Document MNXKKZDLaYy3ZKYxzGm2p3kL

3M General Officals 3M Center St . Paul, MN 55144-100G 651 7331110 Certified Mail September 13, 2007 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 P. 1 M~,~ 3~ ~~( t 'e ZZ6-,%37 Sanitized ~wF Q u RE: TSCA 8(e) Substantial Risk Notice : Docket No. 8EHQ-07-16721 To Whom It May Concern : Company Sanifized In May of 2007 3M notified the EPA that preliminary data had been received from a 28-day repeat dose oral gavage toxicity study in rats performed on an experimental chemical, [fluorinated surfactant salt] showing a statistically significant increase in mean liver weights in mid and high dose (30 and 100 mg/kg) males as compared to controls at the end of the 28day treatment period . This incregse was remarkable in high dose males where the mean liver weights were 15 .49 +/- 1 .95 grams in high dose males as compared to 9.46 +/- 1 .24 grams in control males. A statistically significant increase in adrenal weights in high dose (100 mg/kg) females was also noted at the end of the 28-day treatment period. Histopathological examination of the livers revealed an increased incidence and severity of hepatocellular hypertrophy/hyperplasia in males at 30 and 100 mg/kg . Although the morphological changes of the liver were deemed to be adaptive, the magnitude of the increase in liver weight at these dose levels was considered adverse . The final report for this study is enclosed. For reference, 3M has submitted data from an oral (gavage) developmental toxicity screening study in rats, a five day repeat oral study in rats, and a mouse local lymph node study conducted on the same chemical . These submissions have also been assigned the docket number listed above . Please contact me at 651-737-1374 or djluebker ,manm .com ifyou have any questions or if we c_on provide additional information . ~; Sincerely, Deanna J. Luebker, PhD 3M TSCA 8(e) Coordinator Enclosure ! !INII I E !I il 9 ! I! U ! !I 7 !i Ili!~ li i I ~! I ! ~ I!I ! !I!i! I!I~ i ! ! I I i! NII 000 U4 E