Document Xye0bJeZ5x7GVBab5JpgeVby

TELOMER RESEARCH PROGRAM 1200SouEtAhHayes Sror AinVdiggro2220n0-5,050 Vv 2 ETRY = Clariant. QTR February 14, 2003. iUESo.EErmDaominocnsoProotnon cy TTroPoaornanaSsta Emad dominakimary@op.gov 2:Z oz =5z 33=3=585 ga = DTreenaroTMEbarmyne:Rr R1o01s50s,%a55P0rXohg0Sr0a0o(TaoTaPm)rendcsstTmoosrreepcnmna5oan,nCS,AoSArNsoeaTGrSlss, Clofaonn,5oCTmoonr,rard8sDAuos~,n Fi EesrtsOesEhdaouoosayoeemsr,wetToes emaesaiaaTBHB e.oTaoa S ptst o sSopaoes Cty roargyg TSroitrpeessxmenaVtcitoorc,1hOCaEGGrDDaH2c0a0or0faa noh5tnGpsuearnreoaDdoScovtoenorstaAocsse1tThsoesu kaTsesbis e0ofHmaEch tvogaeh ttoo nn1og oo msae C5omae pr oo o oo. Bes omk hfeoa:saty TJoF unedsia oteedaiooosaethorSSarrracdoSeokroidmoor orapyinesTR soiOnpSer-- e A------ -- Soca HKootitie Wrusfe-- SR Rien Katie D. Smythe > Tidocumat dosnocon TSCA BL. 000003 DR. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafiuoro- Acute Immobilisation Test (48 h) to Daphnia magna STRAUS, Limit Test with the Saturated Solution acc. to OECD-Guidoline 202 fo Testing of Chemicals (adopled Apr 04, 1984) Sponsor TelomeArsRwesaeGaurcshsProject Arora Cus Oar oouvesoTnRtES LTo Author Martina Noack Tost Facity 'FDORR.MUNGOEAWGAKN-DLTAEBOBROALTOORGIEM K0at3h1o1-P5a7uiSvosr-sStte.dt1 Laboratory Project ID SPtruodjeNcot.o. oD2A01R09A0K Study Complted On August 07, 2002 Page 10131 Onginai 707 000004 -- RDAaRpe_ etUidnnNgO1aA3sCe4Ka4Ln5TAe5BG8OS8R4aA7bT7ae On8R1e00WW9mMe pae8FtsO1acSR0aTARt1AoNSr0SGEWANOTCJ EBoIOFL-- STOaGEIsE Statement of GLP Compliance Te reooeinoaanmte5ot3na4ss4.t5o5nT0o677(48883)38O10o.p1s01a0g STRAUS, Lit ae Gunn OECD 202 orofchs am (pndAo, 500 Totem 00a.s53o44o5.86778895.10,10 hoptscatoo: Toray RUamoNa eossrsercarce aosepecneOe--TReBSThoRe eo OnifomoGLPPninss A C --o --wn mac G5 opte nochen ont -- Austo7, 2002 inMnoNkM,oSoydsdo nant, 02 iva Gate. Scns .ohysonao, A Tosi Fi 00000S Reon DR.UNOAGK-LABORATORUM FOR ANGEWAVDTE BIOLOGIE Li1Ac-muDituecTaIansmetmlow3bi3ih4it,sha4et.So8an5t6uT6rea.st7te,d(748S88o91t,)9too.n1D0a.oc1e.p01Oo0EhmaCpaDtgan2d0ee2cSa|TfRiAorUoS- PStruodjyeNcot.o. 0D2A0I1B0A0T101K Statement of the Quality Assurance Unit Tito Gudeine Test tam Stuy Diector ADceuctaenIcmlm,ob33i4s4s.a5o.n56T,o6s7,(748.)8,8t9o9D.1a0p.h1i0a,m10ahgenpataSdaTcRaAfUuSo,roLim testwin th Saturated Soiton OECD 2021 fortsting of chemicals (acted Apr 04,1984) 1.Decanc, 3.34.45.5667.7,8899.10.10,10hepadecatioro(eaten No: PO0IOOY) Martina Noack Thstwuasvdatyid as follows: en sty pon orocaes based ot wo | emer orasrz mmwozzaotna0ss jmoov2e0untn mmaoozaurn morasar war Eunzras)os 2200002200400190 nZnazaaninz 20807 aTnhd orbespeorrvteadtiroenssulatsoaaccccuurraattellyyaannddccoommppleetllyrdefelseccrtitbredrain dhaetrafpth.esly. Also method, procedures, Tishgusacrcaonredsadnc of the suc wi stu lanandth principlesofGoodLaboratoryPractcn August 07.2002 - BrMoamasKa.sbous"s 000006 DR.U.NOACK-LABORATORIM FOR ANGEWANDTE BIOLOGIE Re1p-oDarctancl, 33,44,5,5,66.7.7,8.89,10,10.10-heptadecafluoro- Page 40131 ALcimaitle-TIemsmtowbiihlitshaeioSantTureastted(4S8olhu)titoon,Daacpeh.niOaEmCaDgn20a2S|TRAUS PSrtoujdoyctN:oN.o. D0A2I0B1A0191C1K Personnel Involved Study Diector: S(cAennaltysttic:al par) Technical Staff: Qualty Assurance Uni: DiTroescttFoarcoiftyt.he Marta Noack (Biologist) "Thomas Geffke (Chemica Engineer) AGwneknedGoellinerKtraetzig G(@uidirougnstM)onmann-Kalabkidts