Document JN055Q6q69KwjnZg6BmOJm27r
3M General Offices
3M Center St. Paul, MN 55144-1000 651 733 1110
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Certified Mail
November 20,2007
EHQ
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 Company Sanitized
RE: TSCA 8(e) Substantial Risk Notice: Docket No. 8EHQ-07-16721
To Whom It May Concern:
In October of 2007, 3M notified the EPA that draft data from a mouse local lymph node assay (LLNA) performed on an experimental chemical, [fluorinated surfactant salt], had been received. 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 naive controls. These data suggest the test article is a dermal sensitizer.
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, 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 me at 651-737-1374 or diluebker@mmm.com if you have any questions or if we can provide additional information.
Sincerely,
Deanna J. Luebker, PhD 3M Toxicologist and TSCA 8(e) Coordinator
Enclosure
89080000045/S
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