Document LK8kXEv9rMQO2RYkvb0QNQbnz

TELOMER RESEARCH PROGRAM 1200 SoTutehMHayesSSeeosI t 81gioPno,VSiSa 2N2025050 Vv oii} =X Clari:ant CPORR [---- y Eo Er-- i arcioo siglomat Emai, domnakman@epagov gz= o33.22 s z 3z38=8 2# Ss Onsen Tp BoTSomeES r Re7s4ea8c.h8PE5rEog10,r1S0armmso(mTiaAedlcssmooo grosncn mom|ap:nanaCs,SASsHaonn.TlasS,s)Cowiras5n aDTakoinr,aSnndiDnuis, CPoniroauEP yEanecr apa osenofss oSnaae he TP Thossooowar og tnre TeShe ahsyssaicohncoamicttlarc,h1arOOaEEcCClDDtcML0sa0o0ftoaeu oh3at(ssebupionmsa,nDtcoGoeslstahoSntAouoottTsoinStyahTrmot2of"ocHnyc B e ioe eT a in TD h TAPare tsmara ecompaansboteeto oedeia gatheredom as studs re constreise ee mn svn Koti Q), ateR0 aSyrne. is document dosent oan SGA GB. 000035 DRLNOACKLABORATORIM FOR ANGEWANGTE BIOLOGE 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro- Acute Immobilisation Test (48 h) to Daphnia magna STRAUS, Limit Test with the Water Accommodated Fraction (WAF) cc. to OECD-Guidelne 202 for Testing of Chemical (adopled Apel 04, 1984) `Sponsor Tomer Research Project `AsAwraoGmuass ACINOuUSmTRIS LTO owont Author Marta Nosck Tost Facity DFROURNAOMAGGEKW-ALNADSTOERBKlToOLRoGITU:M K3at1he1-5Pa7ulSuasr-sStte.dt1 Laboratory Project ID PSrtoujdye-cNto.o. oez01n 09cK Study Completed September 25, 2002 Page 10128 Orginal 7017 000036 U SRepcino, 3344O5nR 5N6o67r7G80L8h8oap1tasS d0raocn.oaAu1cvmr0o-earTBoiosnoA c ACotmees ImmvoibianneiaWnasTsosA(c4 oomDmapohFndricaeimodangnaceeSOTERCAUDS2021 PSruopjeec.t. Dcaboetrosscsx Statement of GLP Compliance Tie Guideine Testom Tes Fay Dovfaom tGLPoPrnocises K{eeDttesoctar,mo3st3tvo,aro4An.cT4cs5oa5m6o5idr.eaD7ctoh7dt.t18m0a9tge9npa.aSd1ToRc0aA.tGuS1oir0-t 05002021 or TesoftCihincags adpAtpod 04,198) (DSeacnao:3P3000401.) 4556677.88190a9t.ad1e0ca.t1io0KPDiRonrUeeNa (O 65c0s6c1 6RDAy8T1To1oR5MF, SFoUaR(tA4N)oG5E0W8A1TE7B8E8K00E Cet emo Nona GGoWvooastdooLncasrnmsrotrootnrhPeirdascheontawanusdcosncdutcoytnaGnLd rpoerqtuetdoni scolapneiwinn hhacowinaoOrcE,CsDpcroitcesof 25002002 ariMnoNMoSOuocOOkv.oc.i.o . som TomeOs Gfat,Saris) -- laa Uo Noack,Hoa asin Fac) 000037 Report DR.U.NOAGK-LABORATORIUM FOR ANGEWADTE BioLOGIE gam Lci1-umDitetscTaenIosmltm,aw3bi,it3hi,s4h,ae4i,oW5an,t5T,e6er,As6tc,c7(.o478m,8mh,o8c,t9oa.tD9e,a1dp0,hF1ri0a,ac1i0om-nah.egpnstcaaed.eScTOafRElAuCoUDrSo-2021 SPrtodjaycNto.N.o. 0D2A0I1B0S91CTK Statement of the Quality Assurance Unit Tite Guidaine Test tom Study Director 1-Docanol, 3,3.4.4,6.5,66.77.8,8.9,9.10.10.10-heptadacafioroALicmiutttIsmtmwaibtihlstahteiWoantTeorstAc(4c8ho) motdoaeDadpnFnraicatimoangna STRAUS, `OECD 2021 for Tasting of Chemicals (adopted April 04, 1984) 1-Docanol, 3,3.4.45.5,6.6.7,7.8.8.9.9,10,10,10 heptadecafiuoro(@atch No: PO0IGOT) Martina Noack The study was veri as follows: meron |_ames| sey plan 2002.03.12 process based 20020820 sort m20o02z0o71r8 | _swetreoon 20020312 20020620 a200e2.o07r.1r8 pTrhoecerdeuproerst,edarnedsoubssearcvcautriaotneslyaraendscccoumrpalteatyelayndefcoocmtpltehtlryawdedsactraibofedthine hsteudyr.epAorltso mthods, T=hgeuaarcacntoeredd.ancoef the study with ts sty lan and the principloefs Good Laboratory Practice 25002002 Gud) Hommannh.Kaatlanooksi,cs 000038 [DFU NOAGK-LABORATORIUM FOR ANGEWANDTE BIoL0GIE Report 1-Decanol, 33.44,5.5,6.6.17,8,89.9,10.10.10-heptadscafiuoro- Page 40129 ALciutmeiitmm-obwTiitelhisstahtteiWoantTeorsA!cc(4o8mmh)odtoatDeadphFnriacatimona.gnacac.STOREACUDS202 | PSrtoujdeyctN:oN.o. 