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UNION Rdiiitgd BUSHY RUN RESEARCH CENTER FO. +. Mallon Road, Export, Pennsylvania 15632 Telephone (412) 733.5200 PROJECTREPORT. 47-527 SRE TITLE: T-3607 Acute Inhalation Toxicity Test AUTHOR: Donald J. Nachreiner DEC 27 ies: Zp,Hien SPONSOR: 33M1 CCoemnptaenry 2St2.0-2Pa8u-l0,2 NN 55144 INITIATOR: William C. MeCormick DATE: December 19, 1984 000062 A Joint Mallon insutshuhtya URnuinoRneseCaarrchdsCoGnotreproration Operation UNION CRU BUSHY H75. orFonn e, Exper, RUN RESEARCH CENTER Pemwmoo aranaTeas0eTrems P11roPjaegcetsReport 47-527 December 19, 1984 Acute Inhalat2f1o-n360T7oxtetty Study Sponsor: 3M Company rans Abstract Five male and five female Wistar albino rats vere exposed for four hours to aTtPhhoeevsratepepooxwsrpetoreosexfuprnoeTos-u3prm6ee0or7ri.topaedrsli.iTothdie.eMsaecaTtonhrueabrlcoeldiycwnheiwarcemeaiblgenhrotsicggognransoicsnesonfwtarpsaaftothxioolobelnsioetgwryiaveseddul3er.fsi7oin4rognmbsgos.h/tehL es(xe1pv8oe2srnpcdpeum)r.oirng The revise of this study indicate that the four-hour LCSO for 1-3607 is greater than 3:74 mg/L. Objective resulTthiinsgsftruodny waassindgelsei,gnfeodurt-ohoduerteerxnpionseurtehetoac1u-t9e60i7n.halation toxicity to rats Materials and Methods StandTahrids asnteunddyaefnotlltoowetdhethperostpoeccoilfipcreppraorteodcolby (tBhReRCBuPsrhoyjeRcutn 8R4e-s6e2a-r4c0h122C)entaenrd. Test Article 1(1St6.. APatuwlo,-q1ua)r,t absostitglneedofBRTA-C36S07abwiaes Infornation received fron the Nruemcbeeirve4d7-o2n09A,uguansdt Sponsor stared the s9t,or1e9d841afrSoemca3sM purity to be SC0o5spaanndy aRpepgriosxttrayatNeulsybe1r00v%aspneortfluaovreoiolcatbyile sfurlofnontyhle fSlpuoonrsiodre:. An sdestisitaton or CAS A doit Mallon 0IS0nu0sty0Fr6un3oaRnoGaorceCaGnoevroraton Opin Antnal Spectes, Source and Husbandry RPaegpeort2 47-527 oaLnanbdSeMAfnpaeitlmmeeaamllbaesen,rdfa1tIf9sne,cm.aw,1le9er8eS4cH,oi4t5latlndtadanoldpea-,sW5si9isPgAtd)naaeyrdwseaurolnefbiiquanusgoeeed,r.iadtresensOtnp[ie2fct0ith0cei-av3ted0ila0oyyn.g,ofauTHsehLbxeAepyCroWswsIeu)rbrByeeR]trhe(ecHeimilavlletedop stPtohaeoi~tncollpeiesprspiionsdgt.etehlroTwuhigerheoruamttessthwheercaepgoeshstoueosxnepdoscuaFrriervieeprepsreiroidns.eRxoAoimnl12a03y9:e5ranxodf4Kb0ee.po0ttxivoen1d5&.A01n3ci-amhahouirgh Cage Board (Shepherd Specialty Papers, Inc., Kalamazoo, MI) vas placed WeuCxehnpsodowte,saruorrAeeega.lvcaahnydrIonwCco.uo,nftySc,yargeaGscr.ueseen,sPbeuNlrYl)ge,taendPdA)fteaweepdrwe(aAtagevwraaiyl(aHPburlnoeileaaibdpaRl1MiHAb3ui0tt0hu0osrCieteryxtcioeffpietddRuordienngt Inhalation Chamber Design and Operational Characteristics The rats were individually housed in 16.5 x 9.5 x 15.0 ca wire mesh cages aao1nppadperrRoeaoxxtoipimmooasn1te1ea8d.lryeinT2sa5outml1ami2lat0re-iarlzisiertdfpeleriornw(mTatiaphnbprulroteouexg.i1h.matTthheeevcoihlnauhmmabele)artwicaousnboicmdhaaailmnbteParliendxeeidsgilagasnsancdhamber Exposure Regizen SepteFmibveera2l4e, 