Document 77pKa5y5KbJ8X6we6qkdkaQa

AR226-2842 9n d iu U ia B I O - T E S T i 1810 FRONTAGE ROAD NORTHBROOK, ILLINOIS 60062 Dnc. REPORT TO E . I. D PONT DE NEMOURS & COMPANY EY IRRITATION TESTS WITH I H-8580 ! IN ALBINO RABBITS FEBRUARY 12, 1974 QQTS" RECEIVED FEB 2 219W HASKELL LAS, j tvLtdU al BI O T E S T laM oia^ie, Shc. REPORT TO I E. I. DU ^ONT DE NEMOURS h COMPANY EYEi IRRITATION TESTS WITH i h -8580 ! IN ALBINO RABBITS 0 FEBRUARY 12, 1974 I. Introduction i At the re q u e s t of E. I. jdu Pont de Nemours & Company w ashed and unw ashed eye irritation testjs were conducted with a sample identified as H-8580. 'S nd itsttlal B I O - T E S T JfUoKW tiet, Une. II. Summary The re su lts of the ye irritation tests conducted with H-8580 are summarized below. Test Conditions Maximum Irritation Score Rating Washed Eye 20-Secon<jl Contact Period : Unwashed Eye 13.0/110.0 19.0/110.0 Minimally Irritating Mildly Irritating Respectfully submitted, ! INDUSTRIAL BIO-TEST LABORATORIES, INC. Report prepared by: snald G. B aker, B .S. Ajssistant Toxicologist Ajoute Toxicity Report approved by: tv C. W. Mastri, B.S. Section Head. Acute Toxicity meb Got'1'? atil ed- Qoes noi'\ con G*<** DniLutual BIO - T E S T lalonaionlu. jflxe. i * III. Investigational P rocedure; ' Young albino rab b its of tjhe New Zealand stra in w ere u sed to ev alu ate the eye irrita tin g p ro p e rtie s iof the te st m aterial. The test method w as p a t terned after that of D raize e tja l.* The test material was instilled 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 erio d of 20 se c o n d s, th e rig h t eye of one animal w as jrinsed for one m inute w ith 150 ml of tap w ater w hile the rig h t eye of the otljier anim al rem ained u n w ash ed . At each sco rin g interval the cornea, iris , anji palpebral conjunctiva w ere exam ined and graded for irritatio n and in ju ry according to a standard scoring system *. T he maximum p o ssib le sc o re at any one exam ination and sco rin g p erio d is 110 p o in ts, w hich in d icate s maximal irrita tio n ajnd damage to all th re e o cu lar tis s u e s . Zero score indicates no irritation.! The scoring system is presented in Table I. In this scoring system, speejal emphasis is placed upon irritation or damage I' to the aornea, while less em phasis is placed upon damage to the iris and conjunctiva. | After t' e com pletion of tljie te st, th e sco res w ere an aly zed , and a descriptive eye irritation rating was assigned to the test m aterial. The c ri teria used for assignm ent of'the descriptive rating are the frequency, the e x ten t, and the p e rsiste n c e cjf irrita tio n or damage w hich o ccu r to the th re e I ocular tissues. j v; ' * D raize, John H ., Woodard^ Geoffrey, and C alv ery , H erbert O .. "Methods for the Study of Irritation and Toxicity of S ubstances A pplied Topically to the Skin and Mucous Memfcjranes," J . P h a rm . & E xp. T h e r. 82, 377 (1944). j Company Sanitized. Does not contain TSCAC8B %uifoial BI O- TES T la kw tvM ' fa 4 O cular Tissues Cornea Iris TABLE I Eye Irritation Test - Albino Rabbits ' Scal^ of Weighted Scores for G rading thjc S everity of O cular Lesions I Description Opacity (A) O pjaanciityy - Degre_eof d en sity (area w hich is most dense is tjiken for reading). Scattered or diffuse area, details of iris clearly visible. Easily discernible translucent areas, details of iris slightly obscured. Oppdailceaswcceinikt a revwas,i n--o----d-e--t-a--ils. of iris visible, size of pupil barely discernible, Opaque, iris invisible. Arreda uojf. C ornea Involved (-B-) One quarter (or less) but not zero. Greater than one+quarter but less than one- half. | , Greater than onefhalf but less than three- quarters . j ... Greater than th r4e-quarters, up to whole area. ! annals A ___ ;____ - on Values (A) j Folds above norrhal, congestion, sw elling, circumcorneal Ejection (any or all of these .or combination! of any th ereof), iris still reacting to ligjit (sluggish reaction is p o sitiv e). No reactio n to lifeht, hem orrhage, g ro ss destruction (any