0D2A0I1B049NCIKS Personnel Involved Study Director: S(cAinnatlyitsitcal part) Technical Staff: QualityAssurance Unt. Deputy. TDoirsetctFoar ocf:the Martina Noack. (Biologist) Thomas Geffke (Chemical Engineer) Anke Gehlert Gudrun Mohmann-Kalabokidis (@ilogst) `(BSiuoslaogninset)Backer Dr. Udo Noack. (Biolog) 000039 Report [DR.U.NOACK-LABORATORIUM FOR ANGEWANOTE BioLoaie Co Page 50129 A1c-uDatceanIomlm,ob3i.l3s4a,4t,i5o,n5,T6e,s6!.7(74,88,18),0to9,D1a0p,1h0n,i1a0-mhaepgtnaadsScaTfRluAoUroS- Project-No. 020109CK Limit-TestwiththeWarAccommodaled Fraction. ace. OECD 202| Study-No. DAIB4113 Table of Content Page Tite Page 1 StatemofeGnLtP Compliance 2 Statement of QualtyAssurance Urit 3 Personnel Involved . Taeof Contont s Listof Tables 6 1 Summary 7 2 Characterisation Data of the Tost item 3 Method 8 9 Rosuts a `Solubility of the Test item 15 15 a2 Results of the Definitve Test 15 43 Results of the Reference lem 1s as Water Parameters 15 5 Validity Criteria 1 5 Literature / References 1 7 Physicochemical data: pH-Values, Dissolved Oxygen i" 8 GC - Analysis of 1-Decancl, 3.34.4,6,5,6.6.7,7.8,8.99,10,10,10- hoptadecaluoro- 81 Mathod 3 82 Method Validation 821 Linowrity 20 20 822 Quantification Limit and Detection Limit 20 823 Precision (Repeatabilly) 21 824 Poak Symmetry 21 825 Accuracy 2 83 Results 84 Calibration Curve 2 2 s8s ChCrerotmiafitcoatgoraofms1.-Dacancl, 3.34,4.5,5,6.6.7.7.8.8.89.10,10,10- 25 heptadecafluoro- Analysis 10 GLP-Cartiicate of DR UNOACK-LASORATORIM 2 2 000040 DR NoxcK-LABORATUOMR FOR ANGEWANOTE BioLoGE R1e.pDoarctanol,3.3.4.458,66.7,7.8,8,9,10.10,10haptadecafluoro- Page 60129 ALicmuitteTeIsmmtowbiitlhsiahtoiWoanlToerstAc(c4o8mhmotdoalDaepdhFnriaaciomna.gnacae.STOREACUDS202 | PSrtoujdoyc-tN:oN.o. 02DA0I1B0A81CTK3 List of Tables Tables Page Table 1: aPfotrrce2n6taagnedN4u8mhboofrEoxfpDoaspuhrneids Incapable of Swimming 7 Table 2: Water Paramtrs at tno Bagining of th Tost Table3: Water Paramators attho End ofTost (48 1) 7w"v Table 4: Water Paramoter of tho Dilton Water " Table 5: Ropeatabiy of Injections of Tost em 21 Table 6: Mean Recovery Rate of Forified Samples 2 Table 7: Concentrations of the Active Ingredient 1-Decanol, 3,3,44.5,5.6.6.1.7.8,8.9,8,10,10,10-hopladecafluoro 2 List of Figures Figures Fig. 1: Caliration Curve of Standard - concentration rang 0.01 - 0.08 mall 2 Fig. 2: Chiomatogram of Standard Fig. 3 Chromatogram of Test llam 22 Fig. 4: Chromatogram of Control 27 000041 DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-Do0rctanol, 334,45,68.1.7.88,9.9,10,1010-heptadocauoro- Foe Tor LAicmuitteTiemsmtowbiiltitsahtiWonatTeorsAtc(c4o8mhm)dtaotDeadphFnriacaiomna.gnacac.STOREACUDS202 1 PSrtoujdoycNtoN.o. 0D2A0I1B0491C1K3 1 Summary nfrtahcteiaocnwuitheiamnmoamtiiniaslatoodnitnegsotwfi1h0D0aMphLniaamaigintac(oSTnRcAUeS)ntotefrftheaecttetsiotfotthenemwateraccomodated -Docancl, 3344.55667.7,889.9.10.10,10heptadecafuoro- r(@oomtc2h0n0u2m.0b6e.r18P01012000)2..0w6a.s20deateDrRmiUneNdOaAcGcKor-dLiAnBgOoRAOTEOCRUDMGFuOiRdAiNnGgE2W0A2V.GTTEhBIiOiLtOGeIsEt0w3a1s1c5o7nducted Sarstedt icmoatpironpgopreireisoad nodf i1n4daacycsowrdaasncceawritehdoheur,elTehveapnrtepgauriadtainocnemdeotcuhmoednwtassc(hOoECsDen2w0i0th0,rBegAaUrdAf2o00t1)e.fost ex"Tphoessetdytotwhaeswcaotndauctcedcundoermtamcorcaocndiiolnaoannstdacveoenrtrdaodlu.Trahtoiwonaofr48ahcoucrs.o2m0 mesotfordragcatainotinswemasdwsere aanaclcyotimcmaolldyavetreidfiferdabctyioGnwaCs 0-7 