Document wDzXz4Yq8J2gvmEERZLKGnkg6

HAZLR-T-MN 3Wl KINSMAN BLVD. - P.O.BOX 75a o MADISON. WISCONSIN 63707 Chemical& BlaMediCS1SciencesDivision PHONE ISM 241-44719 TLX 703956HAZRAL MDS UD SCE ?. II/C'@ 0 FINAL REPORT 4'!0JA2@'4-2 -2 "-3!838 ROGER G. PERKINS MINNESOTA MINING MANUFACTURING TOXICOLOGY SERUICES ST. PAUL, MN 55101 COMPANY SAMPLE: T-4101 PURCHASE ORDER NUMBER: T837389-410 7133. SAMPLE NUMBER: SAMPLE ENTERED: REPORT PRINTED: 70905394 09/23/87 01/17/88 ENCLOSED: PRIMARY DERMAL IRRITATION/CORROSION (OECD GUIDELINES) Key Personnel Method Summary References Raw Date Appendix STUDY IN RABBITS SIGNED: STEUEN M. GL-AZA STUDY DIRECTOR ACUTE TOXICOLOGY ......... DATE ........ I@"@ WHAZLETON U&MCWIMWOU$M ANWRR-A. rr- Chemical& SloModicalSciences Division 3301 KINSMAN BLVD. - P.O.BOX 7545 - MADISON, WISCONSIN S3"7 - PHONE (OW 241-"71 - TLX 703M MAZRAL MOS UD SAMPLE NUMBER: 70905394 SAMPLE: T-4101 PAGE 2 KEY PERSONNEL Acute Toxicoloov Steven M. Glaze Study Director Calvin L. Horton Group Leader Support Services Sharon L. Howery Report Coordinator QualitV Assurance Debra Curley Arndt Manager LaboratorU Animal Veterinarian Cindy J. Cary, DVM Diplomats, ACLAM (EHAZLEMON L&MORWOMM &AAEPCA. W-X- 33DI KINSMAN BLVD. - P.O. BOX ?US - MADISON. WISCONSIN S3M7 Chemical & SloMedicalSciences Division PMONE (608)241-4471 - TLX n39M HAZAAL MDS UD SAMPLE NUMBER: SAMPLE: T-4101 70905394 PAGE 3 OECD DERMAL IRRITATION Objective: corrosion according Guidelines To determine the relative level of primary skin irritation/ of a test substance on rabbits under somiaccluded conditions to the Organisation for Economic Cooperation and Development's for Testing Chemicals. Test Material: T-4101 Physical Description: Purity and Stability: Storage and Retention: Safety Precautions: Amber liquid Sponsor assume& responsibility for purity and stability determination&. The test moterial was stored at room Any unused material will be discarded to HLA Standard Operating Procedure. Normal handling procedures were used to HLA Standard Operating Procedure. temperature. according according Test Animal: Young adult rabbits of the Now Zealand White &train were procured, maintained individually in screen-bottom cages in temperatureand humidity-controlled quarters, provided access to water Ad libitum and a measured amount of Purina High Fiber Rabbit Chow, and hold for an acclimation period of at least 7 days. Animal husbandry and housing at HLA comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals". If variations from the prescribed environmental conditions existed, they were documented and considered to have no effect on the study outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study. Three acclimated animals, weighing from 2240 to 2397 g, were chosen at random for the test@ treated, and maintained during the observation period as specified for the acclimation period. Test animals were identified by animal number and corresponding ear tag. Approximately twenty-four hours before treatment the hair was clipped from the back of each animal. Reason for Species Selection: Historically, the Now Zealand albino rabbit has been the animal of choice for evaluating of chemicals on the skin. White the effect Preparation and Administration of Test Material: received. The pH was determined to be 12.9. The sample was dosed as WHAZLEZON LANDRO-CPWM A&IMCA. 01@C 3301 KINSMAN BLVD. - P.O. BOX ?S45 - MADISON. WISCONSIN Chemical & SloM*dicalSciences Division S3707 - PHONE COW 241-4471 - TLX 7039M MAZRAL MDS UD SAMPLE NUMBER: SAMPLE: T-4101 70905394 PAGE 4 OECD DERMAL IRRITATION (CONTINUED) Treatment: The test material was applied to the intact skin of each rabbit in the amount of 0.5 ml. The treated area was covered with a 2.5 x 2.5-cm gauze patch secured with paper tape and overwrapped with Saran Wrap and Elastoplast tape to provide a somiocclusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure period. Reason for Route of Administration: based on the method of Draize. Historically, the route of choice Observations: After the exposure period, the patches were removed. The test sites were wa&hed using lukewarm top water and disposable paper towels. The test material was removed from the test site& as thoroughly as possible without irritating the skin. Thirty minutes following removal of the test