Document 3qVK3B3r18jNrEeNoBkvEKYO

,.@V@:HAZLEMON LABCNQATC)RIES AN@EF:%C.A. rl.C. 3301KINSMAN BLVD.,P.O.BOX 7545 MADISON, Wl S3707 USA FINAL REPORT Karen Armstrong 3M Toxicology Services Building 220-2E-02 St. Paul, MN 55144-1000 Sample: T-4416 HLA Number: 91201740 Enclosed: Primary Dermal Irritation/CorrosionStudy in Rabbits (OECD Guidelines) o Key Personnel o Methodology o Summary of Results o References o Raw Data Appendix Signed: \t@ Steven M. Glaza Study Director Acute Toxicology PHONE (608)241-4471 FACSIMILE (608)241-7227 TELEX TLX 703956 HAZRAL MDS UD -z-- @A-c@-,) Date a OCO%NWAO LS*Qrmkwv Swwc" conwww HAZLETON LABC)RATORIES AN4El4C-A3301 KINSMAN BLVD., P.O. BOX 7545 MADISON, Wi S3707 USA HLA Number: 91201740 Sample: T-4416 Page 2 Acute Toxicology Steven M. Glaza Study Director Section Supervisor Steven R. Sorenson Study Coordinator Patricia Padgham Group Leader Sharen L. Howery Report Coordinator KEY PERSONNEL Ouality Assurance Deborah L. Keller Manager Laboratory Animal Veterinarian Cindy J. Cary, DVM Diplomate, ACLAM PHONE (W8) 241-4471 FACSIMILE (608)241-7227 TELEX TLX 703956 HAZRAL MDS UD a OC)RW,10 Labonmv 4 c.."..y HAZLEMON LABC,.AT.F,.S AN4ERC-4- 3301 KINSMAN BLVD., P.O. BOX MADISON, Wl S3707 USA r-JC:. 7545 HLA Number: 91201740 Sample: T-4416 Page 3 METHODOLOGY Objective: To determinethe relativelevel of primaryskin irritation/ corrosion of a test material on rabbits under semioccludedconditions according to the Organization for Economic Cooperation and Development's Guidelines for Testing Chemicals.' Test Material: T-4416 Physical Description: Purity and Stability: Storage and Retention: Safety Precautions: Clear colorlessliquid Sponsor assumes responsibility for purity and stabilitydeterminations(includingunder test conditions). The test material was stored at room temperature. Any unused material will be returned to the Sponsor according to HLA Standard Operating Procedure. Normal handling procedures were used according to HLA Standard Operating Procedure. Test Animal: Young adult albino rabbits, Hra:(NZW)SPF, were procured, maintained individually in screen-bottom cages in temperature- and humidity-controlledquarters, provided access to water ad libitum and a measured amount of High Fiber Rabbit ChowO 5326, Purina Mills, Inc., and held for an acclimationperiod 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".2 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 2040 to 2247 g, were chosen at random for the test, treated, and maintained during the observation period as specifiedfor the acclimationperiod. Test animals were identified by animal number and correspondingear tag. Within 24 hours prior to treatment the hair was clipped from the back and flanks of each animal. Reason for Species Selection: Historically, the New Zealand White albino rabbit has been the animal of choice for evaluating the effect of chemicals on the skin. Preparation of Test Material: The sample was dosed as received. The pH was determined to be 9.9. PHONE (608) 241-4471 FACSIMILE (608)241-7227 TELEX TLX 703956 HAZRAL MDS UD 0 CXDRPAPOG LabwaiorVS.M. Cowwny HAZLETON LAEX3FtATC)FIES AhAERC-Ar@C. 3301 KINSMAN BLVD., P.O.BOX 7545 MADISON, Wl S3707 USA HLA Number: 91201740 Sample: T-4416 Page 4 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, loosely overwrapped with Saran Wrape and secured with Elastoplastl&tape to provide a semiocclusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure period. Reason for Route of Administration: Historically,this is the route of choice based on the method of Draize.3 Observations: After the exposure period, the patches were removed. The test sites were washed using lukewarm tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritatingthe skin. Thirty minutes followingremoval of the test material, the degree of erythema and edema was read according to the Draize technique. Subsequent