ama(lon.r daealis3y00psarts8).Themeanmeasuredconcontatonofthowater b1iohloegitceasltleydsiwgantiefricaacnctfofmemcotdwaatseddfertaecrtmiionneodf.100 mg. (mean measured concentration 0.7 mg) no Ts 1 aurcaag Nuomfoepri napalm tr2430 40 of spurs accoamtoodrated rocion [hee wou [TeloToTwliTeaTslsTw] 3) Aterfeofraanrcnecteoitcetsydi ectaarmdineodu.t oTnhceeEpCosrvmaolnutshowfitheporteafsesreinucmedfiechmroatma1t.e5 amsarfearftaenrc2e4fhomwaasnwdithheinthe prescribed concentration range of 1.010 2.5 mg. according to AGS, DIN Guideline 3412 30. Weatteerrmiqnuaeldtyobpaorawmietterhseofapc-cavpalkaateieainmddsi.ssTohlevevdoaxlyigecnecronicaaonf itrhaetotnomteuaisduariende awto0raenfdul4f8ilhewero 000042 [DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BI0LOGIE R1-eDpeocratnol, 33,445.56,6.1.7,88,89,10.10.10-haptadecafluoro- Page 8012 ALicmuitteTIemsmtowbiitlhstahteiWoontTeersAtc(c4o8mhmotdoaiDeapdhFnriacatimona.gnacae.STOREACUDS202 1 SPrioujdecytN-oNo.. O0A2I0B140191C3K 2 Characterisation Dataofthe Test Item TEST TEM h1e-gDteacdanecc,at3o3r4o4-.5,56,6.7.7,8,8991010,10- Batch Number Pocot cash e307 Chemical characerzaion ~~ 3.34.4,55.66.7,76.8.8.9,10,10,10hepladecafiuorodocane-1-0l EINECS) purty sCBu-mpopretruuorooraokayllethtahnacnio:l3999.9.3%% ((laa)f,) Appearance Waterslubity Yoliowish sod wax 113374pggiaat1225dooggrreensCC,, $$d42593yyggl.L, nn==1(7D(uOPuoPnto,n.2020020)2) stabitiyn water Stablea totconditions Density ca. 17 glen' Expy date Recommended storage Storageattestingfacity Retention datetnesttiitngifoanciptayrameter Unlimited stored undor the recommended conditions. Room lemperaure (20C), protected rom moisture, Roomtemperature, proflromemocisttureeandd ght. At1lghaes beaensretaitned. Nemo, batch number and colour. Thetst temand th infomation concomingthtst omworopovidedbyth sponsor. 000043 'DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE R1-eDpoocratnol, 3.34,4.5.5,6,6.17,8,8,99,10,10,10-haptadecafluoro- Page 90129 Li`mAciutteToIsmmtowbiitlhstahteiWoantTeerstAc(c4o8mhm)otdoaDtaepdhFnriacatimona.gnacas.STOREACUDS202 I PSrtoujdeyc-tN-oN.o. D02A0I1B0H81C1K3. 3 Method TEST GUIDELINE TYPE AND PURPOSE TEST SYSTEM Tost organism oRfetaesstonsyfsortetmhe selection ong Broader Gute Culturemedium Fading "`AcOuteEImmCobiOisa-ftoirGoTnesTuteisntigoofdfDCahepehmnliicaanmlasgNnoa. S20T2R1AUSTM `adopled Apri 04,1084. `stermination ofthe acut tosctof1-Decanol, 3.34,4556,6.7.7,88,89.10.10,10-heptadecatiuoro10Daphnia magna STRAUS ina lit testwiththewateraccomodated fraction. Daphnia magna STRAUS (Clone 5) DtoatphhensiuatmabalgonDaapShTnRiAatUySpebesloanngdsa,rionbaredcin tch towoittrfatchdeis.taudynguidceliene, In`sgteistuuntdfnoeirtWsaasmiseosr,,CBoomdreenns-pluantdz,Lu1f4t1h9y5geBneredine,sFBRuGndesDRU.NOAGK-LABORATORUM, 31157 Sarstedt, FRG M14n)2.31L2g1lasCs tvoemsspeelrsatwuirhesaopfp20r-o25xiCmar1ae.ttoiLlcevruaelttdlu)ry,eimneadniiunmcub(aEtloern,d: 11620h0d0uxm)i.naton,luminatin strength max. 20 UEIM2s(corresponding 0 Btrooed damphipfdosraewterereasmta4ai8nthatpirneidouiontr1h0e0eo%sdtilutionwater atth test E1l0o1n8d0tMmAg,CaacCOc. otrEledndi: 1n950g), modiied {0a total hardnoef1s6s0 `vSuxlgwaereisk,lywaitdh antaum wlictahlgadmeinaxsoitfySoecfo>na1d0escmoulsssmuLb.spicatusandChlorola 000044 --DRo--pRo--rtU--NOACKLASORTORUMFURABioNLOGGIEEWMPaNgeO10T012E9 1`A-cDuetceaniomlm,ob3i.l3i4s4a,t5i,o5n,6T,e6s,t1.(74,88h.)8,009D,1a0p.h1n0i1a0-mheapgtnadaeScaTfRluAoUroS- ProjoctNo. 