TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-17-0347, P-17-
0348, P-17-0349, P-17-0350 P-17-0351, P-170-352
Number: P-17-0347, P-17-0348, P-17-0349, P-17-0350 P-17-0351, P-17-0352
TSCA Section 5(a)(3) Determination: The chemical substances are not likely to present an
unreasonable risk (5(a)(3)(C))
Chemical Name:
Specific:
P-17-0347: Oxirane, 2-methyl-, polymer with oxirane, mono(2-butyloctyl) ether;
CASRN:252756-20-0
P-17-0348: Oxirane, 2-methyl-, polymer with oxirane, mono(2-hexyldecyl) ether; CASRN:
125005-52-9
P-17-0349: Oxirane, 2-methyl-, polymer with oxirane, mono(2-octyldodecyl) ether; CASRN:
102640-44-8
P-17-0350: Oxirane, 2-methyl-, polymer with oxirane, mono(2-decyltetradecyl) ether; CASRN:
72484-69-6
P-17-0351: Oxirane, 2-methyl-, polymer with oxirane, mono(2-dodecylhexadecyl) ether;
CASRN: 102640-42-6
P-17-0352: Oxirane, 2-methyl-, polymer with oxirane, mono(2-tetradecyloctadecyl) ether;
CASRN: 102640-46-0
Conditions of Use (intended, known, or reasonably foreseen)1:
Intended conditions of use (generic): Import for use as an oilfield surfactant, consistent with the
manufacturing, processing, use, distribution, and disposal information described in the
PMNs.
Known conditions of use: Applying such factors as described in footnote 1, EPA evaluated
whether there are known conditions of use and found none.
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-17-0347, P-17-
0348, P-17-0349, P-17-0350 P-17-0351, P-170-352
Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
evaluated whether there were reasonably foreseen conditions of use, and based on a
patent search and information from another TSCA submission, identified uses other than
the use as described in the PMNs, including in textile processes and paints and as a
lubricant, surfactant, and chemical intermediate.
Summary: The chemical substances are 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.2 Although EPA
estimated that the new chemical substances could be very persistent, the substances have a 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 Nonionic Surfactants3, physical/chemical properties and test
data on the chemical substances and analogous chemical substances, EPA estimates that the
chemical substances have high environmental hazard and and potential for the following human
health hazards: severe irritation to the eyes, surfactant effects on the lungs, irritation to skin
(chronic), mucous membranes and lungs and eye damage. The PMNs describe conditions of use
that mitigate the human health and environmental risks. Therefore, EPA concludes that the new
chemicals are 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 substances
under the conditions of use that are not subject to the proposed SNUR, in order to determine that
the chemical substances are 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
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
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-17-0347, P-17-
0348, P-17-0349, P-17-0350 P-17-0351, P-170-352
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 found no 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 substances are 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 substances using
biodegradation data submitted for the substance described in P-17-0347 and analogues
(surfactants) of the new chemical substances. In wastewater treatment, the new chemical
substances are expected to be removed with an efficiency of 90% due to sorption and
biodegradation. Removal of the new chemical substances by biodegradation is negligible to high.
Sorption of the new chemical substances to sludge is expected to be strong and to soil and
sediment is expected to be very strong. Migration of the new chemical substances to
groundwater is expected to be negligible due to very strong sorption to soil and sediment, in
addition to biodegradation. Due to low estimated vapor pressure and Henry's law constant, the
new chemical substances are expected to undergo negligible volatilization to air. Overall, these
estimates indicate that the new chemical substances have low potential to volatilize to air or
migrate to groundwater.
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 substances using biodegradation data
submitted for the substance described in P-17-0347 and analogues (surfactants) of the new
chemical substances. EPA estimated that the new chemical substances' aerobic biodegradation
half-lives are < 2 months and anaerobic biodegradation half-lives are > 6 months. These
estimates indicate that the new chemical substances may have limited persistence in aerobic
environments (e.g., surface water) and may be very persistent in anaerobic environments (e.g.,
sediment).
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)

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-17-0347, P-17-
0348, P-17-0349, P-17-0350 P-17-0351, P-170-352
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 substances to bioaccumulate
using data submitted for analogue(s) (surfactants). EPA estimated that the new chemical
substances have low bioaccumulation potential based on bioconcentration or bioaccumulation
data reported for surfactants and expected metabolism for the low molecular weight portion of
the chemical substances. Although EPA estimated that the new chemical substances could be
very persistent, the substances have a low potential for bioaccumulation, such that 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 these chemical substances
based on their estimated physical/chemical properties and by comparing them to structurally
analogous chemical substances for which there is information on human health hazard.
