Document 2joGjOdgZ5MQKNjZ1Ok2RmjOr

TELOMER RESEARCH PROGRAM 1200 SuTthT HoyeO SvecI e4 AngF,a V(Ti4o328212.5050 Ww ETE =< Clariant. CPR February14, 2003 MUaSryEFn.vironmjeanktalProtecion Agency EW1aP2s0A0hnEPagesintoi(npMaiDdaCCnoad20eA4v6704e0r5MN) W Eat domimony@epagov E5zs 3o3x88 S=S 5%= 0== Bo 8 Dear Mary: Tathee TpelromoervRlieosnUeaSgr.chEPrPoAgrDaomc(kTeRtF)AsRnZd2i6sfmneamlbreorpocornspeonritehse,AacsuateGhaaszsa,rCdioafr5a.n,2DTeaokm,arand8DAukPorn, Cor(en3s3dh.uy4a.t4e,r5b5sy66ao7nu.7sn.d8al8po.t9a.n9so.pna1c0se1sb0.a,r1a0hlTpohtyeasadseecraerbpeuqoousreosrcteeoscfeanhnte--hToReFC.rAeSTshuNesos.ef6S7u6to.e.9s9aw1c)uiewe.hcesncoueaslntcac1waiucchccsoaieernsagdrtido oPursatciincgesO(EGCLPD) lraosqtiagiounsl.es and i accorsance wih he proviions of he appropiate Good Laborary The oryscalchanical charoctasic of the lest substance idle that he lest subsance s a "GH" ssSuttboissnttgaanncwceee,rseaasrnidndeMciartfeeodsf,eitn hOOcsEEoCCbiDDserM2vvo0an0tio0eog)nr.3apxhC1o23mm(eoGxunpipedrraavncectenctDeloscdfueomrseknestsiosnneglAehqceutsaeedtifcopTonexesiocstfcyuTatesstailnqguoafraDIniodf,Xficcluryt vDarieaipnagahonfortenesutsorormepoersttss.of 050 ypesof mera. weresed urn the conoftdnSuurdcesatnd he TphoathTeRsPiasnhda khs eme6m:b2Teerccmoemr pBAacnbieoleesvseotoha wth1e maetdagainceorncefmoemthmeseosfiu5pesoatraectonosicstsentiwiahcthte feesctos conoaqtmuaoa3sc0pechtiaets.my 1 tdhreee ayroucruQsuseistoinosnCsooncoemiopgptahperitsoechTicRaPlmaesmpbecetrs cofomhpeansyiupceiressonSneUlIS, Sincere. Ve Hotie, ar KToRtPeA0d. rSiyanean "TisdocumentdoesnotcontainTSCA CBI. 000036 DR. NoAGK-LABORATORLM FOR AGEWANOTE BctoGE ~Repeor1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro- LimiFtiTsehst(Zweibtrhaftihseh)W,aAtceurteAcTcoxoimcimtoydTaetset,d SFtraatcict,io9n6(hW,AF) 265. to OECO-Guidaine No. 20 for stoifChenmicgals (1952) ToomerSRpeosnesaocrh Project "htawoGruas Cuan Oak hoouusnTRES LTD Ok SAeuhtoheorroaum OR. NoosAtGinKgLaFsacoiRliAtTyORUM FORaAtNhGoE-WPAaNuOuTsE-SBtl.ot1ogiE 031157 Sarstedt Laboratory Project ID PrSotjudeycNtoo.. oFza0zte0i9tczc Pago tor 22 Study Gomploted August 07, 2002 Original 7 of 7. 000037 RBeepcoartnel, 304455D8A,U6N7o.7A.G.L8a.9s9o,m1T0.o1R0U,0M-FnuonpAtaEdnaAcvaOorToE-Boose Fotos iFohn onoitnr.AAccioToouFmsaemncth.aSaHolAeFdsoe6 nlneGoECTDo2w03 PSrjrocatNo. 0F2a01g0u96sK Statement of GLP Compliance Tae vDe0tcaadneoca,t9ua4r.:4556611.8899.10.10.10 iWoinn(inahpatrer,AAcctca oTmoms TFoastc,ioSnta(tW,A0T Lin Test Gudeina OECO.Gudaln or Tostng of Chamicls No. 203 Toston hDeotcadsu,ca9u.a4:.465861.7.8809.10.10.1- (atch nambor P0001) Tos Facity KOPRha.otnPeNoO(i+A4o3Hn)L14A1B0O,R8A80T.O10R01U11M05.FSUFRooM.sGE(aW4A9)NE0T5E0 6Bi17t08 780 Eman io@nancaks du Deviations from GLP Princes Noro Wioncditcerofh53t08sLatboruatowraysrcaocndiicctaadndahnderneptoortneld nGLcPomeplnianocenwitah hspaeccui OnEhCDow oan ances evans anion Soom. nr 52 Di f Sonora,m Stody Ores August07,2002 J-- variasC Gaitl , Souris ---- (6 doiNase. on|dof a.sin Fai 000038 Report RU NoACK-LABORATORIM FOR ANcEWANTE Biotocre 1-Docancl, 33,44,,5,6,67.7.8,89.910.10,10-heptadecafiuoro- Page 3032 WFiisthh t(hZeebWroatfiesrhA),ccAocumtmooTdotxeidcyFrTacoiso,nS(tWiAc,)9o6cc1.ioLiOmEitCTDo2s0t3___ PSrtoujteycotN.o. 0~_2F0A1ZB0A81CIZK Statementofthe Quality Assurance Unit Tae Gueine Tost hom Study Oiocter FDaohcaZnad,b3r34.a4A.tc55it.T6n.o6)x7t.,y7.T8s89.9S.t1a0t.e1,09160he,pLtaidmecTeasttoroWith heWater AccommdatedFracton (WAP) `OECD.Guidlne for Testing of Chemicals No. 203 (1@Dteecnanmdb,a3r3:44.P55O.6O.67).7.8895,10.10.10 eptadecatoroOi Schoaoaum Thestwuasvderye os follows: npecion su on seconvases on a waz | wzzoaeucn mwzzaarn1isz aw trop Er mom Zoazm0zornates zanzaarits Tprhoocedpuorers,eaondlsseravcactuirosneslyaarndaccompcleutealrynadfcetocmteptllhetryawddesocabfehdensthudyr.oArls.ometh, Tishguaaracntocndaorfthdesatudny wcith toyplanandth prinocfGeoosd LaboratoryPraccs August 07, 2002 _-- Pr-- arie " 000039 DR. NOACK-LASORATIOMR FOR ANGEWANDTE BI0LOGIE R1e-pDaocratnol, 3,3,4.45.5,6,6.77,8,8,9.9,10,10,10-hep--tadscafluoro- Pagedoisz WFiislhht(hZoeWbraatfeirshA)c,cAocmumtoedTaotxeicditFyraTctsi,on S(tWaAtiF,) 9a6ceh, foLiOmEitCTDes2t03 SPrtojoecot.-No. 0F2A0ZB1A018IC2K Personnel Involved `Study Director Dik Schoerbaum (Biologist) Scientist: Thomas Geftke (Chemical Enginoer) cRoenstproonlsainvaileysfiosr concentration Technical Sta: Christian Rebl Quality Assurance Unit: Gudrun Mohrmann-Kalabokidis (@iologist) Deputy `Susanne Becker (Biologist) TDiersetcitnogrFoofotlhye: or. Udo Noack (Biologist) 000040 [OR.U.NOACK-LABORATORIUM FOR ANGEWANOTE BIOLOGIE R1e-pDoerctanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecaflu~ oro- Pagesoraz FWiisthh t(hZeebWraatfiesrh)A,ccAcoumtmeodTaoxtiecditFyraTcetsito,n S(tWaAiFc,) 3ac6c.h,loLiOmEitCTDos2t03 SPrtoujdecyt--NNoo.._F0A2Z0B1A0T9ICZK Table of Content Page Title Pago 1 `Statement of GLP Compliance 2 `Statement of Quality Assurance Unit 3 Personnel Involved 4 Table of Content 5 List of Tables and Figures. 6 1 `Summary 7 2 Characterisation Data of the Test tem 9 3 Method 10 a Results 15 a Preliminary Tost 15 a2 Definitive Tost 1s 5 Validity Criteria 7 6 Conclusions kid 7 Literatur/e References. 7 8 Physicochemical Data i 81 Water Quality Measurements 8 5 GC ~ Analysis of 1-Decanol, 3,3,4,4,5.5.6.6.7.7,8.89.9, 10,10,10- heptadocafiuoro- 1 a1 Method i 92 Method Validation 2 921 Linearity 2 922 QuantificationLimit and Detection Limit 2 923 Precision (Repeatabilty) 2 924 Peak Symmetry 22 925 Accuracy 2 03 Results 2 94 Calibration Curves 2 95 Chromatograms 2 0 Certificate of 1-Decanol, 3.3.4.4,5.5.6.6.7.7.8,8.9.9,10,10,10- heptadecafiuoro- Analysis 3 " `GLP-Cortificale of DR.U.NOACK-LABORATORIUM 32 000041 DR. NOACK-LABORATORIUM FOR ANGEWANDTE BioLOGIE R1e-pDoorctanol, 3,3,4,4,55,8,6,7.7,8,8,9.8,10,10,A 10-heptadscafluoro- Fage6 lz FWiisthht(hZeeWbaratfeisrhA),ccAocmumtoedTaotxiecdiFtryaTcetsito,n(SWaAiF,)o9c6c.h,L0iOmiEtCTDo2s0t3 ___ SPtruodjye-cNto-.N_o. 0F2A0Z81A0181C2K List of Tables Page Tab. 1: LC-Values with 95 % Confidonce Intervals 5 Tab.2i Cumulative Mortaltiyn[%] in the Preliminary Tost 1s Tab.3 Observations in the Tost Vessels 1s Tab.4: Cumulative Mortaliityn[%] inthe Tost Vessels 1s Tab.5 Lr. LCir-, NOEC-Values (0-96 h) 1 Tab. 6: LCu-Values with 9 % Confidence Inorvals 1 Tab.7. Water Parameters Tab.8: Repeatabiliotfy Infectioonfs Test tom 2 Tab. 9: Moan Recovery Rale of Fortified Samples 2 Tab. 