Document qmQEpGqba94a6KYL8zG59dK8K

? I FOR D PONT USE ONLY AR226-2940 Du Pont HLR 391-89 Approximate Lethal Dose (ALD) of " >in Rats Author John W. Server Study Completed On July 21, 1989 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 Iaboratorv Project ID Haskell Laboratory Report No. 391-89 Paae 1 of 6 ISompany Sanitized. Does not contain TSCACBS Material Tested: ' Medical Research No.: Haskell No.: Physical Form: Purity: Composition: GENERAL INFORMATION Du Pont HLR 391-89 17,869 White dispersion Synonyms: Other Code: Stability: The test material was assumed to be stable under the conditions of administration. Sponsor: Chemicals and Pigments Department E. I. du Pont de Nemours and Company, Inc. Wilmington, Delaware Material Submitted By: Chemicals and Pigments Department E. I. du Pont de Nemours and Company, Jackson Laboratory Deepwater, New Jersey Inc. In-Life Phase Initiated - .Completed: 6/12/89 - 7/3/89 Notebook : There are 6 pages in this report. Distribution: - 2^ n . v any Sanitized. Does not contain TSCA C8? Du Pont HLR 391-89 Approximate Lethal Dose (ALP) of In Rats SUMMARY _______[approximately 100% pure) was administered as a single oral dose ByTntragastrlc intubation to male rats. No deaths occurred and no adverse clinical signs of toxicity were observed. Under the conditions of this test, the ALD was greater than 11,000 mg/kg of body weight. This material is considered to be very low in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose. Work by: O ^tyyjJL. > 0 . Anni M. GrandfzTj Technician Study Director: John W. Sarver Technologist Approved by: Lk ' Dolores E. Malek, Ph.D. Research Toxicologist Acute and Developmental Toxicology Division Reviewed and Approved for Issue: John W. Sarver Study Director / /av /in JWS:alr:HLR29.16 -3Co m p a n y Sanitized. Does not contain T S C A CBf Du Pont HLR 391-89 QUALITY ASSURANCE DOCUMENTATION STUDY: 17,869 Approximate Lethal Dose (ALD) in Rats AUDITS: Items Audited Records, Report Audit Dates 7/20/89 SHORT-TERM AUDIT REPORT NUMBER: . DATE FINDINGS REPORTED TO MANAGEMENT AND STUDY DIREuiOR: 7/20/89 Reported by: William J. Lynam Quality Assurance Auditor Date -4Company Sanitized. Does no! contain TSCA CBS INTRODUCTION Du Pont HLR 391-89 K t s^ T sr^ sr'fi'S..,-.,..-. significantly affected the validity of the study. MATER IALS AND METHODS A. Animal Husbandry Male Crl :CD*BR rats, approxintely 7 w ^ k s old. ^ r e c e i v g f r M Charles River Breeding Laboratories, Raleigh, North Carolina. Rats were S S s i TM l y "n suspl,k W , stainless steel. Ire-mesh cages. Each rat was assigned^ unique Identification number affixed to the caae. Purina Certified Rodent Chow #5002 and water were available ad libitum. Rats were quarantined, weighed, and observed for general health forTpproximately one week prior to testing. Animal TM ms Sere maintained oi a timer-controlled, 12-hour Hght/12-hour dark cycle. Environmental conditions of the rooms were targeted for * of 23 1 2-C and relative humidity of 5 0 + 1 0 % . Excursions outside these ranges were of small magnitude and/or brief duration and did not adversely affect the validity of the study. B. Protocol The test material was dispersed in d?sj1 SoSS rat Stered to one rat per dose rate by intragastnc intubation. Dose rates administered ranged from 2300 to a w S d e d at increments of approximately 50%. Additionally, one rat was dosed at mg/Eg? T h e l s i n g day was test day dav 15 Following administration of the test material, rats were o b U . H fop clinical signs of toxicity. S u r g i n g ra s era wa.ghed and observed dailv until signs of toxicity subsided, and then at least 4 times per week throughout the 14-day postexposure period. Observations for mortality were made daily throughout the study. 5 " Company SanHized. Does noi contain TSCA CBS Du Pont HLR 391-89 c. Records Retention ,, .L. rjni rennrt will be Stored in thG 3 PChV6S Of Haskell Laboratorya?or Toxicology and de Nemours and Company, Inc., Newark, Delaware or i n w Management Center, Wilmington, Delaware, RecoSs RESULTS A. Dosage and Mortality Data The dosage regimen and the mortality resulting over the 15 day tes period are detailed below. No deaths occurred. Dosage img/kal Dose Voi urne (mL) Emulsion Concentration (mq/mL) Initial Body Weight (g) Mortality 670 2300 3400 5000 7500 11,000 1.1 3.7 1.7 2.4 3.6 5.6* 150 150 500 500 500 500 241 No 242 No 247 No 244 No 239 No 253 No Admi niistered in two portions, approximately 15 minutes apart. B. Clinical Signs The rat dosed at 11,000 ,, / k g I . W t e d approximately one hear after fsing. The STclSSS/ilS. V K ^ weight) 0,,e wer/ohseLd. CONCLUSION Under the conditions of this study. the ALD |r (ALMreater^than^OOO M - ' - " dose to male rats. |0 r*' ! Company Sanitized. Does not contain TSCA C SI