Document RaQYM72RLgeBY0ZKXmZawebQX

Larry R. Zobel, MD, MPH Staff Vice President and Medical Director i6 i f-r 3M Medical Department AR10&-0555 3M Center, Building 220-2E-02 PO Box 33220 St. Paul, MN 55133-3220 651 733 5181 Office 651 733 5152 Facsimile 3M April 20, 2000 Attn: Section 8(e) Coordinator Document Processing Center (7407) Office Of Pollution Prevention And Toxics United States Environmental Protection Agency 401 M Street, S.W. Washington, DC 20460 "X3 ;o -S r n -7 0 rn 0 .7 : Re: SUPPLEMENT TO TSCA SECTION 8(e) NOTICE ON: N-Ethyl Perfluorooctyl Sulfonamido Ethanol (N-EtFOSE) and Perfluorooctane Sulfonate (PFOS) Docket Numbers: 8EHQ-0998, 373, 374, 394 Dear Sir or Madam: On February 15, 2000, 3M submitted final reports for two-generation rat reproduction studies on the above referenced compounds. 3M had originally submitted a TSCA Section 8(e) notice dated September 14, 1998 based on preliminary data from these studies. With this letter, 3M is supplementing these earlier submissions as follows: => 3M is submitting an amended final report for the two-generation rat reproduction study on PFOS (Sponsor's Study number T-6295.9). This amended final report supercedes our earlier submission. It contains several clarifications, including that there were no toxicologically important effects on pup survival or growth at the 0.4 .g/kg/day dose level. The amended report also includes all data tables - both individual and summary. => 3M is submitting additional studies and documents which relate to the PFOS two-generation rat reproduction study (Sponsor's Study number 6295.9). These additional studies and documents are listed in Attachment A to this letter. 1 ON 5 oE P A -O T S 000811782R 00Dflll7aaR f 'O C=3 C=3 <=> ~V5 3 no j O ~n ~ om ~v<r> -- tm ~o P oo O OOOOOl Section 8(e) Coordinator April 20, 2000 Page 2 Please do not hesitate to contact the undersigned at (651) 733-5181 or Dr. John ButenhofF, 3M Toxicology, at (651) 733-1962 for further information. Sincerelv Larry R. Zobel, MD MPH Staff Vice President & Medical Director Enclosures cc: Dr. Charles Auer, Director Chemical Control Division CG0C02 Attachment A Protocol 418-008 Combined oral (gavage) fertility, developmental and perinatal/postnatal reproduction toxicity study of PFOS in rats (Sponsor's study number: 6295.9), Table E20, 1-3. Harb, R.V., Hartman, H.A., and Cox, R.H. (1994), Prevention of fluvastatin induced toxicity, mortality, and cardiac myopathy in pregnant rats by mevalonic acid supplementation. Teratology, 50, 19-26 Haughom, B. and Spydevold, 0. (1992), The mechanism underlying the hyperlipemic effect of perfluorooctanoic acid (PFOA), perfluorooctane sulphonic acid (PFOS) and clofibric acid. Biochimica et Biophysica Acta, 1128, 65-72. Levin, M.S., Pitt, A.J.A., Schwartz, A.L., Edwards, P.A. and Gordon, J.I. (1989), Developmental changes in the expression of genes involved in cholesterol biosynthesis and lipid transport in human and rat fetal and neonatal livers. Biochimica et Biophysica Acta, 1003, 293-300. Final Report Protocol 418-013 Oral (Gavage) Pharmacokinetic Study of PFOS in Rats (Sponsor's study number: T-6295.12), June 24, 1999 Protocol FACT-TOX-110 Oral (Gavage) Pharmacokinetic Study of PFOS in Rats, Protocol, June 8, 1999 Final Report Protocol 418-015 Oral (Gavage) Pharmacokinetic Recovery Study of PFOS in Rats (Sponsor's study number: T-6295.14), July 23, 1999 Protocol FACT-TOX-111 Oral (Gavage) Pharmacokinetic Recovery Study of PFOS in Rats, Protocol, June 8, 1999 Summary PFOS Rat Two-Generation Reproduction Study (Study numbers: 3M T-6295.9, Argus 418-008 [in-life], FACT-TOX-012 [analytical]) Report Amendment I, 13 April 2000, Protocol 418-008 (Sponsor's study number: 6295.9) Combined Oral (Gavage) Fertility, Developmental and Perinatal/Postnatal Reproduction Toxicity Study of PFOS in Rats, Final Report Analytical Laboratory Report on the Determination of the Presence and Concentration of Potassium Perfluorooctanesulfonate (CAS Number: 2759-39-3) in the Serum and Liver of Sprague-Dawley Rats Exposed to PFOS via Gavage, Laboratory Report No. <U2006>, Requestor Project No. <3M TOX 6295.9>, October 27, 1999 0C 0C 03 Interoffice Memo from Tom Kestner to Leo Gehlhoff, "Fluorochemical Isomer Distribution by 19F-NMR Spectroscopy, December 1, 1997 Final Report Protocol 418-008 Combined Oral (Gavage) Fertility, Developmental and Perinatal/Postnatal Reproduction Toxicity Study of PFOS in Rats (Sponsor's study number 6295.9, June 10, 1999 Summary PFOS Rat Cross-Fostering (Study numbers: 3M T-6295.13, Argus 418014) Final Report Protocol 418-014, Oral (Gavage) Cross-Fostering Study ofPFOS in Rats (Sponsor's study number: T-6295.13)r July 23, 1999 Analytical Laboratory Report on the Determination of the Presence and Concentration of Perfluorooctanesulfonate (PFOS) (CAS Number: 2759-39-3) in the Serum of Sprague-Dawley Rats Exposed to Potassium Perfluorooctanesulfonate via Gavage, Laboratory Report No. U2779, Requestor Project No. 3M Tox 6295.13, June 10, 1999 CC004