Document wDMwYpZkNyEMM2r5Mw6kbBEK3

.`SWJCTiV .rjg! : p I * rr! l SKIN fBRlhTlflN TEST I 881# PF Haskell Laboratory Report No. 586-85 E. I. du Root de Neaours and Company Haskell Laboratory for Toxicology ami Industrial Medicine P. 0. Box 50, Elkton Road Newark, Delaware 19714 Date Issued: February 11, 198$ Sanitized. Does not contain T S C A CB1 Company r _______ _______ was evaluated for acute skin Irritation'.potential in ml rabbits* Slight erythena was observed In 2 of 6 rabbits bt 24 hours but was absent by 48 hours after application. Edeas was not! observed during thi study. Under the conditions of this study, slight skin irritant. was a Work by: At-, < \ c t Deborah A. Vick Technician JM I& J? Study Director: \1 X- John E. Henry Technologist ?-//P / Sr Approved by: H C j fl ,, ------ A i n Nancy IT* Chromey,OP|.D. Section Supervisor, Acute Investigations Section IK, JEH:smk:HLR13.12 Company Sanitized. Does not contain TSCA CB1 bu sa*~8S M STUDY QUALITY ASSURANCE DOCUMENTATION I R# 15900 HLRt 586-85 AUDITS: Itens Audited Protocol, records and inal report Audit Dates 1/7,8/86 SHORT-TERM AUDIT REFORT iNUMBER DATE FINDINGS REPORTED TO HANAGEHENT AND STUDY DIRECTOR: 1/8/86 In-life critical phases from a representative study of this test type are inspected quarterly. Since short-tern studies are numerous and routine in nature, the in-life critical phases from one study exenplify the conduct bf other studies from the same test type. Reported by Christiann Barba Quality Assurance Auditor Date 3Company Sanitized. Does not contain T SCA CBh Sponsor: : Chemicals and Pigments Department ' E. I., du Pont de Nemours and Company Wilmington, Delaware Material Submitted By: nemica is and Pigments Department E. I. du Pont de Nemours and Company Jackson Laboratory Deepwater, New Jersey Test Facility: E. I. du Pent de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine P. 0. Box 50, Elkton Road Newark, Delaware 19714 Study Initiated - Completed: 8/17/85 - 8/19/85 There are 9 pages in this report. Distribution: 4- the purpose o f t h t s s t u d f.as to *galatfc|ii*imain irritation potential of ^ l i e n ' < 1 W i B W f e # H ( P * intact study"*^ co^S^iiitecordlns to the applicable EPA Good laboratory Pfactiep docwented in the study rec Regulations, p a s Of noncompl lance are ds. ho deviations existed that significantly affected the validity of the study. ; MATERIALS A METHODS A. Animal Husbandry v m m n adult male NeW Zealand White rabbits were received from BucksMre Corporation, Perkasie, Pennsylvania. The rahbits were housed S 2 5 " suspended, sinless steel, *lre-~sh ses. Each rehbit w s uniaue identification number which was recorded on a card i i J K M the^cage. Purine Certified Babbit Cho* 3 2 2 and a t e r r e available lnU?n oepeswitfnnc of the rooms were targeted for a temperature of 20 C ^ 2 C and Of 5 M 101. Excursions outside tnese ranjes ere of brief duration and did not adversely affect the outcome of the study. B. Protocol : On the day prior to study initiation, the hair of 6 TM le ^ J e a l a n d White rabbits weighing from 2347 to 3463 grams, was closely clipped to expose the back from the scapular to the lumbar region. Each rabbit was placed into a stoek which had been fitted with a piece of rubber sheeting, approximately^* x 18". J f* a idthout^nduepressure/ Three other testmaterials were applied to 3 other separate sites on the same animal. Annmvinateiv 24 hours after application of the test material, the rubber^sheetlngwas loosen, end the skin at the corners squares was marked with a waterproof pen; wrappings and gauze squares -5- .3U. /N.mn^nu CanUiToH fines nnf nonfain TSCA C B I animi s returned to tiiijr cges. Approximately 24*5 iw 48 tours a ^ f application of the test material the test sitei evidence of dermal etfi (Table I). The adjacei imif^.ievaiiiat^ ^ y t h e m a , edema and other ;s and mere scared according to the Oraize scale areas of the untreated skin were used for comparison. j C. Test-Material Physical Form: Purity: Composition: Pinkish-grey liquid Synonyms: Other Codes: CAS Registry No.: Stability: The test material was assumed to be stable under the conditions of administration. D. Records Retention All raw data and th final report will be stored 1n the archives of Haskell Laboratory for toxicology and Industrial Medicine, E. I. du Pont de Nemours and Company,; Newark, Delaware or in the Du Pont Hall of Records, Wilmington, Delaware. RESULTS produced slight erythema without edema in 2 of 6 rabbits at 24 hours, NO erythema or edema was observed at 48 hours. Denudi responses observed ape summarized In the following table* Individua* animal data are presented Ih Table II. - 6- r.nmnanv Sanitized. D o rr nnf rnnfain T S C A C B f f*Y?!SrtW!tHgrosh jf coifcuiHSii Under the conditions of this study, slight skin irritant. # was a i 7- Company Sanitized. Does not contain T S C A CB1 i j&>i':*:pr' WISSB1 fiMniK 9liPirVfi*Vnr9 fefer*!-/'. Evaluation of Skib RMCttOnS Erythema and eschar formation: (to erythema i .. Very siigherythema j(barely perceptible) Hell'defined erythema Moderate-to^evere-efythema - Severe erythema (beet redness) to slight eschar formation (injuries in depth) Edema formation: No edema Very slight edema (barely perceptible) Slight edema (edges Qf area well defined by definite raising) Moderate edema (raised approximately1.0 mm) Svere edema (raised'more than 1.0 mm extending beyond the area of exposure) Value 0 1 2 3 4 0 1 2 3 4 A * Abraded 1 Intact T * Thickening C * Eschar - No Effect B = Blanching F * Fissuring N * Necrosis G Fissuring with ; Bleeding S * Epidermal Scaling l = Sloughing R Raw Areas X = Compound Adhered to Skin SN = Superficial Necrosis i Draize, J. H.. "Dermal Toxicity." Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics. The Editorial Committee of the Association o f food and brug Officials of the United States, Austin, Texas, 1959, pp. 46-59. - 8- Company Sanitized. Does not contain T S C A CB1 . . w.L - .-.&' ^'ii ' -y * -faiaI$^'rwi V f^||| .: ;S.;;} `> M 0 S 3 ^ 1- HUt 566-85 Rabbit Number 19252 19253 19255 19256 19257 19243 24 HOBf Q 1 1 0 0 0 0 ... 0 0 0 0 8 Edema 24 Hour 48 Hour 00 00 00 00 00 00 - 9CdWpany Sanitized. Does not contain T SC A CB\