Document 3Q1MjX1VKDRR6vRGKdjOOg1da

AR226-2940 FOR DU PONT USE ONLY Du Pont HLR 391-89 Study Title Approximate Lethal Dose (ALD) of ^n Rats Author John M. Sarver Study Completed On July 21, 1989 Performing Laboratory Haskell E. I. du Pont de Nemours and Company, Inc. Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box 50 Newark, Delaware 19714 Laboratory Project ID Haskell Laboratory Report No. 391-89 Page 1 of 6 <SompanySanitized. Does not contain TSCA CBS I Material Tested: Medical Research N3. Haskell No.; Physical Form: Pun'ty: Composition: GENERAL INFORMATION Ou Pont HLR 391-89 17,869 White dispersion Synonyms: Other Code: Stability: The test material was assumed to be stable under the conditions of administration. Sponsor; Chemicals and Pigments Department E. I. du Pont de Nemours and Company, Wilmington, Delaware Inc. Material Submitted By: Chemicals and Pigments Department E. I. du Pont de Nemours and Company, Inc. Jackson Laboratory Deepwater, New Jersey In-Life Phase Initiated -.Completed: 6/12/89 - 7/3/89 Notebook: There are 6 pages in this report Distribution: 2 - oapany Sam'tizsd. Does not contain TSGA C8? Du Pont HLR 391-89 Approximate Lethal Dose (ALP) of SUMMARY JfUHapproximately 100% pure) was administered as a single oral doseDyTntragastric intubation to male rats. No deaths occurred and no adverse 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 (ALD greater than 5000 mg/kg) when administered as a single oral dose. Work by: ^ ^ n ^ t e . ^ Toecphnmipcian t/ Study Director: Qp^ c5o^^ ^ John W. Sarver /jJohn C/ T&ec^hhnnoolloogaist Approved by: ____^^jtt^-i^r.' j^JL'K <1\^A*^________ ------------Doloirreess E. MaalleekO^hh..DD.--. ---------- Research Toxicologist Acute and Developmental Toxicology Division ^ } J o h n Reviewed and Approved for issue: LJ|0CA^^ 1^3. O^A^^\ U. Sarver (--/ Study Director '? /3. \ 1'TS^ JWS:a1r:HLR29.16 - 3 - Company Sanitized. Does not confam TSCA CBI Du Font HLR 391-89 QUALITY ASSURANCE DOCUMENTATION STUDY: ^ U17,86 f9 l Approximate Lethal Dose (ALD) ofj AUDITS; Items Audited Records, Report Audit Dates 7/20/89 in Rats SHORT-TERM AUDIT REPORT NUMBER: ------9 DATE FINDINGS REPORTED TO MANAGEMENT AND STUDY DIRECTOR: 7/20/89 Reported by: 1^/^-Q. ^T. Vilrniam J. Lynnaam Quality Assurance Auditor fMef Date V <?3Wp?mydaniiaed. Doss not contain TSCA CBS Oil Pont HLR 391-89 INTRODUCTION The purpose of this test was to determine an approximate lethal dose of 1^----^when 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 significantly affected the validity of the study. MATERIALS AND METHODS A. Animal Husbandry Male Cr1: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 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 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 23 + 2C and relative humidity of 50 ^ 101. 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 distilled 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 501. 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. 5 " Company Sanitized. Does not contain TSCA CB8 Du Pont HLR 391-89 C. Records Retention A11 raw data and the final report will be stored in the archives of Haskell Laboratory for Toxicology and Industrial Medicine, E. I. du Font de Nemours and Company, Inc., 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 below. No deaths occurred. Dosage (mg/kg) 670 2300 3400 5000 7500 11,000 Dose Volume (mL) 1.1 3.7 1.7 2.4 3.6 5.6* Emulsion Concentration (mg/mL) 150 150 500 500 500 500 Initial Body Height (g) 241 242 247 244 239 253 Mortality No N0 No No No No * Administered in two portions, approximately 15 minutes apart. B. Clinical Signs The rat dosed at 11,000 mg/kg exhibited lethargic behavior approximately one hour after dosing. The rats dosed at 5000 or 7500 nig/kg had slight weight losses (4 or 51 of initial body weight) one day after dosing. No other clinical signs of toxicity were observed. CONCLUSION Under the conditions of this study, the ALD for--------B^as 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. Comply San,.,,.,. ^. no, ,,,,,,,,,,,, TSCA CM