Document Dv3zERBYagB02xrQ5K11KYL04

AP.&26 _ oG6 PFOA Acute Toxicity - X 000837 I? ^ HAZLETON LABCJRATOWES AMEBCA SIC. 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. G l a z a O Study Director Acute Toxicology 'V PHONE (608) 241-4471 FACSIMILE (608) 241-7227 TELEX TLX 703956 HAZRAL MDS UD _________ Date * O O M N M O la borato ry Snrvteoa Company 000838 HLABAORZATLOREES TAMOERGNA.IMC. 3301 KINSMAN BLVD.. P.O. 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 Veterinarian Cindy J. Cary, DVM Dipl ornate, ACLAM PHONE (608) 241-4471 FACSIMILE (606) 241-7227 TELEX TLX 703956 HAZRAL MDS UD 000839 H A Z L E T O Nl a b o r a t o ir e s a v e b c a . im c. 3301 KINSMAN BLVO.. 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 libitum 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. PHONE (608) 241-4471 FACSIMILE (608) 241-7227 TELEX TLX 703956 HA2RAL MDS UD O C W N W O Laboratory Samiean Company 000840 HLABAORAZTOLF4EE S TA MOE BNC A .I'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. PHONE (608) 241-4471 FACSIMILE (608) 241-7227 TELEX TLX 703956 HAZRAL MDS UD OO^NWO Laboratory Sarmcaa Company OOQ841 HlabAorZatLorEies TajvOerNca. rsic. 3301 KINSMAN BLVD,. P.O. BOX 7545 MADISON. Wl 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 Start Date (In-life): 01/09/90 End Date (In-Life): 01/12/90 Animal Number F31148 F31141 F31147 Individual Dermal Irritation Scores Erythema (Hour) Edema (Hour) Sex 4 2 48 Tl 4 M 42 Tl 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 C N m io Laboratory Sarvioaa Company 000842 HLABAORZATLOWEESTA MOEBNC A .N C 3301 KINSMAN BLVD., P.O. BOX 7S45 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). PHONE (608) 241-4471 FACSIMILE (60S) 241-7227 TELEX TLX 703956 HAZRAL MDS UD OOBNWO UbonHoy Santem Campan, 000843 HLA: g i a m - y i n PERSONNEL SIGNATURE SHEET ACUTE TOXICOLOGY Name Job Title Signature Initials Becky Beckwith Lab Animal Technician iu L u ld h ... & __ Ann Bursaw Sr. Clerk / j h w u tb/SCXL/s r* Anthony Cass Lab Animal Assistant D t ;\/rvut Ccuih. ac Cindy J. Cary, DVM Lab Animal Veterinarian ClAviiiA \ .L i L M V Kari Gassen ~T W Z T ' GSr. Lab Animal Assistant f^ o A ji V J C k A A t >-v_ Steven M. Glaza Ben Haley Section Supervisor SSr. Lab Animal Assistant ils kM / m) Jeff Hicks Lab Animal Technician jtjdB. -- ItL Sharen L. Howery Research Assistant umiM\ Jim Jirschele Wayne Madison Lab Animal Assistant ^5 ^ Senior Section Supervisor '/.w >>c 0 - JJ- f} * c j-M M Bud McDonald Sr. Lab Animal Assistant S i d / % < ! \ p \ c z l 0 >;(SS Eileen McConnell Henry Mikula Albert Oleson Administrative Clerk Lab Animal Assistant Sr. Lab Animal Assistant 0&41+K S 7` j AO. Patricia Padgham Group Leader Jane Pol now Lab Animal Teclinician Steven R-. Sorenson Study Coordinator M lO Q-- j C)?Q- Dawn Thieding / Annette R. Turner S&kL sih -, '. n (09/11/89) 000844 best copy available DERHAL IRR I TATIOH/BODY WEIGHT RECOIIU 14-Hour Exposure) l aA: 'Ill'll H O iluay fille r Rrli'urv Derm 1 Ir r it a t io n Tui M a te ria l: ' f - t f a U i o ____________________________________________________ __ I'hys it.41 liescript Ion: C-LEfto Crst/pia/ _________________ ___________ pll Result: *),9 with COP.tllMG oH METER HO. 05510 Cose:_______ (*yg; Per S ite iQ < \ Moistened with 0 . S - S a l i n e C*ie Aii ici* I s Recelyed: ,a /i9 lfiS TecimlcUn/Uate Anluals Clipped: Source/StrA In / S p e c i e ;: llarleton H csearch Products/Hew ?ealaiiJ I l l i li c /H jM i lt Huoh Hueiier: lOM / *|$fao_________ ___ I n i t i a t e d by:___________ _________ Uj I u :_______' h i 9(3 Ski n prcuarat Ion: In ta c t Qfti Abraded (wills a clipper bladu) R uvluwud by:____________ _________ Uatu: / - t?'-IT O _____ cP *nIrtj 1 hun4iir/Sei 3 II48 M il l 111 Oudv Urlilht ini 1 a n 8 1 2QMa I 2-2.cn 7-Djv ftudv Utlnht 1o1 11 1\ 1\ 14 Oar 8udv UclnM in) 1 I"" 1 )\ :i njv OoiJv Uelnl.t io) 1 11 \ 1 1 1 1 1 1 1 1 Rccorucd 1990 KTRON ToclmIc1in hv Hate Scale used: ___ d & ___ -! < & i >h J__ 4C2.I___ 1 ~~ --- 1| 1 1 1 ---- j I 1 I I " '------- JbServal Ion Per lud Doi wj I Jrr 11at Ion Sinm 1 Hours 46 hours 77 hours Erythema fdewi frvthru fdeu# Ervlhem fdnu Erylliciu fjrm Erythema I 1 1 r> Io Ii ! i0 | 0 1o I o lo | O 1o I n ____L O | o 1O l\ I 1 1O 1O 1O 1O 1O iO 1o 1 1 1 I 1 1 1 1 1 1 l\ 1 1\ 1 1\ 1 1\1 1 \1 I \1 1 1 l\ 5 (i-\ as & E i/ >4j\ I-/S-5D k r-v <-n-qc t / w f l-t$-9o % cs .-A, if- , i -n -qc uI in Iq .O I6t| l-ll-^C ! ^ xfc# 'k n o /ve '/iil'h IdJin* I\ 1 1 1 1 1\ 7 C.rs (rvfheua I Ejl'114 1 i 1\ 1 1 1 1\ 1 1 1\ H Says Ervlhem 1 1 1 1 1\ Edciaa 1 1K 1 1 1\ Zl Cays Crvflieoa | i i\ 1 1 1 \ fdein 1 1 1 \l 1 1\ IIA hut app I Icab le. A - SiiULiilineouj hecorr!^.! C/I 8 8 I ancii lug. ' H Possible necrotic ir e *. U Unenle tu deterulne pH. A ll anluals appeared norsa I Just p r i o r to dosing. Tocim Ic Ian . S u r v i v i n g a n i r . a l s d e s i g n a t e d f o r s a c r i f i c e and d i s c a r d . T e c h n ic ia n d Uj t o 'fa lQ fi Oate '/ir l d r Uata reviewed by: D a t e : / ~ / 5? t f O 0008 HLA: q i a o n u o 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 0 1 2 3 __4 4 0 1 2 3 4_ 4 Dralze, J. H., "Appraisal of the Safety of Chemicals 1n Foods, Drugs, and Cosmetics - Dermal-Tox1c1ty." Association of Food and Drug and Drug Officials of the U.S., pp. 46-59 (1975). (00261/vmt) 000816