "Entomology" OR "Environmental Sciences & Ecology" OR
"Fisheries" OR "Forestry" OR "Marine & Freshwater Biology" OR "Microbiology" OR "Mycology" OR
"Plant Sciences" OR "Reproductive Biology" OR "Zoology" OR "Oceanography")) OR (TI=toxic*) OR
(TS=(ecotox* OR environment* OR phytotox* OR pollut* OR "A. platyrhynchos" OR "agnatha" OR
"agnathan" OR "alligator" OR "alligators" OR "amphibian" OR "amphibians" OR "amphipod" OR
"amphipoda" OR "amphipods" OR "Anas platyrhynchos" OR "annelid" OR "annelida" OR "annelids" OR
"Antilocapridae" OR "apidae" OR "Aplodontidae" OR "Apoidea" OR "aquatic" OR "archiannelid" OR
"archiannelida" OR "Arvicolinae" OR "aves" OR "avian" OR "avians" OR "badger" OR "badgers" OR
"barnacle" OR "barnacles" OR "bass" OR "bear" OR "bears" OR "beaver" OR "beavers" OR "bee" OR
"bees" OR "bird" OR "birds" OR "bivalve" OR "bivalves" OR "bleak" OR "bluegill" OR "bluegills" OR
"bluehead" OR "bobwhite" OR "bobwhites" OR "Bovidae" OR "C. carpio" OR "caiman" OR "Canidae"
OR "carp" OR "Castoridae" OR "catfish" OR "cephalopod" OR "cephalopoda" OR "cephalopods" OR
"Cervidae" OR "chicken" OR "chickens" OR "chiselmouth" OR "clam" OR "clams" OR "cockle" OR
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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48


"cockles" OR "cod" OR "copepod" OR "copepoda" OR "copepods" OR "coturnix" OR "crab" OR "crabs"
OR "crappie" OR "crappies" OR "crayfish" OR "croaker" OR "crocodile" OR "crocodiles" OR
"crustacea" OR "crustacean" OR "crustaceans" OR "Cyprinus carpio" OR "D. magna" OR "D. rerio" OR
"dace" OR "Danio rerio" OR "daphnia" OR "Daphnia magna" OR "darter" OR "darters" OR
"Dasypodidae" OR "Dicotylidae" OR "Didelphidae" OR "Dipodidae" OR "dog" OR "dogs" OR "dogfish"
OR "duck" OR "duckling" OR "ducklings" OR "ducks" OR "earthworm" OR "earthworms" OR "ec50" OR
"ec50s" OR "echinoderm" OR "echinoderms" OR "eel" OR "eels" OR "elasmobranch" OR "Equidae"
OR "Erethizontidae" OR "Felidae" OR "ferret" OR "fish" OR "fisher" OR "fishers" OR "fishes" OR
"flagfish" OR "flatworm" OR "flatworms" OR "flounder" OR "frog" OR "frogs" OR "galaxias" OR "gallus"
OR "gastropod" OR "gastropoda" OR "gastropods" OR "Geomyidae" OR "goldfish" OR "gourami" OR
"gouramy" OR "Green Algae" OR "grunion" OR "guppies" OR "guppy" OR "haddock" OR "hagfish" OR
"haplodrili" OR "Harvest mice" OR "Harvest mouse" OR "herring" OR "Heteromyidae" OR "honeybee"
OR "honeybees" OR "hooknose" OR "inanga" OR "killifish" OR "L. idus" OR "L. macrochirus" OR
"lamprey" OR "lampreys" OR "Ic50" OR "Ic50s" OR "leech" OR "lemming" OR "Lepomis macrochirus"
OR "Leporidae" OR "lethal concentration" OR "Leuciscus idus" OR "lizard" OR "lizards" OR "lobster"
OR "lobsters" OR "macroinvertebrate" OR "macroinvertebrates" OR "mallard" OR "mallards" OR
"marten" OR "medaka" OR "menhaden" OR "Microtus" OR "milkfish" OR "mink" OR "minnow" OR
"minnows" OR "mollusc" OR "molluscs" OR "mollusk" OR "mollusks" OR "molly" OR "mrigal" OR
"mudfish" OR "mudsucker" OR "mulles" OR "mullet" OR "mummichog" OR "mummichogs" OR
"mussel" OR "mussels" OR "Mustelidae" OR "Myocastoridae" OR "Mysid shrimp" OR "newt" OR
"newts" OR "northern pike" OR "0. latipes" OR "0. mykiss" OR "Ochotonidae" OR "octopi" OR
"octopus" OR "oligochaeta" OR "oligochaete" OR "Oncorhynchus mykiss" OR "Onychomys" OR
"opossum" OR "Oryzias latipes" OR "oyster" OR "oysters" OR "P. promelas" OR "P. reticulata" OR "P.
subcapitata" OR "perch" OR "Peromyscus" OR "Pimephales promelas" OR "pinfish" OR "pinfishes" OR
"planaria" OR "planarian" OR "Poecilia reticulata" OR "polychaeta" OR "polychaete" OR "polychaetes"
OR "Procyonidae" OR "Pseudokirchneriella subcapitata" OR "puffer" OR "puffers" OR "pumpkinseed"
OR "pumpkinseeds" OR "pupfish" OR "quahog" OR "quahogs" OR "quail" OR "quails" OR "rasbora"
OR "rasboras" OR "Reithrodontomys" OR "reptile" OR "reptiles" OR "rohu" OR "S. erythrophthalmus"
OR "S. quadricauda" OR "S. subspicatus" OR "salamander" OR "salamanders" OR "salmon" OR
"scallop" OR "scallops" OR "Scardinius erythrophthalmus" OR "Scenedesmus quadricauda" OR
"Scenedesmus subspicatus" OR "Sciuridae" OR "sea anemone" OR "sea anemones" OR "sea
cucumber" OR "sea cucumbers" OR "sea urchin" OR "sea urchins" OR "seabass" OR "seabream" OR
"shark" OR "sharks" OR "shiner" OR "shiners" OR "shrimp" OR "Sigmodon" OR "Sigmodontinae" OR
"silverside" OR "silversides" OR "skunk" OR "skunks" OR "snake" OR "snakehead" OR "snakes" OR
"songbird" OR "songbirds" OR "Soricidae" OR "squid" OR "starfish" OR "stickleback" OR "sticklebacks"
OR "sting ray" OR "sting rays" OR "sucker" OR "suckers" OR "Suidae" OR "sunfish" OR "Talpidae" OR
"teleost" OR "teleostei" OR "teleosts" OR "terrapin" OR "terrapins" OR "tilapia" OR "tilapiaz" OR "toad"
OR "toadfish" OR "toadfishes" OR "toads" OR "tortoise" OR "tortoises" OR "trout" OR "tubificid" OR
"tubificidae" OR "tubificids" OR "turkey" OR "turkeys" OR "turtle" OR "turtles" OR "Ursidae" OR "vole"
OR "walleye" OR "walleyes" OR "water flea" OR "water fleas" OR "waterbird" OR "waterbirds" OR
"waterfowl" OR "waterfowls" OR "weakfish" OR "weasel" OR "whelk" OR "whelks" OR "wildlife")))
lndexes=SCI-EXPANDED, CPCI-S, CPCI-SSH, BKCI-S, BKCI-SSH, CCR-EXPANDED, IC
Timespan=AII years
Toxline
Same as human health strategy synonyms only
TSCATS1
Same as human health strategy CASRN only
XXXV

