Document K6LKZe6z6vnm5M4n0Eb7O9yK0
t Cjlcl :,, kill Ices
St@P@itiil',vl5n5'144-1000
6-S1 73 ")II10
3M
July 24, 2000
Document ProcessingCenter (7407) Attn: SectionS(e)Coordinator Office of PollutionPrevention and Toxics US EPA 401 M Street,SW Washington, DC 20460
CERTIFIED MAIL
TSCA 8(E) SUBSTANTIAL FJSK NOTICE ON: N-Methyl PerfluorooctanesulfonamidoEthanol
Dear Sir:
3M isreportinginformationthatshows N-Methyl Perfluorooctanesulfonamido toxic;IL--iyscons:)Istewn-4@,t'@,Ullieo,ilrelatepde,7fuorooc*arylsulfona+,@p-rseviously submitted to EPA [see8(e)dockets #373 and 374]. Enclosed isthe finalreport from Covance Laboratory on a 13-Week Dietary Study of N-Methyl PerfluorooctanesulfonamidoEthanol (N-MeFOSE) inRats. As expected,higher dose levels(30 and 100ppm N-MEFOSE infood) produced livereffects.The liverchanges includedincreasedliverweights,hepatocyte hypertrophy, and hepatocellularvacuolation.Lower cholesteroland triglyceridelsevelswere also found inthe high dose (100ppm) and niiddose (30ppm) animals. Neitherliver effectsnor cholesterol/triglycericdheanges were found in the low dose (3ppm) animals.
Significantlyreduced body weights were presentin the high dose animals beginning at week 4 and continuinguntilthe end of thestudy. Significantly reduced body weights'oecurredin the mid dose animals beginning at week 7 and continueduntilthe end of the study. Weekly body weights of the low dose animals during the second halfof the study were somewhat lessthan controls. None of the low dose weekly body weights were significantldyifferentfi-om controls.However, the overallbody weight gain duringthe study (weeks I through 14) of the low dose animals was significantllyessthan the controls.
Document Processing Center (7407) Page Two July 24, 2000
The Covance reportconcludes thatthe 3ppm dose was theno-observableadverse-effectlevel(NOAEL) as theminor body weight effectfound at3ppm was not correlatedwith any clinicalchemistry or anatomic pathologicalchanges; itwas not considered to be biologicallyadverse.
The study reportis attached.
Please contactDr. William Weppner, 651-733-6374, forfurtherinformation.
Sincerely,
Char eJs'c@eic@h Vice President, SpecialtyMaterialsMarkets
Enclosures:
1. 4-Week Range-Finding DietaryToxicityStudy withN-Methyl
Perfiuoro o eta,-ies-iaolr.-LaniiEctihoario'L
0 S E) irtr'-els('L-ul 4')
2. 13-Week Dietary Study with N-Methyl PerfluorooetanesulfonamidoEthanol
(N-MeFOSE) inRats (T-6314)