020108CK Limit-Test with theWater Accommodaied Fraction. acc. OECD 202 | Study-No. DAIBA11S TEST ITEM Pretreatment 1-Docanol, 3.3,4,4,5,5,6,67,7,8,89,10.10,10-heptadecafluoroThetestHomwas heated t 50 Cbeforeweighingfo homogerisation. TEST CONDITIONS. CoTaosttivnogsosafltsh.e Preparation Coatingporiod Preparation of the test medium Acoatingphaseof 14 dayswascarried out. 100mg 1-D0canol, 3,3.4.4.5,5.6,67,7.8.8,9.910,10,10"2 hoptafdoa0 rc9af6h1uo1rm Lo2-0(fCot.al1vLolubmreow1Ln)gwleasrseflsahsakkswenernoausrootda.tAinfgtsehrapkhearsweith `csleepaarrlatqiuoind (p1h8a0semi1n)e2a0chmlr.eppleircatteestarnedplciocvateerewdewriotahgnlsafsosrtrodps.frDoimlutthiaon water was used orth preparationofthe coating sokitn. "Thereadyfiledandcoveredbeakerswero stored atnominal 1822C, 21Cconstantfor 14 days. Al hoendofthecoatingperiod the beakerswereemptiodandused forthetest. (o1t0a0lmvgol1u-mDeec1aLn)cwler3e.3s4h.a4.k5e5n.66.a7.r7o,a6t.i8n.g9s.h9.a1k0e,r10w,i1t0h-2he0ptoamdofcoarf9lu6oroa-t1. 21 0LC -gbassrflasokswewreun sed. Afterphasesepar(a19t5i(0o21n0. min) 20 mL.pertest repofithceceaartqueidphase (uprosanttihneg WAF) were transferadto each repbcate. Thoproparation methodhadboenchowisth reeganrdtothetest ftom p2r0o0p0e,rtBiAesUaAnd200in1)a.ccordance withtherelevantguidance documents (OECD. conTROL (iutonwaterwithout test tom estedundersameconditionsasthetest orou. 000045 BEL teats roe revametopon --pmoeten ju I J -- J w--oos PoRe -- eeose strareni J sea ng 0 rc [o|r een r] owweeT 1wew] ] e=r=asssyearmrs mour rat esasen) ts 000046 _ DR.U NOACK-LABORATORIUM FOR ANGEWANDTE BioLoGIE R1-eDpeocratnol, 33,4/4.5,5,8,67.7,8,88,9,10,10,10-heptadscafluoro- Page 120128 ALicmuitteTeIsmtmowbiitlhstahteiWoanteTersAtc(c4o8mhm)odtoatDeapdhFnriacatimona.gnacae.STOREACUDS202 | PStruodjye-cNtoN.o. 0D2A0I1B0491C1K3. Nsuammbpleerspofarpacroanlcleelntration Ageof estorganisms. Testtemperature mination Photoperiod a@) 2-24n0d 18-22C2,1Cconstant O(icfoumseespgohnd,inugmi0na1t2i0on0)siemanx20gmilmh 5" 16/8 ghia cycle `COOFUTHRE SSTUEDY TSthudryeosurlgtasnoifsmasfs(ot.9.st2u2dysw)oriotnhoWtAcoFmpaanrdatbhleestwuidtitehsercoancesrnoiunfgolthser Ssaptounrsaotredassokleudtioinhse.cAontrshaectilanbcoroamtopraytDir.y cU.ouNdoancokLbaeboerxaptloariinuemd t(h0e wsitthydrreapwotrhtoedihsetrsetdudoysannotisnhaotweadniynstienacdonasissatecnotndssutlutdsy.TThhaesescaocnodnd dfraoctiionttsoetnuadbylweatshepedreftoerrmmiendaatiomniotffismtmowbilihiztahtewoantaefrtera2c4coamnodd4a8tehdous. Adefinitvestudy caied outpreviouslywas ol reported. 2ob1t0a.i2n4edhboyldrdeampohviindgswtheermootuhsedrfaonitmhalsdtefwiincietwive istud2y.2hTheByrwooadre foarpahtildesaswte4r8ohomauisntpaiinretdoitnh1e0t0e%stdun wate atthe les temperature 2we0rGeapuhseeid.dsCoonitirdoeldrpnlfioca4t(s2sw)igtrhoouuptsewsittham(1w0o)ranliomsailosd puonrdotrestthveassasmale. C( onditg ionscayh sctlho1t6a e%stfgorrr 4ou8psh. 8A1l2t0e.s1beCa)k.ers were placed in an incubator "eTxhpeosiumrmeo.bilisation ofthe daphids was observedafter 2 and 48 hours of Tcoonrceefnetrreantcoen rfaonmgewa0s.5t8est5e.8imnoil.concentrationswithin the `beOlboswe.rvations, measurements andevaluationwere carriedoutasdescribed Tho imation scot on stof hice so 000047 _ DRLU.