TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0164

Number: P-19-0164

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

Chemical Name:

Generic: Bis-alkoxy substituted alkane, polymer with aminoalkanol

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

Intended conditions of use (specific): Manufacture for use as, and use as, a site-limited
intermediate for coating resin manufacture, 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 a known use, based on another
TSCA submission, which is the same as the intended conditions of use described in the
PMN.

Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
has identified use of the new chemical substance in the manufacture of demulsifiers as
reasonably foreseen based on a patent search.

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
the cut-off date for a significant new use. Therefore, manufacturers and processors would not commence a

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0164

estimated that the new chemical substance could be 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 Category for Polycationic Polymers,3 test data on analogous chemical
substances, estimated physical/chemical properties, and other structural information, EPA
estimates that the new chemical substance has high environmental hazard and potential for the
following human health hazards: irritation/corrosion and systemic, neurological, reproductive
and developmental effects. 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) (polymers with low molecular weight fractions) and EPI (Estimation Program

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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Interface) Suite™ (http://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-program-
interface). In wastewater treatment, the new chemical substance is expected to be removed with
an efficiency of 0% to 50% due to possible sorption and possible partial biodegradation.

Removal of the new chemical substance by biodegradation is unknown and destruction
(mineralization) of the new chemical substance by biodegradation is possible partial. Sorption of
the new chemical substance to sludge, soil, and sediment is expected to be low to moderate.
Migration of the new chemical substance to groundwater is expected to be moderate to rapid due
to low to moderate 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 moderate to high 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)
(polymers with low molecular weight fractions) and EPI Suite™. EPA estimated that the new
chemical substance's aerobic biodegradation half-life is 2 to 6 months and anaerobic
biodegradation half-life is 2 months to > 6 months. These estimates indicate that the new
chemical substance may be persistent in aerobic environments (e.g., surface water) and may be
persistent or very persistent in anaerobic environments (e.g., sediment). Based on the high water
solubility and low log Kow, this compound is expected to partition primarily to surface water.
Thus, its expected persistence is based on its estimated half-life in aerobic environments.

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 EPI Suite™.
EPA estimated that the new chemical substance has low bioaccumulation potential based on
BCFBAF model result < 1000 (bioconcentration factor = 3 [estimated] and bioaccumulation
factor = 1 [estimated]). Although EPA estimated that the new chemical substance could be
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.

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-19-0164

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, by comparing it to structurally analogous chemical
substances for which there is information on human health hazard and other structural
information. Absorption of the new chemical substance (molecular weight: 20% <500, 39%
<1000) is expected to be poor through the skin and GI tract and good through the lungs based on
physical/chemical properties. For the residual [claimed CBI], absorption is expected to be good
through the skin based on test data. For the new chemical substance, EPA identified irritation to
skin, eyes, and mucous membranes as hazards based on the structural alert for aliphatic amines
and the high estimated pH. For the residual, EPA identified eye and skin irritation/corrosion,
systemic effects (body weight changes and liver effects), neurological effects, and reproductive
and developmental effects as hazards, based on test data for [claimed CBI] ([claimed CBI]
residual). No POD was selected for the parent substance since irritation cannot be quantified. For
the residual, EPA identified aNOAEL of 75 mg/kg/day based on dermal developmental study of
the residual, which is protective for all hazards and was used to derive exposure route- and
population-specific points of departure for quantitative risk assessment, described below. EPA
qualitatively evaluated irritation/corrosion effects.

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-19-0164

upon both the hazard (or toxicity) of the chemical substance and the extent of exposure to the
substance. EPA determined environmental hazard for this new chemical substance based on
SAR predictions for Polycationic Polymers (special class within ECOSAR v.2.0). This substance
falls within the TSCA New Chemicals Category Polycationic Polymers. Acute toxicity values
estimated for fish, aquatic invertebrates, and algae are 0.28 mg/L, 0.1 mg/L, and 0.04 mg/L,
respectively. Chronic toxicity values estimated for fish, aquatic invertebrates, and algae are 0.02
mg/L, 0.01 mg/L, and 0.02 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 0.01 mg/L (10 ppb) and 0.001 mg/L (1 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 dermal exposure; inhalation exposure to
workers is not expected. No releases to water are expected. Releases to air are expected to be
negligible (below modeling thresholds). Exposure to the general population was not assessed
because no releases to water or landfill are expected, and releases to air are expected to be
negligible. 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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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 level (i.e., NOAEL) described above. Risks were not identified for workers for
developmental effects via dermal contact based on quantitative hazard data for a residual of the
new chemical substance (MOE = 124; Benchmark MOE = 100). Risks were not evaluated for
workers via inhalation exposures, because exposures are expected to be negligible.

Irritation/corrosion hazards to workers via dermal contact were identified based on structural
alerts for amines, high estimated pH for the new chemical substance, and test data for a residual.
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 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 evaluated for the general population because general population exposures are
not expected. Risks to consumers 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, based on a patent search, that the new chemical substance could be
used in the manufacture of demulsifiers and could result in releases and exposures that differ
from those assessed under the intended conditions of use. 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: (1) releases to water resulting in a surface water concentration of
the substance exceeding 1 part per billion; and, (2) manufacture, processing, or use of the
substance in any manner that results in inhalation exposure. 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-19-0164

1/31/2020		IsL

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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