Document 6R633jX75mENZygeG4xjap2E6

FOR DU FONT USE ONLY AR226-2969 Du Font HLR 802-91 gtudy Title Skin Irritation Test vith----------in Rabbits Author John V. Sarver Study Completed On February 13, 1992 Performing Laboratory Haskell E. Z. du Font de Nemours and Company Laboratory for Toxicology and Industrial Eikton Road, P. 0. Box 50 Newark, Delaware 19714 Medicine Laboratory Project IP Haskell Laboratory Report No. 802-91 ^^^S.n^.B-'^-"1""*""TM*08' Page 1 of 9 GENERAL INFORMATION Du Font BLR 802-91 Substance Tested; Medical Research HO.! Haskell Ho.8 Haskell Test Code No. Physical Fora: Composition: 19,173 Yellow liquid Contaminants; Purity: Synonya; Submitter's Notebook No. CAS Registry Ho.; Stability; None available In the absence of visible evidence to the contrary, the test substance vas assumed to be stable under the conditions of administration. Sponsor; Du Font Chemicals I. E. d . Font de Nemours and Company Vilmington, Delaware Substance Subaitted By: ' Study Initiated -- Completed; Du Font Chemicals I. E. du Font de Nemours and Company Deepvater, New Jersey 10/31/91 - 2/13/92 In-Life Phase Initiated - Completed; 11/6/91 - 11/9/91 Notebook; There are 9 pages in this report. Oees-tioi contain TSCA CBi Distribution: GENERAL INFORMATION (COHT'P) Du Pent BLR 802-91 ^iip^ ^ -- '^ "' - ^ ^snw" is^''" Skin Irritation Test with Du Font HLR 802-91 SUMMARY [100Z pure) was evaluated for acute skin irritation potential in smaieann'E"f*emale rabbits. The test substance adhered to the skin of the rabbits throughout the study. No dermal irritation vas observed in any of the rabbits by 24 or 48 hours after administration of the test substance. At 72 hours, 1 rabbit exhibited slight erythema. Under the conditions of this test but only after prolonged exposure ( a slight skin irritant, taiT'48 hours). Votk by: <Lv^A^J<. 3\V\^^..\CT^^iOon-T^UdC^y----H--.----H--ah--n-- Technician "TyJohn^T. Study Director; '^fiJ^^- bC) ^aA>v^~\ Sarver Technologist Approved bys Na^/j7e1 ^Na^ncQy ^Cu. rqfytruom^e_y, _P_h_.D_. Manager Acute Toxicology Reviewed and Approved for Issue: SQW^ ^. John ff. Sarver Study Director s /n/loL Acknowledgments: JffS/lmr Carol Finlay, Bryan Crossley, and Terri Settlpinyre also participated in the conduct of this study. - 4 - Company Sanitized. Does not contain TSCA cy Du Pent HLR 802-91 QUALITY ASSURANCE DOCUMENTATION Audit Dates In-life Observation: 11/6/91 Records, Final Report; 1/24,28/92 DATE FINDINGS REPORTED TO STUDY DIRECTOR; 1/28/92 - TO MANAGEMENT; 2/11/92 bv^j>^>u^ \L N^-f- phoned ^g^^H--n..-"D" onna R---. H--o.^lftc Quality Assurance Auditor ^\\\y^ iDnait>eA re^R'"'" Du Font HLR 802-91 INTRODUCTION The purpose of this study vas to evaluate the skin irritation potential of MPD-"110 when applied to the shaved, intact skin of New Zealand Vhite rabbits. This study vas conducted according to the applicable EPA Good Laboratory Practice Regulations. Areas of noncompliance are documented in the study records. Ho deviations existed that affected the validity of the study. MATERIALS ASP METHODS A. Animal Husbandry Young adult male and female New Zealand White rabbits were received from Hare Marland, Hevitt, Nev Jersey. The rabbits were housed singly in suspended, stainless steel, wire-mesh cages. Each rabbit vas assigned a unique identification number which vas recorded on a card affixed to the cage. Purina Certified High Fiber Rabbit Chow #5325 and water were available ad libitua except: as noted under Protocol. Babbits vere quarantinedT weighed, and observed for general health for approximately 2 weeks. Animal rooms were maintained on a timer-controlled, 12-hour light/12-hour dark cycle. Environmental conditions of the rooms were targeted for a temperature of 20C 2aC and relative humidity of 50X 10X. Any excursions outside these ranges were of small magnitude and/or brief duration and did not adversely affect