material, the degree of orythems and edema was read according to the Dreize technique. Subsequent examinations were made at 24, 48 and 72 hours after patch removal. Individual body weights ware taken just prior to study initiation. Pathology: At study termination all animals were outhenatized and discarded. Statistical Methods: Other than average skin irritation scores, no other statistical method was performed. Location of Raw Data and Final Report: The raw data and a copy of the final report will be retained in the archives of HLA. 9@"@HAZLEZON 6&MCPMCrMW ANEPCA. WC 3301 KINSMAN BLVD. 0 P.O. BOX 7US - MADISON, WISCONSIN Ch*mical & SioMedical Sciences Division S3?07 - PHONE (OW 241-4471 - TLX 703M MAZFTAL MOS UD SAMPLE NUMBER: SAMPLE: T-4101 70905394 PAGE 5 OECD DERMAL IRRITATION (CONTINUED) SUMMARY Test Animal: Albino Rabbits - New Zealand White Source: Hazleton Research Products, Inc., Denver PA Date Animals Received: 10/20/87 Date Test Started: 11/02/87 Date Test Completed: 11/05/87 Animal Number Sax F20312 m F20313 m F20331 F Mean INDIVIDUAL DERMAL Erythems Hours 4 24 48 72 0 1 1 0 0 0 0 0 0 0 0 0 0.0 0.3 0.3 0.0 IRRITATION 4 SCORES Edema Hours 24 46 0 0 0 0 0 0 0 0 0 0.0 0.0 0.0 72 0 0 0 0.0 PRIMARY DERMAL Observation Period 4 Hours: 24 Hours: 49 Hours: 72 Hours: IRRITATION SCORES 3 Rabbit Mean 0.0 0.3 0.3 0.0 The Primary Dermal Irritation for all the animals (arythema sites (3) at each observation Score is the total and edema) divided period. dermal by the irritation score number of test Comment: The right hind foot of Animal No. F20312 appeared 24 hours following patch removal. injured too HAZLETON LANORAnxwAmP-0-0=^. Chemica&l SloM*dicaSlcienceDsivision 3301KINSMAN BLVD.- P.O.BOX 7545- MADISON,WISCONSINS3"7 * PHONE (6062)41-447o1 TLX 7039M HAZFTALMDS UD SAMPLE NumeER: SAMPLE: T-4101 70905394 PAGE 6 OECD DERMAL IRRITATION (CONTINUED) References: 1. Organisation for Economic Cooperation and Development's Guidelines for Testing of Chemicals, Section 404, Acute Dermal Irritation/ Corrosion, adopted May 12p 1981. 2. OECD's Principles of Good Laboratory Practice, Annex 2, c(el)30(Final). 3. Dreize, J.H., "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics - Dermal Toxicity", Association of Food and Drug Officials of the U.S., pp. 46-59 (1975). 4. NIH Publication No. 86-23 (revised 1985). PersonnelSignatureShoot Acute Toxicology OLANo. 7(f'905-,7CI'-l PAK Job Title Sionature Becky Beckwith Steve Beloungy Sr. Lab. Animl Asst. Lab. Animl Asst. e-7' Ken Bridges Pat Crary Sr. Lab. Animl Asst. Sr. Lab. Anisel Asst. Shane Eith Shatm Frazier Steven R. Glaza Lab Animl Asst. Lab Animl Asst. Group Leader Molly Kahn Admin. Clerk Kevin HW Iton Lab. Animl Asst. Jeff Hicks Sr. Lab. Animl Asst. ol Calvin Morton Group Leader Sharon L. Mwry Gregory Johnson Paul Krebs Mayvw obdison Scott fteonnell Shelley MCContwIl Dawn Conant ow Ravi s Robin Olson Patricia Padghn Joseph J. Damn Administrati" Asst. Lab. Animl Tech. Lab. Animl Asst. Section Supervisor Lab. Animl Tech. Lab. Animl Tech. Sr. Lab. Animl Asst. Lab. Animl Asst. Lab. Animl Asst. Team Leakr Lab. Animl Asst. Rho T.'JWUW rAC4A&IL-if (:kux@j Michael Patzka John Paulson ULb. Animl Asst. Sr. Lab.* Animl Asst. J&DO Polnow Utb. Animl Toch. Domis B. Steiner Lab. Animl Tech. T--:- A? ltichTahoelsing Lab. Animl Asst. Paul& C. vanm AdministrativAesst. Albert Olson ftnmwr JiM Jirschole LTE Ben Haley Sr. Lab Animal Eileen M. McConnell Admin. Clerk Annette R. Turner Manpower Asst. Initials se, Sk,,, t-AL ;> 44,@ L cx chdclco OCCC (C c 7a 046 am MLA: 7@'9("71C/q PRIPIARY DERMAL IRRITATION SCORING SCALE (DRAIZEI TECHNIQUE) (1)fryth@ and Eschar Formation No trythem 0 Very slight oryth@ (barely perceptible) I Well-defined orythma 2 Moderate to severe orythem 3 Severe tryth@ (beet redness) to slight eschar 4 formation (injuriesin depth) Highest possible oryth@ score 4 (2)Ed@ Formation go ed@ 0 Very slight odma (barely perceptible) 1 Slight od@ (edges of area well-definedby 2 definiteraising) Moderate od@ (raised approximately I m) 3 Severe odm (raised more than I m and 4 extending beyond area of exposure) Highest possible od@ score 4 I Oraize. J. H., 'Appraisalof the Safety of Chemicals in Foods, Drugs, and Cosmetics - Derml--Toxicity.8 Association of Food and Drug and Drug Officials of the U.S., pp. 46-59 (1975). (00261/vot)