Document 06GGdy6qZw0zx1wYob6Vw4GzM

AR226-3015 Study Title Approximate Lethal Dose (ALD) of H-21095 in Rats Laboratory Project ID Haskell Laboratory Report No. 290-95 Author M. Scott Karr Study Completed On April 19, 1995 Performing Laboratory E. I. du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine Elkton Road, ?. 0. Box 50 Nevark, Delaware 19714 Medical Research No. Company Sanitized. Boss notcontainTSCACM Page 1 of 6 Subst u e Tested: Synonyms/Codes ; ffiRAL IHFORKATIPN Physical Form; Composition; Transparent tan liquid H-21095 contains; Contaminants; Purity; CAS Registry No.; Sponsor; Study Initiated - Completed; In Life Phase Initiated - Completed; None 30X None available DuPont Specialty Chemicals E. I. du Pont de Nemours and Company Vilaington, Delaware 3/13/95 - 4/19/95 3/14/95 - 4/5/95 -2 - Company Santffced. Does notcontattiTSCACBt SUMMARY H-21095 vas administered as a sing'e oral dose by intragastric intubation to male rats. No deaths and no clinical signs of toxicity r e observed during this study. Under the conditions of this test, the ALD vas greater than 11,000 ag/kg of body veight. This substance is considered tn be very lov in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose. Work by: M . Scot t Karr Toxicology Technician Revieved and Approved for Issue: <3. Tracy A . Filliben Study Director V/ TF/alv I i i INTRODUCTION DuPont BUI 290-95 Tb. purpose o f . h i s . . . . " " - S T S i . " E T S S ; ' S l i i . - 5325 i y ' j S S T i ' L i S S - uhich caused death * * - * * * of dosing or Within 1A days post exposure. MATERIALS a n d me t h o d s a . Animal Husbandry Hale CrlsCD*BR rats, approximately ^oliM^Rsts^re Charles giver Breeding Labor,r ="*! R = * f ' ^ h c a g . Eech rat housed singly in suspended, stainles:nuiber'vhich was recorded on a card was assigned a unique identification number whicn was nsoiuble T'XttLZr*.*-' S w l ARodent Chov* j^digits - r e available ad libitTM. -***- eash.ll Laberatoty has an program is monitored and administere y totai bacterial counts and Water samples are periodically ^ ^ / ^ ^ ^ J n ^ n a n t s . for the presence of conforms, 1 cages and cage racks are Additionally, samples from f.es sanitation by the cagewashers. periodically analyzed to assur .J L separately from study records. Bata from this program f " ' ^ " ^ ^ ^ ^ S r e r to meet specified Animal feed is certified by the list of specified !ith the results of this study. gats era quarantine veighed and observed J" aoproximately one week prior t0 te f*h cycle. Environmental on a tiaar-controlled. 12-hou` " S ' d t p . r 5 r . of 23*C t 1*C conditions of the rooms were targ slons outside these ranges Si.'S'SSl'SSSdi S ; drirat-on and did-not advaraal, affect the validity of the study. B. Protocol ' H-21095 van aired vitb daionised - J f dose rate by intragastric intubation. In the abse ^^ under*11he1c o n d * t i o n s ^ administrationt1*Dose rates administered ranged &mmsat*tee& om netmMnf|g | ggf -4- & 'Stiffs 'H P P DuPont B 1 m%{:^ _ifJfRtrp fro. 2300 to 11.000 / * of b o d y " Sf ! S T " S o . ? rC t li IcSm UiiifMiiftSia;uloSlfy.^th1.~r.e.t.-wya.si**dos--eda.tt6*7%*0 *!r/s**vS,,5:^?vyS0g*J*".i*Mclii'l2liMnl VM^9throughout*.. u l L y " b." v*tIou porloO. " " " T ` ^ i<,r mortality were bade daily throughout the study. Pathological examinations of test animals were not performed. Records Retention A n raw data and the final report will be. Y * f ^Poilt Haskell Laboratory for Toxicology and Industrial Medicine, E. I. du Pont de Nemours and Company, Newark, Delaware or m the DuPon Management Center, Uilming.cn, Delaware. RESULTS A. Dosage and Mortality Data The dosage regimen and the mortality resulting over the 15-day test period are detailed below. Dosage 670 2300 3400 5000 7500 11,000 Dose Volume imL) 1.1 3.7 1.6 2.6 3.8 5.4 Mixture Concentration (mg/mL) 150 150 500 500 500. 500 Initial Body Weight (g) 256 243 241 262 252 245 Mortality No No No No No No clinical Signs No clinical signs of toxicity were observed during this study. Company Sanitized. -5 fitttont wwim-n CONCLUSION Under the conditions of this study, the ALD for H-21095 ran greater than 11,000 ag/kg of body weight. This substance is considered to be very low in toxicity (ALD greater than 5000 eg/kg) when adninistered as a single oral dose to rale rats. C&CBt ncrtco^aU?t San*6**' oeS