1a9n8d4,fitvoe were perforned. afevmaaploer raattmsoswpehreereexopfosTe-d36o0n7c.e fNoor cfoonutrrohlouerxspoosnures Generation of the Test Material The 17-3607 vas metered with a piston pusp (FHI Model REG-6/Lab Pump Jr. Aesvsaepmobrlayt)ioinnatto aamgbliaesnst ttuebmepecraotnutraei.ningThgelafslsuibdeavdass umseetderetdo faatcailirtaattee that waectovoruamflppldororewapstrsoie(vodainpdapeirtroubaxewi.snaaostmeiuFlnisyageludr2e5ctoonl1civteapenprrtoesrrsaietpznieetorsntmahioenfsucttaheepse)ptmrawomtaxaisitcmeaprdtaiiesaalslgye,rda5mtThmohgrfe/oLuet.ghnhetiDtrgrheeyen,cehrfaaimtlbiteoernreadn,d exposure systea. fLilteeerArslexdowfathwsartoreuergm.hovtehdreferosmcrtuhbebicnhgasdbeevricveisa eaacvhaccuounntallinnei.ng aTphperoexxihmaautsetlyaiwr owas Target Concentration guideTlhienetsarfgoert c"olnacietn"trtaetsitoinngfosretthfiosrtehxpobysurtehe waTsoxi5c mSgu/Lb,stabnacseesd Coonnttrhoel Act (1sca). 000064 Report 47-527 Page 3 Chamber Concentration Analysis everyThe30 cmoinncuetnetsr.atiAonknoofwnT-v3o6l0u7meinofthaeirchwaamsbesramwpalsedmefarsoumretdheapbprreoaxtihmiantgelzyone of the flasks animals through evacuated containing the atmosphere flasks supplied by the samples of T-3607 were 3M Company. sent to the The Sponsor for analysis of perflurooctyl sulfonyl fluoride. the Ttheestnommaitnearlialconucseendtrbaytitohne wtaostadletveorlmuimneedofbyaidrivwihdiicnhgpathsesetdottahlrowuegihghttheof chamber during the exposure period. Temperature and Relative Humidity The temperature and relative humidity in the recorded continuously with a seven-day recording animal housing room were hygrothermograph (Cole Parmer Instruments, Chicago, IL). with a Series 400 A Digital TDruernidnigcatthoerex(pDoorsiucreSctiheenttiefmipce,ratSuanreDwiaesgo,moCnAi)toarnedd the humidity was monitored Inc., Oakland, CA). with a Model 8501 A Humidity Module (Hygrometrix Animal Observation exposAulrle afnoirmaslisgnwseroef otbosxeircveedffdeucrtisn.g exposure, and for 14 days following Body Weights and The animals were weighed fourteen. The change in bpordiyorwetioghetxpwoassurcealacnudlaotnedpobsytesxupbotsruarcetidnagysthseeven pre-exposure values from each successive weight. Necropsy The aninals anesthesia, the were sacrificed on October animals were exsanguinated 8, by 1984. Following methoxyflurane severing the brachial blood vessels. A complete necropsy was performed. No tissues were saved. Statistical Procedures and The mean exposure aconndcesnttarnadtairodnsd,evwiearteioncaslcouflattheed.bodNyowesitgahttiss,ticbaoldycwomepiagrhitsocnhsanwgeerse, made. Storage of Records BushyThReunfiRneaslearrecphorCtenatnedr.all raw data are retained in the Archives of the 000065 PRaegpeor4t 47-527 Chamber Concentration Results sulfoTnhyelmfelaunor(i+desta(nTd-a3r6d07diesviaatpiporno)ximmaetaesluyred100c%oncPOeSnEt)ratiinontheofexppeorsfulrueorocohcatmybler wcaosnce3.n7t4rat(io0n.s26r)ecmegi/vLe.d fTrhoem