Document jmpp1QpNgwZDzrgaQxn4Qq3rk
3M General Offices
3M Center St. Paul, MN 55144-1000 651 733 1110
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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
Sanitized
RE: TSCA 8(e) Substantial Risk Notice: Docket No. 8EHQ-07-16721 C O fT ipfiT iy S S flitiZ O d To Whom It May Concern:
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 increase 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 diluebker@mmm.com if you have any questions or if
we c^n provide additional information.
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Sincerely,
Deanna J. Luebker, PhD 3M TSCA 8(e) Coordinator
Enclosure
89070000485/S
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