S(@uoslaogninset)Becker O(r@.ilUodgostN)oack 000007 [DFU NOACK-LABORATORIUM FOR ANGEWANDTE Biotoie R1e-pDoerctanol 3.3.44.556,6.1.7.8,89.9.10,10,10-heptadecafluoro- Page Sofa LAicmuitteTiemsmtowbiitlhistahteSiaontuTreastte(d4S8ohlu)tio0n,Daacpch.niOaEmCaDgn2a012STRAUS PSrtoujdeyc-tN-oN.o. 0D2A0I1B0A01C1K1. Table of Content Page Tile Page 1 Statement of GLP Compiance 2 StatementofQuaity Assurance Unit 3 Persone Involved + Table of Content 5 Listof Tables 5 1 Summary 7 2 Characterisation Data of the Test ltam 8 3 Metnod s 4 Results 1s a1 Solubily of the test item 15 a2 Results of the definitive test 15 43 Results of the reference im 15 as Water parameters 15 5 Validity criteria 1 s Literature/References. 1 i Physicochemical data: p-values, dissolved oxygen " 8 GC - Analysis of 1-Decancl, 3.34.4,8,5,6.67.7.8.8.99, 10,10,10- heptadecafiuoro- 18 81 Method 1 82 Method Validation 2 821 Linearity 2 822 Quantification Limit and Detection Limit 2 823 Precision (Repeatabily) 2 824 Peak Symmetry 21 825 Accuracy 2 83 Results 2 84 Calibration Curves. 2 8s Chromatograms. 27 s Certiicats of 1-Decancl, 3.3.4.4,5.6.6.6.7.7,8.89.9.10,10.10- `heptadecafiuoro- Analysis EB 10 GLP-Cartifcate of DR.UNOACK-LABORATORIVM 3 000008 Report OR. NoreLasomaTouu FOR AvaewmDTE BioLoa Page Sorat 1AcDuatceanIcmlm,ab3l.3i.s4a4i5o,n56T6e.s7,(7488,8h9f9o.1D0a,p1h0r.i1a0-meapgtnadaoScaTfRiAorUoSUimiTost witthaSaksatedSolan, ac. OECD 2021 PStraoajyeNcot.o. 0D2A0I1B0A911C1K List of Tables Tables Page Table 1 Percentage number of aphids incapable of swimming ator24 and48 h of exposure , Table2: Waterparametersat the beginniongf the test " Table3: Watarparameters at teandoftast (408) Table 4 Water parametars of tho dition water w Table 5:Ropoatabity of InjactonsofTost lam 21 Table 5 Mean Racovery Rate of Foriiad Samples 2 Table 7: Concantations of the Acie Ingredient 1-Decancl 3.3.44,55,6.8.7.7,889.8.10, 10,10-naptacacatucro List of Figures Figures Fig. 1: Calbration Curve of Stan-codnceantrratidon range. 001-008 man. 2 Fig.2i Calibration Curva of Standard - concantaton range 01-10 mg 2 Fi.3: Calibration Curva of Standard -concantaton ange 0.1-06mgL 2 Fig. 4: ChiomatoofSgtarndaarmd z Fig.5: Chromatogram of Test lam = Fig.6: ChvomatogramofControl 2 000009 Report DRUNOACK-LABORATORIM FOR ANGEWAOTEBiot00iE Page 7or31 A1c-uDlescaInmcm,ab3l3i.s4a.t.i6o5n86T.o7s,7(888,0h.)9{,01D0a,p10h,r1i0ahmaaptgandaeScaTfRiAoUrSoLimitTest wih the Saturated Soon, acc. OECD 202 PSrtoujdeycNtoo.._ 0OA2I0B1A0T9101K 1 Summary cIntohenconaicauttiaoinmomfonbeistoasttofnomastwihDaphriamagna (STRAUS) heefectothesaad solausiotn Dacanol,3344.55877,8893.10.10.10-noptadocatuoro- f(Braotmc2h n0um0be2r P.O002O04)02,..0w04a.s305dealoDrRmiUneNdOaAGcKLcABoCrRtoAiTOOEnRCIgDLMGFuOidRelAiVnGeE2W0A2V.GTTEhBOnLiOGteEstDw.a3s1c15o7nducted Sarsoat. fceomntpriogpperrtioesdaonfdi1n4daaycscwoasrcdawarienhdchoeu lTehvepnr:egpuairdaatnicoenmdootcuhmewntasc(hOEoCsDen20wi00r,oBgAarUdA2o00e1)tst exhpeossteuddyowaescsoantdruactteodn cunodnecrostnatvicactoaonndndiicoonnsocv.erTahdeusraakutroiafo4cn3 oourn.2c0 weesatsnragnatanlilaacmasttwyveoreo rne woaysGO0-.1a6nmaoyli.s ordota soepart8).Thamean measured concenotftraasattuiratoionn concenration siIntgheniftiecasnttefdsfactturwaatisodnecterominnecd.enoft0.r18amLt.i(moeann measured concentration)nobiologically Tal 1 0Pa7ca%riage nuomfdabphiads Incapableof mingafr24 