Document J3rpYDZ0MrOBdbaNwxkqy5DNX

AR226-2843 9w$JUfrUJ, BIO - T EST Jiid&iat'uz', 9m. 1810 fRONTAGE ROAD N O R T H B R O O K , ILLIN O IS 60062 REPORT. TO E . I . DU PONT DE NEMOURS fc COMPANY EYE IRRITATION TESTS WITH H-8583 IN ALBINO RABBITS FEBRUARY 12, 1974 Company Sanitized. Does not contain TS CA CBS RECEIVED FEB2 21974 HASKELL LAB, itdusiial Bi O - T ES I JabyiaLvUcA, Sue. REPORT TO E . I . DU PONT DE NEMOURS E, COMPANY EYE IRRITATION TESTS WITH H 8583 IN ALBINO RABBI':. FEBRUARY 12, 1974 I. Introduction . At the req u e st of E. I. du Pont de Nemours & Company w ashed and unw ashed eye irritatio n tests were conducted w ith a sample identified as H-8583. Sai CO!;OPanV Does noto iu L tii^ia l B I O - T E S T la& otaioiei., Suc. 2 II. Summary T he re s u lts of the eye irritatio n tests conducted with H -8583 are sum m arised below. T est Conditions Washed Eye 20-Second Contact Period Unwashed Eye Maximum Irritation Score 6 . 0/ 110.0 11. 0/ 110.0 R tin Minimally Irrita tin g Minimally Irrita tin g Respectfully subm itted, INDUSTRIAL BIO-TEST LABORATORIES, INC. Report prepared by: .X /--- ^ Ronald G. B ak er, B.S^ A ssistant Toxicologist Aicute T oxicity k Report approved by: ^ C. W. M astri, B .S . Section Head, Acute Toxicity mcb Company Sanit'szed- Does not contain TSCACBI 9*idu&bUaL BI O - T EST jlaltM aivuei, Utip. 1 III. Investigational Procedure Young albino rabbits of the New Zealand strain w ere used to evaluate the eye irrita tin g p ro p erties of the test m aterial. The test m ethod was p a t tern e d after th at oi D raize et ah * The test m aterial was instilled into the conjunctival sac of the right eye of each of two r a b b its . After an e x p o su re p e rio d of 20 s e c o n d s , the rig h t eye of one anim al w as rin se d for one m inute w ith 150 ml of tap w ater while the rig h t eye of the oth^r anim al rem ained unw ashed. At each scoring interval the cornea, iris , and palpebral conjunctiva w ere exam ined and graded for irrita tio n and in ju ry according to a stan d ard scoring sy stem *. T he maximum p o ssib le sc o re at any one exam ination an d sco rin g p erio d is 110 p o in ts , w hich indicates maximal irritation and damage to all th ree ocular tis s u e s. Zero score indicates no irritatio n . The scoring system is p resen ted in T able I.. In this scoring system , special em phasis is placed upon irrita tio n or dam age to the c o rn e a , w hile less em phasis is p lac e d upon dam age to th e ir is an d conjunctiva. After the completion of the test, the sco res w ere analyzed, and a d e scrip tiv e eye irritatio n rating was assig n ed to the test m a te ria l. The c r i teria used for assignm ent of the d e scrip tiv e rating are the freq u en cy , the ex ten t, and the p ersisten ce of irritatio n or damage which o ccur to the th ree ocular tissues. * D raize, John H ., W oodard, Geoffrey, and Cal v e ry , H erbert O ., "Methods for the S tudy of Irritatio n and T oxicity of S u b stan ces A pplied T opically to the S kin and M ucous M em branes," J . P h a rm . & E x p . T h e r. 8 2 , 377 (1944). !Snot contain ,tS*'CA CBS Company Sanitized. Uoei duibUal B I O - T E S T a&onataiiM, 9c. 4 TABLE I Eye Irritation T est - Albino R abbits Scale of Weighted Scores for Grading the Severity of Ocular Lesions O cu lar T is s u e s ______________ D e sc rip tio n ------------------------ ---- Cornea O pacity (A) O pacity - D egree of d en sity (area w hich is most dense is taken for read in g ). Scattered or diffuse area, details of iris clearly v isib le. Easily d iscernible translucent areas, details of iris slightly obscured. O palescent areajs, no details of iris v isib le, size of pupil barely discernible. Opaque, iris invisible. A rea of C ornea Involved (B) One quarter (or less) but not zero. G re a te r th a n o ije --q u a rte r b u t le s s th a n one h a lf. : G reater than oqe-half but less than th ree- quarters . G reater th an th iree-q u arters, up to whole area. Score equals A x B x 5 T otal m aximum = 80 Iris V alues (A) Fuids above norm al, congestion, sw elling, circum corneaj