Document gbOjpBBDGXVpw4r1aDRyONKGQ

AR226-2843 .^W^ BID-TEST J^aJ^oJa'ueA, Sw. 1810 FRONTAGE ROAD NOftTHBROOK, ILLINOIS 60062 REPORT.TO E. I. DU PONT DE NEMOURS l. COMPANY EYE IRRITATION TESTS WITH H-8583 IN ALBINO RABBITS FEBRUARY 12. 1974 Company Sanitized. Does not contain TSCA CBi RECEIVED FEB221974 HASKELL LAB. Uttduihial B I 0 - T E S l jSa&atalMusS,^Swt, REPORT TO E.I. DU PONT DE NEMOURS fc COMPAXY EYE IRRITATION TESTS WITH H 8683 IN ALBINO RABBI- <^^^_^^"7 FEBRUARY 12, 1974 I. Introduction At the request of E. I. du Pont do Nemours k Company washed and i unwashed eye irritation tests were conducted with a sample identified as H-8583. DOS TlOtC,' 9Sf^ ^VSi^' con^ Shutu^al B I 0 - T E S T 2a^iala^i. DM. ^R It II. Summary The results of the eye irritation tests conducted with H-8583 are summarised below. Test Conditions Washed Eye- 20-Second Contact Period Unwashed Eye Maximum Irritation Score 6.0/110.0 11.0/110.0 Rating.' Minimally irritating Minimally Irritating Respectfully submitted, INDUSTRIAL BIO-TEST LABORATORIES, INC. Report prepared by: Ronald G. Baker, S.S*. Assistant Toxicologist Aicute Toxicity Report approved by: \ \ > V^ .''VYItu/k^ C. W. Mastri, B.S. S.ection Head, Acute Toxicity mcb Company Sanil^d. Does not contain T3CACBI Swiui^al B I 0 - T E S T 2alwiMwi. 9^ 3 -^ III. Invustigational Procedure Youn" albino rnbbits of the New Zealand strain were used to evaluate the eye- irritating properties of the lest material. The tu.st method was patreriiRd after that 01 Draize et^ aL* The test mati'l-ial 'v.'-s instilled into the conjuncti-.-al sac of the right eye of each of two rabbits. After an exposure period of 20 seconds, the right eve of one animal was rinsed for one minute with 150 ml of tap water while the right eye of the other animal remained unwashed. At each scoring interval the cornea, iris, and palpebral conjunctiva were examiiicd and graded for irritation and 'injury according to a standard scoring system*. The maximum possible score at any one examination and scoring period is 110 points, which indicates maximal irritation and damage to all three ocular tissues. Zero score indicates no irritation. The scoring system is presented in Table I.. In this scoring system, special emphasis is placed upon irritation or damage to the cornea, while less emphasis is placed upon damage to the iris and conjunctiva. After the completion of the test, the scores were analyzed, and a descriptive eye irritation rating was assigned to the test material. The cri teria used for assignment of the descriptive rating are the frequency, the .-xtcnt, and the persistence of irritation or damage which occur to the three ocular tissues. * Draize. John H., Woodard, Geoffrey, and Calvery, Herbert 0., "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes," J. Pharm. & Exp. Ther. 82^. 377 (1944). c,.?-----------------"-"''3"6" ^Adt^kial B I 0 - T E S T ^a^milMl^. 9tt6. TABLE I Eye Irritation Test - Albino Rabbits Scale of Weighted Scores for Grading the Severity of Ocular Lesions Ocular Tissues Cornea Iris Description 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 iris slightly obscured. Opalescent areajs, no details of iris visible, size of pupil ^barely discernible. Opaque, iris invisible. Area of Cornea Involved (B) One quarter (or less) but not zero. Greater than or^e-quarter but less than one- half. : Greater than one-half but less than three- quarters. Greater than thiree-quarters, up to whole area. Score equals A x B x 5 Total maximum 80 Values (A) Fu;ds above normal, congestion, swelling, circuracorneai injection (any or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) No reaction to light, hemorrhage, gross destruction (any or all of these). Score equals A x 5 Total maximum =10 Draize Grade 1 2 3 4 Company Sanitized- Oeesflo<cMte7SCACB| Sfidull-uil