Document pBgeMGxQmQ3EYq6koGxOB9MM7

Le RecoyrporSatenTioo and. S3M CiomerN, BSualkg i02o002502 #5R226-_ 1324 651733 1773 Fax AEDES BEug-2o-323 Me Certified Mail 5 503-0037 i. 0328 1 6: 0133 EHR -- O -00, Document Processing Center Cont. EOfPfAiceEofa--PoRsllouottiimon6P4r2e8veAntttino:nSaencdtiToonxi8c(sc.) ". 8 EPA-OTE cCiB] U12S00EPPeAnnsylvania Avenue NW - `WashingtonDC 20460-0001 2008336570 RE: TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: I-Butanesulfonamide, 1,1,22,3,3,4,4,4-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,1,1,2,2.3,3.4,4 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 of0, 10, 50 or 250 mg/kg/day beginning fourteen days before cohabitation and continuing until after ~ csouhbasbtiatnacteioant,tfhoersaammeindiosmaugmeolfev2e8lsdabyesgionfnidnosgafgoeu.rtFeeenmadlaeysrabtesfworeerecoahdambiintiasttieorneadntdhe ~~&E o continuing until day S of lactation. bT 33g In the 250 mg/kg/day dosage group, several significant effects were observed. The = B= `wnausmbseigrnoiffilciavntelbyorinncpruepassewd.asTshiegnnifuimcbanetrlyofdepcurpesasfeodunadnddethaed number of stillbom or presumed pups > SG 2 cannibalized on days 1 and 2 to day 5 postpartum was significantly increased. The 2 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% ofCAS 34454-97-2 and 4-5% functionally 1 2b7028 frienlaaltepdrobdruacntcsheatd tirsaocmeearmsoaunndtsm.onohydrides. The fluorochemical alcohol is present in 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 snusmibde,r postal card to Cheri Kedrowski, 3M Center Bldg. 220-2E-02, St. Paul, MN Sincerely, Cary, 1, MD MPH Staff Vice President and Medical Director Enclosure >