Document 6b19a5rJrOwMV78GdRDJZwBVR

FOR DU PONT USE ONLY AR226-2922 s\Copies to Haskell : T du Pont de Nemours and Company Inc. aboratcry For Toxicology and Industrial Hadicine ` Elkton Road, P. 0. Box 50 Newark, Delaware 19714 HASKELL LABORATORY REPORT NO. HLO-97-85 ftudy Init iated/Completed 1/17B4 - 12/247&T Material Submitted b) nemici igments Department taakell Evaluation: w r s r sjs: 3. *.*. appen8d,ix Bio/dynsmics Project No. 5444-84). ^ M ^ B L s applied under occlusion to the skin of ^ r a b b i t s ]r four h B W u ^ t o a l s had very slight or slid erythema with little or 3 edema. . ien tested by this n^oeedure, kin. 1|is not corrosive to - 1- Company Sanitized. Does not contain TSCA CBf Report by: Reviewed by; Carol S. Auletta/Donna L. Blazcak Bio/dynamics Inc. Technologist HrGerald L. Kennedy Senior Research Toxiccooiloocgist Approved by: Manager, Toxicology JEH/egg Date Issued: February 22, 1985 Haskell Lab. Report Appendix attached: No. HLO-97-85 7 pp, Bio/dynamics Project No. 5444-84 Total pages in this report: 9 -2 lffipany : unu/'Z^w- uwss not contam fSCA cBi Bio/ciynamics Inc. Division of Biology and Safety Evaluation PROJECT NO.: 5444-84 DOT SKIN CORROSION TEST IN RABBITS TEST MATERIAL: 15.615 Submitted to: I. duPont de Nemours & Co. skell Laboratory for Toxicology ind Industrial Medicine 3. Box 50. Elkton Road tfark, Delaware 19711 Attn I Date: January 30, 1985 I. INTRODUCTION This study was conducted ;for E.I. duPont de Nemours & Co. to evaluate the dermal corrosivity produced by 15,615 1n rabbits. The study was performed at Bio/dynam1cs, Inc., Mettlerts Road, East Millstone, New Jersey 08873. The protocol was based on the following guideline: DDT regulation 173.1300 Appendix A - Method of Testing Corrosion to Skin 46 FR 49889, October 8, 1981. effective July 1, 1982], This report has been reviewed by the Quality Assurance Unit of Bio/dynamics, Inc. to assure its conformance with the protocol and raw data. All raw data, the original study protocol and final report will be retained on file In the Bio/dynamics Archives. H . DATES OF STUDY Animal Receipt: Initiation (Dosing): Termination i (Last Observation): III. STUDY PERSONNEL November 12, 1984 December 18, 1984 December 20, 1984 Study Director: Laboratory Supervisor: Technlci an-i n-Charge: Study Monitor (Report Preparation): Donna L. Blaszcak, B.S., AALAS R.L.A.T. Janet Erickson, A.A.S., AALAS L.A.T. Mary Webb, B.S., AALAS L.A.T. Ellen C. Levitz, B.S. IV. MATERIALS A. Test Animals: Breed: Reason for' Selection: Supplier: Albino Rabbits New Zealand White Standard laboratory animal for dermal Irritation studies. The New Zealand White breed was used because of its availability and because of the existing historical data base for comparative evaluation. Hazleton-Dutchland, Inc. Denver, Pennsylvania Company Sanitized. Does not contain TSCA CBI IV. MATERIALS (cont.) -- - /dynmmtem tn c . - 2- 5444-84 j ! Number: Six (3 males, 3 females) Age: Height: (Pretest) Young adults 2.7 to 3.0 kilograms Equilibration Period Husbandry: Housing: Cages: Environmental Conditions: 36 days Currently acceptable practices of good animal husbandry were followed, e.g.. Guide for the Care and Use of Laboratory Animals: p h e w Publication No. IMfH) 76-23 Revised 1978. Individually housed Suspended, stainless steel. Temperature: 60-70*F Is considered an acceptable temperature range for rabbits; room temperature was monitored and recorded twice daily and maintained within this range to the maximum extent possible. Humidity: 30-70S is considered an acceptable humidity range for rabbits; room humidity was monitored and recorded dally and maintained within this range to the maximum extent possible. i Food: Light Cycle: 12 hours light, 12 hours dark (controlled by an automatic timer). Lab Rabbit Chow HF (Purina #5326), ad libitum. Water: Automatic watering system, ad libitum. Municipal water supply (Elizabethtown Hater Co.) Identification: Each animal was identified with a monel ear tag bearing a unique number prior to testing. mpzj) uei T ic contain TSC n ' Selection: B. Test Material: Description: Date of Receipt: Received from: Storage: V. METHODS Animals were randomly placed in cages upon receipt ana were placed on study as available at the time of study Initiation. Animals considered unsuitable for study because of poor health, unacceptable skin, or outlying body weights were excluded from selection. 