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
considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of absorption, distribution, metabolism, and excretion ADME, repeated dose, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances.
CFR Citations: 40 CFR 721.11615 P
18179, 40 CFR 721.11616 P18180, and 40 CFR 721.11617 P18181.
PMN Number: P18192
Chemical Name: Benzenesulfonic acid, alkenediylbishydroxyalkylaminophenylamino-triazin-2-ylamino-, Nhydroxyalkyl derivs., salts, compds.
with polyalkyl-substitutedalkanol generic.
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance will be as an optical brightener for use in paper applications. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for respiratory tract effects, systemic toxicity, developmental effects, and irritation to the skin, eye, and mucous membranes 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:
Use of the PMN substance only as an optical brightener for use in paper applications; and No manufacture, 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 specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11618.
PMN Number: P18197
Chemical Name: Metal, alkylcarboxylate oxo complexes generic.
CAS Number: Not available.
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Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as a polymer composite additive. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for lung overload and respiratory irritation 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 other than for the confidential use described in the PMN; and No manufacture or processing of the PMN substance without the confidential engineering controls described in the PMN.
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 721.11619.
PMN Number: P18221
Chemical Name: Polyglycerol reaction product with acid anhydride, etherified generic.
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance will be as a binder for wood panels. Based on estimated physical/chemical properties of the PMN substance, identified structural alerts, and comparison to structurally analogous chemical substances, EPA has identified concerns for skin and lung sensitization, germ cell mutagenicity, carcinogenicity, and developmental, reproductive, liver, and kidney 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 measure:
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 this protective measure.
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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 absorption, specific target organ toxicity, irritation, sensitization, and developmental toxicity testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11620.
PMN Numbers: P18258 and P18259
Chemical Names: Dioic acids, polymers with caprolactam and alkyldiamines generic P18258 and Fatty acids, dimers, hydrogenated, polymers with caprolactam and alkyldiamine generic P18259.
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic non-confidential use of the PMN substances will be as copolyamides for packaging films.
Based on estimated physical/chemical properties of the PMN substances and comparison to structurally analogous chemical substances, EPA has identified concerns for lung toxicity if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs 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 pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substances.
CFR Citations: 40 CFR 721.11621 P
18258 and 40 CFR 721.11622 P18
259.
PMN Number: P18277
Chemical Name: Poly2Dimethylaminoethyl acrylate chloride salt, vinyl acetate, methacrylic acid and alkyl acrylates generic.
CAS Number: Not available.
Basis for action: The PMN states that the generic non-confidential use of the
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