TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236 Chemical Name Generic Metal Alkenoic Acid-alkyl Alkenoate-alkyl Substituted Alkenoate Polymer Carbopolycycle Complexes


TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

Number: P-18-0236

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

unreasonable risk (5(a)(3)(C))

Chemical Name:

Generic: Metal, alkenoic acid-alkyl alkenoate-alkyl substituted alkenoate polymer

carbopolycycle complexes,

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

Intended conditions of use (generic): Import for processing and use as a paint additive, consistent
with the manufacturing, processing, use, distribution, and disposal information described
in the PMN. The manufacture (import) and processing are subject to TSCA. The end use
final product is subject to regulation under another authority.

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 the
following reasonably foreseen conditions of use: disposals that involve water releases

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

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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

based on information in the initial PMN, which was subsequently amended to prevent
such environmental exposures.

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
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.
Although EPA estimated that the cation could be very persistent, the substance does not
bioaccumulate by lipophilic partitioning and there is low concern that it will accumulate in
organisms by other mechanisms; thus, repeated exposures are not expected to cause food-chain
effects via accumulation in exposed organisms. Based on test data on the new chemical
substance and analogous chemical substances, EPA estimates that the chemical substance has
moderate environmental hazard and potential for the following human health hazards: respiratory
sensitization, skin sensitization, reproductive toxicity, specific target organ toxicity, and
immunotoxicity. The PMN describes conditions of use that mitigate the human health and
environmental risks. Therefore, EPA concludes that the new chemical is not likely to present
unreasonable risk to human health or the environment under the intended conditions of use.

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-18-0236

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 reactive groups); of the hydrolysis product using data for analogues
(polymers); and of the cation using data for analogue(s) (metals). In wastewater treatment, the
new chemical substance is expected to be removed with an efficiency of 90% to 99% due to
hydrolysis and sorption; the hydrolysis product is expected to be removed with an efficiency of
90% due to sorption; and the cation is expected to be removed with an efficiency of 90% due to
sorption. Removal of the new chemical substance by biodegradation is negligible and removal
of the hydrolysis product by biodegradation is negligible. Sorption of the new chemical
substance and 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 and the hydrolysis
product to groundwater is expected to be negligible due to very strong sorption to soil and
sediment. Due to low reported vapor pressure, the new chemical substance is expected to
undergo negligible volatilization to air and the hydrolysis product is expected to undergo
negligible volatilization due to low estimated vapor pressure and Henry's law constant. 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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

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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 for analogues
(polymers with reactive groups) and of the hydrolysis product using data for analogues
(polymers). EPA estimated that the new chemical substance's hydrolysis half-life is 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 reactive groups); of the hydrolysis product to bioaccumulate using
data for analogues (polymers); and of the cation to bioaccumulate using data for analogues
(metals). EPA estimated that the new chemical substance has low bioaccumulation potential
based on hydrolysis; the hydrolysis product has low bioaccumulation potential based on large
predicted molecular volume, which limits bioavailability; and the cation does not bioaccumulate
by lipophilic partitioning, and there is low concern that it may accumulate in organisms by other
mechanisms. EPA estimated that the new chemical substance could have limited persistence and

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

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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

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. Although EPA estimated that the cation could be very
persistent, the substance does not bioaccumulate by lipophilic partitioning and there is low
concern that it will accumulate in organisms by other mechanisms; thus, 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, 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 nil via all
routes for the neat material. The [claimed CBI], [claimed CBI] moiety, and [claimed CBI]
anionic component are expected to be absorbed from the GI tract based on the acidic
environment of the stomach and the expected hydrolysis of the [claimed CBI] bond. For the new
chemical substance, EPA identified lung effects as a hazard based on analogue data; GI effects,
anemia, liver and kidney toxicity, immunotoxicity, and developmental toxicity as hazards based

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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

on the [claimed CBI]; reproductive/developmental toxicity and sensitization as hazards based on
the anionic component; neurotoxicity, developmental effects, and hematological effects as
hazards based on the [claimed CBI] moiety; and developmental toxicity and blood effects as
hazards based on the structural alert for chelation for the hydrolysis product. Submitted test data
for the new chemical substance reported the test substance to be negative in an Ames assay (with
and without metabolic activation). EPA identified aNOAEC of 1 mg/m3 based on lung effects
and a NOAEL of 0.0272 mg/kg/day based on gastrointestinal effects, which were used to derive
exposure route- and population-specific points of departure for quantitative risk assessment,
described below. The selected points of departure are expected to be protective of all other health
effects. EPA qualitatively evaluated sensitization 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
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. Acute toxicity values estimated for fish, aquatic invertebrates,
and algae are 15.8 mg/L, 1.37 mg/L, and 2.0 mg/L, respectively. Chronic toxicity values
estimated for fish, aquatic invertebrates, and algae are 1.37 mg/L, 0.89 mg/L, and 0.5 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
0.274 mg/L (274 ppb) and 0.05 mg/L (50 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.

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
ChVs is less than 0.1 mg/L (Sustainable Futures https://www.epa.gov/sustainable-futures/sustainable-futures-p2-
framework-manual).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

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 assessment, EPA assessed worker exposure via dermal contact, and inhalation exposure
is not expected. Releases to air via incineration were estimated. No releases to water, fugitive air,
or landfill were expected. Exposures to the general population were assessed via stack air
inhalation and releases from fugitive air are not expected. Exposures to the general population
via drinking water ingestion, fish ingestion and groundwater ingestion (from landfill leachate)
were not assessed because releases to water and landfill are not expected. 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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

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., LOAEC and NOAEL) described above. Risks were not identified for workers
for gastrointestinal effects via dermal contact based on quantitative hazard data for the metal
[claimed CBI] (MOEDermai = 123; Benchmark MOE = 3). Risks were not identified for workers
via inhalation exposure because exposure was expected to be negligible. Sensitization hazards to
workers via dermal contact were identified based on [claimed CBI], 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 identified for the general population for lung effects via inhalation exposure
based on quantitative hazard data for an analogous polyanionic polymer. (MOEinhalation = 2,710;
Benchmark MOE = 100). Sensitization hazards to the general population are not expected via
stack air releases due to dilution of the chemical substance in the media. Risks to consumer were
not evaluated because consumer uses were not identified as conditions of use.

Risks to the environment were not identified due to no releases to water.

It is reasonably foreseen that increased exposure could occur from disposal involving water
releases, based on information in the initial PMN, which was subsequently amended to prevent
such water exposures. 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
predictable or purposeful release of the PMN substance, or any waste stream from manufacturing
or processing containing the PMN substance, that results in surface water concentrations
exceeding 50 ppb. 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).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0236

1/27/2020		/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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