Document nmDrqq0N1bkk04NKQn6K8Zm91

AR226-2842 SwSu&t^, BIO-TEST AA^zA^A Sw. \ 1810 FRONTAGE ROAD NohTMBROOK. ILLINOIS 60062 F.EPORT TO E. I. UU FONT DE NEMOURS (!i COMPANY ; IRRITATION TESTS WITH H-8580 IN ALBINO RABBITS FEBRUARY 12, 1974 ^ a-a^^ C^ RECEIVED FEB 2 2 t9M HASKELL LAS. DwLU^al B 10 T E S T 2ai<yiatvU&i. Sue. REPORT TO E. 1. DU FONT DE NEMOURS fe COMPANY EYEi IRRITATION TESTS WITH H-8580 IN ALBINO RABBITS FEBRUARY 12, 1974 I. Introduction | At the request of E. I. ;du i Pont de Nemours & Company washed and unwashed eye irritation testjs were conducted with a sample identified as H-8580. \ .^SC^( <^ ^ ^ QO' ^ CO^ 59<v&\weA' fwUii^al B 10 - T E S T ^cw^^, ^w, 2 II. Summary The results of the pye irritation tests conducted with H-8580 are summarized below. Test Conditions Washed Eye 20-Secon(ll Contact Period ' Unwashed Eye Maximum Irritation Score 13.0/110.0 19.0/110.0 Rating Minimally Irritating Mildly Irritating R|espectfully submitted, INDUSTRIAL BIG-TEST LABORATORIES, INC. ^ L ^ J . ^ A ^'7^7^^ Report prepared by: /f, U^/^U ^ Riaonnaalldd G. Baker, BB..SS'.. ,, A[ssistant Toxicologist Acute Toxicity Report approved by: ! d. \..VN> .l^VUuC___________ W. Mastri, B.S. SectionHead. Acute Toxicity mcb ,-.nT5C ,OIC0^0 O085"' .d ..sao^ CO^^5 Sttdnit^al B 10 T E S T laioMityUu. ^& 3 ^& III. Invcstigational Procedure' Young albino rabbits of t|he New Zealand strain were used to evaluate the eye irritating properties iof the test material. The test method was ^at torned after that of Draize etjaL* The test material was instilk-d into the conjunctival sac of the right eye of each of two rabbits. .After an exposure period of 20 seconds, the right eye of one animal was Irinsed for one minute with 150 ml of tap water while the right eye of the ot^ier animal remained unwashed. At each scoring interval the cornea, iris, an^l palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system*. The maximum i possible score at ?:ny one examination and scoring period is 110 points, which indicates maximal irritation and damage to all three ocular tissues. Zero score indicates no irritation. 1 The scoring system is presented in Table I. In this scoring system, special emphasis is placed upon irritation or damage to the -ornea, while less emphasis is placed upon damage to the iris and conjunctiva. | After t' e completionof 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 extent, and the persistence df irritation or damage which occur to the three i ocular tissues, i S : ^^B|p * 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. 8, Exp. Ther. 8^. 377 (1944). j Company Sanitized. Does not contain TSCACBS Smtmh^ B 10 T E 5 T la&awtwua, yw. Ocular Tissues Cornea Iris | TABLE I Eye Irritation Test - Albino Rabbits Scal^ of Weighted Scores for Grading th|c Severity of Ocular Lesions Description Opacity (A) j Opacity - Degreel of density (area which is most dense is tkken for reading). Scattered or diffuse area, details of iris clearly visible. Easily discernible translucent areas, details of iris slightly obscured. Opalescent areas, no details of iris visible, size of pupil barely discernible. Opaque, iris invisible. Area of Cornea Involved (B) One quarter (or ^ess) but not zero. Greater than one-j-quarter but less than one- half. 1 Greater than oneyhalf but less than three- quarters . i Greater than thr^c'quarters, up to whole area. Score equals A x $ x 5 Total maximum 80 Values (A) ; Folds above norrhal, congestion, swelling, circumcorneal Injection (any or all of these .or combination! of any thereof), iris still reacting to lig it (sluggish reaction is