Document VN2eBxBppe8v5D3jbwO2xVOg

3M Medical Department Corporate Toxicology 3M Center, Building 220-2E-02 St. Paul, MN 55144-1000 651 733 1773 Fax 3M Certified Mail nil r 'i 8EHQ-03-15262 January 10, 2003 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 8E H O -03 -15262 Come t u , CBI RE: TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: 1-Butanesulfonylfluoride, l,l,2,2,3,3,4,4-octafluoro-4-[(trifluoroethenyl)oxy] (CAS: 88190-28-7) 03 QO CTi ac I lJ )-- CO UOJfQx_, CM zn Cc3 CM Dear Sirs: 3M has received preliminary data for a 28-day oral toxicity study in rats conducted with a research and development chemical intermediate 1-Butanesulfonylfluoride, l,l,2,2,3,3,4,4-octafluoro-4-[(trifluoroethenyl)oxy] (CAS: 88190-28-7) indicating neurological, kidney, liver and male secondary sex organ effects. The study was conducted by Aventis Pharma Deutschland, GmbH. Sprague Dawley rats were given either 0, 3, 15, 60 or 240 mg/kg/day doses of 1Butanesulfonylfluoride, l,l,2,2,3,3,4,4-octafluoro-4-[(trifluoroethenyl)oxy] by oral gavage for 28 days. A 14-day recovery period without compound administration was included for the 0 and the 240 mg/kg/day dose groups. Uncoordinated or stilted gait and a hunched posture was observed in the 15 mg/kg/day dose group beginning on day 15 of the study. A 3 mg/kg/day dose group was initiated approximately 3 weeks after the other dose groups due to these effects. Stilted gait and squatting posture have been observed in the 3 mg/kg/day dose group, starting on the 23rd day of dosing. No animals died during the dosing phase of the study. One male rat in the 240 mg/kg/day dose groups was found dead on day 13 of recovery. At necropsy, gross observations included discolored kidneys in 3 of 5 males and in 1 of 5 female rats given 15 mg/kg/day, and in the higher dose groups. Liver and intestinal effects were observed in the 240 mg/kg/day dose groups. Gross histopathologic evidence of male secondary sexual organ abnormalities were noted at necropsy in the 240 mg/kg/day recovery group animals. The kidney and liver effects observed at the end of the 88030000057 8803000005 I (dc&g! dosing period were, for the most part, no longer visible in the 240 mg/kg/day recovery group. The study is not complete at this time. Necropsy of the low dose group is in progress, and an additional dose group of 0.3 mg/kg/day is planned. A final report will be forwarded to EPA when received. Please contact Andrew Seacat (651-575-3161) if you have any questions or if we can provide additional information. Sincerely, il U/i Dr. Larry R. Johnson Director, Corporate Toxicology and Regulatory Services