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3M General Offices 3M Center St. Paul, MN 55144-1000 651 733 1110 SH-010h-. ir7S /8o^ Certified Mail June 28, 2004 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 RE: TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: protective material ho V? SANITIZED Dear Sirs: 3M has received preliminary results for a four-hour acute inhalation study in rats conducted with a protective material. The composition for this test substance is attached. The study was conducted by TNO Nutrition and Food Research. Eight male and eight female rats were exposed to the test substance vapor at 5.4 mg/L for four hours. Animals were scheduled to be observed for fourteen days. Shortly after exposure, all animals showed slight breathing abnormalities, slight or moderate sluggishness, piloerection, and blepharospasm. Within one day of exposure, all animals were observed to have labored breathing and body weight loss. Within four days of exposure, two male and two female rats had died. The test material is an industrial (non-consumer) product commercially available in Europe. Trained operators apply the product using low-pressure spray equipment, which forms large (40-200 microns), non-respirable droplets compared to the aerosolized particles (1-2 microns) used in the subject study. 3M has conducted an exposure assessment which indicates minimal-to-no respirable exposure to this product when used as directed. Two earlier studies are relevant to EPA's analysis of these results. First, 3M had previously conducted an acute inhalation study on a solvent control (the test substance with all components except the active ingredient) at 5.5 mg/L. In this study, two male and two female rats showed slight breathing abnormalities during exposure, but these effects were no longer observed shortly after exposure. Second, 3M had previously conducted an acute inhalation study on a related product (containing 1.2% active ingredient) at 20.7 mg/L. One of the eight animals exposed 88040000180/S K it Document Processing Center Office o f Pollution Prevention and Toxics Page 2 6/28/2004 (four of each sex), scheduled for sacrifice immediately after exposure, died before necropsy. Seven of the remaining eight animals (four of each sex) died during the scheduled fourteen-day observation period, and the final animal was sacrificed due to its moribund condition. This study had not been reported earlier because there was no exposure as the formulation was never commercialized, and the results of the study could not definitively be attributed to the active ingredient. We have included it as supplemental information in this submittal. Enclosed please find "Augmented acute (4-hour) inhalation toxicity study with T-7875 in rats." A final report will be forwarded to EPA when received. Once a docket number has been assigned for this submittal, please send the docket number postal card to Cheri Kedrowski, 3M Center Bldg. 220-2E-02, St. Paul, MN 55144. Please contact Roger Perkins, Ph.D., DABT (651-733-3222) if you have any questions or if we can provide additional information. Confidentiality claim: The specific chemical identity of one ingredient of the test substance is held to be confidential business information until a patent application is filed. Sincerely, 1. Staff Vice President and Medical Director Document Processing Center Office o f Pollution Prevention and Toxics Page 3 6/28/2004 Protective Material Test Substance Composition Chemical Name Lemon Fragrance (AR111968 from CPL Aromas) Ethyl Acetate Methoxymethylethoxypropanol C9-C12-iso-alkanes [Copolym er o f perfluoroalkylsulfonam idoalkyl acrylate and alkyl acrylate m odified fatty acid dimmers] CAS# None 141-78-6 34590-94-8 90622-57-4 None Concentration (%) 0.02 0.7 19.4 77.88 2.0