TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0341, P-18-
0342, P-18-0343, and P-18-0344
Number: P-18-0341, -0342, -0343, -0344
TSCA Section 5(a)(3) Determination: The chemical substances are not likely to present an
unreasonable risk (5(a)(3)(C))
Chemical Name:
Generic (P-18-0341): Alkane dicarboxylic acid, polymer with alkoxylated polyalcohol, alkyl
polyglycol, alkyl dialcohol, and functionalized carboxylic acid,;
Generic (P-18-0342): Alkane dicarboxylic acid, polymer with alkyl polyglycol, alkyl dialcohol,
and functionalized carboxylic acid,;
Generic (P-18-0343): Alkane dicarboxylic acid, polymer with alkoxylated polyalcohol, and alkyl
dialcohol, (hydroxy alkyl) ester,;
Generic (P-18-0344): Aromatic dicarboxylic acid, polymer with alkane dicarboxylic acid,
alkoxylated polyalcohol, and alkyl dialcohol,
Conditions of Use (intended, known, or reasonably foreseen)1:
Intended conditions of use (generic): Manufacture for use and use as components in coatings,
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 substances are not likely to present an unreasonable risk of injury to
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.
1

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0341, P-18-
0342, P-18-0343, and P-18-0344
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 substances could be very persistent, the
substances have 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 for Esters and estimated physical/chemical
properties and other structural information, EPA estimates that the chemical substances have
moderate environmental hazard and potential for the following human health hazards: skin, eye,
and lung irritation. EPA concludes that the new chemical substances are 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 new chemical substances using data for
analogue(s) (compounds with variable composition and small to large molecular volume). In
wastewater treatment, the new chemical substances are expected to be removed with an
efficiency of 25% to 90% due to sorption and possible biodegradation. Removal of the new
chemical substances by biodegradation is negligible to high. Sorption of the new chemical
substances to sludge is expected to be low to strong and to soil and sediment is expected to be
very strong. Migration of the new chemical substances 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 substances are expected to undergo negligible
volatilization to air. Overall, these estimates indicate that the new chemical substances have low
potential to volatilize to air or migrate to groundwater.
j
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 substances using data for analogue(s)
(compounds with variable composition and small to large molecular volume). EPA estimated
that the new chemical substances' aerobic biodegradation half-lives are < 2 months to > 6
months and anaerobic biodegradation half-lives are > 6 months. These estimates indicate that the
new chemical substances may be persistent or very persistent in aerobic environments (e.g.,
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.
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)
2

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0341, P-18-
0342, P-18-0343, and P-18-0344
surface water) and may be very persistent in anaerobic environments (e.g., sediment).
Biodegradation potential will vary depending on the molecular weight.
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 analogue(s) (compounds with variable composition and small to large molecular
volume). EPA estimated that the new chemical substances have low bioaccumulation potential
based on bioconcentration or bioaccumulation data reported for compounds with variable
composition and small to large molecular volume. Although EPA estimated that the new
chemical substances could be very persistent, the substances have 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 these chemical substances based on their
estimated physical/chemical properties and other structural information. Absorption of the new
chemical substances is expected to be good via all routes based on physical/chemical properties.
For the new chemical substances, EPA identified skin, eye, and lung irritation based on their
estimated physical and chemical properties and information provided in the SDS. EPA
qualitatively evaluated irritation effects.
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)
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.
3

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0341, P-18-
0342, P-18-0343, and P-18-0344
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 the new chemical substances described in P-
18-0341, P-18-0342, and P-18-0343 using the Ecological Structure Activity Relationships
(ECOSAR) Predictive Model (https://www.epa.gov/tsca-screening-tools/ecological-structure-
activitv-relationships-ecosar-predictive-modeD; specifically the QSAR for Esters ([LMW]
oligomer with MW of [claimed CBI]). These substances fall within the TSCA New Chemicals
Category of Esters. Acute toxicity values estimated for fish, aquatic invertebrates and algae are
all >100 mg/L. Chronic toxicity values estimated for fish, aquatic invertebrates, and algae are
8.5 mg/L, > 10 mg/L, and >10 mg/L for fish, aquatic invertebrates, and algae, respectively.
These toxicity values indicate that the new chemical substances are 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 20 mg/L
(20,000 ppb) and 0.85 mg/L (850 ppb), respectively.
EPA estimated environmental hazard of the new chemical substance described in P-18-0344
using the Ecological Structure Activity Relationships (ECOSAR) Predictive Model
(https://www.epa.gov/tsca-screening-tools/ecological-structure-activitv-relationships-ecosar-
predictive-model): specifically the QSAR for esters (LMW oligomer with MW of 686). This
substance falls within the TSCA New Chemicals Category of esters. Acute toxicity values
estimated for fish, aquatic invertebrates and algae are 44 mg/L, 86 mg/L, and 33 mg/L,
respectively. Chronic toxicity values estimated for fish, aquatic invertebrates, and algae are 2.9
mg/L, > 10 mg/L, and >10 mg/L for fish, aquatic invertebrates, and algae, respectively. These
toxicity values indicate that the new chemical substance is expected to have moderate
environmental hazard. Application of assessment factors of 4 and 10 to acute and chronic
toxicity values, respectively, results in acute and chronic concentrations of concern of 8.25 mg/L
(8,250 ppb) and 0.29 mg/L (290 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 substances
under the intended conditions of use described in the PMN using ChemSTEER (Chemical
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).
4

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0341, P-18-
0342, P-18-0343, and P-18-0344
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 worker exposure via dermal and inhalation
exposure. Releases to water, air, and landfill were estimated. Exposure to the general population
was assessed via drinking water and fugitive air inhalation. Exposure to the general population
via fish ingestion, groundwater via landfill leachate, and stack air inhalation was not assessed
because the bioaccumulation potential was evaluated to be low and releases to landfill and stack
air 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
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).
Irritation hazards to workers via inhalation and dermal contact were identified based on
estimated physical and chemical properties and information provided in the SDS. 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, eye protection, and respiratory 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.
Irritation hazards to the general population are not expected via drinking water or fugitive air
emissions due to dilution of the chemical substance in the media. Risks were not evaluated for
the general population via fish ingestion because bioaccumulation potential was evaluated to be
low. Risks were not evaluated for the general population via groundwater impacted by landfill
leachate or stack air because exposures are expected to be negligible. 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 to the environment were not
identified due to releases to water that did not exceed the acute or chronic COC.
5

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0341, P-18-
0342, P-18-0343, and P-18-0344
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.
12/16/2019		/s/
Date:	Tala R. Henry, Ph.D.
Deputy Director for Programs
Office of Pollution Prevention and Toxics
6

-------