ad43 ofaxpossrs IWHOBILISATION 14] Swen [anTen | conconvaton| Repeats | Repleates | mou oe [7T2ToTeTwIwT2TsTeTw] "Aorfeorfernocencoxtcetsyi dtcoamriniedu.toTnhcEporCmi.owafithplroetfauesrseinnucmedacmvoamta2t1omaoflraafnerc2e4fhowmaasnwd ihothhe rescrived concentrationrangeof 1.010 2.5 mol accord0iAGnSg, DIN Guideline 34121 30, Woatlrauarltiy bpneaweritaimthoeeafplc-covaorlpusetanamdtddaies.sTolavevdaokxiytgyecnceoincoafn1iratoasnmgeasuureddawei0sanlndie4ad.hwera hetmouna 0 ECOSan No. 220008 000010 DR. NOACKLABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-Doerctanol, 3.144:5.5,6.6.7.7.8,89.9.10.10.10-heptadscafhuoro- Page 8of31 `LAicmuitte-TIemsmtowbiitlhstahteiSoantTureastted(4S8olhu)titoon,Daacpch.niOaEmCaDgn2a02S|TRAUS. SPtruodjeyc-tN:oN.o. 0DA2I0B140191C1K 2 Characterisation Data of the Test tem TEST TEM 1-D6cano), 3.34.4,5566.7.788.99.10,10,10hopladecafioro- Batch Number Pooot casRN 78397 (Chemical charecterzation ~~ 3.3,44,55.66.77,8.8.9.9,10,10,10-heptadecafuorodecan--ol (EINECS) purty C8-perfioroalkylothano'; 99% .(sf3). sum peruoroalkyfethanol 9.9 % (sla) Aopearance Yetoush sold wax. Watersoubity 134 137 lL gl a a 12 25 degreeC, Sd29 dogrooC,SHd 53 gL, pL, n=8 (OuPon, ne=17 (DuPont, 2002) 2002) Stabily in water Stable at test conditions. Density ca. 1.7 gion? Expiry date Recommended storage Storage attesting facity Retention Identification parameter attesting faciity Unliitod if storedundertherecommeconnddiieonds. Room temperature (20 C). protected from moisture. Room temperature, protected from moisture and ight. Atleas1t g hasboonretained. Name, batch numanbdceolorur. Thetest tomandtheinformationconcerning the testHomworeprovidedbythesponsor. 000011 R--eDp--oRrt--UNOAKLAORTORUNFIRANGEWMDTEBOPagIe O00fG31E `1A-cDuatceainmomlo,b3i,l3i,s4a4t.i5o,n56T.e6s.t1,(74,88h,)89t.o9,D1a0p.1h0n,i1a0-mhaepgtnaedeScaTfRiuAoUroS- Project-No. 020109CK Limit-Testwihtho Saturated Solution, acc. OECD 202 | StudyNo. DABA111 3 Method `GUIDELINE. TYPE AND PURPOSE TesT SYSTEM ofRetaessotnsyosrttehme selection origin Broader Cure Culture medium Feeding "`AOcEuClDl-IGmumiodtiiniesaftoornTeTsetsitngofofDaCphhenmiiacamlasgNnoa. S20T2R1AUS `adopted Apri 04,1984. Determination ofthe acutoxicyof 1-Decand, 33,44,55667.7.88.99,10,10,10-hapladecafluoro10Daphniamagna STRAUS inamt testwihthesaturatedsoln. Daphnia magna STRAUS (Clone 5) DoatphhenisaumitaabglneaDaSpThnRiAaUtSybpeelsoanngds,airno abcrcedoridnatnhcetwoisthatch ts.tudyguideline, Instat or Wasser. Boden- und Luthygiena des Bundes`gesundheitsamies, Comensplaz, 14195 Bern, FRG DRU.NOAGK-LABORATORUN, 31157 Sarstedt, FRG 1nMd2):,3a.t 2g1lassCv(estseelmspwietrhaapotpfur2or0x-iem2as5tiCvelayr1e.t6oLlecrualtetdu)r,eimneadniiuncmub(aEtloern,dt16 1u2m0i01n0a0t.ion, Buminaton strength max. 20 UEHT2l (coresponding to teBmrpoeocdadtauprhiiodrsawtelreeasmta4i8ntapirnieodrfino t1h00et%estd.ilaton watatethre est E10la1n8d0! mMsg,CacacoCrOdi.ng to Eland: (1990),modified 0 ota hardnoef1s6s0 5vxulwgeaerkilsywaitdh antuaimgwasitcheladmeinxsoitfyoScfa>ns10dascmaulsisu.bspicatus and Chlorella 000012 DR.U.NOACK-LABORATORIUM FUR ANGEWANDTE BIOLOGIE R1-eDpeocratnol, 3.344,5,56,6.7.7,8.89.9,10,10,10-heptadecafluoro- Page 100131 LAcuitemimimowbtiitlhi-tshaTteSiaoentuTsreasttted(4S8ohlu)titoon,Daacpch.niOaEmCaDg2n0a2S|TRAUS SPrtoujdeyc-tN-oN.o. 0D2A0I1B04911C1K TEST EM Pretroatmentof 1-Docanol, 