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SFOEONOFNUNRBAETPS'SS F0-E3M4A8L,E0-338 WEIGHT OF FULL FOOD JAR:S ESOGRANS EEK 62 F1A6T04576 015 FRoRopSia?e 101155 F1AFTedsrs eis F1oRo0o4J5A7R5 011153 RLAPTo4sWen 013 F1OROoDaIsReRs 01115s) E1AFT04522 015 F1oRoeD4IzAeRs 10115S T1R64sSs 615 R1AFTpases ess iFaoooee 115 11rFeeddssse?s oei1ss 1FFoeoaosdsese e111s5 R1AFT0aSEs 215 FERoTooeR 115 R1ARTEa530 013 F1FoeodDsIsAsR 1e1i5s i1r7e0a4s5o9s2 0v4i5s F1ORO0D4I5A9R4 011155 F1oRo0o4J5A9R5 10115s 1R00445T9S67 0011S5 1FeO0O4D5J3AeR 011135 Foo1D4I5A3R5 101155 11rRa0a4c5o0L0 001155 FERoToDJWeR 115 iRraossc0az 0a1r5e 1reasT0s0e2is 1 7Si17.600 441 1R04578ee0l15s 1 aS7tssi2sze 0 1om 1reass0Ge0z1S 1 asesr1eese 0+ 11 1resss"zaeesis 1 Sa0a4n 6a3nc 111 eo sees 4 1redsseseeeis 1 i8a.73 11 e9r5.6e800 11 ieeess 1a1 1roaseCsaoesas 1 1redseeseesis 11 180455S8000515 1 sdie5a.e4s2 a11 a48i5z.o47ec 11 saam2a8z2 0 111 53733326620 11 4as3ziassac 11 sEsaeRrc Y11 dsoazzeas7 0 11 as-saeezsc 11 Rossae7ls.70s15 a1 3a84i25i0 d1 6.02 een ees 6.04 60 0.65 6.65 8.05 6.62 HOT0.62ON STUDY 3pr7ed 16 n2o0t1ow STUDY 447755..2526 N5O6T3ON STUDY 4So5v16&5 0N6OT4ON STUDY S40447..2613 378 66 WeooT on STUDY e472 33975.668 a3e51ses aNOTesOn STUDY oNeorson STUDY -oN.OT08ON STUDY 541654.6432 aaszs 47 423492. 4822 335733. .6226 35474..4954 336744. 2662 e32231075 a45562.65 4Wo7T5.7O9N STUDY W 364n .25 . 1071 014865 BEST CBOOPSY ApAeT Abie En a ly Lam Som er es ES ALR 1. 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F1oRo0p4JcA7R2 012255 sdeism eorcc 212 541083.9617 i1RR0a44c677a3 G02255 S000534 0 22 -o5100354 ERAnTnnar 125 1Re4sS74ea825 12 0.03 5NO3T 6O4N STUDY . . 1073 01467 R11ARRT0e446E7756 002255 3e82e3s5 1RedsTE 025 22 235028.35 0.05 NT ON STUDY F1oRo0D4JsA7R7 102255 1R03E7S 025 asse1ss7s- 122 oes <2 s1y3 9675 -o.65 | EXi)ne 12s 1reds475s240225 12 0.65 4NO5T2 4O2N STUDY . 1irraeedccrasn 062255 ss9e7s.s94ic 22 FoooRk 125 327.65 0 12 55937. 5914 327.63 a1Reacs1 e25 355.030 o2 95 03 iFOROoDaJcAeRz 102255 awarsesn2c 212 443174..6572 1iRR00d4c6ees3 o02zss FOO0JRR 125 adms962300 22 eer 0 12 443295..5623 360 87 11RRa0a4cceess 002255 aS7251924 00 22 5a725.9142 1FrooodoeJee?R 012255 3C6e2e0s3 212 -a3.602363 1RAFTessss ozs 1RedsSs2?00525 2 -e.63 4N3O2T 0O6N STUDY 1FroaodDsIsAsR 612255 ses2ees8 212 -ope04 R1RA0Ts"cs0 025 1Reaseers.8602s0 2 8.04 3NO7T.8ON STUDY 1FROeOdDEJsALR 012255 ase2s 41830 212 Sa026 1483 R1ARTe46#92 025 1R0465o2e0s25: 2 6.05 oNeOTsON STUDY F1oRoep4JsesR3 10225s a39z3.3045 21)2 349238..3045 1FRoeodpcJsasR 182255 a7s.a7s1ec0 122 . 348374..7316 11RR0a445E9s5e o0z2s5 38619 22 318009.4178 1FRO0O4D6ISA7R 102255 3a5s..4039 0 122 3a0e5s'e43s T1aRas69s ozs amar 2 433.17 1FRoeo4DsIsAsR 012255 3a5e1s8:0 212 53.950.618 1RArTeazo0 025 1R04649255.40525 2 6.06 4NO2T9.4O9N STUDY F1oroepdJraerr 102255 sao3i5e01 0 212 3se5i 961 F1oroeo4g7a0r2 102255 5361378900 122 39653..1789 11rRe044v7e0d3 602255 505.06.404 22 e5e05s04 FRAOTODIAR 125 1R047as0s4. 8025 12 8.64 N4O9T5 eOsN STUDY R1ARTa47&05 025 1R0470o5e0s25 2 ~e.63 -NeO.TesON STUDY IResros 035 2 338.63 F1oroooaJ7A0R7 013355 i34387.630 133 433478..063 11Rr0e4a7z0e8s 003355 i3s%sa4e1 0- 33 345%5.1441 1FoRoooaJvmire 813355 33727687300 313 332767.6734 91468 F1poeoaDrJaRsR 103355 3a67m.3s0 133 346373..335 11r407471a3z 0@3355 s4e3s5a47 0 33 30033..3447 F1oRo0o4s7A2r4 103355 338576.871200 133 338%7.7812 F1ro0o47A4R5 103355 63637.048 133 336876..348 i1pR0o4a77a167 083335 3a1e23s4 0 33 33132.8554 F1oRo6o4J7A1R8 013355 iarsiasaec. 