Document wg7Kw9rXzeVMXKG0nxROdQ4GQ

p-'tS" i Z-? BEST COPY AVAILABLE Submitted to: BICSEARCH INC. p.c. box 8598 Philadelphia, Pennsylvania 19101 telephone.' (215) 848-4499 P r o j e c t Number - 77--1127A 3M Company 3M C e n t e r S t. P a u l, Minnesota 55101 Ha t e r i a 1: Sample Received: Date of Report: T e s t: Ob j e c t o f T e s t : Method o f Tes t : 3M Company - T-2001CoC 11/21/77 S tu d y I n i t i a t e d : 11/22/77 Study Completed: 11/25/77 1/6/78 Prim ary Skin Ir r it a t io n Study - Rabbits To d e t e r m in e th e d e g re e o f i r r i t a t i o n , i f a n y , w h ic h t h e s u b j e c t m a t e r i a l may produce when a p p lie d to the i n t a c t and abraded skin o f a lb in o rabbi t s . The method employed in the t e s t in g , e v a lu a tio n and the s c o r in g o f the r e s u l t s was s i m i l a r to t h a t d e s c r i b e d in S e c t i o n 1500.1*1 - Hazardous S u b s ta n c e s and A r t i c l e s , A d m i n i s t r a t i o n and Enforcement Regulations, Federal Register, V o l. No. 187, P. 27019, 27 September 1973- 38, In c a rr y in g out the study the experim ental sample was used as s u p p lie d . A group of s ix a lb in o r a b b i t s w e re c l i p p e d o v e r a w id e a r e a . One s id e o f the a n i m a l s ' backs was abraded a t one s i t e w ith a la n ce t s u f f i c i e n t l y deep to pen etrate the s tr a tu m corneum but not e n t e r the derma to produce b le e d in g . The s k in o f the o th e r s id e was a l l o w e d t o remain i n t a c t . A 0 .5 ml p o r t i o n o f m a t e r i a l was a p p l i e d to an abraded and an i n t a c t s k i n s i t e on the same r a b b i t . Gauze p a tc h e s were then p la c e d o v e r the t r e a t e d a r e a s and an im pervious m a te ria l was wrapped snugly around the trunks o f the anim als to hold the patches in p la ce . The w ra p p in g was removed a t the end o f the tw entyfo ur hour p e rio d and the tre a te d areas were examined. R e a d in g s w ere a l s o made a f t e r s e v e n t y - tw o h o u r s . The D r a iz e method o f s c o r in g was employed. 000187 3M Company - T-2001CoC, P r im a r y S k in I r r i t a t i o n S t u d y . Re s u 1t s : Cone 1us ion : See T a b le 1. Based on th e accompanying t a b l e , th e s u b j e c t m a t e r i a l would n o t be c l a s s i f i e d as a prim ary i r r i t a n t to alb in o rab b its w ith in the d e fin itio n o f the A c t - R e fe r e n c e : S e c t io n 1500.3 (c ) (4) and r e q u ir e s no c a u t io n a r y lab elin g w ith respect to that section . tu t-ku . Karl L. G a b rie l, V.M .D., Ph.D. Di r e c t o r 000188 TABLE 1 Prim ary Skin Ir r it a tio n M a t e r i a l : 3M Company - T-2001CoC, as s u p p l i e d . Erythem a and E s c h a r F orm ation Reading (Hours) R a b b it Number 123k 56 Average In tact Skin In ta ct Skin Abraded Skin Abraded Skin Ik 000000 0.00 72 000000 0.00 Ik 000000 0.00 72 000000 0.00 Subtotal 0.00 Edema F o r m a tio n In tact Skin In tact Skin Abraded Skin Abraded Skin 2k 000000 0.00 72 000000 0.00 2* 000000 0.00 72 0 0 00 00 0.00 Subtotal 0.00 Total 0.00 Primary Ir r it a tio n Score: 0 000189