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-Doerctanol, 3,34.4,5,5,6.6.7.7.88,9,10.10,10-haptadiocafluoro- Page 130120 `LAicmuitte-TiemsmtobwiitlhistahteiWoantToorsAtcc(4o8mmho)dtaotDoadphFnriaactomna.gancac.STOREACUDS202 | PSrtoujdeyc-tN-oN.o. 0D2A0I1B0A91CISK TOYFPMEEAANSDURFERMEEQNUTESNCY AND OBSERVATIONS Equpmont P(rpiHo-rvatleuos,tdstirthseowxsaytgaeornpcalornacmvoentiererastiodofnt,heamdpiatriaolnurwea,tecronductivity and ota hardness) wore measured. Axtyt9heenbecognicneinntrgoatfiohne)tweesrtatmheeawsaurredpairnaomneeteardsdi(ptHi-ovnaleupe,iciastsecpveerd concentration and control, Acfotnecre4nt8rattihoen waantdecronptarrola.meters were measured in al replicates per "TThhee tpeomrpcearnattaugreeiwmamosbirletcyorwdaedstdhertoeurgmhionuetdthi atlesltoswtiahnda hcoyngtroolhegrromuopgs.rah. ator24h and 48h. pOHxvyagleune OpxiHmet-erM, 0ox1t53o0pH(rLWoTnvWel)o1LWaTWb) TWeamtpeerrahtaurrdene:ss: HSpyegcrtor-otphheorlmoomgartoerp,h (CLaUdFaFTs)100 LPG 168 Fluorescence (Ox Lance) ofDaisipgeersoion usaiment:+ CRholtoartoinpghSyhlaFkleuror3o0m4e0t,erGF(LK.LENFELD) Contiugo: 2K 364, Ziavs. SOTFAETVIASLTUIACATLIOMNETHODS EanCa-laylsueses and statistical Tdehteeorfmfienctesdoifrtheetmiftocmontcheenttresattiroensaussimmobilsaton npercentwero. EECGi1n5aanndd EECvG.avlaulueess wweerrooocnalkyuclaaltcoudlvaitaepdrfoobrtihteanarleyfseisr.ePncreotbom.according fCoalWcuelatsion(o1f88t6h)e.confidence intervalswas camied out using standard procedures according to BREMI&G TOWPLNG (1982). SOFTWARE SigmaPieol.2000 2000), S753 CORPORATION 000048 DR. NOACK-LABORATORIUM FUR ANGEWANDTE BIoLoGIE Re1p-Doorctanol, 33,445,56,6.77,8,8,09,10,10,10-heptadacafiuoro- Page 140120 ALicmuilte-TIemsmtowbiitihstahtoiWoantTeerstAc(c4o8mhm)oodatDeapdhFnriacatimona.gnacae,STOREACUDS202 | PSrtoujdeyc-tN:oN.o. 0D2A0I1B0491C1K3 VALIDITY CRITERIA Tahroo timemtobiisluisnedaducricngetihpfem4to8raeh ebtshltanpe1r0iopde.rcontofthecontrol crganisms Theconirol daphnids should notba rappedonthesurfaceofthewate. Th10e-E2C5samfotle.r24hofthereferencesubstance shouldbein therange from T(h6e0 d%isosfotlhveedairO;scatounrcaetnitornatviaolnueaatttthheeentedmspheorualtdurbeeu>sed5)..21 gL THhuentdeviation of the pH-value fom th nial vakue should not bo more than DETERMINATION OF THETEST TEM. "vTehroiwatebrygaascchromcatoogrfarpamhcytiwoimntahnmdoacsosndstpreolcwaterormetetanraielcydteitcdealcltyion(mz = 463 and395)at tos tartandtestend.Additonalropicates werosotupfor theanalyticalwork. Fordetsaeeipalrts. ""TDHEEVIGAUTIIDOENLSIFNREOM. None DEVIATIONS FROM THE STUDY PLAN LPOuDyanwadsLCO8Gpweerfrleio0r.o0a0l9kaynltdha0n.o0l279m0ol.l%3,r(esapae)ctively. Thesadeviations had no impacton thequality and intgriyofthestudy. REPORTING. rTahcoorfdina(l1 report is origina. issued as paper copy (8 originals) and an electronic ARCHIVING `The following was rotained in the archive of the test acilty for the p+eralilordaawsdsapteacified in the operative national GLP regulations: ++ sfitnuadlyppolrant(poraipganralc1o0p1y2)(Orginal 1 + al records performed by the qualty assurance programme. + sianmclpuldeinog mtaessttefrtosmchedulos MVioclrkosfbiamnsk wSialrsbtoedrto,laDi-n3e1d1i5n7aSsaarfset-eddotposit by 000049 DR.U.NOACI-LABORATORIM FOR ANGEWANDTE BIOLOGIE Re1p-Doarctanol, 334,455,6.6.7,7,8,89.9,10,10.10-heptadecafiuoro- Page 150120 `LAicmuitte-TiemsmtowbiitlhitsaetiWoanlTeersAtc(c4o8mmh)odtoaiDeadphFnriacatimoan.gnacac.STOREACUDS202 | PSrtoujdoyc-tN-oN.o. 0D2A0I1B0A81C1KS. 4 Results 41 Solubilityofthe Test tem "Thetes temwasclearydissofvedthroughoutexpose. 