positive) No reaction to lii[ht, hemorrhage, gross destruction (any or all of these). Score equals A x p Total maximum = 10 Draize Grade Company Sanilhed.Does^contein7sCACB3 Hwtu^Ual B 10 T E S T 2a^aiyUe4,\ ^HC. TABLE I. continued Eye Irritation Tent - Albino Rabbits Scjalc of Weighted Scores for Gradind the Severity of Ocular Lesions Ocular Tissues Description Conjunctiva Redness (A) i Redness (refers to palpebral conjunctiva only). Vessels definite .y injected above normal. More diffuse, dieper crimson red, individual vessels not e.sily discernible. Diffuse beefy rd. i Chemosis (B) Any swelling above normal (includes nictitating ' membrane). . Obvious swelling with partial eversion of the lids. - Swelling with lids about half-closed. Swelling with lids about half-closed to completely closed, i ^ Discharge (C) | Any amount different from normal (does not in clude small amount observed in inner canthus of normal animals). Discharge with moistening of the lids and hairs just adjacent to the lids. Discharge with imoistening of the lids and hairs and considera'ble area around eye. Score (A + B + C) x 2 Total maximum = 20 Draize Grade 1 2 3 1 2 3 4 1 2 3 Note; The maximum total scoi-e is the sum of all scores obtained for the cornea, iris, and conjunctiva. ', GompanySanrt^Q.Does "i contain TSCAC65 . M^W B 10 T E S T 2atwl^9.w. 6 ^P The rating is arrived at by selecting the maximum irritation score at one, 4, 24. 48 or 72 hpurs after instillation. If the rate of dissipation of injury dons not meet Ui>e requirements defined for the descriptivu rating appropriate for a particullar numerical score, the descriptive rating is i-uiacd by one o)- more levels. The rating system ip presented in Table II. Company Sanifeed. Does not e onfainTSCACBI WM.I/W B t 0 T E S T ^aAia^^&L^w. ; TABLE II Eye Irritation Test - Albino Rabbits Classification of Test Materials Dasejd on Eye Irritaiion Properties Rating Range Definition Non-Irritating 0.0 - 0.5 Practically Non-Irritating >0.5 -I 2.5 Minimally Irritating >2.5 -. 15.0 Mildly Irritating Moderately Irritating >15.0 - 25.0 >25.0 ^ 50.0 Severely Irritating >50.0 f 80.0 Extremely Irritating >80.0 i- 110.0 To maintain this rating, score at the 24-hour reading roust be zero; otherwise, increase rating 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 sa;'o; otherwise, increase rating one level. To maintain this rating, score at the 7-day reading must be r'*ro; otherwise, increase rating one level. 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, otherwise increase rating one level. Company Sanitized. Does not contain TSCA C3? ^wtnU^.1 B I 0 - T E S T ^a^wUo^a, ^ws. IV. Results The results of the eye irritation tests are presented in Table III Company Sanitized. Does not contain TSCA CBI ^ TABLE III Eye Irritation Test - Albino Rabbits Test Cor. ditions TEST MATERIAL: H-8580 FORM ADMINISTERED: Instillation (0.1 ml. Undiluted) DESCRIPTIVE RATING: WASHED EYE: Minimally Irritating -UNWASHE&-^ - Mildly. Irritating -._...._.. ............ .... .. 1 4 24 48 Tissue Hour_____Hours____Hours____Hours 72 96 Hours____Hours__ Washed Eye. Cornea (D-A) ZC-Second Contact 0Period* Iris Conjunctiva (R-S-D) Total 8 (2-1-1) 13 12 (2-2-2) 12 8 (2-1-1) 8 2 (1-0-0) 2 o .^Jnwashed ^ye w ID 3 Cornea (D-A) 0 Iris 0 Conjunctiva (R-S-D) 12 (2-2-2) 14 (2-2-3) 8 (2-1-1) Z (1-0-0) 0 Total 17 19 0 &bte: Sterile sodium fluorescein strips were used at each scoring interval starting with the 24-hour sc .3 presence or absence of corneal irritation. ;;* The eye was washed for one minute with running tap water (approximately 150 ml of water). en 0 > 0