133 345731.5381 F1ORO0D4I7A1R5 013355 ea134784 0 133 348318.7448 i1RR00a47722s0 BB3355 as3712c0 33 3a8a837921 1FRO0O4D7I2A2R G12355 i37o98e3 c0 313 5307.5.6638 F1oRo0oas7A2r3 813355 a3r6s48s3z 0 133 a3674.6532 11Rreeaa7r22se 0a3355 s3e%sa052400 33 23944.5 9042 1Fro0o4D7J2A6R 013355 a3r1e6.9e4sc0 313 73166.. 6554 F1oRoeoaJrA2R? 103355 339454..2444 13)3 334945 4244 1irr0e4a7r2z8s 003355 SGoe7e 2s6o 33 6G087.526 1FFoooaD7J3AeR 013355 6s81.a6855 0 313 331648.. 6653 iFroeoaDrJ3A1R 013355 a3s975..2778 133 435973..2778 11rpeeaarra3z2 003355 23695.7657 0 33 3265355..6775 iFkoeodorJzaaR 013255 s36e6.s15s 313 433666.1695 R1AFTe4735 035 1R04735660s35c 3 @69 0NO6TsON STUDY F1oRoeo4J7e3r6 103355 S3o9a.12284 0 313 S3e9s1. 2284 FioRoeDaira3k? 10335s 4c0e0i 6e2sc 313 4s0e0i 6092 11FRe044773398 003355 aaeasc 33 443136 6318 F1Fo0o4o7A4R0 103355 a35s9i.e4r6 c 133 43935.36476 F1koeoaDrJaAsR 103355 430655..9724 31)3 e36s3.7942 i1Rreeadr7aas2 003355 Saszezsz3cc 33 S45262. 7523 1FRoeoap7J4A4r 013355 37e0.e9s6 : 313 o37e6z.96 R1ARTedras 035 pr357.51 0 3 @03 3NO5T7.5O1N STUDY 1FRO0OaD7JaAsR 013355 a4e95s.9e0r + 133 9ae5s.907 FirRo0D4I7R4R7 103355 33974177 co 133 349143..1777 iRo1a477a4ss 03355 S3774a.a0s9 oc 33) S37744.434 F18o04o75r0 103355 eSz55s4e - 133 356125.5448 R1ARTe47sL 635 1rearsy628635 3 @.26 aNOT26ON STUDY. 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EaSits Gas Foudee 135 Pr"SeBoiz Sse iaz ce.en &nT on STULY amg EFiirrees ooiies z Saaiizcs:oz p23e5 FFoooniirmee o1i3s3 EE is R1m &33128 iEAFTearos 035 kaz"ea7B35 % eee 4N7O4T 7O3n STUY e F1oPu0b4I7R3E0 013122 4S7a2esz 13 azzozzz 1REFToarWzL ons prsoe: 2 "eer NoOTaon STUY FFAoToo0Ik 125 ReaTI1seolis 13 662 6HATaOn STUY R1ArTearsz ois rearszseezis bez noTezow STUDY F1aPnea0TIsazk 013338 SSo3w155% 133 4p43y .23 EPaaWrze 835 PeaTIaGe035 3 Ger o20T1on STUY F1APT047IS 035 1Re4r3sse0e38 3 oe NOT OM STUGY F1FO4GTLIEE 813355 siaieez 313 5ee1n62 Lowvaetes 61333 ="55zess 13 m4552352 E1Fiia7Is Bis 1Fear3csoo0:3s 3 cee Leenenr on stony F1Poacara3asr B1i3s afadoer:Ln 14405. 636 1FRaoiazThael 683333 wessecc 33 a5e51 EFRoTou ies 135 ikea7daalaorzs 1 een sNOaT aorn STUDY E1aFrGaTaz 025 koa7aozoBo25 3 6.08 NeOT on STUDY REeAais exs 1R047aC3he0r35 Fooriee 135 ceo 3 13 662 aHeooTezON STUDY EERiT ra 625 1/047S4aez06.35 -e6z aWOTezon STUDY F1oroeUaIrRaRs 103355 sdezs earoc 13 s40z2.754 R1AFTiiTas 035 1Redra"soo6o35 1 0.60 NeOT on STULY FFeoaurIanrk 103335 Sseaos2s6 a33 S5e4e1.8252 Fraetsting 1Foaras 035 RearaSs000235 3 "sez 3 ez 6MoT02ow STUDY -o ez IFu)tiak 125 1roaTaSsee0s25 13 ez o T on STUY FLAFToarse 513 1koa7EcDse0z35 3 -oez eowarezow Stuy EPuEa)res azz 1K0a7ESLh03e5 r: a0 6oT62on STUDY FFoeoarrTse:e e13e5 sSieaemso 313 3e 514s . 01595 Froeoatresr 1e3x5s 11RR004aTTSs4S 603385 sFoeosrisTseieea1d35 s4e1s38420 313 isaersa 33 sn Sse 31 430508 234 a3615 a7sa Seas 1202 01596 Stephen Distner, DVM. Res6e8n5deRMoemasAovennu5e5.110 oryDg) CrRONI~ _---- AppendixItem G April 18,1983 MPaartvnionlogTy.C-aTsoexicDo.lVo.gHy.,PMha.nDager BS3a1if8ee%rt5y LSanEbvocaerlnauttaeotrriyon Laboratories St. Paul,Minnesota Dear or. Case: On April 15,1983 I performed ocular eaminations on a . group of approximately two year old Sprague Dawley rats being used in 3M study 0281CR-0012. All rats had their