Document B8Rko1orJykQmmwo80weezNNX
Katherine E . Reed, Ph .D. Staff Vice President
3M Environmental, Health and Safety Operations
1 900 Bush Avenue, Buildmg 42-2E-26
PO Box 33331
St. Paul, MN 55133-3331
651 7784331
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October 11, 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
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TSCA 8(e) Substantial Risk Notice : Docket No. 8EHQ-07-16721 To Whom It May Concern : 3M recently received draft data from a mouse local lymph node assay (LLNA) performed on an experimental chemical, `fluorinated surfactant salt]. The design of this study included immunophenotyping via flow cytometry to determine %B cells, %T cells, and B:T cell ratio to ascertain whether the observed response was a result of irritation or sensitization . Topical application of the test material resulted in a stimulation index greater than 3 as well as a greater than 25% increase in %B cells and in B :T ratio compared to both vehicle and na3ve controls . These data suggest the test article is a dermal sensitizer. The final report will be forwarded to the EPA once it is available . For reference, 3M has submitted data from an oral (gavage) developmental toxicity screening study in rats, a five day repeat oral study in rats, a 28 day repeat dose toxicity study in rats, and a standard mouse local lymph node assay conducted on the same chemical . These submissions have also been assigned the docket number listed above . Please contact Deanna Luebker at 651-737-1374 or djluebkerc(~,mmm .com if you have any questions or if we can provide additional information .
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Staff Vice President, Environmental Health and Safety Operations
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