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AR226-2844 ttdttiiial BI O T E S T JaitmioMei, % # ! REPORT TO E. I. DU PONT DE NEMOURS & COMPANY EYE IRRITATION TESTS WITH H-8524 H ALBINO RABBITS p-'' m# I&li |5 FEBRUARY 12, 1974 [BT NO. 601-04594 I . Introduction At the re q u e s t of E. I d Pont de Nemours & Company w ashed and unwashed eye irritation tests were conducted with a sample identified as H-8584. Company Sanitized. Does not contain TSCA CBi 9nd**ii\ial B10 - T E S T jtoUtotMk*, Pue, r # II. Summary The resu lts of the eye irritation tests conducted with H-8584 are summarized below. Test Conditions Maximum Irritation score Rating Washed Eye 20-Second Contact Period 11. 0/ 110.0 Minimally Irritatin g Unwashed Eye 15.0/110.0 Minimally Irritatin g Respectfully submitted, INDUSTRIAL BIO-TEST LABORATORIES, INC. i# Report prepared by Ion aid G. B aker, B .S . Ass: stant Toxicologist Acute Toxicity Reporrt a p p ro v ed by: C. W. M astri, B .S . Section Head, Acute Toxicity meb 0 I Company Sanitized. Does not contain TSCA OB ittdminiai B10 T EST Jaiwakiict. ins. 3 III. Investigational Procedure | Young albino rabbits of th j New Zealand strain were used to evaluate the eye irrita tin g p ro p e rtie s of the test m aterial. The test method was p attern ed after that of Draize et a1.* The test material was insti lied into the conjunctival sac of the rig h t eye of each of two ra b b its . After an ex p o su re p e rio d of 20 seco n d s, the r ig h t eye of one animal was rinsr-d for one m inute w ith 150 ml of tap w ater while the rig h t eye of the other animal rem ained unw ashed. At each scoring interval the cornea, iris , and palpebral conjunctiva were examined and graded for irrita tio n and injury according to a stan d ard scoring system *. The maximum p o ssib le sc o re at any one examn: ination and sco rin g p erio d is 110 p o in ts, w hich indicates maximal irritation anc damage to all three ocular tissu e s. Zero score indicates no irritation, fh e scoring system is presented in Table I. In this scoring system , special em phasis is placed upon irritatio n or damage to th e c o rn e a , w hile le ss em phasis is p laced upon dam age to the ir is and conjunctiva. After the completion of the test, the scores w ere analyzed, and a d e sc rip tiv e ey e irrita tio n rating w as assig n ed to the te st m a teria l. The c r i teria used for assignm ent of the descriptive rating are the frequency, the extent, and the persistence of irritation or damage v/hich occur to the three ocular tissues. \ * D raize, John H ., W oodard, Geoffrey, and C alv ery , H erbert O ., "Methods for the S tu d y of Irritatio n and Toxicity of S u b stan ces A pplied T opically to the Skin an d Mucous Mcmbrai*e s ," J Pharm & Exp T h e r 82, 377 (1944) Company Sanitized. Does not contain TSCA CBI ttduiU ial BI O - T E S T J oIm oIvUca,, #H I1:'; Ocular Tissues Cornea Iris TABLE I Eye Irritation Test - Albino Rabbits I Scale] of Weighted Scores for Grading thp Severity of Ocular Lesions D escription Opacity (A) | Opacity - Degree of density (area which is most dense is taken for reading). Scattered or diffuse area, details of iris clearly visible. Easily discernible translucent areas, details of ir i s slig h tly ptib sc u re d . Opalescent areas, no details of iris visible, size of pupil barely discernible. Opaque, iris ir."i!:ible. Area of Cornea Involved (B) One q u a rte r (or lless) but not zero. G reater than one-jquarter but less than one- half. G reater than one-half but less than th ree- quarters . ; G reater than th r - quarter s , up to whole area. Score equals A x B Total maximum = 80 V aries (A) Folds above nornjal, congestion, sw elling, circum corneal injection (any or all of these o r com bination Iof an y th e re o f), ir is still reactin g to light (sluggish reaction is positive), No reaction to lig h t, h em orrhage, g ro ss destruction (any or all of th ese). S core equals A x El Total maximum = 10 D raize Grade 1 2 3 4 1 2 3 4 1 2 l Company Sanitized. Does not contain TSCA CBI uLihiaL B I O - T E S T a /m a fa ki, fm TABLE I. continued Eye Irritation Test - Albino Rabbits Scale of Weighted Scores for Grad ng the Severity of Ocular Lesions O cular T issu es Description Conjunctiva Redness (A) R edness (refp r s to p alp eb ral conjunctiva o nly) V essels defirnitely injected above n orm al, More diffuse, deeper crimson re d , individual vessels not easily discernible, Diffuse beefy red. Chetnosis (B) Any swelling above normal (includes nictitating membrane) Obvious swt.^ing with partial eversion of the lid s. ______ lids about half-closed. Swelling with lids about half-cloped to com pletely closed. Discharge (C) . Any amount different from normal (does not in clude small amount observed in in n er canthus of normal i.nimals). D ischarge with moistening of the lids and h airs ju st adjace:it to the lid s. D ischarge with moistening of the lids and h airs and considerable area around eye. S core .(A + B *! C) x 2 Total maximum = 20 D raize Grade 2 3 1 2 3 Note: The maximum total core is the sum of all scores obtained for the cornea, iris, and conjunctiv^. .Company Sanitized. Does not contain TSCA CBI The ra tin g is a rriv e d at by selecting the maximum irritatio n score at one. 4, 24, 48 or 72 h o u rs after in stillatio n . U the >ate of dis^ip &r^ : of in ju ry does not moot the requirements defined for the d e s c rip ln e ra tin g ap p ro p ria te for a p artic u la r num erical core, the S c r i p t , v o ratin g raised by one or more le v c lf The rating system is presented in Table It. # m Company Sanitized. Does not.contain TSCA CB OnJuikud BIO T E S T JalxnatMieX, $tt& ! TABLE II j / Eye Iriritation Test - Albino Rabbits Classification of Test Materials Base i on Eye Irritatio n P ro p erties Rating Rang|a Definition N o n -Irritatin g 0.0 - 0.5 i To maintain this ratin g , score at the 24-hour reading must be zero; otherw ise, increase rating one level. Practically N on-Irritating i> 0.5 - iI2.5 II To maintain this ratin g , score at the 24-hour reading must be zero; otherw ise, increase rating one level. Minimally Irritating > 2 .5 - 15.0 To maintain this ra tin g , score at the 72-hour reading must be zero; otherw ise, increase rating one level. . # Mildly ' Irritating > 15.0 - 25.0 Ii To maintain this ratin g , score at the 7-day read in g m ust b e v.ero; o th e rw ise , increase rating one level. ! M oderately Irritating >25.0 - 50.0 .i To maintain this ra tin g , score at 7 days must be < 10, otherw ise in crease ratin g one level. Severely Irritating E xtrem ely Irritating >50.0 - 50.0. !_ i >80.0 - ilO.O To maintain this ratin g , score at 7 days must be < 30, otherw ise increase rating one level. # , Company Sanitized, Does not contain tsoa CM B ^ ------ is ax -ois TABLE III Eye Irritation T est - Albino R abbits Test Conditions TEST MATERIAL: H-8584 FORM ADMINISTERED: In stillatio n (0 .1 m l, U n d ilu ted ; DESCRIPTIVE RATING: WASHED EYE: Minimally Irrita tin g -Minimally: I r r ita tin g________________ Tissue 1 Hour 4 H ours 24 H ours Washed Eye, 20-Second Contact Period* Cornea (D-A) Iris Conjunctiva (R-S-D) Total 0 5 6 (2-1-0) 11 0 0 6 (2-1-0) 6 0 0 0 0 1BT NO 601-04594 48 H ours 0 0 0 0 72 H ours 0 0 0 0 96 H ours 0 0 0 0 7 Days 0 0 0 0 Unwashed Cornea (D-A) 0 0 00 0 0 0 Eye Iris 5 5 50 0 0 0 C onjunctiva (R -S-D ) 6 (2 -1 -0 ) 10 (2 -2 -1 ) 8 (2 -1 -1 ) 4 (1 -1 -0 ) 0 0 0 Total 11 15 13 4 0 0 0 Note: S terile sodium flu o rescein s tr ip s w ere u se d at each s c o rin g in te rv a l s ta rtin g w ith the 2 4 -h o u r s c o rin g to v e rify the presence or absence of corneal irritatio n . * The eye was w ashed for one m inute w ith ru n n in g tap w a te r (ap p ro x im ately 150 ml of w a te r) . Company Sanitized. Does not contain TSCA CBl