Absorption of the new chemical substances is expected to be nil for the neat material; if in
solution, absorption of the low molecular weight fraction is expected to be poor via all routes
based on physical/chemical properties. For these new chemical substances, EPA identified lung
toxicity (surfactant effects) and irritation to the eye, skin (chronic), mucous membranes and lung
as hazards based on analogue data and surfactant properties. EPA qualitatively evaluated
irritation hazards.
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)
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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-17-0347, P-17-
0348, P-17-0349, P-17-0350 P-17-0351, P-170-352
n
Environmental Hazard : Environmental hazard is 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 determined environmental hazard for these new chemical substances based on
SAR predictions for nonionic surfactants (special class within ECOSAR v.2.0) and using hazard
data on analogous chemicals (C16-18 linear alkyl-2 PO-10 EO and C16 linear alkyl-7PO-7EO).
These substances fall within the TSCA New Chemicals Category of Nonionic Surfactants. Acute
toxicity values estimated for fish, aquatic invertebrates, and algae are 0.4 mg/L (SAR for
nonionic surfactants), 0.4 mg/L (analogue; C16 linear alkyl-7PO-7EO test data), and 42.1 mg/L
(analogue; C16-18 linear alkyl-2 PO-10 EO), respectively. Chronic toxicity values estimated for
fish, aquatic invertebrates, and algae are 0.04 mg/L (SAR for nonionic surfactants with
an ACR 10), 0.04 mg/L (CI6 linear alkyl-7PO-7EO analogue test data with an
ACR 10), and >10 mg/L (CI6-18 linear alkyl-2 PO-10 EO analogue test data with an ACR 4),
respectively. These toxicity values indicate that the new chemical substances are expected to
have high environmental hazard. Application of assessment factors of 5 and 10 to acute and
chronic toxicity values, respectively, results in acute and chronic concentrations of concern of
0.08 mg/L (80 ppb) and 0.004 mg/L (4 ppb), respectively.
Exposure: The exposure to a new chemical substance is potentially relevant to whether a new
chemical substance is likely to present unreasonable risks because the significance of the risk is
dependent upon both the hazard (or toxicity) of the chemical substance and the extent of
exposure to the substance.
EPA estimates occupational exposure and environmental release of the new chemical substances
under the intended conditions of use described in the PMNs 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
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-17-0347, P-17-
0348, P-17-0349, P-17-0350 P-17-0351, P-170-352
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. Worker exposure via
inhalation was not assessed because exposure is expected to be negligible. Releases to water
and landfill were estimated. Exposure to the general population was assessed via drinking water
ingestion. Exposure to the general population via fish ingestion and ground water ingestion (via
landfill leaching) were not assessed because releases to landfill were expected to be negligible
(below modeling thresholds), and the new chemical substances are not expected to
bioaccumulate. Exposure to the general population via inhalation was not assessed because there
are no expected releases to air. Consumer exposures were not assessed because consumer uses
were not identified as conditions of use.
Risk Characterization: EPA assesses risks to workers considering engineering controls
described in the PMN but in the absence of personal protective equipment (PPE) such as gloves
and respirators. If risks are preliminarily identified, EPA then considers whether the risks would
be mitigated by the use of PPE (e.g., impervious gloves, respirator).
Risks to human health for the new chemical substances were evaluated qualitatively. Risks were
not evaluated for workers via inhalation because inhalation exposures are expected to be
negligible. Irritation hazards to workers via dermal contact were identified based on analogue
data and surfactant properties. Risks for this endpoint 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 irritation to the eyes, skin, and mucous
membranes via drinking water since these concerns are expected to be mitigated by dilution in
the media. Risks were not evaluated for the general population via inhalation because inhalation
exposures are expected to be negligible. Risks to consumer were not evaluated because consumer
uses were not identified as conditions of use.
Risks to the environment were evaluated by comparing estimated surface water concentrations
with the acute and chronic concentrations of concern. Risks 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.
It is reasonably foreseen, based on a patent search and information from another TSCA
submission, that these substances could be used other than as described in the PMNs with greater
human exposure and releases to the environment. The SNUR that has been proposed for these
chemical substances defines certain conditions of use as significant new uses. The proposed
significant new uses include use other than the confidential use described in the PMNs.
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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-17-0347, P-17-
0348, P-17-0349, P-17-0350 P-17-0351, P-170-352
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).
8/29/2019	/s/
Date:	Tala R. Henry, Ph.D.
Deputy Director for Programs
Office of Pollution Prevention and Toxics

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