TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0052

Number: P-20-0052

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

Chemical Name:

Specific: Oxirane, 2-methyl-, polymer with oxirane, mono(3,5,5-trimethylhexanoate); CASRN
148263-50-7

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

Intended conditions of use (specific): Import for use as a liquid shrinkage reducing admixture for
concrete, 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 as a lubricant for refrigerators, as a wetting agent in water miscible
metalworking fluids, as a low-foaming surfactant and wetting agent in water-based
coatings, inks, adhesives, sealants, and glass fiber sizing, as an emulsifier in oilfield
acidification processes, as a textile emulsifier, and as a non-ionic surfactant for automatic
dishwasher detergents, hard surface cleaners, industrial laundry, textile formulations, and
wetting agents as reasonably foreseen based on patents on the new chemical substance
and information in previous TSCA submissions.

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

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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0052

2

the terms of the proposed Significant New Use Rule (SNUR) signed by EPA. 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 estimated physical/chemical properties, test data
on the new chemical substance and analogous chemical substances, and other structural
information, EPA estimates that the chemical substance has moderate environmental hazard and
potential for the following human health hazards: skin and 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 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

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
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-20-0052

analogue(s) (polymers) and data submitted for the new chemical substance. 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. Sorption of the new chemical substance to sludge is expected to be moderate to strong and
to soil and sediment is expected to be moderate to very strong. Migration of the new chemical
substance to groundwater is expected to be negligible due to moderate 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.

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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 submitted for the new
chemical substance. 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).

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) (polymers). EPA estimated that the new chemical substance has low
bioaccumulation potential based on bioconcentration or bioaccumulation data reported for
polymers and expected metabolism of the lower molecular weight fractions. 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

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 (B AF) 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)

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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0052

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, by
comparing it to structurally analogous chemical substances for which there is information on
human health hazard, and other structural information. Absorption of the new chemical
substance and of the low molecular weight (LMW) fraction (5% < 500 Daltons, 27% < 1000
Daltons) is expected to be poor through the skin and lungs and moderate through the
gastrointestinal (GI) tract based on physical/chemical properties. For the new chemical
substance, EPA identified hazards for lung irritation and lung effects (surfactancy), if inhaled,
based on the surfactant properties of the new chemical substance. EPA also identified hazards for
skin and eye irritation, kidney and liver effects, and developmental toxicity based on test data for
an expected metabolite, 3,5,5-trimethylhexanoic acid (CASRN 3302-10-1; 17% of the new
chemical substance). The concern for eye irritation is supported by information provided in the
safety data sheet (SDS) prepared by the submitter. Submitted test data on the new chemical
substance reported an LD50 of 5000 mg/kg-bw in an acute oral toxicity study in rats (OECD 423)
and inconclusive findings in an in vitro skin irritation assay (OECD 439). EPA identified an
analogue to the new chemical substance with a reported oral NOAEL of 5 mg/kg-bw/day based
on liver and kidney effects, which was also protective for developmental effects, and an analogue
with a reported Benchmark Concentration Level-Human Equivalent Concentration (BMCLhec)
of 0.6 mg/m3 based on lung effects (surfactancy). These values were used to derive exposure
route- and population-specific points of departure for quantitative risk assessment. 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

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.

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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0052

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 chemicals. This substance falls within the TSCA New Chemicals Category

n

of Nonionic Surfactants. Acute toxicity values estimated for fish, aquatic invertebrates, and
algae are 29 mg/L, >100 mg/L, and >100 mg/L respectively. Chronic toxicity values estimated
for fish, aquatic invertebrates, and algae are 6 mg/L, 80 mg/L and >10 mg/L 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 5.8 mg/L
(5,800 ppb) and 0.58 mg/L (580 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 substances
under the intended conditions of use described in the PMNs 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 assessment, EPA assessed worker exposure via the dermal route; inhalation exposure to
workers is 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 and inhalation because exposures are expected to be
negligible (below modeling thresholds). Consumer exposures were not assessed because
consumer uses were not identified as conditions of use.

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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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0052

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
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 substances were evaluated using the route-specific
effect levels (i.e., NOAEL and BMCLhec)- Risks were not evaluated for workers via inhalation
exposure because exposures are expected to be negligible. Risks were identified for workers for
liver and kidney effects via dermal exposure based on quantitative hazard data for a metabolite
(MOE = 6; Benchmark MOE = 100). Risks were not evaluated for workers for pulmonary effects
via dermal exposure because the hazards are not relevant to the exposure route. Irritation hazards
to workers via dermal contact were identified based on surfactant properties of the new chemical
substance, metabolite data, and information in the SDS prepared by the submitter. 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 SDS prepared by the submitter, in a
manner adequate to protect them.

Risks were not identified for the general population for liver and kidney effects via drinking
water based on quantitative hazard data for a metabolite (MOEs > 3,000; Benchmark MOE =
100). Risks were not evaluated for the general population for pulmonary effects via drinking
water because the hazards are not relevant to the exposure route. 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 and inhalation because exposures are expected
to be negligible. Irritation hazards to the general population are not expected via drinking water
ingestion due to dilution of the chemical substance in the media. Consumer exposures were not
assessed because consumer uses were not identified as 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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0052

It is reasonably foreseen, based on a patent search and previous TSCA submissions, that the new
chemical substance could be used as a lubricant for refrigerators, as a wetting agent in water
miscible metalworking fluids, as a low-foaming surfactant and wetting agent in water-based
coatings, inks, adhesives, sealants, and glass fiber sizing, as an emulsifier in oilfield acidification
processes, as a textile emulsifier, and as a non-ionic surfactant for automatic dishwasher
detergents, hard surface cleaners, industrial laundry, textile formulations, and wetting agents.
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 any consumer use, any use
other than use as liquid shrinkage reducing admixture for concrete, and any changes in
manufacture, processing, or use resulting in inhalation exposures. 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).

Date:

4/29/2020

/s/

Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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