*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Dossier for Candidate Low-Priority Substance 1-Octadecanol
(CASRN 112-92-5)
For Release at Proposal
August 9, 2019
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue
Washington, DC 20460
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Contents
1. Introduction 1
2. Background on 1-Octadecanol 3
3. Physical-Chemical Properties 4
3.1 References 7
4. Relevant Assessment History 8
5. Conditions of Use 10
6. Hazard Characterization 15
6.1 Human Health Hazard 18
6.1.1 Absorption, Distribution, Metabolism, and Excretion 20
6.1.2 Acute Toxicity 21
6.1.3 Repeated Dose Toxicity 21
6.1.4 Reproductive and Developmental Toxicity 22
6.1.5 Genotoxicity 22
6.1.6 Carcinogenicity 22
6.1.7 Neurotoxicity 23
6.1.8 Skin Sensitization 23
6.1.9 Skin Irritation 23
6.1.10 Eye Irritation 24
6.1.11 Hazards to Potentially Exposed or Susceptible Subpopulations 24
6.2 Environmental Hazard 24
6.2.1 Acute Aquatic Toxicity 24
6.2.2 Chronic Aquatic Toxicity 24
6.3 Persistence and Bioaccumulation Potential 25
6.3.1 Persistence 25
6.3.2 Bioaccumulation Potential 25
7. Exposure Characterization 26
i
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
7.1 Production Volume Information 26
7.2 Exposures to the Environment 26
7.3 Exposures to the General Population 27
7.4 Exposures to Potentially Exposed or Susceptible Subpopulations 27
7.4.1 Exposures to Workers 27
7.4.2 Exposures to Consumers 27
7.4.2 Exposures to Children 28
8.Summary of Findings 29
8.1 Hazard and Exposure Potential of the Chemical Substance 29
8.2 Persistence and Bioaccumulation 30
8.3 Potentially Exposed or Susceptible Subpopulations 30
8.4 Storage Near Significant Sources of Drinking Water 31
8.5 Conditions of Use or Significant Changes in Conditions of Use of the Chemical Substance 32
8.6 The Volume or Significant Changes in Volume of the Chemical Substance Manufactured or Processed... 33
8.7 Other Considerations 33
9. Proposed Designation 34
Appendix A: Conditions of Use Characterization I
A.1 CDR Manufacturers and Production Volume I
A.2 Uses II
A.2.1 Methods for Uses II
A.2.2 Uses of 1-Octadecanol IV
A.3 References XXVI
Appendix B: Hazard Characterization XXXI
B.1 References XLI
Appendix C: Literature Search Outcomes XLIV
C.1 Literature Search and Review XLIV
C. 1.1 Search for Analog Data XLV
C.1.2 Search Terms and Results XLV
C.2 Excluded Studies and Rationale LVII
C.2.1 Human Health Hazard Excluded References LVII
ii
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
C.2.2 Environmental Hazard LXVII
C.2.3 Fate LXXV
iii
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Tables
Table 1:1-Octadecanol at a Glance 3
Table 2: Physical-Chemical Properties for 1-Octadecanol 4
Table 3: Conditions of Use for 1-Octadecanol 12
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects 15
Table 5:1-Octadecanol and Analog Structures 19
Table A.1:1986-2015 National Production Volume Data for 1-Octadecanol (Non-Confidential Production ^
Volume in Pounds)
Table A.2: Sources Searched for Uses of 1-Octadecanol II
Table A3: Uses of 1-Octadecanol IV
Table B.1: Human Health Hazard XXXI
Table B.2: Environmental Hazard XXXVII
Table B.3: Fate XXXIX
Table C.1: Sources Used for Analog Search XLV
Table C.2: Search Terms Used in Peer-Reviewed Databases XLVI
Table C.3: Search Terms Used in Grey Literature and Additional Sources LVII
Table C.4: Off-Topic References Excluded at Title/Abstract Screening for Human Health Hazard LVII I
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 LXVIII
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for
Environmental Hazard LXXIII
iv
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
Environmental Hazard
Table C.11: Off-Topic References Excluded at Initial Screening for Fate LXXV
Table C.12: Screening Questions and Off-Topic References Excluded at Full Text Screening for Fate LXXIX
Table C.13: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for
_ < LXXIX
Fate
v
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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-
Octadecanol 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).
1
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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.
2
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
2. Background on 1-Octadecanol
Table 1 below provides the CAS number, synonyms, and other information on 1-octadecanol.
Table 1:1-Octadecanol at a Glance
Chemical Name
1-Octadecanol
CASRN
112-92-5
Synonyms
Stearyl alcohol; Octadecanol; Octadecyl alcohol; N-Octadecanol
Trade Name(s)
Polaax; Aldol 62; Aldol 68; Siponol S; Lorol 28; Lanette 18 DEO
Molecular Formula
C12H38O
Representative Structure
1-Octadecanol is a long-chain, saturated fatty alcohol. It is a waxy solid that often takes the form of
water-insoluble granules or flakes. 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 they have the same formula - CH3(CH2)nOH - with variations in "n".
Specifically, 1-octadecanol is a saturated aliphatic alcohol with an 18-carbon chain, known as
octadecane, with a hydroxy group (-OH) at the terminal carbon and has the formula CH3(CH2)170H.
1-octadecanol functions as a thickener, emulsifier, emollient, and opacifier.
3
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
3. Physical-Chemical Properties
Table 2 lists physical-chemical properties for 1-octadecanol. 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-Octadecanol
Source/Model
Data Type
Endpoint
Endpoint value
Notes
PubChem2019
Experimental
State at room
temperature
Solid
HSDB2006; ChemlD2019;
OECD SIDS 1993; OECD
SIDS 2006; PubChem 2019;
ECHA 2019
Experimental
Molecular weight
270 g/mol
EPISuite v.4.113
Calculated
Molecular weight
270.5 g/mol
Lyman etal. 1990
Experimental
Molar volume
414 cm3/mol
HSDB2006; ChemlD2019;
PubChem 2019; EPISuite
v.4.11
Experimental
Water solubility
1.10x10-3 mg/L
OECD SIDS 1993
Experimental
Water solubility
1.1x10-3 mg/L at
34°C
ECHA 2019
Experimental
Water solubility
<1 mg/L
EPISuite v.4.11
Estimated
Water solubility
9.43x10-3 mg/L
HSDB2006; ChemlD2019;
PubChem 2019; EPISuite
v.4.11
Experimental
Water solubility
4.07x10"9 mol/L
ECHA 2019
Experimental
Water solubility
<3.7x10 6 mol/L
OECD SIDS 1993
Experimental
Water solubility
4.07x10"9 mol/L at
34°C
OECD SIDS 2006
Experimental
Log Kow
7.19
PubChem2019
Experimental
Log Kow
8.22
3 EPI Suite (Physical Property Inputs - Melting Point = 59.5 deg C; Vapor Pressure = 2.7E- 6mm Hg; Water Solubility = 0.0011 mg/L; SMILES: OCCCCCCCCCCCCCCCCCC)
4
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 2: Physical-Chemical Properties for 1-Octadecanol
Source/Model
Data Type
Endpoint
Endpoint value
Notes
ECHA 2019
Experimental
Log Kow
7.4
EPISuite v.4.11
Estimated
Log Kow
7.72
EPISuite v.4.11
Estimated
Log Koa
10.93 (exp.); 9.18
EPISuite v.4.11
Estimated
Log Koc
4.19 (MCI); 4.78
(Kow)
HSDB2006
Experimental
Vapor pressure
2.7x10"6 mm Hg at
25°C;
0.1 at 125°C;
15 at210.5°C
ChemID 2019; OECD SIDS
2006
Experimental
Vapor pressure
2.76x10 6 mm Hg
ECHA 2019
Experimental
Vapor pressure
5x10-4 (<0.001 mbar)
at 38°C
PubChem2019
Experimental
Vapor pressure
1 at 150.3°C
150.3 °C at 1 torr corresponds to a normal vapor pressure of 2.4E-05 torr
EPISuite v.4.11
Experimental
Vapor pressure
2.73x10"6 mm Hg; 15
at210°C
210 °C at 15 torr corresponds to a normal vapor pressure of 1.4E-05 torr
EPISuite v.4.11
Estimated
Vapor pressure
1.83x10-6 mm Hg
EPISuite v.4.11
Estimated
Henry's Law
constant
8.74x10"4 atm-
m3/mol (VP/WS
method);
1.23x10-3 (group
method)
EPISuite v.4.11
Estimated
Volatilization
2.92 hours (river)
7.03 days (lake)
EPISuite v.4.11
Estimated
Photolysis
(Indirect)
4.81 hours (T1/2)
OH rate constant 26.7 E-12 cm3/molecules-second (12 hours day; 1.5E6
OH/cm3)
Pittaway et al. 2015
Experimental
Photolysis
(Indirect)
5.7 hours (T1/2, brown
water)
31.3 hours (T1/2,
distilled water)
EPISuite v.4.11
Estimated
Hydrolysis
Rate constants
cannot be estimated
5
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 2: Physical-Chemical Properties for 1-Octadecanol
Source/Model
Data Type
Endpoint
Endpoint value
Notes
EPISuite v.4.11
Estimated
Biodegradation
potential
Ready prediction:
Yes
6
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Based on its reported physical form (PubChem, 2019), 1-octadecanol is a waxy solid under ambient
conditions. Solids have the potential for exposure via inhalation as dusts as well as direct dermal
contact or oral ingestion. Based on its vapor pressure (HSDB, 2006), it is likely to have minimal
volatility and a low potential for inhalation exposure in the vapor phase. The estimated Henry's Law
constant (EPISuite, 2019) for 1-octadecanol reflects both the low volatility and low aqueous solubility
of this compound; volatilization from water and aqueous solutions is expected to be minimal. Based
on its measured water solubility (PubChem, 2019), 1-octadecanol is insoluble in water and does not
readily form aqueous solutions, decreasing the potential for exposure via contaminated water,
including drinking water. Water insoluble substances have a decreased potential for absorption
through the gastrointestinal tract or lungs. Based on its measured Kow (EPISuite, 2019), 1-octadecanol
may cross lipid membranes and has the potential for absorption in fatty tissues if ingested. 1-
Octadecanol is expected to be immobile in soil based on its estimated Koc (EPISuite, 2019). This
indicates a decreased potential for contamination of groundwater compared to substances that are
more mobile in soil. In addition, 1-octadecanol is expected to biodegrade in the environment to
carbon dioxide and water based on experimental biodegradation data and its predicted biodegradation
potential (EPISuite, 2019). Expected intermediate biodegradation products include fatty acids, which
can be incorporated into biomass via normal metabolic processes.
3.1 References
ChemlDPlus. (2019). Stearyl alcohol. Retrieved from https://chem.nlm.nih.gov/chemidplus/rn/112-
92-5
European Chemicals Agency (ECHA). (2019). Octadecan-l-ol. Retrieved from
https://echa.europa.eu/substance-information/-/substanceinfo/100.003.652
Hazardous Substance Database (HSDB). (2006). 1-Octadecanol. 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
OECD (1993). 1-Octadecanol. Retrieved from
https://heronet.epa.gov/heronet/index.cfm/reference/download/reference_id/4934169
OECD (2006). SIDS initial assessment report for SIAM 22. TOME 2: SIDS dossiers. Long chain
alcohols. Retrieved from
https://heronet.epa.gov/heronet/index.cfm/reference/download/reference id/4949228
Pittaway, P., Herzig, M., Stuckey, N., Larsen, K. (2015). Biodegradation of artificial monolayers
applied to water storages to reduce evaporative loss. Water, Sci, & Tech.
PubChem. (2019). Stearyl alcohol. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/8221
U.S. EPA. (2019). Estimation Programs Interface Suite, v 4.11. United States Environmental
Protection Agency, Washington, DC, USA
7
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
4. Relevant Assessment History
EPA assessed the toxicological profile of 1-octadecanol 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 SCIL4 is a continuously updated list of chemicals that meet low-concern Safer Choice
criteria.5
The OECD SIAM 3 discussed the SIDS Initial Assessment Report (SIAR) on 1-octadecanol in
December 1995. The SIAM recommended further work based on data indicating the substance is
firmly bound to sediments and anaerobic biodegradation may be an important factor in understanding
fate for this chemical. A 21-day daphnid study indicated the substance may be toxic at a range
between 1 and 3 mg/L. The SIAM suggests measuring anaerobic biodegradability to determine if a
long-term fish toxicity test is required. EPA relied on anaerobic biodegradation data from a closely-
related analog to better understand the fate of octadecanol (discussed in Section 6.3.1).
The United Kingdom sponsored a SIAR on long chain aliphatic alcohols in April 2006. 1-
octadecanol was included in this SIAR with updated information since the previous report. The 2006
SIAR concluded that the longest chain members of the long-chain aliphatic alcohols (carbon chain
length > 16), including 1-octadecanol, have low water solubility, limiting the amount of the dissolved
chemical that is bioavailable to aquatic organisms. The SIAR also concluded that chemicals of this
length are also significantly biodegradable, further reducing their likelihood to exhibit acute or
chronic toxicity.
The Australian Government's Department of Health National Industrial Chemicals Notification and
Assessment Scheme (NICNAS) determined 1-octadecanol does 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.6
The Canadian Government, through an assessment of toxicity and exposure as part of its
categorization of the Domestic Substance List, found that 1-octadecanol did not meet its criteria for
further attention.7
The German Environment Agency (UBA) designated 1-octadecanol as "non-hazardous to water" in
August 2018 based on an assessment of ecotoxicity and environmental fate.8
4 https://www.epa.gov/saferchoice/safer-ingredients
5 https://www.epa.gov/sites/production/files/2013-12/documents/dfe master criteria safer ingredients v2 l.pdf
0 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/chemical-infonnation/imap-assessments/imap-assessments/liuman-
health-assessments
7 https://canadacheniicals.oecd. org/CheniicalDetails.aspx?CheniicalID=4FEB9293-7CE0-416F-9FF7-BAFED9BAClF7
8 https://webrigoletto.uba.de/rigoletto/public/searcliDetail.do?kennummer=656
8
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
New Zealand's Environmental Protection Authority lists 1-octadecanol in its Chemical Classification
and Information Database (CCID), which includes hazard and physical information about single
chemicals for use in hazard classifications and safety information. It has a classification description as
"mildly irritating to the skin" (corresponding to R-Phrase 38) and "irritating to the eye"
(corresponding to R-Phrase 36).9 See Sections 6.1.9 and 6.1.10 for EPA's assessment of skin and eye
irritation.
