Document DMMBgZDYRnNjOYN4n7O336RxO

1 E 2 E i: g i da Ef4l . b. 7] = Ei E4 pe AR226-2844 oh a ar } A fo aC nia a | Heenea ee By! en 1 Lae ei BaBSoo 11 J] ol a HC A a Li . ih =so : Ca-- To 2 So aE "ouidl || L GE r a ha EEin e iE ea e LFueislnoissyig CT adEe R e SEA LE a [ gm + a fm he Ho si RecEwEea|cDl SC oa a E mE a mma ea] Li EE Gapny Saniliied; Dogs Ot cOnIATB TSCA CRIT]  .Swtuikial B 10 T E S T ./^WM^ ^. ! REPORT TO E. I. UU P(NT DE NEMOURS & COMPANY EYE IRRITATION TESTS WITH H-8534 1^ ALBINO RABBITS PEBRUARY 12, 1974 IBT NO. 601-04594 I. Introduction i At the request of E. I. dn Font de Nemours & Company washed and unwashed eye irritation tests [were conducted with. a sample identified as H-8584. Company Sanitized. Does not contain TSCA CBi 1 SndMU^ial B I 0 - T E S T ^a^i^ia. HM, / -j ... 11. Summary I The results of the cyd irritation tests conducted with H-85B4 are summarized below. Test Conditions Maximum Irritation score Rating Washed Eye- 20-Second Contact Period 11.0/110.0 Minimally Irritating Unwashed Eye i 15.0/110.0 Minimally Irritating Respectfully submitted, INDUSTRIAL BIG-TEST LABORATORIES. INC. i^&^ /O / Report prepared by: ^^ Kon ?/ aid >^ G. y Ba k e^r,^B. . S , . Assistant Toxicologist Acute Toxicity Report approved by: _C. \ . W . Vj . y\. Mastri, t^y^' B.S. Section Head, Acute Toxicity mcb Company Sanitized. Does not contain TSCA C8! J^tUtial B I 0 T E S T Ja^wa^iia. 3^a, III. Invt'stigational Procedure | Young alhino rabbits of th^ New Zealand strain were used to evaluate the eye irritating properties ofl the test material. The h'al method was pat terned after that of Draize at al.* The test material was insti led into the conjunctiva! sac of the right eye of each of two rabbits. A: ter an exposure period of 20 seconds, the right eye of one animal was rinsi-d for one minute with 150 ml of tap water while the right eye of the othe- animal remained urwashed. At each scoring interval the cornea, iris, and aalpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system*. The maximum possible score at any one ex^.rr ination and scoring period is 110 points, which . indicates maximal irritation anc damage to all three ocular tissues. Zero score indicates no irritation. ' 'he 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 extent, and the persistence of rritation or damage v.'hich occur to the three ocular tissues. S \ * Draize, John H. , Woodard, Cjeoffrey, and Calvery, Herbert 0., "Methods for the Study of Irritation anA Toxicity of Substances Applied -Topically to the Skin and Mucous Mcmbrahes," J. Pharm. & Exp. Ther. 82. 377 (1944). Company Sanitized. Does not contain TSCA CBI Industrial B1O-TEST oege 4 @ | TABLE1 Eye teitaon Test - Albino Rabbits f GradinSgcatleh]e oSfevWeeriigthyteodf OSccuolraers Lfoersions If Tissues | DT escription Grade ! 5 ; Cornea OpaOpcmaicotisytty(dA-)enDseegrioeeota|fkendenfsoritryea(dairnega).which is Scattered or diffu area, details of iris ti : EasCilleyarldyiseveirsniibbllee||. translucent aress, details 1 2 :i Opaofleisrciasntsalirgehatlsy, bnboscduerteadi.ls of iis visible, size of pupil bapely discernible. 3 % I Opaque, iris ir. gible. 4 ol&i AvAGerneaotferCotrhnaenatoIonnrev-aqluTvoaseer)dteb(ruBt)bnuottlessesro.than one- 1 z i i halt. Greater than | oneal but less than three- quarters. 