3,3,44,5,5,6,67,7,8,8.99,10,10,10-heptadecafluoro"Thetest temwasheated to 50 Cbeforeweifogr hohmogienisnatigon. TEST CONDITIONS. Coatingofthe. Tost vessols. Preparation `Coatingperiod Preparationofthe test `medium (saturated solution) Acoating phaseof 14dayswascaredout 200 mg 1-Decandi, 3,3,44.5,5,66.7,7.8.8.9.9,10,10,10-heptadecafluoro- A (o2t0aCl.vo2lLum~ebr2oLw)nwgelraessshfalakseknsweinraeruotsaetdin;gAfsthearkpehrawsieths2e0prapmrfaort290i6moLhna.t portast rpiiate wore transferred from the clea iuid phase to each roplicato andcovoredwith lass tops. Dilutionwaterwasuse for the preparationofthe coating solution. "Thereadiyfled andcoveredbeakerswerestoredat nominally 18.- 22C, 1C constora14ndayts. A theendofthecaating petrheibeaokerds. `wereemptiedandusedforthetest. 200 mg 1-Decanl, 334.4,55.6.6,7.7,8,8.9,9.10.10,10-hoptadecafluoro- 1. (otalvolume 2L)wereshaken inarotatingshakerwith20 rpm for 96 hat 20C. 2L -brown glass flasks were used. After phase separation the suspension `wascentforr2i0mfinaut3g00e0 rdpm.20 mLpertestrepliocfatthee cloar saturaledsolution were transferred to each repicate. Thepreparationmethod hadbeenchosenwih regardto thetostfem properties and in accordance with the elovantguidance documents (OECD. 2000, BAUA 2001). CONTROL (Dilution waterwithouttesttemtested undarsameconditionsasthotest group. 000013 rer aPomeeR ro-- hw--obteoao Rangeofvalidity roansommes ron a amr , m raaa oma aem--e s 0mpeo rmis 1.0mglL < ECyo (24 h) < 25 mglL. vase ss Arr [o|r rnn ] prassesa te Numberofanimalsper Zoomoe wnoeBT peaere e new 5(107) 000014 DRL. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE R1-eDpaocratnol, 33,44.5,58617,8,69,9.10,10,10-heptadecafluoro- Page 120131 ALicmuiteTIemsmtowbiitlhstahtoioSantTuroastted(4S8ohlu)titoon,Daacpch.niOaEmCaDgn20a2S|TRAUS SPtruodjye-cNto-.No. 0DA2I0B1A0191C1K Nu`smabmpelresopferpcaorncaelntration `Ageoftestorganisms. Testtemperature amination Photopeiod s@) 2-2nod 18-2212CconCsta,nt D(ciofmuessepgohntd,inugmi0n1a2t0i0on5r)angemax20 UE/2Ss 16/8 ghia cycle `COOFUTHRESSTUEDY (TOYFPMEEAANSDURFERMEEQNUTESNCY AND OBSERVATIONS T0heendaebfiioitvheesdteutadrymwianastpioonrofforimmemdoabsizmaittotneasfttwrih24tahensda4tu8rahtoeudrsso.luion o2b1t0a.i2n6edh obiydrdeampohvniindgswtheermeuotsheedraonrimhaoldsoifrciotvwesttudy2.2Thh.eByrwoeorde afoprhatildoasstw4o8 hmoauirnstpariinoerdtonth1e00te%st.don wateathe tes temperature. 2w0ordeaupshendi.dsCdonitvriodledrenptlioca4te(s2w)igtrhoouuptsewsifh 5m(w10r)ealnsitmeadupnedrteerstthveessasmeel. conditions a to tst groups. Altosbeakerswes laced in an incubator (ightdarkcycle 167 for4812120.1 C). "The immbisatonoftedaphidswas observed afer 24 and 48 hours of exposure. "Tcohnecernotfreartoinocnortaomnwgaes0.t5a8s1t0a5d.8inmfaiv.econcentrawtitihiontnhse. Observations, measurements and evaluationwero cared out as described below, (PrpiHovratloutoe,stdisstsaorltvheedwoartyagropnacroanmceetnetrrastoifotn,heteimpteiroatnuwraet,ecronductivityand oAthalohabredgniensis)ngwoofrethmeetaesstutrhee.water parameters (pH-value, dissolved `Cooxnycgeenntcroantcieonntarantdioconn)trowle,ra measured inonoadditonal opiate per flor48 thowat parameterswere measured inal opiatesper `concontraton and control. 