Document X7gB2r6RL1DNG6wn35Lx296q4

AR226-2957 FOB DO POUT USE ONLT Du Pent HLS 320-91 Study Title Approgieste Lethal Dose (ALD) of Ha Bats Author John 9. Sarver Study Completed On Hay 20, 1991 Performing Laboratory Raskell E. I. du Font de Nemours and Company Laboratory for Toxicology and Industrial Elkton Boad, P. 0. Box 50 Newark, Delaware 19714 Medicine Medical Research Mo. Laboratory Project IP Haskell Laboratory Report Ho. 320-91 Page 1 of 7 (company Sanitized. Does not contain TSCA CW Bategtcl Tgstedt efedical Research B&. Baafcell So.; aaakell Test Code; Physical Pora; Purity s Coaposition: GENEKAL DIFOBM&TIOy Du Font BLS 320-91 18,920 Off-white opaque liquid Other Codes: .sy.sw. CAS Registry Ho.i Stability; y In the absence of visible evidence to the contrary, the test material was assumed to be stable under the conditions of administrstic".. ^^nv^iin^86-. '-^-^' s^ .:on*a'n ra^ ^- Du Font BLR 320-91 GENERAL INFORMATION COHT'D Sponsor: Du Font Chemicals Ec I. du Font de Neaours and Company Vilmlngton, Delaware Haterial Submitted By; Study Initiated - Completed: I.ont Chemicals __ E. du Font de Nemou.-s and Company Jackson Laboratory Deepvater, M.J. 3/28/91 - 5/20/91 In-Life Phase Initiated - Completed: A/A/91 - 4/22/91 Notebook: There are 7 pages in this report Distribution: 3 - v a-- Du Font HLR 320-91 Approximate Lethal Dose (ALP) of SUMMARY was administered as a single oral dose by intragastric 'to male rats. No deaths occurred and no clinical signs of toxicity vere 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: Q^VL^JI-, -7^7. ^'f^ia-c^ --------------Anne M. Tessagno Technician Study Director: <_lg^U^-- cQ. OQA^g-\. /\------------John W. Sarver \y Technologist Approved by: --__--_--_--A--/--AN^aLnecyy>C(.? (^ ^^oam-e^y,uPu^^ffN ^er Acute ioxicology 7 T J o h n Reviewed and Approved for Issue; ^--jt9t^-- L-Q. C>CJ^r<^____'/3Q/(:^\ V. Sarver ^ Study Director JVS/lmr . ...TCPA^1" c^."'^-00"''01" Du Font HLR 320-91 QUALITY ASSURANCE DOCUMENTATION STUDY: W 18,920 Approximate Lethal Dose (ALD) of I in Rats AUDITS: Items Audited In-life observations Protocol, Records and Final Report Audit Dates </4/91 5/16/91 SHORT-TESM AUDIT REPORT NUMBER; DATE FINDINGS REPORTED TO MANA.GEB^nWD STUDY DIRECTOR: 5/16/91 Or^t feLJ/ Reported by:: fV v^/ C Joseph Cc7. Hamill Senior Auditor Quality Assurance $h/^ Date 5 - - Sanitized; Koes not contain TSCA CBi Du Font HLR 320-91 INTRODUCTION The purpose of this test was to determine an approximate lethal dose of ----H^vhen administered as a single oral dose to male "ats. The ALD vas defined as the lowest dose administered which caused deain 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 noncofflpliance are documented in the study records. Ho deviations existed that significantly affected the validity of the study. MATERIALS AND METHODS A. Animal Husbandry Male Cr^CD^R 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 11 bi turn. Rats were quarantined, weighed, and observed for general health for approxima . 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 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 material was dispersed in Mazola corn oil and administered to one rat per dose rata by intragastric intubation. Dose rates administered ranged from 2300 to 11,000 mg/kg of body weight in increments of approximately 50Z. Additionally, one rat was dosed at 670 me/leg. The dosing day was test day I? 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 recovery period. Observations for mortality were made dally throughout the study. Du Font HLR 320-91 C. Records Retention All raw data and the final report will be stored in the archives of Easkell Laboratory for Toxicology and Industrial Medicine, E. I. du Font de Neaours and Company, Newark, Delaware or in the Du Font Records Management Center, Vihaington, Delaware. RESULTS A. Dosage and Mortality Data The dosage regimen and the mortality resulting over the 15-day test period are detailed belov. No deaths occurred. Dosage (ing/kg) Dose Volume (inL) Emulsion Concentration (mg/mL) Initial Body height (g) Mortality 670 1.1 150 2300 3.8 150 3400 1.7 500 5000 2.6 500 7500 3.7 500 11,000 5.4* 500 250 No 250 No 250 Ho 259 No 248 No 247 No * Administered in 2 portions, approximately 15 minutes apart. B. Clinical Signs There were no clinical signs of toxicity observed in any of the rats during the study. CONCLUSION Under the conditions of this study, the ALD forflUMRvas 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. company Sanitized. Does ;'.:-' c-?n'.?!n T?CA c-