Document 0qNNyXvERGGj0Y65R7ddo8eOR

ARm -OHlC B IO SE A R C H . IN C . p.o. box 8598 Philadelphia, Pennsylvania 19101 telephone: (215) 848-4499 Submi t t e d t o : 3M Company 3H Center St. Paul, Minnesota 55101 Mate ri al : Sample Received Date o f Report: Test : Ob ject o f T e s t : Method o f Test: Results: 3M Company - T-1585 August 25, 1976 September 16, 1976 Primary Eye I r r i t a t i o n Study - Rabbits To determine 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 r ia l may produce when i n s t i l l e d into the eyes o f a lb in o ra b b its. This te st was performed in order to c l a s s i f y th is material under the Federal Hazardous Substances Labeling Act. The methods employed in the t e s t i n g , e v a lu a t i o n and in the gra d in g o f the te s t m aterial are those described in Section 1500.42 - Hazardous Substances and A r t i c l e s , A d m in ist r a tio n and Enforcement R e g u la t io n s , Federal R e g i s t e r , V o l . 38, No. 167, P. 27019, 27 September 1973* The sample was used as s u p p lie d . S i x healthy young a d u lt a lb in o r a b b it s were used in t h i s stud y. 0.1 gm o f the experim ental m a te r ia l was i n s t i l l e d in t o the r i g h t eyes o f the t e s t animals while the other eyes remained untreated to serve as c o n t r o l s . The t e s t m a te r ia l was not washed from the eyes. The tre a ted eyes were examined a t 1, 24, 48 72 h r s . 5 6 7 days follow ing i n s t i lla t i o n o f the test material into the eyes. In te rp re ta tio n o f the r e s u l t s was made in accordance w ith the g r a d in g system outlined in the " I llu s t r a t e d Guide for Grading Eye I r r i t a t i o n By Hazardous S u b s t a n c e s ". 6 The r e s u l t s o f the t e s t s are shown in the accompanying Table which covers each o f the animals treated with the te st m a t e r ia l. 000111 3M Company - T - 1585, Primary Eye I r r i t a t i o n Study. Conclusion: Based on the accompanying t a b le , the sub ject material is a primary ocular irrita n t within the d e fin itio n o f the Act-Reference: Section 1500.42 (b) (1) (2) P. 27019 and requires cautionary labeling with respect to that section. Karl L. G a b rie l, V.M.D., Ph.D. Di r e c t o r 000112 TABLE 1 Grades for Ocular Lesions M a te ria l: 3M Company - T-1585, a s s u p p lie d . _____ Cornea Rabbit No. O p a c ity Area 1 hour 1 2 3 1* 5 6 kk 1* it k it it it k it it it 2A hours 1 2 3 It 5 6 1* It It It It It It It It It It It it8 h o u r s 1 2 3 It 5 6 it it it it it k it it it it it it 72 h ou rs 1 2 3 it 5 6 it it it it it it it it it it it it 5 days 1 2 3 it 5 6 it it it it it it it it it it it it 7 days 1 2 3 it 5 6 it it it it it it it it it it it it Iris 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 Conjunct i vae________________ Redness Chemos i s D isch a rqe 2 It 2 It 2 It 2k 2 It 2 It 2 t 2 It 2 It 2k 2 It 2 i 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 It 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it 2 it U IU IU 1U IU IU J Va M W U O J U I V * ) U U U IU W U WWW WWW U I W W Ul WVM 00011