TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0367

Number: P-18-0367

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

Chemical Name:

Generic: Acid-modified polyether

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

Intended conditions of use (specific): Imported for use as a wetting and dispersing additive for
pigments in industrial paints and 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 identified, based on a previous TSCA
submission, the same use as the intended use (i.e., use as a wetting and dispersing
additive for pigments in industrial paints and coatings) as a known use.

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 use as a
dispersing agent for other products as reasonably foreseen, based on use of structurally
analogous chemical substances.

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. Although EPA

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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0367

estimated that the new chemical substance could be very persistent, the new chemical 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 Categories for [claimed CBI]3 and test data on analogous chemical
substances, EPA estimates that the chemical substance has high environmental hazard and
potential for the following human health hazards: lung, systemic, and
reproductive/developmental effects, skin irritation, and corrosion to eyes and mucous
membranes. 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.

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 previously assessed the new chemical substance under the 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
analogue(s) (high MW polymers with biodegradable low MW fractions) and of the

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.

3 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-18-0367

biodegradation product using data for analogue(s) ([claimed CBI]). In wastewater treatment, the
new chemical substance is expected to be removed with an efficiency of 90% due to sorption and
possible biodegradation. Removal of the new chemical substance by biodegradation is negligible
to high. Sorption of the new chemical substance to sludge, soil, and sediment is expected to be
low to strong. Migration of the new chemical substance to groundwater is expected to be slow to
rapid due to low to strong sorption to soil and sediment. Due to low estimated vapor pressure and
Henry's law constant, the new chemical substance is expected to undergo negligible
volatilization to air. Overall, these estimates indicate that the new chemical substance has low
potential to volatilize to air and has unknown potential to migrate to groundwater.

Persistence4: 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 analogue(s) (high
MW polymers with biodegradable low MW fractions) and of the biodegradation product using
data for analogue(s) ([claimed CBI]). EPA estimated that the new chemical substance's aerobic
and anaerobic biodegradation half-lives are > 6 months; and that the biodegradation product's
aerobic and anaerobic biodegradation half-lives are > 6 months. These estimates indicate that the
new chemical substance and the biodegradation product may be very persistent in aerobic
environments (e.g., surface water) and anaerobic environments (e.g., sediment).

Bioaccumulation5: 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) (high MW polymers with biodegradable low MW fractions) and of the
biodegradation product to bioaccumulate using data for analogue(s) ([claimed CBI]). EPA
estimated that the new chemical substance has low bioaccumulation potential based on
bioconcentration or bioaccumulation data reported for high MW polymers with biodegradable
low MW fractions, while the biodegradation product does not bioaccumulate by lipophilic
partitioning and there is low concern that it may accumulate in organisms by other mechanisms.
Although EPA estimated that the new chemical substance 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

4	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)

5	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-18-0367

biodegradation product 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 Hazard6: 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 parent
polymer is expected to be nil all routes and for the low molecular weight fraction is expected to
be poor all routes based on analogue data. For the new chemical substance, EPA identified lung
effects, systemic effects and reproductive/developmental effects as hazards based on the ether
moieties. EPA also identified skin irritation, and corrosion to the eyes and mucous membranes
based on analogue data. EPA identified a NOAEC of 10 mg/m3 based on lung effects and a
NOAEL of 50 mg/kg-day based on kidney effects which are protective for all oral and inhalation
health concerns, with the exception of irritation and corrosion, and were used to derive exposure
route- and population-specific points of departure for quantitative risk assessment, described
below. Irritation and corrosion were evaluated qualitatively.

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

6	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.

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
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-18-0367

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. This substance falls within the TSCA New Chemicals Category
of [claimed CBI], Acute toxicity values estimated for fish, aquatic invertebrates, and algae are
>100 mg/L, >100 mg/L, and 0.28 mg/L, respectively. Chronic toxicity values estimated for fish,
aquatic invertebrates, and algae are >10 mg/L, >10 mg/L, and 0.092 mg/L, respectively. These
toxicity values indicate that the new chemical substance is expected to have high 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 0.07 mg/L (70 ppb) and
0.009 mg/L (9 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 assessment, EPA assessed worker exposure via inhalation and dermal routes. Releases to
air, water and landfill were estimated. Exposure to the general population was assessed via
drinking water and landfill release. Exposure to the general population via inhalation was not
assessed because releases to 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 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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0367

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., NOAEC and NOAEL) described above. Risks were identified for workers for
lung effects via inhalation exposure based on quantitative hazard data for an analogue (MOE =
31; Benchmark MOE = 100; Fold Factor= 3). Risks were not identified for workers for systemic
effects via dermal exposure during either processing (assuming a concentration of 52% in
formulation) or use (assuming a concentration of 2% in formulation) based on quantitative
hazard data for [claimed CBI], a metabolite of the new chemical substance (MOE> 3,333;
Benchmark MOE = 100). Irritation and corrosion hazards to workers via inhalation and dermal
contact were identified based on analogue data. Risks for these endpoints were not quantified
due to a lack of dose-response for these hazards. Risks will be mitigated if exposures are
controlled by the use of appropriate PPE, including impervious gloves, eye protection, and
respiratory protection. EPA expects that employers will require and workers will use appropriate
PPE (i.e., impervious gloves, eye protection, and respiratory protection), consistent with the
Safety Data Sheet prepared by the PMN submitter, in a manner adequate to protect them.

Risks were not identified for the general population for systemic effects via oral ingestion based
on quantitative hazard data for an analogue [claimed CBI] (All MOEs > 8,000; benchmark MOE
= 100). Risks to the general population via inhalation were not assessed because releases to air
were expected to be negligible (below modeling thresholds). Risks to consumers were not
assessed because consumer uses and exposures are not expected.

Risks to the environment were evaluated by comparing estimated surface water concentrations
with the estimated acute and chronic COCs. 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. 8

It is reasonably foreseen, based on analogue information, that the new chemical substance could
be used other than as described in the PMN, which could result in greater exposures or releases.

8 The 20-day criterion for concluding chronic risk is not likely is based on partial life cycle tests (daphnid chronic
and fish early life stage tests) that typically range from 21 to 28 days in duration.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0367

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 processing the substance to
greater than 2% concentration by weight in the final product formulation, use in consumer
products, and release of manufacturing, processing, or use stream associated with any use of the
PMN substance into the waters of the United States exceeding a surface water concentration of 9
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).

1/31/2020		IsL

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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