3 t Graaaretse.r than threp! -quarters, up to whole 4 ia Score cquals Ax B| x5 Total maximum = 80 ris Vaesesisv,eaACm)oeoovrenenaolrsiIanlj,ecctioonngeastniyon,orswalellloifngt,hese L or combination of any, thereof), iris still i Noseviemacatciioonn.to Glaigyht,or haelmloorfrhtahgees,e)gross 2 Score equals A x 3 Total maximum = 10 e ; | | i  [' ^ ^ UmL^htoL BIO-TEST Jia/.waiv (rt,A, , TABLE I. continued Eye Irritation Test - Albino Rabbits 8 f Scale of Weighted Score's for Grad ng the Severity of Ocular Lesions 1 ^fL ^^y Ocular Tissues Description Conjunctiva Redness (A) Redness (refi Vessels defin More diffuse, vessels noc Diffuse beefy rs to palpebral conjunctiva only). tely injected above normal. deeper crimson red, individual easily discernible. red. Chemosis (B) Any swellingj above normal (includes nictitating membrane) I Oblvidiosu. s swi(p1Iiinng with partial eveir-ssion of the Swelling with lids about half-closed. Swelling with lids about half-closed to completely closed. '."^ ' Discharge (C) Any amount different from normal (does not in clude smal amount observed in inner canthus of normal i nimals) . Discharge wi:h moistening of the lids and hairs just adjace it to the lids. Discharge wi ;h moistening of the lids and hairs and consid srable area around eye. Score .(A + B -t C) x 2 Total maximum = 20 Draize Grade 1 2 3 1 2 3 4 Note: The maximum total score is t.he sum of all scores obtained for the cornea, iris, and conjunctiva. i ' '\ ; ,,: s | j j f ; ,3 '! n .Company Sanitized. Does not contain TSCA CBt  JmlLuhiol B 10. TEST 2<t&owiliei, Ji'M. ^ i^ The rating is arrived at by selecting the maximum irritation score at one. 4, 24, 48 or 72 hours after instillation. If the rate of dissipation of injury docs not meet the ij-oquircniehts defihfd f"; the descriptive rating appropriate for a particular pur.-';rical score, the .descriptive r?'.;i'.g is 1 "": :' ::::. i raised by one or more level:j>. The rating system is presented in Table II. Company Sanitized. Does not contain TSCA CBI | -:.,i-,\^i.:-^,S Dwt^ual B 10 T E S T 2<tSwtyMU^M,. \ TABLE II i Eye IHritation Test - Albino Rabbits Classification of Test Materials Basea on Eye Irritation Properties Rating Non-Irritating Rangjs 0.0 - |0.5 Practically Non-Irritating >0.5 - 2.5 Minimally Irritating >2.5 - 15.0 Mildly Irritating Moderately Irritating Severely Irritating Extremely Irritating >15.0 - 25.0 >25.0 - >0.0 >50.0 - ^0.0. I >80.0 - tlO.O Definition To maintain tilis rating, score at the 24-hour reading must 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 zero; otherwise, increase rating one level. To maintain this rating, score at the 7-day reading must be -'.ero; 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. JCpmpanySanitized, Does not contain TSCA CBI , ) " ERT CHER E51 Sotto! BIO-TEST h4 ihi 4 he ey i. F TETERI E V ER R Ai RR a | IV. Results Th ent of he fi feebUEA E aG dSatpd ed i bina .5 p PUl TA e Ei - So hg bo 4 TRL drag Lug o.o &fiantesaanl | ptt al : Eg Ey L. ): - hee a hSHe EE l wa aE o Palha ea Ce me PUEDE = Ina +| FSEET EeeaAee e chan .: To. SeLolbigeta a o E CigSohn Se EPeE . SS lk ite s a Ls LR . Solan te ib C heL ,l Th) FE . SeEE y ii 1 Tele hEe i= EE 4. i i # hGo Ela iho a - rSiAnd LoHe Ay Je hy i . 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U-l (U > 0 0 00 2 00 c '2 0 u in 000 0 000 0 ^ 0 1 o o <r -a' '> |"M r--< N s-/ o >n oo > I--l -N i-< ^ !3 0 f. <f (M /" >- U U r5* *-* ? ? .. j:? '3 ? oil ^ , s fi3 ln - *.* . M > s--t ^(f-l 0 * > rt ^. E i !lu y SS C 0 8 ^ 5w y "* A-l rt ? M (M ^^ 0 iTl 0 in 1-1 /0-\ 1 i--l r~l \y o in 'o ^ cQ 1 u ^0- (Q "a " "' QC g -0 C u <n . 'Sa 3 ," . C - o5 ,, a ^ n) g <U S .^ In .-S ? ' ^ M '-' g | Q. .rt -mJ Sm i ^o i In .Sr! 0 U p c w S-3 g ^ in - S S 5 <^ -/ < < " u ^ . Q q 3 C 0 >-. ^ G in -- u S S ^ c'3 in o " o o UAUH i ^e -"i 5^ 2 ^ 'o ^ 5 ? u in u C vs ^ S^ -s t^0 0. ^^ JS : in n) 1 ? U a '- -- f-< PM C >s 0 IZ * Conipany Sanitized. Does not contain TSCA CBl