Document Byq52MJyGRzv79DM9aJmdEXx8

HAZLC%CN LAEIORATORIES AfvlERICA. INC. 3301 KINSMAN BLVD. P.O.BOX 7545 MADISON, WISCONSIN 53707 Chemical& BioMedicaSlciencesDivision PHONE (608)241-4471 TLX 703956HAZRAL MOS UD FINAL REPORT c E II/I t@'o Jf'@,2N7 'i9S8 RNGER G. PERKINS MINNESOTA MINING & MANUFACTURING TOXICOLOGY SERVICES ST. PAUL .;MN 55101 COMPANY SAMPLE: T-4102 PI.JRCHASE ORDER NIJMBER: T837389-410 754 SAMPL" BER: 70905763 SAMPLE ENTERED: 09/25/87 REPORT PRINTED: 01/21/88 FNCL.OSFD: PRIMARY DERMAL IRRITATION/CORROSION (OECD GUIDELINES) Key Per5onnel Methorl Summary Reference5 Raw Data Appendix STUDY IN RABBITS STGNFD: STEVEN M. GLAZA STUDY DIRECTOR ACLJTE TOXICOLOGY ........ ............... DATE IFIH"ALZLEZON \W LM3CnMURIES ANAERICA, INC. Chemical& B!oMedicaSlciencesDivision 3301 KINSMAN BLVD. 0 P.O.BOX 7545 MADISON, WISCONSIN 53707 - PHONE (6082)41-4471o TLX 703956HAZRAL MDS UD C;AMPLE NI-JMBFR: 70905763 SAMPL.E: T-41.02 PAF-,E 2 KEY PERSONNEL Acute Toxicoi-gr@ki Ste,,)enM. Glaza Study Director Cal-,.)iLn. Horton C,roup Leader Sijppr)rt SF-,rvice.5 Sharen L. Howery Report Coordinator Qualit@2 Assurance Debra Curlek) Arndt Manager L.aborator@2 Animal @)i-teringrian Cindy J. Cary, D(JM Diplomate, ACLAM IFIH"ALZLOTON \W LAEN3RATORIES Ak,.IERICA,INC. Chemical& BioMedicalSciencesDivision 3301 KINSMAN BLVD. o P.O.BOX 7545 9 MADISON, WISCONSIN 53707 o PHONE (6082)41-4471o TLX 703956HAZRAL MDS UD SAMPLE NUMBER: 7ngnc5763 SAMPLE: T-4102 PAGE 3 OFCD DERMAL.. IRRITATION n-bier.ti,,,)Teo: determine the relative level of primary skin irritation/ corrosion of a test substance on rabbits under semioccluded conditions according to the Organi5ation for Economic Cooperation and Development's Guidelines for Testing Chemicals. Test Material: T-4102 Physical Description: Pijrit.y and Stability: Storage and Retention: I;afet@j Precautions: Dark amber liquid Sponsor assumes responsibility for purity and stability determinations. The test material was stored at room Any unused material will be discarded to HLA Standard Operating Procedure. Normal handling procedures were used to HI-A Standard Operating Procedure. temperature. according according Test Animal: Young adult rabbits Of the New Zealand White strain were procured, maintained individually in 5creen-bottom cages in temperature- and humidity-controlled quarters, provided access to water ad libitL,IM and a measured amount of Purina High Fiber Rabbit Chow, and held For an acclimation period of at least 7 days. Animal hi-isbandry and housing at HLA comply with standards outlined in the "Guide for the Care and Use of L.aborator@j Animals". If variations from the prescribed environmental conditinn5 existed, they were documented and considered to have no effect on the -,tijd,,o;utcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the restilts of the study. Three acclimated animal5,, weighing from 2202 to 2325 g, were ch05en at random for the te5t,, treated., and maintained during the observation period as specified for the acclimation period. Test animals were identified by animal number and corresponding tL,ient5j-four hoi-jrs before treatment the hair ear tag. was cl ipped Approximatelki from the back of each animal. Reason for Species Selection: albino rabbit has been the of chemicals on the skin. Hi5torically., animal of choice the New Zealand for evaluating White the effect Prpoaration and Administration of Test Material: receik,,ed. The pH was determined to be 9.1. The sample was dosed as 6-"***1 HAZLOTON LAEnRXURlr=S APAERICA, INC. Chemical& BloMedicalSciencesDivision 3301 KINSMAN BLVD. 9 P.O.BOX 7645 o MADISON, WISCONSIN 53707 o PHONE (608)241-4471* TLX 7039S6HAZRAL MDS UD ';AMPL.