Document KGNV8Jgo3vaxpN21Zvo9vbM8Q

HAZLETON LABORATORIES AM ERCA.M C. 3301 KINSMAN BLVD., P.O. BOX 7545 MADISON. Wl 53707 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/Corrosion Study in Rabbits (OECD Guidelines) o Key Personnel o Methodology o Summary of Results o References o Raw Data Appendix Signed: Steven M. Glaza Study Director Acute Toxicology CT Date PHONE (608) 241-4471 FACSIMILE (608) 241-7227 TELEX TLX 703956 HAZRAL MDS UD O O m vm iO LaO orauy S a m e Company HAZLETON L A B O R A T O R I E S A M E R C A . *MC. 3301 KINSMAN BLVD.. P.0. BOX 7545 MADISON. Wl 53707 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 Quality Assurance Deborah L. Keller Manager Laboratory Animal Veteri nari an Cindy J. Cary, DVM Diplomate, ACLAM PH O N E (608) 241-4471 FACSIMILE (608) 241-7227 TELEX TLX 703956 HAZRAL MDS UD O O R N M O Laboratory Sorv-- > Company HAZLETON LABORATCWES AM EBCA. rsjc. 3301 KINSMAN BLVD., P.O. BOX 7545 MADISON. Wl 53707 USA HLA Number: 91201740 Sample: T-4416 Page 3 METHODOLOGY Objective: To determine the relative level of primary skin irritation/ corrosion of a test material on rabbits under semioccluded conditions according to the Organization for Economic Cooperation and Development's Guidelines for Testing Chemicals.1 Test Material: T-4416 Physical Description: Purity and Stability: Storage and Retention: Safety Precautions: Clear colorless liquid Sponsor assumes responsibility for purity and stability determinations (including under 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-controlled quarters, provided access to water ad 1ibitum and a measured amount of High Fiber Rabbit Chow 5326, Purina Mills, Inc., and held 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".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 specified for the acclimation period. Test animals were identified by animal number and corresponding ear 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. PHO N E (608) 241-4471 FACSIMILE (608) 241-7227 T ELEX TLX 703956 HAZRAL MDS UD a C X W N tN O Laboratory Sonneaa Company HAZLETON LABORATORES AM ERCA. rs)C. 3301 KINSMAN BLVD., P.O. BOX 7545 MADISON, Wl 53707 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 Wrap and secured with Elastoplast 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 irritating the skin. 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, 48, and 72 hours after patch removal. Individual body weights were taken just prior to study initiation. Termination: At termination of the experimental phase, all animals were euthanatized and discarded. Statistical Methods: No 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. PHO NE (608) 241-4471 FACSIM ILE (608) 241-7227 T ELEX TLX 703956 HAZRAL MDS UD a OORNINO Laboratory S rw cw Company 0 s jf' HAZLETON l ABORATCWES AN4EF*CA.vJC 3301 KINSMAN BlVD., P.O. BOX 7545 MADISON. Wl 53707 USA HLA Number: 91201740 Sample: T-4416 ^a9e ^ SUMMARY OF RESULTS Test Animal: Albino Rabbits - Hra:(NZW)SPF Source: Hazleton Research Products, Inc., Denver PA Date Animals Received: 12/19/89 Start Date (In-life): 01/09/90 End Date (In-Life): 01/12/90 Animal Number F31148 F31141 F31147 Individual Dermal Irritation Scores Erythema fHourl Edema fHourl Sex 4 24 48 72 4 24 48 72 M 11 0 0 00 0 0 F 00 0 0 00 0 0 F 00 0 0 00 0 0 Average Primary Dermal Irritation Scores* Observation Period (Hour) Average Score 4 0.3 24 0.3 48 0.0 72 0.0 The average primary dermal irritation score is the total dermal irritation score for all the animals (erythema and edema) divided by the number of test sites (3) at each observation period. PHONE (608)241-4471 FACSIMILE (608) 241-7227 TELEX TLX 703956 HAZRAL MDS UD O O PN W O LMOotmary Smrmom Company 0v355/ HlabAorZatoLriEesTamOerNcarsC 3301 KINSMAN BLVD., P.0. 