TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-21-0174

Number: P-21-0174

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

Chemical Name:

Generic: Carbonic acid, ester, polymer with alkanediol (C=4,5)

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

Intended conditions of use (generic): Import and process for use as and use as a raw material for
polyurethane, consistent with the manufacturing, processing, use, distribution, and
disposal information described in the PMN.

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

whether there are known conditions of use and found none.

Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA

evaluated whether there are reasonably foreseen conditions of use and identified use as an
ingredient in coatings as reasonably foreseen based on prior TSCA submissions for
analogous substances.

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.
Although EPA estimated that the new chemical substance could be very 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. Based on test data for the new
chemical substance and on analogous chemical substances, EPA estimates that the chemical
substance has moderate environmental hazard. No human health hazards were identified. EPA
concludes that the new chemical substance is not likely to present an unreasonable risk under the
conditions of use.

Fate: Environmental fate is the determination of which environmental compartment(s) a
chemical moves to, the expected residence time in the environmental compartment(s) and

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 chemical substance may be manufactured, processed, distributed, used, or disposed of. EPA expects
that the identification of "reasonably foreseen" conditions of use will be made on a fact-specific, case-by-case basis.
EPA will apply its professional judgment and experience when considering factors such as evidence of current use
of the new chemical substance outside the United States, information about known or intended uses of 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-21-0174

removal and degradation processes. Environmental fate is an important factor in determining
exposure and thus in determining whether a chemical may present an unreasonable risk. EPA
estimated physical/chemical and fate properties of the new chemical substance using data
submitted for the new chemical substance and EPI (Estimation Program Interface) Suite™

(http ://www. epa.gov/tsca-screening-tool s/epi-suitetm-estimati on-program-interface). In
wastewater treatment, the new chemical substance is expected to be removed with an efficiency
of 25% to 50% due to possible sorption and possible biodegradation. Removal of the new
chemical substance by biodegradation is negligible to moderate. Sorption of the new chemical
substance to sludge, soil, and sediment is expected to be low to moderate. Migration of the new
chemical substance to groundwater is expected to be slow due to biodegradation and hydrolysis.
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.

Persistence2: 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 and EPI Suite™. EPA estimated that the new chemical substance's aerobic
and anaerobic biodegradation half-lives are < 2 months to > 6 months and hydrolysis half-life is
> months. These estimates indicate that the new chemical substance may be persistent or very
persistent in aerobic environments (e.g., surface water) and anaerobic environments (e.g.,
sediment).

Bioaccumulation3: 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
submitted for the new chemical substance. EPA estimated that the new chemical substance has
low bioaccumulation potential based on submitted data (bioconcentration factor = 62
(measured)). Although EPA estimated that the new chemical substance could be very 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.

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

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

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Human Health Hazard4: 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, by comparing it to a structurally analogous chemical
substance for which there is information on human health hazard, and other structural
information. Absorption of the new chemical substance is expected to be nil to poor through the
skin when neat, poor through the skin when in solution, poor through the lungs, and good
through the gastrointestinal (GI) tract based on physical/chemical properties. Absorption of the
low molecular weight fraction < 500 Da is expected to be nil to poor through the skin when neat,
poor to moderate through the skin when in solution, poor through the lungs, and good through
the GI tract based on physical/chemical properties. For the new chemical substance, EPA did not
identify any hazards.

Environmental Hazard5: 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 determined the environmental hazard for this new chemical substance based on
acute toxicity data submitted for the new chemical substance. This substance falls within the
TSCA New Chemicals Category of Esters. Acute toxicity values for fish, aquatic invertebrates,
and algae are >50.3 mg/L, >20.1 mg/L, and >31.9 mg/L, respectively. Chronic toxicity values for
fish, aquatic invertebrates, and algae are 5.0 mg/L, 2.0 mg/L, and 21.9 mg/L, respectively. These

4	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.

5	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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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 4.02 mg/L
(4020 ppb) and 0.2 mg/L (200 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, worker exposures via inhalation are not expected under the
intended conditions of use; EPA did not assess dermal exposures because no human health
hazards were identified. Exposures to the general population were not assessed because no
human health hazards were identified. Consumer exposures were not assessed because consumer
uses were not identified as intended conditions of use.

Risk Characterization: EPA assesses risks to workers considering engineering controls
described in the PMN but in the absence of personal protective equipment (PPE) such as gloves
and respirators. If risks are preliminarily identified, EPA then considers whether the risks would
be mitigated by the use of PPE (e.g., impervious gloves, respirator).

No relevant human health hazards were identified for the new chemical substance; therefore,
risks were not evaluated for workers or the general population. Based on no identified hazards,
risks are not expected.

Risks to the environment were evaluated by comparing estimated surface water concentrations
(SWCs) with the acute and chronic concentrations of concern (COCs). When evaluating risks
from chronic exposures, the number of the days of exceedance (SWC > chronic COC) is also
considered in the risk assessment. Risks from acute exposures to the environment were not
identified because the estimated 7Q10 SWC did not exceed the acute COC. Risks from chronic
exposures to the environment were not identified because the estimated 7Q10 SWC did not

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exceed the chronic COC under the intended conditions of use. EPA expects that releases from
the reasonably foreseen coating use are unlikely to be substantially higher than the intended use
and unreasonable risks are not expected.

Because no unreasonable risks to workers, consumers, the general population, or the
environment were identified, EPA has determined that the new chemical substance is not likely
to present unreasonable risk to human health or the environment under the conditions of use.

11/15/2022			[s[	

Date:	Madison H. Le, Director

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

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