TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0135
Number: P-19-0135
TSCA Section 5(a)(3) Determination: The chemical substance is not likely to present an
unreasonable risk (5(a)(3)(C))
Chemical Name:
Generic: Alkyl polyoxyethylene ethers, carboxymethylated
Conditions of Use (intended, known, or reasonably foreseen)1:
Intended conditions of use (generic): Import for use as a lubricant additive, consistent with the
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.
EPA estimated that the new chemical substance will have limited persistence and 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 Categories for Anionic Surfactants and for Nonionic Surfactants, 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: skin and eye irritation, lung effects, and systemic toxicity. 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
hypothetical 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	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.
1

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0135
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
submitted for the new chemical substance and EPI (Estimation Program 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 90% to 95% due to sorption and biodegradation. Removal of the new chemical substance by
biodegradation is high. Sorption of the new chemical substance to sludge, soil, and sediment is
expected to be low. Migration of the new chemical substance to groundwater is expected to be
moderate due to low 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 and has moderate potential to migrate to
groundwater.
-2
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 the new
chemical substance. EPA estimated that the new chemical substance's aerobic and anaerobic
biodegradation half-lives are < 2 months. These estimates indicate that the new chemical
substance may have limited persistence in aerobic environments (e.g., surface water) and
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 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 submitted for the new chemical substance and EPI Suite™. EPA estimated that the new
chemical substance has low bioaccumulation potential based on submitted data (bioconcentration
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 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)
4	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)
2

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0135
factor = 3 [estimated] and bioaccumulation factor =120 [estimated]). EPA estimated that the
new chemical substance could have limited persistence and a 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, available data on the new chemical substance, by
comparing it to structurally analogous chemical substances for which there is information on
human health hazard and other structural information. Absorption is expected to be good through
the skin, moderate through the GI tract, and poor through the lungs based on physical/chemical
properties. For the new chemical substance, EPA identified lung effects (surfactancy) if
respirable particles are inhaled, based on structure and surface tension data; dermal and eye
irritation based on data on the new chemical, analogue data, and information in the submitted
SDS; and systemic effects based on analogue data. Submitted tests of the new chemical reported
no adverse effects in an acute oral toxicity study (OECD 401), irritation in a dermal irritation
study (OECD 404), and negative effects in a mutagenicity assay (OECD 471). EPA identified a
"3
NOAEC of 0.6 mg/m based on lung effects (surfactancy) and a NOAEL of 250 mg/kg/day
based on systemic effects that were used to derive exposure route- and population-specific points
of departure. The selected PODs are protective of all hazards identified. EPA qualitatively
evaluated irritation effects.
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
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.
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
3

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0135
upon both the hazard (or toxicity) of the chemical substance and the extent of exposure to the
substance. EPA determined the environmental hazard for this new chemical substance based on
acute toxicity data on fish and daphnia submitted for the new chemical substance and based on
SAR predictions for nonionic surfactants (special class within ECOSAR v.2.0). This substance
falls within the TSCA New Chemicals Categories of Anionic Surfactants and Nonionic
Surfactants. Acute toxicity values measured or estimated for fish, aquatic invertebrates, and
algae are 3 mg/L (data), 4 mg/L (data), and 6.1 mg/L (ECOSAR), respectively. Chronic toxicity
values measured or estimated for fish, aquatic invertebrates, and algae are 0.6 mg/L (data with
ACR), 0.8 mg/L (data with ACR), and 1.9 mg/L (ECOSAR), respectively. These toxicity values
indicate that the new chemical substance is expected to have moderate 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 0.6 mg/L (600 ppb) and 0.06 mg/L (60
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 dermal exposure, and
inhalation exposures to workers are not expected. Releases to water, air, and landfill were
estimated. Exposure to the general population was assessed via drinking water, fish ingestion,
and groundwater (via landfill leachate) ingestion. Exposure to the general population via
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).
4

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0135
inhalation was not assessed because releases to air were expected to be negligible (below
modeling thresholds). Exposure to consumers was assessed via dermal contact.
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
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 substances were evaluated using the route-specific
effect level (i.e., NOAEL) described above. Risks were identified for workers for systemic
effects via dermal exposure during formulation (MOE =13; benchmark MOE = 100), but not
during use (MOE = 6,364; benchmark MOE = 100) based on quantitative hazard data for an
analogue. Risks were not evaluated for workers via inhalation because exposures are not
expected. Irritation hazards to workers via dermal contact were identified based on surfactant
properties and low pH of the new chemical substance, submitted data, analogue data, and
information in the SDS. 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, fish
ingestion, or groundwater impacted by landfill leachate based on quantitative hazard data for an
analogue (MOEAduit >13 million; MOEjnfant > 3 million; MOEFish = 6,427; MOEy-m^n = 80,906;
Benchmark MOE = 100). Risks were not evaluated for the general population via inhalation
because exposures are expected to be negligible (below modeling thresholds). Irritation hazards
to the general population are not expected via drinking water, fish ingestion, or ingestion of
groundwater (from landfill leaching) due to dilution of the chemical substance in the media.
Consumer use is not an intended or reasonably foreseen condition of use, but was assessed. Risks
were not identified for consumers for systemic effects via dermal exposure to used motor oil
based on quantitative hazard data for an analogue (MOE >13,000; benchmark MOE = 100).
5

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0135
Irritation hazards via dermal exposure were identified but not expected for consumers based on
the weight fraction [claimed CBI] of the new chemical substance in the final product.
Risks to the environment were evaluated by comparing estimated surface water concentrations
with the estimated acute and chronic COCs. 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.
12/18/2019	/s/
Date:	Tala R. Henry, Ph.D.
Deputy Director for Programs
Office of Pollution Prevention and Toxics
6

-------