42 Resultsofthe Definitive Test 2T6ho1apanrdca4n8tha.geThimemiombmioibtiylwsaatsiodnetaetromsiniend%iatteoe2s4tehdanmdit48concoefnetxrpatoisounreanadrethgeivceonntirnolTaafbtir 1. Thera is no biologically significant effect (z 10 %) neither nthe tested mi concantatin nor in control group. 43 Results of theReference tem dTehteepremricneendtdaigreectilmyfmoobmiityhfeorttehste rreesfuelsr.enTcheeteEmC1woaasnddeEtCsewritmhai9f5ne%re2dc4onhf.iTdhenoceEiCntservvaallu(eCwIaswere. `otorminod by probit analysis according to standard procedures. EC-values after24 hofth refrenc fominmollwere as olows: CECuo 0:185(C113-17) Cu :58 aThnegEeCofs1v.a0l2ue.6ofmroeifeorfevnaclelftlycrriptoetriaasascicuomrddiicnhgrtoomaAtQeSa:ftDeIrN24Guhidselwiinteh3in84th1e2prLo3s0cribed concentration 4.4 Water Parameters. bTehgoinwnaitnegropfatrhaemteetsetrsi(n6sosroelpvleicdaotxepygoernccoonnccoennitrraattiioonna, npd-cvoanltureo)laofntdesntaalndrapcloinctartoolsgraofutpr4s8alhhaere fisted in Tables 2.3. pm-evaasluuree,dOpxriyogretno ceosntcesnttarr.atiTonh, rleemspualrsaatruoros,tceodndiuctTiavbiltey 4a.nd total hardness ofthe ikonwaterwere During thetestthe temperature was in the range of 18~ 22 C, + 1 C constant. 000050 DR. NOAGK-LABORATORIUM FUR ANGEWANDTE BIOLOGIE 1R-eDpaocratnol, 3.34,45,5,6.6.7,7,8,89,9,10,10,10-heptadscafluoro- Page 160129 L`Aicmuitte-TiemsmtobwiitlhistahteiWoantTeorsAtc(c4o8mhm)otdoeaDtaepdhFnriacatimona.gancac.STOREACUDS202 | SPrtoujdeyc-tN:oN.o. 02DA0I1B0491C1K3 5 Validity Criteria vaTlhiedsittyucdriytwearisa wpeerrefofrumieedd:according to OECD Guideline 202 EEC Directive 92/69/EEC Method C2. The. nthecontrol 0roup io Daphniawero immobilisedor rappedonthe surfaceofthewater, Tho ECss-valueafier24h ofthereference emwas in the rangeof 1.010 2.5 mL. The dissolved O; concentration was > 5.21 gl. (60% oftho ai saturation value al the temperature used). + ThepH-valuedid not varyby more than 1 uni. 6 Literature / References nBAaUcAh,doBmunCdheesamnisktaallstngfoersAertbze.ts3.scUhbuertazrubneidtAtrebeAiutfaamgedeizin (2001) Letaden irAnmeldungen neuer Stffe BVReErIiTagI,G Gd.ona&.TOUPLINGW. (1962): Methodender Wasseruntersuchungen Bd. VEB Gustav Fischer `DUunPpounbtl,isDheetderrmeisnuast,ioUnpodfaptheysFiacb.o-c15h,em2i0c0a2l parametersof Porucrcoctylethand, CAS No. 678-38-7, ELeNoT B. P. (1990): Selenium Deficiency in Crustacea, Proloplasma 154, 25 - 30 ``AOdEoCpDt-egduAipdreiln0e4,210928-4for testing of chemicals. Acula Immobilsaion Test of Daphnia magna STRAUS. s`eOrEiCesDo(n20t0e0s)t:inGguainddanacsesedsoscmuemnetnt10o.n2a3quatictoxic esting of diffu substances and mixtures. OECD. `Weber E (1986): Grundriss der biokogischen Statist9,. Auflage 000051 oA rA ore ro cem o kos teT0E8 7 Physicochemical Data: pH-Values, Dissolved Oxygen as. arxitssssieisstasuin rm] nore =%faction = mat) = cvs | - Soiis riaipia TE = oo on oreo we etre etre rroevree oraa a|v r[rea oeee | ovwe rt wae mn town pseomenToren Tor Tro Tm| rowmnain [moa[om[oJmTIPoo oowy[oenes ] 000052 Report DR.U.NOACK-LABORATORIUM FORANGEWANDTE BioLoGIE TT A1c-uDatceaIncmlm,ob3l.i3s.a4t.i4o5n,5T6a,6s7,(74.8b89i9o.1D0a,p1h0n,i10ahmaoptaancaecSaTfiRuAoUroSimi.Testwih heWatar ccommanartaceiodn: ace. OECD 2021 SPrtoujdeycNtoo.. 