Document zQwbmMVZjZOqwMwKVvx61JvBB

3M Larry R. Zobel, MD, MPH Staff Vice President and Medical Director 3M Medical Department _ _ .. . . -C -O -- / Q / May 24,2001 $//&-O*0l-Oo373 3M Center, Building 220-2E-02 PO Box 33220 St. Paul, MN 55133-3220 651 733 5181 Office 651 733 5152 Fax Document Processing Center (7407) Attn: Section 8(e) Coordinator Office of Toxic Substances USEPA 401 M Street, SW Washington, DC 20460 TSCA 8(e) SUPPLEMENTAL NOTICE (DOCKET 8EHQ 1288-0373): N-ethyl perfluorooctanesulfonamidoethanol (CASRN 1691-99-2) Dear 8(e) Docket Coordinator: 3M has received a revised draft statistical report from Covance Laboratories in connection with a two-year dietary study of N-ethyl perfluorooctanesulfonamidoethanol (N-EtFOSE) in rats. Based on review of a previous draft statistical report, 3M on December 4, 2000 submitted a notice to the 8(e) docket informing EPA of a statistically significant increase in hepatocellular adenomas in female rats. 3M is supplementing that notice with additional information regarding thyroid follicular-cell tumors in male rats. The final report for this study is in preparation. In the study design, male and female rats were assigned to one of two control groups or one of five dosed groups that received the compound mixed into their feed. The dietary dose levels were 1,3, 30, 100 and 300 parts per million (ppm), plus additional "recovery" groups at 100 ppm and 300 ppm. (The 300 ppm dose group was terminated early due to toxicity. The 1 ppm dose group and an additional concurrent control group were added several weeks later.) The attached table presents the relevant findings with respect to thyroid lesions in the male rats. When the final report on this study becomes available, it will be submitted to the EPA. The findings of statistical significance presented in the attached table are not meant, in and of themselves, to imply biological significance. These data will be interpreted for biological significance in the final report. Additional data regarding interim results and other toxicity testing for N-EtFOSE, including negative genotoxicity assays, can be found in EPA docket AR-226. Please contact me for further information. Regards, Larry RTZobel, MD MPFI. Staff Vice President and Medical Director c: Dr. Charles Auer Dr. Oscar Hernandez --5 m LO s Contain NO CBl S o epa-ots 000811818R OOOlllflR Attachment TABLE RESULTS OF STATISTICAL ANALYSIS OF SELECTED THYROID LESIONS IN MALES FROM TW O-YEAR DIETARY STUDY WITH N-EtFOSE Tumor Thyroid Follicular-Cell Adenoma Thyroid Follicular-Cell Carcinoma Thyroid Follicular-Cell Adenoma & Carcinoma Historical Control(a) 17/391 (4.3 %) (0 % - 11.3 %) 4/391 (1.0%) (0 % - 3.2 %) NA (0 % - 14.5 %) Control A <b) 1/60(1.7%) 0/60 (0 %) 1/60(1.7%) 1ppm 2/60 (3.3 %) 0/60 (0 %) 2/60 (3.3 %) Control B (c) 0/55 (0 %) trend* <d) 0/55 (0 %) 0/55 (0 %) trend* 3 ppm 3/50 (6.0 %) 0/50 (0 %) 3/50 (6.0 %) 30 ppm 1/50 (2.0 %) 1/50 (2.0 %) 2/50 (4.0 %) * denotes statistical significance, p<0.05 a) Data from six prior two-year studies with Sprague-Dawley rats in the same laboratory. b) Control for 1 ppm dose group. c) Control for 3, 30, 100 ppm and 100 ppm recovery dose groups. d) The significance indications in the control column are one-tailed for trend. 100 ppm 6/60 (10.0 %)* 0/60 (0 %) 6/60 (10.0 %)* 100 ppm Ree 1/40 (2.5 %) 1/40 (2.5 %) 2/40 (5.0 %)