9 https://www.epa.govt.nz/database-searcli/chemical-classification-aiid-infonnation-database-ccid/view/8315
9
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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-octadecanol (Appendix A) to inform which uses would be determined conditions of
use.1" One source of information that EPA used to help determine conditions of use is 2016 Chemical
Data Reporting (CDR). The CDR rule (previously known as the Inventory Update Rule, or IUR),
under TSCA section 8, requires manufacturers (including importers) to report information on the
chemical substances they produce domestically or import into the U.S., generally above a reporting
threshold of 25,000 lb. per site per year. CDR includes information on the manufacturing, processing,
and use of chemical substances with information dating to the mid-1980s. CDR may not provide
information on other life-cycle phases such as the chemical substance's end-of-life after use in
products (i.e., disposal).
Based on CDR, 1-octadecanol is manufactured domestically and imported. It is used in processing
(incorporation into formulation, mixture or reaction and processing as a reactant, and processing
repackaging for soap, cleaning compound, and toilet preparation manufacturing, petroleum
lubricating oil grease manufacturing, paints and coating manufacturing, and other applications).
Examples of industrial uses include gas resource extraction and concrete and construction. Consumer
and commercial uses include paints and coatings, paper products, cleaning and furnishing care
products, arts, crafts, and hobby materials (including finger paints), and anti-freeze and de-icing
products, among others. Based on the known manufacturing, processing, and uses of this chemical
substance, EPA assumes distribution in commerce. According to CDR, 13 facilities reported not
recycling (e.g., not recycled, remanufactured, reprocessed, or reused) 1-octadecanol. Two facilities
withheld recycling information, 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) Program11 since 1-octadecanol is not a TRI-reportable chemical. Although
reasonably available information did not specify additional types of disposal, for purposes of this
proposed prioritization designation, EPA assumed end-of-life pathways that include releases to air,
wastewater, surface water, and land via solid and liquid waste based on the conditions of use (e.g.,
incineration, landfill).
To supplement CDR, EPA conducted research through the publicly available databases listed in
Appendix A (Table A.2) and performed additional internet searches to clarify conditions of use or
find additional occupational12 and consumer uses. This research improved the Agency's
understanding of the conditions of use for 1-octadecanol. Although EPA identified uses of 1-
octadecanol 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.
10 The prioritization process, including the definition of conditions of use, is explained in the Procedures for Prioritization
of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (82 FR 33753).
11 https://www.epa.gov/toxics-release-inventorv-tri-program
12 Occupational uses include industrial and/or commercial uses
10
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Exclusions to TSCA's regulatory scope regarding "chemical substance" can be found at TSCA
section 3(2). Table 3 lists the conditions of use for 1-octadecanol 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).
11
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 3: Conditions of Use for 1-Octadecanol
Life Cycle Stage
Category
Subcategory of Use
Source
Manufacturing
Domestic manufacture
Domestic manufacture
EPA (2017b)
Import
Import- manufacture
Processing
Processing- incorporation
into formulation, mixture or
reaction
Other -personal care, soap, cleaning compound, and toilet preparation manufacturing
EPA (2017b)
Lubricants and lubricant additives - petroleum lubricating oil and grease manufacturing
Surface active agents - soap, cleaning compound, and toilet preparation
manufacturing, all other basic organic chemical manufacturing
Paint additives and coating additives not described by other categories - paint and
coating manufacturing
Processing aids, not otherwise listed - textiles, apparel, and leather manufacturing,
paper manufacturing
Solvents (for cleaning and degreasing) - petroleum lubricating oil and grease
manufacturing
Defoamer use- water treatment, paper manufacturing
Not Known or Reasonably
Ascertainable (NKRA)
Wholesale and retail trade, pharmaceutical and medicine manufacturing, fabricated
metal product manufacturing, soap, cleaning compound, and toilet preparation
manufacturing, all other chemical product and preparation manufacturing
Processing as a reactant
Intermediates- all other basic organic chemical manufacturing
Processing aids, not otherwise listed- paper manufacturing
Raw material for antioxidant production (esters)- all other basic organic chemical
manufacturing
Processing repackaging
Paint additives and coating additives not described by other categories- miscellaneous
manufacturing
Commercial and industrial products- all other basic organic chemical manufacturing
Furniture and related product
manufacturing
Manufacture of furniture
ECHA (2018)
All other chemical product
and preparation
manufacturing
Petrochemical manufacturing, plastics product material, and resin manufacturing
Dionisioet al (2015)
Adhesives and sealants
Manufacturing
CPCat (2019); ECHA (2018);
Synapse Information Resources
(n.d.)
12
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 3: Conditions of Use for 1-Octadecanol
Life Cycle Stage
Category
Subcategory of Use
Source
Recycling
Recycling
EPA (2017b)13
Distribution
Distribution
Distribution
EPA (2017b)
Industrial uses
NKRA
Wholesale and retail trade
EPA (2017b)
Building/construction
materials not covered
Concrete, construction
ECHA (2018)
elsewhere
Oil and gas drilling,
Gas resource extraction
Dionisioet al (2015)
extraction, and support
activities
Industrial/
Fabric, textile, and leather
Leather treatment products, textile dyes
ECHA (2018)
commercial uses
products not covered
elsewhere
Fuels and related products
Metal working fluids
Other
Polymer preparation and compounds
NKRA
NKRA
EPA (2017b)
Paints and Coatings
Coatings and paints
Industrial/
commercial/
Lubricants and greases
Lubricants, greases, release products
EPA (2017b); CPCat (2019);
ECHA (2018); Synapse
Information Resources (n.d.);
consumer uses
Brown (2018)
Paper products
NKRA
EPA (2017b)
Odor agents
Air care products
ECHA (2018)
Ink, toner, and colorant
Ink and toners
products
Metal products not covered
Welding and soldering products
elsewhere
Commercial/
Fabric, textile, and leather
Textile and leather products
EPA (2017b); Dionisio et al
consumer
products not covered
elsewhere
(2015)
13 In the 2016 CDR, 13 facilities reported not recycling (e.g., not recycled, remanufactured, reprocessed, or reused) 1-octadecanol. Two facilities withheld recycling information,
and one facility reported recycling information as CBI.
13
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 3: Conditions of Use for 1-Octadecanol
Life Cycle Stage
Category
Subcategory of Use
Source
Paper products
NKRA, toilet paper
Lawn and garden products
Fertilizers, other lawn and garden products
ECHA (2018), Dionisio et al
(2015)
Anti-freeze and de-icing
products
Anti-freeze and de-icing products
ECHA (2018)
Plastic and rubber products
not covered elsewhere
Rubber and plastic products
CPCat (2019); Kirk-Othmer
(2000)
Cleaning and furnishing care
products
Degreaser, polishes and wax blends
EPA (2017b; 2018d); CPCat
(2019); ECHA (2018)
Consumer
Electrical and electronic
products
Electronics
Dionisio et al (2015)
Veterinary
Pet conditioner
DeLima Associates (2013c)
Arts, crafts, and hobby
materials
Finger paints, arts & crafts materials, modelling clay
2016 CDR, ECHA (2018)
Disposal
Releases to air, wastewater,
solid and liquid wastes
Though not explicitly identified,
releases from disposal are
assumed to be reasonably
foreseen14
14 See Section 5 for a discussion on why releases are assumed to be reasonably foreseen for purposes of this proposed prioritization designation.
14
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
6. Hazard Characterization
EPA reviewed primary literature and other data sources to identify reasonably available information.
This literature review approach15 is tailored to capture the reasonably available information associated
with low-hazard chemicals. EPA also used this process to verify the reasonably available information
for reliability, completeness, and consistency. EPA reviewed the reasonably available information to
identify relevant, quality studies to evaluate the hazard potential for 1-octadecanol against the
endpoints listed below. EPA's New Chemicals Program has used these endpoints for decades to
evaluate chemical substances under TSCA16 and EPA toxicologists rely on these endpoints as key
indicators of potential human health and environmental effects. These endpoints also align with
internationally accepted hazard characterization criteria, such as the Globally Harmonized System of
Classification and Labelling of Chemicals17 as noted above in Section 4 and form the basis of the
comparative hazard assessment of chemicals.
Human health endpoints evaluated: Acute mammalian toxicity, repeated dose toxicity,
carcinogenicity, mutagenicity/genotoxicity, reproductive and developmental toxicity, neurotoxicity,
skin sensitization, and eye and skin irritation.
Environmental fate and effects endpoints evaluated: Aquatic toxicity, environmental persistence,
and bioaccumulation.
The low-concern criteria used to evaluate both human health and environmental fate and effects are
included in Table 4 below.
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
Human Health
Acute Mammalian
Toxicity18
Very High
High
Moderate
Low
Oral LDso (mg/kg)
<50
> 50 - 300
> 300 - 2000
>2000
Dermal LD50 (mg/kg)
<200
> 200- 1000
> 1000 -2000
>2000
Inhalation LC50
(vapor/gas) (mg/L)
<2
>2-10
>10-20
>20
Inhalation LC50
(dust/mist/fume)
(mg/L)
<0.5
>0.5-1.0
>1.0-5
>5
15This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
10 https://www.epa. gov/sustainable-futures/sustainable-futures-p2-framework-manual
17 https://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs rev07/English/ST SG AC10 30 Rev7e.pdf
18 Values derived from GHS criteria (Chapter 3.1: Acute Toxicity. 2009, United Nations).
15
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
Repeated Dose
Toxicity (90-day
study)19
High
Moderate
Low
Oral (mg/kg-bw/day)
< 10
10-100
>100
Dermal (mg/kg-
bw/day)
<20
20 - 200
>200
Inhalation
(vapor/gas)
(mg/L/6h/day)
<0.2
0.2-1.0
>1.0
Inhalation
(dust/mist/fume)
(mg/L/6h/day)
<0.02
0.02-0.2
>0.2
Reproductive
Toxicity20
High
Moderate
Low
Oral (mg/kg/day)
<50
50 - 250
>250
Dermal (mg/kg/day)
< 100
100-500
>500
Inhalation (vapor,
gas, mg/L/day)
< 1
1-2.5
>2.5
Inhalation
(dust/mist/fume,
mg/L/day)
<0.1
0.1-0.5
>0.5
Developmental
Toxicity20
High
Moderate
Low
Oral (mg/kg/day)
<50
50 - 250
>250
Dermal (mg/kg/day)
< 100
100-500
>500
Inhalation (vapor,
gas, mg/L/day)
< 1
1-2.5
>2.5
Inhalation
(dust/mist/fume,
mg/L/day)
<0.1
0.1-0.5
>0.5
Mutagenicity/
Genotoxicity21
Very High
High
Moderate
Low
Germ cell
mutagenicity
GHS Category 1A
or 1B: Substances
known to induce
heritable mutations
or to be regarded
as if they induce
heritable mutations
GHS Category 2:
Substances which
cause concern for
humans owing to the
possibility that they
may induce heritable
mutations in the germ
cells of humans.
Evidence of
mutagenicity support by
positive results in vitro
OR in vivo somatic cells
of humans or animals
Negative for
chromosomal
aberrations and gene
mutations, or no
structural alerts.
19 Values from GHS criteria for Specific Target Organ Toxicity Repeated Exposure (Chapter 3.9: Specific Target Organ
Toxicity' Repeated Exposure. 2009, United Nations).
20 Values derived from the U.S. EPA's Office of Pollution Prevention & Toxics criteria for HPV chemical categorizations
(Methodology* for Risk-Based Prioritization Under ChM tP), and the EU REACH criteria for Annex IV (2007).
21 From GHS criteria (Chapter 3.5: Germ Cells Mutagenicity'. 2009, United Nations) and supplemented with considerations
for mutagenicity and genotoxicity in cells other than germs cells.
16
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
in the germ cells of
humans.
Mutagenicity and
genotoxicity in
somatic cells
OR
Evidence of
mutagenicity
supported by positive
results in in vitro AND
in vivo somatic cells
and/or germ cells of
humans or animals.
Carcinogenicity22
Very High
High
Moderate
Low
Known or
presumed human
carcinogen (GHS
Category 1Aand
1B)
Suspected human
carcinogen (GHS
Category 2)
Limited or marginal
evidence of
carcinogenicity in
animals (and
inadequate23 evidence
in humans)
Negative studies or
robust mechanism-
based structure
activity relationship
(SAR)
Neurotoxicity
(90-day study)19
High
Moderate
Low
Oral (mg/kg-bw/day)
< 10
10-100
>100
Dermal (mg/kg-
bw/day)
<20
20 - 200
>200
Inhalation
(vapor/gas)
(mg/L/6h/day)
<0.2
CD
CM
CD
>1.0
Inhalation
(dust/mist/fume)
(mg/L/6h/day)
<0.02
0.02-0.2
>0.2
Sensitization24
High
Moderate
Low
Skin sensitization
High frequency of
sensitization in
humans and/or high
potency in animals
(GHS Category 1A)
Low to moderate
frequency of
sensitization in human
and/or low to moderate
potency in animals
(GHS Category 1B)
Adequate data
available and not
GHS Category 1Aor
1B
Respiratory
sensitization
Occurrence in
humans or evidence
of sensitization in
humans based on
animal or other tests
Limited evidence
including the presence
of structural alerts
Adequate data
available indicating
lack of respiratory
sensitization
11 Criteria mirror classification approach used by the IARC (Preamble to the L4RC Monographs: B. Scientific Review and
Evaluation: 6. Evaluation and rationale. 2019) and incorporate GHS classification scheme (Chapter 3.6: Carcinogenicity.
2009, United Nations).
23 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.
24 Incorporates GHS criteria (Chapter 3.4: Respiratory or Skin Sensitization. 2009, United Nations).
17
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 4: Low-Concern Criteria for Human Health and Environmental Fate and Effects
(equivalent to GHS
Category 1A or 1B)
Irritation/
Corrosivity25
Very High
High
Moderate
Low
Eye irritation/
corrosivity
Irritation persists
for >21 days or
corrosive
Clearing in 8-21
days, severely
irritating
Clearing in 7 days or
less, moderately
irritating
Clearing in less than
24 hours, mildly
irritating
Skin irritation/
corrosivity
Corrosive
Severe irritation at 72
hours
Moderate irritation at 72
hours
Mild or slight irritation
at 72 hours
Environmental Fate and Effects
Acute Aquatic
Toxicity Value
(L/E/ICso)26
Chronic Aquatic
Toxicity Value
(L/E/ICso)26
Persistence (Measured in terms of level of
biodegradation)27
Bioaccumulation
Potential28
May be low concern
if <10 ppm...
...and <1 ppm...
...and the chemical meets the 10-day window as
measured in a ready biodegradation test...
Low concern if >10
ppm and <100
ppm...
...and >1 ppm and
<10 ppm...
...and the chemical reaches the pass level within
28 days as measured in a ready biodegradation
test
...and BCF/BAF <
1000.
Low concern if >100
ppm...
...and > 10 ppm...
... and the chemical has a half-life < 60 days...
6.1 Human Health Hazard
Below is a summary of the reasonably available information that EPA included in the hazard
evaluation of 1-octadecanol. 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-octadecanol. Appendix B contains more information on each study.
