Document Z4Xm1ggvL98RaGbMByqk4JN2d

FOR DU PONT USE ONLY AR226-2945 Du Pont HLR 107-90 Study Title Approximate lethal Dose (ALO) of In Rats Author . John H. Sarver Study Completed On March 5, 1990 Performing Laboratory Haskell E. I. du Pont de Neroours and Company, Inc. Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box 50 Newark, Delaware 19714 Laboratory Project ID Haskell Laboratory Report No. 107-90 Page 1 of 7 Company Sanitized. Does not contain TSCA CB1 dEHERAtINFORMATION Du Pont HLR 107-90 Material Tested; Medical Research No.: Haskell No.: Haskell Test Code: Physical Form: Purity: Composition: 18.267 Amber dispersion Synonym: Stability: The test material was assumed to be stable under the conditions of administration. Sponsor: Chemical and Pigments Department E. I. du Font de Nemours and Company, WIlBlngton, Delaware Inc. Material Submitted By: Study Initiated - Completed: herolcals and Pigments Department E. I. du Pont de Nemours and Company, Jackson Laboratory Deepwater, New Jersey Inc. 1/31/90 - 3/5/90 In-Life Phase Initiated - Completed; 2/1/90 - 2/16/90 Notebook: There are 7 pages In this report Distribution: ^ 2 - Company Sanitized. Does not conlam TSCA CBI Du Pont HLR 107-90 Apprqxiaate lethal Dose (AID) of SUMMARY dBBHIHH^^ administered as a single oral dose by Intragastric Intubation to mie rats. No deaths occurred during the study and no^ll ntcal _s1gns_of jsoxicit^ were_ observed, under thejcondl tions of this test, the ALD was grea|terthan 11,000 ng/kg of bod/weight. This material 1s considered to b|e very low In toxiclty (ALD greater than 5000 mg/kg) when administered as a single oral dose. Work by: ./,^tf<C,a,raol ^F,in- Technlcia Study Director: Qg&^ /r----' ('^^oh).n DO/UST^ U. Sarver---- V Technologaist Approved: by: ^fi^E.Mks. kV.t--. Dolores E. Haiek, Ph.D. Research Toxicologlst Acute and Developmental Toxicology Division Reviewed and Approved for I s s u e -: U ^ ^ .LJ. ^Qh^\ John W. Sarver Study DDirector JWS:a1r:HLR38.18 S/S-^o 3 Company Sanitized. Does not contain TSCA CB1 ). AEE 1 3 E. i 4 Jim anFUEm EETavont BIR107-50 E ! a 5 EAwh ' i ERa e i -- i ston: ------ i# 18,267 te Lethal Dose (ALD) of in Rats arts: || o Inens hudteed || suds bates In-lite Observations 2250 sFtisnpsd,RReepcoortrds and 27,2809 saDAnTgE.FrIaNnDwINaGSrReEaPOeRoTEnDsTO whan: ( AND STUDY DIRECTOR: 2/28/30 Reported by orcs Quality As: ! hod 7 ce Auditor pTaitene ori tei=da gi SLaign ]4 } | Po ; | | I. | `CompanySanitized.DoesnotcontTSaCAiCBnI | Du Pont HLR 1.97-90 The purpose ofo8li^tej$l: JRwhen adraln1stored ai Thed-as the IOTO^^ ^K of dosing or ^Ithintt;^^ i ji to the applicable EPA fiooci }.f ^rfl$flJRyl||ii^!ti| noncompilance are docui^nted n ^e$Nd^reci significantly affected the vir" --as- 'E-? ipproxinate lethal dose of > oale rats. The ALO was id death either on the day ;udy was conducted according ilatlons. Areas of Ho deviations existed that A. Animal Husbandry Male Cr1;CDBR rat approximately 7 we^ks old. were received from Charles River Breeding I aboratories, Raleigh, North Carolina. Rats were housed singly In suspem led, stainless sfee'l, wire-mesh cages. Each rat was assigned a unique 1i lentlflcation numper which was recorded on a card affixed to the cage. Pi rina Certified Rodent Chow #5002 and water were available ad Hbltum. 1ats were quarantined, weighed, and observed for general heiTth for aapppprroximately one week prior to testing. Animal rooms were maintained on a tinl er-controHed, l^-hou"' 1 lght/12-hour dark cycle. Envlronmentat condlt1oinns of the rooms were targeted for a temperature of 23 ^ 2C and relative thumidity of 50 + 101. Excursions outside these ranges were of small madni ttude and/or'brlef duration and did not adversely affect the varIdlty of the study. B. Protocol The test material 'as dispersed In distilled water and administered to one rat per dose rat by intragastric intubation. Dose rates administered ranged froijti 2300 to 11,006 (ng/^gof body weight in Increments of appprrooxxiimmaately 501. Additionally, one rat was dosed at 670 mg/kg. The dosing lay was test day One; postexposure day 14 was test day 15. Following adml ilstration of the test material, rats were observed for clinical s gns of toxiclty. Rats were weighed and observed daily until signs of to deity subsided, and then at least 3 times per week throughout the 14-' lay postexposure period. Observations for mortality were made dall y throughout the study. Company Sanitized. Does not contain TSCA CBI Du Pont HLR 107-90 C. Records Retention ] All raw data and the final report yliy be stored In the archives of Haskell Laboratory for Toxicology and Industrial Medicine, E. I. du Pont de Nemours and Conpan), Inc., Newark, Del aware or In the Du Pont Records Management Center, Ullmlngton, Delaware. RESULTS A. Dosage and Mortality data The dosage reglmcjnand the mortality resulting over the 15-day test period are detailed be|1ow. No deaths occurred during the study. Dosage (ing/kg) 670 2300 3400 5000 7500 11.000 Dose Volume (mL) 1.2 4.2 1.9 2.6 4.1 6.1* Emulsion Concentration (nig/mL) 150 150 500 500 500 500 Initial Body Weight (g) 269 275 272 261 274 279 * Administered In 2 portions, 15 minutes apart. Mortality No No No No No No 6 Company Sanitized. Does not contain TSCA CBI 7 - fioffipany Sanitized. Does not contain TSCA CB1