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48

Proquest
TITLE=("112-92-5" OR "143-28-2" OR "30303-65-2" OR "593-47-5" OR "629-96-9" OR "661-19-8" OR
"1-Docosanol" OR "1-Eicosanol" OR "1-Hydroxyoctadecane" OR "1-Octadecanol" OR "1-Stearyl
alcohol" OR "9-Octadecen-1-ol" OR "9-Octadecenol" OR "9-cis-Octadecenol" OR "Abreva" OR "Adol
85" OR "Alcohol C18" OR "Aldol 62" OR "Arachic alcohol" OR "Arachidic alcohol" OR "Arachidyl
alcohol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "C18 alcohol" OR
"cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl alcohol" OR "Decyl octyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol")
TITLE=("Eicosan-1-ol" OR "Eicosanol" OR "Eicosyl alcohol" OR "Fatty alcohol C18" OR "Icosanol" OR
"Lanette 18" OR "Lanette 22" OR "n-Docosanol" OR "n-Eicosanol" OR "n-Octadecanol" OR "n-
Octadecyl alcohol"OR "Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR "Octadecanol, 1-"
OR "Octadecenol" OR "Octadecyl alcohol" OR "Oleic alcohol" OR "Oleo alcohol" OR "Oleol" OR
"Oleoyl alcohol" OR "Oleyl alcohol" OR "Olive alcohol" OR "Stearic alcohol" OR "Stearol" OR "Stearyl
alcohol" OR "Stenol" OR "Tadenan" OR "Witcohol 85")
SUBJECT=("112-92-5" OR "143-28-2" OR "30303-65-2" OR "593-47-5" OR "629-96-9" OR "661-19-8"
OR "1-Docosanol" OR "1-Eicosanol" OR "1-Hydroxyoctadecane" OR "1 -Octadecanol" OR "1-Stearyl
alcohol" OR "9-Octadecen-1-ol" OR "9-Octadecenol" OR "9-cis-Octadecenol" OR "Abreva" OR "Adol
85" OR "Alcohol C18" OR "Aldol 62" OR "Arachic alcohol" OR "Arachidic alcohol" OR "Arachidyl
alcohol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "C18 alcohol" OR
"cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl alcohol" OR "Decyl octyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol")
SUBJECT=("Eicosan-1-ol" OR "Eicosanol" OR "Eicosyl alcohol" OR "Fatty alcohol C18" OR "Icosanol"
OR "Lanette 18" OR "Lanette 22" OR "n-Docosanol" OR "n-Eicosanol" OR "n-Octadecanol" OR "n-
Octadecyl alcohol"OR "Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR "Octadecanol, 1-"
OR "Octadecenol" OR "Octadecyl alcohol" OR "Oleic alcohol" OR "Oleo alcohol" OR "Oleol" OR
"Oleoyl alcohol" OR "Oleyl alcohol" OR "Olive alcohol" OR "Stearic alcohol" OR "Stearol" OR "Stearyl
alcohol" OR "Stenol" OR "Tadenan" OR "Witcohol 85")
ABSTRACT=("112-92-5" OR "143-28-2" OR "30303-65-2" OR "593-47-5" OR "629-96-9" OR "661-19-
8" OR "1-Docosanol" OR "1-Eicosanol" OR "1-Hydroxyoctadecane" OR "1 -Octadecanol" OR "1-Stearyl
alcohol" OR "9-Octadecen-1-ol" OR "9-Octadecenol" OR "9-cis-Octadecenol" OR "Abreva" OR "Adol
85" OR "Alcohol C18" OR "Aldol 62" OR "Arachic alcohol" OR "Arachidic alcohol" OR "Arachidyl
alcohol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "C18 alcohol" OR
"cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl alcohol" OR "Decyl octyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol")
ABSTRACT=("Eicosan-1 -ol" OR "Eicosanol" OR "Eicosyl alcohol" OR "Fatty alcohol C18" OR
"Icosanol" OR "Lanette 18" OR "Lanette 22" OR "n-Docosanol" OR "n-Eicosanol" OR "n-Octadecanol"
OR "n-Octadecyl alcohol"OR "Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR
"Octadecanol, 1-" OR "Octadecenol" OR "Octadecyl alcohol" OR "Oleic alcohol" OR "Oleo alcohol" OR
"Oleol" OR "Oleoyl alcohol" OR "Oleyl alcohol" OR "Olive alcohol" OR "Stearic alcohol" OR "Stearol"
OR "Stearyl alcohol" OR "Stenol" OR "Tadenan" OR "Witcohol 85")
TITLE=("(Z)-9-Octadecen-1-ol" OR "(Z)-Octadec-9-enol" OR "9-Octadecen-1-ol, (Z)-" OR "Octadec-9-
en-1-ol, (Z)-")
XXXVI

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48


SUBJECT=("(Z)-9-Octadecen-1-ol" OR "(Z)-Octadec-9-enol" OR "9-Octadecen-1-ol, (Z)-" OR
"Octadec-9-en-1-ol, (Z)-")
5 - still returned above - not searched
ABSTRACT=("(Z)-9-Octadecen-1 -ol" OR "(Z)-Octadec-9-enol" OR"9-Octadecen-1-ol, (Z)-" OR
"Octadec-9-en-1-ol, (Z)-")
TITLE=("Alcohol stearylicus" OR "n-1-Octadecanol" OR "Steraffine" OR "USP XIII stearyl alcohol" OR
"Atalco S" OR "Alfol 18" OR "Alfol 18NF" OR "Cachalot S 43" OR "Cachalot S-43" OR "Conol 1675"
OR "Conol 30F" OR "Conol 30S" OR "Conol 30SS" OR "Crodacol S" OR "Crodacol S 70" OR
"Crodacol S 95" OR "Crodacol S 95 NF" OR "Crodacol-S" OR "Dytol E-46" OR "Hainol 18 SS" OR
"Hainol 18SS" OR "Hyfatol 18-95" OR "Hyfatol 18-98" OR "Kalchol 8098" OR "Kalcohl 80" OR "Kalcohl
8098" OR "Kalcohl 8099" OR "Kalcol 8098" OR "Lanol S" OR "Laurex 18" OR "Lorol 28" OR "Lorol C
18" OR "Polaax" OR "Rofamol" OR "Sipol S" OR "Siponol S" OR "Siponol SC" OR "Tego alkanol 18"
OR "VLTN 6" OR "Conol 2265" OR "Hainol 22 S" OR "Hainol 22S" OR "Kalcohl 22080" OR "Kalcol
22080" OR "Lidavol" OR "Nacol 22-97" OR "Nacol 22-98" OR "Stenol 1822" OR "Stenol 1822A" OR
"Toho BH 65" OR "lcosan-1-ol" OR "icosane-1-ol" OR "n-1-Eicosanol" OR "n-Eicosyl alcohol" OR "Pri-
N-eicosyl alcohol" OR "Hainol 20 SS" OR "Hainol 20SS" OR "cis-Octadecen-1-ol" OR "cis-Delta9-
Octadecenol" OR "HD oleyl alcohol 70/75" OR "HD oleyl alcohol 80/85" OR "HD oleyl alcohol 90/95"
OR "HD oleyl alcohol CG" OR "Octadeca-9-cis-en-1-ol" OR "(Z)-9-Octadecenol" OR "9-Octadecen-1-ol,
(9Z)-" OR "Atalco O" OR "Cachalot O 1" OR "Cachalot 0-1" OR "Cachalot 0-15" OR "Cachalot 0-3"
OR "Cachalot 0-8" OR "Crodacol A.10" OR "Crodacol O" OR "Crodacol-O" OR "Dermaffine" OR "H.D.
eutanol" OR "HD-Eutanol" OR "HD-Ocenol 90/95" OR "HD-Ocenol 92/96" OR "HD-Ocenol K" OR
"Lanette 18DEO" OR "Lancol" OR "Loxanol 95" OR "Loxanol M" OR "Ocenol" OR "Ocenol 90/95" OR
"Oceol" OR "Rikacol 90BHR" OR "Satol" OR "Sipol O" OR "Siponol OC" OR "Unjecol 110" OR "Unjecol
50" OR "Unjecol 70" OR "Unjecol 70N" OR "Unjecol 90" OR "Unjecol 90BHR" OR "Unjecol 90N" OR
"Unjecol 90NR" OR "Vegecol 90B" OR "Witcohol 85NF" OR "Witcohol 90" OR "Witcohol 90NF")
ABSTRACT=("Alcohol stearylicus" OR "n-1-Octadecanol" OR "Steraffine" OR "USP XIII stearyl alcohol"
OR "Atalco S" OR "Alfol 18" OR "Alfol 18NF" OR "Cachalot S 43" OR "Cachalot S-43" OR "Conol
1675" OR "Conol 30F" OR "Conol 30S" OR "Conol 30SS" OR "Crodacol S" OR "Crodacol S 70" OR
"Crodacol S 95" OR "Crodacol S 95 NF" OR "Crodacol-S" OR "Dytol E-46" OR "Hainol 18 SS" OR
"Hainol 18SS" OR "Hyfatol 18-95" OR "Hyfatol 18-98" OR "Kalchol 8098" OR "Kalcohl 80" OR "Kalcohl
8098" OR "Kalcohl 8099" OR "Kalcol 8098" OR "Lanol S" OR "Laurex 18" OR "Lorol 28" OR "Lorol C
18" OR "Polaax" OR "Rofamol" OR "Sipol S" OR "Siponol S" OR "Siponol SC" OR "Tego alkanol 18"
OR "VLTN 6" OR "Conol 2265" OR "Hainol 22 S" OR "Hainol 22S" OR "Kalcohl 22080" OR "Kalcol
22080" OR "Lidavol" OR "Nacol 22-97" OR "Nacol 22-98" OR "Stenol 1822" OR "Stenol 1822A" OR
"Toho BH 65" OR "lcosan-1-ol" OR "icosane-1-ol" OR "n-1-Eicosanol" OR "n-Eicosyl alcohol" OR "Pri-
N-eicosyl alcohol" OR "Hainol 20 SS" OR "Hainol 20SS" OR "cis-Octadecen-1-ol" OR "cis-Delta9-
Octadecenol" OR "HD oleyl alcohol 70/75" OR "HD oleyl alcohol 80/85" OR "HD oleyl alcohol 90/95"
OR "HD oleyl alcohol CG" OR "Octadeca-9-cis-en-1-ol" OR "(Z)-9-Octadecenol" OR "9-Octadecen-1-ol,
(9Z)-" OR "Atalco O" OR "Cachalot O 1" OR "Cachalot 0-1" OR "Cachalot 0-15" OR "Cachalot 0-3"
OR "Cachalot 0-8" OR "Crodacol A.10" OR "Crodacol O" OR "Crodacol-O" OR "Dermaffine" OR "H.D.
eutanol" OR "HD-Eutanol" OR "HD-Ocenol 90/95" OR "HD-Ocenol 92/96" OR "HD-Ocenol K" OR
"Lanette 18DEO" OR "Lancol" OR "Loxanol 95" OR "Loxanol M" OR "Ocenol" OR "Ocenol 90/95" OR
"Oceol" OR "Rikacol 90BHR" OR "Satol" OR "Sipol O" OR "Siponol OC" OR "Unjecol 110" OR "Unjecol
50" OR "Unjecol 70" OR "Unjecol 70N" OR "Unjecol 90" OR "Unjecol 90BHR" OR "Unjecol 90N" OR
"Unjecol 90NR" OR "Vegecol 90B" OR "Witcohol 85NF" OR "Witcohol 90" OR "Witcohol 90NF")
XXXVII