1-Octadecanol is a linear C18 saturated aliphatic alcohol. EPA used best professional judgement to
select analogs 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 linear long
chain saturated aliphatic alcohols and have chain lengths from C16 to C22. Based on these factors,
the environmental and toxicological effects of these analogs are expected to be very similar to each
other and to 1-octadecanol.
25 Criteria derived from the Office of Pesticide Programs Acute Toxicity Categories (U.S. EPA. Label Review Manual.
2010).
20 Derived from GHS criteria (Chapter 4.1: Hazards to the Aquatic Environment. 2009, United Nations), EPA OPPT New
Chemicals Program (Pollution Prevention (P2) Framework, 2005) and OPPT's criteria for HPV chemical categorization
(Methodology> for Risk Based Prioritization Under C1l4MP. 2009).
27 Derived from OPPT's New Chemicals Program and DIE Master Criteria and reflects OPPT policy on PBTs (Design for
the Environment Program Master Criteria for Safer Chemicals, 2010).
28 Derived from OPPT's New Chemicals Program and Arnot & Gobas (2006) [Arnote, J.A. and F,A. Gobas, A review of
bioconcentration factor (BCF) and bioaccumidation factor (B*4F) assessments for organic chemicals in aquatic organisms.
Environmental Reviews, 2006. 14: p. 257-297.]
18
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table 5:1-Octadecanol and Analog Structures
CASRN
Name
Structure
112-92-5
1-Octadecanol
(C18)
^ch3
661-19-8
1-Docosanol
(C22)
629-96-9
1-Eicosanol (C20)
67762-27-
0
Alcohols, C16-18
Representative structures
36653-82-
4
Cetyl alcohol
(C16)
^^Cl"
19
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Alcohols, CI6-18 and C18 unsaturated (CASRN 68002-94-8) was also included in analog data
searches; relevant, quality studies29 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-octadecanol is not expected to be absorbed from dermal,
inhalation, or oral (from the gastrointestinal tract) exposures.
Distribution
No quality experimental data3" on 1-octadecanol" s distribution were available. Based on 1-
octadecanol's estimated log Kow, 1-octadecanol will likely be distributed to fatty tissues in the body.
However, it is expected to be metabolized and excreted through urine and feces (described below
under Excretion).
Metabolism
Because quality experimental data31 on 1-octadecanol metabolite formation were limited, the
Quantitative Structure-Activity Relationship (QSAR) toolbox32 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-octadecanol metabolites. All three metabolism
simulators predicted octadecanoic acid and octadecanal as metabolites of 1-octadecanol. The rat liver
S9 and in vivo rat metabolism simulators predicted acetic acid and hexadecanoic acid as metabolites
of 1-octadecanol. Additional metabolites of 1-octadecanol identified by the rat liver S9 and/or the in
vivo rat metabolism simulators included derivative diols, fatty acids, alcohols, aldehydes, and ketones.
Excretion
To assess 1-octadecanol" s excretion pathways, EPA used at experimental studies. Chinchilla rabbits
were administered 1-octadecanol via oral gavage (OECD. 2006). Excretion of glucuronic acid in
urine was measured to be 7.6% 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.
29 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances Under TSCA."
30 This process is further discussed in the document "Approach Document for Screening Hazard Information for
Low-Priority Substances Under TSCA."
31 This process is further discussed in the document "Approach Document for Screening Hazard Information for Low-
Priority Substances under TSCA."
32 https://www.oecd.org/chemicalsafetv/risk-assessment/oecd-qsar-toolbox.htm
20
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
6.1.2 Acute Toxicity
EPA assessed mammalian toxicity from acute exposures to 1-octadecanol using experimental data. A
study following OECD Guideline 423 exposed rats to 1-octadecanol via oral gavage. No mortalities
were reported at the highest dose, resulting in an LD50 greater than 2000 mg/kg (OECD. 2006;
ECHA. 1996a). In a study following OECD Guideline 401, rats were exposed to a single dose of 1-
octadecanol orally. No mortalities were reported, resulting in an LD50 greater than 5000 mg/kg
(OECD. 2006; ECHA. 1981). Another oral gavage study in rats exposed to 1-octadecanol reported no
mortalities at the highest dose of 7960 mg/kg (ECHA. 1965) These studies indicated low concern for
acute toxicity with LD50 expected to be greater than the low concern criteria threshold of 2000 mg/kg.
EPA assessed mammalian toxicity from acute dermal exposures using read-across from an analog.
Rabbits exposed to alcohols, CI6-18 dermally for 24 hours resulted in an LD50 greater than 8000
mg/kg (OECD. 2006). These results indicate low concern based on the dermal low-concern threshold
of 2000 mg/kg.
EPA assessed mammalian toxicity from acute inhalation exposures using read-across from an analog.
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 saturation air concentration) (ECHA.
1979). Since no adverse effects were observed at saturated air concentration, the results indicate
moderate to low concern based on no effects at saturation.
6.1.3 Repeated Dose Toxicity
EPA assessed toxicity from repeated exposures. In an OECD Guideline 422 study, rats exposed to 1-
octadecanol in their diet for 45 days (males) to 54 days (females) resulted in a no observed adverse
effect level (NOAEL) of 2000 mg/kg-day (OECD. 2006). In a study following OECD Guideline 407,
rats exposed via oral gavage to 1-octadecanol for 28 days (OECD. 2006. 1993) resulted in a NOAEL
of 500 mg/kg-day and a lowest observed adverse effect level (LOAEL) of 1000 mg/kg-day based on
reduced body weight gain. In an OECD Guideline 422 study, rats exposed to 1-octadecanol in their
diet for 45 days (males) or 54 days (females) resulted in a no observed adverse effect level (NOAEL)
of 2000 mg/kg-day (OECD. 2006). Rats exposed to 1-octadecanol at very high doses for 3 months
reported a LOAEL of 28,000 mg/kg-day based on enlarged hepatic mitochondria (Wakabavashi et al..
1991). Another oral diet study in rats exposed to 1-octadecanol for 3 to 5 weeks reported a NOAEL of
14,000 mg/kg-day and a LOAEL of 19,000 mg/kg-day based on enlarged hepatic mitochondria
(Wakabavashi et al.. 1984). However, these hepatic effects on mitochondria occur at extremely high
doses. In a study following OECD Guideline 407, rats exposed via oral gavage to 1-octadecanol for
28 days (OECD. 2006. 1993) resulted in a NOAEL of 500 mg/kg-day and a LOAEL of 1000 mg/kg-
day based on reduced body weight gain.
These studies" results indicate low-concern for toxicity from repeated exposures because the NOAEL
and LOAEL meet the low-concern criteria threshold of 100 mg/kg-day for a 90 day repeated dose
study or 300 mg/kg-day for a -30 day repeated dose study.
21
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
6.1.4 Reproductive and Developmental Toxicity
EPA assessed the potential for 1-octadecanol to induce reproductive toxicity using experimental data.
In a combined repeated dose, reproductive, and developmental toxicity OECD Guideline 422 study,
rats were exposed to 1-octadecanol in their diet for 45 days (males) to 54 days (females). Endpoints
evaluated include mortality, clinical signs, body weight, food consumption, estrous cycles, ovary
weight and histology, testes and epididymis weight and histology, pregnancy rate, gestation length,
implantations, corpora lutea, resorptions and fetal evaluations. No reproductive toxicity was observed,
resulting in aNOAEL of 2000 mg/kg-day (OECD. 2006; ECHA. 1992). These results indicate low
concern for reproductive toxicity for 1-octadecanol because the NOAELs meet the low-concern
criteria threshold of 250 mg/kg-day.
In the same OECD Guideline 422 study discussed under repeated dose and reproductive toxicity, rats
were exposed to 1-octadecanol in their diet for 45 days (males) to 54 days (females) (OECD. 2006;
ECHA. 1992). Fetal endpoints included litter size, litter weight, sex ratio and fetal anomalies (visceral
and external). No developmental toxicity was observed, resulting in a NOAEL of 2000 mg/kg-day.
These results indicate low-concern for developmental toxicity because the NOAELs meet the low-
concern criteria threshold of 250 mg/kg-day.
6.1.5 Genotoxicity
EPA assessed 1-octadecanol" s potential to cause genotoxicity using experimental gene mutation and
chromosomal aberration studies. A gene mutation study in Salmonella typhimurium was negative, but
1-octadecanol reportedly precipitated (Florin et al.. 1980). Other studies in Salmonella typhimurium
and E. coli exposed to 1-octadecanol were all negative for gene mutations (OECD. 2006; ECHA.
1996b; Prival et al.. 1991; Blevins and Taylor. 1982; Mortelmans and Tanaka. 1979). A chromosomal
aberration study in mice exposed 1-octadecanol was negative for increases in micronuclei (OECD.
2006).
6.1.6 Carcinogenicity
Because quality experimental data on 1-octadecanol were limited, EPA relied on predictive models to
evaluate carcinogenic potential. The cancer expert system OncoLogic33 which comprises knowledge-
based rules for chemical classes to predict cancer concern, estimated that medium-sized (by
molecular weight) aliphatic alcohols (i.e. carbon chain length 6 to 20) can be oxidized to aliphatic
carboxylic acids and could be potential nongenotoxic carcinogens. However, this chemical has a
carbon chain length of 18, and in general, alcohols greater than 20 are associated with a low-concern
for carcinogenicity based on knowledge within OncoLogic. In addition, processing 1-octadecanol
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
33 https://www.epa.gov/tsca-screeniiig-tools/oncologictm-computer-svstem-evalmte-carcinogemc-potential-chemicals
22
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
or rigidity, and the balance between its reactivity and stability.34 For this chemical, there is an absence
of the types of reactive structural features that are present in genotoxic carcinogens. 1-Octadecaol is
not an electrophile. Further, predictions from the Virtual models for property Evaluation of chemicals
within a Global Architecture (VEGA) models"35 indicate 1-octadecanol has a low potential to be
carcinogenic or mutagenic
Overall, 1 -octadcanol's ADME profile coupled with an absence of genotoxicity in experimental
studies also provide supporting evidence that this chemical has a low concern for carcinogenicity.
6.1.7 Neurotoxicity
No guideline neurotoxicity studies were available for 1-octadecanol or closely-related analogs.
However, several repeated dose oral 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 only). 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; Iglcsias et al.. 2002a).
Assays related to neurological functions were not identified for 1-octadecanol in ToxCast36.
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,
EPA expects low concern for neurotoxicity.
6.1.8 Skin Sensitization
Because quality experimental data on 1-octadecanol or closely-related analogs were limited, the
potential for 1-octadecanol 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-octadecanol, indicating low concern for skin sensitization by 1-octadecanol.
6.1.9 Skin Irritation
EPA assessed the potential for skin irritation. A study following OECD Guideline 404 exposed
rabbits to 1-octadecanol (OECD. 2006). No evidence of skin irritation was reported. In a dermal patch
34 "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.
35 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.
30 Chemical specific assay list can be found at https://actor.epa.gOv/dashboard/#chemical/55934-93-5.
23
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
study in humans, 1-octadecanol was also found to be non-irritating (Sato et al.. 1996). These results
indicate low concern for skin irritation by 1-octadecanol.
6.1.10 Eye Irritation
EPA assessed 1-octadecanol"s potential to act as an eye irritant. A study following OECD Guidelines
405 exposed rabbits in their eyes to 1-octadecanol (OECD. 2006). At one hour, all animals had slight
conjunctival, cornea, and iris irritation. However, these results were completely reversible by 72
hours. Based on these studies, 1-octadecanol was 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-octadecanol based on low -
concern criteria. This finding includes considerations such as the potential for developmental toxicity,
reproductive toxicity, and acute or repeated dose toxicity that may impact potentially exposed or
susceptible subpopulations. Based on the hazard information discussed in Section 6, EPA did not
identify populations with greater susceptibility to 1-octadecanol given the chemical's low hazard
profile.
6.2 Environmental Hazard
EPA assessed environmental hazard for 1-octadecanol based on available acute experimental data and
estimated chronic toxicity values using the Ecological Structure Active Relationships (ECOSAR)
Predictive Model.37 Appendix B contains a summary of the reasonably available environmental
hazard data.
6.2.1 Acute Aquatic Toxicity
EPA assessed environmental hazard from acute exposures using experimental data. However, all of
these studies report predicted effect levels at concentrations that exceed the water solubility of 1-
octadecanol (Table 3), indicating the physical-chemical properties of 1-octadecanol limit the
dissolved and bioavailable concentrations of the chemical in the water column that acute toxicity is
unlikely to be exhibited. A study in aquatic vertebrates resulted in an LC50 value greater than 0.4
mg/L (OECD. 2006). Another study in aquatic vertebrates exposed to 1-octadecanol reported the
LC50 to be greater than 10,000 mg/L. A study on aquatic invertebrates exposed to 1-octadecanol
reported an EC50 of 1700 mg/L (OECD. 2006; ECHA. 1992). Studies on algae exposed to 1-
octadecanol reported EC50S between 10 mg/L and 250 mg/L (OECD. 2006; ECHA. 1992). These
aquatic toxicity values indicate low concern for acute aquatic exposure based on no effects at
saturation.
6.2.2 Chronic Aquatic Toxicity
EPA assessed environmental hazard from chronic exposures using experimental data and the
ECOSAR Predictive Model. A study on aquatic invertebrates reported a no observed effect
concentration (NOEC) of 0.98 mg/L (OECD. 2006). The ECOSAR predictive model estimated
chronic toxicity values for aquatic vertebrates to occur at 0.01 mg/L and for algae at are 0.01 mg/L.
37 https://www.epa.gov/tsca-screeniiig-tools/ecological-striictin'e-activity-relationships-ecosar-predictive-model}
24
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
However, these estimated chronic toxicity values exceed the water solubility (Table 3) for 1-
ocatdecanol, indicating the physical-chemical properties of 1-octadecanol limit the dissolved and
bioavailable concentration of the chemical in the water column to the point that chronic toxicity is
unlikely to be exhibited. These results indicate 1-octadecanol is low concern for chronic aquatic
toxicity based on no effects at saturation.
6.3 Persistence and Bioaccumulation Potential
6.3.1 Persistence
EPA assessed environmental persistence for 1-octadecanol using experimental data. An OECD 30IB
Guideline study reported that 1-octadecanol degraded 43% in 28 days (OECD. 2006). Two studies
following OECD 30ID Guidelines reported that 1-octadecanol degraded 69% (OECD. 2006) and
67% (OECD. 2006) in 28 days. These results indicate that 1-octadecanol is inherently biodegradable.
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-octadecanol 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, 1-
octadecanol had a half-life of 5.7 hours in brown water in an indirect photolysis study (Pittawav et al..
