Document gbqGnLrNO1959mB2vbpGbq8z9

AR 226 -0666 PFOA Acute Toxicity - L 000837 . & HHT SAAEZZELLREEe TTOONN, FINAL REPORT pre Armstrong Toxicology Services Building 220-2E-02 St. Paul, MN 55144-1000 Sample: T-4416 HLA Number: 91201740 i 3 x - Enclosed: Primary Dermal Irritation/Corrosion Study in Rabbits (OECD Guidelines) o Key persomel o30 MSReoetmfhaoedrroyeloeogFsy,Results 0 Raw Data Appendix Stone: Nise WW, teven M. Glaza Study Director Acute Toxicology us Date LrsLotreet oaoeemariporet N00838 . @ HA T E azLS eTE eont,e HLA Number: 91201740 Sample: T-4416 Acute Toxicology SStteuvdeynDiM.recGtloarza Section Supervisor Steven R. Sorenson Study Coordinator Patricia Padgham Group Leader Sharen L. Howery Report Coordinator Page 2 KEY PERSONNEL QualityAssurance MDaenbaorgaehr L. Keller LaboAnr imaa l Vt eteo rinr ariyan Cindy J. Cary, DVM Diplomate, ACLAM AEERRE E, oso seommoimmaptey ) 000829 . @ HHpSaAOezZRLLlTEETtTOONsN sample: T4816 HLA Number: 91201740 Page 3 METHODOLOGY Objective: To determine the relative level of primary skin irritation/ caocrcroorsdiionng toof tahetesOtrgamantiezraitailon onforrabEbciotnsomiucndCeoropseermaitoicocnludaendd Dceovnedliotpimoennst's Guidelines for Testing Chemicals.' 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 re keh Standard Spursting. Procedure. Tchoenditteisotnsm)a.terial was stored at room temperature. Any unused material will be returned to the Sponsor Normal handling procedures were used according to HLA Standard Operating Procedure. TesmtainAtniamianle:d inYdouinvgiduaadlullyt ainlbisncoreeranb-bbiottst,omHcraag:e(sNZWi)nSPtFe,mpwerearteurper-ocuarnedd, 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". 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. fL r E J 00830 . @PHhHraAzZrLLerEETlTOONN, 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 Feria: and secured with Elastoplast tape to provide a semiocclusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure Reason for Route ofAdministration: Historically, this is the route of choice based on the method of Draize. 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 pein ovat 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 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. nes cen moire0r0i0r5e71  . @HuESaEzERLESETE ON HLA Number: 91201740 Page Sample: T-4416 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 Bmhe Animal Mumber F31147 Individual Dermal Irritation Scores fWF o 51b 59 80 p0 o0 50 00 Erythema (Hour~) ~__Edema(Hour) Sex & 24 48 2 & 24 #8 12 F oo 0 0 0 0 0 0 Observation Average Primary Dermal Period(Hour) 4 24 48 2 average Irritation Scores* Score 0.3 0.3 0.0 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. RnEess enon etme mee roe C0082 . @EHHSeAAEZZLELEERTTOON&N HLA Number: 91201740 Page 6 Sample: T-4416 erences 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 SAsasfoectiyatoifonCheomficFaolods ainndFoDordusg, OfDfriucgisalasndofCostmheetiUc.sS.,- Dpep.rma4l6-4T7oxi(c1i9t7y5,). bAeRSE PHONE(608)241-4471 ome mee nter- Nn0N843 ' WA: Quando PERSONNEL SIGNATURE SHEET ACUTE TOXICOLOGY lime Becky Beckwith Ann Qursaw Anthony Cass Cindy J. Cary, DWH Kari Gassen Steven H. Glaza Ben Haley Jeff Hicks Sharen L. Howery Jin dirschele Wayne Hadison Bud HeDonald Eileen HeComell Henry Hikula Albert Oleson Patricia Padghan Jane Polo Steven R.' Sorenson Dawn Thieding Annette R. Turner Lo Raspes (09/11/89) Lob Title Lab Animal Technician Sr. Clerk Lab Animal Assistant Signature Broly Lickin LorBeuneaeer QadamsgCon nitials BA Gn QC Lab Animal Veterinarian (unduy) Cony oa Sr. Lab Animal Assistant om VN Section Supervisor Eph Sr. Lab Animal Assistant Noeur / 2 So RH Lab Animal Technician LL AAT 22 Research Assistant i, S| Ch Lab Animal Assistant Afischilr 4 Senior Section Supervisor {( dune @ NV0udiven (gone sr. Lab Animal Assistant idAmal Leh Administrative Clerk Lab fnimal Assistant gee TZ oem? Loney FE, zi Vz sr. Lab Animal Assistant (04dOar, AO Group Leader Mics gles 72 Lab Animal Technician Quuzbhww Or Study Coordinator Seblo ms Clerk 27 Sr. Clerk i" : ; Tro Ne Solos Boman hn di [8,4 4 AB. 0nn844 J BEST COPY AVAILABLpuEs prisnons era ces a: 4 fotos Eres) re esta RISE Bh TermmaaClepnees ce CB Laplears u bse t crce etcnSet d tei stwsnow wpalpEA101 [emceeelua TianTT] Lean I [os] [festte seen 12008 | 2008 220N1 11 8 Tg Tal on [romeo erm tn ToeUT WNTTe [roetua veinaTT ~~ 1\Xe ilemer) | ee a | wl nlodie ne TN | re CE a TETTe eeSTTTTN T mene memEt NT 3 we -- EES : so | glen al al aellf LJoeie] oS 1 IS | | oh a 2 b me mey FEET aTrirn seTatsGerearce forpcrerei mwe sire. Te eomiuen hro BeeiTe obe wn evtont on, Ql ou 115 50 Ha:_91201740 PRIMARY DER(MOARLAIIZRERITTEACTHINOINQUSEC)ORING SCALE (1) Erythema and Eschar Formation VNoeryerystlhiegmhat erythema (barely perceptible) 10 wMeoldle-rdaetfeinteod seevreyrtehemearythena 32 Sevfeorremaetriyotnhe(m1anju(rbfeeest redness) to in depth) sight eschar i Highest possible erythema score . (2) Edens Formation HVoeryedesm1aignt edena (barely perceptive) 10 STidgehftinietdeemarai(seidngge)s of area well-defined by 2 SMeovdeerreateedeemdaema(ra(irsaeldsedmoraepprtohaxnima1 tmelyan1dmm) 3i . extending beyond area of exposure) Highest possible edema score ` TDDDrrrauutggzse,a,nd`a3n.dDruCK.go,imOeF"tfAiipccpslraali~ssaDleofrmofatlhe-tTheoU.xSiS.ca,ifteytp.yp." of46A.sC5sh3oecmii(ca1at37li5so)n.ionf FoFoodosd, and (00261/vnt) 660816