Document 2J3ZbJQOnrkJX5oDgZmZ4V98N

ARR26 _ 0662 N-EtFOSA Acute Toxicity - | 000466 acute oma. sostetty screen ond Netciu) cman rs I CXELEDTobCsa Htires srEiesn i ae ei ys oo 1 00 i LEnRThEbes E fhhem mm s T7A79 000467 sumary Jo acute rad tosicity screen vith -306705C vas condeuted from ApELd 8, 1961 to Apri) 22, 1981 using male and famale albino race ranging in boty eight from 325-299 grams. The cast astarial vas administered by gastric intubation at a dosage level of 5,000 mg/kg body weight. No mortalities, intounza behavioral cesctions or body weight losses oScurTed during the 1 ay chasrvation pariod. Necropey of the sniasis performed wen teraisation of the study revesled no visible lesions. Toe approxisate oral 1030 of 7306700 5 groatar than 5,000 ma/kg in fasted male 42d female albino rats. Intsotserion The abjectiveofthisstutyvastoapproxiaatethe acuteoralL150 of T-30670aC in fasted albino rata. This study ie not replaced by the Pood and Drug Adatsistcetion's Good Laboratory Practice Negulaticn of 1978, Althoughthestandardoperating proceduresof thls laboratoryadhersto the Generalprinocfthiispoapullatison. The avdatagunabrysthteSetuddy Directorandthefinalruportare storedintheconductinglaberstery's achive. 000468 patron a0 penises founaipizn cats vereweed in thi at. ALJ asian verePaidsnder quacancin for seveceh yn prio ta Casting Sh cnly arama VNCh appessed co ve 40 3008 akieh an auicable an Coss anmais B She Aniiation of She scoty used, om sues vere Douead in suspend, wise-mesh cages in Semperatase and mami contesting zooms and puEnSEsad 4 seandard Mbarasary dies pine "hte 3811pmance uniothe 26 -20 ho period mediacaly pric ta saver dntation Five male 1a vhan tion foo vas withheld. female Sa vere adminietared the Cort material 4c @ preselected dnsge Lowi. ALL doses vars aduisiatared a & consent "ohmof10 hg directlyLacethm sKcmAGhSoFShe Fe aig Wpodermic areinpe savioped vieh bai-cipped incubating nesdieS, Attar saver aminietraion of che test Arcicla, She Face vere fenumed o thir cages and cheavad fox the following 1 day. Incial and fined sat woh, serialities (hla 1) and adverse senceions (Fabled) ware se Corda. nocopey van conducted on 411 animale Chat died ring he sendy 48 we a those suthanatisd at the and of She 14 day corervation period (ble 1). The prosoca, prineipal perscnnel. veiw 4n th indy, compoetslon ennractaiatice, and Gully ewssance scatemen 45s Soncained 13 Aopendicer E TonpapAnesorme ,Tac.yweE res Pe arks BTea orkiWeg . Ton,ks, Miasourt 000469 \ a mosac ie Sooo nw AcUze OAAL TOKICITY SCREEN - ALBDIO WATS wien s-30670a Mortality, Necropsy, Body Meight Daca and Behaviors) Maacticns mmmsesad weaTeset bay Wombaitsa @ FJeudresmetbeerss Pesoosuent wwmrrme0 aw @as os o awaarere maawwm @sSee Ptaa anmee asme ap0t os ammme aaw E2d8 2me tase article vas aduinistared as an aqueous suspension. Tha approxiastaoral 350dagreaterthan5,000m/kginfastedmaleandfemale dNeeccriooppetyi.as pertored wen termination of the study revealed no vista lssices. RBounacvioourenr)dDseasacveiiosnTeal reactions vase noted during the 14 day evaluation paricd. 