TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0037
Number: P-20-0037
TSCA Section 5(a)(3) Determination: The chemical substance is not likely to present an
unreasonable risk (5(a)(3)(C))
Chemical Name:
Specific: Lithium Chloride (6LiCl); CASRN: 20227-31-0
Conditions of Use (intended, known, or reasonably foreseen)1:
Intended conditions of use (generic): Manufacture and process for use and use in the
manufacture of devices for gamma and neutron radiation detection, 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 manufacture, processing, or use of the new chemical substance for the
detection of rare alkali earth metals or for the manufacture of lithium ion batteries 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. The new chemical
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
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
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0037
substance is an ionic compound, or salt, that is comprised of both an anion (chloride) and cation.
Estimations of physical/chemical and fate properties are not applicable for the anion (chloride);
the anion (chloride) is an ion of an element (chlorine) and is unlikely to impact the overall
persistence and bioaccumulation of the new chemical substance. Although EPA estimated that
the cation could be very persistent, the substance does not bioaccumulate by lipophilic
partitioning and there is low concern that it will accumulate in organisms by other mechanisms;
thus, repeated exposures are not expected to cause food-chain effects via accumulation in
exposed organisms. Based on test data on analogous chemical substances, EPA estimates that the
chemical substance has moderate environmental hazard and potential for the following human
health hazards: acute toxicity, skin irritation, eye irritation, reproductive toxicity, and 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 cation using data available for the cation.
The anion (chloride) is not expected to drive the human health and eco hazard assessments. The
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-20-0037
anion (chloride) is also not expected to be a concern for food chain effects and was not evaluated
for persistence and bioaccumulation. In wastewater treatment, the cation is expected to be
removed with an efficiency of 0% to 50% due to possible sorption. Removal of the cation by
biodegradation is negligible. Sorption of the cation to sludge, soil, and sediment is expected to be
low to moderate. Migration of the cation to groundwater is expected to be moderate to rapid due
to low to moderate sorption to soil and sediment. Due to low estimated vapor pressure and
Henry's law constant, the cation is expected to undergo negligible volatilization to air. Overall,
these estimates indicate that the cation has low potential to volatilize to air and has moderate to
high potential to 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 cation using data available for the cation. EPA estimated
that the cation's aerobic and anaerobic biodegradation half-lives are > 6 months. These estimates
indicate that the cation may be very persistent 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 cation to bioaccumulate using data available for
the cation. EPA estimated that the cation does not bioaccumulate by lipophilic partitioning, and
there is low concern that it may accumulate in organisms by other mechanisms. Although
EPA estimated that the cation could be very persistent, the substance does not bioaccumulate by
lipophilic partitioning and there is low concern that it will accumulate in organisms by other
mechanisms; thus, 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
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 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 there are equivalent or analogous data.
(64 FR 60194; November 4 1999)
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
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0037
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, by comparing it to structurally analogous chemical
substances for which there is information on human health hazard, and other structural
information. Absorption of the new chemical substance is expected to be poor to moderate
through the skin for the neat material (salt) and moderate when in solution, and good through the
lungs, based on physical/chemical properties. In stomach acid, absorption of the lithium ion is
expected to be good through the gastrointestinal (GI) tract. For the new chemical substance, EPA
identified hazards for skin, eye, and respiratory tract irritation, systemic effects, and
developmental effects based on analogue data. No test data were submitted on the new chemical
substance. EPA identified a Lowest Observed Adverse Effect Level (LOAEL) of 2.1 mg/kg-
bw/day based on systemic effects from human data. EPA considered this value protective for all
of the identified hazards, with the exception of irritation. EPA used this value to derive exposure
route- and population-specific points of departure for quantitative risk assessment. 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
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 an analogous chemical. Acute toxicity values estimated for fish, aquatic invertebrates,
and algae are all >100 mg/L. Chronic toxicity values estimated for fish, aquatic invertebrates,
and algae are >7 mg/L, >10 mg/L, and >10 mg/L, respectively. These toxicity values indicate
that the new chemical substance is expected to have moderate environmental hazard. Application
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-ftitures-p2-
framework-manual).
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0037
of assessment factors of 5 and 10 to acute and chronic toxicity values, respectively, results in
acute and chronic concentrations of concern of 20 mg/L (20,000 ppb) and 0.7 mg/L (700 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 exposures via the dermal and inhalation
routes. Releases to water, air, and landfill were estimated. Exposure to the general population
was assessed via drinking water. Exposure to the general population was not assessed via fish
ingestion because bioaccumulation potential was evaluated to be low nor via groundwater
impacted by landfill leachate or inhalation because releases to landfill and air were 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 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 (UF) 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
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0037
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 the route-specific
effect levels (i.e., LOAEL) described above. Risks were identified for workers for systemic
effects via dermal exposure based on quantitative hazard data for an analogue (MOE = 0.87;
Benchmark MOE = 100). Risks were not identified for workers for systemic effects via
inhalation exposure based on quantitative hazard data for an analogue (MOE = 1,352;
Benchmark MOE = 100). Irritation hazards to workers via inhalation and dermal contact were
identified based on analogue data. 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, eye protection, and
respiratory 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 systemic effects via drinking water
exposure based on quantitative hazard data for an analogue (MOEAduitDw = 6,243; MOEinfantDw =
1,486; Benchmark MOE = 100). Risks were not evaluated for the general population via fish
ingestion because bioaccumulation potential was evaluated to be low or via groundwater
impacted by landfill leachate or inhalation because exposures are expected to be negligible.
Irritation hazards to the general population are not expected via drinking water ingestion due to
dilution of the chemical substance in the media. Risks to consumers 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 to the environment were not
identified due to releases to water that did not exceed the acute COC or the chronic COC.
It is reasonably foreseen, based on a patent search, that the new chemical substance could be
used for the detection of rare alkali earth metals or for the manufacture of lithium ion batteries.
The SNUR that has been proposed for this chemical substance defines certain conditions of use
as significant new uses. The proposed significant new uses include use other than as described in
the PMN. 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).
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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0037
5/29/2020	/s/
Date:	Tala R. Henry, Ph.D.
Deputy Director for Programs
Office of Pollution Prevention and Toxics
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