000015 Report (OR. NOACK-LABORATUOMR FOR ANGEWANDTE BIOLOGIE Page 130131 DAcauclasnIomlm,ob3i3l4s4a5t,i5o,n6,T6e.s7t.7(.4888,h89t,o10D,a1p0h.n1i0a-hmeapgtandaecSaTflRuAoUroSLimit Test wih the Saturated Soluton, acc. OECD 20|2 PSrtoujdeycNtoN.o. 0D2A0I1B0A911C1K Equipment "T"Thheepteermcpeenrtaatguereimwmaosbiriatcoyrwdaesddtehtreorugmhionuetditnhealtelsetswtiahndachoenrtmoolnyggrroougprsa:ph. afer 24 hand48 pOHxyvgaleune pOxeitmteerr,inOxoiLa5b3p0H(LWeTvWel)1 (WTW) TWoamtpeorrhaatrudrnoess: : SHpyegcrtor-ophheomloogmerlaeprh,(CLaudFeaTs)100 LPG 158 Fluorescence (OR. Lance) ofDisgpearnsion veatmont: ChRoltoartoipnhgySlh-aFkieuror3o0m4e0te,rG(FKLLEWFELD) Contrituge: 2K 384, ZiRous. ESVTAALTUISATTIICOALNMETHODS aEnCawlvyasleusos and statistical SOFTWARE VALIDITYCRITERIA Tdheeteefrfmeicntesdodfictohcatymfirlocmotnhceanleisattroensaussmmobilsaton npercentwere. ECEuCsrvvaalluueewwaassocnallyccuasltcoulvaitoedprfoortthaenarleyfseisr.encPereomd.saccording oWEBER C(a1l9c8u9l)a.tion ofth confidenceintervalswascarried outusingstandard procedures according to BREIG & TOMPUNG (1882), `SigmaPlool.2000 2000), $755CORPORATION "TahreetIestims unmaccceuoprtianbgblteheim4o5rsettehseatnpe1rd0ipode.rcentofthecontrolorganisms. Thecontrol daphnidsshoudnotbo rappedonthesurfaceofhewater. Th10e-E2C5smafge.r24 h of thereferencesubstanceshouldban herangefom. "T(6h07e% diosfsothlveadi0rs;actounrcatairoinravtaolnueaalt htohe8tnedmspheoruatludrbeese>d5)..21mg. "TTuendeviationof the pH-value fromtheinalvalueshoudno bemorethan 000016 DR NOACK-LABORATORIM FOR ANGEWANDTE BIOLOGIE Re1p-Doorctancl, 33,4/4.6,5,6,6,1.7,8,8.9,10,10.10-heptadecafluoro- Page 140131 ALicmuitteTeIsmmtowbiitlhstahteioSantTureastted(4S8olhu)loton,Daacpch.niOaEmCaDgn2a02S|TRAUS PSrtoujdoyc-tN-oN.o. 0D2A0I1B0A9T1C1K DETERMINATION OF THETEST TEM DEVIATIONS FROM `THE GUIDELINE DEVIATIONS FROM THE STUDY PLAN REPORTING ARCHIVING v"eTrihfeiteedsbt ycgoansccharonmartaeovgtreiapaohnyndwicthmoaswsasnspeancatrlryotmiecotalrliycdetscton (iz= 453and395) ttoststatand estond. Additonalreplicateswerosetupfor tho anaytical work. None PuLrOitDyawnadsLCOB-pweerfrueor0o.a0l0k9yalnatdha0n.d0l2799m.a3l%, (raelsap)e.ctively. Those eviations had no impact onthe quality and integrity of the study. "rTehcaorfdina(l1 raport is origina). issued as paper copy (6 originals) andan aeclronic The folowing was retained inthe archiveofthe est facil for the p+eralilordaawsdsapteacified in the operative national GLP regulations: + + fsitnualdyropploarnt(pOarpgienrnc1o1p2y)(Osga1i of 6) + all records parformed by the quality assurance programme + sianmclpuldoinogfmtaessttetromschedules. MVioclrkosfbiamnskwSialrbsteerdett,aDi-n3e1di1n57asSaarfsote-ddtoposbiyt 000017 DR.U.NOACK-LABORATORIUM FOR ANGEWANTE BIOLOGIE R1e-pDoacratnol, 3344,5,5,66.7,7,8,99.10,1010-heptadecafluoro- Page 150131 ALcuite iimmtowbiit-lhitsThaetSieaontusTreasttted(4S8ohluttoon,Daacpch.niOaEmCaDgn20a2S|TRAUS PSrtoujdeyc-tN-oN.o. 0D2A0I1B0A91C1K1. 4 Results 41 Solubility ofthetest tem Tho test tem was clearly dissolved throughout exposure. 42 Rosult ofthe definitive test 2"The 4perc4ean8tha.geTihmemiambmiolbtiyliwsaastidoentaetremsiinned%ianttohre t2e4stheadnmdi4t8conocefnetxraptoisounreaanrddthGeivceonntinoTlaabflteer1 There is no biclogialy significant afec ( 10 %) nother in the tasted imi concentration nor in contol group. 