Document peDBmBEDk69bVDz9beeLX0wza

/)Rm-OHI Submitted to : BIOSEARCH, INC. p.o. box 8598 Philadelphia, Pennsylvania 19101 te leph one: (215) 848-4499 3M Company 3M Center S t . P a u l, Minnesota 55101 M ater?al: Sample Received Date o f Rep ort: T e s t: Object of Test: Method o f T e s t: Results : 3M Company - T-T 395 December 6, 1975 March 4, 1976 Prim ary Eye Ir r it a t io n Study - Rabbits To determ ine the degree o f i r r i t a t i o n , i f any, which the s u b je c t m a te ria l may produce when in s t ille d in to the eyes o f a lb in o ra b b its . This t e s t was performed in o rd e r to c l a s s i f y th is m aterial under the Federal Hazardous Substances Labeling A ct. The methods employed in the t e s t in g , e v a lu a tio n and in the grading o f the t e s t m a te ria l are those d escrib ed in S e c tio n 1500.42 - Hazardous Substances and A r t i c l e s , A d m in is tra tio n and Enforcem ent R e g u la tio n s , Federal R e g is t e r , V o l. 38, No. 187, P. 27019, 27 September 1973- The sample was used as s u p p lie d . S ix h e a lth y young a d u lt a lb in o r a b b its were used in t h is stu d y. 0.1 gm o f the exp erim ental m a te ria l was i n s t i l l e d in to the r ig h t eyes o f the te s t animals w h ile the o th er eyes remained untreated to se rve as c o n t r o ls . The t e s t m a te ria l was not washed from the eyes. The tre a te d eyes were examined a t 1,24,48 & 72 h r s . 5 7 days fo llo w in g i n s t i l l a t io n o f the te s t m aterial into the eyes. In te rp re ta tio n o f the r e s u lts was made in accordance w ith the grading system o u tlin e d in the " I llu s t r a t e d Guide fo r Grading Eye I r r i t a t i o n By Hazardous Substances". The r e s u lts o f the te s ts a re shown in the accompanying Table which covers each o f the anim als treated w ith the te st m a te ria l. 000094 3M Company T-1395, Primary Eye Irritation Study. Conclus ion : Based on the accompanying t a b le , the sub je c t m aterial is a primary o cu la r ir r it a n t w ith in the d e fin itio n o f the Act-Reference: S e c tio n 1500. kZ (b) (1) (2) P. 27019 and re q u ire s cautionary labeling w ith respect to that sectio n . Ltf&jM1 Karl L. G a b r ie l, V .M .D ., Ph.D. Di r e c to r 00095 TABLE 1 Grades fo r O cular Lesions M a terial: 3M Company - T-1395* as supplied. Rabb i t Number 1 Co 1 C Hours A fte r A p p lica tio n 24 Co 1 C !t8 Co T C 1 0 5 10 0 2 0 5 10 0 3 0 56 0 It 0 5 10 0 5 0 5 10 0 6 0 58 0 Co Cornea 1 = I r i s C = Conjunctivae 56 5k 5 it 56 56 58 0 56 0 52 0 52 0 5 l| 0 5 It 0 52 5 Days Co 1 C 0 5 It 0 00 0 00 0 52 0 00 0 00 72 Co 1 C 0 56 0 52 0 00 0 52 0 02 0 50 7 Pays Co 1 C 0 52 0 00 0 00 0 50 0 00 0 00 000096