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 Development's Guidelines for Testing of Chemicals, Section 404 (adopted May 12, 1981). 2. NIH Publication 86-23 (revised 1985). 3. Draize, J. H., "Primary Irritation of the Skin," In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics - Dermal Toxicity, Association of Food and Drug Officials of the U.S., pp. 46-47 (1975). PHO NE (608) 241*4471 FACSIMILE (608) 241-7227 TELEX TLX 703956 HAZ RAL MDS UD OCWNHMO L iD oraw y S tr a n i Company IILA: q i a p o U n PERSONNEL SIGNATURE SHEET ACUTE TOXICOLOGY Name Job Title Signature Initials Becky Beckwith Lab Animal Technician k -PkrLuiith /3ft., Ann Bursaw Sr. Clerk r Anthony Cass Lab Animal Assistant (~)f-AVi /TV\j> CtUWi. (a C. Cindy J. Cary, DVM Lab Animal Veterinarian C u \x\ \ .L A t V U jL- Kari Gassen Steven M. Glaza Sr. Lab Animal Assistant K o A j ' Section Supervisor _ t*r Ben Haley Sr. Lab Animal Assistant __ Jeff Hicks Lab Animal Technician /Ij A r A / O l r A p __ JJ=L-- Sharen L. Howery Research Assistant fJUi/AAj Jim Jirschele Wayne Madison Lab Animal Assistant V Senior Section Supervisor V 0. / ___Hi ; t/V Bud McDonald Eileen McConnell Henry Mikula Albert Oleson Sr. Lab Animal Assistant f i u A / V \ v \ r A l & 7^ Administrative Clerk a-/^ Lab Animal Assistant (-A. O Sr. Lab Animal Assistant C h A Q j & < i+ y\ AO Patricia Padyham f)* Jane Pol now Steven R-. Sorenson Dawn Thieding / Annette R. Turner S4S .J Z l -- A h'.n- (09/11/89) ' OERHAL IRR I TAT IOH/BODY W E I C H T RECOIIU ( 1-Hour Expo su re ) Iil A ; ' I \cl )\ H O Study M l U ': Frln urv Derm I I r r i t a t i o n Tct Kj L e r i a I : T- ^l <4l l o I' l i y s i u l D e s c r i p t i o n : C t - E ^ a C o U ?.ft< .. S ^ Cuie : y t; Per Site I Q u - I t t -------------------------------------------rQ E \ Mo i s t e n e d wi t h O . S S j l l n e pl l R e s u l t : ^ . 9 w i t h CORIIltiG oH t'ETEP. IIP. CESIO C . t e A h ima 1s R e c e i v e d : __ **iriq |g<q Ted.i.lL-Un/UAte A n l.jili Clipped: S o u r c e / S t r J I n / S p e c l e ;: l l i t l e t o n R c s e s r c l i P r o d u c t s /Hew 7 l' j I j m J till It c / l l j M i 11 H u o u H u e i ' i e r : t O H / ' I s h o ______________ I n I t I a L e d b y :-------------------- ---------------- Uj I u :------------ l i i l i l Q ------ Ski n R r c u j r d l Ion: ^ Intact Q A Abraded (with i c lip p e r b lid u ) R u v l u w u d b y : ______________ S r t J ______ U a t u : ______ / ---- HLA: q i a O n U Q PRIMARY DERMAL IRRITATION SCORING SCALE (DRAIZEl TECHNIQUE) (1) .Erythema and Eschar Formation No erythema Very slight erythema (barely perceptible) Well-defined erythema Moderate to severe erythema Severe erythema (beet redness) to slight eschar formation (Injuries 1n depth) Highest possible erythema score (2) Edema Formation 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) Highest possible edema score J ' 3 3 -- 4 0 1 2 3 4 1 Dralze, J. H., "Appraisal of the Safety of Chemicals 1n Foods, Drugs, and Cosmetics - Dermal-Toxicity." Association of Food and Drug and Drug Officials of the U.S., pp. 46-59 (1975). (00261/vmt)