Document 4ymmkM82Z7mRGXv7GxdVGmoG

AR226-2936 FOR OU PONT USE ONLY Du Pont HLR 805-88 Study Title iroximate Lei LD) of Author John W. Sarver Study Completed On December 15, 1988 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 Laboratory Project ID Haskel1 Laboratory Report No. 805-88 Page 1 of 7 Company Sanitized. Does not contain TSC CBS Material Tested: Medical Research No.: Haskell No.: Physical Form: Purity: Contaminants: GENERAL INFORMATION 17,503 White powder Du Pont HLR 805-88 Synonyms: Other Codes: Submitter's Notebook No.: Stability: Sponsor: The test material was assumed to be stable under the conditions of administration. Chemical and Pigments Department E. I. du Pont de Nemours and Company, Inc. Wilmington, Delaware Material Submitted B y : In-Life Phase Initiated - Completed: Chemical and Pigments Department E. I. du Pont de Nemours and Company, Inc. Chambers Works, New Jersey 11/9/88 - 12/1/88 Notebook: There are 7 pages in this report. Distribution: 2- Sanitized. Does not contain TS C A CBS CosBpsnV Ou Pont HLR 805-88 Approximate Lethal Dose (ALP) of SUMMARY ^ __________ f) was dose by intragastric intubation ^ J e / a t s . Deaths occurred up to 5 days after dosing. Clinical si^gns of toxicity were observed in lethally and nonlethally dosed J1*;18* this test the ALD was 2300 mg/kg of body weight. This material is considered to be slightly toxic (ALD 500 - 5000 mg/kg) when administered as a single oral dose. Work by: C b iM A s m il. Anrfe M. Grandi m o Technician^ Study Director: (O John W. Sarver Technologist Reviewed and Approved for Issue: John W. Sarver Study Director JWS:jjb:HLR22.18 Sam tiixi. Does noi coni T S C A C B 5 Company I Du Pont HLR 005-88 QUALITY ASSURANCE DOCUMENTATION STUDY: H# 17,503 AUDITS: Items Audited Test System Identification and Housing Annroxima ise (ALP of t in Rats Audit Dates 11/9/88 SHORT-TERM AUDIT REPORT NUMBER:1,. DATE FINDINGS REPORTED TO MANAGEMENT AND STUDY nfarrrnnDIRECTO . 11/10/88 Reported by: --- William J. Lynam Quality Assurance Auditor tT /n /a e Date h t S C A CB* not contain Cotnpan^ San zed. Does Du Pont HLR 805-88 INTRODUCTION The purpose of this test was to determine an approximate lethal dose of when administered as a single oral dose ^ ^ J ^ ^ ^ t s ^ T h ^ L ^ I a ^ e f i n e ^ i 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.h ^ S ^ s t u d v Practice Regulations. Areas of noncompliance are documented in the study recordt. No deviations existed that significantly affected the validity of the study. MATERIALS AND METHODS A. Animal Husbandry Male Crl:CD*BR 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 |*corded " " affixed to the cage. Purina Certified Rodent Chow #5002 and water were available ad libitum. Rats were quarantined, weighed, and ^served ^ general health for approximately one week prior to testing. Animal rms were'maintained on a timer-contfolled, 12-hour light/12-hour dark cycle. Environmental conditions of the rooms were targeted f o r a f 23 + 2C and relative humidity of 50% + 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 material was suspended in Mazola corn oil and administered to one rat Der dose rate by intragastric intubation. Dose rates administered ranged from 450 to 11,000 mg/kg of .bod^ n ^ 'nostexoosure^ay5 of approximately 50%. The dosing-day was test day one; r.2 14 was test day 15. Following administration of the test material, rats were observed for clinical signs of toxicity. S u r v i a t weighed and observed daily until signs of toxicity subsided and then at least 3 times per week throughout the 14-day postexposure period, nhservations for mortality were made daily throughout the study. not contain TSCA CBl - gconipaiiy Sanlilz**' Soss Du Pont HLR 805-88 C. Records Retention All raw data and the final report will be stored In the arcMves o! rssjrsrs^.w as! s Management Center, Wilmington, Delaware. RESULTS A. Dosage and Mortality Data The dosage regimen and the mortality r e s u l t i n y v e ^ h ^ ^ a j ^ e s t period are detailed below. The lowest dose of which resulted in the death of a test animal was ^.300 mg/kg* S S K S f r i d pT o 5 dayl after dosing. The survival of theaninal dosed at 3400 mg/kg is attributed to animal variability, and do change the ALD. Dosage (mg/kg) 450 670 1000 1500 2300 3400 5000 7500 11,000 Dose Vol ume CmL) 0.6 1.1 1.3 2.0 4.0 4.4 ' 4.1 5.9* 8.4* Suspension Concentration (mq/mL) 200 150 200 200 150 200 300 300 300 Initial Body Wei ght Cflj____ 264 256 265 271 264 259 247 235 230 Mortali No No No No Yes No Yes Yes Yes inistered in 2 portions, approximately 15 minutes apart. - 6- TSCA CB8 SanHteed. Does nntconlam Du Pont HLR 805*88 B. Clinical Signs Nonlethal Doses The only c li n i c . l sig n o f to x ic ity observed as t0 ?evro " 4 TM i S h r i o S s T f l o " " initial bod, eight) were observed In ail rats u d to 4 days after dosing. Lethal Doses The rat dosed at 2300 mg/kg exhibited lethargic behavior, hunched posture, limpness. EllT 21The^ats^dosed 00 ~ J ^ M u n d l e a d " days after " 5 m CONCLUSION Under the conditions of this study, the ALD for - - considered to be to male rats. s t e r e d as a single oral dose not contain TSC A CBS . 7 Sanitiied-Ooes . c o m p 8"*