0D2A0I1B0A8I01KS 8 GC-Analysis of 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9, 10,10,10heptadecafiuoro- 81 Method WDEETTEHROMDINOAFTION Equipment A1n-aDloycsaensc,of5v.a3.r4i.o4u,s5.c6,o6n.c7e.n7t,8r,a6t9i9o,1n0s.1o,f 0heptadecafioro-were cCaarpriiledayocuoliuamngaussicnhgroemxattoorgtraspthayndoanrdas.FuDseetdecStiiocnawCaPs-pSIaLro8rmed Vina mass selective detector (MS) AGuatsoscahmvpolmoarograph +GCPT-C36C0o0m,bViaPrAuL,n CTC AuaLyrics SOnotfotcwtaorre SWaS.liSmatGuCrnIM20S00W,orVksAtRatAion 5.51, Varian - Roagonts erty methy ther 99.6 %, Batch 42337011 31101, FLoxa CONDITIONS OF ANALYSIS Cotmn iInnjjeeccttoorr temperature TInejmepcetiroantvuorleumeprogramme " rege CLhOrWomBpaLckEC/PEM-sSDI,LF8i(mVtAhAiNck)n,es3s:0 m0,2i5:ym.0.26 mm, 2S5pi0toCss (20 pi prassure pul) for 1 min Ta HeaCtCiinmginrate | ( Temperature | Holdiinng time =Ta T7700 heme 50 | Cm 1 a0 50 CCeaterctrorgas oRnuinattiimoen mode Retention ima Hwosllum 1 mL min column flow E15l.t3r3omninionisation () approx. 49min 000053 _ DFU NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1-pDoecratnol, 3,3,44,65,6,6,17,8,,8.9,10,10,10-heptadecafluoro- Page 190128 ALcimuitto-TiemsmtobwiitlhistahteiWoanaTres!Ac(c4o8mhm)odtoatDeadphFnriacatimona.gnacae.STOREACUDS202 | PStruodjye.cNtoN.o. 0D2A0I1B0H91C1K3 STANDARD PSRTEAPNADRAARTDISON OF PSRAEMPPALREASTION OF Tost tom was used as standard. Tinwtoerstt-obcutkylsomluettihonyseotfhetrh,esdtialuntdeadr(d6 ocfon2c0e0ntmratLiownsereaacphr)epaanrdedused for calibration. For callration range soe part 8.2.1, 4et0hemr.LAolfotrhoPshaamsplsoepwaerraotieoxntrtahceteexdtrwaictth w4.a0smdii.lftoerdt.-1b:u2t0ylamnedthyt injocted directly Into tho GC/MS. METHOD VALIDATION Paak symmetry Ropoatabity Accuracy Quantification of tho tes tem was calculated by peak area of the. mcaalsibsreastio6n9p+ro3c9e5du+re48a3nd(itzh)e based on the extemal standards. principl for the determination of The datocton and quantitation mits wero adapled from DIN 32645. The. method was validatod as doscribod below: sPteaankdasrydmsmeatnrdietesstweirtaemcaaclccuolradtiendgtforotmhechfrololmoawtinoggreaqumastioofn:analytical Te Wew/@h T= paskeymmeny W7 ass == Pfrasstksweicdtolrhoaftpe%akowfiptehak(dhieviigdhetdfbmym]tha parpandicuiar ine fom the peat masimum (mm) 5assiunbg-lsoahmpolmoosgeonfotuheshsiagmhpolste awnadreloawnsasltysceodn.ceMneraantivoanlupesr,epsatraenddafrrdo.m deviations and variations of coeficants werd calculated. 5 samples with 40 mL water wero spiked wih an amountof 8 ug 1oDfoc1a0n0olm,gi3L.)34t,o4.g6i.v5e,6a.f6i.n7a.l7c.o8n,c8e,n9t.r9a,t1i0o,n10o,f102-0h0epgtiad.ecaAffltueorrwoa-rd(s80 L. samples wore oxractad as described above, 000053 RU. NOAGK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-Doarctanol, ,344,8,5,6,6.17.8,89,10,10.10-heptadecafluoro- Page 200128 ALcimuitte-TIemsmtowbiitlhstahteiWoantToorsAtcc(4o8mmh)odtoatDeadphFnriacatimona.gancae.STOREACUDS202 | PStruodjyo-cNtoN.o. 0D2A0I1B0491C1K3 82 Method Validation The method was validated and tested with satisfactory results with respect lo - npraecrisyion (repaatabilty) peak symmetry - daoctaourrmaicnyation limit and detection imi 82:1 Linearity T33h.e4.a4n,a5l,yt5i,c6a.l6.s1y7s,t6e,m8.g9a.v9.e10l,in1e0a,r10r-ehseppotnasdeocianfhloeror-a.ngTehoaf c0a1lbr~a0t.i6onmgc/uLr.veofa1n-dDoccharnoomla,tograms obtained for standard and tes tem are given in Fig. 1 - Fig. 4. For mit of determination and imit of datection soe part 8.3. 522 Quantification Limit and Detection Limit mTheethloidmitdaofscquiabnotdifiincaDtiIoNn3(2L6O4Q5)"aNnadchlwiemliso-fudnetdecBteisotni(mLmOuDng)swgerreenzcea.lculated using the bind value The LOD was datermined to bo 0.008 mg/L and therefore the LOQwas0.027 mL. threefold the LOD), seo part 8.3. 