TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0058

Number: P-18-0058

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

Chemical Name:

Specific: Phosphonium, trihexyltetradecyl-, salt with 1,1,1-trifluoro-N-
[(trifluoromethyl)sulfonyl]methanesulfonamide (1:1); CASRN 460092-03-9

Conditions of Use (intended, known, or reasonably foreseen)1:

Intended conditions of use (specific): Import for processing and use as a component of

electroconductive low-noise greases used for long-term lubrication of capped or sealed
ball bearings, consistent with the 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: EPA evaluated whether there are reasonably foreseen

conditions of use and identified the following reasonably foreseen uses based on patents:
heat stabilizer and antioxidant for lubricants; material for light emitting
electroluminescent device; separation membrane for fermentation process; and
products for dyeing and/or brightening keratin fibers.

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 intended 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

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.

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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0058

Although EPA estimated that the chemical substance could be very persistent, it has 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 the new chemical
substance and on analogous chemical substances, EPA estimates that this new chemical
substance has a moderate environmental hazard, and potential for the following human health
hazards: neurotoxicity, liver effects, thyroid effects, respiratory effects, and
developmental/reproductive effects. The PMN describes conditions of use that mitigate the
human health and environmental 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 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 anion using data for analogue(s) (CASRN
82113-65-3) and data submitted for the new chemical substance and of the cation using data for

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
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 present an unreasonable risk.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0058

analogue(s) and EPI (Estimation Program Interface) Suite™ (http://www.epa.gov/tsca-screening-
tools/epi-suitetm-estimation-program-interface). In wastewater treatment, the anion is expected
to be removed with an efficiency of 0% to 90% due to possible sorption and the cation is
expected to be removed with an efficiency of 90% due to sorption. Removal of the anion by
biodegradation is negligible and removal of the cation by biodegradation is negligible. Sorption
of the anion to sludge, soil, and sediment is expected to be low to strong and sorption of the
cation to sludge, soil, and sediment is expected to be strong. Migration of the anion to
groundwater is expected to be slow to rapid due to low to strong sorption to soil and sediment
and migration of the cation to groundwater is expected to be slow due to strong sorption to soil
and sediment. Due to low reported vapor pressure, the anion is expected to undergo negligible
volatilization to air and the cation is expected to undergo negligible volatilization due to low
estimated vapor pressure and Henry's law constant. Overall, these estimates indicate that the
anion has low potential to volatilize to air and has unknown potential to migrate to groundwater;
and that the cation has low potential to volatilize to air or migrate to groundwater.

•j

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 anion using data for analogue(s) (CASRN 82113-65-3)
and data submitted for the new chemical substance and of the cation using data for analogue(s)
and EPI Suite™. EPA estimated that the anion's aerobic and anaerobic biodegradation half-lives
are > 6 months; and that the cation's aerobic and anaerobic biodegradation half-lives are > 6
months. These estimates indicate that the anion and cation may be very 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 anion to bioaccumulate using data for
analogue(s) (CASRN 82113-65-3) and of the cation to bioaccumulate using EPI Suite™. EPA
estimated that the anion has low bioaccumulation potential based on high water solubility, which
increases elimination and the cation has low bioaccumulation potential based on BCFBAF model
result < 1000 (cation bioconcentration factor = 4 [estimated by linear regression from log Kow]

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 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 (BAF) of less than 1,000 or 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)

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0058

and bioaccumulation factor = 25 [estimated by the Arnot-Gobas method (2003)5]). Although
EPA estimated that the anion and the cation could be very persistent, they have low potential for
bioaccumulation, such that repeated exposures are not expected to cause food-chain effects via
accumulation in exposed organisms.

Human Health Hazard6: 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, available data on the new chemical substance, and by
comparing it to structurally analogous chemical substances for which there is information on
human health hazard. Absorption of the new chemical substance is expected to be poor via all
routes based on physical/chemical properties. EPA identified neurotoxicity, liver effects, thyroid
effects, respiratory effects, and developmental/reproductive effects as hazards based on analogue
data. Submitted tests of the new chemical substance reported the test substance as mildly
irritating to the eye (OECD 405), not irritating (OECD 404) or corrosive (Guideline Not
Specified) to the skin, as having low acute oral toxicity (OECD 423), and that it is not a
sensitizer (OECD 429) or mutagenic (Guideline Not Specified). EPA identified a LOAEL of 2
mg/kg/day based on thyroid effects which was protective for neurotoxicity, liver effects, and
developmental/reproductive effects and was used to derive exposure route- and population-
specific points of departure.

n

Environmental Hazard : Environmental hazard is relevant to whether a new chemical
substance is likely to present unreasonable risks because the significance of the risk is dependent

5	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.

6	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
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.

7	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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0058

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 hazard
data on an analogous chemical and acute test data on the new chemical substance. Acute toxicity
values estimated for fish, aquatic invertebrates, and algae are no effects at saturation (new
chemical substance), 1.8 mg/L (analogue), and 1.8 mg/L (analogue), respectively. Chronic
toxicity values estimated for fish, aquatic invertebrates, and algae are 0.11 mg/L (analogue), 0.12
mg/L (analogue), and 0.45 mg/L (analogue), respectively. These toxicity values indicate that the
new chemical substance is expected to have moderate environmental hazard. Application of
assessment factors of 5 and 10 to acute and chronic toxicity values, respectively, results in acute
and chronic concentrations of concern of 0.36 mg/L (360 ppb) and 0.011 mg/L (11 ppb),
respectively.

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 dermal exposure to workers; 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 and fish ingestion.

Exposures to the general population via groundwater ingestion (from landfill leaching) and
inhalation were not assessed because these exposures were expected to be negligible (below
modeling thresholds). Consumer exposures were not assessed because consumer uses were not
identified as intended conditions of use.

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-18-0058

Risk Characterization: EPA applies a margin of exposure approach to calculate potential
human health risks of new chemicals. A benchmark (acceptable) margin of exposure 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 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 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 levels (i.e., LOAEL). Risks were identified for workers via dermal exposure based on
quantitative hazard data for and analogue (MOE = 14; Benchmark MOE = 1,000). Risks were
not evaluated for workers via inhalation exposure because exposures were expected to be
negligible. Risks will be mitigated if exposures are controlled by the use of appropriate PPE,
including impervious gloves. EPA expects that employers will require and workers will use
appropriate PPE (i.e., impervious gloves), consistent with the Safety Data Sheet prepared by the
PMN submitter, in a manner adequate to protect them.

Risks were not identified for the general population via drinking water or fish ingestion based on
quantitative hazard data for and analogue (MOEs >21,000; Benchmark MOE = 1,000). Risks
were not evaluated for the general population via groundwater ingestion (from landfill leaching)
or stack or fugitive air inhalation because exposures were expected to be negligible (below
modeling thresholds). Risks to consumers were not evaluated because consumer uses were not
identified as intended conditions of use.

Risks to the environment were evaluated by comparing estimated surface water concentrations
with the acute and chronic concentrations of concern. Risks from acute and chronic exposures
to the environment were not identified due to releases to water that did not exceed the acute or
chronic COC.

It is reasonably foreseen, based on a patent search, that the chemical substance could be used
other than as described in the PMN, resulting in higher releases and exposures and thus
unreasonable human health and ecological risk. 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 manufacturing, processing, or uses that result in inhalation
exposure, and release to water exceeding a surface water concentration of 11 ppb. Conditions of
use that fall under the restrictions of the proposed SNUR are not likely to present unreasonable

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0058

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).

1/31/2020	/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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