Document nmMZygVYjmXqMY61Q56ybgJD1

AR226-2968 FOR DU FONT USE ONLY Du Font HLR 632-91 Study Title Approximate Lethal Dose (ALD) of in Rats Author John W. Sarver Study Completed On February 11, 1992 Performing Laboratory Haskell E. I. du Laboratory Font de Nemours and Company for Toxicology and Industrial Elkton Koad, P. 0. Box 50 Newark, Delaware 19714 Medicine Medical Research No. Laboratory Project ID Haskell Laboratory Report No. 632-91 eA.a^^0A6E5* * G^1^s^ Page 1 of 7 ^0^f"8^ Substance Tested; Medical Research Ho.; Haskell No.; Haskell Test Code; Physical Form; Composition; Contaminants; GENERAL INFORMATION Du Font HLR 632-91 Purityi Synonyms; CAS Registry No.s Stability; In the absence of visible evidence to the contrary, the test substance was assumed to be stable under the conditions of administration. Sponsor; Du Font Fibers I. E. du Font de Nemours and Company Vilmington, Delaware Substance Submitted By: Font Fibers I. E. du Font de Nemours and Company Chattanooga, Tennessee Study Initiated - Completed: 8/9/91 - 2/11/92 In-Life Phase Initiated - Completed; 8/12/91 - 9/10/91 Notebook: There are 7 pages in this report. Distribution; 2 - - ^ 0>' es no Cot .^^ Du Font BLR 632-91 Approximate Lethal Dose (ALP) of ^? SUMMARY 'vas administered as a single oral dose by Intragastric s. Clinical signs of toxicity were observed in lethally and nonlethally dosed animals. Deaths occurred up to one day after dosing. Surviving animals were observed for clinical signs of toxicity for up to 14 days after dosing. Under the conditions of this test, the ALD vas 7500 ing/leg of body weight. This substance is considered to be very low in toxicity (ALD greater than 5000 mg/kg) vhen administered as a single oral dose. work ^ _______g.fbC^atrXol.^ti.n'tl^ayfr(^[ U 1T1e--c1h--n.1ic_.i2a-n_ Study Director: /jJohn ^--^K^(^/ L-C). 0<aA^v^-\ V. Sarver Technologi s t Approved by: A/Q^c^CL CL^cjyT^^------- (TidancyC. ChromesuPh.D. Manager Acute Toxicology Reviewed and Approved for Issue; "~- ~7 ^0\^- L^J . Oph^t^"^____^/ H /^S^ John V. Sarver L/ Study Director JVS/lnr ,. {s com ,p^^.------ 3 - - Du Font HLR 632-91 QUALITY ASSURANCE DOCUMENTATION AUDITS; I tens Audited Protocol, conduct Records, final report Audit Dates 8/12/91 1/23/92 DATE FINDINGS REPORTED TO STUDY DIRECTOR: 1/23/92 DATE FINDINGS REPORTED TO MANAGEMENT! 2/6/92 CL^. ^ c ^ Reported by: ^ ftames Hackay 11^- Quality Assurance Auditor dA/9JL Date Company Sanitized. Does not contain TSCA CBI 4 - INTRODUCTION Du Font HLR 632-91 purpose of this test was to determine an approximate lethal dose of when administered as a single oral dose to male rats. The ALD vas fe fine? 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 BPA Good Laboratory Practice Regulations. Areas of noncompilance are documented in the study records. No deviations existed that affected the validity of the study. MATERIALS AND METHODS A. Animal Husbandry Male Cr^CD-BR rats, approximately 7 weeks old, were received from Charles River Breeding Laboratories, Kingston, New York. Rats were housed singly in suspended, stainless steel, wire-mesh cages. Each rar 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 lib!turn. 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 23c t 2c and relative humidity of 50X 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 Mazola corn oil and administered to one rat per dose rate by intragastric intubation. Dose rates administered ranged from 2300 to 11,000 ng/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. coa"'a'"'s!mil^^,^ Du Font HLB 632-91 c' Records Retention I. All raw data and the final report will be stored in the archives of Haskell Laboratory for Toxicology and Industrial Medicine, B. du Font de Nemours and Company, Newark, Delaware or in the Du Font Records Management Center, Wilnington, Delaware. RESULTS A. Dosage and Mortality Data The dosage regimen and the mortality resu period are detailed below. The lowest dose o the death of a test animal was 7500 ing/kg. after dosing. gr the 15-day test (which resulted in is oc< til-red up to one day Dosage ("^kg) 670 2300 3400 5000 7500 11,000 Dose Volume (aL) 1.1 3.8 2.6 3.9 5.5" 8.4" Emulsion Concentration (mg/mL) 150 150 350 350 350 350 Initial Body geight (g) 245 246 265 270 255 266 Mortality No No No No Yes Yes Administered in two portions approximately 15 minutes apart. Company Sanity. Does not contain TSCA CB| Du Font HLR 632-91 B. Clinical Signs Nonlethal Poses No clinical signs of toxicity were observed in the rats dosed at 670, 2300, or 3400 nig/kg. Slight weight losses (up to 2X of Initial body weight) occurred in rats dosed at 2300 and 3400 Rg/kg one day after dosing. The rat dosed at 5000 rag/kg had diarrhea and severe weight loss (102 of Initial body weight) one day after dosing. Lethal Doses The rats dosed at 7500 or 11,000 ng/kg had low posture and were lethargic one hour after dosing. Death occurred on the day of dosing in the rat dosed at 11,000 nig/kg and one day after dosing in the rat dosed at 7500 ing/kg. CONCLUSION Under the conditions of this study, the ALD fonr--^--^^----^&gwas 7500 mg/kg of body weight. This substance is considered to be very--row fntoxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose to male rats. Company Sanitized. Does not contain TSCA CBI