2015). The available degradation results meet the low-concern threshold and indicate 1-octadecanol
will have low persistence.
6.3.2 Bioaccumulation Potential
Fatty alcohols are known to be absorbed and metabolized by fish to form molecules for energy,
growth and reproduction.38 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-octadecanol are expected to 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 (Freitag et al.. 1982).
These data indicate 1-octadecanol has low potential for bioaccumulation in the environment based on
the low-concern threshold of less than 1000.
38 Douglas R. Tocher. {2003}. Metabolism and Functions of Lipids and Fatty Acids in Teleost Fish, Reviews in Fisheries
Science, 11:2, 107-184
25
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
7. Exposure Characterization
EPA considered reasonably available information on exposure for 1-octadecanol. In general, there is
limited information on exposure for low hazard chemicals. EPA consulted sources of exposure and
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 used these other databases and public
sources (described in Table A.2) only where they augmented information from the CDR database to
inform intended, known, or reasonably foreseen uses (Section 5).
As shown in Tables 3 and A.3, 1-octadecanol is used as a processing aid, surfactant, and/or
intermediate for soap, cleaning compound, and toilet preparation manufacturing, petroleum
lubricating oil grease manufacturing and other applications, as well as in various industrial,
commercial, and consumer 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, consumers, and children.
7.1 Production Volume Information
Production volume information for 1-octadecanol is based on an analysis of CDR data reported from
1986 to 2015.39 The CDR database indicates that for reporting year 2015, 15 companies manufactured
or imported 1-octadecanol at 16 sites. In the 1986, 1990, and 1994 reporting years, aggregate
production volume for 1-octadecanol was between 10 and 50 million lbs. In all subsequent reporting
years, aggregate production volume rose to between 50 and 100 million lbs. The exact amount is
available for one year, 2011, in which 73,915,741 lbs of 1-octadecanol was produced or imported. In
general, since 2012, production volume has remained relatively stable.
7.2 Exposures to the Environment
EPA expects most exposures to the environment to occur during the manufacture, import, processing,
and industrial, commercial, and consumer uses of 1-octadecanol. Exposure is also possible from other
uses, distribution and disposal. These activities could result in releases of 1-octadecanol to media
including surface water, landfills, and air.
EPA expects high levels of removal of 1-octadecanol 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-octadecanol 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
39 The CDR requires manufacturers (including importers) to report information on the chemicals they produce domestically
or import into the U.S above 25,000 lb. per site per year.
26
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
expected to be limited by its water solubility and break down, reducing exposure to aquatic organisms
in the water column, benthic organisms, and ground water 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-octadecanol 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-octadecanol from the
environmental releases described above. The general population is unlikely to be exposed to 1-
octadecanol via inhalation of ambient air because 1-octadecanol is a solid, has a low vapor pressure,
and will break down if incinerated. 1-Octadecanol is also unlikely to be present in surface water
because of low water solubility 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 low bioconcentration and bioaccumulation potential of 1-
octadecanol, oral exposure to 1-octadecanol via fish ingestion is unlikely.
7.4 Exposures to Potentially Exposed or Susceptible Subpopulations
EPA identified workers, consumers, and children as potentially exposed or susceptible subpopulations
based on greater exposure to 1-octadecanol than the general population during manufacturing,
processing, distribution, use, or disposal. EPA identified consumers as a population that may
experience greater exposure to 1-octadecanol than the general population through use of paper
products, paints and coatings, and laundry and dishwashing products, for example. EPA also
identified children (including any adults working closely with children) as a population that may
experience greater exposure to 1-octadecanol than the general population during use of art and hobby
supplies, finger paints, and modelling clay.
7.4.1 Exposures to Workers
Based on its reported physical form and measured melting point, 1-octadecanol is a solid under
ambient conditions. Based on 1-octadecanol" 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-
Octadecanol 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-octadecanol in manufacturing,
processing, distribution, use, and disposal.
7.4.2 Exposures to Consumers
Consumers could be exposed to 1-octadecanol 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-octadecanol is expected to be minimally absorbed through the skin. If the
chemical is in an aerosol product and inhalation exposure occurs, 1-octadecanol"s absorption from the
lungs is unlikely. Consumer exposure could also occur through inhalation or incidental ingestion of
27
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
dust if using consumer products in a powdered form, such as powdered laundry and dishwashing
products. 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-Octadecanol is expected to be metabolized and excreted, further reducing the duration of
exposure.
7.4.2 Exposures to Children
Children may be exposed to 1-octadecanol through use of art and hobby supplies, finger paints, or
modelling clay. Given the molecular weight, water solubility, and partitioning coefficients in Table 2,
this chemical is expected to be poorly absorbed through the skin. Based on the low vapor pressure
and predicted Henry's Law constant (provided in Section 3), 1-octadecanol" s volatilization is
expected to be minimal from these products, reducing inhalation exposures to children. While using
these products, children may rub their eyes or incidentally ingest the product. 1-Octadecanol is
expected to be metabolized and excreted (Section 6.1.1), reducing the duration of exposure.
28
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
8.Summary of Findings
EPA has used reasonably available information on the following statutory and regulatory criteria and
considerations to screen 1-octadecanol against each of thepriority 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 unreasonably 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-octadecanol. EPA used this
information to inform its proposed determination of whether 1-octadecanol would meet the statutory
criteria and considerations for proposed designation as a low-priority substance.
• Hazard potential:
For 1-octadecanol'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-octadecanol 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,
29
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
children, and consumers (discussed in Sections 3 and 7). EPA also gathered information on
environmental releases. EPA identified workers, the general population, consumers, and the
environment as most likely to experience exposures. EPA determined that while the general
population, consumers, children and workers may be exposed to 1-octadecanol, exposure by the
dermal, inhalation, and ingestion pathways are limited by 1-octadecanol" s physical-chemical
properties. If 1-octadecanol is released into the environment, its exposure potential will be minimal
because of low water solubility, and further reduced through biodegradation.
Rationale: Although 1-octadecanol 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 handling and splashing or hand-to-
face and eye contact. Other uses covered under TSCA, especially consumer uses in laundry and
dishwashing products and potential use in finger paints, 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 effects and addressed by rinsing with
water.
Proposed Conclusion: Based on an initial analysis of reasonably available hazard and exposure
information, EPA proposes to conclude that the risk-based, screening- level review under 40 CFR
702.9(a)(1) does not support a finding that 1-octadecanol 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-octadecanol
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's review of experimental data indicates 1-octadecanol is inherently biodegradable
under aerobic conditions and expected to biodegrade under anaerobic conditions (Section 6.3.1).
Read-across from a closely-related analog indicates low potential for bioaccumulation (Section 6.3.2).
Proposed Conclusion: Based on an initial screen of reasonably available information on persistence
and bioaccumulation, EPA proposes to conclude that the screening- level review under 40 CFR
702.9(a)(2) does not support a finding that 1-octadecanol 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,
30
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
such as infants, children, pregnant women, workers, or the elderly." EPA identified workers engaged
in the manufacturing, processing, distribution and use, and disposal of 1-octadecanol as a potentially
exposed or susceptible subpopulation (described in more detail in Section 7). EPA also identified
children (and any adults working closely with children) as a population that may experience greater
exposure to 1-octadecanol than the general population during use of arts and crafts products.
Consumers are also a potentially exposed subpopulation because of their use of products such as arts,
crafts, and hobby materials and laundry and dishwashing products, for example.
Rationale: EPA did not identify hazard effects for this chemical that would make any population
susceptible. EPA expects workers, consumers, and children to have a higher exposure to 1-
octadecanol than the general population. Higher exposure to children could result from use of finger
paints containing 1-octadecanol, which might lead to inadvertent eye contact. Because of the
chemical's low-concern hazard properties and reversibility of effects, this exposure does not pose a
significant increase in risk for children, consumers, or workers.
Proposed Conclusion: Based on the Agency's understanding of the conditions of use and expected
users such as potentially exposed to susceptibly subpopulations, EPA proposes to conclude that the
screening- level review under 40 CFR 702.9(a)(3) does not support a finding that 1-octadecanol meets
the standard for a high-priority substance. 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-octadecanol 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-octadecanol is expected to present low concern to the general
population, including susceptible subpopulations, across a spectrum of health endpoints.
In the event of an accidental release into a surface drinking water source, 1-octadecanol is not water
soluble (see Section 3) and it is not expected to persist (see Section 6.3.1) in the drinking water
supply. In the event of an accidental release to land, its low water solubility and biodegradability
(aerobically and anaerobically, section 6.3.1) reduces its potential for leaching into groundwater,
including well water. Fate and transport evaluations indicate 1-octadecanol is likely to partition into
sediment, predicted to biodegrade under aerobic and anaerobic conditions (see Section 3), and
unlikely to bioaccumulate (see Section 6), minimizing the likelihood that the chemical would be
present in sediment or groundwater to pose a longer-term drinking water contamination threat.
A sudden release of large quantities of the chemical near a drinking water source could have
immediate effects on the usability of a surface drinking water source. If such a release were to occur,
31
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
two primary factors would operate together to reduce concern. First, the chemical would be expected
to present low concern to the general population, including susceptible subpopulations, across a
spectrum of health endpoints (see section 6). Second, 1-octadecanol 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 US environmental
statutes in the past. EPA searched lists of chemicals and confirmed that 1-octadecanol does not appear
on these lists. The lists reviewed include EPA's List of Lists
(https://www.epa.gov/sites/production/files/2015-Q3/documents/list of lists.pdf). EPA also searched
the lists of chemicals included in the National Primary Drinking Water Regulations and the
Unregulated Contaminant Monitoring Rule (UCMR) under the Safe Drinking Water Act (SDWA).
Proposed Conclusion: Based on a qualitative review of a potential release near a significant source
of drinking water, EPA proposes to conclude that the screening- level review under 40 CFR
702.9(a)(4) does not support a finding that 1-octadecanol meets the standard for a high-priority
substance. The reasonably available information on storage near significant sources of drinking water
described above provides sufficient information to support these proposed findings.
8.5 Conditions of Use or Significant Changes in Conditions of Use of the
Chemical Substance
Approach: EPA evaluated the conditions of use for 1-octadecanol and related potential exposures
and hazards.
Rationale: EPA evaluated the conditions of use of 1-octadecanol (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 exposure 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-
octadecanol'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-octadecanol 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-octadecanol
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.
32
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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-octadecanol (Section 7.1) and related
potential exposures (Sections 7.2 through 7.4).
Issues and rationale: EPA used reasonably available information on production volume (see
Appendix A) in considering potential risk. It is possible that designation of 1-octadecanol as a low-
priority substance could result in increased use and higher production volumes. EPA expects,
however, that any changes in 1-octadecanol's production volume would not alter the Agency's
assessment of low concern given the chemical's low-hazard profile. EPA bases this expectation on 1-
octadecanol'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-octadecanol 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 need be included in the evaluation and proposed
designation of 1-octadecanol as a low-priority substance.
33
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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-octadecanol as a low-priority
substance as it does not meet the statutory criteria for a high-priority substance.
34
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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, 15 companies
manufactured or imported 1-octadecanol at 16 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-octadecanol from the CDR (previously known
as the Inventory Update Rule, or IUR) from 1986-2015. In the 1986, 1990, and 1994 reporting years,
aggregate production volume for 1-octadecanol was between 10,000,000 and 50,000,000 lbs. In all
subsequent reporting years, aggregate production volume rose to between 50,000,000 and
100,000,000 lbs. The exact amount is available for one year, 2011, in which 73,915,741 lbs. of 1-
octadecanol was produced or imported. In general, since 2012, production volume has remained
relatively stable without significant increases or decreases.
Table A.1:1986-2015 National Production Volume Data for 1-Octadecanol (Non-Confidential Production Volume
in Pounds)
1986
1990
1994
1998
2002
2006
>10M -
50 M
>10M -
50 M
>10M -
50 M
>50 M -
100M
>50 M
100M
50-
<100M
2011
2012
2013
2014
2015
73,915,741
50-
100M
50-
100M
50-
100M
50-
100M
Source(s):
EPA (2018a; 2017b; 2006; 2002)
Note(s):
K = Thousand; M = Million; NDR = No data reported
I
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
A.2 Uses
A.2.1 Methods for Uses
Section A.2 provides a list of known uses of 1-octadecanol, 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-Octadecano
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)
112-92-5; 1-octadecanol; stearyl
alcohol
No
Canada Chemicals
Management Plan
information sheets
Government of Canada
(2018)
1-octadecanol; stearyl alcohol
No
Chemical and Product
Categories (CPCat)
CPCat (2019)
112-92-5
Yes
ChemView2
EPA (2018b)
112-92-5
Yes
Children's Safe Product
Act Reported Data
Washington State Dept. of
Ecology (2018)
112-92-5
No
Consumer Product
Information Database
(CPID)
DeLima Associates (2018)
112-92-5
Yes
Danish surveys on
chemicals in consumer
products
Danish EPA (2018)
N/A, There is no search but report
titles were checked for possible
information on the chemical
Yes
Datamyne
Descartes Datamyne
(2018)
1-octadecanol
No
DrugBank
DrugBank (2018)
112-92-5; 1-octadecanol; stearyl
alcohol
No
European Chemicals
Agency (ECHA)
Registration Dossier
ECHA (2018)
112-92-5
Yes
eChemPortal2
OECD (2018)
112-92-5
No
Envirofacts2
EPA (2018c)
112-92-5; 1-octadecanol
No
Functional Use Database
(FUse)
EPA (2017a)
112-92-5
Yes
Kirk-Othmer Encyclopedia
of Chemical Technology
Kirk-Othmer (2000)
112-92-5; 1-octadecanol; stearyl
alcohol
Yes
Non-Confidential 2016
Chemical Data Reporting
(CDR)
EPA (2017b)
112-92-5
Yes
PubChem Compound
Kim etal. (2016)
112-92-5
Yes
II
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.2: Sources Searched for Uses of 1-Octadecanol
Title
Author and Year
Search Term(s)
Found Use
Information?1
Safer Chemical Ingredients
List (SCIL)
EPA (2018f)
112-92-5
Yes
Synapse Information
Resources2
Synapse Information
Resources (2009)
1-octadecanol
Yes
Resource Conservation
and Recovery Act (RCRA)
EPA (2018e)
1-octadecanol; stearyl alcohol
No
Scorecard: The Pollution
Information Site
GoodGuide (2011)
112-92-5
Yes
Skin Deep Cosmetics
Database
EWG (2018)
112-92-5
Yes
Toxics Release Inventory
(TRI)
EPA (2018g)
112-92-5
No
TOXNET2
NLM (2018)
112-92-5
Yes
Ullmann's Encyclopedia of
Industrial Chemistry
Ullmann's (2000)
112-92-5; 1-octadecanol; stearyl
alcohol
Yes
Additional sources identified from reasonably available information
U.S. Food and Drug
Administration (FDA)
Everything Added to Food
FDA (2018)
Incidentally identified while
researching details of this chemical's
uses and products.
