TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0174

Number: P-19-0174

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

Chemical Name:

Generic: Octadecanoic acid, (alkylphosphinyl), polyol ester
Conditions of Use (intended, known, or reasonably foreseen)1:

Intended conditions of use (generic): Manufacture for use and use as a phosphorus antiwear

compound, 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
has identified use of the new chemical substance in consumer products at a high percent
in formulation as reasonably foreseen based on the submitter's amendments to the
submission.

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 and
the terms of the proposed Significant New Use Rule (SNUR) signed by EPA.2 Although EPA

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
hypotheticals 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.

2	Reasonably foreseen conditions of use subject to a proposed SNUR are not likely to present an unreasonable risk
of injury to health or the environment. Based on EPA's experience, it is the Agency's judgment that a new use
would not commence during the pendency of a proposed SNUR because web posting of a proposed SNUR serves as
the cut-off date for a significant new use. Therefore, manufacturers and processors would not commence a
prohibited new use that would be legally required to cease upon the finalization of the SNUR. Once a SNUR is final
and effective, no manufacturer or processor - including the PMN submitter - may undertake the conditions of use

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0174

estimated that the new chemical substance could be persistent, the new chemical substance has
low potential for bioaccumulation, such that repeated exposures are not expected to cause food-
chain effects via accumulation in exposed organisms. Based on estimated physical/chemical
properties and test data on analogous chemical substances, EPA estimates that the chemical
substance has low environmental hazard and potential for the following human health hazards:
skin irritation, eye irritation, reproductive toxicity, and specific target organ toxicity. The PMN
describes conditions of use that mitigate the human health risks. Therefore, EPA concludes that
the new chemical is not likely to present unreasonable risk to human health or the environment
under the intended conditions of use.

As set forth below, the information available to EPA is sufficient to permit the Agency to
conduct a reasoned evaluation of the health and environmental effects of the chemical substance
under the conditions of use that are not subject to the proposed SNUR, in order to determine that
the chemical substance is not likely to present an unreasonable risk under those conditions of
use. As such, EPA does not need to impose testing requirements to conduct this evaluation.
Whether testing is needed to evaluate the effects of the intended, known, or reasonably foreseen
conditions of use of a chemical substance subject to a PMN is determined on a case-by-case
basis. To the extent that testing may be necessary to conduct a reasoned evaluation of the health
or environmental effects of the reasonably foreseen conditions of use that are subject to the
proposed SNUR, EPA will make the appropriate determination if a Significant New Use Notice
(SNUN) is submitted following finalization of the SNUR.

EPA found no known conditions of use, assessed the intended conditions of use, and addressed
reasonably foreseen conditions of use by proposing a SNUR. Therefore, EPA determines the
new chemical substance is not likely to present unreasonable risk to human health or the
environment.

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 for
analogue(s) [claimed CBI] and compounds with large molecular volume. In wastewater
treatment, the new chemical substance is expected to be removed with an efficiency of 90% due
to sorption. Removal of the new chemical substance by biodegradation is moderate. Sorption of
the new chemical substance to sludge, 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

identified as a significant new use of the PMN substance in the SNUR. EPA must first evaluate the new use in
accordance with the requirements of TSCA Section 5 and (a) either conclude that the new use is not likely to present
an unreasonable risk under the conditions of use; or (b) take appropriate action under section 5(e) or 5(f). If EPA
were not to finalize the proposed SNUR, then that decision would be based on information and data provided to the
Agency during the comment period demonstrating that the reasonably foreseen conditions of use subject to the
proposed SNUR are not likely to present an unreasonable risk. Under either scenario, the reasonably foreseen
condition of use is not likely to present an unreasonable risk.

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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.

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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 for analogue(s)
[claimed CBI], EPA estimated that the new chemical substance's aerobic and anaerobic
biodegradation half-lives are 2 to 6 months. These estimates indicate that the new chemical
substance may be persistent in aerobic environments (e.g., surface water) and anaerobic
environments (e.g., sediment).

Bioaccumulation4: 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
data for analogue(s) ([claimed CBI] and compounds with large molecular volume). EPA
estimated that the new chemical substance has low bioaccumulation potential based on large
predicted molecular volume, which limits bioavailability. Although EPA estimated that the new
chemical substance could be persistent, the substance has 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

3	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 there are equivalent or analogous data. (64 FR 60194;
November 4, 1999)

4	Bioaccumulation: A chemical substance is considered to have a low potential for bioaccumulation if there are
bioconcentration factors (BCF) or bioaccumulation factors (B AF) 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 there are equivalent or analogous data.
(64 FR 60194; November 4 1999)

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 https://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

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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, by comparing it to structurally analogous chemical
substances for which there are information on human health hazard, and other structural
information. Absorption of the new chemical substance is expected to be nil through the skin, the
gastrointestinal (GI) tract, and the lungs based on physical/chemical properties. Absorption of the
ester hydrolysis product/metabolite (MW [claimed CBI] Daltons) is expected to be nil to poor
through the skin for the neat material, poor when in solution, and nil through the GI tract and
lungs, based on physical/chemical properties. For the new chemical substance, EPA identified
irritation to skin and eyes, systemic effects, reproductive and developmental effects based on
analogue data, and blood clotting effects based on structural information, as hazards. No data
were submitted on the new chemical substance. EPA identified a NOAEL of 20 mg/kg-bw/day
based on systemic effects (kidney and body weight effects), which was protective for other
systemic, reproductive, and developmental effects and was used to derive exposure route- and
population-specific points of departure. EPA qualitatively evaluated irritation effects.

