Document evpKG6ZwZXZmYND4KDeo9ZvaM

ff BEHp-0103-1522 C33o1rpMoerdaitcealToDxeicpoalrotgyment S3tM PCaanlerI. NBuSiSHld0ing02020-2602 BN 651733 1773 Fax AR2 26 _1.202 3M wo 2 & 8ZS8Ze == gr& &Z > 8 Certified Mail January 10,2003 h HIReED I BEHD-83-15262 DEoPcAumEeasntt--PrRoocoesmsi6n4g2C8eAnttenr: Section 8() Office of Pollution Prevention and Toxics US EPA 1200 Pennsylvania Avenue NW. Washington DC 20460-0001 Conta, CBI RE: TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: 1-Butanesulfonylfluoride, 1,1,223,3,4.4-octafluoro-4-[(rifluoroethenyloxy] (CAS: 88190-28-7) Dear Sirs: s= = w3iMthhaasrerseecaericvhedanpdredleivmeinlaorpymednattacfhoermaic2a8l-dianyteorrmaelditaoxtieciIt-yBusttaundeysuinlfroantyslcfolnuodruicdtee,d = === n1e,u1r,o2l2o.g3i.c3a.l4,4-iodchteayf,luiovreor-4a-n[d(rmiaflleuosreoccotnhdeanryylosxeyx]o(rCgAaSn:ef8f8e1ct9s0.-28-7) indicating ~~ S== == Thestudy was conducted by Aventis Pharma Deutschland, GmbH. Sprague Davey N= EE rats were given cither 0, 3, 15, 60 or 240 mg/kg/day doses of 1- = Butanesulfonylfluoride, 1,1.2.2,3,3,4,4-octafluoro-4-[(sifluoroethenyloxy]byoral ginacvlaugdeedfofror28thdeay0s.andAth1e4-2d4a0y mrgec/okvge/rdyaypedroisoed gwriotuhopust compound administration was mUynkcogodrdaiynadtoesdeorgrsotiulptebdeggaiintnainndg aonhudnacyhe15dopfostthuersetuwdays. oAbse3rmvge/dkign/tdhaey1d5ose 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 23" 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 of5 males and in 1 of5 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 ! ws! dosing period were, for the most part, no longer visible inthe 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. Afinal report will be forwarded to EPA when received. PplreoavsiedecoandtdaicttioAnanldrinefworSmeaatcioant.(651-575-3161)if you have any questions orifwe can Sincge erely, ny Ady Xtra Dr. Larry R. Johnson Director, Corporate Toxicology and Regulatory Services. 2