Document v67gn9d2RQv7a4kKE2KLg4gMR

FOR DU PONT USE ONLY AR226-2946 Du Pont MLR 112-90 l Skin Irritati n Toft wltl in Rabbits Author I John H. Server Study Completed On I March 5, 1990 Performing Laboratory E. I. du Pont de Nemours and Company, Inc. Haskell Laboratory fjor Toxicology and Industrial Medicine Elktpn Road, P. 0. Box 50 Newark, Delaware 19714 Laboratory Project ID Haskell Laboratory Report No. 112-90 Page 1 o f 8 ompany Sanitized. Does not contain TSCA CBf SEMERAI INFORMATION Du Pont HLR 112-90 Material Tested: Medical Research No.: Haskell Mo.: Haskell Test Code Ho.: Physical Form; Purity: Composition: Synonym: Stability: Sponsor: The test material was 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: fiimlcals andTigments Department E. I. du Pont de Nemours and Company, Inc. Jackson Laboratory Deepwater, New Jersey Study Initiated - Completed: 2/2/90 - 3/5/90 In-Life Phase Initiated - Completed: 2/6/90 - 2/8/90 Notebook: - There are 8 pages in this report Distribution: - 2Company Sanitized. Does not contain TS CA CBI Skin Irritation Tost with Du Pont HLR 112-90 In Hobbits SUMMARY rwas evaluated for acute skin Irritation potential In 5 male rabbits. Thetest malterial produced no donnai Irritation In any of Lted rabotts during the study. Under the conditions of this study, "vas not a skin Irritant. Work by: Technician^ Study Director: 0 ^ - ^4.hilk s r Technologist Approved by: _ WfcB- . Dolores E. Maiek, Ph.D. Research Toxicologist Acute and Developmental Toxicology Division Reviewed and Approved for Issue: s/r/so Acknowledgment: Craig Llghttfap also participated 1n the conduct of this study. JWS:alr:HLR39.12 - 3- Company Sanitized. Does not contain T S C A CBI n.H.n u^iiim iiv! Pu Punt B W U 2 -90 "'h' i ! AUDITS: Items Audited In-life Observations STSPS, Records and Final Report Audit Dates 2/7/90 2/28/90 ! mSHORT-TERM AUDIT REPORT DATE FINDINGS REPORTED TO MANAG: STUDY DIRECTOR: 2/28/90 Reported by: Joafepb (7 w m Quality Assiliranee Auditor '<?o te I I -4- Company Sanitized. Does not contain TSCA CB1 The purpose of this of when ep.pi:l||.. rabbits This study wal e Laboratory Practice Refftti; the study records. No lav validity of the study Dll font HID 112*90 skin Irritation potential In of New Zealand Kite applicable IPA Good 1lance are documented In nlflcantly affected the A. Animal Husbandry Young adult male Hew -.. . were received from Hare Marland, Hewitt, New Jersey. The rabW tt wife housed singly 1n suspended, stainless steft*;Wfl?f*#ih i ||| Each rabbit was assigned a unique Identification nupitP Which was.. on a card affixed to the cage. Purina Certified Hidh Fiber Rabbit -j|h|pe #5325 and water were available ad libitum excitpf as noted undd protocol. Rabbits were quarantine^ WeifhSf weeks. Animal rooms and Observed for fit mini mMntSined Oh,i > r W hbalfh for approximately tfgpr-control 1ed, 12-hour 2 11ght/l2-hour dark cycle * InvIronmentAi ^ i t l o n s of the rooms were targeted for a temperatu *e of 2b*C + 2*0 ihfWiatlve humidity of 50% + 10%. Any excursions outride these ranges ligii of small magnitude and/or brief duration and did m i adversely arfe :t the validity of the study. B. Protocol On the day prior to study Initiation;, the hair of 6 male New Zealand White rabbits was closely clipped to expose the skin from the scapular to the lumbar region of the hack. The r e b p l s ^ o d y weights ranged from 2477 to 2733 grams on the day of ti^atmfrtt. Each rabbit was placed Into a stock:WhfC$ had been fitted with a piece.of rubber sheeting, approximately G* X 18 . The rabbits remained 1n the stocks throughout the exposure periof-and during t h a ^ t m e did not have access to food dr water. Apprd$sitelaM>5 mL of was applied directly on the test site bendath *-1nch gauze square that was held In place with non-Irritating tape. Th*. rubber sheeting was then wrapped around the animal and secured With fjips io retard evaporation and to keep the test material In contact with the skin without undue pressure. 1 - 5Company Sanitized. Does not contain T S C A CB1 J! V-:: M.% Approximate! rubber sheeting squares was mar* were then removed, to remove animals were the test sites r e e*i! dermal effects and weft" The adjacent areas of W on Pont HtR 112*90 the test ' .he corners of >1ng$ andgauze sqtfares washed with warn water ently patted dry and the atlon of the test material, a and other evidence of . Oralze scale (Table I). jsed for comparison. C. Records Retention All raw data and tbfe fenil rdport Wifi theParSh1!*.! Haskell Laboratory for Toil l o g y iff M M f * 1 M!d1f?"e 'IIE;nh \ de Nemours and Company pwark, Delaware or 1n the Du Pont Records Management Center, Mllwlhaton, Delaware. RESULTS AND CONCLUSIONS One rabbit died during the exposure period. #ross pathological examination revealed no abnormalities. Th% l ^ ^ 0L51aintbbi* l ^ ^ t o attributed to stress associate with the fthf| Of restraint. produced no dermal Irritation In any Of the remaking rafbits durlng the study. Individual skin Irritation scores W M * * " 1? in Table 11 * A sunmiary of responses Is presetted in the following table. Summary o f Skin Responses Response h glvr No Response 5/5 . 5/5 I Under the conditions of this study. ^Was not a skin irritant. y - 6- Company Sanitized. Does not ontan T S C A CB1 Du Pont HLR 112-90 me i DRAT2E* SCALE FDR SCORING PRIMARY SKIM IRRITATION I Evaluation of Skip Reactions I Erythema and es>har formation): No erythena ; Very slight erythema (barely perceptible) Well-defined erythema ! Moderate to severe erythema Severe erythema (beet redness) to slight eschar formation (Injuries Inj 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 am) Severe edema (raised more' than 1.0 mm extending beyond the area of exposure) 0 1 (Slight) 2 (Mild) 3 (Moderate) 4 (Severe) Abbreviations of other dermal effects are: A = Abraded F = Assuring I Intact N s Necrosis T = Thickening G 3 Fissurlng with C 3 Eschar - * No Effect bleeding S 3 Epidermal B = Blanching Scaling L 3 Sloughing R 3 Raw Areas X 3 Compound Adhered to Skin SN 3 Superficial Necrosi s 1 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 or the United States, Austin, Texas, 1959, pp. 46-59. ; Company Sanitized. Does not contain T S C A CB1 ' ''1 vfrGi Du Pont Hfcl %Z*9& .i *'SS M ..fi Rabbit Nuaer 2456$ 24566 24567 24568 24569 24570 0 00 00 0 0 m Edema hr 4B"KF 00 00 00 00 00 - Rabbit diet during the exposure period. - 8- I Company Sanitized. Dees not contain T S C A CBl