Document QkZ4M6gOm9L1m8jjVg84Bd4oo

AR226-2953 FOR DU POUT USE ONLY Du Pont HLR 121-91 Approximate Lethal Dose (ALD) of tin Rats Author John H. Sarver Study Completed On March 14, 1991 Performing Laboratory E. I. du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medi Elkton Road, P. 0. Box 50 Newark, ; 1aware 19714 ne Laboratory Project ID Haskell Laboratory Report No. 121-91 Page 1 of 8 Ibpftipany Sanitized. Does not contain TSca r n i HateH a l Tested; Medical Research No.: Haskell Ho.: Haskell Test Code: Physical Form: Other Codes: Synonyms: Purity: Composition: GENERAL INFORMATION Du Pont HLR 121-91 18,790 Milky white liquid Contaminants: Stability: Sponsor: Material Submitted By: Study Initiated - Completed: In-Life Phase Initiated - Completed: Notebook: In the absence of visible evidence to the contrary, the test material was assumed to be stable under the conditions of administration. Du Pont Chemicals E. I. du Pont de Nemours and Company Wilmington, Delaware Du Pont Chemicals E. I. du Pont de Nemours and Company Chambers Works Dpwater, N.J. 1/25/91 - 3/14/91 1/29/91 - 2/18/91 2- He. GENERAL INFORMATION (CONT.) There are 8 pages in this report. Distribution: Du Pont HLR 121-91 -3- Du Pont HLR 121-91 Approximate Lethal Dose (ALP) of n Rats SUMMARY ^__j was administered as a single oral dose by in t r a ^ a s t n ^ i n t U D a t T o r ^ o m a l e rats. No deaths occurred. No 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 (AID greater than 5000 mg/kg) when administered as a single oral dose. Work by: ^ Anne M. Pessagno Technician Study Director: lJ. John W. sarver Technologist Approved by: DReviewed and Approved for Issue: Manger Acute Toxicology John K. Sarver Study Director 3m JWSrsfl: (144.7) i Sanitized. Does not contain TSC A C8J -4- Du Pont HLR 121-91 QUALITY ASSURANCE DOCUMENTATION STUDY: 8,790 >roximate Lethal Dose (ALD) of in Rate AUDITS: Items Audited Conduct protocol, records, final report Audit Dates 1/29/91 3/6/91 SHORT-TERM AUDIT REPORT NUMBER: DATE FINDINGS REPORTED TO MANAGEMEN STUDY DIRECTOR: 3/6/91 Reported by: Tames Mackay iff Quality Assurance Auditor Date p ifflp a n y Sanitized. Does not contain T S C a C8I 5 Du Pont HLR 121-91 INTRODUCTION The purpose of this test was to determine an approximate lethal dose of when administered as a single oral dose to male rats. The ALD was d e f i S ^ a s 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 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 was 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 approximately one week prior to testing. Animal 'ms were maintained on a timer-controlled, 12-hour light/12-hour dark eye Environmental conditions of the rooms were targeted for a temperature oi 23 + 2C and relative humidity of 50 + 10S. 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 deionized water and administered to one 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 50i. Additionally, one rat was dosed at 670 mg/kg. The dosing day was test day one; 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 postexposure period. Observations for mortality were made daily throughout the study. |ggggps| -6- ffo! eonialn TS'CA CB Du Pont HLR 121-91 C. Records Retention All raw data and the final report will be stored in the archives of Haskell 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. RESDi-TS A. Dosage and Mortality Data The dosage regimen and the mortality resulting over the 15-day test period are detailed below. No deaths occurred. Dosage (mg/kg) 670 2300 3400 5000 7500 11,000 Dose Volume (mL) 1.2 4.0 1.6 2.4 3.7 5.1* Emulsion Concentration (mg/mL) 150 150 500 500 50C 500 Initial Body Weight (g) 274 258 231 244 244 230 Mortality NO No No No NO No * Administered in 2 portions, approximately 15 minutes apart. Ipfipany Sanitized. Does not contain T S C a o ui -7- i % Du Pont HLR 121-91 B. Clinical Signs There were no clinical signs of toxicity observed throughout the study. COHCLUSIOH Under the conditions of this study, the ALD for ( J K was 9reat?r than 1-1.4300 mg/kg of body weight. This, material, is considered to be_yery_low in toxicity (ALD greater than 5000 mg/kg) when actainistered as a single oral dose. Pees not contain TSCa w t -8-