Document YDK6kVbRa9511JYVNY14mV8Nk

New Datatiff AR.&3.6-062.5 Completion of two generation reproductive studies for perfluorooctane sulfonate and EpetFrfOluSoEro, oacntdancerossusl-ffoonsatetreinstgufdoyllow up to Pharmacokinetics during pregnancy studies Second species (rabbit) teratology study Completion of 180 day repeat dose study in primates with one year recovery 3M Medical Department March 7,2000 I Pending Two-year feeding studies EtFOSE - In-life done 4/2000 Perfluorooctane sulfonate - In-life done 4/2000 6 month and one year recovery after 180 day feeding study in primates ADME study in primates 3M Medical Department March 7,2000 Pending Human sera studies Health claims study Update mortality study Mechanistic and metabolic studies 3M Medical Department March 7,2000 3 ResultsFo- sRteerpirnogdSutcutidoines/Cross- N0.O4 EmLg/fkogr/dreopfrpoedruflcutiovreoeonctdapnoeinstuslfonate is Perinatal mortality is predominantly a pup effect rather than a maternal effect Effect on cholesterol metabolism is hypothesized mechanism - studies planned to test hypothesis 3M Medical Department March 7,2000 ResultsD-oPseriSmtuatdeyRepeat 0.15 mg/kg/d well tolerated for 6 months (apparent NOEL) Cholesterol level decreased at perfluorooctane sulfonate serum concentrations greater than 100 ppm (in the high dose group) 2 deaths in males at 0.75 mg/kg/d that were apparently compound relateyd At the high dose (0.75 mg/kg/d) body weight liver weight and liver morphology were affected 3M Medical Department March 7,2000 r Results - Sera Concentrations Perfluorooctane sulfonate serum concentrations increase linearly with dose in l8o3w-1a0n7dpmpmid) dose groups (16-20 ppm and Perfluorooctane sulfonate serum tchoencheinghtradtoisoengs rfooullpows, ewditahbmipahxaimsicumcurvvaeluiens at 250-300 ppm 3M Medical Department March 7,2000 Background "19O6r8ganic fluorine" reported in human sera in 3M medical surveillance from 1976 to present Aconmalpyosuesndfosrdsopseecaiffitcerflu19o9ro2o-rdgeatneicction limit less than 50 ppb in 1997 Mcoocncuutltepimpaltpeiooanrnaaarlllyyysseiesxrpfaroossamemd)hpfilsientsodr(nipcoeanrfn-ludorooctane sulfonate at less than 50 ppb 3M Medical Department March 7,2000 7 Background Various studies, including medical surveillance, done over the last 25 years In the last two years have used outside experts to identify needs and help define studies Have created Scientific Advisory Panel for additional review 3M Medical Department March 7,2000 2 Review - Data in Health Effects Paper ADME Metabolic precursors to perfluorooctane sulfonate Repeat dose feeding studies - rat and primate Genotoxicity Teratology 3M Medical Department March 7,2000 Review - Data in Health Effects Paper (Continued) Cross-sectional study of exposed employees Mortality study at production plant site Irnepterroidmucdtaivtae fsrtoumdy2-generation Interim data from new repeat dose primate study 3M Medical Department March 7,2000 10 Results The additional data does not suggest a health risk associated with the levels of perfluor loctane sulfonate found in the sera of occupationally or non-occupationally exposed employees, blood bank samples or commercially available serum. 3M Medical Department March 7,2000 //