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3M General Offices
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3M Center St. Paul, MN 55144-1000 651 7331110
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Certified Mail December 14, 2007
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Document Processing Center EPA East - Room 6428 Attn: Section 8(e) Office of Pollution Prevention and Toxics, US EPA 1200 Pennsylvania Avenue NW Washington DC 20460-0001
RE : TSCA 8(e) Substantial Risk Notice : Docket No. 8EHQ-07-16721
To Whom It May Concern:
In January of 2007 3M notified that EPA that preliminary data from an oral (gavage)
developmental toxicity screening study in rats conducted on an experimental chemical, [fluorinated surfactant salt] had been received. At that time, rats were in the final days of gestation or beginning of lactation and deaths had occurred in the high (500 mg/kg/day) and mid (270 mg/kg/day) dose group females . Remaining rats in the high dose group were humanely euthanized and three dams in the 270 mg/kg/day dose group had delivered litters . Observations in the 270 mg/kg/day dose group included increased number of pups found dead or presumed cannibalized, reduced live litter size, and reduced pup weight per litter as compared to control (lactation day one).
In February of 2007 the in-life phase ofthe study was complete. At that time 3M notified the EPA that additional observations at the 270 mg/kg/day dose group included an increased percentage of dams with all pups dying during lactation days one through four; reduced liveborn pups per litter, and increased stillborn pups per litter as compared to control ; reduced viability index as compared to control ; and reduced pup weight per litter through lactation day six (day of sacrifice). At the 90 mg/kg/day dose level, reductions in pup weight per litter were observed through lactation day four.
The final report for this study is enclosed.
Please contact me at 651-737-1374 or djluebkerna,mmm .com ifyou have any questions or need additional information .
Sincerely,
Deanna J. Luebker, Ph.lS. Toxicologist and 3M TSCA 8(e) Coordinator
Enclosure
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