TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0025

Number: P-20-0025

TSCA Section 5(a)(3) Determination: The chemical substance is not likely to present an
unreasonable risk (5(a)(3)(C))

Chemical Name:

Specific: Octadecanoic acid, 12-(acetoxy)-, 2-ethylhexyl ester; CASRN 61800-40-6
Conditions of Use (intended, known, or reasonably foreseen)1:

Intended conditions of use (specific): Manufacture and process for use as and use as a motor oil
lubricant for commercial and consumer uses (including any application typical for a base
oil), consistent with the manufacturing, processing, use, distribution, and disposal
information described in the PMN.

Known conditions of use: Applying such factors as described in footnote 1, EPA evaluated

whether there are known conditions of use and found none.

Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
evaluated whether there are reasonably foreseen conditions of use and found none.

Summary: The chemical substance is not likely to present an unreasonable risk of injury to
health or the environment, without consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by
the Administrator under the conditions of use, based on the risk assessment presented below.
EPA estimated that the new chemical substance could have limited persistence and low potential
for bioaccumulation, such that repeated exposures are not expected to cause food-chain effects
via accumulation in exposed organisms. Based on test data on analogous chemical substances
and estimated physical/chemical properties of the new chemical substance, EPA estimates that
the chemical substance has low environmental hazard and low human health hazard. EPA
concludes that the new chemical substance is not likely to present an unreasonable risk under the

1 Under TSCA § 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." In general, EPA considers the intended conditions of use of a new
chemical substance to be those identified in the section 5(a) notification. Known conditions of use include activities
within the United States that result from manufacture that is exempt from PMN submission requirements.

Reasonably foreseen conditions of use are future circumstances, distinct from known or intended conditions of use,
under which the Administrator expects the chemical substance to be manufactured, processed, distributed, used, or
disposed of. The identification of "reasonably foreseen" conditions of use will necessarily be a case-by-case
determination and will be highly fact-specific. Reasonably foreseen conditions of use will not be based on
hypothetical or conjecture. EPA's identification of conditions of use includes the expectation of compliance with
federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate
otherwise. Accordingly, EPA will apply its professional judgment, experience, and discretion when considering such
factors as evidence of current use of the new chemical substance outside the United States, evidence that the PMN
substance is sufficiently likely to be used for the same purposes as existing chemical substances that are structurally
analogous to the new chemical substance, and conditions of use identified in an initial PMN submission that the
submitter omits in a revised PMN. The sources EPA uses to identify reasonably foreseen conditions of use include
searches of internal confidential EPA PMN databases (containing use information on analogue chemicals), other
U.S. government public sources, the National Library of Medicine's Hazardous Substances Data Bank (HSDB), the
Chemical Abstract Service STN Platform, REACH Dossiers, technical encyclopedias (e.g., Kirk-Othmer and
Ullmann), and Internet searches.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0025

conditions of use.

Fate: Environmental fate is the determination of which environmental compartment(s) a
chemical moves to, the expected residence time in the environmental compartment(s) and
removal and degradation processes. Environmental fate is an important factor in determining
exposure and thus in determining whether a chemical may present an unreasonable risk. EPA
estimated physical/chemical and fate properties of the new chemical substance using data
submitted for analogue(s) (CASRN 1365345-64-7) and EPI (Estimation Program Interface)
Suite™ (http://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-interface). In
wastewater treatment, the new chemical substance is expected to be removed with an efficiency
of 90% due to sorption and biodegradation. Removal of the new chemical substance by
biodegradation is high and destruction (mineralization) of the new chemical substance by
biodegradation is complete. Sorption of the new chemical substance to sludge is expected to be
strong and to soil and sediment is expected to be very strong. Migration of the new chemical
substance to groundwater is expected to be negligible due to very strong sorption to soil and
sediment. Due to low estimated vapor pressure and Henry's law constant, the new chemical
substance is expected to undergo negligible volatilization to air. Overall, these estimates indicate
that the new chemical substance has low potential to volatilize to air or migrate to groundwater.

Persistence : Persistence is relevant to whether a new chemical substance is likely to present an
unreasonable risk because chemicals that are not degraded in the environment at rates that
prevent substantial buildup in the environment, and thus increase potential for exposure, may
present a risk if the substance presents a hazard to human health or the environment. EPA
estimated degradation half-lives of the new chemical substance using data submitted for
analogue(s) (CASRN 1365345-64-7) and EPI Suite™. EPA estimated that the new chemical
substance's aerobic and anaerobic biodegradation half-lives are < 2 months. These estimates
indicate that the new chemical substance may have limited persistence in aerobic environments
(e.g., surface water) and anaerobic environments (e.g., sediment).