-E@ILIMBER: 70905763 SAMPLE: T-4102 PAf--,E 4 NFCD DFRMAI- IRRITATION (CONTINUED) Treatment: The test material was rabbit in the amount of 0.5 ml. 2.5 x 2.5-cm gauze patch secured Saran Wrap and Elastopla-st tape Collar5 were applied to restrain period. applied to the intact skin of each The treated area was covered with a with paper tape and overwrapped with to provide a semiocclusive dressing. the test animals for the 4-hour exposure Reason for Route of Administration: based on the method of Draize. Historically , the rr3i.iteof choice Observations: After the exposure period, the patches were remo,,.jed. The test 5ite$ were washed using lukewarm tap water and disposable paper The test material was removed from the test 5iteS a$ thoroughly as possible without irritating the 5kin. Thirty minutes following removal of the test material, the degree of erythema and edema was read according to the Draize technique. Subsequent examinations were made at 24.1 4R and 72 hours after patch removal. Individual body weights were taken just prior to study initiation. Pathology: discarded. At stud@j termination all animals were euthanatized and Statistical Methods: statistical method Other than average was performed. dermal irritation score5, no other L-ncation report of Raw Data and Final Report: The raw data will be retained in the archives of HL.A. and a copy of the final HAZLOTON LAEK3PWC)RIES AAAERICA. INC. Chemical& B!oMedicalSciencesDivision 3301 KINSMAN BLVD. a P.O.BOX 7545 9 MADISON, WISCONSIN 53707 * PHONE (6082)41-44719 TLX 703956HAZRAL MDS UD c;AMPI..F NI-JmeFR: 70905763 SAMPI..F: T-4102 PAGE 5 OECD DFRMA[- IRRITATION (CONTINUED) SUMMARY Test Animal: Albino Rabbits - Now Zealand White Source-.': Hazleton Research Products, Inc., Denver PA Date Animal.5 Received: 10/20/87 Date Test Started: 11/02/87 Date Test Completed: 11./05/87 Animal Numb F-.r -C;ex F20309 m F?.0349 F F20311 m Mean INDTVIDIJAT- DERMAL. IRRITATION SCORES Erythema Edema Hours 4 24 48 72 1 1 1 1 0 a 0 0 a 1 1 1 0.3 0.7 0.7 0.7 Hours 4 24 48 72 1 0 1 0 0 0 Li 0 0 a 0 0 0.3 0.0 0.3 0.0 PRIMARY DERMAL Observation Period 4 Hours: 24 Hours: 48 Hours: 72 Hours: IRRITATION SCORES 3 Rabbit Mean 0.7 0.7 1.0 0.7 The Primarv Dermal Irritation Score is the total dermal irritation score for all th; animals (er5)thema and edema) divided by the number of test sites (3) at each observation period. HAZLMMON LMBCXR=C)RIES AVERICA, INC. 3301 KINSMAN BLVD. 9 P.O.BOX 7545 o MADISON, WISCONSIN 53707 Chemical& BloMedicalSciencesDivision PHONE (608)241-4471* TLX 703956HAZRAL MDS UD ,;AMP(.-.FNI.IMBFR: 70905763 C;AMPLE: T-4102 PAGE 6 OFCD DERMAI- IRRITATION (CONTINUED) References: 1. Organisation for Economic Cooperation and Development's Guidelines for Testing of Chemicals, Section 404, Acute Dermal Irritation/ Corro-sion,, adopted Ma5i 12, 1981. 