eEeyxxeaasmmiinnpaerteivtoihnoe.usalnAyteFridisioolrnateaidnnddwiirpteohcstte1ro%ipohartthraooclpumilnoaesrpcroipsoeergmveatnsot:oucsueldarto ALL findings were recorded in the laboratory notebook as pcTfenaarttsatrhtaoihcfsetssGtrohooiiudsspasLogeafeeb.noTarhnaaesitromeranylosrwemPrnarelaamcetsaloigymceeeisnagcAhrrcacothnn.adinTocghmeesducvihesinaitntrgiitesbhsuetciaolosbenesnsesrovfoaefndd 2ps3euucp1tederdfibeciinaolbasegkrrevoreuadptitocifhsatanpiwrmeoarbellsemisonfdibucttahtisitvheaegseeo,f agNtoahienoccuowlmoapuroludnfdibenudniednxeg-rs Study. Tf 1 may answer any additional questions tna you nave please let me know. sincerely, SStAeepphheenr BBiussttnae2r dDVHM a Associate professor Comp. Ophthal. 1203 01597 APPENDIX ITEM G Two YearOOfraFlluo(rDoiceht)emiTcoaxliciFtCy-1-4O3ncoIgnenRiatcsity Study Individual Opthalmological Findings HALES Animal No. Eve Comment(s) Control **IIRR--3355331 S**1IRR--33554389 *SIHIRR--33556652 S+*1IRR--33556697 *1IRR--33557727 RiLegfhtt RiLgefhtt RRiigghhtt BBiillaatteerraall BBiillaatteerraall PPoosstteerriioorr ssuubbccaappssuullaarr ccaattaarraacctt PPoosstteerriioorr ssuubbccaappssuullaarr ccaattaarraacctt CDhirfofnuisceduvleenistisc-aspeaccoitnydar(dhyptoopybolne)e;dincghronic uveitis with microphthalmia CPhorsotneirciorsupleernsficoipaalcitkyeratitis VPeorsyterpiaolre cshuobrcoaipdsaullarcicractulaartaicotn 300ppm *IIRR--33663419 **+IIRR--33662333 *IR1-R-33661102 *I+RIR--33650983 1*IRR--33558827 *I*RIR--33664202 *IR-3617 RRiigghhtt BBiillaatteerraall RRiigghhtt RLiegfhtt RiBiglhatteral RiBiglhatteral RLiegfhtt DCahcrronyiacdensiutpiesrficial keratitis CChhrroonniicc ssuuppeerrffiicciiaall kkeerraattiittiiss CPhhrtohniiscis sBuuplebrific(isaelcoknedraartyittios bleeding) PPoosstteerriioorr ssuubbccaappssuullaarr ccaattaarraaccttss CPhhrtohniiscisuvBeulibtiis(secondary to bleeding) DAinftfeursieodr synechia Tens opacity Atrophy* Focal posterior capsul Tens opacity 30pon **IIRR--33665682 1R-3666 *1R18--33668807 RiLegfhtt Right RLiefgtht OFoccuallarco(rcnoeranlealo)paocpiatcyitwyi?th pannus Ocular (corneal) opacitya OActurloaprhy (corneal) opacity? ROTE+Sini:nddiiccaatteessblanoiondalsahmapdlipnogssitbalkeenSOfArovmireayles.involvement. # indicates clinical observation sign. 1204 1598 APPENDIX ITEM 6 Two YearOfOraFlluo(rDoiceht)eniTcoaxliciFtC-y1-4O3ncoIgnenRaitcsity Study Individual Opththimologic Findings FEMALES ------ ee -------------- Aninal No. Eye Coment (s) Control S**1IRR--44558836 $S**I1RR--44650929 **IIRR--44661260 s 1R-4623 S 1R-4625 *1R-4636 LLeefftt RiRigghhtt Left RRiigghhtt Right Bilateral Left ADtirfofpuhsye?corneal opacity CCohrrnoenailc ospuapceriftiyc-idailffukseerdatiutlicserated - SOA? F(occharloniicrisuvesittaipshylwoimtah; sceocronnedaalryoepxaocpihttyhalmia) ADtarcorpyhayd?gnitis Cpoarrnteiaalllyopaccoiltlya,pseednla-rgSeOdA,} ulcerated, uIlricserasttiaopnhyloma, focal corneal opacity, Posterior subcapsular cataract 300 ppm S"*1IRR-C44664829 *1R-4634 RiRigghhtt AAttrroopphhyy?? Right Atrophy? 3p0 om *+1IRR--44772479 **1IRR--44775530 RRiigghhtt AAttrroopphhyy?