Document xzj1V5e02epgp2NgaLZZbzag0

/\RXl(rOl93 Submitted to : BIO SEA RC H , INC. p.c. box 8598 Philadelphia, Pennsylvania 19 10 1 t e le p h o n e : (215) 848-4499 P r o je c t Number - 78-1161A 3M Company 3M C en ter S t . P a u l, Minnesota 55101 M aterial: Sample R eceived : Date o f Report: T e s t: Object of Test: Method o f T e s t: 3M Company - T-2038CoC 1/5/78 Stud y I n i t i a t e d : 1/9/78 Study Com pleted: 1/12/78 2/ 2/78 Prim ary Skin Ir r it a t io n Study - Rabbits To d eterm ine th e degree o f i r r i t a t i o n , i f an y, w hich th e s u b je c t m a te r ia l may produce when a p p lie d to th e in t a c t and abraded sk in 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 co rin g o f the r e s u lt s was s im ila r to th a t d e s c rib e d in S e c tio n 1500.41 - Hazardous Substances and a r t i c l e s , a d m in is tra tio n and Enforcement R eg u latio n s, Federal R e g is te r, V o l. No. 187, P. 27019, 27 September 1973- 38, In c a rry in g out the study the experim ental sample was used as s u p p lie d . A group o f s ix a lb in o r a b b its were c lip p e d o v e r a wide a r e a . One s id e o f the a n im a ls ' backs was abraded a t one s i t e w ith a la n c e t s u f f i c i e n t l y deep to p en e tra te the stratu m corneum but not e n te r the derma to produce b le e d in g . The s k in o f the o th e r sid e was a llo w e d to remain i n t a c t . A 0.5 gm p o rtio n o f m a te r ia l was a p p lie d to an abraded and an in t a c t s k in s i t e on th e same r a b b it . Gauze patches were then p laced o v e r the tr e a te d are as and an im pervious m a te ria l was wrapped sn u gly around the trunks o f the anim als to hold the patches in p la c e . The wrapping was removed a t the end o f the twentyfo u r hour p e rio d and th e tr e a te d a re as were examined. Readings were a ls o made a f t e r seventy-tw o hours. The D ra iz e method o f s c o rin g was employed. 004371 3M Company - T-2038CoC, P rim a ry Sk in I r r i t a t i o n S tu d y. R esu lts: Cone 1us i on : See T ab le 1. Based on the accompanying t a b le , the s u b je c t m a te r ia l would not be c la s s if ie d as a prim ary i r r i t a n t to albino rab b its w ith in the d e fin itio n o f the A c t- R e fe re n c e : S e c tio n 1500.3 (c ) ( k ) and re q u ire s no c a u tio n a ry la b e lin g w ith respect to that se ctio n . Karl L. G a b rie l, V.M .D., Ph. Di r e c to r 004372 TABLE 1 Prim ary Skin Ir r it a t io n M a t e r i a l : 3M Company - T-2038CoC , as s u p p lie d . Erythema and Esch a r Form ation Reading (Hours) R a b b it Number 12 3 k 56 Averaqe In ta c t Skin In ta ct Skin Abraded Skin Abraded Skin 2k 000000 0.00 72 0 0 0 0 00 0.00 2k 000000 0.00 72 000000 0.00 Subtotal 0.00 Edema Form ation In ta ct Skin In ta ct Skin Abraded Skin Abraded Skin 2k 000000 0.00 72 000000 0.00 2k 000000 0.00 72 0 0 0 0 00 0.00 Subtotal 0.00 Total 0.00 P rim a ry 1r r i t a t ion S c o re : 0 004373