Document EqvZaYryvMaY6YGm5v7NggyVx

3IM C orporate Toxicology and Regulatory Services 3M Center, Building 0220-02-E-02 St. Paul, MN 55144-1000 651 733 1773 Fax jK (9 | ^ * -2 5 6 _ \$z]+. Certified Mall May 22, 2003 03 H/iY28 AH 6: 3 F&fQ. - 003_00313 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 C o/Wc.; EPA-OTS 000811857U ooofliias7u RE: TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: 1-Butanesulfonamide, l,l,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methyl, (CAS 34454-97-2) Dear Sirs: 3M has received data for a subchronic oral toxicity study in rats conducted with a chemical intermediate 1-butanesulfonamide, l,l,2,2,3,3,4,4,4-nonafluoro-N-(2hydroxyethyl)-N-methyl, (CAS 34454-97-2) (fluorochemical alcohol) indicating developmental effects. The study was conducted by Argus Research; a copy of the final report is enclosed. Male rats were administered the fluorochemical alcohol at doses of 0, 10, 50 or 250 mg/kg/day beginning fourteen days before cohabitation and continuing until after cohabitation, for a minimum of 28 days of dosage. Female rats were administered the substance at the same dosage levels beginning fourteen days before cohabitation and continuing until day 5 of lactation. In the 250 mg/kg/day dosage group, several significant effects were observed. The number of livebom pups was significantly decreased and the number of stillborn pups was significantly increased. The number of pups found dead or presumed cannibalized on days 1 and 2 to day 5 postpartum was significantly increased. The viability index and number of pups surviving per litter on postpartum day 5 were significantly reduced. These effects at the highest dosage level (250 mg/kg/day) were not observed in the lower dosage groups. Additionally, some rats in the 50 and 250 mg/kg/day dosage groups were observed to have significantly increased liver weights and microscopic changes in the liver, thymus and/or stomach. 3M uses the fluorochemical alcohol as a chemical intermediate to manufacture polymeric materials. In the manufacturing setting and as administered during toxicity testing, it contains approximately 93-94% of CAS 34454-97-2 and 4-5% functionally c-o cCr_ 3Z r vo "Of--irn a3Sr Q rn vo* o o Co I related branched isomers and monohydrides. The fluorochemical alcohol is present in final products at trace amounts. Please contact James Zappia (651-733-5180) if you have any questions or if we can provide additional information. Once a docket number has been assigned for this submittal, please send the docket number postal card to Cheri Kedrowski, 3M Center Bldg. 220-2E-02, St. Paul, MN 55144. Sincerely, Staff Vice President and Medical Director Enclosure