} LRiegfhtt DAitfrfoupsheyd? Tens opacity with pannus micro-ophthalmia -- ee-------------------- NOTES: * iinnddiiccaatteess abnlionoadl shaamdplipnogssitbalkeenSOfAromvireayles.involvement. indicates clinical observation sign. 1205 01599 Appendix reen 8 - cer Mr5ooDnl.. GcRaersniedeersseon FcWlECK!.orLmoeidceeon.maineCnx. Goamer 58 neteon/t. postetis 5RR..EAA.. pGNreeolrksoodpn./v.b.PoJtohhanpseoonsads G1073 Ssiebaitnteeknd (origina + 1) TITLE: PFlrlootrooccoalrbfoonrsTwFoH-3Y9e2a4r aOrnadlFC(-D1i4et3) inToxRaiccai.ty-o(nRciokgaeniSceiutsyy NSot.udGy26o1fCRO012) OBJECTIVE: RECvTa1l4u3ateincahrtounoicyetaorxicratandstoudnyc.ogenic affects of FM-392% and TEST ARTICIBS: Fawin-la3ll9y2tb4iec2aslualnpydplbiPyeC-d1t4ah3ne%d,,Coa3mserafcplipuarolorporcCiaharetbmeoin,csa.lwselDTlihvehiascrioaomcnpe,oesurhn:idssed SSE.FCPCauLl4,3 wWNi.i bAee.prnoexediemdateflory t1h.e0 kagcuof.F-3934 ana 2.0 ks CONTROL ARTICLE: GroundCeresfied Purina Laboratory Chow #5002. SPowSOR: Commercial Chemicals Divisi3oHn. TESTING FACILITY: S5a5fetpyaaE,valMuiantneisoontaL.aboratory, Riker Laboratories, Inc., S0SING INIERVAL: sSFettbuardruytardoyfires-tcuMtdaoyrr.cvhil1l961isstuherouaghdetFaeiblreudarsytu-dyMarscchhed1u9l83e.befhoere TEST SYSTEM: Tirnahtraeh,eanhg3ui5nn-gd4r2esddcaayaisnndieosltsdhiocrnutsyeddmoasleceagdeaasyndw1i.3t3h0ThwfeiermeaaltemsesCh#hialrfllleosobresRhiovauensrdedCD C1Fre2omnhptoesur"arc(uTsriaelgehaen/-dda1h/cckuamgcdeyi,ctleyf.ecmoanletsroll2e/dcavgiet)h. thTehe1igcnoeosn woinl8l be JUSTIFICATIuCOsoeNxdiFcbiOetRcyaSuEssLeeEaCdiToeIfsObNaicnOkFgtrThoEautSnTdscSdrYaSeTtiEanM:oobftaCfihatna.reldesfrRoinvperrevCiDoursatssuwbihlElORbSeC TESS SYSTEbcMeaIsDiEnVdIiIcFaItCeAdTIoOnN:theEaocuhtsiadneimaolf wtihlelcbaegeasansdigonnedana innudsibveirduwahlichsawrill E uN-a3o92c4ode1ad acson2m-i2c9a0l9cagcrade me-22 Mito coded as nz99000c 1206 91600 Appendix Ttem H (continued) RANDOMIZAgTrIoOupNsOFbyTEuSsTingSYSaTEcMo:mpuAtneirm-aglesnerwaitlledberaansdosmignnuemdbetro mtehtehovda.rious DIET ANDgrOoTuHnEdR FceOrRtMiUfLiAeTdIONP/uArNiAnLaYTLIaCbAoLratSoPrECyIFCIhCoAwTI#O5N0S0:2 aTnrdeawatteedrawnidllunbtereated atevsatilaabrlteiclaed alnidbidtiuenttwhirlolughbeoupthytshiecasltludyy.mixeFdresehvermyixtounreestooffoturhe Weeks, depending on the stability of the test articles in the chow. Tchhearascptoenrsiozrewitlhel ptreosvtidaertitchleesnecaensdsathrey analytical support to test article diet mixtures. Ptoresttheudytesatnalfyatciiclailtyrbeesfulotrse otfhetshteudtyestwilalrtbiecleisnitmiuasttedb.e fAonrawlayrtdiecdal canhdaraatctetrheizactoimopnletofiontheOfttehset adrotsiicnlgesinwteirlvlalb.e deSttaebrimliinteyd prior to of the tuessitngarttriicallesbleinnd(dsi)etowrilflrobme tdheetefrimrisntebdlpernidorfotro thtehedodsoisnigng initnetrevravla.l Rceoplrleescetnetdabtiyvethesamtpelsets foafcielaicthy tduersitngarwtiecelke diet mixture will be 3 or 4 and approximately eCvheermyica1l3sweAenkaslyttihcearleafLtaebroraantdorwyi/l3l bfeorsutebsmtittaerdtictloetcheontCeonmtmeracnidal uniformity-of-concentration analyses. ADNIDETAARCYCEPCTOANBTLAEMINLAENVTESLSKNTOHEWRNEOTFO: BENCoAPdAiBeLtEaryOFcoInNtTaEmRiFnEaRnItNsG WITH TEST are known ARTICLE to interfere wbiyththetheventedsotr afrotrichleea.vy Hmeotwaelvse,r,aftlhaetocxeirnt,ificehdlodriientatehdashybdereoncaarnbaolnysz,ed 2C8, and organophosphates. DOSAGE LbEeVEcLaSu,seROiUtTEa,ppeGaRrOUsP,toSbIeZE,anETaCp.p:roprOiraatle (rdoieutt)e dtoosiunsge wfiolrlevbealuuasteding ltoonxgicitteyrmsttuodxiiecsityt-hoinscorgoeuntieciwtays. useAdlsoandinatthheigprheevrioduossessubtcoxhirconiecffercatts were demonstrated. Taensitmalasrtiicnleglamsisxtufroeosd ajnards.theFcroensthrotlreaartteidclaendwiulnltrbeeategdivedniettowitlhle