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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48


SUBJECT=("Alcohol stearylicus" OR "n-1-Octadecanol" OR "Steraffine" OR "USP XIII stearyl alcohol"
OR "Atalco S" OR "Alfol 18" OR "Alfol 18NF" OR "Cachalot S 43" OR "Cachalot S-43" OR "Conol
1675" OR "Conol 30F" OR "Conol 30S" OR "Conol 30SS" OR "Crodacol S" OR "Crodacol S 70" OR
"Crodacol S 95" OR "Crodacol S 95 NF" OR "Crodacol-S" OR "Dytol E-46" OR "Hainol 18 SS" OR
"Hainol 18SS" OR "Hyfatol 18-95" OR "Hyfatol 18-98" OR "Kalchol 8098" OR "Kalcohl 80" OR "Kalcohl
8098" OR "Kalcohl 8099" OR "Kalcol 8098" OR "Lanol S" OR "Laurex 18" OR "Lorol 28" OR "Lorol C
18" OR "Polaax" OR "Rofamol" OR "Sipol S" OR "Siponol S" OR "Siponol SC" OR "Tego alkanol 18"
OR "VLTN 6" OR "Conol 2265" OR "Hainol 22 S" OR "Hainol 22S" OR "Kalcohl 22080" OR "Kalcol
22080" OR "Lidavol" OR "Nacol 22-97" OR "Nacol 22-98" OR "Stenol 1822" OR "Stenol 1822A" OR
"Toho BH 65" OR "lcosan-1-ol" OR "icosane-1-ol" OR "n-1-Eicosanol" OR "n-Eicosyl alcohol" OR "Pri-
N-eicosyl alcohol" OR "Hainol 20 SS" OR "Hainol 20SS" OR "cis-Octadecen-1-ol" OR "cis-Delta9-
Octadecenol" OR "HD oleyl alcohol 70/75" OR "HD oleyl alcohol 80/85" OR "HD oleyl alcohol 90/95"
OR "HD oleyl alcohol CG" OR "Octadeca-9-cis-en-1-ol" OR "(Z)-9-Octadecenol" OR "9-Octadecen-1-ol,
(9Z)-" OR "Atalco O" OR "Cachalot O 1" OR "Cachalot 0-1" OR "Cachalot 0-15" OR "Cachalot 0-3"
OR "Cachalot 0-8" OR "Crodacol A.10" OR "Crodacol O" OR "Crodacol-O" OR "Dermaffine" OR "H.D.
eutanol" OR "HD-Eutanol" OR "HD-Ocenol 90/95" OR "HD-Ocenol 92/96" OR "HD-Ocenol K" OR
"Lanette 18DEO" OR "Lancol" OR "Loxanol 95" OR "Loxanol M" OR "Ocenol" OR "Ocenol 90/95" OR
"Oceol" OR "Rikacol 90BHR" OR "Satol" OR "Sipol O" OR "Siponol OC" OR "Unjecol 110" OR "Unjecol
50" OR "Unjecol 70" OR "Unjecol 70N" OR "Unjecol 90" OR "Unjecol 90BHR" OR "Unjecol 90N" OR
"Unjecol 90NR" OR "Vegecol 90B" OR "Witcohol 85NF" OR "Witcohol 90" OR "Witcohol 90NF")
Fate
wos
TS=("112-92-5" OR "1-Octadecanol" OR "Alcohol(C18)" OR "C18 alcohol" OR "n-Octadecanol" OR
"Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR "Octadecyl alcohol" OR "Stearic
alcohol" OR "Stearol" OR "Stearyl alcohol" OR "Stenol" OR "661-19-8" OR "30303-65-2" OR "1-
Docosanol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl alcohol" OR "Docosan-1-ol"
OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol" OR "n-Docosanol" OR "Abreva" OR "IK
2" OR "IK.2" OR "Tadenan" OR "629-96-9" OR "1-Eicosanol" OR "Arachidyl alcohol" OR "Eicosan-1-
ol" OR "Eicosanol" OR "Icosanol" OR "n-Eicosanol" OR "143-28-2" OR "593-47-5" OR "(Z)-9-
Octadecen-1-ol" OR "(Z)-Octadec-9-enol" OR "9-cis-Octadecenol" OR "9-Octadecen-1-ol" OR "9-
Octadecenol" OR "Adol 85" OR "cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl alcohol" OR
"Octadecenol" OR "Oleic alcohol" OR "Oleol" OR "Oleoyl alcohol" OR "Oleyl alcohol" OR "Adol
85NF" OR "Arachic alcohol" OR "Decyl octyl alcohol" OR "Eicosyl alcohol" OR "lcosan-1-ol" OR
"Ocenol" OR "Satol" OR "Witcohol 85") AND TS=(adsorp* OR aerob* OR anaerob* OR
bioaccumulat* OR bioavail* OR bioconcentrat* OR biodegrad* OR biomoni* OR biotrans* OR
degrad* OR dispers* OR fish* OR hydroly* leach* OR migrat* OR partic* OR partition* OR persisten*
OR photoly* OR volatil* OR abiotic OR absorb OR absorption OR accumulation-rate OR aerosol OR
aerosols OR air OR anoxic OR atm-m3/mol OR biomagnification OR biosolids OR biota OR
breakdown-product OR breakdown-products OR chelation OR coagulation complexation OR decay-
rate OR diffusion-coefficient OR dissolution OR dust OR effluent OR environmental-fate OR
evaporation-from-water OR excretion OR flocculation OR flux OR fugacity OR gas-phase-mass-
transfer OR ground-water OR groundwater OR half-life OR henry's-law OR incinerate OR
incineration OR indoor-outdoor-ratio OR influent OR ingestion OR intake OR kinetics OR liquid-
phase-mass-transfer OR mass-transfer-coefficient OR microcosm OR modified-state-space OR
particle-size OR particulate OR pathway OR pathways OR penetration-factor OR penetration-ratio
OR photostability OR placenta OR plasma OR plume OR point-source OR point-sources OR pore-
water OR pretreatment-program OR redox OR sediment OR serum OR sewage-treatment OR
sludge OR soil OR subsurface-intrusion OR surface-water-concentration OR time-weighted-average
OR transfer OR transformation OR trophic-magnification OR vapor OR wait-time OR wastewater-
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Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms48


treatment OR weight-fraction OR wildlife OR BAF OR BCF OR BSAF OR BSAFs OR KAW OR Kd
OR KOA OR KOC OR POTW OR SES OR WWTP OR ((OECD OR OPPTS OR OCSPP) AND
(Guideline OR guidelines)))
lndexes=SCI-EXPANDED, CPCI-S, CPCI-SSH, BKCI-S, BKCI-SSH, CCR-EXPANDED, IC
Timespan=AII years
Table C.3: Search Terms Used in Grey Literature and Additional Sources
Chemical
Search terms
Fatty alcohol
cluster (1-
Octadecanol; 1-
Docosanol; 1-
Eicosanol)
Searched as a string or individually depending on source: "112-92-5" OR "1-Octadecanol" OR "Alcohol(C18)"
OR "C18 alcohol" OR "n-Octadecanol" OR "Octadecan-1-ol" OR "octadecane-1-ol" OR "Octadecanol" OR
"Octadecyl alcohol" OR "Stearic alcohol" OR "Stearol" OR "Stearyl alcohol" OR "Stenol" OR "1-
Hydroxyoctadecane" OR "Decyl octyl alcohol" OR "Fatty alcohol(C18)"
"661-19-8" OR "30303-65-2" OR "1-Docosanol" OR "Behenic alcohol" OR "Behenyl 80 Alcohol" OR "Behenyl
alcohol" OR "Docosan-1-ol" OR "docosane-1-ol" OR "Docosanol" OR "Docosyl alcohol" OR "n-Docosanol" OR
"Abreva" OR "IK 2" OR "IK.2" OR "Tadenan"
"629-96-9" OR "1-Eicosanol" OR "Arachidyl alcohol" OR "Eicosan-1-ol" OR "Eicosanol" OR "Icosanol" OR "n-
Eicosanol" OR "Eicosyl alcohol" OR "lcosan-1-ol"
"143-28-2" OR "593-47-5" OR "(Z)-9-Octadecen-1-ol" OR "(Z)-Octadec-9-enol" OR "9-cis-Octadecenol" OR
"9-Octadecen-1-ol" OR "9-Octadecenol" OR "Adol 85" OR "cis-9-Octadecen-1-ol" OR "cis-9-Octadecenyl
alcohol" OR "Octadecenol" OR "Oleic alcohol" OR "Oleol" OR "Oleoyl alcohol" OR "Oleyl alcohol"
Analogs
searched
alcohols, C16-18 (CASRN 67762-27-0); cetyl alcohol (CASRN 36653-82-4); alcohols, C16-18 and C-18
unsatd. (CASRN 68002-94-8)
After the search terms were applied, more than 2,700 references were returned by all search efforts across
peer-reviewed databases and grey literature sources. The total number of references include database
results, additional strategies, and analog searches for the fatty alcohol cluster including 1-Docosanol. All
references from the search efforts were screened and evaluated through the LPS literature search and
review process.46 Of these, 48 references were included for data evaluation and used to support the
designation of 1-docosanol 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-docosanol. The excluded references are organized by discipline (human health
hazard, environmental hazard, and fate), presented along with a rationale based on exclusion criteria. The
criteria46 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-docosanol, EPA excluded a total of 2163 references when assessing human
health hazard. Off-topic references (e.g., studies that did not contain information relevant to human
XXXIX

