TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0088
Number: P-19-0088
TSCA Section 5(a)(3) Determination: The chemical substance is not likely to present an
unreasonable risk (5(a)(3)(C))
Chemical Name:
Specific: Ethanamine, N-ethyl-, 2-hydroxy-l,2,3-propanetricarboxylate (1:?); CASRN 23251-73-
2
Conditions of Use (intended, known, or reasonably foreseen)1:
Intended conditions of use (generic): Manufacture for use and use as a feedstock for amine
recovery, 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
has identified the use of different disposal processes than those described in the amended
PMN as reasonably foreseen conditions of use based on the initial PMN submission, and
has identified use in ladder silicones and use in electrolytic capacitor electrolytes as
reasonably foreseen based on a patent search.
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 and
the terms of the proposed Significant New Use Rule (SNUR) signed by EPA.2 EPA estimated
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	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
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0088
that the anion and the cation could both 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 hazard data on the cation of the new chemical
substance and analogous substances, and estimated physical/chemical properties, EPA estimates
that the chemical substance has moderate environmental hazard and potential for the following
human health hazards: acute toxicity, skin corrosion, serious eye damage, reproductive toxicity,
specific target organ toxicity. The PMN describes conditions of use that mitigate the human
health and environmental risks. Therefore, EPA concludes that the new chemical is 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 substance
under the conditions of use that are not subject to the proposed SNUR, in order to determine that
the chemical substance is 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
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 Significant New Use Notice
(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 substance is 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 anion using data for analogue(s) (citric
acid) and EPI (Estimation Program Interface) Suite™ (http://www.epa.gov/tsca-screening-
tools/epi-suitetm-estimation-program-interfacehttp://www.epa.gov/tsca-screening-tools/epi-
suitetm-estimation-program-interface) and of the cation using data for analogue(s)
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 to present an unreasonable risk.
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0088
(diethylamine) and EPI Suite™. In wastewater treatment, the anion is expected to be removed
with an efficiency of 95% due to biodegradation and the cation is expected to be removed with
an efficiency of 90% to 95% due to biodegradation. Removal of the anion by biodegradation is
high, destruction (mineralization) of the anion by biodegradation is possible partial to complete,
and removal of the cation by biodegradation is high. Sorption of the anion and the cation to
sludge, soil, and sediment is expected to be low. Migration of the anion and the cation to
groundwater is expected to be slow due to low sorption to soil and sediment, mitigated by
biodegradation. Due to low estimated vapor pressure and Henry's law constant, the anion and the
cation are expected to undergo negligible volatilization to air. Overall, these estimates indicate
that the anion and the cation have low potential to volatilize to air and low 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 anion using data for analogue(s) (citric acid) and of the
cation using data for analogue(s) (diethylamine). EPA estimated that the anion's aerobic and
anaerobic biodegradation half-lives are < 2 months; and that the cation's aerobic and anaerobic
biodegradation half-lives are < 2 months. These estimates indicate that the anion and the cation
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 anion and the cation to bioaccumulate using EPI
Suite™. EPA estimated that the anion and the cation have low bioaccumulation potential based
on BCFBAF model result < 1000 (anion bioconcentration factor = 3 [estimated] and
bioaccumulation factor = 1 [estimated]; cation bioconcentration factor = 3 [estimated] and
bioaccumulation factor = 1 [estimated]). EPA estimated that the anion 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. EPA estimated that
the cation could have limited persistence and a low potential for bioaccumulation, such that
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
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 Notice (PMN) P-19-0088
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 and by comparing it to structurally analogous chemical
substances for which there is information on human health hazard. Absorption is expected to be
nil to poor through the skin for the neat material, poor through the skin when in solution, poor
through the gastrointestinal (GI) tract, and good through the lungs based on physical/chemical
properties. For the new chemical substance, EPA identified hazards for serious eye damage and
skin corrosion, acute oral, dermal, and inhalation toxicity, developmental and reproductive
effects, neurotoxicity, and systemic effects based on test data for the cationic component of the
new chemical substance and analogues. EPA identified a no observed adverse effect
concentration (NOAEC) of 48 mg/m3 for the cationic component based on reproductive effects
and respiratory tract effects which was protective for systemic and neurological effects and was
used to derive exposure route- and population-specific points of departure for quantitative risk
assessment. EPA qualitatively evaluated corrosion and acute toxicity hazards.
