Document 1QeBzXyMXXGvXpnv7kQNLXbZK

FOR DU PONT SE ONLY AR226-2939 Du Pont HLR 360-89 Study Title Skin Irritation Test in Rabbits o Author John W. Sarver Study Completed On June 29, 1989 Performing Laboratory E. I. du Pont de Nemours and Company, Inc. Haskell Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box 50 Newark, Delaware 19714 Laboratory Project ID Haskell Laboratory Report No. 360-89 Page 1 of 8 Company Sanitized. Does not contain TSCA CBfe Material Tested: Medcal Research No.: Haskell No.: Physical Form: Purity: Composition: GENERAI INFORMATION 17,869 White dispersion Du Pont HLR 360-89 Synonyms : Other Code: Stability: Sponsor: The test materialwas assumed to be stable under the conditions of administration. Chemicals and Pigments Department E. I. du Pont de Nemours and Company, Inc. Wilmington, Delaware Material Submitted By: Chemicals and Pigments Department E. I. du Pont de Nemours and Company, Inc. Jackson Laboratory Deepwater, New Jersey In-Life Phase Initiated - Completed: 6/14/89 - 6/16/89 V - 2- Company Sanitized. Does not contain TSCA CB1 99 Du Pont HLR 360-89 Skin Irritation Test 1n Rabbits of SUMMARY was evaluated for acute skin Irritation potential in one female and 5 male rabbits. No dermal Irritation was observed throughout the study, Under the conditions of this study, ^ w a s not a skin Irritant. Work by: Technician Study Director: 1 . John W. Sarver Technologist Approved, by: Alik __ Dolores E. Malek, Ph.D. Research Toxicologist Acute and Developmental Toxicology Division Reviewed and Approved for Issue: lO . C$( John W. Sarver Study Director L /2\ / I e? Acknowledgment: Lisa Lewis also participated in the conduct of this study. JWS:ai r:HLR29.9 - 3Company Sanitized. Does not contain TSCA CBf Du Pont HLR 360-89 miAi.TTY ASSURANCE DOCUMENTATION STUDY: H# 17,869 Skin Irritation Test in Rabbits of AUDITS: Items Audited Evaluation of Skin Response to Test Article Audit Dates 6/15/89 SHORT-TERM AUDIT REPOP" NUMBER:.,-- _____ DATE FINDINGS REPORTE TO MANAGEMENT AND STUDY DIRECTOR: 6/22/89 hsi bkv~jl/Reported by: Joseph C. Hamili (furaallity Assuurance Auditor Date - 4- Company Sanitized. Does not contain TSCA CBi Du Pont HLR 360-89 INTRODUCTION The purpose of this study was to evaluate the skin imitation of f l H ^ w h e n applied to fche clipped, Intact skin 4Ne . f ' "J1te rabbltsTThls study was conducted according to the applicable EPA Good Laboratory Practice Regulations. Areas of noncompliance are documented In the study records. No deviations existed that significantly affected the validity of the study. MATERIALS AND METHODS A. Animal Husbandry Your,, adult male and fajale New Zealand ,, from Hare Marl and, Hewitt, New Jersey. The rabbits were boused singly in suspended, stainless steel, wire-mesh cages. Each rabbit a uniaue identification number which was recorded on a card affixed to the cage. Purina Certified High Fiber Rabbit Chow #5325 and waver were available ad libitum except as noted under Protocol.. Rabbits were quarantined, weighed and observed for general health for approximateiy 2 weeks. Animal rooms were maintained on a 1 1mer-contro11ed, hour light/12-hour dark cycle. Environmental conditions o i v h e rooms were targeted f o r a temperature of 20C + 2C and relative humidity of 50% + 10%; Any excursions outside these ranges were of small ma9nJJ"d* * 2 j /or brief duration and did not adversely affect the validity of the study. B. Protocol On the day prior to study initiation, the hair of one female and 5 male New Zealand White rabbits was closely clipped to expose the skin from the scapular to the lumbar region of the back. The rbbi,.s w c,g..cd from 2773 to 3145 grams oh the day of treatment. Each rabbit was placed into a stock which had been fitted with a piece of rubber sheeting, approximately 8" x 18". t i 1d"0t in the stocks throughout the exposure period and d u n n ^ h a t time ^ d ^ot have access to food or water. A 0.5 mL aliquot of I ^ H V w a s applied directly on the test site beneath a 2-mch gauze square that place with tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test material in contact with the skin without undue pressure. -5- Company Sanitized. Does not contain TSCA CBI Ou Pont HLR 360-89 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 wit a waterproof pen; wrappings and gauze squares were then removed. Thlie test sites were gently washed with warm water to remove excess test material. The skin was gently patted dry and the animals were returned to their cages. Approximately 24 ahd 48 hours after application of the test material, the test sites were evaluated for erythema, edema and other evidence of dermal effects and were scored according to the Dralze scale (Table I). The adjacent areas of the untreated skin were used for comparison. C. 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 Pont de Nemours and Company, Inc., Newark, Delaware or 1n the Du Pont Records Management Center, Wilmington, Delaware. RESULTS AND CONCLUSIONS _ _ fas evaluated for scute skin Irritation potential in one female and 5 male rabbits. No dermal irritation was observed throughout the study. Individual skin Irritation scores are presented in Table II. A summary of responses is presented in the following table. Summary of Skin Responses to! Response No Response Erythema 24 hr 48 hr 6/6 6/6 Edema 24 hr 48 hr 6/6 6/6 Under the conditions of this study,! ^ w a s not a skin irritant. I V - 6- Company Sanitized. Does not contain TSCA CBS Du Pont HLR 360-89 TABLE I PRAIZE1 SCALE FOR SCORING PRIMARY SKIN IRRITATION Evaluation of Skin Reactions Erythema and eschar formation: No erythema Very slight erythema (barely perceptible) Well-defined erythema Moderate to severe erythema Severe erythema (beet redness) to slight eschar formation (Injuries 1n depth) Value 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) Edema formation: No edema Very slight edema (barely perceptible) Slight edema (edges of area well defined by definite raising) Moderate edema (raised approximately 1.0 mn) Severe edema (raised more than 1.0 mm extending beyond the area of exposure) 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) A - Abraded I = 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 Draize, J. H., "Dermal Toxicity." Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. The Editorial Committee of the Association of Food and Drug Officials of the United States. Austin, Texas, 1959, pp. 46-59. - 7Company Sanitized. Does not contar TSC CB Du Pont HLR 360-89 TABLE II i. . -R'ABI'1'B!I11T S1KI1N- 1IRRI'T..A.T.I.O.N TEST SKIN[RESPONSES OBSERVED IN TEST RABBITS FOLLOWING TOPICAL EXPOSURE TO Rabbit Number 23913 23917 23918 23919 23920 23924 - Erythema 24 tjir 48 hr 00 00 00 00 00 00 Edema 24 hr 48 hr 00 00 00 00 00 00 - 8Company Sanitized. Does not contain TSCA CB|