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health) were excluded at either title/abstract screening (see Table C.4), or full-text screening (see Table
C.5). Unacceptable references (e.g., studies that did not meet data quality metrics) were excluded at full-
text screening (see Tables C.6 and C.7). Off-topic and unacceptable references are displayed next to the
corresponding exclusion criteria.
XL

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs49 relevant to human health hazard
1022420
4936774
4934150
4929473
4929337
1617954
4936986
4936291
4929536
4929422
1023649
4936932
4934151
4929500
4929338
1629199
4936987
4936292
4929573
4929423
1036897
4936933
4934152
4929502
4929341
1689817
4936988
4936297
4929574
4929424
1048762
4936934
4934153
4929503
4929343
1786996
4936989
4936298
4929576
4929425
1054609
4936937
4934157
4929505
4929344
1796863
4936990
4936299
4929577
4929426
1055722
4936938
4934159
4929507
4929347
1799769
4936991
4936301
4929578
4929427
1066804
4936939
4934160
4929509
4929366
1799943
4936992
4936304
4929579
4929428
1083310
4936940
4934162
4929510
4929367
1921479
4936993
4936306
4929580
4929429
1180326
4936941
4934164
4929512
4929368
1922729
4936994
4936307
4929581
4929430
1182858
4936942
4934165
4929513
4929371
1942034
4936996
4936309
4929582
4929431
1183605
4936944
4934166
4929516
4929372
1942090
4936998
4936311
4929583
4929432
1184441
4936945
4934167
4929518
4929373
2013215
4936999
4936312
4929586
4929433
1201393
4936946
4934168
4929519
4929375
2052484
4937312
4936315
4929587
4929453
1298180
4936947
4934170
4929520
4929376
2114411
4937317
4936316
4929589
4929455
1314409
4936948
4934171
4929522
4929378
2114490
4937334
4936317
4929590
4929456
1332580
4936950
4934172
4929523
4929379
2115523
4937372
4936321
4929593
4929457
1333586
4936952
4934193
4929524
4929380
2142633
4940070
4936322
4929594
4929460
1335600
4936953
4934194
4929525
4929381
218703
4940374
4936324
4929595
4929461
1335601
4936955
4934195
4929527
4929382
2198513
4940381
4936325
4929597
4929462
1454877
4936977
4934197
4929529
4929415
2239576
4940417
4936327
4929598
4929463
1535286
4936978
4936279
4929530
4929416
2241165
4940470
4936328
4929599
4929464
1609897
4936979
4936282
4929531
4929417
2279749
4940481
4936329
4929600
4929465
1610348
4936981
4936283
4929532
4929418
2553466
4940529
4936330
4929602
4929466
1615034
4936982
4936285
4929533
4929419
2582663
4940580
4936331
4929603
4929467
1615229
4936984
4936289
4929534
4929420
2592724
4940594
4936332
4929604
4929468
1616488
4936985
4936290
4929535
4929421
2598412
4940647
4936335
4929605
4929469
4229640
4943454
4936421
4930662
4934104
2630975
4940681
4936336
4929606
4929471
4307605
4943484
4936424
4931196
4934106
2676957
4940685
4936337
4929607
4929472
4360860
4943496
4936425
4931197
4934107
2736581
4940742
4936342
4929609
4936523
49 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.
XLI

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4407501
4943511
4936426
4931198
4934110
2751190
4940747
4936343
4929611
4936524
4415125
4943518
4936427
4931199
4934111
2778777
4940787
4936344
4929612
4936526
4657051
4943598
4936428
4931200
4934112
2778903
4940812
4936345
4929614
4936528
4683785
4943603
4936429
4931201
4934113
2792512
4941754
4936346
4929615
4936529
4702660
4943606
4936430
4931202
4934114
2850268
4941773
4936347
4929616
4936530
4702949
4943610
4936431
4931203
4934115
2850717
4941805
4936348
4929617
4936532
4703541
4943637
4936432
4931735
4934117
2861607
4941851
4936350
4929618
4936533
4704266
4943666
4936434
4931835
4934119
2886973
4941853
4936352
4929619
4936534
4754296
4943687
4936437
4932655
4934121
2902056
4941863
4936353
4929620
4936535
4755704
4943690
4936438
4932656
4934122
2960467
4941903
4936354
4929622
4936537
4824314
4943830
4936439
4932658
4934123
2997327
4941910
4936355
4929624
4936538
4837527
4943831
4936440
4932660
4934124
3006582
4941933
4936356
4929625
4936539
4837631
4943993
4936442
4932663
4934149
3036421
4941942
4936357
4929627
4936540
4854956
4944012
4936443
4932667
4936501
3036831
4941953
4936358
4929628
4936541
4861399
4944044
4936444
4932668
4936502
3037540
4941954
4936359
4929629
4936544
4862450
4944047
4936447
4932669
4936504
3037597
4941955
4936360
4929630
4936618
4864847
4944080
4936448
4932673
4936505
3038125
4941964
4936362
4929632
4936635
4867770
4944097
4936449
4932674
4936508
3038131
4941965
4936363
4929633
4936643
4885573
4944184
4936450
4932675
4936510
3038686
4941975
4936364
4929634
4936719
4923332
4944189
4936451
4932679
4936514
3038849
4941976
4936365
4929635
4936733
4929232
4944247
4936453
4932684
4936515
3039428
4942009
4936366
4929637
4936737
4929233
4944248
4936455
4932692
4936516
3039460
4942011
4936367
4929638
4936752
4929234
4944254
4936456
4932693
4936518
3039499
4942017
4936369
4929639
4929281
4929236
4944264
4936457
4932694
4936520
3039606
4942021
4936370
4929641
4929282
4929238
4944289
4936458
4932698
4936521
3039656
4942070
4936371
4929642
4929284
4929239
4944309
4936463
4934038
4936522
3040053
4942179
4936373
4929643
4929285
4929240
4944342
4936464
4934039
4929274
3040498
4942209
4936375
4929644
4929286
4929241
4944375
4936467
4934041
4929275
3041004
4942245
4936376
4929646
4929287
4929243
4944388
4936468
4934042
4929276
3041038
4942401
4936378
4929647
4929288
4929244
4944395
4936470
4934043
4929277
3041115
4942465
4936381
4929651
4929289
4929245
4944412
4936472
4934044
4929278
3046658
4942474
4936383
4929653
4929290
4929247
4944423
4936474
4934046
4929279
3047306
4942478
4936384
4929654
4929291
4929248
4944425
4936475
4934048
4929280
3047450
4942481
4936386
4929655
4929314
4929249
4944494
4936477
4934049
4934085
3060406
4942488
4936389
4930607
4929315
4929250
4944528
4936478
4934051
4934088
3120107
4942500
4936390
4930608
4929316
XLII

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
4929251
4944562
4936481
4934052
4934090
3153771
4942677
4936394
4930609
4929317
4929254
4944567
4936482
4934053
4934091
3220885
4942740
4936395
4930611
4929318
4929255
4944634
4936483
4934057
4934080
3270232
4942806
4936396
4930613
4929320
4929256
4944653
4936484
4934059
4934081
3329064
4942896
4936397
4930614
4929321
4929257
4949200
4936485
4934060
4934084
3347947
4943090
4936398
4930616
4929322
4929258
495881
4936486
4934063
4936497
3360098
4943094
4936399
4930617
4929324
4929259
615565
4936488
4934064
4936499
3489777
4943105
4936400
4930620
4929325
4929260
658179
4936489
4934065
4936500
3539765
4943173
4936401
4930622
4929326
4929261
659153
4936490
4934066
698371
3539879
4943205
4936404
4930623
4929327
4929262
662088
4936492
4934070
791097
3605567
4943212
4936406
4930624
4929328
4929265
662407
4936493
4934072
846220
3716876
4943244
4936407
4930626
4929329
4929266
669806
4936494
4934075
4929270
3769616
4943252
4936408
4930627
4929330
4929267
673420
4936495
4934076
4929271
3784853
4943259
4936409
4930628
4929331
4929269
697436
4936496
4934077
4929273
3817669
4943373
4936410
4930629
4929332
4080833
4943430
4936418
4930655
4934101
3846363
4943419
4936413
4930651
4929333
4146230
4943436
4936419
4930657
4934102
3859469
4943424
4936414
4930652
4929334
4220986
4943444
4936420
4930660
4934103
3859486
4943426
4936415
4930653
4934092
4080205
4943428
4936416
4930654
4934097





Reference excluded (HERO ID) because the reference primarily contained in silico data
1580276
4929640








Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain information pertaining
No
4949221
to a low- priority substance candidate?