injection (any or all of these or com bination of any th ereo f), iris still reactin g to light (sluggish reaction is positive) No reactio n to lig h t, hem o rrh ag e, g ro ss destruction (any or all of th ese). Score equals A X 5 Total m aximum = 10 D raize G rade 1 2 3 4 1 2 3 4 1 2 Company Sanitized. Beesua^ H tu U iliitd BI O - T EST Joiw afouet, $*c. TABLE I. c o n tin u e d Eye Irritation T est - Albino R abbits Scale . f W eighted S co res for G rading tlie S e v erity of O cular L esions U cular T issu e s ; D escription C onjunctiva R ed n ess (A) R e d n e s s ( r e f e r s to p a lp e b r a l c o n ju n c tiv a o n ly ) . V essels definitely injected above norm al. M ore diffuse, deeper crim son re d , individual v essels not easily d iscern ib le. D iffuse beefy red . Chem osis (B) . A ny sw elling above norm al (includes nictitating ' m em brane) . ' O bvious sw elling with p a rtia l ev ersio n of the lid s. Sw elling with lids about half-closed. S w elling w ith lids about half-closed to com pletely c lo :e d . D ischarge (C) : A ny am ount different from norm al (does not in elu d e small amount observed in in n er canthus of norm al anirhals), D isch arg e w ith m oistening of the lids and h airs j u s t a d jacen t to the lid s . D isch arg e w ith m oistening of the lids and h airs and considerable area around eye. - . S co re (A + B + C) x 2 T o tal m axim um = 20 D raize G rade 1 2 3 1 2 3 4 1 2 3 Note: T he maximum total score is the sum of all sco res obtained for the cornea, iris , and conjunctiva. Company Sanitized. Does not contain TSCA CBI B I O T E Tftdu&bal 5 lawiayei, \c. T he r a tin g is a r r iv e d at fcjy se le c tin g the m axim um ir r ita tio n s c o r e at o n e . 4, 24, 48 o r 72 h o u rs: a fte r in s tilla tio n . If th e r a te of d is s ip a tio n ! of in ju r y cl.- s not m eet the re q u ire m e n ts d e fin e d for th e d e s c r ip tiv e r a tin g appropriate for a particu lar num erical score, the descriptive ratin g is .! '. raised by one or more levels.! The rating system is p resen ted in T able II. m I 1 i Company Sanitized. Does not contain TSCA CB ttd,usbal BI O - T EST laho*aMe&. Sw, 7 TABLE II Eye Irritation T est * Albino R abbits Classification of T est M aterials B ased on Eye Irrita tio n P ro p e rtie s R atin g N on-Irritating Range. 0.0 - 0.5 P ra c tic a lly N on-Irritating > 0 .5 - 2.5 M inimally Irrita tin g > 2 .5 - 15.0 M ildly Irrita tin g > 15.0 - 25.0 M oderately Irrita tin g >25.0 - 50.0 Severely Irrita tin g >50.0 - 80.0 Extrem ely Irritating * > 80.0 - 110.0 D efinition To m aintain this ratin g , score at the 24-hour reading m ust be zero; otherw ise, increase ratin g one lev el. To m aintain this ratin g , score at the 24-hour reading m ust be zero; otherw ise, increase rating one level. To m aintain this ratin g , score at the 72-hour reading m ust be zero; o therw ise, increase rating one level. To m aintain this ratin g , score at the 7-day reading m ust be zero; otherw ise, increase rating one level. To m aintain this ratin g , score at 7 days m ust be < 10, otherw ise.increase rating one level. To m aintain this ratin g , score at 7 days m ust be < 30, otherw ise increase rating one level. Company Sanitized. Does not contain ISC ACBI P ' 3nd uiiai B I O -TE ST Jc TABLE III Eye Irritatio n T est - Albino R abbits TEST MATERIAL: H-8583 FORM ADMINISTERED: In stilla tio n ( 0 .1 m l, U n d ilu te d ) DESCRIPTIVE RATING: WASHED EYE: M inim ally I r r ita tin g UNWASHED EYE: M inim ally I r r it a ti n g Test C o n d itio n s T issu e - 1 ................... ...4-........... Hour H ours 24 H ours Washed Eye, 20-Second C o n tact P e rio d * Cornea (D-A) Iris C onjunctiva (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 U nw ashed Eye Cornea (D-A) Iris C onjunctiva (R-S-D ) T o tal 0 5 6 (2-1-0) 11 0 5 6 (2-1-0) 11 0 0 4 (1-1-0) 4 48 H ours 0 o c 0 72 H ours o 0 4 (1-1-0) :4 % Hours 0 0 0 0 0 0 7 e: at each scorin8 ,nterval *** T he ey e w as w a sh e d for one m inute w ith r u n n in g tap w a te r (a p p ro x im a te ly 150 ml of w a te r ) . Days 0