Document M70gQQXbq0GYXdQ5wyDmne7a

Study Completed On March 5, 1990 Performing Laboratory E. I. du Pont de Nemours and Company, Inc. Haskell Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box 50 Newark, Delaware 19714 Haskell Laboratory Report No. 107-90 Page 1 of 7 Company Sanitized. Does not contain TSC A CB! Du Pont HLR 107-90 CERERAI INFORHAtlOM Material Tested: Medical Research No.: Haskell Ho.: Haskell Test Code; Physical Form; Purity: Composition: Synonym: Stability: Sponsor: Material Submitted By: Study Initiated - Completed: In-Life Phase Initiated - Completed: Notebook : Jimber dispersion The test material was assumed to be stable under the conditions of administration. Chemical and Pigments Department E. I. du Pont de Nemours and Company, Irte. Wilmington, Delaware ^ScfisandPIgments Department E. I. du Pont de Nemours and Company, Inc. Jackson Laboratory Deepwater, New Jersey 1/31/90 - 3/5/90 2/1/90 - 2/16/90 - 2Company Sanitized. Does noi contain TSCA n W V iifr. Du Pont MLR 107-90 Approximate Lethal Dose (ALP) of H u Rats SUMMARY rwais administered as a single oral dose by Intragastrlc Intubation to kale rats. No deaths occurred during the study and no_cl_1nical signs of toxic1ty were observed. Under the condi tlons of this test, the ALD was greater than 11,000 mg/kg of body weight, material 1s considered to b|e very low In toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose. Work by: Technician Study Director: John w. sarver Technologist Approved by Dolores E. Naiex, pn.D. Research Toxicologist Acute and Developmental Toxicology Division Reviewed and Approved for I$sue: JWS:alr:HLR38.18 u ) -John W. Sarver Study Director 3 /S'IS* i -3- Company Sanitized. Does not contain TSCA CB1 Alai il' QUALITT iSSURANCB DOCUMENTATION n3r ?. STUDY: H# 18,267 FApproxiaatte {tha Dose (ALD) of fl Rats 1 AUDITS: Items Audited In-life Observations STSPS, Records and Final Report Audit Dates 2/2/90 2/27,28/90 SHORT-TERM AUDIT REPORT NUMBER: H I DATE FINDINGS REPORTBD TO MANAGEMENT AND STUDY DIRECTOR: 2/28/90 I Reported by: (JJoseph C. HBasailTi Quality Assur ince Auditor JzlMlll Date II i j Ii - 4 II i Company Sanitized. Does not contain TSCA CB! The purpose of iwhen i defined as the 1owStJjp.se * of dosing or within to the applicable EjfA m9$ t nonconpllance are doc significantly affected the v fidiapproxtaate lethal dose of lilio male rats. The ALO wbs ^filled death either on the day ifttjdy was conducted according julatlons. Areas of ! no deviations existed that MATERIALS AND METHODS )1 Animal Husbandry ChhoaursleMedsalseRiinCvgrellry:CBIDnreBesRduisnpragetns>ls<aebdaooraostrtooarxiilnemlsae,tseslRyaslt7eeiewgle,he,kw1sNororelt-dhm,esCwaherrocelaignerase..ceivEReaadtcshfwrreoarmte jaagwfveanfsaeiiraxlaesaldsbiltgehoneeaaddtThtehlalbucflanotgirieqm.uaiep.pP1r<il<irnexlotinstmaiawftCieeecrlraevttiioqofnunieaerwdnaenuRetMoik|ndreepdnr,tiowCrehiotgwohet#de,5s0t0ia2nngd.anodbAsJwneairJmtveaeerlrd wweerree for rooms WE2re3narvne+igremso2animwCneentrataenaidlnoefrdceolsnoamdnatilitlvaieomtniehnsiiic.inomllftdultdtheyeoafrnod5o/0mosr+"wber1r01*ee.ftadrEugxrecatuteridsoinofnoasrndaoudittsedimpdneeortatthuersee of adversely affect the va31d1ty of the study. B. r protocol KtSSliTSf Seta6widomdo7edaonba0yremcslotkreilmanyenr1lgTe5mvit/h.eesuh1kerndntrtgttaeoy.isttrFufleeowgospdleohrteTlfroshroecruimewlaatgaimdpinntnopgandsteirseodghrcoedseeoiaxifaallndrf1dlarmmga4ttolla-osiillIclayaagl>bs2vynlcy3tsylwd0phta0oi51orys0fsnso*tpsttu.otuteregobrexahxs1gsspoiAi1eoatucdd,sdstied0duttdia0rr1ty,t0yne1h,icemodpaognienIIsn/amrsndtemlhitt;umlgo*uidtydabylph,..alOoett*esfneidt*orobenOarnwioxelbt.adpsatIyoerllefsarewrufDvtaerSasawseihttenageidshodd3rantaaysdjtdtoIniemnsdm1fisee4ondosriwbbsasasptseteeerrrvvteeeedddst i) Company Sanitized. Does not contain TSCA CBI Du Pont HLR 107-90 C. Records Retention All raw data and HdaeskNeelmlourLsaboarnadtCoormypafnovyr the final report plli be stored In the Toxicology and Industrial Medicine, E. I. , Inc., Newark, Delaware or 1n the Du Pont jj du Pont Records Management Center, W1i*inlngton, Delaware. RESULTS A. Dosage and Mortality l^ata The dosage regimen and the mortality resulting period are detailed below. No deaths occurred during the study. test Dosage (mg/kg)_ 670 2300 3400 5000 7500 11,000 Dose Volume (ml) 1.2 4.2 1.9 2.6 4.1 6.1* Emul sion Concentration (mg/mL) 150 150 500 500 500 500 Initial Body Weight (g) 269 275 272 261 274 279 * Administered 1n 2 portions, 15 minutes apart. Mortality NO No No No No No -6 Company Sanitized. Does not contain TSCA CBI t1o1x,i00ci0Utnmydge/r(kAgtLhDoegfcroebnaodtgiyetr*iot0nh$sa$n.O'ifii.OOthOTfhiiKgfSs/'f'Pu^datyei*,hrliaf^lfe^*i^s jtnfeos^rrlee^,dr,Be^BatsVoawbesainsveggrlyereloeortwearl Intdhoasne to male rats. w -7 fioffipany Sanitized. Does not contain TSCA CB1