660848


1333463


1580238


1815447


3039801


4929246


4934082


4936487


4940326


4940347
XLIII

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard


4942963


1320113


2143371


3039802


3041821


4929335


4929458


4929636


4934093


4934095


4936295


4936338


4936392


4936935


4936951


4936956


4940327


4941960


4942074


4944059


4949204


4949218


4949229


4962993


4963012


4963038


4949225


1976706


4929237


4929283


4932648


4932654


4932657


4934067


4934118
XLIV

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard


4934154


4934161


4934198


4936310


4940935


4941653


4942034


4942038


4942469


4943035


4943918


4945110


4945111


4945112
What type of source is this reference?
Review article or book chapter that contains only
4949221

citations to primary literature sources
660848


1333463


1580238


1815447


3039801


4929246


4934082


4936487


4940326


4940347


4942963
What kind of evidence does this reference
In silico studies that DO NOT contain experimental

primarily contain?
verification

The following question apply to HUMAN evidence only
Does the reference report an exposure route that
No
4929283
is or is presumed to be by an inhalation, oral, or

4929526
dermal route?

4930618
Does the reference report both test substance
No
4929283
exposure(s) AND related health outcome(s)?


XLV

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard
If the reference reports an exposure to a chemical
No
4944301
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,
No
N/A.
choose "Not Applicable".


The following question apply to ANIMAL evidence only
Does the reference report an exposure route that
No
4963003
is by inhalation, oral, or dermal route?

4963007


4963008


4963007


4963008


32772


4929621


4930658


4932652
Does the reference report both test substance-
No
4963007
related exposure(s) AND related health

4963008
outcome(s)?

4929621


4949218


1616835


4929506
Does the reference report the duration of
No
4963007
exposure?

4963008


4934118


4949225


4949226
Does the reference report an exposure to the test
No
4963007
substance only (i.e. no mixtures with the exception

4963008
of aqueous solutions and reasonable impurities

4949225
and byproducts)?

1621193


1629232


2744702


3037827
XLVI

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.5: Screening Questions and Off-Topic References Excluded at Full Text Screening for Human Health Hazard


4942469


4943827


4962997


4963009


4963038


4930658
Does the paper report a negative control that is a
No50
4963007
vehicle control or no treatment control?

4963008


4949225


2744702


3037827


4942469


4930658


4949226


4929621


4949218


4932652


4963003
The following questions apply to MECHANISTIC/ALTERNATIVE TEST METHODS evidence only
Does the reference report a negative control that is
No
4949226
a vehicle control or no treatment control?


Does the reference report an exposure to the test
No
1617542
substance only (i.e. no mixtures with the exception

2232626
of aqueous solutions and reasonable impurities

4934067
and byproducts)?


For genotoxicity studies only: Does the study use a
No
4949226
positive control?


50 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).
XLVII

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
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.
4963010
58939


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).
4962996
4963006


Metric 3:
Positive Controls
When applicable, an appropriate concurrent positive
control (i.e., inducing a positive response) was not
used.
N/A.
Metric 4:
Reporting of Doses/Concentrations
Doses/concentrations were not reported and could
not be calculated using default or reported
estimates of body weight and diet/water intake (e.g.,
default intake values are not available for pregnant
animals).
2454784
4930615
4936314
4962994
4962995
4963042
58939
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).
2454784
4930615
4936314
4936469
4963006
58939
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
4936382
4963006
58939
XLVIII

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)

the specific outcome(s) of interest (e.g., genetically
modified animals, strain was uniquely susceptible or
resistant to one or more outcome of interest).

Metric 7:
Number of Animals Per Group
The number of animals per study group was not
reported.
OR
The number of animals per study group was
insufficient to characterize toxicological effects (e.g.,
1-2 animals in each group).
4963000
4963001
58939
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.).
4930615
4936314
4936469
Metric 9:
Reporting of Data
Data presentation was inadequate (e.g., the
report does not differentiate among findings in
multiple exposure groups).
OR
Major inconsistencies were present in reporting of
results.
4930615
4962995
4963006
58939

Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test Substance Identity
The test substance identity or description cannot be
determined from the information provided (e.g.,
nomenclature was unclear and CASRN or structure
were not reported).
OR
For mixtures, the components and ratios were not
characterized or did not include information that
could result in a reasonable approximation of
components.
N/A.
XLIX

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 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.
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).
4963005
4963043
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
N/A.

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)

The test model was not routinely used for
evaluation of the specific outcome of interest.

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).
N/A.
C.2.2 Environmental Hazard
For the screening review of LPS candidate 1-docosanol EPA excluded a total of 1815 references when assessing environmental hazard. Off-topic
environmental hazard references excluded at title/abstract screening are listed in Table C.8, and those excluded at full-text screening are listed in
Table C.9. References in Table C.10 represent unacceptable studies based on specific data quality metrics for environmental hazard. Off-topic and
unacceptable references are displayed next to the corresponding exclusion criteria.
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs51 relevant to environmental hazard
4936344
4944097
4942715
4941853
4931198
4081878
4940679
4943671
4942244
4936923
4936346
4944100
4942716
4941854
4931199
4084200
4940680
4943673
4942245
4936927
4936347
4944101
4942717
4941855
4931202
4146230
4940681
4943678
4942288
4936959
4936350
4944103
4942718
4941856
4931735
4236566
4940685
4943683
4942289
4936961
4936353
4944111
4942721
4941857
4932648
4239751
4940688
4943684
4942290
4936965
4936389
4944112
4942722
4941858
4932650
4244979
4940692
4943687
4942294
4936973
4936444
4944116
4942723
4941859
4932652
4307605
4940695
4943690
4942297
4937003
4936448
4944117
4942724
4941861
4932654
4335934
4940702
4943691
4942298
4937013
4936449
4944120
4942726
4941862
4932655
4366990
4940709
4943692
4942301
4937016
4936450
4944121
4942727
4941864
4932656
4395162
4940712
4943697
4942302
4937017
51 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.
LI

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs51 relevant to environmental hazard
4936453
4944123
4942733
4941865
4932657
4407501
4940715
4943699
4942303
4937019
4936457
4944124
4942738
4941867
4932658
4408854
4940722
4943700
4942350
4937021
4936458
4944125
4942745
4941890
4932660
4415125
4940724
4943703
4942351
4937030
4936464
4944126
4942751
4941893
4932661
4428588
4940729
4943704
4942354
4937038
4936467
4944129
4942753
4941894
4932663
4433785
4940730
4943707
4942355
4937040
4936468
4944130
4942777
4941895
4932666
4559854
4940732
4943708
4942356
4937047
4936932
4944131
4942778
4941896
4932667
4567128
4940741
4943709
4942358
4937073
4936933
4944135
4942779
4941897
4932668
4585086
4940742
4943710
4942359
4937074
4936934
4944137
4942782
4941898
4932669
4657051
4940747
4943713
4942360
4937081
4936938
4944138
4942783
4941899
4932673
4658174
4940754
4943714
4942361
4937087
4936939
4944142
4942785
4941900
4932674
4660710
4940759
4943715
4942362
4937098
4936940
4944143
4942800
4941901
4932675
4699816
4940762
4943717
4942363
4937106
4936941
4944169
4942801
4941902
4932679
4703541
4940767
4943718
4942364
4937109
4936942
4944170
4942802
4941903
4932680
4704266
4940770
4943721
4942365
4937112
4936944
4944173
4942806
4941904
4932682
4730460
4940772
4943723
4942367
4937187
4936945
4944175
4942807
4941905
4932684
4824309
4940773
4943725
4942391
4937188
4936946
4944177
4942808
4941906
4932691
4824314
4940781
4943726
4942392
4937190
4936947
4944179
4942810
4941907
4932692
4837527
4940782
4943759
4942393
4937197
4936948
4944184
4942811
4941908
4932693
4837631
4940784
4943762
4942394
4937205
4936950
4944186
4942813
4941909
4932694
4854956
4940787
4943766
4942395
4937207
4936952
4944189
4942842
4941914
4932698
4855089
4940788
4943795
4942396
4937214
4936953
4944190
4942843
4941915
4934038
4855197
4940791
4943798
4942397
4937221
4936978
4944196
4942845
4941916
4934039
4861399
4940794
4943799
4942399
4937234
4936979
4944197
4942850
4941918
4934041
4862450
4940795
4943800
4942400
4937267
4936982
4944198
4942851
4941919
4934042
4864847
4940798
4943804
4942401
4937272
4936985
4944203
4942854
4941920
4934043
4866029
4940799
4943805
4942403
4937278
4936986
4944204
4942855
4941922
4934044
4867770
4940800
4943807
4942404
4937283
4936987
4944205
4942856
4941923
4934046
4873855
4940801
4943808
4942405
4937294
4936990
4944206
4942858
4941925
4934049
4875163
4940802
4943812
4942406
4937299
4936991
4944209
4942861
4941927
4934050
4883397
4940806
4943815
4942410
4937300
4936993
4944238
4942862
4941928
4934051
4885804
4940812
4943816
4942411
4937301
4936996
4944242
4942863
4941929
4934052
4929232
4940814
4943819
4942412
4937302
4936998
4944243
4942864
4941930
4934053
4929234
4940817
4943820
4942413
4937303
Lll