itnhdeivSipdounaslordaatrae fporrestehneteadctiunalTaebxlpeos2u.reThe nominal concentration was 5.2 mg/L. Hunidity and Exposure Chamber Conditions The betveen 2t1emapnedra2t2urCe and and 4r3elaantdive57%hurmeisdpietcytiivneltyh,e tahnriomuaglhohuotusithneg srtouodmyrpaenrgieodd. Tchheammbeeranwa(s* s2t6an(dar0d)Cdeavnidati1o6n)(*te5)m%p,erarteusrpeectainvdelhyu.nidity in the exposure Antnal Observations durinTghetrheew1e4r-edanyo pcolsitneixcpaolsusriegnsperoifodt.oxicity observed during the exposure or Mortality No rats died during exposure or during the l4~day postexposure period. Body Weights TableThe3. inMdeiavnidbuoadlybwoediyghwteigghaitnssawnedrebodobysewreviegdhtfocrhabnogtehs days 7 and 14. saerxeessuomnmaproiszetdexpionsure Necropsy No gross pathologic lesions were found in any animals. Discussion mg/LATs-i3n6g0l7epfrooudru-cheodurnoexmpoorstaulrietyt.o anThaecrteuawlerechnaombecrlicnoinccaelntsriagtnisonobosferv3e.d74 wdueriignhgt edxuproisnugretheorpdousrtienxgpostuhreel4p~edraiyod.postTehxeproesuwreerepenroiogdr.ossBoptahthsoelxoegsicgained lWeissitoanrs.albiThneo rreastusltiss ogfreathtiesr stthuadny3i.n7d4icnagt/Le.that the LC50 for T-3607 vapor in 000066 Project Tean WD. LJ. B. K. SNtaecehlretaez, B.S. Kiome, Ph.D. Reviewed and Approved by: T1564 WPC/rkk/0630B-2 RFeaptoer'ts 47-527 SPSertnoutjdoeyrctDiTMeracenhcaatgcoelrroptst Dovad Y Yuhnsonan 13-021 Da SotmuadTyc dDiJrh ectorre3t5er, Tate TPDerononjiersctaR,HanKR aigoewre,W Ph: 1Lo Fred R. Sete Frank, Fob. Director pp -Dxate Alep tate 000067 Report 47-527 Page 6 Table 1 Inhalation Chamber Design and Operation 1-3607 Acute Inhalation Toxicity Test ----------- CHAMBER Location: Room 118 Construction: The chamber was made of Plexiglas. Shape: Cuboidal Dimensions: Height - 0.38 meter WLiedntghth-- 0.61 0.52 meter meter Total Volume - Approximately 120 liters Alrflow Measurement: AdrMyantoessttatmetfelro,wmewtaesr,poscailtiibornaetdedinwitthhe a Singer air supply line to the evaporator tube. Test Article Generation: eFvMaIpoMroadteolrRtPuGb-e6/cLoanbtaPiunmipngJr.glaAssssebmebaldys;; galmabsisent temperature. Chanber Atmosphere Conditions: Chamber Number Nominal Concentration (mg/L) 120-1 5.2 Temperature cc) Mean * SD 26+0 Relative Humidity** @) Mean + SD ts Afr Flowrate (L/min) 25 --_-- * Deternined **Deternined using using a a Series 400 Model 8501 A A Digital Trendicator. Humidity Module. ------ WRC/rkk/06308-2 11-19-84 00068 Report Page 7 47-527 Table 2 Exposure Concentration Measurements _--mm---- 1-3607 Acute Inhalation Toxicity Test Actual Concentrations: Sample Number Time into Exposure (min) Sample Flowrate L/min) Sample Duration (atn) POSF* Concentration (ng/L) (pp). a 55 B 65 c 1s > 125 E 175 F 185 210 H 25 1 5 3.45 168 1 5 3.47 169 1 5 3.65 178 1 5 3.48 169 1 5 3.94 192 1 5 3.87 188 1 5 3.99 194 1 5 4.11 200 Nominal Concentration: Standard Mean Deviation 3.74 0.26 182 13 Target Concentration (mg/L) 5.0 