-2

Bioaccumulation : Bioaccumulation is relevant to whether a new chemical substance is likely to
present an unreasonable risk because substances that bioaccumulate in aquatic and/or terrestrial
species pose the potential for elevated exposures to humans and other organisms via food chains.
EPA estimated the potential for the new chemical substance to bioaccumulate using EPI Suite™.
EPA estimated that the new chemical substance has low bioaccumulation potential based on
BCFBAF model result < 1000 (bioconcentration factor = 35 [estimated by linear regression from

2	Persistence: A chemical substance is considered to have limited persistence if it has a half-life in water, soil or
sediment of less than 2 months or if there are equivalent or analogous data. A chemical substance is considered to be
persistent if it has a half-life in water, soil or sediments of greater than 2 months but less than or equal to 6 months
or if there are equivalent or analogous data. A chemical substance is considered to be very persistent if it has a half-
life in water, soil or sediments of greater than 6 months or if there are equivalent or analogous data. (64 FR 60194;
November 4, 1999)

3	Bioaccumulation: A chemical substance is considered to have a low potential for bioaccumulation if there are
bioconcentration factors (BCF) or bioaccumulation factors (BAF) of less than 1,000 or if there are equivalent or
analogous data. A chemical substance is considered to be bioaccumulative if there are BCFs or BAFs of 1,000 or
greater and less than or equal to 5,000 or there are equivalent or analogous data. A chemical substance is considered
to be very bioaccumulative if there are BCFs or BAFs of 5,000 or greater or if there are equivalent or analogous
data. (64 FR 60194; November 4 1999)

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0025

log Kow] and bioaccumulation factor = 1 [estimated by the Arnot-Gobas method (2003)]).4 EPA
estimated that the new chemical substance could have limited persistence and low potential for
bioaccumulation, such that repeated exposures are not expected to cause food-chain effects via
accumulation in exposed organisms.

Human Health Hazard5: Human health hazard is relevant to whether a new chemical substance
is likely to present an unreasonable risk because the significance of the risk is dependent upon
both the hazard (or toxicity) of the chemical substance and the extent of exposure to the
substance. EPA estimated the human health hazard of this chemical substance based on its
estimated physical/chemical properties and by comparing it to structurally analogous chemical
substances for which there is information on human health hazards. Absorption of the new
chemical substance is expected to be poor through the skin and nil through the gastrointestinal
tract and through the lungs based on physical/chemical properties. No data were submitted on the
new chemical substance. EPA did not identify any specific hazards based on submitted test data
on an analogous substance (CASRN 2348483-91-8) in an OECD 422 study. In addition, a
different analogue (CASRN 91031-48-0) supports this finding in an OECD 414 study
(developmental toxicity study).

Environmental Hazard6: Environmental hazard is relevant to whether a new chemical
substance is likely to present unreasonable risk because the significance of the risk is dependent
upon both the hazard (or toxicity) of the chemical substance and the extent of exposure to the

4	Arnot JA, Gobas FAPC. 2003. A generic QSAR for assessing the bioaccumulation potential of organic chemicals
in aquatic food webs. QSAR and Combinatorial Science 22: 337-345.

5	A chemical substance is considered to have low human health hazard if effects are observed in animal studies with
a No Observed Adverse Effect Level (NOAEL) equal to or greater than 1,000 mg/kg/day or if there are equivalent
data on analogous chemical substances; a chemical substance is considered to have moderate human health hazard if
effects are observed in animal studies with a NOAEL less than 1,000 mg/kg/day or if there are equivalent data on
analogous chemical substances; a chemical substance is considered to have high human health hazard if there is
evidence of adverse effects in humans or conclusive evidence of severe effects in animal studies with a NOAEL of
less than or equal to 10 mg/kg/day or if there are equivalent data on analogous chemical substances. EPA may also
use Benchmark Dose Levels (BMDL) derived from benchmark dose (BMD) modeling as points of departure for
toxic effects. See httos ://www.epa. gov/bmds/what-benchmark-dose-software-bmds. Using this approach, a BMDL
is associated with a benchmark response, for example a 5 or 10 % incidence of effect. The aforementioned
characterizations of hazard (low, medium, high) would also apply to BMDLs. In the absence of animal data on a
chemical or analogous chemical substance, EPA may use other data or information such as from in vitro assays,
chemical categories (e.g., Organization for Economic Co-operation and Development, 2014 Guidance on Grouping
of Chemicals, Second Edition. ENV/JM/MONO(2014)4. Series on Testing & Assessment No. 194. Environment
Directorate, Organization for Economic Co-operation and Development, Paris, France.

