Federal Register - October 12, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 194 / Tuesday, October 12, 2021 / Proposed Rules
for lung effects if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:
Application method during use other than the confidential method described in the PMN; and No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.
The proposed SNUR would designate as a significant new use the absence of these protective measures.
Potentially Useful Information: EPA
has determined that certain information may be potentially useful to characterize the human health effects of the PMN
substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11606.
PMN Number: P17284
Chemical Name: 2-Heptanone, 4hydroxy-.
CAS Number: 25290146.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as an in-process intermediate. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for solvent neurotoxicity and irritation, sensitization, mutagenicity, neurotoxicity, reproductive toxicity, developmental toxicity, systemic toxicity, and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:
No release of the PMN substance resulting in surface water concentrations that exceed 1,000 ppb.
The proposed SNUR would designate as a significant new use the absence of this protective measure.
Potentially Useful Information: EPA
has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, reproductive/
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developmental toxicity, irritation, sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11607.
PMN Number: P17285
Chemical Name: 4-Hepten-2-one.
CAS Number: 24332227.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as an in-process intermediate. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for solvent neurotoxicity and irritation, eye and skin irritation, developmental, liver, and kidney toxicities, sensitization, and aquatic toxicity if the PMN substance is not used following the limitation noted. The conditions of use of the chemical substance as described in the PMN include the following protective measure:
No release of the PMN substance resulting in surface water concentrations that exceed 730 ppb.
The proposed SNUR would designate as a significant new use the absence of this protective measure.
Potentially Useful Information: EPA
has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, reproductive/
developmental toxicity, sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11608.
PMN Number: P17360
Chemical Names: 2-Propanol, 1amino-, compd. with .alpha.-sulfo.omega.-octyloxypolyoxy-1,2ethanediyl 1:1 P17360, chemical A and 2-Propanol, 1-amino-, compd.
with .alpha.-.sulfo-.omega.decyloxypolyoxy-1,2-ethanediyl 1:1
P17360, chemical B.
CAS Numbers: 2098904744 P17
360, chemical A and 2098904802 P
17360, chemical B.
Basis for action: The PMN states that the generic non-confidential use of the PMN substances will be as surfactants for oil and gas recovery. Based on the estimated physical/chemical properties
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of the PMN substances, comparison to structurally analogous chemical substances, comparison to analogous anionic surfactant substances, and submitted test data on the PMN
substances, EPA has identified concerns for lung effects surfactancy, irritation to the skin, eye, mucous membranes, and lungs, and systemic kidney, liver, and thymus effects if the chemical substances are not used following the limitation noted. The conditions of use of the PMN substances as described in the PMN include the following protective measure:
No manufacturing, processing, or use of the PMN substances in any manner that results in inhalation exposure.
The proposed SNUR would designate as a significant new use the absence of this protective measure.
Potentially Useful Information: EPA
has determined that certain information may be potentially useful to characterize the human health effects of the PMN
substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, skin irritation, eye irritation, and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN
substances.
CFR Citations: 40 CFR 721.11609 P
17360, chemical A and 40 CFR
721.11610 P17360, chemical B.
PMN Number: P1819
Chemical Name: Substituted benzene, 4-2-2-hydroxy-3-3nitrophenylaminocarbonyl-1naphthalenyldiazenyl-, sodium salt 1:1 generic.
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance will be as a dispersive pigment. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, comparison to analogous acid dyes and amphoteric dyes, and submitted test data on the PMN
substance, EPA has identified concerns for eye irritation, skin sensitization, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:
No use of the PMN substance in a consumer product;
No domestic manufacture i.e., import only; and
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