Document gbJjvELRoZXLpy16K30j4yyDL

Study Completed On September 14, 1995 ) Performing Laboratory E I. du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box 50 Company Sanitized. Does net contain TSCA CBi i-S*'- vag Substance Synonyms/Codes s Physical Form: Composition: GENERAL INFORMATION Whitish Liquid Contaminants : Purity: Submitter's Notebook No.: CAS Registry No.: Sponsor: Study Initiated - Completed: In-Life Phase Initiated - Completed: DuPont Specialty Chemicals E. I. du Pont de Nemours and Company Wilmington, Delaware 7/14/95 - 9/14/95 7/18/95 - 8/10/95 Company Sanitized. D ss not contain t s c a c b s -2 T Approximate Lethal DoM (AL- of H-21209 in Rats SUMMARY H-21209 was administered as a single oral dose by intragastric intubation to male rats. Ho deaths occurred, and no clinical signs of observed in any animal during the study. Under the conditions of this test, the ALD was greater than 11,000 mg/fcg of body weight. This substance is considered to be of very low toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose. . Work by k I c l u ^ 0 . Tracy A. Filliben Toxicology Associate Report Prepared by: 1 Reviewed and Approved for Issue r ^ g. tenda Tiffin Office Assistant Q Tracy A. Filliben Study Director 9//*// ^S~ $ Company Sanitized. Does not contain TSCACBl -3- JilfasSsji&g ) '(IIP*1 r.-" ^'./fSfPBWS DuPont HLR 653-95 IHTRODBCTIOH The purpose of this test was to determine an approximate lethal dose of H-21209 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. 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. The rats were tail-marked, using a water-insoluble marker, with the last 3 digits of the animal number. Purina Certified Rodent Chow #5002 and water were available ad libitum. Haskell Laboratory has an animal health monitoring program. This program is monitored and administered by the Animal Laboratory Veterinarian. Water samples are periodically analyzed for total bacterial counts and for the presence of coliforms, lead, and other contaminants. Additionally, samples from freshly washed cages and cage racks are periodically analyzed to assure adequate sanitation by the cagewashers. Data from this program are maintained separately from study records. Animal feed is certified by the manufacturer to meet specified nutritional requirements and. to be free of a list of spcifi contaminants. On the basis of these analyses, there is no evidence suggesting that contaminants were present in the feed or water m amounts which may have interfered with the results of this study. Rats were quarantined, weighed, and observed for general health for approximately one week prior to testing. Animal rooms were maintaine on a timer-controlled, 12-hour light/12-hour dark cycle. Environmental conditions of the rooms were targeted for a temperature of 23 C + 1 C and relative humidity of 502 102. 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 mixed with deionized water and administered to 1 rat per dose rate by intragastric intubation. In the absence of visible evidence to the contrary, the test substance LL stable under the conditions of administration. Dose rates administered ranged from 2300 to 11,000 mg/kg of body weight in i^rements of approximately 502. Additionally, 1 rat was dosed at 670 mg/kg. The dosing day was test day Is postexposure day 14 was test day 15. Compos Sanili. DO TSCA " * ' f 0 DuPont HLR $M-95 Following administration of the test substance, rats were observed for clinical signs of toxicity. Rats were weighed and observed at least 3 times a week throughout the 14-day observation period. Observations for mortality were made daily throughout the study. Pathological examinations of test animals were not performed. 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 DuPont 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 during the study. Dosage (mg/kg) 670 2300 3400 5000 7500 11,000 Dose Volume CmL) 0.79 2.8 1.5 2.2 3.5 4.7 Concentration (mg/mL) 200 200 600 600 600 600 Initial Body Weight (g) 236 241 274 263 279 255 Mortality No No No No No No B. Clinical Signs No clinical signs of toxicity or weight losses were observed in any animals during the study. CONCLUSION Under the conditions of this study, the ALD for H-21209 was greater than 11,000 mg/kg of body weight. This substance is considered to be of very low toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose to male rats. 'rA s Y"i'S -5 - Company Sanitized. Does not contain T SC A CB