Document QJxbRNRJwXVnDZxXROLaZoL2k

AR226-2957 Study Completed On Hay 20, 1991 Performing Laboratory E. I. du Pont de Nemours and Company Baskell Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box 50 Newark, Delaware 19714 Medicai P.esearch No. Laboratory Project IP Haskell Laboratory Report No. 320-91 Page 1 of 7 Company Sanitized. Does not contain TSCA Bsterial Tested Bedical Research Bos BtrH Hi.! Haskell Test Code; Physical Fora; Purity5 Composition: gnwntL mFOBH&TIOH Du Pont HLR 320-91 18,920 Off-white opaque liquid Other Codes: Synonyms: CAS Registry Ho. Stability: V In the absence of visible evidence to the contrary, the test material vas assumed to be stable under the conditions of ads T S C A CB- 2 - K M CtV Du Pont HIJt 320-91 GENERAL INFORMATION COST'D Sponsor; Du Pont Chemicals B= I. du Pont de Nemours and Company Wilmington, Delavare Haterial Submitted By: Pont Chemicals I. du Pont de Nemours and Company Jackson Laboratory Deepvater, N.J. Study Initiated - Completed; 3/28/91 - 5/20/91 In-Life Phase Initiated - Completed; 4/4/91 - 4/22/91 Notebook; There are 7 pages in this report. Distribution; U Du Pont HLR 320-91 Approximate Lethal Dose (ALP) of in Rats SUMMARY >was administered as a single oral dose by intragastric intfctlir'to male rats. No deaths occurred and nojlinicai toxicitv vere observed. Under the conditions of this test, the a l d was greater 11,000 mg/kg of body weight. This material is considered to f^ry low in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose. Work by: -7T7. ----- ' Anne M. 'Pessagno Technician Study Director: ^ John W. Sarver Technologist Approved by: a/ 0^ Nan^>C. ~u omey, I .D> er Acute ioxicology Reviewed and Approved for Issue .Q d ~ - John V. Sarver Study Director JWS/lmr -A- tze.d.nDooeessinotcon**'"' C o m p a q San' Du Pont HLR 320-91 QUALITY ASSURANCE DOCUMENTATION STUDY: H# 18,920 roximate Lethal Doss (ALD) of in Rats AUDITS: Items Audited In-life observations Protocol, Records and Final Report Audit Dates 4/4/91 5/16/91 SHORT-TERM AUDIT REPORT NUMBER:) DATE FINDINGS REPORTED TO MANAG! STUDY DIRECTOR: 5/16/91 Reported by Senior Auditor Quality Assurance Date Du Pont HLR 320-91 INTRODUCTION The purpose of this test was to determine an approximate lethal dose of ^ H H I v h e n administered as a single oral dose to male -ats. The ALD vas defined as the lowest dose administered which caused deatn either on the day of dosing or within 14 days post exposure. This study was conducted according to the applicable EPA Good Laboratory Practice Regulations. Areas of noncomplianee are documented in the study records. No deviations existed that significantly affected the validity of the study- MATERIALS AND METHODS A. Animal Husbandry Male Crl:CDBR rats, approximately 7 weeks old, were received from Charles River Breeding Laboratories, Raleigh, North Carolina. Rats were housed singly in suspended, stainless steel, wire-mesh cages. Each rat vas assigned a unique identification number which was recorded on a card affixed to the cage. Purina Certified Rodent Chow #5002 and water were available ad libitum. Rats were quarantined, weighed, and observed for general health for approxima . one week prior to testing. Animal rooms were maintained on a timer--controlled, 12--hour light/12--hour dark cycle. Environmental conditions of the rooms vere targeted for a temperature of 23C + 2C and relative humidity of 50X 102!. 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 Mazola corn oil and administered to one rat per dose rata by intragastric intubation. Dose rates administered ranged from 2300 to 11,000 mg/kg of body weight in increments of approximately 501. Additionally, one rat was dosed at 670 mv/ktr. The dosing day was test day 1? postexposure day .14 was test day 15. "Following administration of the test material, rats were observed for clinical signs of toxicity. Surviving rats were weighed and observed daily until signs of toxicity subsided, and then at least 3 times per week throughout the 14-day recovery period. Observations for mortality were made daily throughout the study. -6- Du Pont BLR 320-91 C. Records Retention All rav data and the final report vili be stored in the archives of Baskell Laboratory for Toxicology and Industrial Medicine, E. I. du Pont de Nemours and Company, Newark, Delaware or in the Du Pont Records Management Center, Wilmington, Delaware. RESULTS A. Dosage and Mortality Data The dosage regimen and the mortality resulting over the 15-day test period are detailed belov. No deaths occurred. Dosage (mg/kg) Dose Volume (mL) Emulsion Concentration (mg/mL) Initial Body Veight (g) Mortality 670 2300 3400 5000 7500 11,000 1.1 3.8 1.7 2.6 3.7 5.4* 150 150 500 500 500 500 250 250 250 259 248 247 No No No No No No * Administered in 2 portions, approximately 15 minutes apart. B. Clinical Signs - There were no clinical signs of toxicity observed in any of the rats during the study. CONCLUSION Under the conditions of this study, the ALD f o r f l ^ 0 M f e w a s 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 to male rats. -7- Company Sanitized. Does ns*. T?<CAC