be changed on a weekly basis. Dose Group. Dosage Level Group size CHoingthroFlM-392 MLiodw FFN--33992244 HLiogwhFCF-C1-41343 1000 ppppmm 30 ppm 31000 ppppmm 3 ppm s65s0,, 65508 sos, 508 s6a5s,, 6550%2 so, 508 1207 01601 2ppIveenn 8tedontiings ed) METABOLIC tDoIxSiPcOiStIyTIsOtNudOiFesTEShTaveARTiInCdLiEc:atedProervaiolusabosroarlpti(odnietb)ecasuusbechcroonmic mpeotuanbdoltiosximcsteufdfieecstshawveeresphroownduocreadlinabsroatrsp.tioAnloscocpurrseliimnintahreyrat. wDiulrlinbgetchoisllescttueddy poveerrinoidgihctall(y~ f16rohmou5rsr)atusr/isneex/danodsefgercoeuspsafmoprles analysis, as appropriate, of total organic fluorine, FC-143, FanNd-34f2e2ceosrsFaCm-pl9e5s (wpiolslsibbelecoFlMl-e34c2t2edmaettab2,oli5t,e)1.1 anTdhes2e3 muornitnhes. Also at the scheduled 1 and 2 year necropsies, tissue samples wLiilvler,bebsloaovde,d kfirdonney5, rsaptlse/esne,x/dlousneg garnodubpon(eotmhaerrrotwiss(ufeesmurm)igh-t be suggested during the course of the study). After collection, the samples will be stored frozen. tThoexsiecitsyam-polnecsogeanreicintoyt ceovnasliudaetrieodn oafn PiMn-t3e9r2g4ralandparFtC-1of43thien rats mbuettaabroelictakiennfobremcataiuosne. thAeyllmatyhesusapmppllyesusweiflull nsoutppnleemceenstsaalrily obef sancaileynzteidf:icthjeudgeexmteenntt biyn wthhiechspotnhseoyr.areThaenalsypzonesdorisreaprmeastetnetratThieve rweislulltsbe ofrestphoensseibalnealyfsoers cwoiolrldinbeatiroenporoftedtheisne a ansaelpyasreast.e zeport which will be a supplement to the toxicity-oncogenicity report. CLINICAL OBpSoEsRsViAbTlIeONtSu:morsC,linwiiclallbeobsreercvoartdieodnso,nceincalwuedeikng (peavleprayti5ontof8ordays); oIbfsearnvaatniiomnasl hoansalelviodtehnecre dofaysdiwfifilclulbteiebsa,siciatllsyhoullidveb/edeoabdsecrhevcekds. msoarteisfcalcotsoerlyy tsoissiutecasnambpelese.uthaBnoadtyizweedighbtesfowrielldeabtehretcoorodbetdainand sfoioxdmocnotnhssu,mpttihoenn woinlcle ebeverdyetefroumrinweedekosnceunetailchtweeremkinaftoiront.he Tfhierst tthersotugchoomupt.ounthdes swtiuldly.be administered at constant ppm in diet EYE EXAMINAeTxIaOmNiSn:ed bByyesa osftafalflvethteericnonatrrioaln bayndihnidgihrecdtoseophratthsalwmiolslcobpey and/or bsleiftorelamcpombpiooumnidcraodsmcionpiestraattitohne ssttaarrtts)o,f ntheearsttuhedymi(didflepoosfsibtlhee astbundoyrma(l=it1i2esmonftohusn)d oannddadiurliyngobstehervaftiinoanlsmownitlhl boef cdoaslilnegd. toEytehe daetetmeendtinoenceosfsatrhye bsytafthfeveStteurdiynaDirrieacntofro.r further definition, as 1208 01602 AppendixTven4(continued) : CLINICAL PAcToHnOdLuOcGtYe:d onThe15cmlailneicaalndla15borfaetmoarlye rtaetsstsfrloimsteeadchbelgorwouwpilalt b3,e 6, 12, m1a8deanbdy24themonutshes.of rAnainmdaolmsnusmebleercst.ed Baltooeadcwhiltlimbeeicnbttearivnaeldwivlila be svteaniinpluenscsturseteeolf mtehetaobrobliitsamlcasgiensu.s. Urine will be collected in 1. Heam.atoTlootgayl RC cb.. HHeemmaotgolcorbiitn ea.. TDopitfaflerwenctial 2. Clia.nicaTlotaclheBmiilsitrruybin cbo.. AToltbaulminProtein 5a.l Gsluuncose 5. cAlekaline Phosphatase hil sscporr 3. Calcium 3. Uria.nalypsHis bc. ASlpbeucmiifnic Gravity 4. Glucose e.. OBcicluilrtubiBnlood 5. Ketones TISSUE PATHtOhLeOGsYt:udy.GrosAsnyneractropisnieasmowirlilbubned ccoonnddiutcitoend osnhoualldl breatsterinminated otfo tihnesurvearisoautsisftaiscstuoersy wtiilslsubeesacmopllleescte(dseefrboemloawnylriastt).whicShamhpaldes