000055 DR U.NOACK-LABORATORIUM FOR ANGEWANDTE BI0LOGIE R1-eDpeocratnol, 33,44.556,6.1.7,8,89,9.10,10,10-heptadecafluoro- Page 210125 ALicmuitteTIemsmtowbiitlhstahleiWoantTeorstAc(c4o8mhmotdoalDeapdhFnriacatimona.gnacac.SOTREACUDS202 | PSrtoujdoyc-tN-oN.o. 0D2A0I1B0491C1K3. 823 Precision (Repeatability) The results of the repeatabily tests are provided in the table below. Tan. 5: Ropentabllotyf InjecoftTiesotntesm Peak area [V's] 3344558He6p7Tt7ao8dc8aca6a9.u1o0r.:10.10(n= 694305145) |oiT moo smatr| [Te | w aw | CeTew Tam | [ ww= | osoms | a ewT s | aon | [5 1 sw[zoe| [WomnssToassossoso |asasrzzese|s [2Tw 1] 82.4 Posk Symmetry Thepeak symmalry of the test item 1-Dacanol, 3.3.4.4,5.5.6.6.7.7.8.8.9,8,10.10,10heptadecauoro- was 1.8. 000056 Repeorttal 33445.56D86.77N8o8n8L910:a101s0hpotadamrcoaiAauvcsroeT-wooreBmioiu0sE Fo To KConee mnoiwtsianioWnoTtotA4c8 noyorDnophFiracimoangnveao.STOREACUDS2021 SPraoyjee,t. cDaAoBtHoIsTcS 525 Acourmey Ta0.6 Moan RacovaryRaeof Frid Samples cpoonoensor [13F 4T4ore 38e:55a6108.0130 ose mgt) o=u |= [or[ |e oa m|]| [oer | fe onm| ] wes| [|Crooens[m en ue] ] Cer] [sa] T Gpimr on) ---- [as] [ Ceoree n E | e =n|] 2iJ B I i A fe A =i, emd-- e 0000577 Ti o 32.44SA55o8n6rs7p7o8n108op3smi9ec1nat0wu-r0es Bosco FoTE be watremoe oesShs oasor) [ mn--S--s -- TT: CATE A ROAR VSO SAAR SATTARR St) | Tat em [surotanais120020820 | zooa0ez0 | remranyTtenoe al om oe [oomw om we] s ora or w ww ]| ir own] si Sr mr -------------- 000058 cReaponrte, 35448586087.0788N9o0r.o1L0a.p1o0r1a0TbopmladercoamtAvvorcsw:avore Bitoe Foe 2h ACutioTIamsmowbiitaaoiWonotTosAtc(c4om3m)odtaotDinagpirniaomnagnaecSOTREACUDS2021 SProtjecytoor. o0t0Asc1K5 04 Caltrain Cure somo m0 SzZao i wooo ye asocs ares som RE=09072 o Gon. mg) Fist: Galati Curveof ta-on nce rrenga 6.01 0.98mg. 000059 Taani2244o5n5u014s17Tp78os8tn98osBessa FoTB A Te i trcaAsSaSnBsoFtacmtoeg TbRicSaez | sSohee. oShmancs 05 Chroomsntegaams s EEEEEmEEEereEL amBaaEnn B Eye Tn gE enemas Eg FEOOh mTmEm . -- sn - or = - EBrn =man Ffoorm ssoen - i| 1 || | || j a CSoromsoatrSuonnsas08.05. 000060 OU NoACK-LABORATOIMRFORAnGEWANDTEBlot00E RTeBpaocratnol 344.858671.7,9.9.101010-hepadecafiuore- Page Bo ALivmeoIsmmwoinnsiahleVainsToersAtc(c4omnmtoodaDtoepdhFaiceimoangnacacSTOREACUDS202| PSraonjeic.to. 0O2N0B1A0I6TCSK [-- EP SCeoriina ou: 37o0m0oa2 11301384 Sphrir omen pEaoEN e ont m econ fSray a= ima mE Tm SSSenme soon oo - EBB p je os s &fics = i | | RAa A | il [| { S J o Fa 3 WCaht:raoccommmtoodoaftTgeedrsstatcaimmon (VAF) th tt and (ted 200206-20 000061 -- i) re = eS WHFH|iii| " [--- LL - 000062 Dr. NoKGK-LAsoRATORIM FORANGEWANOTE BioLoaE Re1cp-uDoaerctaInmcmlo3b3i4s.4a.t8i.o5n6T,e6s7t,148&,1899l.o10D,o1p0h,n1i0ahmapatgandeecSaTfiRiAoUrSo- Page Bo Projecto. 020109CK Limwi ohaWasle Accommadated Fraction. ace. OECD 202 Study-No. DAIBAIT3 9 Certificate of 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10heptadecafiuoro- Analysis FER . = Clariant 000063 1-Decanol, 3,3,4,4,55,6,6,7,7,8,8,9,5,10,10,10-heptadecafluoro`Acute immobilisation Test (48 h) to Daphnia magna STRAUS Project-No. 020109CK 10 GLP-Certificate of DR.U.NOACK-LABORATORIUM aT r e J o E on en ERSEIEN STII SN orargewandie Bioiogie. ofapple bokogy I rm EmEEsE pE m ----E ----m --n aE or T EEEEEET-- E I --ee--menen r eee E TamE e meT m ae LE EERSTE RESIEEEENEES mn fay Ain tral Ru & 000064