Document 0E1R2wYX0EV65q4d0wwjzjZd

Submitted to: BIOSEARCH, INC. p.c.box 8598 philadelphiap,ennsylvania19101 te Ie p h o n e (2 1 5 ) 8 4 8 -4 4 9 9 Project Number 78-1161A 3M Company 3m Center St. Paul, Minnesota 55101 Material: Sample Received: Date o@rt.@ Test: Object of Test: Method of Test: 3M Company - T-2038CoC 1/5/78 Study Initiated: 1/9/78 Study Completed: 1/12/78 2/2/78 Primary Skin IrritationStudy - Rabbits To determine the degree of irritation,if any, which the subject material may produce when applied to the intact and abraded skin of albino rabbits. The method employed in the testing, evaluation and the scoring of the results was similar to that described in Section 1500.41 - Hazardous Substances and articles, administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973. In carrying out the study the experimental sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one site with a lancet sufficientlydeep to penetrate the 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 portion of material was applied to an abraded and an intact skin site on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place. The wrapping was removed at the end of the twentyfour hour period and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed. 3M Company - T-203BCoC, Primary Skin_lrritation 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: Section 1500.3 (c)(4)and requirenso cautionary labeling with respect to that section. K4t /. ;j4. KarlL. GabrielV,.M.D.P,h.D. Director TABLE I Primary Skin Irritation Material! 3M Company - T-2038CoC, as supplied. Erythema and Eschar Formation Reading (Hours) Rabbit Number 12 3456 Average Intact Skin Intact Skin Abraded Skin Abraded Skin 24 00000 0 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 000000 0.00 72 0 0 0000 0.00 24 0 0 0000 0.00 72 000000 0.00 Subtotal 0.00 Total 0.00 Primary Irritation Score: 0