TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0401

Number: P-18-0401

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

Chemical Name:

Specific: Glycerides, C16-18 and CI8-unsatd. mono- and di-, citrates; CASRN: 91052-16-3.

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

Intended conditions of use (generic): Import for use as additive, 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, based on a previous TSCA submission,
identified use as a solvent for antioxidant in surfactant blends as a known condition of
use.

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 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. Based on EPA's TSCA New Chemicals Program
Chemical Category for Anionic Surfactants and test data on analogous chemical substances,

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.

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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0401

EPA estimates that the chemical substance has high environmental hazard and potential for the
following human health hazards: surfactant effects on the lung. 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) (large molecular volume compounds) and data submitted for the new chemical
substance. In wastewater treatment, the new chemical substance is expected to be removed with
an efficiency of 95% to 99% 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 strong. Migration of the new chemical substance to groundwater is
expected to be negligible due to strong sorption to soil and sediment, mitigated by rapid
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 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 for analogue(s) (large molecular volume compounds). EPA estimated that the new chemical
substance has low bioaccumulation potential based on expected rapid metabolism. EPA

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)

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0401

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: 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 poor from the skin, moderate from the GI tract, and good from the lungs based on analogue
data. For the new chemical substance, EPA identified lung effects as the hazard based a
structural alert for anionic surfactants. However, negative findings in skin and eye irritation
studies and lack of inhalation exposures ameliorate this hazard concern. Due to lack of inhalation
exposures, EPA did not quantitatively assess risks for this new substance.

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 estimated environmental hazard of this new chemical substance using hazard
data on analogous chemicals. This substance falls within the TSCA New Chemicals Category of
Anionic Surfactants. Acute toxicity values estimated for fish, aquatic invertebrates, and algae are
4.1 mg/L, 0.77 mg/L, and 0.32 mg/L, respectively. Chronic toxicity values estimated for fish,
aquatic invertebrates, and algae are 0.63 mg/L, 0.12 mg/L, and 0.24 mg/L, respectively. These

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
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-18-0401

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 0.08 mg/L (80 ppb) and
0.012 mg/L (12 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.
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 and fish
ingestion. Exposure to the general population via ground water (due to landfill leaching) and
inhalation were not assessed because releases from landfills and to the air were expected to be
negligible (below modeling thresholds). Exposure to consumers was assessed via dermal
exposure. Inhalation exposure to consumers is not expected.

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 were not evaluated for workers via dermal exposure because the hazards are not
relevant to the exposure route. Risks were not evaluated for workers via inhalation exposure
because exposure was expected to be negligible.

Risks were not assessed for the general population via oral exposure (drinking water, fish
ingestion) because identified hazards are not relevant to the exposure route. Risks were not
evaluated for general population via inhalation exposures because exposures were expected to be
negligible (below modeling thresholds).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0401

Risks to consumers via inhalation were not evaluated because no inhalation exposures are
expected.

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

EPA previously assessed the known conditions of use and determined that they will not present
unreasonable risk.

Because no unreasonable risks to workers, the general population, consumers, or 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.

7/24/19		/s/	

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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