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
corrosion, eye irritation/corrosion, and skin sensitization testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11627.
PMN Number: P18401
Chemical Name: Glycerides, C1618
and C18-unsatd. monoand di-, citrates.
CAS Number: 91052163.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as an additive.
Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, comparison to analogous anionic surfactants, and submitted test data on the PMN
substance, EPA has identified concerns for lung effects 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 formulations greater than 0.01% in a manner that results in inhalation exposure; and No release of the PMN substance resulting in surface water concentrations that exceed 12 ppb.
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 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 pulmonary effects and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11628.
PMN Number: P193
Chemical Name: Polyaromatic ether symmetrical dicarboxylic anhydride generic.
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance will be as a chemical intermediate. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous anhydrides, carboxylic acids, EPA has identified concerns for cardiac, blood, muscle, reproductive, and developmental toxicity, skin and eye
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irritation, and respiratory sensitization.
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 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.
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 sensitization, reproductive and developmental effects, and specific organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11629.
PMN Number: P1928
Chemical Name: Alkyl salicylate, metal salts generic.
CAS Number: Not available.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will as a lubricating oil additive. Based on the estimated physical/chemical properties of the PMN substance and submitted test data on the PMN substance, EPA has identified concerns for lung surfactancy and sensitization 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 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.
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 skin sensitization and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11630.
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PMN Number: P1940
Chemical Name: Alkyl bisdialkylamino alkyl amide generic.
CAS Number: Not available.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as an intermediate. Based on comparison to structurally analogous chemical substances and metabolites, EPA has identified concerns for corrosion and irritation for the lungs, skin, and eyes, lung damage, systemic effects, reproductive/developmental toxicity, and sensitization 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 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 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
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 skin sensitization and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11631.
PMN Number: P19117
Chemical Name: Polycyclic amine, reaction products with polyalkylalkene, polymers generic.
CAS Number: Not available.
Basis for action: The PMN states that the generic non-confidential use of the PMN substance will be as an additive.
Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and submitted test data on the PMN substance, EPA has identified concerns for liver effects and developmental 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:
Use of the PMN substance only for the confidential use described in the PMN.
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
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