Document J36w7B4w2v0KD4e6nZ1qpO2Yr

Estimation of "Safe" Reference Level (ppb) of PFOS in Plasma Estimation of "Safe" Reference Level (ppb) of PFOS in Plasma BB+aassiiLccOFFAaaccEttoLorrss:i:n Rhesus Monkeys = 0.5 mg/kg/day over 90 days = iLPPnFOFOfOAeSScEeLiisss8icc9nuummRduahluyaelsatstiuaivsvfeetM,,rttaohhnneeik.eeexxyccsrrde=eottsii0oeo.5nnikkmniianngee/stktiigccr/dabbtaeesyiinnmoggavqqeyuurihi9ttaee0vlledooawswyisg((.n33i00f.i.2c2%a%ntiilnny uumrroiinrneee aaunnrddin11ar22y..66%% Abeiesnxxoccfrrreeepcttetiisoionn8o9cncaadpfpaaraybobismlialitiftthtyyeerttGhha.aan1nni.hthvruu.ammcdtaaoninssses}a],il)n.morastts [rats compl may have significantly more ete (>95%) within 24 hours urinary afier SigAaaddnbmimisfnoiiinrscpitsatrtinraoattntiioeofnrmn.oe.mrothheepGai.Ic. tract is almost e-circulation complete occurs. (>95%) within 24 hours after Significant enterohepatic re-circulation occurs. Safety Factors: Safety 1100 10 fFffoooarrrcLsLtouOOrbs-AA:cEEhrLLonttoiocNNtOOo AAchEErLoLnic 10100fofrorsuibnt-cerhsrpoenciicestoexcthrraopnoilcation 10 for exposure ofchildren (Food 100 for interspecies extrapolation 10 for exposure of children (Food Quality Quality Safety Safety Act Act & & Water Water Act) Act) nnTooitteegbbheennbeee: inclined 0 keep or reduce interspecies SF. and increase LOAEL to NOAEL Ianmdigohrtsbuebcihnrcolinniecdttoo ckhereopniocr reduce interspecies S.F. and increase LOAEL to NOAEL and/or subchronic to chronic. AAnappnppollgyyriiannmggsT11k00g00/.,d00a00y00.--ffooFlloddrssaaaff7ee0ttyykffgaacchttuoomrrattono,ssuutbbh--sc<hhisooncnioiccnvRRehrhetesesudussosstt0uu.dd3yy5 ggmiiivvceerssogRRrIfaDfm)oso/fdfa55y. nanograms/kg/day. For a 70 kg human, this is converted to 0.35 micrograms/day. nPnoloteteeasbbeeenrneee:c:all that FDA wes 5.0 microgramsiday from all sources asa risk levelfor N- PmEEotltehhlayyalslreFFbOrOaeSsSciEEas..ll We can compare that FDA uses 5. We can compare PFOS and N-Ethyl FOSE risk values stated 0 micrograms/dayfrom all sources as a risk PFOS and N-Ethyl FOSE risk values stated here on a levelfor N- here on a m0o5l..a53r.005bmmaimsciiicrscr:oorggorgraarmmasmssd/d/aadyayyNN-P-EEtOthhSyyll =FFOO0.7SSnEEan-=o88m..o55lnneaasnn/oodmmaoyolleess//ddaayy 0.35 micrograms/day PFOS = 0.7 nanomoles/day oSSfiinnPccReeOooSuurrabbsaasssoiicssiaiisteaad99w00i--tddhaaytyhisssttuuRddIyyDiinnofRR0h.he3ess5uussmimmcoornonkgkereyyasms,,swwphhearattdiiasytt?hheI ceeassttniimomnaalttyeeddthppillnaakssmtmoaadlloeevvteehllis bobmyiyfcPmmrFuoulOgltrtSiaippmallsysy.siinongcgOifa00t..he33d5s5,wmmiilitccherr'otohggairrssaasmRmusfsmDpepeeor1rf0dd0a%a.3yy5isbbmyyini99cp00rloaddgsaarmyaaysmtts(osompgageeyertt adaacatttyoou?ttaaallIlycddaoobnsseeeoanoollffyt33teh11.i.en55sks)t.o do this So, m33h1.u1i1cm55raommngirichcaarrmosogsg3.rraalOmmtsfrs stiihonnifspp,plllalaesastms'mstaanaaggsisi(vuv6eem0ss9e%aao1ccf0oob%nnlcceoiensontidtrnraavtptoiiloloanunsmmooeaff, (w11mh..55aiycppphpabbci,,tsuaaasslslsluiyutmmebriisenniggan ltttihhthataelttentthloheeersmsaaa)vv.leerrSaaogg,ee hhuummaann,haasss3umliitnegrsnoofrpmalalsmheama(6to0c%riotfobfl4o0o%d)v.olume, which is 5 liters in the normal human, assuming normal hematocrit of 40%). TeTxhhpeeorrseefufoorreree,,frI oddmeerraiilvvl eesowwuirittchhes11...55 ppb ppb as as a reference reference level level in in plasma plasma for for chronic chronic PFOS PFOS exposure from all sources. WWsahfhieiltleye ttfhhaicisstommrsaayyussseeedeemcmoueelxxdttrrbeeemmese,i,giinttifffoiolcllalonowtwlssyttrhheeedaauppcpeprdroowaaiccthhhuutssheeeddrebbsyyulffteesddoeefrraaalldaadggieetnnocnciiaeelss..stTuTdhhieees. safety factors used couRlEdCbAeCsTigEnDificantly reduced with the results of additional studies. Exhibit 1486 141488660.0000011 |