Document 3J6K9gd8ENN8wrpM7dyNYgZKO

-;-:%- AR226-2795 Haskell Laboratory Report No. 586-85 Naslcell LabEo.raIt.ordyu foPorftTt odxeicoNlsosgoyursandfimI!nCdouasptarniay l P. 0 Box 50, Elkton Road Newark, Delaware 19714 Medicine Date Issued: February 11, 198$ not contain TSCA CBl i Company Sanitized. Docs r HLH58&-85 acute skin Irritation potential 1n male rabbits. Slight erythew was observed in 2 of 6 rabbits ^t 24 hours but jiitts .absent by 48 hours after application. Edesa was not' observed during thS study. Under the conditions of this study, slight skin irritant. Mas a Ubrk by: CLita \< cJn^'1., -. Deborah A. Vick Technician ^/OlSjf Study Director: tU^^ i. John E. Henr^ Technologist T-f/0/9^ Approved by; f^ yN^^^flCAlC^Csjrf^l^_r--K^------Al 11 Nancy X* CChhrrooinmeye,y(3.P^|..DD_ .. Section Supervisor, Acute Investigations Section JEH:smk:HLIU3.12 Company Sanitized. Does not contain TSCA CBI ^ M -^'ife^ t'- '^'r/^^i^ri? ,:. .'...; fsMs'y.'w .;r.^.'-...;>..-.fc^^;^:'^.\v-?/;p^^tiy^-a ;^ .'.',*% ^ff^fSSSS HLK sa^^:;;^;^-^ STUD?: AUDITS: I tens Audited Protocol, records and Final report Audit Dates 1/7,8/86 : f l ^ 1 SBORT-TEKM AUDIT REPORT NUMBER DATE FINDINGS REPORTED TO MANAGEMENT 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 nuaerous and routine in nature,'the in-life critical phases from one study exeaplify the conduct Of other studies from the saae test type. Reported by: >. -A.. '. J>.' Christlann Barba Quality Assurance Auditor Date - 3 - Company Sanitized. Does not contain TSCA CBh wwlilwi^rarjt^ ^ 586.85 Hasken No. 15.900 Material Tested: Chemicals and Pigments Department I* J- du Pont de Nanours and Company Wllmington, Del aware Hatenal Submitted By; lenncais and Pigments Department E. I. du Pont de Nemours and Company Jackson Laboratory Deepwater, Mew Jersey Test Facility: E. I, du Pont de Nemours and Coifipany Haskell Laboratory for Toxicology and Industrlat Hedlc i ne 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 ^ ....;. HtirS86-85 ^'^^^K^-.. ______,, 'A/'-': The purpose of thtt . ,ws. ^g^lu| > skin Irritation potential of----------------""""" liihefi^^N^ clipped Intact skin of New Zealand White rrabbit^ Th^SiJ$ta!(if1Nsc^a(i^^^^a^c^c^o^rding to the applficaabble EPA Good Laboratory Practice; Regulations. Areas of noncoapllance are docuRented In the study reato-ds. w'dewiafc^ that significantly affected the validity of the! study* t..-..r- MATERIALS AND METHODS ' ' : ' A. Animal Husbandry Young adult male New Zealand White rabbits were received fron Buckshire Corporation, Perkasle, Pennsylvania. The rabbits Mere housed singly In suspended, stainless steel, wire-mesh cages. Each rabbit was assigned a unique Identification nuaiber which was recorded on a card affixed to the cage. Purtna Certified Rabbit Chow* 93322 and water were available ad Hbltum. ftabbits were quarantined, weighed and observed for general heaTth for approximately 2 weeks* Animal rooms were maintained on a timer-controlled, 12 hour/12 hour Tight/dark cycle. Envl ronstental conditions of the rooms 'were targeted for a temperature of 20C + Z^ and relative humidity of 50S ^ IDS. Excursions outside these ranges~were 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 male New Zealand 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 stock which had been fitted with a piece of rubber sheeting, approximately 8" x 