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
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.
(hllp://w\\w.occd.org/orncialdocumcnls/publicdisplavdocuincnlpdr/?colc=cn\7iin/inono(2014)4&doclanmi;mc=cn)).
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-19-0088
substance. EPA estimated environmental hazard of this new chemical substance using hazard
data on the cation of the new chemical substance (CASRN 109-89-7). Acute toxicity values
estimated for fish, aquatic invertebrates, and algae are 25 mg/L, 4.6 mg/L, and 20 mg/L,
respectively. Chronic toxicity values estimated for fish, aquatic invertebrates, and algae are 2.5
mg/L (acute-to-chronic ratio, ACR of 10), 0.46 mg/L (ACR of 10), and 5 mg/L (ACR of 4),
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
0.92 mg/L (920 ppb) and 0.46 mg/L (46 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 assessment, EPA assessed worker exposure via dermal exposure; inhalation exposures
were expected to be negligible. Releases to air from incineration were estimated. No releases to
surface water or to landfills were expected. Exposure to the general population was assessed via
inhalation of stack air emissions. Exposures to the general population via ingestion of
groundwater (impacted by landfill leachate) or inhalation of fugitive air emissions were not
assessed because releases to fugitive air and landfills were expected to be negligible (below
modeling thresholds). Exposures to the general population via drinking water or fish ingestion
were not assessed because releases to surface water were not expected. Consumer exposures
were not assessed because consumer uses were not identified as conditions of use.
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
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0088
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 a route-specific
effect level (i.e., NOAEC) described above. Based on the hazard determination and available
quantitative and qualitative risk information, EPA did not identify risks for the new chemical
substance. Risks were not evaluated for workers via inhalation exposure because inhalation
exposures are expected to be negligible. Risks were not evaluated for workers via repeated
dermal exposures because dermal exposures are not considered likely due to the corrosivity of
the new chemical substance. Acute toxicity hazards were qualitatively assessed. Corrosion and
acute toxicity hazards to workers via dermal contact were identified based on measured data for
the cationic component. 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, protective clothing, and eye
protection. EPA expects that employers will require and that workers will use appropriate PPE
consistent with the Safety Data Sheet (SDS) prepared by the submitter, in a manner adequate to
protect them.
Risks were not identified for the general population for reproductive effects and respiratory tract
effects via inhalation of stack air emissions based on quantitative data for an analogue (MOE =
286,958, Benchmark MOE = 100). Risks were not evaluated for the general population via
drinking water ingestion or fish ingestion because there are no releases to surface water. Risks
were not evaluated for the general population via groundwater ingestion (from landfill leaching)
or fugitive air emissions because those exposures are expected to be negligible (below modeling
thresholds). Corrosion and acute toxicity hazards to the general population are not expected via
stack air releases due to dilution of the chemical substance in the media. Risks to consumer were
not evaluated because consumer uses were not identified as conditions of use.
Risks to the environment were not identified due to no releases to water.
It is reasonably foreseen, based on information in the initial PMN submission which was
subsequently amended, that the new chemical substance could be used under conditions such that
releases to water occur that may result in unreasonable risks to the environment. Additionally, it
is reasonably foreseen, based on a patent search, that the new chemical substance may be used in
ladder silicones and in electrolytic capacitor electrolytes, which may result in releases and
exposures that differ from those assessed under the intended conditions of use. The SNUR that
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-19-0088
has been proposed for this chemical substance defines certain conditions of use as significant
new uses. The proposed significant new uses include (1) releases to water resulting in a surface
water concentration of the substance exceeding 46 ppb; and, (2) manufacture, processing, or use
of the substance that results in inhalation exposure to workers. 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 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).
5/29/2020		ls[	
Date:	Tala R. Henry, Ph.D.
Deputy Director for Programs
Office of Pollution Prevention and Toxics
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