examinations were made at 24, 48, and 72 hours after patch removal. Individualbody weights were taken just prior to study initiation. Termination: At terminationof the experimentalphase, all animals were euthanatized and discarded. Statistical Methods: No statisticalmethod 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. PHONE (608)241-4471 FACSIMILE (W8) 241-7227 TELEX TLX 703956 HAZRAL MDS UD s CX@iRrIWAOLabo,060ry't 1 cow4nny HAZLETON LAEOP.ATOFOES AN4ERC.A. 3301 KINSMAN BLVD., P.O.BOX 7545 MADISON, Wi 53707 USA HLA Number: 91201740 Sample: T-4416 Page 5 SUMMARY OF RESULTS Test Animal: Albino Rabbits - Hra:(NZW)SPF Source: Hazleton Research Products, Inc., Denver PA Date Animals Received: 12/19/89 StartDate (In-life):01/09/90 End Date (In-Life): 01/12/90 Animal Number F31148 F31141 F31147 IndividualDermal IrritationScores Erythema (Hour) Edema (Hour) Sex 4 24 48 72 4 24 48 72 m I1 0 0 00 0 0 F 00 0 0 00 0 0 F 00 0 0 00 0 0 Average Primary Dermal IrritationScores* Observation Period (Hour) Average Score 4 0.3 24 0.3 48 0.0 72 0.0 The average primary dermal irritationscore is the total dermal irritation score for all the animals (erythema and edema) divided by the number of test sites (3) at each observationperiod. PHONE (608)241-4471 FACSIMILE (608)241-M7 TELEX TLX 703956 HAZRAL MDS UD a CC)RPMPJOLabwamy SerwomCe"oww HAZLETON LAaoF*ATCFIES AkAERC.Ar,.r- 3301 KINSMAN BLVD., P.O. BOX 7545 MADISON, Wl 53707 USA HLA Number: 91201740 Sample: T-4416 Page 6 REFERENCES 1. "Acute Dermal Irritation/Corrosion," Organization for Economic Cooperation and Deve7opment's Guide7ines for Testing of Chemicals, Section 404 (adopted May 12, 1981). 2. NIH Publication86-23 (revised 1985). 3. Draize, J. H., "Primary Irritation of the Skin," In: Appraisal of the Safety of Chemica7s in Foods, Drugs and Cosmetics - Dermal Toxicity, Association of Food and Drug Officials of the U.S., pp. 46-47 (1975). PHONE (608)241-4471 FACSIMILE (608)241-7227 TELEX TLX 703956 HA.ZRAL MDS UD 0 OORWVQ LAbWanry Swv@ Con"ny IILA: PERSOtIlIEL SIGIIATURE SliEET ACUTE TOXICOLOGY tlame Job Title Signature Initials Becky Beck@-titli Lab AiiimalTeciiiiician Anti Bursa@-i Sr. Clerk Antliony Cass Lab Animal Assistant Cindy J. Cary, DVI,L Lab Animal Veterinarian n k@u@ c-0,-b-)@ C.,C- Kari Gasseti Sr. Lab Animal Assistant Steven 1-1.Glaza Section Supervisor Ben Haley Sr. Lab Animal Assistant Jeff Hicks Lab Animal Tectinician SilarenL. Hoviery ResearciiAssistant AA, JiniJirscliele @-layiIi-eladison Lab Animal Assistant JL. 2 Senior SectioiiSupervisor Bud I,IcDonald St-.Lab AiiiiiiAaslsistant Eileen I-IcConnell Ad iiiiiiisti-atCilveerk lienryt-likula Lab AiiiiiiAaslsistant Albert Olesoii Si-.Lab AiiiiiiAaslsistant Pati-iciaPadyliaiii Group Leader ("-az-Ca, Z.(/-..o /.@',, Jane Poliiow Lab Animal Teciiiiician Steven R..'Sorenson Study Coordinator 2,I(@l DavinTliieditig C.1erk Annette R. T-u 'riiei, Sr. Clet-k ,t r L4py,( a,71) 1,-) (09/11/89) cl: cr CD.2 ca @tj CL -@l ti U L V, cr lu Vc.ri ci m Of 13 Ot -,3 41 tj ci cc u u 3L i L.1 c c -1 -3 n D w C3 c 0 0 cj C) C3 ai 3 tx CL L ai 4u L. u a. Iz. j C c w C,-r95 HLA: PRIMARY DERMAL IRRITATION SCORING SCALE (DRAIZEI TECHNIQUE) (1)frythema and Eschar Formation No erythema 0 Very slight erythema (barely perceptible) I Well-defined erythema 2 Moderate to severe erythema 3 Severe erythema (beet redness) to slight eschar 4 formation (injuries in depth) Highest possible erythema score 4 (2)Edema Formation No edema 0 Very slight edema (barely perceptible) 1 Slight edema (edges of area well-defined by 2 definite raising) Moderate edema (raised approximately I mm) 3 Severe edema (raised more than 1 mm and 4 extending beyond area of exposure) Highest possible edema score 4 Draize, J. H., "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics - Dermal-Toxicity." Association of Food and Drug and Drug Officials of the U.S., pp. 46-59 (1975). (00261/vmt)