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs51 relevant to environmental hazard
4937334
4944245
4942866
4941931
4934057
4929251
4940821
4943822
4942463
4937304
4937372
4944246
4942867
4941932
4934059
4929254
4940826
4943827
4942464
4937305
4940070
4944247
4942869
4941934
4934060
4929255
4940828
4943830
4942465
4937306
4941863
4944248
4942872
4941936
4934063
4929256
4940834
4943831
4942466
4937309
4941910
4944252
4942896
4941937
4934064
4929261
4940835
4943838
4942467
4937310
4941933
4944253
4942922
4941938
4934065
4929265
4940842
4943841
4942468
4937311
4941942
4944254
4942929
4941940
4934066
4929266
4940849
4943842
4942469
4937312
4941954
4944255
4942956
4941941
4934067
4929269
4940863
4943845
4942470
4937313
4941955
4944257
4942957
4941943
4934072
4929274
4940871
4943849
4942471
4937314
4941964
4944259
4942960
4941945
4934075
4929275
4940875
4943852
4942472
4937315
4941965
4944260
4942961
4941946
4934076
4929276
4940877
4943853
4942474
4937316
4941975
4944264
4942963
4941947
4934077
4929277
4940879
4943854
4942476
4937317
4941976
4944268
4942966
4941948
4934080
4929281
4940884
4943888
4942478
4937318
4942009
4944275
4942967
4941949
4934081
4929282
4940885
4943891
4942483
4937319
4942011
4944277
4942968
4941950
4934082
4929284
4940886
4943893
4942484
4937320
4942017
4944279
4942969
4941951
4934083
4929289
4940893
4943894
4942485
4937321
4942021
4944281
4942972
4941953
4934084
4929315
4940895
4943896
4942486
4937322
4942070
4944289
4942979
4941956
4934085
4929317
4940935
4943901
4942487
4937323
4942179
4944295
4942980
4941957
4934088
4929321
4941653
4943902
4942488
4937324
4942209
4944296
4942982
4941958
4934090
4929322
4941661
4943903
4942489
4937325
4942481
4944301
4942983
4941959
4934091
4929326
4941663
4943905
4942490
4937326
4942740
4944303
4942984
4941961
4934092
4929340
4941665
4943906
4942491
4937327
4943090
4944304
4942987
4941962
4934093
4929341
4941667
4943908
4942492
4937328
4943105
4944306
4942988
4941963
4934094
4929343
4941677
4943910
4942493
4937329
4936446
4944307
4942993
4941966
4934097
4929347
4941691
4943912
4942494
4937330
4936935
4944308
4942996
4941967
4934099
4929366
4941717
4943918
4942495
4937331
4936951
4944309
4942997
4941969
4934101
4929367
4941718
4943921
4942498
4937332
4936956
4944310
4943002
4941970
4934102
4929373
4941719
4943968
4942499
4937333
4940069
4944314
4943005
4941971
4934103
4929375
4941720
4943969
4942500
4937336
4941960
4944315
4943006
4941972
4934104
4929376
4941723
4943973
4942501
4937337
4942038
4944316
4943008
4941974
4934106
4929382
4941727
4943980
4942552
4937338
4942074
4944317
4943009
4942001
4934107
4929418
4941741
4943983
4942553
4937339
4943035
4944319
4943012
4942002
4934108
4929422
4941749
4943992
4942554
4937341
LIN

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs51 relevant to environmental hazard
32772
4944320
4943013
4942003
4934110
4929427
4941750
4943993
4942555
4937342
34905
4944321
4943014
4942004
4934111
4929431
4941752
4943994
4942556
4937343
34906
4944322
4943025
4942005
4934112
4929462
4941753
4943995
4942559
4937344
59200
4944325
4943026
4942006
4934113
4929467
4941754
4944000
4942560
4937347
194837
4944326
4943027
4942007
4934114
4929473
4941755
4944001
4942562
4937348
495881
4944327
4943028
4942008
4934115
4929502
4941756
4944003
4942563
4937349
513717
4944329
4943029
4942010
4934117
4929503
4941758
4944004
4942564
4937350
613226
4944331
4943031
4942012
4934118
4929506
4941764
4944005
4942566
4937352
658179
4944332
4943032
4942013
4934119
4929508
4941765
4944006
4942568
4937353
660848
4944334
4943033
4942014
4934121
4929510
4941767
4944009
4942569
4937354
662407
4944335
4943034
4942015
4934122
4929516
4941768
4944012
4942573
4937356
664147
4944342
4943036
4942018
4934123
4929518
4941769
4944013
4942599
4937357
669806
4944344
4943042
4942019
4934124
4929519
4941770
4944015
4942600
4937358
673420
4944345
4943060
4942020
4934149
4929528
4941773
4944019
4942601
4937359
688977
4944348
4943063
4942022
4934150
4929533
4941777
4944025
4942602
4937360
697436
4944349
4943065
4942023
4934151
4929534
4941804
4944032
4942603
4937362
698371
4944350
4943068
4942025
4934152
4929535
4941805
4944034
4942604
4937364
699391
4944351
4943069
4942027
4934153
4929573
4941806
4944035
4942606
4937365
791097
4944352
4943071
4942028
4934154
4929577
4941807
4944038
4942609
4937366
820061
4944354
4943072
4942029
4934157
4929578
4941809
4944039
4942613
4937367
1023649
4944359
4943073
4942031
4934159
4929579
4941810
4944040
4942614
4937368
1038607
4944370
4943075
4942032
4934160
4929580
4941811
4944042
4942615
4937369
1043433
4944375
4943085
4942033
4934161
4929582
4941814
4944043
4942616
4937371
1048762
4944388
4943086
4942034
4934162
4929583
4941815
4944044
4942617
4937373
1054985
4944391
4943087
4942035
4934164
4929585
4941817
4944047
4942619
4937374
1055722
4944395
4943088
4942036
4934165
4929586
4941818
4944054
4942620
4937375
1062474
4944397
4943089
4942037
4934166
4929587
4941819
4944057
4942621
4937376
1066804
4944399
4943092
4942039
4934167
4929588
4941820
4944059
4942622
4937381
1066911
4944404
4943093
4942041
4934168
4929594
4941821
4944066
4942623
4937382
1107881
4944406
4943094
4942042
4934170
4929595
4941823
4944068
4942625
4937385
1180326
4944408
4943095
4942044
4934171
4929604
4941825
4944069
4942626
4937418
1183605
4944409
4943098
4942045
4934172
4929605
4941826
4944074
4942627
4940289
1184441
4944412
4943100
4942047
4934193
4929606
4941833
4944075
4942629
4940290
LIV

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs51 relevant to environmental hazard
1184956
4944413
4943103
4942048
4934194
4929607
4941835
4944077
4942633
4940291
1193690
4944416
4943129
4942049
4934195
4929612
4941836
4944079
4942636
4940295
1201393
4944418
4943132
4942050
4934196
4929614
4941848
4944080
4942637
4940296
1206833
4944419
4943133
4942051
4934197
4929616
4941849
4944092
4942638
4940297
1230933
4944422
4943135
4942052
4934198
4929618
4941850
4940344
4942639
4940305
1232514
4944423
4943138
4942053
4936285
4929619
4941851
4940347
4942640
4940307
1293111
4944424
4943139
4942054
4936291
4929624
4941852
4940349
4942641
4940314
1311549
4944425
4943140
4942056
4936297
4929626
4942680
4940355
4942644
4940321
1313686
4944430
4943143
4942057
4936298
4929629
4942681
4940361
4942668
4940323
1314409
4944457
4943144
4942058
4936306
4929641
4942683
4940363
4942670
4940325
1332580
4944460
4943148
4942059
4936309
4929642
4942686
4940364
4942671
4940326
1333463
4944462
4943171
4942060
4936311
4929644
4942687
4930626
4942673
4940327
1333586
4944488
4943173
4942061
4936312
4929647
4942689
4930627
4942674
4940328
1335600
4944490
4943174
4942062
4936315
4929649
4942690
4930651
4942675
4940331
1335601
4944494
4943176
4942063
4936316
4930613
4930654
4930653
4942677
4940332
1342169
4944512
4943177
4942064
4936321
4930617
4931196
4942678
4940335
4940342
1445642
4944514
4943186
4942065
4936322
4930620
4931197
4942679
4942210
4936705
1447796
4944517
4943187
4942067
4936324
3044660
4940481
4943549
4942211
4936713
1452217
4944518
4943190
4942068
4936325
3046658
4940484
4943550
4942213
4936717
1454619
4944523
4943191
4942069
4936329
3047256
4940529
4943555
4942214
4936719
1454877
4944524
4943193
4942071
4936336
3047306
4940540
4943556
4942215
4936722
1462603
4944525
4943194
4942072
4936337
3060406
4940542
4943561
4942216
4936733
1463310
4944528
4943199
4942075
4936342
3120107
4940544
4943562
4942217
4936737
1509821
4944531
4943200
4942077
4936343
3220885
4940548
4943563
4942218
4936742
1522006
4944532
4943201
4942078
4936355
3457657
4940549
4943565
4942219
4936747
1580238
4944533
4943204
4942079
4936358
3479045
4940557
4943597
4942220
4936748
1580276
4944539
4943205
4942080
4936360
3480260
4940558
4943598
4942223
4936750
1609897
4944543
4943212
4942081
4936362
3481353
4940565
4943600
4942224
4936759
1610348
4944545
4943242
4942082
4936365
3491553
4940577
4943603
4942225
4936770
1615229
4944546
4943244
4942084
4936373
3539879
4940580
4943604
4942227
4936774
1616835
4944549
4943247
4942085
4936376
3586858
4940593
4943606
4942228
4936824
1617954
4944552
4943249
4942087
4936386
3586922
4940594
4943607
4942229
4936825
1621193
4944554
4943250
4942088
4936400
3605567
4940602
4943608
4942231
4936826
LV