B I 0 " T E S T 2alivia{o^ei, IM, 5 TABLE I. continued Eye Irritation Test - Albino Rabbits Scale ..f Weighted Scores for Grading tlie Severity of Ocular Lesions Ucular Tissue"; Conjunctiva Draize _______: Description_________________Grade Redness^ (A) Redness (.raters to palpebral conjunctiva only) . Vessels definitely injected above normal. More diffuse, dejaper crimson r-ed, individual vessels not easily discernible. Diffuse beefy red. Cheu-.osis (B) Any swelling above normal (includes nictitating membrane). " 1 Obvious swelling with partial eversion of the lids. ; 2 Swelling with lids about half-closed. 3 Swelling with lids about half-closed to completely clo-.ed. 4 Discharge (C) ^ Any amount different from normal (does not in- elude small amount observed in inner canthus of normal animals). Discharge with moistening of the lids and hairs just adjacent to the lids. Discharge with moistening of the lids and hairs and considerable area around eye. Score (A + B + C) x 2 Total maximum = 20 Note: The maximum total score is tlie sum of all scores obtained for the cor-.-ca, iris, and conjunctiva. Company Sanitized. Does not contain TSCA CB6 SftdM^ual B 1 0 - T E 5 T laiwaiivuei. ^c. The rating is arrived at y selecting the maximum irritation score at one- 4, 24, 48 or 72 hours after instillation. If the rate of dissipation of injury cL-.'s not nieut the rdqluuiirrerr.ents defined for thi? descriptive rating appropriate for c particular n merical score, the descriptive rating is raised by one or more levels. The rating system is presfntecl in Table II. Company SaaWzwL Does mi contain TSCA CB Judicial B 1 0 - T E S T A^Mfl^Ktet. 5w. TABLE II Eye Irritation Test - Albino Rabbits Classification of Test Materials Based, on Eye Irritation Properties Rating Non-Irritating Range. 0.0 - 0.5 Practically Non-Irritating >0.5 - 2.5 Minimally Irritating >2.5 - 15.0 Mildly Irritating >15.0 - 25.0 Moderately Irritating >25.0 - 50.0 Severely Irritating >50.0 - 80.0 Extremely Irritating >80.0 - 110.0 Definition To maintain this rating, score at the 24-hour reading must be zero; otherwise, increase ratin-g one level. To maintain this rating, score at the 24-hour reading must be zero; otherwise, increase rating one level. To maintain this rating, score at the 72-hour reading must be zero; otherwise, increase rating one level. To maintain this rating, score at the 7-day reading must be zero; otherwise, increase rating one level. To maintain this rating, score at 7 days must Be < 10, otherwise .increase rating one level. To maintain this rating, score at 7 days must be < 30, otherwise increase rating one level. Company Saniloed. Does not coiitaift TSCA CBt SF. Adal BIO-TEST Loko, Jo s 4 ( 2 ve : cliyang B 3 i The results of the eye ipitationtestsse = --- in Table 0. i a faTaOr] 23 1 ie eS Ce i i ce fs Foi .i LE SR TR Spe Ee Aa i | ; A pSnTpaEs 3!is 8 | . vis ; . LL, Come Sees.Bors nonTeich T ABLE III Ey<3 Irritation' 'Test - Albir10 Rabbits Test Conditions TEST MATEF-'AL,: H- 8583 FORM AD:.UKIST ERED;; Instillation (0.1 ml, DESCRIPTIVE RjATlNG WASHED EYE: Min imally Irritati"g UNWASHED E''{E.: 1ilinimally Irriilating U ndiluted) Tissue .... -^ .. .. .......... ............4-...... ..... Hour Hours 24 Hours Washed Eye,, 20-Second Contact Period* Cornea (D-A) Iris Conjunctiva (R-S-D) Total 0 0 6 (2-1-0) 6 0 0 6 (2-1-0) 6 0 0 4 (1-1-0) 4 Unwashed Eye Cornea (D-A) Iris Conjunctiva (R -S-D) Total 0 5 6 (2-1-0) 11 0 5 6 (2-1-0) 11 0 0 4 (1-1-0) 4 -48 Hours 0 0 0 0 72 Hours 0 0 0 0 0 0 0 0 4 (1-1-0) 0 4 0 ^6 Hours 0 0 0 0 0 0 . 0 0 Note: Sterile sodium fluorcscei.^ strips were used at each scoring interval starting with the 24-hour sc presence or absence of corneal irritation. * The eye was washed fur onr ininutf with running tap water (approximately 150 ml of water).