Document JNJ8yKMjoM1pVgnDZQeZoDzQK

BIOSEARCH, INC. p.o.box 8598 philesdelphipae.nnsylvania19)01 t e Ie p k o n e 2 1 5 848-4499 Submitted to: Material: Sample Received: Date of Report: Test: Object of Test: Method of Test: 3M Company 3M Center St. Paul, Minnesota 55101 3M Company - T-1395 December 6, 1975 March 4, 1976 PrimarySkin IrritationStudy - Rabbits To determinethe degreeof irritation,if any, which the subject material may produce when applied to the intactand abraded skin of albino rabbits. The test was performed in order to classifythis materialunder the Federal Hazardous Substances Labeling Act. The method employed in the testing,evaluation and the scoringof the resultswas similarto that described in Section 1500.41.-Hazardous Substancesand Articles,Administrationand EnforcementRegulations,Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973. In carrying out the study the experimentalsample was used as supplied. A group of six albino rabbitswere clippedover a wide area. One side of the animals'backs was abraded at one site with a lancet sufficientlydeep to penetratethe stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact. A 0.5 gm portionof materialwas applied to an abraded and an intactskin site on the same rabbit. Gauze patches were then placed over the treated areas and an imperviousmaterial was wrapped snugly around the trunksof the animalsto hold the patches in place. The wrapping was removed at the end of the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-twohours. The Draize method of scoring was employed. Both sites (intactand abraded) were examineddry as well as after treatment with water. 3m Company- T-@-1395,Primary Skin Irritation Study. Results: Conclusion: See Table 1. Based on the accompanying table, the subject material would not be classified as a primary irritant to albino rabbits within the definition of the Act-Reference: Section1500.3 (c) (4)and requires no cautionary labelingwith respectto that section. )b /, zaz-@ Karl L. Gabriel,V.M.D., Ph.D. Director Material: TABLE I Primary Skin Irritation WET 3M Company - T-1395, as supplied. Erythema and Eschar Formation Reading (Hours) Rabbit Number 1 2 3 456 Average Intact Skin Intact Skin Abraded Skin Abraded Skin 24 0 0 0 0 0 0 0.00 72 000 000 0.00 24 0 0 0 0 0 0 0.00 72 00 00 00 0.00 Subtotal 0.00 Edema Formation Intact Skin Intact Skin Abraded Skin Abraded Skin 24 0 0 0 0 0 0 0.00 72 00 0000 0.00 24 0 0 0 0 0 0 0.00 72 000000 0.00 Subtotal 0.00 Total 0.00 Primary Irritation Score: 0 Material: TABLE I Primary Skin Irritation DRY 3M Company - T-)395,as supplied. Erythema and Eschar Formation Reading (Hours) Rabbit Number 1 2 3456 Average Intact Skin Intact Skin Abraded Skin Abraded Skin 24 0000 00 0.00 72 000000 0.00 24 000000 0.00 72 000000 0.00 Subtotal 0.00 Edema Formation Intact Skin Intact Skin Abraded Skin Abraded Skin 24 0 0 0 0 0 0 0.00 72 0 00000 0.00 24 0 0 0 0 0 0 0.00 72 0 00000 0.00 Subtotal 0.00 Total 0.00 Primary Irritation Score: 0