Document 6wXdERB6z3nOpadmjBegm3Zj3
lo Submitted to:
BIOSEARCH, INC.
pt.oe.lbeoxp8h5o98neph:iladel(ph2i1a,5)penns8yl4va8n-ia441991091 Project Number - 78-1161A
31 Company 3St. CePanutle,r Minnesota 55101
Material: Sample Received:
3H Company - T-2038CoC 1/5/78 Study Initiated: 1/9/78 Study Completed: 1/16/78
Date of Report: Test: Object of Test:
2/2/78 Primary Eve Irritation Study - Rabbits wThoicdhetetrhmeinseubjtehcetdemgatreereiaolf miaryritpartoidounc,e wIhfenany, instilled into the eyes of albino rabbits.
Method of Test:
aTnhde mienthtohdesgreandpilnogyedof inthethetesttestmiantge,riaelvalauraetitohnose danedscrAirbteidcleisn, SAedcmtiionnist1r5a0t0i.o4n2 a~ndHazEanrfdoorucsemeSnutbstRaengcuelsations, Federal Register, Vol. 38. No. 187, P. 27019, 27 September 1973. The sample was used as supplied.
Sinixthhiesaltshtyudyy.oung0.1aduglntofalbtihenoexrpaebrbiimtesntwaelremautseerdial wwahsileinsthteilloetdherinetyoestheremraiignhted eyuenstroefatetdhe totessteravneimaasls Controls. The test material was not washed fron the eyes.
:
T5h6e t7rdeaaytsed efyoelslowwienrge eixnasmtiinleldatiaotn 1,of24t,he48tes&t7m2atherrsi.al&
miandteo tihneaecyceosr.dancIentweirtphrettahteiognradoifngthesysrteesumltosutlwiansed
Biyn tHhaezar"dIo1u1sustSruabtsetdancGeusi'd.e for Grading Eve Irritation
Results:
See Table 1.
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3H Company - T-2038CoC, Primary Eve Irritation Study.
Conclusion:
Based on the acconpanying table, the subject
mwSaiettcehtriiinoanlth1e5I0s0d.ne4of2tinia(t6)iporni(m1)oafry(2t)ohceuP.lAacrt2-7R0ie1rf3reiratenandncter:equires no
cautionary labeling with respect to that section.
KDairrlectL.orGabriel, V.M.D., :Ph.D.
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TABLE 1 Grades for Ocular Lesions
Material: 3M Company - T-2038CoC, as supplied.
Rabbit No.
Cornea Opacity Area
Iris
Conjunctivae fedness Chemosis
Discharge
1
2
1 hour
3 i
56
1 2 24 hours i3 56
21
48 hours
3 I
65s
21 72 hours 34
56
:
1
2
5 days i3
56
1 2 7 days 3i 56
1 1
b4 11
11
11
11
0 1
0 4
o 1
1 1
1 1
1 1
01
04 00 11
1 1
1 1
0 0
0 0
0
1 1
1 1
1 1
00
00 0
11
1 1
1 1
00
00 00 11
11
11
00
00 00 00
0 0
0 0
0 0
00 00 0
0 0
0 0
00
00 0o 0
0 0
0 0
00
00 00 00
0 0
0 0
00
0 00
0 0
0 0
0
00
00 00 0
0 0
0 0
0 0
00 0
0 0
00
00
00
00 00
0 0
0 0
0 0
00
00 00 00
0 0
0 0
0 0
0 0
0
0 0
0 0
0 0
00
00 00
0 0
0 0
0
00
00 o0 00
0 0
0 0
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