Yes
Note(s):
1. If use information was found in the resource, it will appear in Table 3-2 unless otherwise noted.
2. This source is a group of databases; thus the exact resource(s) it led to will be cited instead of the database as whole.
The U.S. Patent and Trademark Office has an online database that shows 1,007 patents referencing 1-
octadecanol (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-octadecanol 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.
Ill
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
A.2.2 Uses of 1-Octadecanol
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
TSCA Conditions of Use: Manufacturing Uses
CPCat (2019)
Crop and animal production, hunting and related service
activities1
Industrial
CPCat identifies use of 1-octadecanol in agricultural crop, animal, and hunting
applications in Nordic countries. No further information about this specific use
could be found and it is unknown whether this is an ongoing use in the United
States.
Expected users are industrial based on inclusion in industrial sector categories.
ECHA (2018)
Fertilizers
Consumer, commercial
The ECHA registration dossier reports use of 1-octadecanol in fertilizers in
European countries. No further information about this specific use could be
found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's
consumer uses and uses by professional workers.
CPCat (2019); ECHA (2018)
Lawn and garden products (non-pesticidal)
Consumer, commercial
CPCat and the ECHA registration dossier identify use of 1-octadecanol in lawn,
garden, and plant products. No further information about this specific use could
be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on inclusion in ECHA's
consumer uses and uses by professional workers.
IV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
CPCat (2019); EPA(2018d)
Pesticides
Unknown
1-octadecanol is on EPA's list of Inert Ingredients Permitted for Use in Nonfood
Use Pesticide Products. 1-octadecanol is not listed on the National Pesticide
Information Retrieval System as a federally active product in pesticides.
The expected users are unknown, due to the limited availability of information.
TSCA Conditions of Use: Food Products
Synapse Information Resources (2009)
Food packaging2
Unknown
Synapse lists 1 -octadecanol as a component of food packaging adhesives,
food-contact coatings (as a defoamer) and paper, and in cellophane and
textiles for food contact. No information was found on the current status of
these uses in the United States.
The expected users are unknown, due to the limited availability of information.
TSCA Conditions of Use: Household Products
ECHA (2018)
Air care products
Consumer, commercial,
industrial
The ECHA registration dossier identifies use of 1-octadecanol in air care
products. No further information about this use could be found and it is
unknown whether this is an ongoing use in the United States.
Expected users are based on inclusion in ECHA's consumer uses, uses by
professional workers, and uses at industrial sites.
EPA (2017b); CPCat (2019)
Arts, crafts, and hobby materials
Consumer
CDR and CPCat identify use of 1-octadecanol in consumer clay materials and
drawing and coloring products. CDR identified concentrations of 1-30 percent
by weight in reported products.
Expected users are based on CDR's consumer/commercial classification.
V
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
CPCat (2019)
Electronics
Consumer
CPCat identifies the presence of 1-octadecanol in electronic writing and
correction supplies and electronic boards and easels. No further information
was found on the current status of this use in the United States.
The expected users are consumer based on inclusion in CPCat's retail product
categories.
ECHA (2018)
Fillers, putties, plasters, modelling clay
Consumer, commercial,
Industrial
The ECHA registration dossier identifies use of 1-octadecanol in fillers, putties,
plasters, and modelling clay products in European countries. No further
information about this use could be found and it is unknown whether this is an
ongoing use in the United States.
Expected users are based on inclusion in ECHA's consumer uses, uses by
professional workers, and uses at industrial sites.
ECHA (2018)
Finger paints
Consumer
The ECHA registration dossier identifies use of 1-octadecanol in finger paints in
European countries. No further information about this use could be found and it
is unknown whether this is an ongoing use in the United States.
Expected users are based on inclusion in ECHA's consumer uses.
ECHA (2018)
Ink and toners
Consumer, commercial,
Industrial
The ECHA registration dossier identifies use of 1-octadecanol in inks and
toners in European countries. No further information about this use could be
found and it is unknown whether this is an ongoing use in the United States.
Expected users are based on inclusion in ECHA's consumer uses, uses by
professional workers, and uses at industrial sites.
VI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
CPCat (2019); ECHA (2018); Kirk-Othmer (2000)
Laundry detergent
Consumer
CPCat lists 1-octadecanol as a surfactant in detergents. The ECHA registration
dossier identifies consumer use of 1-octadecanol in cleaning and washing
products. Kirk-Othmer states that 1-octadecanol can be used as a foam
controlling agent in detergents.
Expected users are consumer based on CPCat's retail product categories and
inclusion in ECHA's consumer uses.
EPA (2017b)
Paints and coatings
Consumer, commercial
CDR reported use of liquid 1-octadecanol in paints and coatings.
Expected users are consumer and commercial based on inclusion in CDR's
consumer and commercial use report.v
EPA (2017b)
Paper products
Consumer, commercial
CDR reported use of liquid and solid 1-octadecanol in paper products. CDR
identifies concentrations of liquid 1-octadecanol of 1-30 percent by weight.
Expected users are consumer and commercial based on inclusion in CDR's
consumer and commercial use report.
TSCA Conditions of Use: Personal Care Products
EPA's 2016 CDR identifies 1-octadecanol in both consumer and commercial use as well as manufacturing of personal care products (EPA 2017b). The Danish EPA listed
1-octadecanol as a chemical present in cosmetic products (Danish EPA 2011).
ECHA (2018)
Fragrances3
Consumer
The ECHA registration dossier identifies use of 1-octadecanol in perfumes and
fragrances.
Expected users are consumer based on inclusion in ECHA's consumer uses.
VII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
EPA (2018)
Paper handkerchiefs and toilet paper
Consumer
1-octadecanol is on U.S EPA's list of Chemical Substances in Paper
Handkerchiefs and Toilet Paper. Data for this list was collected by the Danish
Consumer Products Survey.
This use was identified in a consumer products survey; therefore the expected
users are consumer.
TSCA Conditions of Use: Pet Care
Delima Associates (2015d)
Pet conditioner
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
TSCA Conditions of Use: Other Consumer and Commercial Uses
CPCat (2019); ECHA (2018); Synapse Information Resources (2009)
Adhesives, sealants
Consumer, commercial,
industrial
CPCat identifies use of 1-octadecanol in adhesives, sealants, and adhesive
manufacturing. Synapse Information Resources lists 1-octadecanol as an
adhesive in food packaging. The ECHA registration dossier also reports use of
1-octadecanol in adhesives and sealants in European countries.
Expected users are based on CPCat's user classifications and inclusion in
ECHA's uses by professional workers.
ECHA (2018)
Anti-freeze and de-icing products
Consumer, commercial
The ECHA registration dossier identifies use of 1-octadecanol in anti-freeze and
de-icing products in European countries. No further information about this use
could be found and it is unknown whether this is an ongoing use in the United
States.
Expected users are based on inclusion in ECHA's consumer uses and uses by
professional workers.
VIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
EPA (2017b; 2018d); CPCat (2019); ECHA (2018)
Cleaning and furnishing care products
Consumer, commercial
1-octadecanol is on a list of ingredients American Cleaning Institute (ACI)
members to manufacture dish care, laundry care, and hard surface cleaning
products. CDR reported use of liquid 1-octadecanol in commercial cleaning
and furnishing care products. The ECHA registration dossier identifies use of 1-
octadecanol in washing and cleaning products.
Expected consumers are based on CDR's consumer/commercial classification
and inclusion in ECHA's consumer uses.
CPCat (2019)
Fabrics, textiles and apparel
Consumer, commercial
CPCat identifies use of 1-octadecanol in fabric, textile, apparel, and leather
products not elsewhere classified. No further information about this use could
be found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer and commercial based on CPCat's user
classification.
ECHA (2018)
Leather treatment products
Consumer, industrial
The ECHA registration dossier identifies use of 1-octadecanol in leather
treatment products in European countries. No further information about this use
could be found and it is unknown whether this is an ongoing use in the United
States.
Expected users are based on inclusion in ECHA's consumer uses and uses at
industrial sites.
IX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
EPA (2017b); CPCat (2019); ECHA (2018); Synapse Information Resources
(2009); Brown (2018)
Lubricants and greases
Consumer, commercial,
industrial
CDR reported use of 1-octadecanol (pellets and large crystals) in commercial
lubricants and greases at concentrations of less than 1 percent by weight and in
industrial lubricants and lubricant additives. CPCat identifies use of 1-
octadecanol in lubricants, greases, and fuel additives. NLM's Haz-Map
database reports use in lubricants, resins, and surface active agents, and the
ECHA registration dossier identifies use in lubricants, greases, and release
products in European Countries.
Expected users are commercial and industrial based on CDR's user
classification, and consumer based on inclusion in ECHA's consumer uses.
ECHA (2018)
Metal working fluids
Commercial, industrial
The ECHA registration dossier identifies use of 1-octadecanol in metal working
fluids in European countries. No further information about this use could be
found and it is unknown whether this is an ongoing use in the United States.
Expected users are based on inclusion in ECHA's uses by professional workers
and uses at industrial sites.
ECHA (2018)
Polishes and wax blends
Consumer, commercial
The ECHA registration dossier identifies use of 1-octadecanol in polishes and
wax blends in European countries. No further information about this use could
be found and it is unknown whether this is an ongoing use in the United States.
Expected users are based on inclusion in ECHA's uses by professional workers
and consumer uses.
X
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
CPCat (2019); Kirk-Othmer (2000)
Rubber and plastic products
Consumer, commercial
Kirk-Othmer states that 1-octadecanol can be used as part of the antioxidant
system in polyolefin plastics. CPCat also identifies use of 1-octadecanol in
rubber and plastic products. No further information about this use could be
found and it is unknown whether this is an ongoing use in the United States.
Expected users are consumer based on CPCat's user classification. Expected
users may also assumed to include commercial users.
ECHA (2018)
Textile dyes, and impregnating products
Consumer, industrial
The ECHA registration dossier identifies use of 1-octadecanol in textile dyes
and impregnating products in European countries. No further information about
this use could be found and it is unknown whether this is an ongoing use in the
United States.
Expected users are based on inclusion in ECHA's consumer uses and uses at
industrial sites.
EPA (2017b); Kirk-Othmer (2000)
Water treatment products
Commercial
CDR does not provide additional details on how liquid 1-octadecanol is used in
commercial water treatment. Kirk-Othmer states that 1-octadecanol can be
used to slow evaporation from reservoirs in arid regions; however, it is unknown
whether this use is currently practiced in the United States.
Expected users are commercial based on CDR's consumer/commercial
classification.
XI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
ECHA (2018)
Welding and soldering products
Consumer, commercial,
Industrial
The ECHA registration dossier identifies use of 1-octadecanol in welding and
soldering products (flux products) in European countries. No further information
about this use could be found and it is unknown whether this is an ongoing use
in the United States.
Expected users are based on inclusion in ECHA's consumer uses, uses by
professional workers, and uses at industrial sites.
TSCA Conditions of Use: Manufacturing and Other Industrial Uses
Kirk-Othmer (2000)
Concrete
Industrial
Kirk-Othmer states that 1-octadecanol is used to make polymer concrete.
Expected user is not stated, but is most likely industrial for concrete
manufacturing.
CPCat (2019)
Construction
Industrial
CPCat reports use of 1-octadecanol in construction in Nordic countries. No
further information about this use could be found and it is unknown whether this
is an ongoing use in the United States.
Expected user is not stated, but is most likely industrial for construction.
EPA (2017b)
Fabricated metal product manufacturing
Industrial
CDR reported use of 1-octadecanol in fabricated metal product manufacturing.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
XII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
ECHA (2018)
Furniture manufacturing
Industrial
The ECHA registration dossier identifies use of 1-octadecanol in furniture
manufacturing in European countries. No further information about this use
could be found and it is unknown whether this is an ongoing use in the United
States.
Expected users are based on inclusion in ECHA's uses at industrial sites.
CPCat (2019)
Oil and gas drilling, extraction, and support activities
Industrial
CPCat identifies use of 1-octadecanol in oil and gas resources extraction and
support activities. No further information on this use is available.
Expected users are industrial based on CPCat's user classification.
EPA (2017b)
Other basic organic chemical manufacturing
Industrial
CDR identified use of 1-octadecanol as an intermediate, surfactant, and raw
material in the processing (reactant and repackaging) phase of other basic
organic chemical manufacturing.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
EPA (2017b)
Other chemical product and preparation manufacturing
Industrial
CDR identified use of 1-octadecanol in the processing phase of other chemical
product and preparation manufacturing.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
XIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
EPA (2017b)
Paint and coating manufacturing
Industrial
CDR identified use of 1-octadecanol in re-packaging and incorporation into
formulation, mixture, or reaction product during paint and coating
manufacturing.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
EPA (2017b)
Paper manufacturing
Industrial
CDR identified use of 1-octadecanol as a defoamer and processing aid in
manufacturing of paper products.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
CPCat (2019)
Petrochemical manufacturing
Industrial
CPCat identifies use of 1-octadecanol in the manufacture of petrochemicals. No
further information on this use is available.
Expected users are industrial based on CPCat's user classification.
EPA (2017b)
Petroleum lubricating oil and grease manufacturing
Industrial
CDR identified use of 1-octadecanol as both an additive and solvent in the
manufacturing of petroleum lubricating oil and grease.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
XIV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
EPA (2017b)
Pharmaceutical and medicine manufacturing
Industrial
CDR reported use of 1-octadecanol in the manufacture of medicine and
pharmaceuticals.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
CPCat (2019); Synapse Information Resources (2009); Kirk-Othmer (2000)
Plastics product, material, and resin manufacturing
Industrial
Kirk-Othmer states that 1-octadecanol can be used as part of the antioxidant
system in polyolefin plastics. Synapse Information Resources identifies use of
1-octadecanol as a lubricant for plastics processing. CPCat identifies use in
plastics product manufacturing and plastics material and resin manufacturing.
Expected users are industrial based on CPCat's user classification.
ECHA (2018); Kirk-Othmer (2000)
Polymer preparation and compounds
Commercial
Kirk-Othmer states that a foamed composition of octadecanol is used for
coating polymers. The ECHA registration dossier identifies use of 1-
octadecanol in polymer preparation and compounds.
Expected users are industrial based on inclusion in ECHA's uses at industrial
sites.
EPA (2017b); CPCat (2019)
Soap, cleaning compound, and toilet preparation
manufacturing
Industrial
CDR reported use of 1-octadecanol in soap, cleaning compound, and toilet
preparation manufacturing.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
XV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
Textiles, apparel, and leather manufacturing
Industrial
EPA (2017b)
CDR identified use of 1-octadecanol in the processing phase of textiles,
apparel, and leather manufacturing.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
Water treatment product manufacturing
Industrial
EPA (2017b)
CDR identified use of 1-octadecanol as a defoamer in the processing phase
(and incorporation into formulation, mixture, or reaction product) of water
treatment product manufacturing.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
Wholesale and retail trade
Industrial
EPA (2017b)
CDR reported use of 1-octadecanol in retail and wholesale trade for non-
incorporative use.
