Document VJywENqvJwapj7jKea1kLgxYj

AR226-2971 John V. Sarver Study Completed On February 24, 1992 3 Performing Laboratory E. I. du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine Blkton Road, P. 0. Box 50 Newark, Delaware 19714 Haskell Laboratory Report No. 813-91 Page 1 of 6 Substance Tostedt Medicei Research Ho: Basiteli Ho. Baskeil Teat Code: Physical Fort Purity Composition} CEEBnAL INFORMATION Du Pont BLR 813-91 19,173 Slightly yellow liquid 100X Synonym: Subaitter's Notebook Ko Stability Sponsor In the absence of visible evidence to the contrary, the test substance was assumed to be stable under the conditions of adainlstration. Du Pont Chemicals B. I. du Pont de Nenours and Company Wilmington, Delaware Substance Submitted By: Du Pont ellenica B. I. du Pont de Nemours and Company Jackson Laboratory Deepwater, NJ Study Initiated - Completed: 10/21/91 - 2/24/92 In-Life Phase Initiated - Completed 10/28/91 - 11/18/91 Notebook There are 6 pages in this report Distribution; Du Font HLR 813-91 Approximate Lethal Do p o (ALP) of In Bat SUMMARY pure) as administered as a single oral dose by Intragsstrlc intubation to sale rats, do deaths occurred and no clinical signs of toxicity were observed. Under the conditions of this test the ALD was greater than 11,000 ag/kg of body weight. This substance is considered to be very low in toxicity (ALD greater than 5000 ag/kg) when administered as a single oral dose. Work by: -m. /m * 2 $ Myers Technician Study Director: u3John V. Sarver Technologist Approved by: a tZ X A ^ -rr y .____ Haney C. Chromsy, Ph.D. Manage r Acute Toxicology Reviewed and Approved for Issue: LO. John W. Sarver Study Director <3 JVS/lmr 3- - >,-is nus Tioi esfttaiiitSC ^ B i Du Pont BLU B13-91 QUALITY ASSURANCE DOCTHHITATIQH Date of Inspection! Conduct - 10/28/91 Recordsi Report(s) - 2/18,19,21/92 Findings reported toi Study Director - 2/21/92 Nanageaent - 2/21/92 Reported by> Kimberly p. Brebner Quality Assurance Auditor f Date s w ,W M d.OO'''jconK*'TSCACW Campon* 4- - Du Pont BLR B13-91 INTRODUCTION ___ The purpose of this test vas to determine an approxiaate lethal dose of V P H | i h e n administered as a single oral dose to male rats. The ALD vas defined as the lovest dose administered which caused death either on the day of dosing or within 14 days post exposure. This study vas conducted according to the applicable BPA Good Laboratory Practice Regulations. Areas of noncoapliance are documented in the study records. No deviations existed that affected the validity of the study. MATERIALS AND METHODS A. Animal Husbandry Male Crl:CD*BR rats approximately 7 weeks old, vere received from Charles River Breeding Laboratories, Kingston, N.T. Rats vere housed singly in suspended, stainless steel, vire-aesh cages. Each rat vas assigned a unique identification number vhich vas recorded on a card affixed to the cage. Purina Certified Rodent Chow* #5002 and water vere available ad libitum. Rats vere quarantined, weighed, and observed for general health for approximately one week prior to testing. Animal rooms vere maintained on a timer-controlled, 12-hour light/12-hour dark cycle. Environmental conditions of the rooms vere targeted for a temperature of 23C t 2C and relative humidity of 50X 10%. Excursions outside these ranges vere of small magnitude and/or brief duration and did not adversely affect the validity of the study. B. Protocol The test substance vas dispersed in deionized vater and administered to 1 rat per dose rate by intragastric intubation. Dose rates administered ranged from 2300 to 11,000 mg/kg of body veight in increments of approximately 50X. Additionally, one rat vas dosed at 670 mg/kg. The dosing day vas test day 1) postexposure day 14 vas test day 15. Following administration of the test substance, rats vere observed for clinical signs of toxicity. Surviving rats vere 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 vere made daily throughout the study. Pathological examinations of test animals vere not performed. 5- - Uses hot cordata T s r e Du Pont HLR 813-91 C. Record Retention All rav data and the final report vili be stored in the archives of Basiceli Laboratory for Toxicology and Industrial Medicine, B. I. du Pont de Kenours and Company, Revaric Delavare or in the Du Pont Records Manageaent Center Vilmington, Delavare. RESULTS A. Dosage and Mortality Data The dosage reginen and the aortality resulting over the 15-day test period are detailed belov. No deaths occurred during the study. Dosage (mg/kg) 670 Dose Volume <mL) 1.1 Emulsion Concentration (mg/aL) 150 Initial Body Veight (g) 246 Mortality No 2300 3.7 150 242 No 3400 5000 1.7 2.5 500 500 251 Ho 250 No 7500 3.6 . 500 239 No 11,000 5.2* 500 236 No * Dosed in 2 portions approximately 15 minutes apart. B. Clinical Signs There were no adverse clinical signs of toxicity observed during the study. CONCLUSION Under the conditions of this study, the ALD for vas greater than 11,000 mg/kg of body veight. nils substance is considered to be very lov in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose to male rats. 6- -