TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0158

Number: P-19-0158

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

Chemical Name:

Generic (P-19-0158): Alkenoic acid polymer with 2-ethyl-2-(hydroxymethyl)-l,3-alkyldiol, 1,1'-
methylenebis(4-isocyanatocarbomonocycle) and 3-methyl-l,5-aklydiol

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

Intended conditions of use (generic): Manufacture for use as an adhesive, 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, based
on a patent search, that it is reasonably foreseen that the substance could be used as a
polyurethane for moldings, adhesives, film binders, or as an elastomer actuator.

Summary: The chemical substance is not likely to present an unreasonable risk of injury to
health or the environment, without consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by
the Administrator under the conditions of use, based on the risk assessment presented below and
the terms of the proposed Significant New Use Rule (SNUR) signed by EPA.2. EPA estimated

1	Under TSCA  3(4), the term "conditions of use" means "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of." In general, EPA considers the intended conditions of use of a new
chemical substance to be those identified in the section 5(a) notification. Known conditions of use include activities
within the United States that result from manufacture that is exempt from PMN submission requirements.

Reasonably foreseen conditions of use are future circumstances, distinct from known or intended conditions of use,
under which the Administrator expects the chemical substance to be manufactured, processed, distributed, used, or
disposed of. The identification of "reasonably foreseen" conditions of use will necessarily be a case-by-case
determination and will be highly fact-specific. Reasonably foreseen conditions of use will not be based on
hypotheticals or conjecture. EPA's identification of conditions of use includes the expectation of compliance with
federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate
otherwise. Accordingly, EPA will apply its professional judgment, experience, and discretion when considering such
factors as evidence of current use of the new chemical substance outside the United States, evidence that the PMN
substance is sufficiently likely to be used for the same purposes as existing chemical substances that are structurally
analogous to the new chemical substance, and conditions of use identified in an initial PMN submission that the
submitter omits in a revised PMN. The sources EPA uses to identify reasonably foreseen conditions of use include
searches of internal confidential EPA PMN databases (containing use information on analogue chemicals), other
U.S. government public sources, the National Library of Medicine's Hazardous Substances Data Bank (HSDB), the
Chemical Abstract Service STN Platform, REACH Dossiers, technical encyclopedias (e.g., Kirk-Othmer and
Ullmann), and Internet searches.

2	Reasonably foreseen conditions of use subject to a proposed SNUR are not likely to present an unreasonable risk
of injury to health or the environment. Based on EPA's experience, it is the Agency's judgment that a new use
would not commence during the pendency of a proposed SNUR because web posting of a proposed SNUR serves as
the cut-off date for a significant new use. Therefore, manufacturers and processors would not commence a
prohibited new use that would be legally required to cease upon the finalization of the SNUR. Once a SNUR is final


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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0158

that the new chemical substance could have limited persistence and a low potential for
bioaccumulation, such that repeated exposures are not expected to cause food-chain effects via
accumulation in exposed organisms. Although EPA estimated that the hydrolysis product could
be very persistent, the substance has a low potential for bioaccumulation, such that repeated
exposures are not expected to cause food-chain effects via accumulation in exposed organisms.
Based on physical/chemical properties and test data on analogous chemical substances, EPA
estimates that the chemical substance has low environmental hazard and potential for the
following human health hazards: irritation to skin, eyes, and respiratory tract, skin and
respiratory sensitization, respiratory tract effects, systemic and reproductive effects and
carcinogenicity. 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
analogues (polymers with isocyanates) and of the hydrolysis product using data for analogues
(polymers). In wastewater treatment, the new chemical substance is expected to be removed with

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-19-0158

an efficiency of 90% to 99% due to rapid hydrolysis and the hydrolysis product is expected to be
removed with an efficiency of 90% due to sorption. Removal of the hydrolysis product by
biodegradation is negligible. Sorption of the hydrolysis product to sludge is expected to be strong
and to soil and sediment is expected to be very strong. Migration of the new chemical substance
to groundwater is expected to be negligible due to rapid hydrolysis and migration of the
hydrolysis product to groundwater is expected to be negligible due to very strong sorption to soil
and sediment. Due to low estimated vapor pressure and Henry's law constant, the new chemical
substance and the hydrolysis product are expected to undergo negligible volatilization to air.
Overall, these estimates indicate that the new chemical substance and the hydrolysis product
have low potential to volatilize to air and low potential to migrate to groundwater.