15.615 Cloudy, pale yellow liquid November 16, 1984 E.I. duPont de Nemours A Co. Room temperature A. Preparation of Test Material: The test material was administered as received; no preparation was necessary. B. Preparation of Animals: On the day before dosing, the hair of each rabbit was closely clipped from the back with an electric clipper, so as to expose the back from the scapular to the lumbar region. The skin remained intact, i.e., no abrasions were made. C. Administration of Test Material: There was one test site on the back of each animal. 0.5 ml of the test material was applied to each site beneath a surgical gauze square, l"xl", placM directly on the test site and held in place with tape. Plastic sheeting was then wrapped around the animal and secured with tape to retard evaporation and keep the test substance in contact with the skin without undue pressure. Elizabethan collars were then placed on the animals to prevent disruption of the wrappings and Ingestion of the test material. Following approximately 4 hours of exposure, the wrappings and gauze squares were removed and the test sites gently wiped free of excess test material with dry gauze. I -- m`dytm m to in e . -4 5444-84 VI. EXPERIMENTAL EVALUATION (In-LIfe) Viability Check: Twice Dally Evaluation of Skin Irritation: 1. Intervals: Approximately 4.5 (30 minutes after removal of wrappings) 24 and 48 hours after administration. 2. Methods : At each Interval all sites were evaluated for erythema and edema or other evidence of dermal Irritation according to the Dralze scoring system (presented In Appendix A). Adjacent areas of untreated skin were used for comparison. Company Sanitized. Does no! contain TSCA CC " ......... .. -- -. .. . ..|........ . VIII. RESULTS AND DISCUSSION ,,11 . Bio//f,iy n a m ie.a I.n c . 5444-84 Dermal observations are presented In Table I; the scoring system used is presented 1n Appendix A. 15,615 was not corrosive, jAll animals had very slight (barely perceptible) or well-defined eryithema with little or no edema at 4.5 and/or 24 hours. This irritation persisted 1n some animals through the 48 hour observa tion. No evidence of tissue destruction was seen. Donna il filaszcak, 7 7 a a l a s R.L.A.T. Study Director Assistant Manager, Acute Toxicology J . <=L Carol b Auietta, B.., d .a .b .t . Manager, Acute Toxicology #/ / " m r ~-- Company Sanitized. Does not contain TSCA Cr TABLE I' mSm 5444-84 PRIMARY DERMAL IRRITATION STUDY IN RABBITS TEST MATERIAL: 15,615 INDIVIDUAL DERMAL IRRITATION SCORES* - 4.5, 24 AND 48 HOURS Time Interval Patch Sites Observations Animal Number and Sex i>4Z4F 5426F 5431M 5433M 5435M " 48F 4.5 Hours Right Side ER 2 1 1 1 2 2 ED 0 0 0 0 0 0 24 Hours Right Side ER 1 1 1 1 2 1 ED 0 0 0 0 1 0 48 Hours Right Side ER 1 0 1 0 2 0 ED 0 0 0 0 1 0 aScored using scale presented In Appendix A. M-Male F-Female ER-Erythema ED-Edema Company Sanitized. Does not contain TSCA APPENDIX A DRAIZE1 EVALUATION OF DERMAL IRRITATION Dermal Observations A-l 5444*64 Erythema and Eschar Formation (Most severely affected area graded): No erythema.................................................... . Very slight erythema (barely perceptible)...................... Well-defined erythema......................................... . Moderate to severe erythema............ *....................... -, Severe erythema (beet rejdness)....................... 4 Eschar formation............... ..............................4 Necrosis............. ................ 4 Edema Formation (Most severely affected area graded): No edema...... ...................... ............... Very slight edema (barely perceptible)......... . Slight edema (edges of area well-defined by definite raising)....................................... Moderate edema (raised approximately 1 mm)......... . Severe edema (raised more than 1 mm and extending beyond area of exposure)....................... ^Draize, J.H. 1959. The Appraisal of Chemicals 1n Foods. Drugs, and Cosmetics, p. 48. Association of Food and Drug Officials of the United States, Austin, Texas.