TSCA Section 5(a)(3) Determination for Premanufacture Notices (PMNs) P-20-0027/0028

Number: P-20-0027/0028

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

Chemical Name:

Generic (P-20-0027): Glycols, .alpha.,.omega.-, C2-6, polymers with adipic aicd, dodecanedioic
acid, hydracrylic acid polyester, isophthalic acid, isophthalic acid, l,l'-methylenebis[4-
isocyanatobenzene], neopentyl glycol and terephthalic acid (PROVISIONAL)

Generic (P-20-0028): Glycols, .alpha.,.omega.-, C2-6, polymers with adipic acid, aromatic
polyester, dodecanedioic acid, hydracrylic acid polyester, isophthalic acid, 1,1 '-methylenebis[4-
isocyanatobenzene], neopentyl glycol and terephthalic acid (PROVISIONAL)

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

Intended conditions of use (specific): Manufacture and/or import for processing and use as

industrial adhesives for application in the window molding industry, 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
evaluated whether there are reasonably foreseen conditions of use and found none.

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.

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.

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TSCA Section 5(a)(3) Determination for Premanufacture Notices (PMNs) P-20-0027/0028

EPA estimated that the new chemical substances could have limited persistence and low
potential for bioaccumulation, such that repeated exposures are not expected to cause food-chain
effects via accumulation in exposed organisms. Although EPA estimated that the hydrolysis
products could be very persistent, the 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, other structural information, and
test data on analogous chemical substances, EPA estimates that the chemical substances have
low environmental hazard and potential for the following human health hazards: respiratory
sensitization, skin sensitization, respiratory tract irritation, skin irritation, eye irritation,
carcinogenicity, and specific target organ toxicity. EPA concludes that the new chemical
substances are 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 substances using data for
analogue(s) (polymers with hydrolysable isocyanate groups) and of the hydrolysis products using
data for analogue(s) (polymers). In wastewater treatment, the new chemical substances are
expected to be removed with an efficiency of 90% due to sorption and hydrolysis and the
hydrolysis products are expected to be removed with an efficiency of 90% due to sorption.
Removal of the new chemical substances by biodegradation is negligible and removal of the
hydrolysis products by biodegradation is negligible. Sorption of the new chemical substances
and the hydrolysis products 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 and hydrolysis and migration of
the hydrolysis products 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 and the hydrolysis products are expected to undergo negligible
volatilization to air. Overall, these estimates indicate that the new chemical substances and the
hydrolysis products have low potential to volatilize to air and low potential to 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 analogue(s)
(polymers with hydrolysable isocyanate groups) and of the hydrolysis products using data for
analogue(s) (polymers). EPA estimated that the new chemical substances' hydrolysis half-lives

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)

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are hours to days; and that the hydrolysis products' aerobic and anaerobic biodegradation half-
lives are > 6 months. These estimates indicate that the new chemical substances may have
limited persistence in aerobic environments (e.g., surface water) and anaerobic environments
(e.g., sediments) due to hydrolysis. Further, these estimates indicate that the hydrolysis products
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 analogue(s) (polymers with hydrolysable isocyanate groups), and of the hydrolysis
products to bioaccumulate using data for analogue(s) (polymers). EPA estimated that the new
chemical substances and the hydrolysis products have low bioaccumulation potential based on
large predicted molecular volume, which limits bioavailability. EPA estimated that the new
chemical substances could have limited persistence and low potential for bioaccumulation, such
that repeated exposures are not expected to cause food-chain effects via accumulation in exposed
organisms. Although EPA estimated that the hydrolysis products could be very persistent, the
substances have 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

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)

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.

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estimated physical/chemical properties, by comparing them to structurally analogous chemical
substances for which there is information on human health hazard, and other structural
information. Absorption of the new chemical substances is expected to be nil through the skin,
gastrointestinal (GI) tract, and lungs based on physical/chemical properties. Absorption of
methylene diphenyl diisocyanate (MDI) residual is expected to be poor to moderate through the
skin, moderate through the GI tract, and poor through the lungs based on physical/chemical
properties. For the new chemical substances, EPA identified hazards for irritation to the skin,
eyes, and respiratory tract based on the reactivity of the new chemical substances, dermal and
respiratory sensitization and lung irritation based on the structural alert for isocyanates, and
dermal sensitization, respiratory tract effects, lung effects, and carcinogenicity based on test data
for the MDI residual. No data were submitted on the new chemical substances. EPA identified a
Benchmark Concentration Level Human Equivalent Concentration (BMCLhec) of 0.06 mg/m3
based on respiratory tract effects. This value was used to derive exposure route- and
population-specific points of departure for quantitative risk assessment. EPA qualitatively
evaluated irritation, sensitization, and carcinogenicity.

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 of these new chemical substances 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.

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-

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-futures-p2-
framework-manual).

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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 air and landfill were estimated.
Exposure to the general population was not assessed via drinking water or fish ingestion because
there are no releases to surface water, or via groundwater impacted by landfill leaching or stack
air inhalation because releases were expected to be negligible (below modeling thresholds), or
via fugitive air inhalation because there are no releases via fugitive air. 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
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., BMCLhec) described above. Risks were not evaluated for workers via
inhalation because exposures are expected to be negligible. Risks were not evaluated for workers
for respiratory tract effects via dermal exposure, because the hazards are not relevant to the
exposure route. Irritation, sensitization, and carcinogenicity hazards to workers via dermal
contact were identified based on the reactivity of the new chemical substances and residual MDI.
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

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TSCA Section 5(a)(3) Determination for Premanufacture Notices (PMNs) P-20-0027/0028

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 to the general population were not evaluated because general population exposures are not
expected. Risks to consumers were not evaluated because consumer uses were not identified as
conditions of use.

Risks from acute and chronic exposures to the environment are not expected at any concentration
of the new chemical substances soluble in water (i.e., no effects at saturation).

Because worker exposures can be controlled by PPE, no unreasonable risks to the general
population or environment were identified, and there are no expected consumer exposures, EPA
has determined that the new chemical substances are not likely to present unreasonable risk to
human health or the environment under the conditions of use.

04/08/2020	/s/

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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