Document j7nNmdJZmBkXJ8ozEv6462yk

Larry R. Zobel,MID,WH StaffVice President and imedicalDirector 3M NledicalDepartinent 3M Center,Building220-2E-02 PO Box 33220 St.Paul,MN 55133-3220 651733 5181 Office 651733 5152 Fax December 4,2000 Document ProcessinCegnter (7407) (Attn: Section8(!e)Coordinator) Office of To)dc Substances US EPA 401 M Street-S,W Washington, DC'20460 CER=D MAIL TSCA 8(E) STJBSTANTLAL RISK SUPPLEMENTAL perfluorooctylsulfona*nu*doethanol,see Docket.8EHQ NOTICE ON: N-Ethyl 1288-0373 Dear 8(e).Coordinator: 3M has received a draftstatisticarleport from Covance Laboratory on a 2-year rat ceding study ofN-EtFOSE {N-Ethyl Perfluorooctanesulfonan@do Ethanol (CAS 1691-99-2)}-.The resultsof thisstudy are corroborative of resultssubmitted in 1988 to EPA. in docket 8EHQ 1288-0373. This study was conducted using.N-ETFOSE at a purity of approximately 98%, in contrastto the earlierstudy which was believedto be 84-88%. Groups of male and female ratsreceived the compound intheirfeed. There were seven groups of rats- two control groups, a low dose of I ppm in diet,a low intermediate dose of 3 ppm in diet,a high intermediate dose of 3 0 ppm 'indiet,a high dose of 100 ppm in diet and a high dose recovery group. The high dose recovery animals received the compound far the ffi-sytear of the study at 100 ppm in dietand no compound during the second year of the study. Statisticaalnalyses of the tumor data from thisstudy revealed thatthe high dose female group showed a statisticalsliygnificantincrease inbenign livertumors. The livertumor data are presented below. MALES Hepatocellular Adenoma Carcinoma Control I Control2 Ippm 3ppm 3 Oppm 2/55 5/60 4/60- 4/50- 2/50- 0/55 0/60 0/60 0150 0/50 4 00ppm 5/60 0/60 100 ppm rec 0/40 0/40 US EPA Officeof Toxic Substances December 4,2000 Page 2 FEMALES Control1 Hepatoceflular Adenoma 0155 Control2 Ippm 3ppm 30ppm 2/60 1/60 1150 3/50 Carcinoma 0/55 0/60 0/60 0/50 0150 significanpt< 0'..0p5a,iredand trend,based on.Control 1 IOOPPM 6/60* 1160 100-ppm rec 3/4-0*0/40 Control2 and the I ppm dose group were added aftera 300 ppm dose group was discontinued.T.hiswas done two months fntothestudy,when itbecame apparentthatthe 300 ppm dose group would not tolerattehislevelas a lifetimdeose. The Everisthetargetorgan of toxicitfyorN-ETFOSE. Liver.toxiciwtays presentinthehigh dose (100 ppm) males and females-T.he livertoxicit'ywasmanifest&dhistologicalalsy hepatocehular-vacuolatiaonnd hepatocehulacrentrilobulhayrpertrophy.These histologic liverchangeswere notmanifestedinthehighdose (100 ppm) recoveryanimalsindicatintghat thelivertoxicitwyas a reversibleeffect. The compound isnot genoto)dc,havingbeen negativeinmultiplein-Wtroand in vivo genotoxicitayssays. The fmal reportwillbe submittedto EPA upon receipt. Pleasecontactme, 651-733-5191,forfurtherinformation. Regards, LarryR- Zobel,MD WH StaffVice President& MedicalDirector