Document zzYm4aLk8Gyn65G32zwr1DYv0

3M General Offices 3M Center F St. Paul, MN 55144-1000 651 733 1110 937/y* 7 W i J i W JAi)- / 2 7 V-/ * f / QJ ; n iA n 'V Jvj July 24, 2000 en Sf oo> Document Processing Center (7407) Attn: Section 8(e) Coordinator Office of Pollution Prevention and Toxics US EPA 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 of related perfluorooctanyl sulfonates previously submitted to EPA [see 8(e) dockets #373 and 374], Enclosed is the final report from Covance Laboratory on a 13-Week Dietary Study of N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats. As expected, higher dose levels (30 and lOOppm N-MeFOSE 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 of the study. Weekly body weights of 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) of the low dose animals was significantly less than the controls. oe=> JE-- 5 i IX> CO FYI-00-001378 FYI-00-00137B 85000000031 S500000003 OOOOOl 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, Vice President, Specialty Materials Markets Enclosures: 1. 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats (T-6314) 2. 13-Week Dietary Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats (T-6314) 000002