TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-22-0051 Number: P-22-0051 Chemical Name: Generic: 2,5-Furandione, dihydro-, monopolyisobutylene derivs., reaction products with substituted alkylamine


TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-22-0051

Number: P-22-0051

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

Chemical Name:

Generic: 2,5-Furandione, dihydro-, monopolyisobutylene derivs., reaction products with
substituted alkylamine

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

Intended conditions of use (generic): Manufacture and process for use as and use as a lubricant
and fuel 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 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 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.
Although EPA estimated that the new chemical substance could be 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. Based on test data on the new
chemical substance, test data on analogous chemical substances, and estimated physical/chemical
properties, EPA estimates that the chemical substance has low environmental hazard and did not
identify any hazards to human health. 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

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 chemical substance may be manufactured, processed, distributed, used, or disposed of. EPA expects
that the identification of "reasonably foreseen" conditions of use will be made on a fact-specific, case-by-case basis.
EPA will apply its professional judgment and experience when considering factors such as evidence of current use
of the new chemical substance outside the United States, information about known or intended uses of 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.

1

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-22-0051

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
submitted for the new chemical substance and data for analogues (polymers). In wastewater
treatment, the new chemical substance is expected to be removed with an efficiency of 90% due
to sorption. Removal of the new chemical substance by biodegradation is negligible. Sorption of
the new chemical substance to sludge is expected to be strong and to soil and sediment is
expected to be very strong. Migration of the new chemical substance to groundwater is expected
to be negligible due to very strong sorption to soil and sediment. Due to low measured vapor
pressure, 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.

Persistence2: 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 for analogues. EPA
estimated that the new chemical substance's aerobic and anaerobic biodegradation half-lives are
> 6 months. These estimates indicate that the new chemical substance may be very persistent in
aerobic environments (e.g., surface water) and anaerobic environments (e.g., sediment).

Bioaccumulation3: 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
analogues (polymers). EPA estimated that the new chemical substance has low bioaccumulation
potential based on large predicted molecular volume, which limits bioavailability. Although
EPA estimated that the new chemical substance could be 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

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)

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

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-22-0051

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, 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 intended use. Absorption of the parent polymer of the new chemical
substance and the LMW fraction < 1,000 Da [claimed CBI] is expected to be poor through the
skin and nil through the GI tract and lungs based on physical/chemical properties. Absorption of
the LMW fraction < 500 Da [claimed CBI] is expected to be moderate to good through the skin,
good through the GI tract, and poor through the lungs based on physical/chemical properties.
For the new chemical substance, EPA did not identify any hazards based on test data on the new
chemical substance and analogue data. Submitted tests of the new chemical substance reported
the test substance as not irritating to the skin and eyes in rabbits (OECD 404 and OECD 405),
non-sensitizing in guinea pigs (OECD 406), non-mutagenic in bacteria (OECD 471), and non-
clastogenic in mammalian cells in vitro (OECD 473). An acute oral toxicity study in rats
reported hunched posture and erected fur with an LD50 of > 2,000 mg/kg-bw (OECD 423).

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 based on analogue test data and the negligible
water solubility of the new chemical substance. This substance falls within the TSCA New
Chemicals Category of Polycationic Polymers. 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 substance is expected to have low environmental hazard. Because

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-futures-p2-
framework-manual).

-------
TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-22-0051

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 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.

Risk Characterization: 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
conditions of use.

02/27/2023			/s/	

Date:	Madison H. Le, Director

New Chemicals Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency

4

-------