000470 age . dn : Riker Experiment Number: PromocoL CmSoOevUaCA Hi TBet Tety Evaluation Laboratory, WEXer TABorRtaTIes The, ST FauT wimnesots COTPRENOSTPTROOSALRE'TDAIRCSTLTEIA(RTINT_G/CRORPLETION TATE OF FEST: 1/8L = TEST SYSTEM AND SOURCE: Rat, Charles ive DTreeA dlngBGERTE RE SWITETE TESeR-- psuemxb:erWsp5,5 Meishe nanos: 380-500 gu. OBJECTIVE" Tttheoesx"tiocBisjtyeysctoetfnivtfhoeorftreetsphtrisodautrcetisibtcillweiitliyln baoeflbitTnoeoscpihnarsreaa;cttReIrsFi.EzoeritchaeBlaatcvyeuet,eweearseoersaielnlehcatneddli5n5gE "and genexal availabiiity. KETHOD: Ttpheeermipoeadrnsai,tmuawrliesthwainldflohoudbgesidhaiontudysevdactoenirtnroosfltflaeeirdnelderososamdsstLediuebrliitnugssu?sb.poetnhPdaecdthheviarqneiumamarleasnthwiinlcelagebasendiLntdeesnttified h5iccholvoirllcotcionrgr,espaocncdordtionga tcoardtheaffLiaxbeodrattoortyh'es dosage of 5,000 ma/ks will be administered osuttasniddaerdoofpetrheatciangge.procAedsuirneg,le each aninal, hoverer, if this . + oaldesdvaeigltesi.onlaelAvnayaniGanodaedlsistiToovntiallaldbdeeoqsuaaagtdeenliynlievcsethleasrreawdcitltelhreibzeeesdttohecuarmtteoinxctileceidtyaantodfsfurptipheeldemtewenistttahlarttdhiiocsslaeg,e PFarneoictmeoaiclvoseld.viflrlTohmebethteresetstpuoamnrestodirc.lteo Avtihtlelierbeacadagmedismniiansnitdsrtaoetbriseoednrvtoeofdtthhfeeoratnaeisnmtyaluasnrttoiiwncalriedhebtehfeeorm BVhaeLva1iro,rbaellurnregcesoa,rcdtelidio.vnesr,AfoSKrriodtsnhseeynsfeoclarlnoodpvsiSynegnhc1ri4aclhdasywasis.ltlroiIinnntciletusidateli,naalbnudttFrinanocattlbweibloldlyimbwieetiecgsohnttso, + @anuicmtaeldsonsuarlvlivianngimatlhse during the conduct of wtehhsietchnpeedcririeoopdsd.yurivniAglnlythbgeerosrcseocnoadrbudnceotdrmowafiltiththieesspteewcshitifciahcs wAerlelobAssertvheed mention to aSttehsetthoearrgatanindclaeonfdw/iotlrhle sboiebtseecraovlbcasuteliravotenedd.p,erTihioafd.spcousAtseLibLlmeer,daiwaudsnaitnlagetahaanplgrodtvhoeessefia(nmDaaSliOv)ariespoofrmttehtweeidtl be stored in the Riker Laboratories Archives, St. Fast, Minnesora. 2 Purina Laboratory Chow, Ralston Purina, St. Louis, Missouri b Efxocoedptwidluribnegvi4th1h6e-l2d0. hour pericd immediately prior to doaing when 0Lo 0 Santer Cl(eopConn on s/c [ . Tate | Gb wedyirecemrw WE 20poyw on 000471 pre s Prineipa) arcicipating ressomel Involved in She seusy nase 5 mer x. . OMetley, 8 Pa-- 6. c. racore sunceton LRaenuoeceaTcearnyicoTieocnmsntcian AStduvdaynceDdirercetxoircologtet RSeuvpeeervTiesmoircolony sagaSrvisoerracory 000472 avers 111 . `Compositioncamacteristics his study is not regulated by the Good Laboratory Practice Regulation of 1976 and therefore information pertaiaing to composition charactesistics Le not applicable for inclusion in this sraty. 000473 ren xv 2% `Quality surance statement This study ie not regulated by the Good Laboratory Practice Magulition of 1978 ang therefore a statanant. signed and prepared by the Qualisy Assurance Group is not applicable. This seudy vas, bovever, sudited by the Quality Aesszance grove. In addition to the data audit, different significant phases for stadia nderey in the Tosicology Laboratory are inspected weekly on a Tecurriog cycle, ana the facilities are examined by Laboratory Quality Assursace on & ehcee month schedule. 000474