43 Rosultsofthe reference item tTheermpeirnceedntdaigsecimfrommtahoftoertterotseullesr.onTchoetEeCm,waasnddeEtCesromiwniehd8a5ft%r 2c4ohn.fiTdehnoceECi,ntcesrvvaallu(aCwI)awse.re. otormined by probit analysis according 0 standard procedures. EC values ata24 ofthereferencetamin mg/Lwereasfolows: CCoo ::1251(CI18-23) Cu 58 TrahnegeEofu1.v0alu2e.o5fmraefleorfenvcaesdkiaymcpottarssacicuomrddiicnhgromoaAtQeS:afDtIrN24Guhiidselwinien38t4h1ep2r1os3c0r.ibedconcentration 4.4 Water parameters. bTehgeinwaitnegropfatreameetsetrsino(ndsesroelpvliecdaotexpyegerncocnocnecnetntrraattiioonna,npdHc-ovnatlruo)l oafntdesntaainrdepclointcraotlesgarfoeurp4s 8ahthaere ised in Tables 2-3. mp-evaasluuree,scpxyrgetnoitcooontcasnttart.atiTonh, rfaompsesrataurreos,tcoendduicntTiviatyoa4.nd ftal hardnessof he dion water were Duringth totthetemperaturewas i therangeof201C. 000018 Report DR.U.NOACH-LABORATORIM FIR ANGEWANDTE BIOLOGIE Page 160131 L1Ai.cmDuiotTcsanIoomlm,was3bii.hi3its.na4ei4o:San5t.Tu5re8ast6te7d(,4S788oh,)o9,0n10D.aac1pch0.n.iO-ahEemCpaDtgan2dee0c2SaTfRuoArUoS- SPrtoujdoyc-tN-oN.o. D0A2I0B1A0191C1K 5 Validity criteria vThaesytudcrytwaarisa wpoerrefofrlmieedd:accoring to OECD Gudline 202 EEC Directive S269/EEC Method C:2. The Inthe conrl group no Daphria wera immoSissd or rapped 0 he surfaceofthewater. The ECc-vaafleru2s4ofth rfatermwaseintnh crangeeof1010.25mg. Th diasoied O concentration was > 5:21 gl. (0% of he asaturation value atth temperature used). The p-value id not vary by more than unt. 6 Literature / References BnaAcUhA,doBmunCdehsoamnisatallstnfgorsAortbzei3s.sdchbuetazrubnadeAerbAeutfasgmeeiz (2001): Lofaden or Anmeidungen neuer Stcfe RVortEag,MGJo.na&.TOWPLINGW. (1982) MedtorWhasseoruntdersuechunngen BA.1, VE Gusay Fischer UDnupPuobnlti,sDheetdsrrmoiuntast,ioUnpodfatphoyFseibc.o-1c5h,em2i0c0a2l parameters of Perforooctehandl, CAS No. 678.38, ELHoT. P. (1980) Selenium Deficiency in Crustacea, Protoplasma 154,25- 30 (AOdEoCpDt-egduAidperln0g4,21092814fo testing of chemicals. Ac ImmabilsatonTet of Daphnia magna STRAUS. sOeEvCesDo(n20t0e0s)t:inGguainddanacsesedsoscmeunmte1no0nt.2s3quat oxic testing of cul substances and mixtures. OECD. Wabar (1966): Grundiss dor ilogischen Statist8,. Autage 000019 OR. NoKGK-LABORATORIM FOR AGEWANOTE BOLOGE Ra{Dpaocratnol, 33,4.55867.78.899.10.10.10haptadecafioro- Page 17151 cLiumit-TIosmtmawbiitiishse iSantuTreasted(4S8o)otno,Doacpoh.iOaEmCaDgn2a02STRAUS PStruodjye-Ncot.o. 0D2A0I1B019101K 7 Physicochemical data: pH-values, dissolved oxygen Tato 2 (Wraaertpear1am6e0tesrs ttheobrlirngoftwhaanst) Sarin | Pas Concontration fog) I 7 72 Control mn 78 Table3: (Warteerpsas ricoate)hmeanedotfota(4s81) Satraton concentration aes no.ofropicate Creare frat] 0.of epic 9 ala lalallala) 016 | 75 | 760| 762 | 763| 768 | 772| 773 | a1 conver | 765| 783| 707 | 758| 789| ver| 784| 735 Table 4: Waterparaomftheedtitieonrtsar Dionvate| pias|Orconc.| Toms. TotoHoraness dato aco, wou| ra) a] moony| 772 |70[mo]wz| mm | 000020 8 GC-Analysis of 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9, 10,10,10heptadecafiuoro- --_-- [=Tw T7700 TeT1 w 10 | [so T77 72 5001] 000021 [DRLU.NOACK-LABORATORFIOUMRANGEWANDTE BIOLOGIE ReA1cpDuoolcraatniomlm,ob3i,l3i,s4a4t:i5o,n5,T6e,s6t.7(.478,8h.)8,t9o9,D1a0p,h1n0,i1a0-mhaegptnaadoScaTfRluAoUroS- Page 190131 Project-No. 0201090K Limit-Testwihthe Satralod Solution, ace. OECD 20|2 Study-No. DAIBE111 STANDARD PSRTEAPNADRAARTDISON OF PREPARATION OF SAMPLES Tost item was used as standard Tinwtoorstt-obcutkylsomleuttihoynlseotfhetrh,eisltuatneddar(d9 ocfon2c0e0ntmrga/tiLownsereeacphr)epaanrdedused for calibration. For calloration ange see part 8.2.1. 