Document 2jgo8gy8MQqG1kB30Lg54qVd7

Copies Co * Haskell L a ET i> borato r d y u f F o o r nt T de oxic Nemou ology r s a n a d n d I r i Comp dust a r ny ia 1 Medicine HASKELL LABORATORY REPORT NO. 1003-76 MR 1 NO 1\ Material Tested *3 Haskell No 10,642 Sample Ready for Testing 9-28-76 Other Codes Materia y\--------KlHHUiH ^oepareiiient, PRIMARY SKIN IRRITATION AND SENSITIZATION TESTS ON GUINEAjPIGS Procedure: The test for primary Irritation was conducted by applying, and lightly rubbing in, 1 drop 100% material as received and a 10% solution (vol/vol) of the test material in distilled water on the skin of ten male albino guinea pigs. To test for the sensltlzation potential, a series of four sacr injections was given, one each week over a three-week period, which consisted of 0.1 ml of a 1% solut material in 0.9% saline. Following a two-week rest period, the test animals were challenged for sens and lightly running in, 1 drop (=0.05 ml) each of the 100% material as received and a 10% solution (v material in distilled water on the shaved Intact shoulder skin. A group of nine prevlqusly unexposed similar applications at the time of challenge to provide a direct comparison of the challenge reaction age. One week after the challenge, the animals were re-challenged following the same procedure as pre further check for sensitlzation. Results: Concentration i. ilstilled water Primary Irritation Test-24 Hours -48 Hours Challenge Test-24 Hours -48 Hours Sensitlzation Response Ratio** Re-Challenge Test-24 Hours -48 Hours Sensltlzation Response Ratio** Reactions* on Intact Guinea! Pig Skin l Test Areas (10 Animals - In . Avg. Wt . = 486 g Avg. Wt . = 778 g Cb^iitrol Areas for (9 N^i Animals - Av Re -chlallenge - Av Re-challenge - Avg. Wt. = 798 8) 100% 10% 1C>0% (as received) (as reicelved) 10 neg. 10 neg. 10 neg 10 neg 1++, 1+, 8 neg. 1++, 2+, 7 neg. 10 neg 1+, 9 neg. 1+. 81 neg. 9 neg. 0/10 1++, 6+, 3 neg. 1+, 9 neg. 1+, 9 neg. 10 1 n neg. 0/10 3+, 6 neg. 9 neg. Qompsmy Sanitized. AR226-2854 Summary ;| ^^^^BB(H-10,642) produced no irritation when tested as received (100%) and as a 10% aque shaved intact skin of male albino guinea pigs. At challenge one control animal had a very mild reac material while one test animal had a moderate and two test animals had mild reactions to the 100% ma difference in response of test over control animals was seen when re-challenged. While the quantitat erythema was not sufficient to call this material a sensltlzer, the increase of test over control ani Chat it may be a very weak sensitlzer. Skin contact should be avoided, with Immediate washing if con * Reaction Code; +, ++, +++ = mild, moderate, strong erythema; I I I I = erythema plus edema; 11111 = n ** Sensltizatlon is defined as a significant score Increase at challenge over the response expected f applied initially or on the concurrent controls. MCG;ms Report No. 1003-76 Date Issued: January 14, 1977 Report by: Approved by: <-^ /^Z-^^^, /2 C^ (< ^^-y ^ Nancy C. Soodma Technician ^^TM^^ ^9 lyymond W. Morr Chief. Dermal and Ocular Company Sanitized. Doe