Expected users are industrial based on identification in CDR's industrial
processing and use report.
Non-TSCA Uses
After shave
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
After sun product
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
XVI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
Delima Associates (2008c)
Anti-itch cream
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Delima Associates (2013d)
Antiperspirant and deodorant
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
DeLima Associates (2015b)
Anti-wrinkle cream
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
EWG (2018)
Around-eye cream
Consumer
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Delima Associates (2008a)
Baby skin cream
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer
EWG (2018)
Baby sunscreen
Consumer
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
ECHA (2018)
Biocidal products
Consumer, commercial,
industrial
The ECHA registration dossier identifies use of 1-octadecanol in biocidal
products (e.g. disinfectants, pest control) in European countries. No further
information about this use could be found and it is unknown whether this is an
ongoing use in the United States.
Expected users are based on inclusion in ECHA's consumer uses, uses by
professional workers, and uses at industrial sites.
XVII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
Body firming lotion
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Body hair removal
Consumer
CPCat (2019)
CPCat identifies use of 1-octadecanol in retail body hair removal products. No
further information about this specific use could be found and it is unknown
whether this is an ongoing use in the United States.
Expected users are consumer based on identification under CPCat's retail
product categories.
Body wash/cleanser
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Conditioner (hair)
Consumer
DeLima Associates (2016a)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Creams and ointments
Consumer, commercial
Kirk-Othmer (2000)
Kirk-Othmer states that 1-octadecanol is used in emollient additives and bases
for creams and ointments. Use status is "ongoing" based on the other creams
containing the chemical identified in this table.
Expected user is not stated in the source, but is likely consumer and
commercial for cream and ointment products.
Deodorant
Consumer
DeLima Associates (2015a)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
XVIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
Detangler
Consumer
Delima Associates (2013a)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Diaper cream
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Diapers
Consumer
Delima Associates (2009c)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Face makeup with sunscreen
Consumer
Delima Associates (2008d)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Facial cleanser
Consumer
Delima Associates (2013e)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Facial moisturizer
Consumer
Delima Associates (2009b)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
First aid
Consumer
CPCat (2019)
CPCat identifies use of 1-octadecanol in retail first aid products. No further
information about this specific use could be found and it is unknown whether
this is an ongoing use in the United States.
Expected users are consumer based on identification under CPCat's retail
product categories.
XIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
CPCat (2019); FDA (2018); Brown (2018); Synapse Information Resources
(2009)
Food additives
Unknown
1-octadecanol is on the FDA's list of Everything Added to Food in the United
States. According to the NLM's Haz-Map database, it has been approved as
both a direct and indirect food additive. Synapse Information Resources
identifies use of 1-octadecanol in food additives and as an intermediate in the
manufacture of food additives.
The expected users are unknown, due to the limited availability of information.
EWG (2018)
Foundation
Consumer
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Delima Associates (2011); GoodGuide (2011)
Hair color
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Delima Associates (2009d)
Hair regrowth product
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
EWG (2018); GoodGuide (2011); Kirk-Othmer (2009)
Hair treatment
Consumer, commercial
Pollution Scorecard lists 1-octadecanol for use in commercial perms, and
consumer and commercial hair coloring preparations (bleaches, dyes, rinses),
hair tonics, and scalp conditioners. Kirk-Othmer states that 1-octadecanol can
be used in permanent hair straightening compositions. EWG lists several hair
treatment products currently being sold with 1-octadecanol. The percent
composition of the chemical within hair treatment products is not included in
any of the sources.
Expected user is consumer and commercial based on EWG and Pollution
Scorecard.
XX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
EWG (2018)
Hand cream
Consumer
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
CPCat (2019)
Juice
Consumer
CPCat identifies use of 1-octadecanol in juice. No further information was found
on the current status of this use in the United States.
The expected users are consumer based on inclusion in CPCat's retail product
categories.
Delima Associates (2008b)
Lip protectant
Consumer
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Kirk-Othmer (2000); EWG (2018)
Lipstick
Consumer
Kirk-Othmer states that 1-octadecanol is used in emollient additives and bases
for lipsticks.
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
EWG (2018)
Makeup primer
Consumer
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
EWG (2018)
Makeup remover
Consumer
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
XXI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
Mask
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Moisturizer w/SPF
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Mouth sore medication
Consumer
DeLima Associates (2016b)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Nail treatment
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Perfumes
Consumer
ECHA (2018); Synapse Information Resources (2009); GoodGuide (2011);
Brown (2018)
Pollution Scorecard lists 1-octadecanol for use in perfume oil mixtures and
blends. Haz-Map and Synapse Information Resources identify use in
perfumery. The ECHA registration dossier identifies use of 1-octadecanol in
perfumes and fragrances.
Expected users are consumer based on inclusion in ECHA's consumer uses.
XXII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
Pharmaceuticals
Consumer, commercial
CPCat (2019); Brown (2018); FDA (2012); Synapse Information Resources
(2009); GoodGuide (2011)
According to CPCat, 1-octadecanol is on the FDA's inactive drug ingredients
list. NLM's Haz-Map database states that the chemical is used as a substitute
for cetyl alcohol in pharmaceutical dispensing. Synapse Information Resources
identifies use of 1-octadecanol as a surfactant, emulsion stabilizer, emulsifier,
emollient, stiffener, and astringent in pharmaceuticals.
Expected user is not stated in the sources, but is likely consumer and
commercial for pharmaceuticals.
Shampoo
Consumer
DeLima Associates (2016c)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Shave cream
Consumer
Delima Associates (2009a)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Skin fading/lightener
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Skin moisturizer
Consumer
Delima Associates (2013f)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Skin toner
Consumer
DeLima Associates (2015c)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
XXIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use
Expected Users
Description of Use and References
Styling gel/lotion
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Styling mousse/foam
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Sunless tanner
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Sunscreen
Consumer
Delima Associates (2013b)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
Sunscreen moisturizer
Consumer
EWG (2018)
Skin Deep generally includes products for consumer use; therefore the
expected user is a consumer.
Wrinkle concealer
Consumer
Delima Associates (2013c)
CPID generally includes products for consumer use; therefore the expected
user is a consumer.
XXIV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table A.3: Uses of 1-Octadecanol
Use | Expected Users | Description of Use and References
Children's Products
CDR identified the presence of 1-octadecanoi in children's arts, crafts, and hobby materials, as well as in industrial organic chemicals used in consumer and commercial
products. Additionally, uses in after sun product, baby skin cream, baby sunscreen, diaper cream, and finger paints are reported in this table. The Danish EPA (2007)
included this chemical in its survey of cosmetic products for children.
Recycling and Disposal
In the 2016 CDR, 13 facilities reported not recycling (e.g., not recycled, remanufactured, reprocessed, or reused) 1-octadecanol. Two facilities withheld recycling
information, and one facility reported recycling information as CBI (EPA 2017b).
Note(s):
1. Assumed to be a mix of TSCA and non-TSCA uses. It is expected that more specifically defined uses in the table are representative of the uses that fall into this
category.
2. TSCA use based on the assumption that the chemical is used in the manufacturing of products and not intended to be a component of food.
3. Potentially a non-TSCA use as the category may contain both TSCA and non-TSCA uses; however, because information is insufficient to determine, it is assumed to be
covered by TSCA.7
XXV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
A.3 References
BASF. (2018). Kolliwax® SA Fine. Retrieved from https^/pharmaceutical.basf.com/cn/Drug-
Formulation/Kolliwax-SA-Fine.html
Brown, J. A. (2018). Haz-Map®: Information on Hazardous Chemicals and Occupational Diseases.
Retrieved from https://hazmap.nlm.nih.gov/catcgorv-dctails?tablc=copYtblagcnts&id=2914
California Dept of Pesticide Regulation. (2013). DPR Databases. Retrieved from
https: //www. cdpr. ca. gov/dprdatabase .htm
Danish EPA. (2007). A survey and health assessment of cosmetic products for children. Retrieved from
https://www2.mst.dk/udgiv/publications/2007/978-87-7052-638-8/pdf/978-87-7052-639-5.pdf
Danish EPA. (2011). Survey and health assessment of cosmetic products marketed as "non-preserved".
Retrieved from https://www2.mst.dk/udgiv/publications/2011/04/978-87-92708-67-0.pdf
Danish EPA. (2018). Danish surveys on chemicals in consumer products. Retrieved from
https://eng.mst.dk/chemicals/chemicals-in-products/consumers-consumer-products/danish-
survevs-on-consumer-products/
Delima Associates. (2008a). Aveeno Baby Soothing Relief Moisture Cream, Fragrance Free. Retrieved
from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/8723/standard/Aveeno%20Babv%20Sooth
ing%20Relief%20Moisture%20Cream.%20Fragrance%20Free/10-001-080
Delima Associates. (2008b). Aveeno Lip Protectant, Intense Relief Medicated Therapy. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/8730/standard/Aveeno%20Lip%20Protecta
nt.%20Intense%20Relief%20Medicated%20Therapv/10-001-088
Delima Associates. (2008c). Aveeno Maximum Strength Anti-Itch Cream, 1 Percent Hydrocortisone.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/873 l/standard/Aveeno%20Maximum%20
Strength%20Anti-Itch%20Cream.%201Percent%20Hvdrocortisone/10-001-089
Delima Associates. (2008d). Cover Girl Smoothers Tinted Moisturizer SPF15, Deep-11/01/2007.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/8254/standard/Cover%20Girl%20Smoothe
rs%20Tinted%20Moisturizer%20SPF15.%20Deep-l 1/01/2007/16-003-788
Delima Associates. (2009a). Barbasol Moisturizing Non-Aerosol Therapeutic Shave Cream, Sensitive
Skin. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/9523/standard/Barbasol%20Moisturizing%
20Non-Aerosol%20Therapeutic%20Shave%20Cream.%20Sensitive%20Skin/16-028-007
XXVI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Delima Associates. (2009b). Dove Facial Lotion, Deep Moisture, Dry Skin. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/9658/standard/Dove%20Facial%20Lotion.
%20Deep%20Moisture.%20Drv%20Skin/21 -010-064
Delima Associates. (2009c). Pampers Baby Dry Diapers Size 1-2, Up to 15 lbs. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/6014/standard/Pampers%20Babv%20Drv
%20Diapers%20Size%201-2.%20Up%20to%2015%201bs/16-030-246
Delima Associates. (2009d). Rogaine, Mens 5 Percent Topical Aerosol Foam. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/9737/standard/Rogainc.%20Mens%205%2
0Percent%20Topical%20Aerosol%20Foam/10-001-120
Delima Associates. (2011). Bal Rung Instant Hair Color, 08050. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/11245/standard/Bal%20Rung%20Instant%
20Hair%20Color.%2008050/08-050-006
Delima Associates. (2013a). Amway Satinique Moisturising Detangler. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/12867/standard/Amwav%20Satinique%20
Moisturising%20Detangler/01-034-028
Delima Associates. (2013b). Australian Gold Sheer Coverage Lotion with InvisiDry SPF 15. Retrieved
from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/13569/standard/Australian%20Gold%20Sh
eer%20Coverage%20Lotion%20with%20InvisiDrv%20SPF%2015/01-036-003
Delima Associates. (2013c). Avon Anew Genics Treatment Concentrate. Retrieved from
https: //www.whatsinproducts. com/type s/tvpe detail/1/13810/standard/Avon%2 0Anew%20Genic
s%20Treatment%20Concentrate/01 -022-184
Delima Associates. (2013d). AXE Dry AntiPerspirant and Deodorant, 24 Hour, Invisible Solid, Apollo.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/13426/standard/AXE%20Drv%20AntiPers
pirant%20and%20Deodorant.%2024%20Hour.%20Invisible%20Solid.%20Apollo/21-010-304
Delima Associates. (2013e). Clearasil Daily Clear Refreshing Superfruit Scrub, Raspberry & Cranberry
Extracts-04/01/2013. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/16300/standard/p%20class=%22pl%22%3
EClearasil%20Dailv%20Clear%20Refreshing%20Superfruit%20Scrub.%20Raspberrv%20&%20
Cranberrv%20Extracts-04/01/2013/p%3E/l 8-001 -979
Delima Associates. (2013f). Dermatone Camphor Ice Skin Balm. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/13803/standard/Dermatone%20Camphor%
20Ice%20Skin%20Balm/02-028-003
DeLima Associates. (2015a). Arm & Hammer Ultra Max Antiperspirant Deodorant, Solid, Active Sport-
11/06/2015. Retrieved from
XXVII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
https://www.whatsinproducts.com/tvpes/tvpe detail/1/17193/standard/p%20class=%22pl%22%3
EArm%20&%20Hammer%20Ultra%20Max%20Antiperspirant%20Deodorant.%20Solid.%20Ac
tive%20Sport-11/06/2015/p%3E/03-005-184
DeLima Associates. (2015b). Olay Age Defying Anti-Wrinkle Eye Cream-02/16/2015. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17728/standard/p%20class=%22pl%22%3
EQlav%20 Agc%20Dcfving%20 Anti-\¥rinklc%20Eve%20Crcam-02/16/2015/p%3E/16-033-084
DeLima Associates. (2015c). Olay Fresh Effects Clear Skin Redness & Pore Reducing Mattifier-
02/13/2015. 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. (2015d). TropiClean Spa Nourish, Pet Conditioner, Oatmeal & Plumeria-02/01/2015.
Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/2023 l/standard/p%20class=%22pl%22%3
ETropiClean%20Spa%20Nourish.%20Pet%20Conditioner.%200atmeal%20&%20Plumeria-
02/01/2015/p%3E/20-022-028
DeLima Associates. (2016a). Aussie 3 Minute Miracle Moist Conditioner-05/04/2016. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/18723/standard/p%20class=%22pl%22%3
EAussie%203%20Minute%20Miracle%20Moist%20Conditioner-05/04/2016/p%3E/16-033-519
DeLima Associates. (2016b). Orajel Mouth Sore Triple Medicated Gel-01/04/2016. Retrieved from
https://www.whatsinproducts.com/tvpes/tvpe detail/l/17243/standard/p%20class=%22pl%22%3
EOraiel%20Mouth%20Sore%20Triple%20Medicated%2QGel-01/04/2016/p%3E/03-005-234
DeLima Associates. (2016c). Pantene Pro-V Expert Intense Repair Shampoo-05/13/2016. Retrieved
from
https://www.whatsinproducts.com/tvpes/tvpe detail/1/18682/standard/p%20class=%22pl%22%3
EPantene%20Pro-V%20Expert%20Intense%20Repair%20Shampoo-05/13/2016/p%3E/16-033-
499
DeLima Associates. (2018). Consumer Product Information Database. Retrieved from
https: //www. whatsinproducts. com/
Descartes Datamyne. (2018). 1-Octadecanol imports 2011-2018.
