Document EvkyrJakmwXxM3BmRX2DgJRRL

FOR DU PONT USE ONLY AR226-2959 SM .tig Du Pont BIX 325-91 j State_ r' ' Skin Irritation Test vi tir 4 :~:#f in Rabbits Author i John V. Server Study Completed On i June 3, 1991 Performing Laboratory E. I. du Pont de Nemours and Company . Haskell Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box SO . NewIark,' Delaware 19714 I E&'fSf i i Laboratory Project ID i Haskell Laboratory Report No. 325-91 1 Page 1 o f 9 Company Sanitized. Does not contain TSCA CBf Material Tested; Medical Research No.; Haskell Ho.: Haskell Test Code Ho.; Physical Form; Composition: ruf-'-'U,^>jl flWP .'V M r-S'-i?Z. 0u fo n t . ' :V:|uS . ..:r :r5 Off-Vhife opaque liquid '3 'j i ;i! Synonyms : Other Codes: CAS Registry No.: Stability: Sponsor: contrary, the test material was assumed to be stable under the conditions of administration. Du Pont Chemicals E. . du Pont de Nemours and Company Wilmington, Delaware - 2- Company Sanitized. Does not contain TSCA CBl Study Initiated - Completed? 4/5/91 - m m In-Life Phase Initiated - Completed; 4/16/91 - 4/19/91 Notebook: There are 9 pages in *u-is reporti. Distribution: V - 3- ,,01contain TSCAC Company Sanitized. Does i P*5! su ?ni* eta 325-91 -s tn Rabbits ,, =- -=- - w s *val # 3 female rabbits. The fees* 48 hours after applioatlphi Bjr72" No edema was observed during the Under the conditions of this study potential in 3 ale and lid erythema by 24 and erythema was observed. - a s a mild skin irritant. 1 Work bj|: i i /"*_^ V Ia / jC j J A v y\ Tracy A. Filliben technician Study Directoif: u ) . S Q A a /-^\ W. Sarver technologist Approved by: Manager Acute Toxicology Reviewed and Approved for Issue: V--u Q>>^_ t O . ^ Q A ^ \ _____(, / 3 ,/ ? t , /] 1 John W. Sarver ~' ,' (_y i Study Director Acknowledgements: C. Finlay Iso participated in the conduct of this study. V - 4- I Company Sanitized. Does not contain TSCA CBI mmmm Skin Irritation Test with TLF-flJOO in Rabbits STUDY: H# 18,920 AUDITS: Item Audited Protocol, Conduct Records, Report Audit Date 4/9,18/91 5/20/91 SHORT-TERM AUDIT REPORT NjuMBER DATE FINDINGS REPORTED TO,'MANAgI AND STUDY DIRECTOR: 5/20/91 I Reported by: G AlfiL- Deborah A . Vick 'Quality Assurance Auditor ~/Q<tkf Date Dj - 5 Company Sanitized, Does not contain TSCA CBl m Ou Pont ose of _______ ,r w o f f M B H 'hen a.p..p.l.i.e.d.l.b 'l.if.e _ _ rabbits, fis study wms e#pdjeted':i Laboratory Practice Regulations. '** study records. No deviations existed muksBrtSm muri-i-k skin irritation potential inof Nev Zealand White |applicable EPA Good lance are documented in the the validity of the study. MATERIALS AND METHODS A. Animal Husbandry | Young adult male and1 female New Zealand iihite rabbits were received from Hare Maryland, Hewitt, New Jersey. The tiabbits were housed singly in suspended, stainless steel, wire-mesh caged* Each rabbit was assigned a unique identification number which was recorded on a card affixed to the cage. Purina Certified High Fiber Rabbit JChov #5325 and water were available ad libitum except as noted under Protocol. Rabbits were quarantined, weighed, andj observed for general health for approximately 2 weeks._ Animal rooms were! maintained on a timer-controlled, 12-hour light/12-hour dark cycle.j Environmental conditions of the rooms were targeted for a temperature of 20"C 2C and relative humidity of 50* + 0%. Any excursions outside these ranges were of small magnitude and/or brief duration and did nojt adversely affect the validity of the study. B. Protocol j On the day prior to treatment, the hair of 3 male and 3 female New Zealand White rabbits was Closely clipped to expose the skin from the scapular to the lumbar region of the back, the body weights of the rabbits ranged from 2415 to 2708 