adbiseodluutnelesmsinismeuvesresamapulteoslysoifsluinsg,prelsiveenrt, iknidanetyi,ssuber.ainAsandanany atunmdor15mafsesmawliesll fbreomceoalclhectoefd.the Antwoinhtiegrhiudmosneecrgoropuspys owfil1l5 males be odonnceogeatni1c ryeesaprontsoedaettertmhiantetiimfe.therAet tihseaanndinodficattheionstuodfy,anall tsiusrsvuievsingtorbaetsfwiixleld bien 1k0i%llbeudfffeorregdrofsosrmnaelcirnopasrye. liSsatmepdlebseloowf. oAnt tthheose1 atnidssu2esyeairdennetcirfoipesdiewsi,thweatn w*eiognht1s5 rwialtls/sbeex/ogbrtoauipn,ed psealiercetdioonrgaonfsanwiilmlalsbebyrercaornddeodm ansumbaercomtbabilneesd.weiWgehitghtasndfoirf waenigohrtgawniltlo nbeotwbeeigthaekdeni.s in(vNootlev:ed Biondya wleairgghettwuimlolr bmeassd,etaermined oofn rtheelsaetiv1e5 oarngiamnalswe/isgehxt/sg.r)oup prior to necropsy for calculation 1209 001603 AppIteemHn(d contiinuxed) aaodrrtenaal (2 brafirnont(a3lseccotritoenxsanidncblausdaisng gaanndgltihaa,lampuasr;ietcaelrecboerltleuxm eyesand pons) gonaodvsaries i, heatretsstes/efpdsfmis Slmaarlgle iinntteessttiinnee (at least 2 areas) Kidneys* Liver (2 sections) L1yuanpgh node (nesentric) Dpaanmcarreyasgland (females) psiatluiivtaarryygland ssppilneae)ntcozd/bone marrow (vertebrac) tsthoymarcohid/parathyroid/cersoapchhaeguas uurcienraursyt bolradpdreorstate aannyy ottihsesuregrmoassssesles(isounsspected tumors) MSieccrtoisoncsopwiicllexabmeinpaetrifoonrmoefd ffoorrmaalllina-nfiimxaeldsstinainceodntrpoalrafafnidnbottihssuheigh duorsienggrotuhpes,couirnsceluodfingtheallstuadnyi.mals in these groups dying or euthanatized fInroamddailtlioann,imatlhse ifnollthoewinlgowtainsdsumeisdwidlolsebegroeuxpasm;ineldivemri,croksidcnoepyi,cally ofnroamdsallandlovallandtimssiudedomsaseselse.velThaenimraelmsaiwniilnlg bteisssuaevsedlifosrtepdosasbiobvele aFnuitmuarelsreifnerleonwceo.r mMiidcrdoossceopgircoupesvawliulaltiboen opefrfaodrdmiteidoniaflintidsiscuaetsedfrom by experizental findings at the high dose level. +210 001603 vin moSSSteapessiisaeeinsmrpaHobesyyesesrreeounertnslfee,fS0E esTepvLeesedfsoensityssarnw lssSorsneesseerpnadtre ssdc0o h,e FSleerw SaeanteSeE a5batptatswSaeameeereB lielms wi SeI E Be Seine a a ie a p Rea ArT fs SRGo) Ph Thea tits ose ; 12 Date Manager, Pathology-Toxicology Safety Evaluation Laboratory QheieBlhelateos,lnaetdh, 1o24i95s ELERJIeEC gitJ 22 HPbo plitnticl "* 12 --_& Pilanilafffy: Roques wor Representative A te 30+ Raps Bas 1211 001604 EE 0 0bSlhag cruer Eeeaane ee HE vn NEEErE eb. sone Lh3 rly Somer ssantines vo the Process for en Tour oust {overt Tsang = SATIN SS 9% FSI FHeTE8 at 20D $n Tate (nee Seuty Yo. ERAENREE) A WN Drue er eg Rar a -- Rh Je Tr yey 5 25 TB Toon rpounes 4Sr oS1miastaebr1T1o.557O80S mi SoUmeSnEahAGSoLUy SJinonAmn".T epLopeemRceeseeeseengd fne5n8 Lin BpI FgpyE agees sL ages OI F SSESrErgpeEEsrEEa r3 brornsy, ff orest n pistes LL enee i.TIE FH I tLd s io ke yt&ty Kren tone eoykAppbleeerdi 0a1si tu. 7l% e-- Ysi, ns Safety Evaluation Laboratory Flat, 2 er vanes Manager, Toxicology Services : . 2 o0 stp ssCor Ls sssamsative :57 1212 001605 Appendix Item H (concluded Two Year OofralFlu(oDrieotc)arbToonxicFiCt-y1-4O3ncoigneRnaitcisty Study Asendsents to the Protocol Aonsceofevsetruydytwdoaywe1e8k3s,. body veights and food consumption will be recorded DureomtRoiktehre Luanbeoxrpaetcotreidesl,eatvhiengfionfalDr.eyeJ.De.xamHienndaetrisoonn,ofththeesstuarfvfivvientgerinarian SctoenvternolsBiastnnderh,igDhVMd,osae cFHo-n3s9u2l4tinagndveFtCe-r1i4n3arTyatsopvhithlallmboelopgeirsfto.rmed by Dr. oPbaslepravtaitoinonfofrorposclsiinbilcealtussiogrnse.