18". A 0.5 mL aliquot of perfluorobutyl ethyl iodide was applied directly on the test site beneath a 1-inch gauze square that was held In place with tape. The rubber sheeting was then wrapped around the animal and secured with tape to retard evaporation and ^.o keep the test material in contact with the skin without undue pressure.' Three other testmaterials were applied to 3 other separate sites on the same animal. Approximately 24 hours after application of the test material, the rubber sheeting was loosened, and the skin at the corners of the gauze squares was marked with a waterproof pen; wrappings and gauze squares - 5- .-.n Can;;ToH nnee nnf nonfain TSCA CBt *& 589.95 X^^L wf were then rewMifed. ,^t^:^^1^.^t^^!l^ w*asshed< with wani laatter to remove excess test naterlal. The sklfl^tas gently patted dry ami the aniBals returned to the^r cages. v- ; r: ApproxiRately 24,5 j^l 48 hours af^er application of the test material, the test site! Nere evaluated for-erytheBW, edeoa and other evidence of denial effei^s and wre scored according to the Oraize scale (Table I). The adjacent; areas of the untreated skin Mere used for ' comparison* C. Tesr-Materl^l Physical Forro: Purity: Composition: Pinkish-grey liquid Synonyms: Other Codes: CAS Registry Nc Stability: The test material was assumed to be stable under the conditions of administration. 0. Records Retention All raw data and the final report will be stored In the archives of Haskell laboratory for toxicology and Industrial Medicine, E. I. du Post de Nemours and Company,: Newark, Delaware or -In the Ou Pont Hall of Records, tfilifflngton, Delaware. RESULTS ^miHH^UHB^ produced slight erythema without edema in 2 of 6 rabbits at 24 hours. So erythana or edsne was observed at 48 hours. Dermal responses observed are summarized In the following table. Individual animal data are presented ih Table II. - 6- fnmnanv San?fized- DORS nnf ff/infam TSCA CBf COHCIUSIM Under the conditions of this study. slight skin Irritant. as a 9 - 7- : Company Sanitized. Does not contain TSCA CB1 _.J. ^___J___-../*... . .. '..... "-.^'teti' .-,.";!-,--^^ ^t ^'\-^1B; . A'S''''-."-.;;,^,-'. ^i''* . ^jSN^!^ '^NS^'rte^v"': ^:.. wwS.sa^ ".iis.!*^^ ., ^<^^-s^g%%?K-g w..- t r'-'- .:^.-,< HIK58 ' ^ . .,1^-ti"'^s7r-i/' - : ,, *?a';.^- IRRITATION Evaluation of SJc1R^eactions Erythena and eschar fornfftion: ''.;..' Ho erytheaM Very slight efythBBa:{ barely . perce.p. .t.tMe) IteII-definea^rythaB^ todepate-to-se*eFe-epytheB Severe erytheoa (beet redness) to slight eschar fornation (Injuries In depth) Value Edema formation: No edema Very slight edena (barely perceptible) Slight edema (edges of Area well defined by definite rising) Moderate edema (raised approximately 1.0 inn) Severe edema (raised more than 1.0 ran extending beyond the area of'exposure) A Abraded I Intact T Thickening C Eschar No Effect B Blanching F Fissuring N Necrosis G Fissuring with Bleeding S Epidermal Scaling I Sloughing R Raw Areas X Compound Adhered to Skin SN Superficial Necrosis 1 Draize, J. H.. Dermal Toxiclty." Appraisal of the Safety of Chemicals In Foods, Drugs and Cosmetics. The Editorial Committee of the Association or Food and Drug Officials OT the United States, Austin, Texas, 1959, pp. 46-59. - 8- Company Sanitized. Does not contain TSCA CB1 '"'.:S3?%^-^ !:,;- ^...-a-d 9 - Company Sanitized. Does not contain TSCA CBl 1