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs51 relevant to environmental hazard
1623806
4944562
4943252
4942089
4936401
3695872
4940614
4943610
4942232
4936830
1629199
4944563
4943255
4942090
4936406
3696986
4940615
4943611
4942233
4936834
1629232
4944566
4943258
4942091
4936407
3747323
4940618
4943616
4942235
4936883
1631061
4944567
4943259
4942095
4936413
3817669
4940620
4943628
4942236
4936890
1716948
4944568
4943260
4942096
4936420
3846363
4940625
4943630
4942237
4936891
1734012
4944569
4943308
4942098
4936421
3849146
4940635
4943633
4942238
4936905
1796863
4944577
4943309
4942099
4936426
3859486
4940638
4943637
4942239
4936908
1799769
4944581
4943317
4942100
4936432
3999151
4940645
4943664
4942240
4936909
1799943
4944626
4943319
4942101
4936437
4079260
4940647
4943666
4942242
4936914
1813008
4944628
4943326
4942102
4936439
4080205
4940650
4943667
4942243
4936917
1815447
4944630
4943354
4942103
4936440
4080833
4940654
4943670
4942151
4936608
1921479
4944633
4943361
4942104
4936442
2850268
4944719
4943457
4942152
4936618
1922729
4944634
4943365
4942105
4936475
2866384
4944720
4943484
4942153
4936621
1938473
4944635
4943366
4942106
4936477
2869405
4944722
4943485
4942154
4936622
1951523
4944637
4943370
4942107
4936478
2886973
4949200
4943488
4942180
4936623
1952548
4944639
4943371
4942108
4936486
2889553
4949230
4943489
4942182
4936639
1963069
4944641
4943373
4942110
4936487
2890731
4949231
4943490
4942185
4936643
1976706
4944642
4943375
4942113
4936488
2902056
4949232
4943493
4942187
4936649
2043010
4944644
4943376
4942114
4936495
2904241
4940367
4943494
4942189
4936650
2048152
4944645
4943378
4942115
4936496
2960467
4940369
4943495
4942190
4936656
2114411
4944647
4943382
4942116
4936497
2990387
4940370
4943496
4942192
4936658
2114490
4944648
4943383
4942117
4936500
2997327
4940371
4943501
4942193
4936676
2115509
4944651
4943385
4942118
4936501
3006582
4940372
4943502
4942195
4936677
2115523
4944653
4943387
4942119
4936502
3036831
4940373
4943503
4942196
4936678
2142633
4944654
4943391
4942121
4936504
3037597
4940374
4943506
4942200
4936681
2232626
4944655
4943419
4942123
4936505
3038125
4940377
4943508
4942201
4936690
2239576
4944657
4943421
4942124
4936514
3038131
4940378
4943510
4942202
4936692
2241165
4944658
4943422
4942127
4936516
3038849
4940381
4943511
4942204
4936695
2241600
4944659
4943424
4942128
4936520
3039606
4940417
4943513
4942205
4936697
2279749
4944661
4943426
4942129
4936523
3041004
4940470
4943518
4942206
4936698
2291292
4944665
4943427
4942130
4936524
3041038
4940471
4943522
4942207
4936702
2309936
4944666
4943428
4942131
4936526
3041821
4940474
4943524
4942141
4936552
2592724
4944668
4943430
4942132
4936529
2744702
4944702
4943437
4942142
4936557
LVI

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
Reference excluded (HERO ID) because the reference did NOT contain information needs51 relevant to environmental hazard
2667123
4944673
4943431
4942133
4936532
2751190
4944704
4943438
4942144
4936580
2700015
4944690
4943432
4942135
4936533
2778777
4944706
4943444
4942145
4936585
2700017
4944694
4943433
4942136
4936534
2778903
4944710
4943449
4942146
4936594
2710254
4944697
4943435
4942138
4936538
2792512
4944711
4943451
4942148
4936597
2733844
4944701
4943436
4942140
4936539
2809961
4944712
4943452
4942150
4936604
2832359
4944713
4943454







Reference excluded (HERO ID) because the reference did NOT present quantitative environmental hazard data
N/A
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for Environmental Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain information pertaining to a low- priority substance
candidate?
No
4949229
4962967
4962970
2017579
4949218
4955546
What type of source is this reference?
Review article or book chapter that contains
only citations to primary literature sources
4955546
4955547
Is quantitative environmental hazard data presented?
No
4962968
Is this primarily a modeling/simulation study? [Note: select "No" if experimental
verification was included in the study]
Yes
4962969
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
4962968
4962971
4962972
Does the reference include endpoints in the information needs?
No
N/A.
LVII

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Environmental Hazard
Question
Unacceptable if:
References excluded (HERO ID)
Metric 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:
A concurrent negative control group was not included or reported.
4949228
Negative Controls


Metric 3:
The experimental system (e.g., static, semi-static, or flow-through regime) was not described.
4949228
Experimental


System


Metric 4:
Test concentrations were not reported.
4949228
Reporting of
Concentrations


Metric 5:
The duration of exposure was not reported.
N/A.
Exposure
Duration
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).

Metric 6:
The test species was not reported.
N/A.
Test Organism
Characteristics
OR
The test species, life stage, or age was not appropriate for the outcome(s) of interest.

Metric 7:
The outcome assessment methodology was not reported.
4949228
Outcome


Assessment


Methodology


Metric 8:
Data presentation was inadequate.
4949228
Reporting of Data
OR
Major inconsistencies were present in reporting of results.

LVIII

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
C.2.3 Fate
For the screening review ofLPS candidate 1-docosanol, EPA excluded atotal of 980 references when assessing environmental fate. Off-topic fate
references excluded at title/abstract screening are listed in Table C.ll, and those excluded at full-text screening are listed in Table C.12.
References in Table C.13 represent unacceptable studies based on specific data quality metrics for fate. Off-topic and unacceptable references are
displayed next to the corresponding exclusion criteria.
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs52 relevant to environmental fate
453473
4937086
4937018
4936663
4929274
4407501
4940371
4944628
4936975
4936554
495881
4937087
4937019
4936664
4929276
4408854
4940784
4949230
4936977
4936555
603694
4937088
4937020
4936665
4929278
4410598
4941653
4738938
4936984
4936556
613226
4937090
4937021
4936666
4929279
4415125
4941769
4754296
4936985
4936557
658179
4937091
4937022
4936667
4929281
4426138
4941770
4755704
4936989
4936558
662407
4937092
4937023
4936668
4929282
4426912
4941809
4771899
4936990
4936560
664147
4937094
4937024
4936669
4929283
4428588
4941820
4783131
4936994
4936561
680131
4937097
4937025
4936670
4929286
4433785
4941825
4789397
4936998
4936563
697436
4937098
4937026
4936671
4929289
4437674
4941852
4824309
4937002
4936564
698371
4937099
4937027
4936672
4929291
4559854
4942193
4853263
4937003
4936565
699391
4937100
4937028
4936673
4929315
4580424
4942216
4854956
4937005
4936566
791097
4937101
4937029
4936675
4929317
4580873
4942294
4855089
4937006
4936568
852358
4937102
4937030
4936676
4929318
4580879
4942355
4864847
4937007
4936569
913357
4937104
4937031
4936677
4929322
4660710
4942362
4885573
4937008
4936570
994977
4937105
4937032
4936678
4929324
4683785
4942465
4890357
4937009
4936571
1043433
4937106
4937033
4936679
4929325
4699816
4942467
4890737
4937011
4936572
1055722
4937107
4937034
4936680
4929326
4702763
4942473
4891667
4937012
4936573
1062474
4937108
4937035
4936681
4929329
4703541
4942474
4891705
4937013
4936574
1066804
4937109
4937036
4936682
4929331
4704411
4942476
4904245
4937014
4936575
1083310
4937110
4937037
4936683
4929332
4711530
4942478
4911351
4937015
4936576
1107298
4937111
4937038
4936684
4929337
4722086
4942483
4923332
4937016
4936577
1107881
4937112
4937039
4936685
4929338
4737333
4942484
4929234
4937017
4936578
1108876
4937113
4937040
4936686
4929343
4929243
4929255
4929266
4929270
4929251
52 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.
LIX