(masses) will occur during the weekly iInnatdevreirntennetclryo,psynofotristshueesMweetraeboltiaskaengrforuopm. the mle rats during the one year 1213 01606 APPENDIX ITEM I STATEMENT OF QUALITY ASSURANCE STUDY NUMBER: TITLE: 0281CRO012 (FC-143) Two Year Oral (Diet) Toxicity/Carcinogenicity Study of Fluorochemical FC-143 in Rats Audits and/or inspections were performed by the Riker Compliance Audit unit for the above titled study, and reported to the study director and to management as follows: DatePerformed DateReported 5/13/81 5/18/81 6/23/81 1117/151//8811 11/20/81 2/8/82 2/9/82 2/12/82 3/10/82 3/31/82 4/15/82 5/10/82 5/18/82 8/18/82 11/9/82 11/22/82 1/25/83 2/22/83 4/44//111285///888333 4/26/83 8/4/83 9/24/84 7/24/81 8/21/81 6/2/81 11/13/81 5/20/81 6/26/81 11/13/81 12/1/81 2/16/82 2/12/82 3/2/82 3/31/82 4/2/82 5/3/82 5/20/82 5/20/82 8/26/82 11/22/82 54/251//8833 12/1/82 2/4/83 3/15/83 5/17/83 6/3/83 8/5/83 9/27/84 7/29/81 8/21/81 RDmikpeer.iLaanbcoeractAauadriitresb, oInc.oS m5e-27 1214 01607 APPENDIXITEMJ CHEMICAL ANALYSES OF FC-143 AND STABILITY ANALYSIS OF FC-143 IN DIET 1215 01608 Internal Correspondence Appendix Iten J ToD. R. RICKER - 53-81 Fon C"OAMNAELRYCTIICAALL,CRHEEFMCIRCTAL#S308 Sant L. D. WINTER- 236-2 ue STFURDEY A4N0D6BPITOES0T39S8TUDY ANALYSIS OF T-3141 COC (FG-143) FOR RIKER3M -- www Reference: COD Analytical Request #'s 16474, 16614, 17958 cAwhaaswrhaictrteeecrpeioizwvadetediroendorsaiongldiindaalnllaaylbyeslioesnd. FOCc-t14o3bLerot2381. xe7n This material d605D2eceLmobter94) was analyzed 3,(T-13194810 CfOoCr) nd vad ne wSsiettvuhedryasla#m0p2s8lt1euCdRri0ee0cs1e2i.viendcTlfhuerdoismnagmD.ptlheReiwcaktsewror2oy9-eaaJnraanl.fyezee62dd.infgoSrasmtppuoldseyt wO(a6s1911909T06H80003s09o)8lidRssti.udkyer The sanple analyzed as follows: GLC of Metnyl Esters Fre Rost C67 hfeettda 00..26 Cg Acid (all tsamers) 97.6 r2t 98.4 CCigoAcAictda 28 21 Cx Actd 5 a ALL values within experimental and integration parameters. Elemental Analysis: Elenent Theo: Fre Fost. cr N 626..2173 662..22 6252..29 3.24 35 3.6 ~H0 by ater. 07l.%22 o7.r4 o 68pm o7.r6 68 pm i = 131 1216 01609 Appendix Iten J "tn Spectroscopic sIpnefcrtarrae.d spectra I64TA-1 and 17958-1 are identical and match reference mMaRtchspreecfterraenHce83s8p6e,ctFra.8383T-h9e (cPhrae)inanids 79%101s6t3r-a4lg(nPtostc)haianr,e i9d%ent(iCcFa3l)LaFn-d branching and 12% baci bone branched. Conclustons FOU.Lot-37 has an analyaiswithingpecificaistsitaoblneasn,d 4s Slag Dime de: EM.TG.arCtanseer -- 221188--22 WE.. CGL. LMaemGpormeicchtk -- 221280--32502 RWI. AHl. PPeraorklospo-n ~2326-2238-65E LJ. Stotnsid - 218-3-3 1217 01610 InternalCorrespondance Appendix ten J TST pied CAONMAMLEYRTCIICAALL CREHPEOMRITCA#L3S48 From R. M. PAYFER - 236-28 | Swi ue MID JUNE STUDY PURITY 22, 1982 CFHEEECKDINOGF SFTCU-D1Y43NO(.T-02298918CCR00C0)12FOR RIKER 3M -_-- Reference: C16o6m1e4r,ci1a7l958C,hemAincalayltsicAanlalyRteipcoarlt 4R3e0q8uests #18319, 16474, A19w82hitfeo,r with the afpnooalulldyoeswriiesndg sfoorrleisaudltmlsia:dbeSlteuddyFC-e1v4a3l,uatLiootn.37 wTahse mraetceeriivaeld woans Haanyal1y7,led GLC pata c5g AAcciidd Cg5 AAcciidd (al isomers) GCAocAicdid (Methyl Esters) Area x 003.6285 90.62.6 <001:13 Elemental Analysis: Elenent Theor. % % Found WcN 20..297 20.s3 3.24 36 0F by difference 667..1432 Fr 0 68..32 17 ppm Titration for Nig* to deternine equivalent wefght. Theoretical Feoqu.ndwt. = 443313 Infrared spectrun F18319-1 matched reference spectra. 