Document aDLenG6Y6jjXmM5My6XBk9mpy

Jean B. Sweeney Vice President 3M Environmental, Health and Safety Operations 3M Center, Building 0224-05^/V-1)3 St. Paul, MN 55144-1000 651 737 3569 Certified Mail 6-00 r*o July 13,2010 Document Processing Center EPA East - Room 6428 Attn: Section 8(e) Office of Pollution Prevention and Toxics US EPA 1200 Pennsylvania Avenue NW Washington DC 20460-0001 NOCBI c~> V jJ Re: TSCA 8(e) Substantial Risk Notice: Supplemental to Docket No. 8EHQ-0598-373; Sulfonate-based and Carboxylic-based Fluorochemicals To whom it may concern: 3M is submitting this notice to supplement its previous submissions on sulfonate- and carboxyl ate-based fluorochemicals. 3M recently received an abstract from a kinetic evaluation in mink (Mustela vison) conducted on perfluorooctane sulfonate (PFOS). The objective of this 84-day study was to assess the toxicokmetic profile of PFOS on wildlife species. Twenty adult male mink were administered 20 mg/kg/day of PFOS in their diet for 56 days. This was followed by a 28-day recovery period during which all animals were fed an untreated control diet. Five animals were sacrificed from the PFOS treated group on study days 28, 56 and 84. Five control animals were sacrificed on study days 56 and 84. At sacrifice, the heart, spleen, kidneys, adrenal glands and thyroid were collected for histological assessment. Body weights of mink fed diets containing PFOS were significantly less compared to controls on study days 42, 49 and 56. Within seven days (study day 63) of being fed the untreated control diet, body weights of the PFOS animals were equivalent to control animal body weights. Absolute and relative (% of body weight) spleen weights of PFOS animals were significantly less than control weights at study days 56 and 84. There were no histological changes in the tissues examined. On study day 28, a maximal serum PFOS concentration was reached. This was followed by a statistically significant drop in concentration by study day 42 that remained constant through study day 56. During the 28-day elimination phase o f the study, serum PFOS concentration declined approximately 40% from serum concentrations observed on study day 56. Flepatic PFOS concentrations were approximately half o f respective serum concentrations and did not change between study days 28 and 56. During the 28-day elimination, hepatic concentrations decreased by approximately 30%. The observation of body-weight reduction effect in mink on dosing with PFOS is not completely unexpected based on the observations o f body-weight reduction effects in other species. Since mink have not been previously used as laboratory animals in the testing o f PFOS, 3M is placing the results of this kinetic evaluation in the 8(e) docket as a supplement to previous submissions. P-2 The in-life portion of this study is complete and an abstract has been produced. It is unknown at this time when a final report will be issued. The final report will be forwarded to the EPA once it is received. If you have any questions or need additional information, please contact Jeanette McCauley at (651) 733-9384. Sincerely, Jean B. Sweeney Staff Vice President, Environmental, Health and Safety Operations Enclosure p.3 Kinetic Evaluation of Perfluorooctane Sulfonate (PFOS) in Mink {Mustela vison) J. L. N ew sted1, S.J. B ursian2, J.E. Link2, M.M. A l-jaw ad2, A.E. Drow2, Scott Fitzgerald2, Stephanie Sm ith-Edw ards2, D.J. Ehresm an3, and J.L. Butenhoff3 1Entrix, Inc., 2Michigan State University, 33M Company Perfluorooctane sulfonate (PFOS), th e ultim ate degradation pro d u ct of sulfonated fluorochemicals derived from perflurooctane sulfonyl fluoride, is w idespread in the environm ent. PFOS has been detected in w ater, soil, fish, birds and mammals, including m ink (Mustela vison). Hepatic concentrations of PFOS in m ink consum ing fish from Saginaw Bay, MI w ere as g reat as 4.0 pg/g. Because relatively great hepatic PFOS concentrations have been detected in mink, assessm en t of the its toxicokinetics is an im p o rtan t step in th e evaluation of th e im pact of PFOS on wildlife species. Twenty adult male mink w ere fed a diet containing 20 mg PFOS/kg feed and 10 m ink w ere fed a control diet. The PFOS diet was provided for 56 d and then animals on that treatm ent w ere provided control feed for the remaining 28 d of the 84-d trial. On d 0, blood and liver sam ples w ere collected from five anim als for determ ination of PFOS concentrations. In addition, th e heart, spleen, kidneys, adrenal glands and thyroid w ere removed, weighed and processed for histological assessm ent. All anim als w ere w eighed w eekly and blood sam ples w ere collected every tw o weeks. On d 28, five PFOS m ink and on d 56 and d 84, five PFOS and five control mink w ere sam pled as described above. Body weights of mink fed diets containing PFOS w ere significantly less com pared to controls on d 42, d 49 and d 56. W ithin 7 d of being provided control feed (d 63), body w eights of PFOS anim als w ere equivalent to control body weights. Absolute and relative (% of body weight) spleen w eights of PFOS anim als w ere significantly less th an control w eights at d 56 and d 84. There w ere no histological changes in the tissues examined. A maximal serum PFOS concentration w as reached at d 28, followed by a statistically significant 25% drop in concentration by d 42 th at rem ained constant through d 56. During the elim ination phase of the study, serum PFOS concentrations declined approxim ately 40% from concentrations observed on d 56. Hepatic PFOS concentrations w ere approxim ately half of respective serum concentrations and did not change betw een d 28 and d 56. During the 28-d elimination phase, hepatic concentrations decreased by approximately 30%.