4th0omr.LAoffatrhephsaasmeplsoepwaerraotieoxntrtahceteexdtwraicht 4w.a0smiLnjetcotretd-bduitryelctmleythinytlo the Gos. METHOD VALIDATION Peak symmetry Repeatabilty Accuracy Qmuaasnstiefsic6a9ti+on3o9f5t+he4t6o3st(liazm) wbaassecdaolcnultahteeedxtbeyrnpaelskstaandrarodefst.aheThe calibration procedure and the principl for the determination of Gotoction and quantitation mits were adapled from DIN 32645. The. matnod was vaidatad as described below: Psteaankdasrydmsmaatnrditaesstwetroamcaaclccoulradtiendg ftrootmhechfroolomwaitnoggreqaumastioofn:analytical Tr Wel T= Wass = pPaeskkewiydmtmheatt y 5% of ask height [mm] = frst soctor of peak with (dvidod by the perpendicular ne rom the peak maximum) (ml a5sisnugbl-seahmopimeosgoefntohues hsiagmhpelste awnedroloawneasltysceodn.ceMnotraantivoanluperse,pastraenddfarrodm aviations and variations of coefficients ware calculate. 5Doscaamncpll,es3w,i3t.h4,4405m.5L,8,w6a.t7e.r7.w8e,r8e,9s.p8i.k1e0d,1w0i,t1h0-ahnopatmaoduencatloufor8o-yg(01- ul o`fsa1m0p0lomsgwiaL)retoegxitvreactafeidnaals cdoensccernitbreadtiaobnoovfe.200 ygiL. Afterwards 000022 D5. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-Doarctanol, 33,44,5,5,66.17.889,10,10,10-heptadscafluoro- Page 200131 ALicmuitle-TIemsmtowbiitlhstahteiSoantuTreastted(4S8olhu)titoon,Daacpch.niOaEmCaDgn2a0S|2TRAUS SPtruodjye-cNto-.No. 0D2A0I1B04911C1K 82 Method Validation "The me+ thotdinowaaristyvalidated and tested with satisfactory rosults with respoct to + precision (repeatabiity) -~ pacecaukrsacyymmetry ~ determination imi and detection limit. 82:1 Linearity T3,h.o6,a4n,a5l,y5ti,c6a,l6.s1y.s7t,e8,m8,g9a.v.e10l,i1n0e,ar10r-ehsepptoandsaecaifnltuhoeror-a.ngTeohfe c0a.l1ib-ra1t0imonaciurovfe 1a-nDdeccahnraolm,atograms obtained for standard and tot tem are given in Fig. 1 -Fig 8. For misofdetermination and quantification see part 8.3 822 Quantification Limit and Detection Limit "The limitof quanification (LOG) and liofmdetiactiton (LOD) were calculated using the bind value method described in DIN 32645 "Nachweis- und Bestmmungsgronzs. Tho LOD was determined to bo 0.009 mil and therefore the LOQ was 0.027 mglL. (tresfold the LOD). see part 8.3 000023 = IL Ho Ae oRa eES[--r--T fonemrebite To 1) Oop mee Sele geo +25 scion Papen O hTY y H CTJ ------ 1 20m [rarer| 2To | o ose | oT ow [wwe| [1 ese [vase| 5 1 [Hoan+50 20045 1525 | 132184 +6139 +24 FakSymmes A 000024 Report [DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Page 220131 1AcDuatceaniomlm,ob3i,l3i,s4a4t5i,o5n,6T8e.s7t,7(,488,8h,)8.to9.D1a0p.1h0n.i1a0-mhaepgtnaadeScaTfRiuAoUroSLimit TestwihtheSaturSaoltuteiond, acc. OECD202 | PStruodjyeNcot.o. 0DA2I0B1A0191C1K 825 Accuracy Tab. 6: Mean Recovery Rate of Fotiflad Samples. coarnFiceoatmoitiadomn |33.4438o86p.T1oi.v7cn6a8ne,o0,s9..10.10.10 0.1906 (mot EE i=ng) [= [wens [om | ve] EE [o vr a | r wos | roe] oa | we| =| oo | ws| [Con1 [t |aom ar u7} cCoommsiact[ oonn (7 eo] ca&Bsacone =a cadcc oneanntaon,o rmancofr cacreasionnon esco1ut 5& en C R rse n dmn c 00025 aon, 334455a4A 6F 77881a 3mwpi5as.dso1e cSa0Ttu1Acss0- J mo neSo Son vee OER 081 Jaioagtion 0A Tt GoanthAat treennEsA AAASSARTIARSI, T mrE | E mr [So |mP om ro sT|e y S Ewors -- ors | eTee | eh | e[ e o |] a oa | Towm w ert] wees] TBioE E-- RTEEE roms msi masts 000026 C nol334458o67n788wo8r0e1LD0ssbaohmevarpmotmaadT