TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0108

Number: P-18-0108

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

Chemical Name:

Generic: Aromatic anhydride polymer with bisalkylbiphenylbisamine compound with
alkylaminoalkyl acrylate ester

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

Intended conditions of use (generic): Manufacture (including import) for use as an ionic salt of a
polyamic acid for coatings, open, non-dispersive use, 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 that the substance is known to be
used for the same use based on information in another TSCA submission.

Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
evaluated whether there are reasonably foreseen conditions of use and found none.

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 anion could be very persistent and the cation could be
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
EPA's TSCA New Chemicals Program Chemical Category of Aliphatic Amines2 and test data

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.

2	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-18-0108

on analogous chemical substances, EPA estimates that the chemical substance has moderate
environmental hazard and potential for the following human health hazards: skin, eye, and
respiratory tract irritation; dermal and respiratory sensitization; acute, systemic, and
developmental toxicity; and neurotoxicity. 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
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 anion using data for analogue(s)
(polymers) and of the cation using EPI (Estimation Program Interface) Suite™
(http://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-programinterface).
In wastewater treatment, the anion 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
biodegradation. Removal of the anion by biodegradation is negligible and removal of the cation
by biodegradation is high. Sorption of the anion to sludge is expected to be strong and to soil and
sediment is expected to be very strong and sorption of the cation to sludge, soil, and sediment is
expected to be low. Migration of the anion to groundwater is expected to be negligible due to
very strong sorption to soil and sediment and migration of the cation to groundwater is expected
to be rapid due to low sorption to soil and sediment. Due to low estimated vapor pressure and
Henry's law constant, the anion and the cation are expected to undergo negligible volatilization
to air. Overall, these estimates indicate that the anion has low potential to volatilize to air or
migrate to groundwater; and that the cation has low potential to volatilize to air and has high
potential to migrate to groundwater.

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 anion using data for analogue(s) (polymers) and of the
cation using EPI Suite™. EPA estimated that the anion's aerobic and anaerobic biodegradation
half-lives are > 6 months; and that the cation's aerobic biodegradation half-life is < 2 months and
anaerobic biodegradation half-life is 2 to 6 months. These estimates indicate that the anion may
be very persistent in aerobic environments (e.g., surface water) and anaerobic environments (e.g.,
sediment). Further, these estimates indicate that the cation may have limited persistence in
aerobic environments (e.g., surface water) and may be persistent anaerobic environments (e.g.,
sediment).

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 lias 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)

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0108

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 anion to bioaccumulate using data for
analogue(s) (polymers) and of the cation to bioaccumulate using EPI Suite™. EPA estimated
that the anion has low bioaccumulation potential based on large predicted molecular volume,
which limits bioavailability and the cation has low bioaccumulation potential based on BCFBAF
model result < 1,000. Although EPA estimated that the anion 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. Although EPA estimated
that the cation could be 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.

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 and by comparing it to structurally analogous chemical
substances for which there is information on human health hazard. Absorption of the polymer
portion of the new chemical substance is expected to be nil via all routes based on physical/
chemical properties; absorption of the [claimed CBI] portion of the new chemical substance is
expected to be good via all routes based on physical/chemical properties. For the new chemical
substance, EPA identified acute toxicity based on analogue data; skin, eye, and respiratory tract
irritation based on analogue data for the cationic component and information provided in the

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 B AFs 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 B AFs of 5,000 or greater or there are equivalent or analogous data.
(64 FR 60194; November 4 1999)

5	A chemical substance is considered to have low human health hazard if effects are observed in animal studies with
a No Observed Adverse Effect Level (NOAEL) equal to or greater than 1,000 mg/kg/day or if there are equivalent
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/wliat-benclimark-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. Enviromnent
Directorate, Organization for Economic Co-operation and Development, Paris, France.

(http://www.oecd.org/officialdocuinents/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-18-0108

SDS; dermal sensitization based on analogue data for the cationic component, the OECD QSAR
Toolbox, and information provided in the SDS, and respiratory sensitization based on the OECD
QSAR Toolbox; developmental toxicity based on analogue data for the cationic component and
information provided in the SDS; and neurotoxicity and systemic toxicity based on analogue data
for the cationic component, as hazards. EPA identified a NOAEL of 10 mg/kg/day based on
developmental toxicity and a NOAEC of 643 mg/m3 based on lung toxicity, which are protective
for neurotoxicity and systemic toxicity and were used to derive exposure route- and population-
specific points of departure for quantitative risk assessment. EPA qualitatively evaluated
irritation and 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 the
Ecological Structure Activity Relationships (ECOSAR) Predictive Model
(https://www.epa.gov/tsca-screening-tools/ecological-structure-activity-relationships-ecosar-
predictive-model); specifically the QSAR for aliphatic amines. This substance falls within the
TSCA New Chemicals Category of Aliphatic Amines. Acute toxicity values estimated for fish,
aquatic invertebrates, and algae are 207 mg/L, 23 mg/L, and 22 mg/L, respectively. Chronic
toxicity values estimated for fish, aquatic invertebrates, and algae are 15 mg/L, 1.8 mg/L, and 7
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
4.6 mg/L (4,600 ppb) and 0.18 mg/L (180 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-

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-18-0108

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, EPA assessed worker exposure via dermal exposure;
inhalation exposure to workers is not expected. Releases to water, air, and landfill were
estimated. Exposure to the general population was assessed via drinking water ingestion,
groundwater ingestion (landfill leachate), and stack air inhalation. Exposure to the general
population via fish ingestion was not assessed because bioaccumulation potential was evaluated
to be low; exposure to the general population via fugitive air inhalation was not assessed because
exposures are expected to be negligible (below modeling thresholds). Consumer exposures were
not assessed because consumer uses were not identified as conditions of use.

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 substance were evaluated using the route-specific
effect levels (i.e., NOAEL, NOAEC) described above. Risks were identified for workers for
developmental toxicity via dermal exposure based on quantitative hazard data for an analogue
(MOE = 5; Benchmark MOE = 100). Risks would be mitigated if exposures can be controlled by
the use of appropriate PPE, including impervious gloves. Irritation and sensitization hazards to
workers via dermal contact were identified based on data on a component of the new chemical
substance, analogue data, the OECD QSAR Toolbox, and information provided in the SDS.

Risks for these endpoints were not quantified due to a lack of dose-response for these hazards.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0108

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 developmental toxicity via drinking
water ingestion based on quantitative hazard data for an analogue (MOEaduit = 8,152; MOEinfant =
1,941; Benchmark MOE = 100). Risks were not identified for the general population for
systemic toxicity via stack air inhalation based on quantitative hazard data for a component of
the new chemical substance (MOE = 23,494; Benchmark MOE = 100). Risks to consumers were
not evaluated because consumer uses were not identified as conditions of use.

Risks to the environment were evaluated by comparing estimated surface water concentrations
with the acute and chronic concentrations of concern. Risks from acute exposure to the
environment were not identified due to releases to water that did not exceed the acute COC.

Risks from chronic exposure to the environment were not identified since the chronic COC is
exceeded less than 20 days per year.

EPA previously assessed the known conditions of use and determined that they will not present
an unreasonable risk to human health or the environment. Because worker exposures can be
controlled by PPE, no unreasonable risks to the general population or environment were
identified, and there are no expected consumer exposures, 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.

1/22/2020		/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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