TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0176
Number: P-18-0176
TSCA Section 5(a)(3) Determination: The chemical substance is not likely to present an
unreasonable risk (5(a)(3)(C))
Chemical Name:
Generic: 5-Isobenzofurancarboxylic acid, l,3-dihydro-l,3-dioxo-, polymer with aminoalcohol,
2,2-dimethyl-l,3-propanediol, 2,5-furandione, polyalkylene glycol and unsaturated anhydride
Conditions of Use (intended, known, or reasonably foreseen)1:
Intended conditions of use (generic): Import in solution for an industrial coating, 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 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 new chemical substance could be persistent or very persistent,
the new chemical substance has low potential for bioaccumulation, such that repeated exposures
are not expected to be cumulative. Based on EPA's TSCA New Chemicals Program Chemical
Categories for Esters, Imides and Polyanionic Polymers (Monomers) and data on analogous
chemical substances, EPA estimates that the chemical substance has low environmental hazard
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	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-18-0176
and potential for the following human health hazards: lung surfactancy due to polyether groups,
developmental and blood toxicity due to trimellitic aid moiety. 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 this new chemical substance using data for
large molecular weight polymers and EPI (Estimation Programs Interface) Suite™, a suite of
physical/chemical property and environmental fate estimation programs
(http://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-interface). The
chemical substance is estimated to be removed during wastewater treatment with an efficiency of
90% based on sorption and biodegredation. Sorption to sludge, soil, and sediment is estimated to
be moderate to strong, resulting in slow to moderate migration to groundwater for the new
chemical substance. Volatilization to air is estimated to be negligible because of the high
molecular volume. Overall, these estimates are indicative of low potential for this chemical
substance to volatilize into the air and a low to moderate potential for this chemical to migrate
into groundwater.
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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. Based on
data for polymers and EPI Suite™, a suite of physical/chemical property and environmental fate
estimation programs (http://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-
interface). EPA estimated the biodegradation half-lives of the new chemical substance. The
aerobic biodegradation half-lives are estimated to be two to greater than six months. The
anaerobic biodegradation half-lives are estimated to be two to greater than six months. These
estimates for biodegradation indicate that the new chemical substance will be persistent to 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
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 (B AF) 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-18-0176
terrestrial species pose the potential for elevated exposures to humans and other organisms via
food chains. The new chemical substance has low bioaccumulation potential. This is based on
data on polymers and EPI Suite™, a suite of physical/chemical property and environmental fate
estimation programs (http://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-
interface), in addition to large predicted molecular volume which limits bioavailability and
biodegradation. The low molecular weight components are expected to be metabolized, which
reduces their bioaccumulation potential.
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 to poor via all routes for the neat material and poor
via all routes for the low molecular weight fractions when in solution, based on
physical/chemical properties.
For the new chemical substance, EPA identified lung surfactancy effects as a hazard based on the
presence of polyether groups and developmental and blood effects based on the presence of
trimellitic acid moiety, if released. A LOAEC of 0.08 mg/m was identified for lung effects using
data on an analogue. A NOAEL of 500 mg/kg/day for the trimellitic acid moiety was identified
in oral studies in dogs and rats, which was used to derive exposure route- and population-specific
points of departure for quantitative risk assessment, described below.
Environmental Hazard6: Environmental hazard is relevant to whether a new chemical
substance is likely to present unreasonable risks 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.
6A 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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0176
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 the Ecological Structure Activity Relationships (ECOSAR)
Predictive Model (https://www.epa.gov/tsca-screening-tools/ecological-structure-activitv-
releationships-ecosar-predictive-modeD; specifically the QSAR for esters for a low molecular
weight (LMW) component (MW [claimed CBI]). Acute toxicity values estimated for fish,
aquatic invertebrates, and algae are all >100 mg/L for the new chemical substance and the LMW
component (MW [claimed CBI]). Chronic toxicity values estimated for fish, aquatic
invertebrates, and algae are all >10 mg/L for the new chemical substance and the LMW
component (MW [claimed CBI]). 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 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, EPA assessed exposure to workers via the dermal route, and
inhalation exposure to workers is expected to be negligible. Exposure to the general population
was assessed via drinking water. Exposure to the general population via inhalation was not
assessed because releases to air are expected to be negligible (below modeling thresholds).
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-18-0176
Exposures to consumers were not assessed because consumer uses were not identified as
conditions of use.
Risk Characterization: EPA applies a margin of exposure approach, which compares an effect
level to an estimated exposure concentration, 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 1000
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. 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 points of
departure (i.e., LOAEC and NOAEL) described above. For the new chemical substance, risks
were not identified for workers for developmental and blood effects via dermal exposure (MOE=
498; benchmark MOE=100). Risks to workers for lung effects were not assessed because
inhalation exposure to workers is not expected under the conditions of use.
Risks were not identified for the general population for developmental and blood effects via
drinking water exposure (MOEaduit = 7,700,000; MOEinfant= 1,860,000; benchmark MOE=100).
Risks to the general population for lung effects were not quantitatively assessed because
inhalation exposure is expected to be negligible under the conditions of use. 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 estimated acute and chronic COCs. Risks to the environment were not identified
because the estimated maximum surface concentrations did not exceed the acute or chronic
COCs.
Because no unreasonable risks to workers, 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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0176
2/27/2019	/s/
Date:	Jeffery T. Morris, Director
Office of Pollution Prevention and Toxics

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