Document XRkRGE21y83mJ88Q7dgkGNLMJ

Larry R. Johnson D.V.M., Ph.D., DABT Director February 8, 2002 Corporati Toxicolpgy 3M Center, Building 0220-02-E-02 3M Medical Department PO Box 33220 St. Paul, MN 55l33-322'0< 651 733 9218 Office ; r , AHi z - i Of 651 733 1773 Fax lrjohnson@mmm.com rU zm -oz-Oozi 0j 551j7 0 Document Processing Center (7407M) EPA East - Room 6428 Attn: Section 8(e) Office of Pollution Prevention and Toxics Ui crA 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 %w Cr-Oo , c o n t a i n 4 0 QfTIFIED MAIL TSCA 8(E) SUPPLEMENTAL INFORMATION ON: N-ethyl perfluorooctanesulfonamidoethanol (CASRN 1691-99-2); Docket R ef-0373 Dear Sir: 3M is submitting the final report from Covance Laboratories on the 2-year rat feeding study on N-ethyl perfluorooctanesulfonamidoethanol (CASRN 1691-99-2), originally notified to EPA in a letter dated December 4, 2000, with additional information provided in a letter dated May 24, 2001. In addition, two reports on serum and tissue analysis from samples collected during the study are enclosed. Sprague-Dawley rats were given N-ethyl perfluorooctanesulfonamido ethanol (98.1 %) in the diet at 0, 1, 3, 30, 100 & 300 ppm for up to 104 weeks. A recovery group at 100 ppm was dosed for 52 weeks, after which, untreated feed was given until termination. Interim sacrifices occurred at 4, 14 and 53 weeks for histopathology, metabolite quantitation, and cell proliferation. The 300-ppm groups were terminated after seven weeks of treatment. Through term, survival was unaffected by treatment, and bodyweights were lower in the 100 ppm dose group. Liver effects occurred at 100 ppm, with the exception of cystic degeneration in 30-ppm males. Hepatotoxicity was not present in 100-ppm recovery animals. In males, thyroid follicular cell adenoma was increased at the 100 ppm dose. For females, hepatocellular adenoma was increased in the 100-ppm and the 100-ppm-recovery groups. j l i j j .> For further information on this study contact Dr. John Butenhoff, 651-733-1962. Director, Corporate Toxicology Enclosures jy EPA-QTS 000811840M GOGllflHDM Reports Submitted with Letter of February 8, 2002: a. Final Report, 104-Week Dietary Carcinogenicity Study with Narrow Range (98.1%) NEthyl Perfluorooctanesulfonamido Ethanol in Rats, (Covance Study 6329-212), December 13, 2001. b. Analytical Laboratory Report, Determination of the Presence and Concentration of PFOS, PFOSA, PFOSAA, EtFOSE-OH, M556 and PFOSEA in Serum and Liver Samples of Crl:CD(SD) IGS BR Rats Exposed to N-Ethyl Perfluorooctanesulfonamido Ethanol, 3M Environmental Laboratory Report No. TOX-OOl, Laboratory Request No. U2103, 3M Refemce No. T-6316.1, June 6, 2001. c. Analytical Laboratory Report, Determination of the Presence and Concentration of PFOS, PFOSA, PFOSAA, EtFOSE-OH, M556, and PFOSEA in Serum and Liver Samples of Crl:CD(SD) IGS BR Rats Exposed to N-Ethyl Perluorooctanesulfonamido Ethanol, 3M Environmental Laboratory Report No. TOX-003, Laboratory Request No. U2104, 3M Reference No. T-6316.1, June 6,2001.