2. nECD'5 Principles of Good Laboratory Practice, Annex 2, C(81)30 (Final). 3. Drai7e, 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). Personnel Signature Sheet Acute Toxicology 14LANo. -7C,@C@7(@,3 Name Job Title Signature Becky Beckwith Sr. Lab. Animal Asst. Steve Beloungy Lab. Animal Asst. Ken Bridges Sr. Lab. Animal Asst. Pat Crary Sr. Lab. Animal Asst. Shane Eith Lab Animal Asst. Shawn Frazier Lab Animal Asst. Steven M. Glaza Group Leader Molly Hahn Admin. Clerk Kevin Hamilton Lab. Animal Asst. Jeff Hicks Sr. Lab. Animal Asst. Calvin Horton Group Leader Sharen L. Howery AdministrativeAsst. Gregory Johnson Lab. Animal Tech. Paul Krebs Lab. Animal Asst. Wayne ftdison Section Supervisor Scott McConnell Lab. Animal Tech. Shelley McConnell Lab. Animal Tech. Dawn Conant Sr. Lab. Animal Asst. Don ftvis Lab. Animal Asst. Robin Olson Lab. Animal Asst. Patricia Padghm Team Leader Joseph J. Daun Lab. Animal Asst. Michael Patzka Lab. Animal Asst. John Paulson Sr. Lab: Animal Asst. Jane Polnow Lab. Animal Tech. Dennis B. Stainer Lab. Animal Tech. Michael Thesing Lab. Aniul'Asst. Paul& G. Vangen AdministrativeAsst. Albert Olson Manpower Jim Jirschele LTE Ben Haley Sr. Lab Animal Asst. Eileen M. McConnell Admin. Clerk Annette R. Turner Manpower . 4a22ki..I@ 7@FL- 'A 1,2a Initials -gEL-sis t@rilzo 'A'o ri MLA DERM IRRITATION/NODV WEIC411 RECORD (4-Hour Exposure) study lttle'. PrimarYbEgai-imAULLO!l li:iM,atterial.- -% @@C) a pi,yi,iL&IDescription; pilResult I & Hater No. 6890 Dust:;---0.5 lbistenedwith 0.9%Saline P,iLeAnimals Received:-L2-0S-o1ur7ce/Strai&Apecies; lialletanResearch PED"tslpAw Zoe and Uh its/RabbitNo" Humbur; Tecilitician/PaAtneimalsClipped'-- %(A / 111.1-/19-7 Sk lotPrgpar&t laii. V Intact A)A_Abrad4;i ivith a clipper bi&de) Initiatedbys Reviewed bys lial Anitul Nintier/Sax ifilti.eBlody Ueiabg (2 Fa-o3ii Tocimici KR Recorded bw ta9f47 scale d Kfft%o /-Day Body Weight (a) -M--@ son=,- 4-na Body Mainlit I-Oa Body Weight serVit lots Period beeval Irritation 4 liours trythema Edei" 10,7 14 liours [dead 48 Hours Erytheam Edoom 7? Hours Erytit@ C) fact" 6 96 Hours Fr 11-30.'I7P ft- bAA, I.o- to CJA, N vs 017 Erltioem [dL"" ! trythma oys 21 fliyt, Edema MA Nut applicable. A Stibi;oitantauhsemorriwi. 0 dianclittig. Possible necrotic area. Nu Unable to determine PN. I/vmi All Animals appeared normal Just prior to dositio. Tocintician D-its Surviving animis designated for sacrifice and discard. Technician Ar@@ Date Data rev lewd by-. -44-- Date: HLA: 70?C,57(.o'@ PRIMARY DERMAL IRRITATION SCORING SCALE (DRAIZE1 TECHNIQUE) (1)Erythema and Eschar Formation No erythema 0 Very slight erythema (barely perceptible) 1 Well-defined erythema 2 Moderate to severe erythema 3 Severe erythema (beet redness) to slight eschar 4 formation(injuriesin depth) Highest possible erythema score 4 (2)Edema Formation No odema. 0 Very slight edema (barely perceptible) 1 Slight edema (edges of area well-defined by 2 definiteraising) Moderate edema (raised approximately I m) 3 Severe edema (raised more than 1 m and 4 extending beyond@are,aof exposure) Highest possible edema score 4 Braize, 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)