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3M EnviroaneataJ and Safety Satvices
900 Bush Avenue Building 42-2E-26 PO Bo* 33331 St Paul, MN 35133-3331 651 778 4331
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February 28,2002
Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e) Office o f Pollution Prevention and Toxics US EPA 1200 Pennsylvania Ave., NW Washington, DC 20460-0001
TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: Ammonium Perfluorooctanoate CAS#: 3825-26-1
Dear Sin
3M has received information in a draft final report on Ammonium Perfluorooctanoate CAS#: 3825-26-1 (APFO) in an Oral (Gavage) Two-Generation (One Litter per Generation) Reproduction Study in rats, by A m is Research Laboratories, identifying the following outcomes from high-dose (30 mg/kg/day) males and females:
A slight but statistically significant decrease in lactation index (percent viability from day 5 - 2 2 post-partum) for F I pups which appears to be spread across several litters and is not apparently sex specific. A slight but statistically significant increase in early post-lactational deaths in F I females. A slight but statistically significant delay in sexual maturation (as measured by vaginal potency) in F I females. A slight but statistically significant increase in estrous cycling in F I females. A significant delay in sexual maturation (as measured by preputial separation) in FI males.
3M believes that th e s e effects may be explained fully or in part by body w e ig h t and age. 3M is currently awaiting results o f covariate analyses that w ill provide information on the effect o f body weight and age on these parameters. Until these analyses are available, it may be premature to draw conclusions concerning 6k causation o f these marginal, but statistically significant, effects. A final report for the study will be available within a few weeks and will be submitted to EPA.
For further information, please contact Dr. John Butenhoff, 651-733-1962.
Sincerely,
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ferine E. Reed StaffVice President, Environmental Technology and Safety Services