1218 01611 Appendix Item J -2- Conclusions: Al3l rneosuclhtasngaeredweittehctiendexinperFiCm-1e4n3t,al Leortro37r. or previous ones, so there has RMP /hc. Fe See de: EM.. T. 6. Case - 218-2 Lamprecht - 218-3 WJ..DC.. MLcaCZoerrmtieck- -23262-01-26-02 LVo. DP.otWhianprtaegrad-a23-6-22386-GB 1219 : 01612 ternalCorrespondence Appendix Item J To Led. SIBINSKI - 218-3-3 ACNOAMLMYETRICCIAALL RCEHPEOMRITCA4L4S13 fom Sect uoRMof. PAYFER - 236-28 HB STUDY PURITY CHECK OF FC-L43 (1-2938C0C) FOR RIKER we 4 JUNE 15, 1983 FEEDING STUDY NO. _0281C 3M --_--_-- ee Reference: 1C6o6m1e4r,ci1a7l958,Che1m9i3c3a1ls Analytical Requests F18319, 16474, Analytical Reports 4308, 348 aA1n9aw8lh3iytzefe,odrwpioatwnhdaelrtyhesedisfsoofllolirodwialnnagbeerlenesdduloFtfCs-:1s4t3u,dyLoteva3l7uawtaison.receiTvheed monateArpiraill w1a8s, 6Lc Data GC76 AAcctiad C9g AAcciidd (a1 isomers) CGClohcAicdia (Methy) Esters) Areas 01.:20 907.7.2 0[21%] Elemental Analysis: Elenent Theor. 3 % Found Hc N 02.25.227 02.28.3 3.20 39 0F by difference 76.64.213 88..00 Titration for NHg* to determine equivalent weight. ay co11622103 seperti tte 3 oe , Ja -- Infrared spectrin ancusions: SES matched reference species 4A 1 rests are wishin eSriEseLnalEerYror of previous one, 0 thre hs while) Fen wLTE5EE8 t LseRaezBesta, L 3 Saa diee 5 1221 c01614 InternalCorrespondence Appendix Item J CReCpDorAtn.al4y2t0i9cal EERE PNY fom P. J. Colbert - 236-28 Sano BGLlCendAendalyIsnitso GorfouFnCd-14La3b.(C-h2o6w98CoC) ove April 16, 1581 3M REFERENCE: * CLaobmoerractioarly CRehqeumeisctals#16A8n6a2lytical CLaobmoerractioarly MCehtehmoidcal#s63A1n0a4l8y1tical wTihtrheeasbalmaplneksloafb FcCh-o1w43sambplleendweedrefntroecGeriovuenddfrLoamb CL.howJ.aSliobnignski on 2-23-81 for analysis. The samples were labeled 2s follows: Compound F163 Theoretical pom F163 Top Sample 200 pom F163 Mid Sample 200 pom FC-143 Botton Sample 200 pom FC-143 Blank [3 TAnhsNeeipfaoolsutr vblsleaenmndpdtloegssadwmaepyrl"ees(a2nw:ae2l0ry2e6z1ep)dreapfnaodrredoconnbtyweeneptklaacnidanngdsttah2ebiplogsirttouynedonnLcatbhe wCihtohwouitn t&heoz.covdearrss oonn t2h-e23-J8a1rs,andleapvliancgingthethesnampilnesa omepteanl tocabtihenet aSiarr.s onTh3e-]28a1ndan2dwe3e-k9-8p1o.st Tbhleendressualmtpsiesareweraes tfoalkleonwsf:ron the pm (ug/g) FC-143 on Compound 2280 328 3.9.80 AS Top Sale on zy FC-143 Mid Sample FC-Botton Sample BLAKK a ed 103/08 0 Fe 13 Akl 1w83/)=Hwo"Th vse Fpitz.e 0 0 ee ir;7 4g Lt weeps fo eb, 1222 01615 Appendix Iten J LC.EDJ.AnaSliybtiincsakli Report #209 APpargiel 216, 1981 Tbheeexapnlaaliynteicda,l rDuersiunlgtsousrhowGLCsomneethvoadridaebvielliotpymewnhtichforneeFdCs-14t3o, Cwehowfoduindd ntohtath0a.v1e aorun0i.2forgmramdissatmrpilbeustioonf otfheFGC-r1o4u3n,d LaTbhe wphaerntimcilxeinsgizeitofwitthhethFeC-G1r4o3unpdowdLearb Cishowexattremtheely2c0r0ituigc/aglram aTenvaelly.sis,Wewhniocwh usgeive1s.0ustoa 2m.o0regrahmomosgaemnpleeosus insaomuplre,GLCbut dFoCe-s143notincothmepleGtreoulnydelLafbmiCnhaotwe. the non-uniformity of the paC/ma0 cc: ME.TG.. CLaasmeprecht 22188-.23 AJ W3.00C.L MLcaCzoerrtmeick 223260--1216-02 RV..AP.othParporkaogpada 223366--238 Li D. Winter 236.28 1223 01616