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs52 relevant to environmental fate
1128044
4937175
4937041
4936687
4929367
4929245
4929257
4929269
4929273
4929254
1170843
4937177
4937042
4936690
4929368
4929248
4929261
4929249
4929265
4936399
1177731
4937178
4937043
4936692
4929371
3039499
4937291
4936594
4936881
4936404
1180326
4937179
4937044
4936693
4929372
3039656
4937292
4936595
4936882
4936407
1182858
4937181
4937045
4936694
4929375
3040053
4937294
4936596
4936883
4936409
1184441
4937182
4937046
4936695
4929378
3040498
4937295
4936597
4936884
4936410
1184748
4937183
4937047
4936696
4929380
3044660
4937296
4936600
4936885
4936413
1184956
4937184
4937048
4936697
4929381
3046658
4937297
4936601
4936886
4936416
1185903
4937185
4937049
4936698
4929382
3047450
4937298
4936602
4936887
4936421
1193690
4937186
4937050
4936699
4929415
3055188
4937299
4936603
4936888
4936425
1202190
4937187
4937051
4936701
4929416
3060406
4937311
4936604
4936889
4936427
1204628
4937188
4937052
4936702
4929417
3120107
4937329
4936605
4936890
4936429
1230933
4937190
4937053
4936703
4929418
3153771
4937338
4936606
4936891
4936432
1298180
4937191
4937054
4936704
4929423
3270232
4937351
4936607
4936904
4936442
1311549
4937192
4937055
4936705
4929424
3280834
4937358
4936608
4936905
4936443
1333586
4937193
4937056
4936706
4929426
3329064
4937369
4936609
4936906
4936446
1342169
4937194
4937057
4936707
4929427
3347947
4937375
4936610
4936908
4936448
1445642
4937195
4937058
4936708
4929428
3475488
4937387
4936611
4936909
4936449
1458431
4937197
4937059
4936709
4929432
3479045
4937388
4936613
4936910
4936455
1462820
4937198
4937060
4936710
4929460
3489777
4937389
4936614
4936911
4936456
1509821
4937200
4937061
4936711
4929462
3539765
4937390
4936615
4936913
4936470
1535286
4937201
4937062
4936712
4929465
3539879
4937391
4936616
4936914
4936478
1609897
4937202
4937063
4936713
4929469
3586922
4937392
4942486
4936915
4936482
1610348
4937203
4937064
4936714
4929472
3605567
4937394
4942498
4936917
4936483
1615034
4937205
4937065
4936715
4929473
3702436
4937395
4942556
4936918
4936485
1615229
4937206
4937066
4936716
4929510
3715419
4937396
4942564
4936920
4936490
1616488
4937207
4937071
4936717
4929513
3759848
4937397
4942617
4936921
4936492
1617542
4937208
4937072
4936718
4929515
3762169
4937398
4942619
4936922
4936496
1631061
4937209
4937073
4936719
4929516
3769616
4937400
4942722
4936923
4936505
1689817
4937211
4937074
4936720
4929522
3817669
4937401
4942872
4936924
4936510
1716948
4937212
4937075
4936721
4929524
3841811
4937402
4943035
4936925
4936514
1729158
4937213
4937076
4936722
4929525
3846363
4937404
4943133
4936926
4936518
1734002
4937214
4937077
4936724
4929527
3857405
4937405
4943139
4936927
4936521
LX

-------
*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs52 relevant to environmental fate
1734012
4937215
4937078
4936725
4929532
3859223
4937407
4943177
4936928
4936522
1754231
4937217
4937079
4936726
4929533
3859469
4937408
4943489
4936929
4936524
1786996
4937218
4937080
4936727
4929577
3859473
4937409
4943633
4936930
4936526
1799943
4937219
4937081
4936728
4929586
3859478
4937410
4943838
4936931
4936528
1921479
4937220
4937082
4936730
4929587
3859479
4937411
4943845
4936952
4936530
1939967
4937221
4937083
4936731
4929594
3859480
4937413
4943902
4936957
4936532
1942034
4937222
4937084
4936732
4929595
3859481
4937414
4943995
4936959
4936533
1942090
4937223
4937085
4936733
4929615
3859482
4937415
4944004
4936960
4936534
1951523
4937226
4936617
4936734
4929627
3999151
4937416
4944025
4936961
4936537
1952548
4937227
4936618
4936735
4930609
4080205
4937417
4944039
4936962
4936539
1963069
4937228
4936619
4936736
4930617
4081878
4937418
4944074
4936963
4936540
1964008
4937230
4936620
4936737
4930618
4146230
4937419
4944079
4936964
4936541
1968320
4937231
4936621
4936738
4930620
4220986
4937420
4944111
4936965
4936544
1970937
4937233
4936622
4936740
4930622
4229640
4937421
4944189
4936967
4936545
1970938
4937234
4936623
4936741
4930623
4239751
4940294
4944252
4936968
4936546
2013215
4937235
4936624
4936742
4930624
4244979
4940296
4944260
4936969
4936547
2043010
4937236
4936625
4936743
4931198
4352480
4940298
4944275
4936970
4936548
2052484
4937237
4936626
4936745
4931199
4360860
4940299
4944306
4936971
4936550
2112446
4937238
4936627
4936747
4931203
4366990
4940300
4944404
4936972
4936551
2114411
4937239
4936629
4936748
4931735
4395162
4940349
4944424
4936973
4936553
2115523
4937240
4936631
4936750
4932692
4402780
4940364
4944525
4936974
4936347
2115821
4937241
4936632
4936751
4932693
2886973
4937274
4936579
4936827
4936348
2241165
4937242
4936635
4936752
4932694
2902056
4937275
4936580
4936828
4936350
2241600
4937244
4936636
4936753
4934041
2907786
4937276
4936581
4936829
4936352
2279749
4937246
4936637
4936754
4934077
3036421
4937277
4936582
4936830
4936353
2394777
4937248
4936638
4936755
4934097
3036831
4937278
4936583
4936831
4936363
2408288
4937250
4936639
4936756
4934152
3037540
4937280
4936585
4936832
4936365
2551884
4937251
4936640
4936757
4934159
3037597
4937282
4936586
4936833
4936367
2553466
4937252
4936642
4936758
4934195
3037827
4937283
4936587
4936834
4936369
2558636
4937253
4936643
4936759
4936282
3038125
4937284
4936589
4936835
4936371
2592724
4937254
4936645
4936760
4936291
3038131
4937285
4936590
4936836
4936381
2630975
4937255
4936646
4936761
4936292
3038686
4937286
4936591
4936837
4936394
2667123
4937257
4936648
4936762
4936299
3038849
4937287
4936592
4936839
4936398
LXI

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs52 relevant to environmental fate
2676957
4937259
4936649
4936764
4936301
3039428
4937289
4936593
4936880
4936328
2684969
4937260
4936650
4936765
4936304
2700017
4937266
4936655
4936770
4936331
2700012
4937261
4936651
4936766
4936309
2736581
4937267
4936656
4936771
4936335
2700013
4937263
4936652
4936767
4936311
2751190
4937268
4936657
4936772
4936336
2700015
4937265
4936654
4936768
4936327
2792512
4937269
4936658
4936774
4936337
2879992
4937272
4936661
4936824
4936343
2850717
4937270
4936659
4936822
4936342
2884409
4937273
4936662
4936826
4936346
2869405
4937271
4936660
4936823

Reference excluded (HERO ID) because the reference did NOT present quantitative environmental fate data
N//V
LXII

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.12: Screening Questions and Off-Topic References Excluded at Full Text Screening for Fate
Question
Off-topic if answer is:
References excluded (HERO ID)
Does the reference contain information pertaining
No
2048152
to a low- priority substance candidate?

3101649


3457657


4657051


4936345


4936552


4936628


4936825


4937103


4937290


4942968


4949225


4955546


1922729


4867770


4936919
What type of source is this reference?
Review article or book chapter that contains only
4955546

citations to primary literature sources

Is quantitative fate data presented?
No
4867770


4949229
Is this primarily a modeling/simulation study?
Yes
N/A.
[Note: Select "Yes" only if there is no experimental


verification]


Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)
Metric 1:
Test Substance
Identity
The test substance identity or description cannot be determined from the information provided (e.g.,
nomenclature was unclear and CASRN or structure were not reported).
OR
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
4934169
4949222
4955550
LXIII

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)

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.
4934169
4949222
4949228
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.
4934169
4949222


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).
4934169
4949228
4955550
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.
4949222
Metric 7: Test
Organism-Degradation
The test organism, species, or inoculum source were not reported, preventing meaningful interpretation of
the study results.
4934169
4949228
4955550
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.
4934169
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.
4955550
LXIV

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*** Internal Review Draft - Do Not Cite, Quote or Release During the Review ***
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Fate
Data quality metric
Unacceptable if:
References excluded (HERO ID)

OR
Data indicate that disappearance or transformation of the parent compound was likely due to some other
process.

Metric 11:
Confounding Variables
There were sources of variability and uncertainty in the measurements and statistical techniques or between
study groups.
4934169
4949222
4949228
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).
4949228
4955550
LXV

-------