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. (2018). DrugBank Database. Retrieved from https://www.drugbank.ca/
XXVIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
European Chemicals Agency (ECHA). (2018). Registration Dossier - Consumer Uses. Retrieved from
https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/3/l/6
EWG. (2018). Skin Deep Cosmetics Database. Retrieved from
https://www.ewg.org/skindeep/ingredient/706325/STEARYL ALCOHOL/#.WvqxSFVKiM9
GoodGuide. (2011). Scorecard Chemical Profiles: 1-Octadecanol. Retrieved from
http://scorecard.goodguide.com/chemical-profiles/summarv.tcl7edf substance id=+l 12-92-5
Government of Canada. (2018). Chemical Substances: Services and Information. Retrieved from
https://www.canada.ca/en/health-canada/services/chemical-substances.html
Kao Corporation. (2016). Safety Data Sheet KALCOL 8098AO BULK. Retrieved from
https://chemical.kao.com/us/pdf/msds/sds usen A0006415.pdf
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. (2000). Alcohols, Higher Aliphatic, Survey and Natural Alcohols Manufacture. Kirk-
Othmer Encyclopedia of Chemical Technology.
Kirk-Othmer. (2009). Hair Preparations. 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
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). ACI Cleaning Product Ingredients List.
Retrieved from https://actor.epa. gov/actor/assav.xhtml?assavld=5
U.S. Environmental Protection Agency (EPA). (2018b). ChemView. Retrieved from
https: //chemvie w .epa. gov/chemview
XXIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
U.S. Environmental Protection Agency (EPA). (2018c). Envirofacts Multisystem Search. Retrieved from
https://www3.epa.gov/enviro/facts/multisvstem.html
U.S. Environmental Protection Agency (EPA). (2018d). Inert Ingredients Permitted for Use in Nonfood
Use Pesticide Products. Retrieved from https://actor.cpa. gov/actor/assav.xhtml ?assavld=969
U.S. Environmental Protection Agency (EPA). (2018e). 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). (2018f). Safer Chemical Ingredients List. Retrieved from
https://www.epa.gov/saferchoice/safer-ingredients
U.S. Environmental Protection Agency (EPA). (2018g). TRI-Listed Chemicals. Retrieved from
https://www.epa.gov/toxics-release-inventorv-tri-program/tri-listed-chemicals
U.S. Food and Drug Administration (FDA). (2012). FDA Inactive Ingredients Database. Retrieved from
https: //actor, epa. gov/actor/assav .xhtml ?assavld= 1398
U.S. Food and Drug Administration (FDA). (2018). Everything Added to Food in the United States
(EAFUS). Retrieved from
https://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm7filteFll2-92-
5 &sortC olumn=&rpt=eafusListing
U.S. National Library of Medicine (NLM). (2018). Toxnet Hazardous Substances Data Bank: 1-
Octadecanol. Retrieved from https://toxnet.nlm.nih.gOv/cgi-bin/sis/search2/f7./temp/~ZHgf9u:3
U.S. Patent and Trademark Office (USPTO). (2018). USPTO Patent Full-Text and Image Database.
Retrieved from http: //patft .uspto. gov/netacgi/nph-
Parser?Sectl=PT02&Sect2=HIT0FF&p=l&u=%2Fnetahtml%2FPT0%2Fsearch-
bool ,html&r=0&f=S&l=5 O&TERM 1=1-
octadecanol&FIELD 1=&co 1 =AND&TERM2=&FIELD2=&d=PTXT
Ullmann's. (2000). ULLMANN'S Encyclopedia of Industrial Chemistry.
Washington State Dept. of Ecology. (2018). Children's Safe Product Act Reported Data. Retrieved from
https ://fortress ,wa. gov/ecv/cspareporting/
XXX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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 rabbits
24 hours
Dose: 25 mmol
Replicates: 3
7.6% of the administered
dose was excreted by
glucuronide
Methods:
• Test substance reported as CASRN 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-Dawley
Single dose,
Dose: 2000 mg/kg
LDso > 2000 mg/kg
Methods:
4962991
rats
14 day
observation
Replicates: 5 per
sex
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 401
• GLP compliant
4949228,
Oral (gavage)
Wistar rats
Single dose,
Dose: 5000 mg/kg
LD50 > 5000 mg/kg
Methods:
4963039
14 day
observation
Replicates: 5 per
sex
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 401
• GLP compliant
4962992
Oral (gavage)
Holzman rats
Single dose
Doses: 2000 and
7960 mg/kg
Replicates: 5 per
sex per group
LD50 > 7960 mg/kg
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• Predates GLP compliance
XXXI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4949228
Dermal
New Zealand
white rabbit
24 hour
exposure,
observed for
14 days
Dose: 8000 mg/kg
Replicates: 4
animals
LDso > 8000 mg/kg
Methods:
• Substance reported as CASRN 67762-27-0
• Purity not reported
• Not GLP compliant
5094502
Inhalation
Sprague-Dawley
rats
6 hour
exposure,
observed for
14 days
Dose: 0.00014
mg/L
Replicates: 6
animals
LCso> 0.00014 mg/L
Methods:
• 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
Wistar rats
45 days
(males), 54
days (females)
Doses: 0,100,
500, and 2000
mg/kg-day
Replicates: 12
per sex per group
NOAEL: 2000 mg/kg-
day
Methods:
• Test substance reported as CASRN 112-92-5
• Purity: 99%
• OECD Guideline 422
• GLP compliant
4949228,
4934169
Oral (gavage)
Sprague-Dawley
rats
28 days
Doses: 0,100,
500, and 1000
mg/kg-day
Replicates: 10
per sex per group
NOAEL: 1000 mg/kg-
day
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 407
• GLP compliant
820061
Oral
Male Wistar rats
1 week- 3
months
Doses: 9400 -
28000 mg/kg-day
Replicates: 15
total, 3-4 per
timepoint
LOAEL: 28000 mg/kg-
day based on hepatic
structural changes in
mitochondria
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• GLP compliance not reported
4949228,
34905
Oral (gavage)
CD rats
26 weeks
Doses: 0,10,100,
and 1000 mg/kg-
day
Replicates: 20
per sex per dose
NOAEL: 1000 mg/kg-
day
Methods:
• Test substance reported as CASRN 661 -19-8
• Purity: 98%
• GLP compliant
Mortality Results:
XXXII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
• 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 CASRN 661 -19-8
• Purity: 98%
• GLP compliant
Reproductive Toxicity
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4949228
Oral
Wistar rats
14 days prior
to mating for a
total of 45
days (males)
or 54 days
(females)
Doses: 0,100,
500, and 2000
mg/kg-day
Replicates: 12
per sex per dose
NOAEL: 2000 mg/kg-
day
Methods:
• Test substance reported as CASRN 112-92-5
• Purity: 99%
• OECD Guidelines 422
• GLP compliant
Developmental Toxicity
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4949228,
4962975
Oral
Female Wistar
rats
14 days prior
to mating,
throughout
mating and
gestation until
PND5 for a
total duration
of 54 days
Doses: 0,100,
500, and 2000
mg/kg-day
Replicates: 12
per group
NOAEL: 2000 mg/kg-
day
Methods:
• Test substance reported as CASRN 112-92-5
• Purity: 99%
• OECD Guidelines 422
• GLP compliant
XXXIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
Cancer
Source
Effect
Study Details
OncoLogic
v8.0
Specific concern level not reported
Based on the Aliphatic Alcohols functional group:
Medium sized alcohols (carbon length 6 to 20) that
can be oxidized to metabolically persistent aliphatic
carboxylic acids are potential nongenotoxic
carcinogens.
ISS v2.440
Negative (Estimated)
1-Octadecanol 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-octadecanol
VEGA 1.1.441
1-Octadecanol was processed through all 4 models. 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-Octadecanol is expected not to be carcinogenic on the basis of the VEGA predictions.42
Methods:
VEGA 1.1.4 contains 4 models for carcinogenicity
-CAESAR2.1.9, ISS 1.0.2, IRFMN/Antares 1.0.0,
IRFMN/ISSCAN-GX 1.0.0
Results:
• CAESAR 2.1.9: Low reliability (1-Octadecanol
could be outside of the applicability domain
(AD) of the model)
• ISS 1.0.2: Low reliability (1-Docosanol could
be outside of the AD)
• IRFMN/Antares 1.0.0: Predicted to be
possible non-carcinogen with good reliability
• IRFMN/ISSCAN-GX 1.0.0: Predicted to be
possible non-carcinogen with moderate
reliability
Genotoxicity
40 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).
XXXIV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
Source
Test Type &
Endpoint
Species &
Strain (if
available)
Metabolic
Activation
Doses and
Controls
Results
Study Details
59200
Gene mutation
(in vitro)
S. typhimurium
strains TA98,
TA100, TA1535
and TA1537
With and
without
Dose: 3
|jmol/plate
Negative,
Substance precipitated
Methods:
• Test substance reported as CASRN 112-92-5
• Purity >97%
• GLP compliance not reported
688977
Gene mutation
(in vitro)
S. Typhimurium
strains TA98,
TA100, TA1535,
TA1537, and
TA1538
With and
without
Doses: 0.033,
0.10,0.33,1.0,
3.3, and 10
mg/plate
Negative
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• GLP compliance not reported
688977
Gene
mutation (in
vitro)
E.coli WP2
With and
without
Doses: 0.033,
0.10,0.33, 1.0,
3.3, and 10
mg/plate
Negative
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• GLP compliance not reported
1316160,
4949228
Gene
mutation (in
vitro)
S. typhimurium
strains TA98,
TA100, TA1535,
TA1537, and
TA1538
With and
without
Dose: 50 pg/plate
Negative
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• GLP compliance not reported
41 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.
42 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.
XXXV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4934099
Gene
E. coli WPR
With and
Doses: 10, 33.3,
Negative, precipitate
Methods:
mutation (in
without
100, 333, 1000,
formed at 333 pg/plate
• Test substance reported as CASRN 112-92-5
vitro)
and 3333.3
|jg/piate
and higher
• Purity not reported
• Not GLP compliant
4934099,
Gene
S. typhimurium
With and
Doses: 50,150,
Negative, Precipitation
Methods:
4962999
mutation (in
strains TA1535,
without
500,1500, and
was reported at
• Test substance reported as CASRN 112-92-5
vitro)
TA1537,
TA1538, TA98,
and TA100
5000 pg/plate
concentrations greater
than or equal to 500
pg/plate
• Purity not reported
• OECD Guideline 471
• GLP compliant
4949228
Gene
S. typhimurium
With and
Doses: 0.63,1.25,
Negative
Methods:
mutation (in
strains TA1535,
without
2.5, 5,10 and 20
• Test substance reported as CASRN 112-92-5
vitro)
TA1537,
TA1538, TA98
and TA100
|jg/piate
• Purity not reported
• GLP compliance not reported
4949228
Chromosomal
aberration (in
vivo)
ddY mice
N/A
Doses: 360, 730,
1450 and 2920
mg/kg
Negative
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• GLP compliance not reported
Sensitization
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses and
Replicate
Number
Effect
Study Details
4963042,
Skin
Guinea Pig
48 hours
Doses: 25% and
Negative
Methods:
4962994
50% of test
material
Replicates: 10
per dose
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 406
• GLP compliant
Irritation
Source
Exposure
Route
Species &
Strain (if
available)
Duration
Doses
Effect
Study Details
XXXVI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.1: Human Health Hazard
4949228,
4962998
Dermal
New Zealand
White Rabbits
4 hour
exposure, 72
hour
observation
Dose: 0.5g of test
material
Replicates: 3
Females
Negative
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 404
• GLP compliant
4949228,
4962998
Dermal
Human
24 hours
Dose: 15 pL of
0.5,1, and 2 M of
test material
Replicates: 20
Negative
Methods:
• Test substance reported as CASRN 112-92-5
• Purity: 95%
• GLP compliance not reported
4949228
Ocular
New Zealand
White Rabbits
72 hour
observation
Dose: 0.1 mL of
undiluted test
substance
Replicates: 3
Moderate
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 405
• GLP compliant
Results:
• Cornea and iris scores were 0, 0, 0.3 at 24, 48
and 72 hours
• Redness of the conjunctiva scores were 0.3,
0,1 at 24, 48 and 72 hours
• Chemosis scores were 0, 0, 0.3 at 24, 48 and
72 hours
• All effects reversible by 72 hours
Table B.2: Environmental Hazard
Aquatic Toxicity: Experimental
Source
Species & Strain
Duration
Doses and
Effect
Study Details
(if available)
Replicate
Number
XXXVII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.2: Environmental Hazard
4949228
Oncorhynchus
mykiss
96 hours
Dose: 0.4 mg/L
Replicates: 10
organisms per
vessel, 2
vessels
LCso > 0.4
mg/L (NES)
Methods:
• Test substance reported as CAS RN 112-92-5
• Purity not reported
• OECD Guideline 203
• GLP compliant
4949228
Danio rem
96 hours
Doses: 0,
1000, 3000,
and 10,000
mg/L
LCso > 10000
(NES)
Methods:
• Test substance reported as CAS RN 112-92-5
• Purity not reported
• ISO 7346/II
• 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, and 300
mg/L unfiltered
and 0.1, 0.3,
1.0, 3.0, and
10.0 mg/L
filtrate
ECso: 250
mg/L
(unfiltered)
ECso > 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
Model
Type
Duration
Species
Predicted
Effect Level
Notes
XXXVIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.2: Environmental Hazard
ECOSAR v2.0
(Class: Neutral
Organics)
Estimate
Chronic
Green algae
<0.01 (NES)
Estimated ChV exceeds the experimental water solubility and estimated
LogKow for this substance.
ECOSAR v2.0
(Class: Neutral
Organics)
Estimate
Chronic
Freshwater fish
<0.01 (NES)
Estimated ChV exceeds the experimental water solubility and estimated
LogKow for this substance.
