Document p4zn1RGLw0EOzrN43NJzbgbE

AR226-2971 Study Completed On February 24, 1992 Performing Laboratory B . I . du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine Box50 . 0 . ElktonRad,P Newark, Delaware 19714 Laboratory Project ID Haskell Laboratory Report No . 813-91 -teeA C.81 ed . oo0S no' co^t$}^ .Comp San iz Page 1 of 6 l i Substance Tested : Medical Research No . : Haskell No . : Haskell Test Code : Physical Form : Purity : Composition : GENERAL INFORMATION Du Pont SLR 813-91 19,173 of Slightly yellow liquid 100% Synonym : Stability: Submitter's Notebook No . : In the absence of visible evidence to the contrary, the test substance was assumed to be stable under the conditions of administration . Sponsors Du Pont Chemicals R . I . du Pont de NemourS and Company Wilmington, Delaware Substance Submitted By : Study Initiated-Completed : Du Pont em c B . I . du Pont de Nemours and Company Jackson Laboratory Deepvater, NJ . 10/21/91 - 2/24/92 In-Life Phase Initiated-Completed : 20/28/91 - .11/18/91 Notebook : There are 6 pages in this report . Distribution : Do Pont BLR 813-91 Approximate LethalDone (ALD) o In Rats (100% pure) was administered as a single oral dose by intragastr c intubation to sale rats . No deaths occurred and no clinical signs of toxicity were observed . Under the conditions of this test, the ALD vas greater than 11,000 sg/kg of body weight . This substance is considered to be very low in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose . pork by : Ow ,,,A- /'yf yens Technician Study Director : C3.V . 11. John V . SaSe Technologist Approved by : Reviewed and Approved for Issue : cy C . Chr Mann Acute Toxicology G%). SW" ' John V . Sarver Study Director a /arc/ q a; JVS/lmr - 3- Dates of Inspection : Conduct - 10/28/91 Records, Reports) - 2/18,19,21/92 Findings reported to : Study Director - 2/21/92 Management - 2/21!92 Reported by : ) Kimberly #. 8rebner Quality Assurance Auditor Date -4- conta9n TSCA CRl (Does not S anmzed. INTRODUCTION The purpose of this test was to determine an approximate lethal dose of Then administered as a single oral dose to male rats . The ALD was defined as the lowest dose administered which caused death 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 noncompliance are documented in the study records . No deviations existed that affected the validity of the study . MATERIALSAND METHODS A . Animal Husbandry Male Crl :CDOW rats, approximately 7 weeks old, were received from Charles River Breeding Laboratories, Kingston, N .Y . Rats were housed singly in suspended, stainless steel, wire-mesh cages . Each rat was assigned a unique identification number which was recorded on a card affixed to the cage . Purina Certified Rodent Move #5002 and water were available ad libitum . Rats were quarantined, weighed, and observed for general heaitlor approximately 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 were targeted for a temperature of 23C t 2C and relative humidity of 50% t 10% . 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 substance was dispersed in deioniaed water and administered to 1 rat per dose rate by intragastric intubation . Dose rates administered ranged from 2300 to 11,000 mg/kg of body weight in increments of approximately 50X . Additionally, one rat was dosed at 670 mg/kg . The dosing day was test day 1 ; postexposure day 14 was test day 15 . Following administration of the test substance, 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 . Pathological examinations of test animals were not performed . tgantain'fS~'''~' pa ar'frea- t'~ Du Pont MA 813-91 C . Records Retention A11 raw data and the final report will be stored in the archives of Haskell Laboratory for Toxicology and Industrial Medicine, B . I . du Pont de Nemours and Company, Newark, Delaware or in the Du Pont Records Management Center, Vilmington, Delaware . RBSU1X9 A . Dosage and Mortality Data The dosage regimen and the mortality resulting over the 15-day test period are detailed below . No deaths occurred during the study . Dosage (mg/kg) Dose Volume (mb) Emulsion Concentration (mg/mL) Initial Body Weight (g) Mortality 670 1 .1 150 246 No 2300 3 .7 150 242 No 3400 1 .7 500 5000 2 .5 500 251 No 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 . CONCWSION Under the conditions of this study, the ALD for was greater than 11,000 mg/kg of body weight . This substance is consider to be very low in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose to male rats . - 6-