Document R3MyoEGGV516pn2OLmL0xDjv

This study ss Standard (40 CFK 7#, study records. No vriom study. Oood laboratory Practica ars docuasnted In tiw tfco validity of tba r* I. i. du Pont ds Nraoura and Cospany Sponsor! 'Honours and Conpany Study Rlrsetopi i '3 / n A i risia] Toxicology Associate 3 ;./fi 1 i., Is fi rs: fi- Compaiy Sanitized. Does no! confato TSCA CK ? R- i~*j a !'|`!'<S.J ,?! r..,,. S u b stanca Syaonym/Godm % Physical Farai CqbpbbI t i e n s contaaiBaratas P u rity g Subm ittar*g Motbook Mo.i CAS R egistry Ko.i w::? ^5 '^ CTOI1AL CAS Registry Ho. (CoM*i)< OttPeill BUI %$-9$ ,'2 rv r* Study InttUtri Ik Life Phase > Initiated - Cawplate&t !wi 'd ?a 'j i* m .`ti .'xm 4 4 e o ^ S a . t e i Doesno!^ rscA^ Ml DuPont R IA 13-93 Approxlaata Lathal Do (ALDI of H-19913 in tot SUMMARY _ H-19913 w djinistortdjM a aingia oral 4 by intragaatric intubation i *!!'a " iMth*.?c^ rr*4 ****** th *udy. Dlarrhaa vaa obaarvad in JtoixiiicSirtywi(fAiLO g*roatar than 5UOO xg/kgu)b9wXhmatnt*ad*a*lneieantaairdaadraadatao abianvglaaryorlaolv in VOrfc b^i Approved byi Toxicology Aaaocsrllaatta Raviavad and Approvad for laadai CF/lar L a j l HCa-1ni Finlay Stu furactor' Company Sanitized. Does not contain TSCA B :i - 5 - Pete of latpectlem Conduct ! Ptu<<) Finding Rcportcd tof ;-r2/d4/W.: . .-i Men** ~ W iM Reported bys <uclity Awurenc* Auditor Mr Oat j -.q 1: J -it f `i s .-J Company Sanitized. Poes not contain TSCA CB1 Duroni BLR 13.93 i, *; !"*rpo" :$* fcfPt,* if detersine n npproxiMi lethal does of H-19913 whend*inist*red n o fiflgf* til dose to ml ml. The ALD vas dofintd M tho lov*| df A(iilniitrd hieh cnii<l donili either on tho dny of dosing or W m M y ss conducesti according to the applicable EPA Oood baliorntory Practice Standards. * matrmals A. Anioni Husbandry CharleMsalReivCerlriBCrpefaBdRinrgatL*iboerpaptrdorxiidaae,teKliyng7s*taoenk**ttoelvd,Yorvka.re received fro Reta vere housed singly , flaai'f3fire*ieeh cages. Each rat vas assigned a vas recorded on a card affixed to the D D|r*lltol--!^ 9iil'Chov* 13002 and vetar vere available ad It :vere owrentinfd, weighed, and observed for general health f$ lilfly; 1 vati,fiioi;to testing. Animi room vere oaintained diia -controlled, li^licUr light/12-hour dark cycle, Enviroseentel condition* of the reo*"991* -targeted for a temperature of 23*c 2*c and relative-humidity of 50 *-'im* Excursions outside these ranges vere of alili agidiiffide and/or hrf'iuration end did not adversely effect the viijdtty of the study. B. Protocol The test suhatenee vies di.parir.d in daionired vster and sdninistered vi?sibJi*e*evpi?d5endc0e##to the osnfrisy, tha tastsubstancaInvestheesasbusaesndcetoofbe stable under the cm^tN*# if Dose ratee adeinlstarad ranged fro 2300 to 11*003 sg/kg of hodr^itfR* in increments of a--ppr,--oxieetely 50f. A*dJ!d"lt`fohlly, 1 ***'ve*Used at 670 ag/kg. The dosing day vas test day 1i posiexposiira vas test day 15. Following adainiatration i the test iubstanc*, rets vare observed for clinical s.igns o.f. toxi-c-it^ fie rets vare weighed and observed daily until signs of toxicity subsided, end then at least 3 tines per veek throughout the 14-day recovery period (holiday# excluded). Observations for nortality vera mde diily throughout the study. Pathological exaninations of test anisis vera not parformad, CompanySanitized. Does not contain TSCA CH m m ik isStSes; i **< DuPont HLA 13-f3 C. Record Retention All rev date end the final report vili be tored in the archive of Haskell Laboratory for Toxicology and Industrial Medicine E. I. du Pont de Nemours and Company, Remark, Delavare or in the DuPont Records Management Center, Vilmipgton, Delavare. RESULTS A. Dosage and Mortality Data The dosage regimen pnd the mortality resulting over the 15-day test period are detailed beloy. No deaths occurred during the study. Dosage <g'kg> 670 Dose Volume Mi 1.2 Emulsion Concentration (mg/mL) 150 Initial Body Weight.(g) 275 Mortality No 2300 3.9 150 254 No 3400 2.9 300 254 No 5000 4.7 300 280 No 7500 7.0 300 279 No 11,000 9.9 300 271 No Administered in 2 portions, approximately 15 minutes apart. B. Clinical Signs No clinical signs of toxicity vere observed in rats dosed at 670, 2300, 3400 7500, or 11,^00 mg/kg. The rat dosed at 5000 mg/kg had diarrhea the day after dosing. CONCLUSION Under the conditions of this study, the ALD for H-19913 was greater than 11,000 mg/kg of body veight. This substance is considered to be very low in toxicity (ALD greater than 5000 mg/kg) vhen administered as a single oral dose to male rats. - 8-