TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0013

Number: P-20-0013

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

Chemical Name:

Specific (P-20-0013): 2-Propenoic acid, 2-methyl-, (2-oxo-l,3-dioxolan-4-yl)methyl ester;
CASRN: 13818-44-5

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

Intended conditions of use (generic): Manufacture and process for use, and use in UV curable
inks, 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, based on another TSCA
submission, that the new chemical substance is known to be used for conditions of use
very similar to the intended conditions of use described in the PMN.

Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
evaluated whether there are reasonably foreseen conditions of use and identified, based
on a patent search and information in a previous TSCA submission, that it is reasonably
foreseen that the substance could be used as a monomer, in adhesives, sealants, and
coatings, or to make electrolytes for batteries.

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-20-0013

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 EPA's TSCA New Chemicals Program Chemical

"3

Categories for Esters and Acrylates/Methacrylates , physical/chemical properties and test data on
the new chemical substance and analogous chemical substances, EPA estimates that the chemical
substance has low environmental hazard and potential for the following human health hazards:
respiratory sensitization, eye irritation, systemic toxicity, neurotoxicity, reproductive and
developmental toxicity, immunotoxicity, and liver and kidney effects. 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 previously assessed the 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.

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.

3	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-20-0013

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 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 biodegradation. Removal of the new chemical
substance by biodegradation is high. Sorption of the new chemical substance to sludge, soil, and
sediment is expected to be low. Migration of the new chemical substance to groundwater is
expected to be negligible due to low sorption to soil and sediment, mitigated by biodegradation.
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.

Persistence4: 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 EPI Suite™. EPA
estimated that the new chemical substance's aerobic biodegradation half-life is < 2 months and
anaerobic biodegradation half-life is 2 to 6 months. These estimates indicate that the new
chemical substance may have limited persistence in aerobic environments (e.g., surface water)
and may be persistent in anaerobic environments (e.g., sediment). Based on level III fugacity
modeling, this substance is expected to partition primarily to surface water; thus, its persistence
was assessed based on its estimated half-life in aerobic environments.

Bioaccumulation5: 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 = 1 [estimated by linear
regression from log Kow] and bioaccumulation factor = 1 [estimated by the Arnot-Gobas method

4	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)

5	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-20-0013

(2003)6]). 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.

n

Human Health Hazard : 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 to
moderate through the skin, moderate through the GI tract and good through the lungs based on
physical/chemical properties. For the new chemical substance, EPA identified respiratory
sensitization as a hazard based on the OECD QSAR Toolbox prediction and data indicating that
other methacrylates are respiratory sensitizers and other structural information. EPA identified
developmental toxicity as a hazard based on data on an expected metabolite and analogues. Mild
eye irritation was identified as a hazard based on test data for the new chemical substance. EPA
also identified systemic toxicity (decreased maternal body weights), neurotoxicity, reproductive
and developmental toxicity, immunotoxicity (blood and spleen effects), liver and kidney effects,
and eye irritation as hazards based on test data for analogues. Submitted tests of the new
chemical substance reported the test substance as slightly irritating in rabbit eyes in an OECD
405, not irritating to rabbit skin in an OECD 404, non-sensitizing to the skin of guinea pigs in an
OECD 406, and non-mutagenic in an OECD 471. EPA identified a NOAEL of 30 mg/kg/day
based on systemic effects (liver, kidney, immunotoxicity, and neurotoxicity), which were
protective for all health effects identified other than eye irritation and respiratory sensitization
and was used to derive exposure route- and population-specific points of departure for
quantitative risk assessment. Eye irritation and respiratory sensitization were qualitatively
evaluated.

6	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.

7	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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0013

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Environmental Hazard : 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 hazard
data on an analogous chemical, and using the Ecological Structure Activity Relationships
(ECOSAR) Predictive Model (https://www.epa.gov/tsca-screening-tools/ecological-structure-
activitv-relationships-ecosar-predictive-modeD; specifically the QSARs for esters and
methacrylates. The chemical substance falls within the TSCA New Chemicals Categories of
Esters and Acrylates/Methacrylates. Acute toxicity values estimated for fish, aquatic
invertebrates, and algae are all greater than 100 mg/L. Chronic toxicity values estimated for fish,
aquatic invertebrates, and algae are all greater than 10 mg/L. These toxicity values indicate that
the new chemical substance is expected to have low 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 20 mg/L (20,000 ppb) and 1 mg/L (1,000 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

8 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-20-0013

basis of greater exposure potential compared to the general population who do not use specific
products.

For this assessment, EPA assessed worker exposure via dermal exposure and inhalation
exposures. 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 leaching or inhalation because releases to landfill and air were expected to
be negligible (below modeling thresholds). Consumer exposures were not assessed because
consumer uses were not identified as conditions of use.

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 substances were evaluated using the route-specific
effect levels (i.e., NOAEL).Risks were identified for workers for systemic effects via dermal
exposure based on quantitative hazard data for an analogue (MOE = 3; Benchmark MOE = 100).
Risks were not identified for workers for systemic effects via inhalation exposure based on
quantitative hazard data for an analogue (MOE = 1,768; Benchmark MOE = 100). Sensitization
and eye irritation hazards to workers were identified based on data for the new chemical
substance and analogues. Risks for these endpoints were not quantified due to a lack of dose-
response for these hazards. However, risks and exposures can be mitigated by the use of
appropriate personal protective equipment (PPE), including dermal protection, eye protection
and respiratory protection with an Assigned Protection Factor (APF) of at least 50. EPA expects
that employers will require and that workers will use appropriate PPE (i.e., impervious gloves,
eye protection, and a respirator with an APF of at least 50) 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
exposure based on quantitative hazard data for an analogue (MOEAduitDw = 550; MOEMantDw =
131; Benchmark MOE = 100). Sensitization and eye irritation hazards to the general population

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0013

are not expected via drinking water ingestion due to dilution of the chemical substance in the
media. 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
leaching or inhalation because exposures are expected to be negligible. Risks to consumer were
not evaluated because consumer uses were not identified as conditions of use.

Risk from acute and chronic exposures to the environment are not expected based on low
ecotoxicity hazards.

It is reasonably foreseen, based on a patent search and a previous TSCA submission, that the new
chemical substance could be as a monomer, in adhesives, sealants, and coatings, or to make
electrolytes for batteries, which were not assessed by EPA in the current assessment and which
could result in greater exposures or releases. 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, annual production volume greater than [claimed CBI] and any
use other than as [claimed CBI], 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).

2/28/2020		/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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