TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0067

Number: P-18-0067

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

Chemical Name:

Specific: Fatty acids, C14-18 and C16-18-unsatd., polymers with adipic acid and
triethanolamine, di-Me sulfate-quaternized CASRN: 1211825-32-9

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

Intended conditions of use (generic): Import for use as an adjuvant agent, 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, 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 test data on the
new chemical substance and analogous chemical substances, EPA estimates that the chemical
substance has moderate environmental hazard and potential for the following human health
hazards: systemic effects and irritation to the eye and skin. EPA concludes that the new

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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0067

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 new chemical substance using data for
analogue(s) (polymers), data submitted for analogue(s) (Fatty acids, C14-20 and C16-18-unsatd.,
reaction products with adipic acid and triethanolamine, di-Me sulfate-quaternized), and data
submitted for the new chemical substance. In wastewater treatment, the new chemical substance
is expected to be removed with an efficiency of 90% due to sorption and biodegradation.
Removal of the new chemical substance by biodegradation is high. Sorption of the new chemical
substance to sludge is expected to be moderate and to soil and sediment is expected to be strong.
Migration of the new chemical substance to groundwater is expected to be negligible due to
strong sorption to soil and sediment, mitigated by biodegradation. 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 or 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 new chemical substance using data submitted for
analogue(s) (Fatty acids, CI4-20 and C16-18-unsatd., reaction products with adipic acid and
triethanolamine, di-Me sulfate-quaternized). EPA estimated that the new chemical substance's
aerobic biodegradation half-life is < 2 months and anaerobic biodegradation half-life is 2 to 6
months. These estimates indicate that the new chemical substance may have limited persistence
in aerobic environments (e.g., surface water) and may be persistent in anaerobic environments
(e.g., sediment).

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Bioaccumulation : 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

2	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)

3	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-18-0067

data for analogue(s) (polymers). EPA estimated that the new chemical substance has low
bioaccumulation potential based on large predicted molecular volume, which limits
bioavailability. Although EPA estimated that the new chemical substance 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 Hazard4: 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 functionally analogous chemical
substances for which there is information on human health hazard. Absorption is expected to be
poor for the skin, moderate for the GI tract, and good from the lung based on estimated
physical/chemical properties and analogue data. For the new chemical substance, EPA identified
systemic effects as a hazard based on analogue data and irritation to the eye and skin as hazards
based on the structural alert for quaternary ammonium compounds. EPA identified a NOAEL of
40 mg/kg/day based on systemic effects, which was used to derive exposure route- and
population-specific points of departure.

Environmental Hazard5: 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

4	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.

5	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-fiitures-p2-
framework-manual).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0067

substance. EPA determined the environmental hazard for this new chemical substance based on
acute toxicity data submitted on the new chemical substance and on an analogue. This substance
falls within the TSCA New Chemicals Category of polycationic polymers. Acute toxicity values
measured for fish, aquatic invertebrates, and algae are 6.7 mg/L, 7.29 mg/L, and 2.3 mg/L,
respectively. Chronic toxicity values estimated for fish, aquatic invertebrates, and algae are 0.67
mg/L, 0.729 mg/L, and 0.845 mg/L, 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 0.575 mg/L (575 ppb) and 0.067 mg/L (67 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 worker exposure via inhalation and dermal
contact. Releases to water, air and landfill were estimated. Exposure to the general population
was assessed via drinking water. 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 ingestion of groundwater impacted by landfill leachate and inhalation were not
assessed because releases to landfills and 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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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) described above. Risks were not identified for workers for systemic
effects via dermal or inhalation exposure based on quantitative hazard data for an analogue
(MOEdermai = 133,333, MOEjnhaiatim >6 million; Benchmark MOE = 100). Irritation hazards to
workers were identified based on structural alert for quaternary ammonium compounds. 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 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 systemic effects via drinking water
exposure based on quantitative hazard data for an analogue (MOEaduitDw =39,793, MOEinfantDw
=9,475; Benchmark MOE = 100). Risks were not identified for the general population via fish or
groundwater impacted by landfill leachate ingestion or stack or fugitive air inhalation, because
bioaccumulation potential was evaluated to be low and exposures to landfill and air are expected
to be negligible.

Irritation hazards to the general population are not expected via drinking water ingestion due to
dilution of the chemical substance in the media.

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 days6 per year.

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

6 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-18-0067

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.

1/13/2020	/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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