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Katherine E. Reed, Ph.D. Staff. Vice President
3M Environmental Technology and Safety Services
900 Bush Avenue Building 42-2E-26 PO Box 33331 St Paul, MN 55133-3331 651 778 4331
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February 28, 2002
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Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e) Office of Pollution Prevention and Toxics
US EPA 1200 Pennsylvania Ave., NW Washington, DC 20460-0001
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TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: Ammonium Perfluorooctanoate CAS#: 3825-26-1
Dear Sir:
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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 Argus 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 FI 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 FI females. A slight but statistically significant delay in sexual maturation (as measured by vaginal
potency) in FI females. A slight but statistically significant increase in estrous cycling in FI females. A significant delay in sexual maturation (as measured by preputial separation) in FI
males.
3M believes that these effects may be explained fully or in part by body weight and age. 3M is currently awaiting results of covariate analyses that will provide information on the effect of body weight and age on these parameters. Until these analyses are available, it may be premature to draw conclusions concerning the causation of 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.
Sincerejy,
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Katherine E. Reed Staff Vice President, Environmental Technology and Safety Services
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