Table B.3: Fate
Environmental Fate: Experimental
Source
Endpoint
Duration
Doses and Number of
Replicates
Results
Study Details
4949228
Biodegradation
28 days
Doses: 2 and 5 mg/L
Inherently
biodegradable
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 301D
• GLP compliance not reported
Results:
• 30% in 7 days
• 52% in 14 days
• 59% in 21 days
• 69% in 28 days
4949228
Biodegradation
28 days
Dose: 100 mg/L
Inherently
biodegradable
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 301D
• GLP compliance not reported
Results:
• 25% in 7 days
• 52% in 14 days
• 66% in 21 days
• 67% in 28 days
XXXIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.3: Fate
4949228
Biodegradation
28 days
Dose: 20 mg/L
Inherently
biodegradable
Methods:
• Test substance reported as CASRN 112-92-5
• Purity not reported
• OECD Guideline 301B
• GLP compliant
Results:
• 10% in 8 days
• 35% in 14 days
• 39% in 20 days
• 43% 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
4949228
Aerobic
biodegradation
28 days
Dose: 100 mg/L
Inherently
biodegradable
Methods:
• Test substance reported as CASRN 36653-82-4
• Purity not reported
• ISO 10708 (BODIS) and RDA-Blok Test
• 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
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
1 mg/L
Total
biodegradation
Methods:
• Test substance reported as CASRN 36653-82-4
XL
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table B.3: Fate
• Purity > 98%
• GLP compliance not reported
Degradation during test:
• 90.1% in 28 days
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
B.1 References
Blevins, RD; Taylor, DE. (1982). Mutagenicity screening oftwentyfive cosmetic ingredients with the salmonella/microsome test. J Environ Sci
Health A Environ Sci Eng 17: 217-239. http://dx.doi.org/10.1080/10934528209375029
ECHA (European Chemicals Agency). (1965). Octadecan-l-ol: acute toxicity: oral: 003 supporting | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/7/3/2/?documentUUID=13e86c38-ff99-4713-999b-671557a015c0
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). (1981). Octadecan-l-ol: acute toxicity: oral: 002 supporting | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/7/3/2/?documentUUID=felab620-6fca-4e5a-b95e-a845b3091d95
ECHA (European Chemicals Agency). (1992a). Octadecan-l-ol: developmental toxicity/teratogenicity: 001 key | experimental result. Helsinki,
Finland. https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/7/9/3
ECHA (European Chemicals Agency). (1992b). Octadecan-l-ol: Short-term toxicity to aquatic invertebrates. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/6/2/4
ECHA (European Chemicals Agency). (1992c). Octadecan-l-ol: Toxicity to aquatic algae and cyanobacteria. Helsinki, Finland.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/6/2/6
XLI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
ECHA (European Chemicals Agency). (1996a). Octadecan-l-ol: acute toxicity: oral: 001 key | experimental result.
https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/7/3/2/?documentUUID=36c99250-9463-4951-b72d-5f6da531clcb
ECHA (European Chemicals Agency). (1996b). Octadecan-l-ol: genetic toxicity: in vitro gene mutation study in bacteria: 003 key | experimental
result. https://echa.europa.eu/registration-dossier/-/registered-dossier/15937/7/7/2/?documentUUID=41clbb6d-e018-4b75-a53e-
6689aff36c44
Florin, I; Rutberg, L; Curvall, M; Enzell, CR. (1980). Screening of tobacco smoke constituents for mutagenicity using the Ames' test. Toxicology
15: 219-232. http://dx.doi.org/10.1016/0300-483X(80)90055-4
Iglesias, G; Hlywka, JJ; Berg, JE; Khalil, MH; Pope, LE; Tamarkin, D. (2002). 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
Mortelmans, KE; Tanaka, W. (1979). Microbial mutagenesis testing of substances. Compound report: F76-056, stearyl alcohol, ashland chemicals,
lot #850-M654-161, CAS no. (10102-17-7) 112-92-5. (FDA 223-77-2118). Rockville, MD: Department of Health, Education, and
Welfare, Food and Drug Administration.
OECD (Organisation for Economic Co-operation and Development). (1993). Screening information data set for high production volume
chemicals: 1-octadecanol. UNEP Publications.
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
Prival, MJ; Simmon, VF; Mortelmans, KE. (1991). Bacterial mutagenicity testing of 49 food ingredients gives very few positive results. Mutat Res
260: 321-329. http://dx.doi.org/10.1016/0165-1218(91)90017-0
Sato, A; Obata, K; Ikeda, Y; Ohkoshi, K; Okumura, H; Ozawa, N; Ogawa, T; Katsumura, Y; Kawai, J; Tatsumi, H; Honoki, S; Hiramatsu, I;
Hiroyama, H; Okada, T; Kozuka, T. (1996). Evaluation of human skin irritation by carboxylic acids, alcohols, esters and aldehydes, with
nitrocellulose-replica method and closed patch testing. Contact Derm 34: 12-16. http://dx.doi.Org/10.llll/j.1600-0536.1996.tb02104.x
XLII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Wakabayashi, T; Adachi, K; Popinigis, J. (1991). Effects of alkyl alcohols and related chemicals on rat liver structure and function: I. Induction of
two distinct types of megamitochondria. Acta Pathol Jpn 41: 405-413. http://dx.doi.Org/10.llll/j.1440-1827.1991.tb03207.x
Wakabayashi, T; Horiuchi, M; Adachi, K; Koyama, T. (1984). Induction of megamitochondria in rat hepatocytes by 1-octadecanol. J Electron
Microsc (Tokyo) 33: 236-238.
XLIII
-------
* * * Proposal Draft - Do Not Cite, Quote or Release During the Review * * *
Appendix C: Literature Search Outcomes
C.1 Literature Search and Review
This section briefly describes the literature search and review process, search terms, and search outcomes
for the hazard and fate screening of 1-octadecanol. Search outcomes and reference details are provided on
the candidate's HERO43 project page.
EPA created a fit-fbr-purpose process to transparently document the literature search and review44 of
available hazard and fate information for low-priority substance (LPS) candidates. References from peer-
reviewed primary sources, grey sources,45 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
from primary peer-
reviewed sources
T
References available
from grey literature
and other sources
References available at
title/abstract screening
T
I
References available at full text screening
T
References available at data quality evaluation
T
References included in LPS screening reviews
References excluded at
title/abstract screening
References excluded at
full text screening
References excluded at
data quality evaluation
43 The HERO low-priority substance candidate project pages are accessible to the public at https://hero.epa,gov/hero/.
44 Discussed in the document "Approach Document for Screening Hazard Information for Low-Priority Substances Under
TSCA", also released at proposal.
43 Grey literature and additional sources are the broad category of studies not found in standard, peer-reviewed literature database
searches. Hiis includes U.S. and international government agency websites, non-government organization (NGO) websites, and
data sources that are difficult to find, or are not included, in the peer-reviewed databases, such as white papers, conference
proceedings, technical reports, reference books, dissertations, and information on various stakeholder websites.
XLIV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
C.1.1 Search for Analog Data
To supplement the information on the candidate chemical, 1-octadecanol, the following analogs were
used for designation: alcohols, C16-18 (CASRN 67762-27-0 and cetyl alcohol (CASRN 36653-82-4).
Alcohols CI6-18 and C18 unsaturated (CASRN 68002-94-8) was also considered but not used for
designation. For more details and justification on analogs, see section 6.1.1. Analogs were used to fill data
gaps on endpoints for which 1-octadecanol lacked quality data or to add to the weight of the scientific
evidence. EPA collected reasonably available information for analogs by searching specific grey literature
and other secondary sources, listed on Table C. 1. 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-octadecanol described above.44 EPA also used read-across from the LPS candidates, 1-
Docosanol (CASRN 661-19-8) and 1-Eicosanol (CASRN 629-96-9). 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.1.2 Search Terms and Results
EPA began the literature review process for the hazard screening of 1-octadecanol 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 fatty alcohols cluster including 1-octadecanol. For grey literature and
other secondary sources, Table C.3 lists the search terms used for the fatty alcohol LPS candidates and
analogs.
XLV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
Discipline
Database
Search terms46
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
40 Additional language or syntax such as [tw], [m], [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.
XLVI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
"Cachalot 0-15" OR "Cachalot 0-3" OR "Cachalot 0-8" OR "Crodacol
A. 10" OR "Crodacol 0" OR "Crodacol-0" 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 0" 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 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"
XLVII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
TSCATS1
WOS
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 I PA [org] OR RISKLINE [org] OR MTGABS [org] OR NIOSH [org]
OR NTIS [org] OR PESTAB [org] OR PPBIB [org]) AND NOT PubMed
[org] AND NOT pubdart [org]
(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]
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
XLVIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
"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" 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=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
XLIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
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 "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
90 NF")
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 &
L
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
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 "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
LI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
"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
TSCATS 1 Same as human health strategy CASRN only
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")
Lll
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
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")
LIN
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
TITLE=("(Z)-9-0ctadecen-1 -ol" OR "(Z)-Octadec-9-enol" OR "9-
Octadecen-1-ol, (Z)-" OR"Octadec-9-en-1-ol, (Z)-")
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 O-
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
LIV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
"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")
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"
LV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.2: Search Terms Used in Peer-Reviewed Databases
OR "Unjecol 90BHR" OR "Unjecol 90N" OR "Unjecol 90NR" OR
"Vegecol 90B" OR "Witcohol 85NF" OR "Witcohol 90" OR "Witcohol
90 NF")
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-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
LVI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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 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-Octadecanol. All
references from the search efforts were screened and evaluated through the LPS literature search and
review process.44 Of these, 48 references were included for data evaluation and used to support the
designation of 1-octadecanol 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-octadecanol. The excluded references are organized by discipline (human health
hazard, environmental hazard, and fate), presented along with a rationale based on exclusion criteria. The
criteria44 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-octadecanol, EPA excluded a total of 915 references when assessing human
health hazard. Off-topic references (e.g., studies that did not contain information relevant to human
health) were excluded at either title/abstract screening (see Table C.4), or full-text screening (see Table
C.5). Unacceptable references (e.g., studies that did not meet data quality metrics) were excluded at full-
text screening (see Tables C.6 and C.7). Off-topic and unacceptable references are displayed next to the
corresponding exclusion criteria.
LVII
-------
*** Proposal 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 needs47 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
47 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.
LVIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
4360860
4943496
4936425
4931197
4934107
2736581
4940742
4936342
4929609
4936523
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
LIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
4929250
4944528
4936478
4934051
4934088
3120107
4942500
4936390
4930608
4929316
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
LX
-------
*** Proposal 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
4940347
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
LXI
-------
*** Proposal 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
4934118
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
N/A.
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)?
LXII
-------
*** Proposal 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
LXIII
-------
*** Proposal 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
No48
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?
48 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).
LXIV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.6: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - Animal
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
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
4936382
4963006
58939
LXV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
The test animal (species, strain, sex, life-stage,
source) was not appropriate for the evaluation of
the specific outcome(s) of interest (e.g., genetically
modified animals, strain was uniquely susceptible or
resistant to one or more outcome of interest).
Metric 7:
Number of Animals Per Group
The number of animals per study group was not
reported.
OR
The number of animals per study group was
insufficient to characterize toxicological effects (e.g.,
1-2 animals in each group).
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.
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.
LXVI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.7: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Human Health Hazard - In Vitro
Data Quality Metric
Unacceptable if:
References excluded (HERO ID)
Metric 3:
Positive Controls
A concurrent positive control or proficiency group was not used.
N/A.
Metric 4:
Assay Type
The assay type was not reported.
OR
The assay type was not appropriate for the study type or outcome of interest (e.g., in vitro skin corrosion
protocol used for in vitro skin irritation assay).
N/A.
Metric 5:
Reporting of
Concentration
The exposure doses/concentrations or amounts of test substance were not reported.
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
The test model was not routinely used for evaluation of the specific outcome of interest.
N/A.
Metric 9:
Outcome Assessment
Methodology
The outcome assessment methodology was not reported.
OR
The assessment methodology was not appropriate for the outcome(s) of interest (e.g., cells were evaluated for
chromosomal aberrations immediately after exposure to the test substance instead of after post-exposure
incubation period).
N/A.
C.2.2 Environmental Hazard
For the screening review of LPS candidate 1-octadecanol, 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.
LXVII
-------
*** Proposal 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 needs49 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
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
49 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.
LXVIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
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
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
LXIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
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
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
LXX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
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
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
LXXI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
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
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
LXXII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.8: Off-Topic References Excluded at Title/Abstract Screening for Environmental Hazard
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
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
No
4949229
to a low- priority substance candidate?
4962967
4962970
2017579
4949218
4955546
What type of source is this reference?
Review article or book chapter that contains only
4955546
citations to primary literature sources
4955547
Is quantitative environmental hazard data
No
4962968
presented?
Is this primarily a modeling/simulation study?
Yes
4962969
[Note: select "No" if experimental verification was
included in the study]
LXXIII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.9: Screening Questions and Off-Topic References Excluded at Full Text Screening for Environmental Hazard
Question
Off-topic if answer is:
References excluded (HERO ID)
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
Mixture
N/A.
is the test substance a mixture (except for
reasonable impurities, byproducts, and aqueous
solutions) or formulated product?
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.
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:
Negative Controls
A concurrent negative control group was not
included or reported.
4949228
Metric 3:
Experimental System
The experimental system (e.g., static, semi-static,
or flow-through regime) was not described.
4949228
Metric 4:
Reporting of Concentrations
Test concentrations were not reported.
4949228
LXXIV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.10: Data Quality Metrics and Unacceptable References Excluded at Data Quality Evaluation for Environmental Hazard
Question
Unacceptable if:
References excluded (HERO ID)
Metric 5:
Exposure Duration
The duration of exposure was not reported.
OR
The reported exposure duration was not suited to
the study type and/or outcome(s) of interest (e.g.,
study intended to assess effects on reproduction did
not expose organisms for an acceptable period of
time prior to mating).
N/A.
Metric 6:
Test Organism Characteristics
The test species was not reported.
OR
The test species, life stage, or age was not
appropriate for the outcome(s) of interest.
N/A.
Metric 7:
Outcome Assessment Methodology
The outcome assessment methodology was not
reported.
4949228
Metric 8:
Reporting of Data
Data presentation was inadequate.
OR
Major inconsistencies were present in reporting of
results.
4949228
C.2.3 Fate
For the screening review ofLPS candidate 1-octadecnol, EPA excluded atotal of 980 references when assessing environmental fate. Off-topic fate
references excluded at title/abstract screening are listed in Table C. 11, and those excluded at full-text screening are listed in Table C. 12.
References in Table C.13 represent unacceptable studies based on specific data quality metrics for fate. Off-topic and unacceptable references are
displayed next to the corresponding exclusion criteria.
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
Reference excluded (HERO ID) because the reference did NOT contain information needs50
relevant to environmental fate
453473
4937086
4937018
4936663
4929274
4407501
4940371
4944628
4936975
4936554
50 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.
LXXV
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
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
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
LXXVI
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
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
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
LXXVII
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
Table C.11: Off-Topic References Excluded at Initial Screening for Fate
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
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/A.
LXXVIII
-------
*** Proposal 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).
4934169
4949222
4955550
LXXIX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
OR
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.
OR
Data indicate that disappearance or transformation of the parent compound was likely due to some other process.
4955550
LXXX
-------
*** Proposal Draft - Do Not Cite, Quote or Release During the Review***
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
LXXXI
------- |