-2

Persistence : Persistence is relevant to whether a new chemical substance is likely to present an
unreasonable risk because chemicals that are not degraded in the environment at rates that
prevent substantial buildup in the environment, and thus increase potential for exposure, may
present a risk if the substance presents a hazard to human health or the environment. EPA
estimated degradation half-lives of the new chemical substance using data for analogues
(polymers with isocyanates) and of the hydrolysis product using data for analogues (polymers).
EPA estimated that the new chemical substance's hydrolysis half-life is hours to days; and that
the hydrolysis product's aerobic and anaerobic biodegradation half-lives are > 6 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., sediments) due to
hydrolysis. Further, these estimates indicate that the hydrolysis product 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 new chemical substance to bioaccumulate using
data for analogues (polymers with isocyanates) and of the hydrolysis product to bioaccumulate
using data for analogues (polymers). EPA estimated that the new chemical substance has low
bioaccumulation potential based on rapid hydrolysis and the hydrolysis product has low
bioaccumulation potential based on large predicted molecular volume, which limits
bioavailability. EPA estimated that the new chemical substance could have limited persistence
and a low potential for bioaccumulation, such that repeated exposures are not expected to cause
food-chain effects via accumulation in exposed organisms. Although EPA estimated that the

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-19-0158

hydrolysis product could be very persistent, the substance has a 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
is likely to present an unreasonable risk because the significance of the risk is dependent upon
both the hazard (or toxicity) of the chemical substance and the extent of exposure to the
substance. EPA estimated the human health hazard of this chemical substance based on its
estimated physical/chemical properties, by comparing it to structurally analogous chemical
substances for which there is information on human health hazard, and other structural
information. Absorption is expected to be nil through the skin, GI tract, and lungs based on
physical/chemical properties. For the new chemical substance, EPA identified irritation to skin,
eyes and respiratory tract, skin and respiratory sensitization and respiratory tract effects as
hazards based on structural alerts. For the [claimed CBI] residual, EPA identified respiratory
effects if inhaled, skin and respiratory sensitization and skin, eye, and respiratory irritation as
hazards based on the New Chemicals Program Chemical Categories for Diisocyanates.6 For the
hydrolysis product of the residual, EPA identified systemic, reproductive effects and cancer as

"3

hazards. For the residual, EPA identified a BMCL of 0.14 mg/m based on respiratory effects via
inhalation exposure, a LOAEL of 7.5 mg/kg/day based on systemic effects following oral
exposure and an oral slope factor of 1.6 per mg/kg-day based on liver cancer, which were used to
derive exposure route- and population-specific points of departure (POD) for quantitative risk
assessment. These PODs are protective of lung, systemic, reproductive, and cancer hazards. EPA
qualitatively evaluated irritation and sensitization effects.

n

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

5	A chemical substance is considered to have low human health hazard if effects are observed in animal studies with
a No Observed Adverse Effect Level (NOAEL) equal to or greater than 1,000 mg/kg/day or if there are equivalent
data on analogous chemical substances; a chemical substance is considered to have moderate human health hazard if
effects are observed in animal studies with a NOAEL less than 1,000 mg/kg/day or if there are equivalent data on
analogous chemical substances; a chemical substance is considered to have high human health hazard if there is
evidence of adverse effects in humans or conclusive evidence of severe effects in animal studies with a NOAEL of
less than or equal to 10 mg/kg/day or if there are equivalent data on analogous chemical substances. EPA may also
use Benchmark Dose Levels (BMDL) derived from benchmark dose (BMD) modeling as points of departure for
toxic effects. See https://www.epa.gov/bmds/what-benchmark-dose-software-bmds. Using this approach, a BMDL
is associated with a benchmark response, for example a 5 or 10 % incidence of effect. The aforementioned
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	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.

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


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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0158

upon both the hazard (or toxicity) of the chemical substance and the extent of exposure to the
substance. EPA estimated environmental hazard of this new chemical substance using
predictions based on the negligible water solubility of the new chemical substance. Acute and
chronic toxicity values estimated for fish, aquatic invertebrates, and algae are all no effects at
saturation. These toxicity values indicate that the new chemical substance is expected to have
low environmental hazard. Because hazards are not expected up to the water solubility limit,
acute and chronic concentrations of concern are not identified.

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 dermal exposure, and inhalation
exposures to workers are not expected. Releases to air and landfill were estimated. Exposure to
the general population was not assessed via groundwater impacted by landfill leaching and
inhalation because releases to air and to groundwater 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 assesses risks to workers considering engineering controls
described in the PMN but in the absence of personal protective equipment (PPE) such as gloves

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-19-0158

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 were not evaluated for workers via inhalation exposures because inhalation exposures are
expected to be negligible. Irritation and sensitization hazards to workers via dermal contact were
identified based on reactivity of the new chemical, information in the SDS, structural alert for
[claimed CBI], residual [claimed CBI], and prolonged/repeated exposure. Risks for these
endpoints were not quantified due to a lack of dose-response for these hazards. However,
exposures can be mitigated by the use of appropriate personal protective equipment (PPE),
including impervious gloves and eye protection. EPA expects that employers will require and
that workers will use appropriate PPE consistent with the Safety Data Sheet prepared by the new
chemical submitter, in a manner adequate to protect them.

Risks were not evaluated because general population exposures are not expected. 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 at any concentration
of the new chemical substance soluble in the water (i.e., no effects at saturation)..

It is reasonably foreseen, based on a patent search, that the new chemical substance could be
used as a polyurethane for moldings, adhesives, film binders, or as an elastomer actuator, which
have not been assessed by EPA 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 manufacture, processing, or use
that results in inhalation exposure, release to water, and consumer use. 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).

1/31/2020	/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics


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