grams on 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*. The rabbits remained in the stocks throughout the exposure period and during.that time did not have access to food or water. Approximately & 5 mL o f S B H M H v a s applied directly to a 2-inch gauze square that was then- placed on the test site. The patch was held in place with nan-irritating tape. The rubber sheeting was then wrapped around the anjtmal and secured with clips to retard evaporation and fo keep the test material in contact with the skin without undue pressur^ ) - 6Company Sanffzecf. Does not contain TSCA CBS 4 |o the test firjifc.. the squares vas ^ ____ vere than ., to remove excda 'fl- ** animais vere rfurnii * I the corners of the gayfe jppings eud gauze |y vashed with verm vater gently patted dry and thf \J" - . `:V- *# Approximately 24, W :??;?^MPPli_c_a_ti_on of the test ! ^ ria1' ih! ***! and'otherl! Vf| ,|V i^ ta & irv tlie ilia . Mim anil' bl... evidence of dermal effects and"were,sc^p^cording to the Draize scale (Table I). The adjacent areas of the n^p^ii|ed skin vere used for comparison* '' C. Records Retention '' \ I -: B .A fa* data ad theI final report will he stored in the archives of Haskell Laboratory for Toxicology and Industrial Medicine, E. I. du Pont de Nemours and Company, Nevark, Delavare or in the Du Pont Records Management Center, Vilmington, Delavare. RESULTS AND CONCLUSIONS J ' ....... .... . " *3>roduced slight|erythema in 2 rabbits and mild erythema in 1 o UI L after *PP}ication- 8y *8 hours, slight erythema vas observed in 3 rabbits, and mfld erythema in 1. A nodule measuring approximately 2 mm in diameter vas observed on the test site of 1 rabbit. B ; L hou^s ' erythema vai observed in 2 rabbits. The nodule vas not present. No edema vas observed throughout the study. Individual skin ' n r f n t ^ n -SC?u6S/ f f Pfesenfed in Table II. A summary of skin responses is presented m the folloving table. K Summary of Skin Resoonses to Response No Response Slight i Erythema 24 hr : Aft h r !' " ' 3/6 i! 2/6 2/6 1 3/6 72 hr 4/6 2/6 Mild 1/6 j 1/6 0/6 Under the conditions of this study, ^! I j I zO*f/ n|*rw Edema 48 nr 72 hr 6/6 6/6 6/6 0/6 0/6 0/6 ` 0/6 0/6 0/6 a mild skin irritant. Company Sanitized. Does not contain TSCA CBI Du Pont B U 325-91 Tgjtf I MAIZE1 SM FOR SCORING PRIMARYSKIN IRRITATION i ' ' '' Evaluation pf Skjjp Reactions Value Erythema and eschar formation: No erythema Very slight erythema (bajrely perceptible) Well-defined erythema : Moderate to severe erythema Severe erythema (beet redness) to slight eschar formation (injuries ih depth) 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) Edema formation: No edema Very slight edema (barel perceptible) Slight edema (edges of area veil defined bv definite raising) ' Moderate edema (raised approximately 1.0 mm) Severe edema (raised morp than 1.0 mm extending beyond the area of exposure) 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) Abbreviations of ot A = Abraded I = Intact T = Thickening C = Eschar - = No Effect B = Blanching dermal effects are: F = Fissuring N = Necrosis G = Fissuring vith Bleeding S = Epidermal Scaling L = Sloughing R = Raw Areas X = Compound Adhered to Skin SN = Superficial Necrosis 1 iapodJ 'n?" "De5inr1 T0Xclty*" Appraisal of the Safety of Chemicals --TM !00^_--S ':-- C-o-someutiii ucsu.a i TKhe Editorial Committee of the Association of Food 46-59. and Drug Officials of the United States. ' Austin, Texas, 1S5S, pp. -8- no contain TSCA CB goTftpany Sannlzed`Does Rabbit number 26269 26271 26284 26285 26257 26263 24 hr 2 5 T fSTkt 00 0 1 0 1% 1 10 1 0p 0 2i 1 * Edema 24 hr 48 hr ~l2 hr 0 PP P PP P PP P PP G PP G PP * Nodule measuring approximately 2 mm in diameter observed on the test site* !i > .. iii - 9-