What is the basis for the health or environmental toxicity concerns?
Analog data
PBT chemicals
Perfluoro Compounds
Chemical testing
Physical/chemical properties
What is the exposure concern to the chemical?
The substance is expected to be produced in substantial quantities, there may be significant or substantial human exposure to the substance, and the substance may enter the environment in substantial quantities
Releases to the environment associated with commercial processing/use of the chemical Aquatic/Terrestrial Species exposure from releases to surface waters in acute and chronic concentrations that exceed 2 parts per billion (ppb) and 1 part per billion (ppb) respectively
Releases to the environment associated with industrial processing/use of the chemical Aquatic/Terrestrial Species exposure from releases to surface waters in acute and chronic concentrations that exceed 2 parts per billion (ppb) and 1 part per billion (ppb) respectively
Releases to the environment associated with manufacture of the chemical
Limitations on manufacture (including import), processing, distribution in commerce, use, or disposal pending submission and evaluation of information:
Any releases to surface waters
Disposal from manufacturing, processing, and/or use that differ from: Disposal of all manufacturing, processing, and use waste streams via incineration (except for the PMN materials/waste that will be recycled and reused in manufacturing of the PMN substances or products made from the PMN substances) in an incinerator with combustion temperature of minimum I 000 degrees C and residence time of minimum 2 seconds
Distribute the PMN substance only: to a person who agrees to follow the same restrictions (except the testing requirements) and to not further distribute the PMN substance
Hazard Communication (labeling, containers, SDS, precautionary statements, etc.)
Record and report impurities of the starting raw materials; not exceed the confidential amount of maximum established impurities
Submit to EPA certain toxicity or fate testing before manufacturing: the confidential aggregate manufacture volumes identified in the Order
Use in the following physical form of the chemical because other forms would result in exposures of concern: No use of the PMN substance in any consumer spray applications
Use of the PMN substance for the uses listed in the TSCA Section 5 Order
Required Testing: The Company is prohibited from manufacturing(including import) the PMN substance beyond the limits or manufacturing volume limits specified in the TSCA Section 5 order, unless the company conducts the following:
Ecotoxicity testing :
OPPTS 850.1300 (OECD 202) -Daphnid Chronic Toxicity Test
OPPTS 850.1400 (OECD 210) - Fish Early-Life Stage Toxicity Test
OPPTS 850.2300 (OECD 206) - Avian Reproduction Test
Health effects testing :
OPPTS 870.7485 (OECD 417) - Metabolism and Pharmacokinetics
Certain ecotoxicity and health effects testing requirements will be met in lieu of testing on the degradants of interest identified by EPA; Conducted on both PMNS: Biodegradation test (Modified Semi Continuous Activated Sludge, SCAS, OPPTS Guideline 835.5045 or OECD 302A, or modified Zahn-Wellens method, OECD 3028, with analysis for degradation products - see EPA general guidance presented in Attachment 2, Key Elements of Biodegradation Testing of Fluorotelomer Based Chemicals. The Company must look for the C6 and C7 possible degradants specified in Table 4 below). Mass balance should. Be attempted, to the best of the laboratory's ability, to achieve 70 - 130% over the course of the study; (conducted on either: (a) P- 11-0543 and P- 11-0484 or (b) the degradants of interest from Table 4 that arc identified by EPA based on the Tier I data) Combined repeated dose toxicity study with developmental/reproduction screening oral route, species to be determined by the test (870.3650), oral route species to be determined by the results of the pharmacokinetics studies with the following modifications increase parental sample size to 20; duration of study extended until pups have reached sexual maturation; parental males dosed for 10 weeks prior to mating; dosing of parental animals continues through lactation followed by direct dosing of pups until they reach sexual maturation; pup body weight recorded on lactation days 0, 4. 7. 14, and 21 and then at weekly intervals: time of sexual maturation (i.e. vaginal opening and preputial separation recorded); litter size can be standardized to 4 pups/ litter on lactation day 4 (optional); at weaning one pup/sex/litter can be randomly selected to follow until sexual maturation
Physical/Chemical properties testing :
OPPTS 830.7050 (OECD 101) - UV/Visible Absorption
Potentially useful information: What additional information would be useful to evaluate the potential health or environmental effects associated with the PMN substance before EPA would make a modification to the TSCA Section 5 Order’s restriction on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance? The order does not require submission of the listed testing at any specified time or production volume. However, the Order's restriciton on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of appropriate testing or other relevant information:
Ecotoxicity testing :
OPPTS 850.1300 (OECD 202) -Daphnid Chronic Toxicity Test
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