the validity of the study. B. Protocol On the day prior to treatment, the hair of 5 male and 1 female New Zealand White rabbits was closely shaved to expose the skin from thf scapular to the lumbar region of the back. The body weights of the rabbits ranged from 2665 to 3123 grams on the day of treatment. Each rabbit vas placed into a stock which had been fitted with a piece of rubber sheeting, thaepperxopxoimsuarteelype8ri"odx a1n8d". duTrhineg rathbabAitstimreemdaiidnednot in the stocks throughout have access to food or water. A 0.5 rol> aliquot o^MlBHB^5 applied directly on the test site beneath a 2-inch gauze square thaT was held in place with non-irritating tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact.with the skin without undue pressure. R-^--y^ ^,,:%& w^T^^^n'i'W1^ 6 - Du Font HLR 802-91 Approxinately 24 hours after application of the test substance, the rubber sheeting was loosened, and the skin at the corners of the gauze squares was Barked with a waterproof pen; wrappings and gauze squares vere then removed. The test sites were gently washed vith warm water, Ivory* soap, and acetone to remove excess test substance. The skin was gently patted dry* and the animals were returned to their cages. Approximately 24, 48, and 72 hours after application of the test substance, the test sites were evaluated for erythema, edema, and other evidence of dermal effects and were scored according to the Draize scale I). (Table The adjacent areas of the untreated skin were used for coBparison. C. Records Retention All raw data and the final report will be stored in the archives of I. Hasfcell Laboratory for Toxicology and Industrial Medicine, E. du Font de Nemours and Company, Newark, Delaware or in the Du Font Records Management Center, vilmington, Delaware. RESULTS AND CONCLUSIONS Although|--------Adhered to the skin of all rabbits, the test sites could be evaluated for dermal irritation. No dermal irritation was observed in any of the rabbits at 24 or 48 hours after application of the test substance. Slight erythema was observed in one rabbit 72 hours after application. Individuarskin irritation scores are presenteff in Table II. A sunmary of skin responses is presented in the following table. Summery of Skin Responses Response Slight 24__h_rEryt4h8e-mhFa" 6/6 6/6 8/6 0/6 72 hr 5/6 1/6 24 _h_r_Ed4e8m'haF 6/6 6/6 0/6 0/6 72 hr 6/6 0/6 Under the conditions of this study,|ffHB|ras a slight skin irritant, but only after prolonged exposure (greater than 48 hours). CompaW580^' . ^ ^ ^ Du Font BLR 802-91 TABLE I PRAIZEl SCALE FOR SCORING PRIMARY SKIS IRRITATION Evaluation of Skin Reactions Erythema and eschar formation: No erythetta Very slight erythema (barely perceptible) Veil-defined erythema Moderate to severe erythema Severe erythema (best redness) to slight eschar foriatibn (injuries in depth) Value 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) Edeea formation: No edeia Very slight edema (barely perceptible) Slight edema (edges of area well defined by definite raising) Moderate edema (raised approximately 1.0 nun) Severe edema (raised eore than 1.0 BUD extending beyond the area of exposure) 0 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) Abbreviations of other A Abraded I = Intact T e Thickening C Eschar - Ho Effect B Blanching dermal effects ares F c Fissuring N = Necrosis G a Eissuring with Bleeding S Epidermal Scaling I. Sloughing R Raw Areas X Compound Adhered to Skin SN Superficial Necrosis Oraize, J. B., "Dermal Toxieity." 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. ,E;,.! Du Font BLR 802-91 TABLE II INDIVIDUAL SKIN IRRITATION SCORES SKIN RESPONSES OBSERVED IK RABBITS FOLLOWING TOPICAL EXPOSURE Kabbit Number 26791 26792 26794 26795 26796 26800 Erythema 24 hr 48 hr 72 hr OX OX OX OX OX OX OX OX OX OX OX OX OX OX IX OX OX OX 24 hr 0 Edema 48 hr 0 72 hr 0 0 0 0 0 0 0 000000 0 0 0 9 -