TSCA Section 5(a)(3) Determination for Premanufacture Notices (PMNs) P-20-0170 - 0172

Number: P-20-0170 - 0172

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

Chemical Names:

Generic: Glycerin, alkoxylated alkyl acid esters

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

Intended conditions of use (generic): Manufacture and process for use as and use as a component
in lubricants, 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.

Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
evaluated whether there are reasonably foreseen conditions of use and identified use in
plasticizers as reasonably foreseen based on patents on the new chemical substances.

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.
Although EPA estimated that the new chemical substances could be very persistent, the new
chemical substances have low potential for bioaccumulation, such that repeated exposures are
not expected to cause food-chain effects via accumulation in exposed organisms. Based on
estimated physical/chemical properties and test data on analogous chemical substances, EPA
estimates that the chemical substances have low environmental hazard and no human health
hazards. EPA concludes that the new chemical substances are not likely to present an

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 Notices (PMNs) P-20-0170 - 0172

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 substances using data for
analogues (compounds with large molecular volume). In wastewater treatment, the new chemical
substances are expected to be removed with an efficiency of 90% due to sorption. Removal of
the new chemical substances by biodegradation is negligible. 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. 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.

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 substances using data for analogues
(compounds with large molecular volume). EPA estimated that the new chemical substances'
aerobic and anaerobic biodegradation half-lives are > 6 months. These estimates indicate that the
new chemical substances may be very persistent in aerobic environments (e.g., surface water)
and anaerobic environments (e.g., sediment).

•j

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 substances to bioaccumulate using data for
analogues (compounds with large molecular volume). EPA estimated that the new chemical
substances have low bioaccumulation potential based on large predicted molecular volume,
which limits bioavailability. Although EPA estimated that the new chemical substances could be

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 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)

3	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 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
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)

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TSCA Section 5(a)(3) Determination for Premanufacture Notices (PMNs) P-20-0170 - 0172

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 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 these chemical substances based on their
estimated physical/chemical properties, by comparing it to structurally analogous chemical
substances for which there are information on human health hazard, and other structural
information. Absorption of the new chemical substances is expected to be poor through the skin
and nil through the lungs and gastrointestinal (GI) tract based on physical/chemical properties.
EPA identified no hazards for the new chemical substances.

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
substance. EPA estimated environmental hazard using predictions based on the negligible water
solubility of the new chemical substances. Acute and chronic toxicity values estimated for fish,
aquatic invertebrates, and algae are all no effects at saturation. These toxicity values indicate that
the new chemical substances are expected to have low environmental hazard. Because hazards
are not expected up to the water solubility limit, acute and chronic concentrations of concern are
not identified.

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 Notices (PMNs) P-20-0170 - 0172

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
basis of greater exposure potential compared to the general population who do not use specific
products.

For this assessment, EPA assessed worker exposure via the dermal route. Inhalation exposures to
workers are not expected. Releases to landfill and air were estimated. Exposures to the general
population were not assessed via drinking water or fish ingestion because of no predicted
releases to water, or via groundwater impacted by landfill leachate or inhalation of fugitive or
stack air because exposures are 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 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). Based on the hazard
determination and available qualitative risk information, EPA did not identify risks for the new
chemical substance.

Due to low hazard, EPA believes that this chemical substance would be not likely to present an
unreasonable risk even if potential exposures were high. Therefore, EPA concludes that the new
chemical substance is not likely to present unreasonable risk under the intended and reasonably
foreseen conditions of use.

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TSCA Section 5(a)(3) Determination for Premanufacture Notices (PMNs) P-20-0170 - 0172

12/21/2020

Date:

/s/	

Madison H. Le, Director

New Chemicals Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

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