rcoSanAuTcAvsse- ne BiomeprseNo. oa01090K neSes tan. a GEG 3031 Tm Sse 54Caradon Curves =Inecola cues shownwer sabia odorant concanvation anges anda dared =[ | fom Tom |. | Calibration CurveofFluowet (2002.04-04) | = | + -- 8 RY=0.9656 Ten em -- om we om Fat CA aran Creo Sandr constr rang O01 038 mot 000027 iRacpeaednre,o34s4a868T06o8.1n84880o8sn.yc1Lo0aa.s1p0on1m0ereompamtgaundeeFcoSanTtARvoAcrUwsS:aore BiotoaPe roceF.aeoTtorsa StTow wih oS Soon, as GEG 252 Sito' Baoan - Calbration Curve of Fuowet (20020410) prsoent ooonmo | foouwnn HE 1o00l00. | o | _, _-- Jeisdseezmo17 | 2 `con.mart. . 0 Fo 2 (Caanlibart2o0n02G0ur0e1s0)of Sanda -consantonrane 1-10ml CalCurlve orfFluaowett(200o2.06n.19) wn | a0 Le son ry | | _ 4R2i02x00w9+072423.83 | 5000 o om er con.mmaer) s es we | Fl 3 G(onatob20a05.C0u8.e15o)f Sands -concenvaton range 8.10 mal 000028 DR.U.NOACK-LABORATORIVM FOR ANGEWANDTE BIOLOGIE Re1p-oDroctanol, 33,44,55,6,6.77,8,89,910.10,10-heptadscafluoro- Page 260131 ALicmuitteTIosmtmowbilihisthaeioSantTureastted(4S3olhutitoon,Daacpeh.niOaEmCaDgn2a02S|TRAUS SPtroujdeyc-tN.oN.o. 0D2A0I1B019101K The frst calibration curve was established 2002-04-04 bul the concentration range (0.01- 0.06 m(2g0i0L2).w04a-s10b)rowahdicehnocuogvehrsto@bemuucshawifodreralrlaensgtas(r0u.n1ni-n1g.0 MTghIeLr)efwoares tuhseedsefcoorntdhecucarlvceulations in tis test. Tho concentration calculations using the two different curves do not differ more than 10% Tfrhoemcealaicbhraottihoenr.curve from 2002-06-19 with a conceniration rang of 0.1 0.6 mgIL shows that the `GCIMS system has a good stability over a ong period of ime. 000029 RaTpeorctan, 334455S667E78S88910.100hoiadiacapuocrsos-e Brice FTE RCiuntieTmoasbwliitsaotnSonoTsoau 4S8u1)d1oo,Daapche.aiOsmEaDgn3e03S1TRAUS SPrhoojencat,o. OazA0iB0As1cK1 85 Chromatograms EEFo Waem SZFiw SER EESR, =oe=m eet Ea E. - -- BE Fae | | | i - Wows BSow--s---- |1| . ii y see = || i= EEm-- |1 i sem |fill LPd rand Re er [C-- at dns-- 0020030 1 | - 000030 TaEpna e334Dn4N8o8r4o.80s.s1p40onAsb0rroamp7adoc7matAuv0ossm-mere Bevo TH EaE sessSonnDibneneemroaomssrascs oTrape. SEAR Ee Fri e EEE -- rEaTRE uarTnE eaE= Be Se Ep - C- V RN | | | ul | J-- i yams RT | | T| o|| I| (ouwi= lxy 1I4 |! iEN| \ . | . Fas Ce ormuogaTomtatotm m ov os 2.0035 000031 I sa Teoek Soyuos obpsteSmaEgeoSstSTRAUS EE ProojenctNo. 0201080K EER L E =e eam jjr r fe Be He Hoenn eeEe iNl|! : cee: nn JMi | Th | | " et Cmos mm) e 000032 Report OU NOAGK-LABORATUOMR FORANGEW--ANOTE BiotoGiE Page 00131 LiaAmcivanTooIlumtm,aib3ln3i.ts4aa4b5So5anu6sT6ao7is7e8d(,4S98o9nl.to1no0,.D1co0cp1.h0l-OahEpmCtaDagdn2ee0c2SatTiRoArUoS- SPlruoajyencot.o, 0DzA0I1B0A6IT0!K 9 Cheerpttiafdieccataefioufo1r-oD-eAcnaanloyls,i3s,3,4,4,5,5,6,6,7.7,8,8,9.9,10,10,10- 2 = Clariant 000033 OR UNoscKcLasomAToRUM FUR AcEwoTE Bitoae RaBpoarctanol33.445.56877.108h8ap9a9dc.a1tu0c1ro0- Page 31001 LiHemaitsToIsmtmwoinhstaataSantuTrotbed(S48onotno,Daocep. OeECmeDg2n0o2S|TRAUS PSirioojyencot,o. 0D2A01B09SCK 10 GLP-Certificate of DR.U.NOACK-LABORATORIUM LrBasp chaavienir tguancr/i Bmiaatpcee moteinteos rf LpPat cCeompliance rS E n ERLenL2FS SR usi ASST T Ig Tn T x onnenen Tomy CprToot repo ann tegenra torres tn FE ee eeeeeneeaSpeeaeeaSc0oasthoeabheanreoseree S-- tpiore o E rTe reniSm tE t tsar earsSemen ov pottteennn 2Autant 20SS msonet nn e abm pre, 801 Ine a) Pr Wit SR antd 000034