Document 5Rq92BXk65q5mDD2DOn7yjz5

_wi ( .ciici :u u n i t e s j.'.i i_entu' St. Paul, iVIN 55144-1000 65i 73? 1110 3M July 24, 2000 Document Processing Center (7407) Attn: Section 8(e) Coordinator Office o f Pollution Prevention and Toxics USEPA 401 M Street, SW Washington, DC 20460 - 'CERTIFIED MAIL TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: N-Methyl Perfluorooctanesulfonamido Ethanol Dear Sir: 3M is reporting information that shows N-Methyl Perfluorooctanesulfonamido toxicity is consistent with that o f related perfluGroudcuiyl oUtfonat^s pieviouoi.j submitted to EPA [see 8(e) dockets #373 and 374]. Enclosed is the final report from Covance Laboratory on a 13-Week Dietary Study o f N-Methyl _ Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats. As expected, higher dose levels (30 and lOOppm N-M eFOSE in food) produced liver effects. The liver changes included increased liver weights, hepatocyte hypertrophy, and hepatocellular vacuolation. Lower cholesterol and triglycerides levels were also found in the high dose (lOOppm) and mid dose (30ppm) animals. Neither liver effects nor cholesterol/triglyceride changes were found in the low dose (3ppm) animals. Significantly reduced body weights were present in the high dose animals beginning at week 4 and continuing until the end of the study. Significantly reduced body weights occurred in the mid dose animals beginning at week 7 and continued until the end o f the study. Weekly body weights o f the low dose animals during the second half of the study were somewhat less than controls. None of the low dose weekly body weights were significantly different from controls. However, the overall body weight gain during the study (weeks 1 through 14) o f the low dose animals was significantly less than the controls. Document Processing Center (7407) Page Two July 24, 2000 The Covance report concludes that the 3ppm dose was the no-observable adverse-effect level (NOAEL) as the minor body weight effect found at 3ppm was not correlated with any clinical chemistry or anatomic pathological changes; it was not considered to be biologically adverse. . The study report is attached. Please contact Dr. William Weppner, 651-733-6374, for further information. Sincerely, etu. Charles Reicn Vice President, Specialty Materials Markets Enclosures: 1. 4-W eek Range-Finding Dietary Toxicity Study with N-Methyl Periluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats (T-6314) 2. 13-Week Dietary Study with N-M ethyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats (T-6314)