TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0098

Number: P-18-0098

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

Chemical Name:

Generic: Polyphosphoric acids, polymers with (alkoxyalkoxy)alkanol and substituted
heteromonocycle

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

Intended conditions of use (specific): Import, process for use, and use as a dispersing additive for
pigments at a maximum concentration of [claimed CBI]% by weight in the formulation
of the final product, 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 very 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. The biodegradation product,
inorganic phosphate, is part of the phosphorous cycle and was not evaluated for persistence or
bioaccumulation. Based on EPA's TSCA New Chemicals Program Chemical Category for

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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[claimed CBI] , test data on analogous chemical substances, and estimated physical/chemical
properties of the new chemical substance and other structural information, EPA estimates that
the chemical substance has high environmental hazard and potential for the following human
health hazards: skin irritation, eye irritation, reproductive toxicity, and specific target organ
toxicity. 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 the new chemical substance using data for
analogue(s) (polymers). In wastewater treatment, the new chemical substance is expected to be
removed with an efficiency of 90% due to sorption and partial biodegradation. Removal of the
new chemical substance by biodegradation is negligible and destruction (mineralization) of the
new chemical substance by biodegradation is partial. Sorption of the new chemical substance to
sludge, soil, and sediment is expected to be strong. Migration of the new chemical substance to
groundwater is expected to be negligible due to partial 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.

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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. EPA
estimated degradation half-lives of the new chemical substance using data for analogues
(polymers). EPA estimated that the new chemical substance's aerobic biodegradation half-life is
2 to 6 months and anaerobic biodegradation half-life is > 6 months. These estimates indicate that
the new chemical substance may be persistent in aerobic environments (e.g., surface water) and
may be very persistent in 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 terrestrial

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 if 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 if 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 if 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

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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
analogues (polymers) and of the biodegradation product, inorganic phosphate, to bioaccumulate
using data for analogue(s) (phosphoric acid and related phosphorous-containing species). EPA
estimated the potential for the new chemical substance to bioaccumulate using data for analogues
(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 very 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 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 of the new chemical substance is expected to be poor through skin when
neat, poor to moderate through skin when in solution, and nil through the lungs and the
gastrointestinal (GI) tract when neat based on physical/chemical properties. For the new
chemical substance, EPA identified hazards for irritation of the skin, eyes, and respiratory tract,
reproductive and developmental effects based on quantitative hazard data for an analogue and
[claimed CBI] structural alert. EPA also identified lung effects based on the structural alert for
surfactants. EPA identified a benchmark dose lower-bound, human equivalent dose (BMDLhed)
of 70.8 mg/kg-bw/day based on developmental effects and a no observed adverse effect
concentration (NOAEC) of 10 mg/m3 based on surfactant effects in the lung which were
protective for all health concerns with the exception of dermal and eye irritation. These values
were used to derive exposure route- and population-specific points of departure for quantitative
risk assessment. EPA qualitatively evaluated dermal and eye irritation effects.

to be very bioaccumulative if there are BCFs or BAFs of 5,000 or greater or if 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.

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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 determined environmental hazard for this new chemical substance based on
structure activity relationship (SAR) predictions for anionic surfactants (special class within
ECOSAR v.2.0) and hazard data on an analogous chemical. This substance falls within the
TSCA New Chemicals Category of Anionic Surfactants. Acute toxicity values estimated for fish,
aquatic invertebrates, and algae are >100 mg/L (ECOSAR), >100 mg/L (ECOSAR), and 0.5
mg/L (analogue), respectively. Chronic toxicity values estimated for fish, aquatic invertebrates,
and algae are >10mg/L (ECOSAR), >10mg/L (ECOSAR), and 0.16 mg/L (analogue),
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 0.125
mg/L (125 ppb) and 0.016 mg/L (16 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.

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).

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For this 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 and stack air releases. Exposure to the general
population was not assessed via fish ingestion because bioaccumulation potential was evaluated
to be low or via groundwater impacted by landfill leaching because exposures were expected to
be negligible (below modeling thresholds). Exposure to consumers was assessed via dermal and
inhalation exposure.

Risk Characterization: EPA applies a margin of exposure approach to calculate potential
human health risks of new chemicals. A benchmark (acceptable) margin of exposure (MOE) 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 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., BMDLni n and NOAEC) described above. Risks were identified for workers
for lung effects via inhalation exposure based on quantitative hazard data for an analogue
(MOEResPirabie = 15; Benchmark MOE = 100; Fold FactorReSpirabie = 7). Risks were not identified
for workers for developmental effects via dermal exposure based on quantitative hazard data for
an analogue (MOE = 31; Benchmark MOE = 30). Irritation 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. However, exposures and risks can be
mitigated by the use of appropriate PPE, including impervious gloves, eye protection, protective
clothing, respiratory protection with APF of at least 10. EPA expects that employers will require
and that workers will use appropriate PPE consistent with the Safety Data Sheet (SDS) prepared
by the new chemical submitter, in a manner adequate to protect them.

Risks were not identified for the general population for developmental effects via drinking water
or fugitive air inhalation based on quantitative hazard data for an analogue (MOEAduitDw >
130,000; MOEinfantDW > 30,000; MOEFugitive air > 280,000; Benchmark MOE = 30). Risks were
not identified for the general population for lung effects via fugitive air inhalation based on
quantitative hazard data for an analogue (MOE = > 500; Benchmark MOE = 100). Risks were
not evaluated for the general population via fish ingestion because bioaccumulation potential was
evaluated to be low or via groundwater impacted by landfill leaching and stack air inhalation,

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because exposures were expected to be negligible. Irritation hazards to the general population are
not expected via drinking water or fugitive air inhalation due to dilution of the chemical
substance in the media.

Risks were not identified for consumers for lung effects via inhalation based on quantitative
hazard data for an analogue (MOE = 295; Benchmark MOE = 100). Respiratory tract irritation
was identified as a hazard but is not expected from inhalation exposure to consumers since risks
were not identified for lung effects to consumers based on the effect level identified for
surfactancy. Risks were not identified for consumers for developmental effects via dermal
exposure based on quantitative hazard data for an analogue (MOE = 267; Benchmark MOE =
30). Irritation hazards to consumers via dermal contact were identified based on structural alerts
for anionic surfactants and the concentration of the new chemical substance in the final product
([claimed CBI]%), but EPA did not find unreasonable risk to consumers from dermal irritation.

Risks to the environment were evaluated by comparing estimated surface water concentrations
with the acute and chronic concentrations of concern. Risks from acute and chronic exposures to
the environment were not identified due to releases to water that did not exceed the acute or
chronic COC.

Because worker exposures can be controlled by PPE, and no unreasonable risks to the general
population, consumers, or the environment were identified, 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.

4/21/2020	/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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