Exposure Duration (ain) 240 Chamber Adrflow (L/nin) 25 Total Mass of T-3607 Used (grams) 31% Nominal Concentration (mg/L) 5.2 _-- * pTehrefl1u-o3r6o0o7ctsyalmpsluelsfowneyrle analyzed fluoride b(Ty-3t6h0e7 sipsonaspoprrofxoirmattheelyco1n0c0e%ntrPOaStEi)o.n of ** TA-3v6o0l7ume(17o.f21m7i.r2demlnsiTt-y36o0f7 was 1.8 metered. gu/nl) was At ambient vaporized. temperature, The density 31 grams was of deternined by weighing 10 ml of T-3607. _--mnmmm---- WRC/rkk/06308-2 11-19-84 000069 Report 47-527 Page 8 T NMummibmearl -_-- 84-14763 84-14764 84-14765 84-14766 84-14767 Table 3 1-3607AcIundtieviIdnuhaallaAtniiomnaTloxDiatcaity Test _e Welght t At t Day Bod7y WE. C1h4ange wMAeLEs S* 261 270 306 246 284 324 253 304 348 245 295 353 258 329 378 29 65 38 78 51 95 50 108 7 120 GroastsNPecarotphsyos NoL NGL NGL NGL NeL Mean: Std. Dev.: 249 296 342 7 22 28 48 93 16 22 Mortality Ratio 0/5 Group Observations: No clinical exposure or signs were observed 14-day postexposure during the periods. 4-hr vapor _-- FFEeMALnESs* 8844--1144882289 21 266 276 201 243 257 25 35 2 16 NL NOL 84-14830 84-14831 251 263 282 243 256 267 12 31 13 24 NGL NGL 84-14832 228 249 252 22 NGL Mean: Std. Dev.: 261 255 267 8 10 13 15 26 9 7 RMaotritoali0t/y5 Group Observations: No clinical exposure or signs were observed 14-day postexposure during the periods. 4-hr vapor -_-- NGL = No Gross Lesions *ExAplobsiunroeraDtatse:[HLSAe(pWtIe)BmRb]erH2i4l,lt1o9p84Lab Animals, Inc., Scottdale, PA were used. EEE EE ---- WEC/rkk/06308-3 12-10-84 000070 | gg< 3B3g svoteer Figure 1 TBGeeneirantionToatntdoBn estePs ne Eiposue chaser i [=] Sicrubebing e-ters hr -- fWi]) cfiees g) cotuen, fi I = == == B PtY est Reservoir Flowmeter pros Afr Source i PRaegpeor1t047-527 UNION Kitab BUSHY RUN RESEARCH CENTER FO. . Mellon Road, Export, Pennsyivania 15632 Telephone (412) 733.5200 Conpliance with TSCA Good Laboratory Practices ContTrhoilsAcsttud(yTSwCaAs) cGoonodducLtaebdoriantoarcycoPrrdaacntciecewsitwhithcurtrheentfoTlolxoiwcinSguvbasrtiaantcieosn: 1. aTvhnoeduldSoptohbneersosrcthaapbrrloaevcitfdeoerrdisttthihecesdpuwureraritetiyonnootfofatvhtaehieltaesbstltuedym.aftoerrHtotawhleeveatrne,dstiitnnhdgeicfcaaotcmeipdloistityht.aitonAint 4dentification or CAS Registry Nusber was not available from the Sponsors influItenc1se tthhee orpeisnuilotns oofr ithnetesrtpurdeytadtiiroenctoofrtthhisatsttuhdeys.e factors did mot '1W2P-C1/0r-k8k4/0500B-1 T SDteud5r.a 3y.aDiicdrecIthorHraBh.egS.il nanne 13-r 10a-t2,4e 000072 A dant Melon InBtuhsuhtys--RunnoRnessGaarrchdeCoGnatrerparaion Operation : Report 47-527 _R ___BE USHS Y RUNEAR CENC TERH Ln) ad BUSHY RUN RESEARCH A. D. 4, Mellon Road, Export, Pennsylvania 15632 CENT R Telephone (412) 733.5200 Qualtey Assurdnce Unit Seuy Tospection sumary 52083 Standard protocol 5-208) 52063 10086 Standard Protocol Amendsent 203-60 fre Bie Av Olid Lhofes Good Laboratory Practices/Quality Assurance A a ton eTyTTCton 000073