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
substance. EPA estimated environmental hazard of this new chemical substance using
predictions based on the negligible water solubility of the new chemical substance. This
substance falls within the TSCA New Chemicals Category of Esters.7 Acute and chronic toxicity
values estimated 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.

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).

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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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 exposure via the dermal route;
inhalation exposures to workers are not expected. Releases to water, air, and landfill were
estimated. Exposure to the general population was assessed via drinking water. Exposure to the
general population was not assessed via fish ingestion because bioaccumulation potential was
evaluated to be low, or via groundwater impacted by landfill leachate because exposures are
expected to be negligible (below modeling thresholds). Exposure to the general population was
not assessed via inhalation because exposures were expected to be negligible (below modeling
thresholds). Consumer exposures were assessed using the [claimed CBI] scenario.

Risk Characterization: EPA applies a margin of exposure approach to calculate potential
human health risks of new chemicals. A benchmark (acceptable) margin of exposure (MOE) is
derived by applying uncertainty factors for the following types of extrapolations: intra-species
extrapolation (UFh = 10 to account for variation in sensitivity among the human population),
inter-species extrapolation (UFA = 10 to account for extrapolating from experimental animals to
humans) and Lowest Observed Adverse Effect Level (LOAEL)-to-NOAEL extrapolation (UFl =
10 to account for using a LOAEL when a NOAEL is not available). Hence, in the New
Chemicals Program, a benchmark MOE is typically 100 and 1,000 when NOAELs and LOAELs,
respectively, are used to identify hazard. When allometric scaling or pharmacokinetic modeling
is used to derive an effect level, the UFh may be reduced to 3, for a benchmark MOE of 30. The
benchmark MOE is used to compare to the MOE calculated by comparing the toxicity NOAEL
or LOAEL to the estimated exposure concentrations. When the calculated MOE is equal to or
exceeds the benchmark MOE, the new chemical substance is not likely to present an
unreasonable risk. 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

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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).

Risks to human health for the new chemical substance were evaluated using the route-specific
effect level (i.e., NOAEL) described above. Risks were not identified for workers for systemic
effects via dermal exposure based on quantitative hazard data for an analogue (MOE = 1,018;
Benchmark MOE = 100). Risks were not evaluated for workers via inhalation because exposures
are expected to be negligible. Irritation hazards to workers via dermal contact were identified
based on analogue data. Risks for these endpoints were not quantified due to a lack of dose-
response for these hazards. However, exposures can be mitigated by the use of appropriate
personal protective equipment (PPE), including impervious gloves and eye protection. EPA
expects that employers will require and that workers will use appropriate PPE consistent with the
Safety Data Sheet prepared by the new chemical submitter, in a manner adequate to protect
them.

Risks were not identified for the general population for systemic effects via drinking water (DW)
ingestion based on quantitative hazard data for an analogue (MOEAduitDw = 612; MOEinfantDw =
146; Benchmark MOE = 100). Risks were not evaluated for the general population via fish
ingestion because bioaccumulation potential was evaluated to be low, or via groundwater
impacted by landfill leachate or inhalation because exposures were expected to be negligible.
Skin and eye irritation hazards to the general population are not expected via drinking water
ingestion due to dilution of the chemical substance in the media. Risks were not identified for
systemic effects for consumers via dermal contact based on quantitative hazard data for an
analogue (MOE = 10,363; Benchmark MOE = 100). Potential for skin irritation hazards to
consumers via dermal contact was identified as a hazard based on an analogue, [claimed CBI],
However, EPA qualitatively determined that the likelihood of dermal irritation occurring from
consumer products was low based on the concentration of the new chemical substance used in
consumer products (i.e., [claimed CBI]%).

Risk from acute and chronic exposures to the environment are not expected at any concentration
of the new chemical substance soluble in the water (i.e., no effects at saturation).

It is reasonably foreseen, based on the original PMN submission, that the new chemical
substance could be used in consumer products at a higher percent in formulation. The SNUR that
has been proposed for this chemical substance defines certain conditions of use as significant
new uses. The proposed significant new uses include formulating above [claimed CBI]% in
consumer products. Conditions of use that fall under the restrictions of the proposed SNUR are
not likely to present unreasonable risk of injury to health or the environment because (1) those
conditions of use are not likely to be commenced during the pendency of the proposed SNUR,
and (2) upon finalization of the SNUR, those conditions of use would be prohibited unless and
until EPA makes an affirmative determination that the significant new use is not likely to present
an unreasonable risk or takes appropriate action under section 5(e) or 5(f).

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4/29/2020

Date:

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	/s/	

Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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