or all of th e se ). Score equals A x j> Total maximum = 10 D raize Grade 1 2 3 4 1 2 3 4 1 2 Company Sanitized. Dees not contain ISC ACB tk b d a l B I O - T E S T la&HatonieS, inc. ! s ; TABLE L continued j Eye Irritation T est - Albino Rabbits O cu lar T issu es Sc^le of W eighted Scores for Grading) the Severity of O cular Lesions II - -- |' ' J_______ D escription_________ Conjunctiva Redness (A) | .,, R edness (re fe rs to p alpebral conjunctiva o n ly ). Vessels definitely injected above normal. More diffuse, deeper crim son red , individual vessels not easily discernible. Diffuse beefy rd. Chemosis (B) Any swelling above norm al (includes nictitating membrane). ; Obvious swellinjg with partial eversion of the lids. Sw elling w ith li ds about h alf_closed. Sw elling w ith li d s about half-clo sed to com pletely D ischarge (C) | .. Any amount different from normal (does not in clude small amount observed in inner canthus of normal ani^nals). D ischarge w ith |moistening of the lids and hairs ju s t ad jacen t to the lid s . D ischarge with moistening of the lids and hairs and considerable area around eye. S core (A + B + Cj> x 2 Total maximum = 20 D raize Grade 1 2 3 1 2 3 4 1 2 3 Note: The maximum total sco^-e is th e sum of all sco res obtained for the cornea iris, and conjunctiva. I Company Sanitized. Does not contain TSCACB I UnduitiUd B I O - T E 5 T lo c a to ti* . f a T h , rating is arrived: a . by selecting the maximum irritatio n sco re ,, one. 4. 24. 48 or 72 h p u rs aiter in s .i.ia .io n . II the ra te of d issip atio n in ju ry does no, meet t,W reguirom ents defined for the d e sc rip tiv e ra tin g a p p ro p ria te for a p a rtic u la r num erical score, the d e sc rip tiv e ratin g is raised by one or more levels. The rating system is presented in T able II. .1 Company Sanitized. Does not contain TSCA G I| Eye Irritation T est - Albino Rabbits Classification of Test M aterials Basejd on Eye Irritatio n P ro p erties Rating N on-Irritating Practically N on -Irritatin g Rang!e * 0.0 - 0.5 j 1 > 0 .5 .-j12.5 Definition To maintain this rating, score at the 24-hour reading must be aero; otherw ise, increase rating one level. To maintain this rating, score at the 24-hour reading must be zero; otherw ise, increase rating one level. ; ; : Minimally Irritating . > 2 .5 -i 15.0 To maintain this ra tin g , score at the 72-hour reading must be zero; otherw ise, increase rating one level. Mildly >15.0 - 25.0 To maintain this rating, score at the 7-day reading must be rero; otherw ise. ; t i Irritating increase rating one level. M oderately Irritating Severely Irritating >25.0 \ 50.0 ! >50.0 f 80.0 To maintain this rating, score at 7 days must be < 10. otherw e increase rating one level. To maintain this rating, score at 7 days must be < 30, otherw ise increase rating one lev el. j j Extremely Irritating >80.0 i- 110.0 - ----- /, Company Sanitized. Does not contain TSCA CB tiduii/tftil B I O - T E S T Ja lw a io tieS, [9*te. IV. Results The re s u lts of the eye irritatio n te sts are p resen te d in T able III Company Sanitized. Does not contain TSCA CBI TABLE III Eye Irritation Test - Albino Rabbits Test Conditions . TEST MATERIAL: H-8580 FORM ADMINISTERED: In stillatio n (0 .1 m l. U n d ilu ted ) DESCRIPTIVE RATING: WASHED EYE: Minimally Irrita tin g I TMWA5SHFDO TTirTTO Tlla* RY F : MildlyJ'* T issu e 1 Hour 4 H ours 24 H ours Washed Eye, ZC-Second Contact Period* Oo .|jn w a sh e d Cf> ) 3 Cornea (D-A) Iris Conjunctiva (R-S-D) Total Cornea (D-A) Iris Conjunctiva (R-S-D) Total 0 5 8 (2-1-1) 13 0 5 12 (2 -2 -2 ) 17 0 0 12 (2 -2 -2 ) 12 0 0 8 (2-1-1) 8 0 5 14 (2 -2 -3 ) 19 0 0 8 (2-1-1) 8 48 72 Hours Hours 0 0 2 (1-0-0) 2 0 0 0 0 0 0 2 (1-0-0) 2 0 0 0 0 96 H ours 0 0 0 0 0 0 0 0 aNote: S terile sodium flu o rescein s tr ip s w ere u sed at each sco rin g in te rv a l s ta rtin g w ith th e 24 3 presence or absence of corneal irritation. 1* The eye w as 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 ) . > oJ 2ST S' C/) I o0o>3 7 Days 0 0 0 0 0 0 0 0 B I O - T E S T la iw d a M , itte.