(http://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=env/im/mono(2014)4&doclanguage=en)).
structure-activity relationships, and/or structural alerts to support characterizing human health hazards.

6	A chemical substance is considered to have low ecotoxicity hazard if the Fish, Daphnid and Algae LC50 values are
greater than 100 mg/L, or if the Fish and Daphnid chronic values (ChVs) are greater than 10.0 mg/L, or there are not
effects at saturation (occurs when water solubility of a chemical substance is lower than an effect concentration), or
the log Kow value exceeds QSAR cut-offs. A chemical substance is considered to have moderate ecotoxicity hazard
if the lowest of the Fish, Daphnid or Algae LC50s is greater than 1 mg/L and less than 100 mg/L, or where the Fish
or Daphnid ChVs are greater than 0.1 mg/L and less than 10.0 mg/L. A chemical substance is considered to have
high ecotoxicity hazard, or if either the Fish, Daphnid or Algae LC50s are less than 1 mg/L, or any Fish or Daphnid
ChVs is less than 0.1 mg/L (Sustainable Futures https://www.epa.gov/sustainable-futures/sustainable-futures-p2-
framework-manual).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0025

substance. EPA estimated environmental hazard of this new chemical substance based on acute
and chronic toxicity data on analogous chemicals. This substance falls within the TSCA New

n

Chemicals Category of Esters. Based on analogue data, acute and chronic toxicity values
measured for fish, aquatic invertebrates, and algae are all no effects at saturation. These toxicity
values indicate that the new chemical substance is expected to have low environmental hazard.
Because hazards are not expected up to the water solubility limit, acute and chronic
concentrations of concern are not identified.

Exposure: The exposure to a new chemical substance is potentially relevant to whether a new
chemical substance is likely to present unreasonable risks because the significance of the risk is
dependent upon both the hazard (or toxicity) of the chemical substance and the extent of
exposure to the substance.

EPA estimates occupational exposure and environmental release of the new chemical substance
under the intended conditions of use described in the PMN using ChemSTEER (Chemical
Screening Tool for Exposures and Environmental Releases; https://www.epa.gov/tsca-screening-
tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases). EPA uses
EFAST (the Exposure and Fate Assessment Screening Tool; https://www.epa.gov/tsca-
screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014) to estimate
general population, consumer, and environmental exposures.

EPA considers workers to be a potentially exposed or susceptible subpopulation (PESS) on the
basis of greater exposure potential compared to the general population. EPA also considers PESS
in conducting general population drinking water exposures by evaluating risks associated with
water intake rates for multiple age groups, ranging from infants to adults. EPA considers
consumers of specific products to be a potentially exposed or susceptible subpopulation on the
basis of greater exposure potential compared to the general population who do not use specific
products.

For this new chemical assessment, EPA assessed worker exposures via the inhalation and dermal
routes. Releases to water, air, and landfill were estimated. Exposures to the general population
were assessed via drinking water, fish ingestion and fugitive air release. Exposures to the general
population via groundwater ingestion impacted by landfill leaching and stack air inhalation were
expected to be negligible (below modeling thresholds). EPA assessed consumer exposures via
the dermal and inhalation routes.

Risk Characterization: EPA assesses risks to workers considering engineering controls
described in the PMN but in the absence of personal protective equipment (PPE) such as gloves
and respirators. If risks are preliminarily identified, EPA then considers whether the risks would
be mitigated by the use of PPE (e.g., impervious gloves, respirator). Based on the low hazard
determination, EPA did not identify risks for the new chemical substance.

7 TSCA New Chemicals Program (NCP) Chemical Categories, https://www.epa.gov/reviewing-new-chemicals-
under-toxic-substances-control-act-tsca/chemical-categories-used-review-new.

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Due to low hazard, EPA believes that this chemical substance would be not likely to present an
unreasonable risk even if potential exposures were high. Therefore, EPA concludes that the new
chemical substance is not likely to present unreasonable risk under the conditions of use.

3/8/2021	/s/

Date:	Madison H. Le, Director

New Chemicals Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency

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