10: Goncontrationsof the Active Ingrediont 1-Docanl, 33.4.5,5,67.7.8,8.9,910,10,10-hapladecafluoro- 2 List of Figures Page Fig.1: Calibration Curveof Standard - concentration range 001-008 mort. 2 Fig.2: Calibration Curve of Standard - concontraion range 01-10 mg Ed Fig.3 Calibration Curve of Standard - conceniration range 01-08 mgt 2% Fig 4: Chromalogram of Standard 2 Fig.5 Chromatogram of Test tom P Fig.6: Chromatogram of Control 0 000042 DR. NOACK-LABORATUOMR FOR ANGEWANDTE BIOLOGIE Re1p-Doerctanol, 3,3,4,4,5.5,8,6,1.7,8,89,9,10,10,10-haptadecafluoro- Fage7 ol 32 WFiisthh (thZeeWbaratfeisrhA)c,cAocmumtoedTaotxiecditFyraTcetsito,nS(tWaAicF,)9ac6c.h,0LiOmEitCTDes2t03 ___ SPrtoujdeycNto-.No._0F2A0Z1B0A9TC2K 1 Summary The acute toxicity of the test fem 1-Docanol. 3,3.4,4,6,5.6.6,7.7,8.8.9.9,10,10,10heptadecalluoro- (Batch no.: PODI0OT) to fish (zebrafish) was determined accordingto the (OECD-Guidoline for Testing of Chamicals No. 203 (1992) from 2002-04-02to2002.04-06 at RU. NOACK-LABORATORIUM FUR ANGEWANDTE BIOLOGIE, 31157 Sarslod, Germany. A static mit tost was conducted with the wator accommodated fraction (WA). The test vessel w3a0stocsotaotregdanwiilshmshewetroosotxepmosfeodr o14tdhaeywsabteerfoarcctohemm(eosdtastteadrtdfr.acDtuironatainodn otfhethceonttraoslt.waFosr9t6heh. p1r0o0pamrga/tLiownaosf tshheakweatnefrorac96cohm.mAoftdeartpehdasfreacsteipoanr(atWiAonFta)hesculsepaornusiiodn wpihthasaenwoamsinuasleldoafdorintgheof test, All effoct values are based on the intially measured concentratiofn the tost ilo. GC-MS `analysis was carried out from the ast tem and the control vessel at fst stat and end (for r7e.s7u.l8t,s8s.8e.e9.p1ar0t,190..21.0-Thhaeptiandioticaalllyumoreos-suwraesd0.co1n4cemgn/tLr.atAitonthoef o1n-dDeocfantohle,(a3s,t3t,4h.e4c,5o.n5c.o6n.t6r.ation of the test om was below the detection Imit of 0.009 molL. Sorption to the glass walls of the st vessols is unlikely a tho was ware already pro-coated for 14 d boforo the fost has started Tho acute oxic of the tes fem 1-Decanol, 3.3,4.45.5,6,6.7,7.8,8,9,9,10,10,10heptadecafiuoro- i summarised i the following table: 000043 t,o Ei taeroe [Conoumont|l tm moms | p-ssimas To oToommT s wweeee|| o omT |wwe| orrmEn twp r oo os ES er Ses ta 000044 Repon DR. NOACK-LABORATORIUM FOR ANGEWANDTE BioLoaie gear; F1i-sDhoc(aZnoborla,fi3s,h3),,4,A4c.u5t,e5,T6o,i6.c7i,y7,T8e,s8,,9.S9t.a1t0i..190,610h,-hLeipmtiatdTeecsatfluoro- Project-No. 020109CK With theWaterAccommodated Fraction (WAF) ace. fo OECD 203 SudyNo. _FAZBAIT2 2 Characterisation Data of the Test Item TEST ITEM Bath Number 1-Docancl 3.3.4.65.5,6.6.7.7.8,8.9.9.10,10,10-heptadecafiuoroPo0i001 cas RN 678.387 Chemical characterization Putty Appearance 3,3.4.4,5,5,6,6.7.7.8,8,9,9.10,10,10-heptadecafluorodacane-1-of (EINECS) `Cs8puemrpfeurofrlouaorloksyllkeytlhetahnaln:ol9$9.99%%.(a(la3al)a.) Yellowish sold wax Water solubility `Stabity in water 113347 ggiiL 3at12152 ddeoggrreo CC,, 5$11dd 2503 gpgi/lL., nn==817(D(uDPuoPonntt,,2200020)2) Stable at test conditions. Oonsity Ca. 1.7 glom Expiry date Recommended storage Storage attesting facity Retention Identification parameter at tosting facility Unlimited i stored under the recommended conditions. Room temperature (20 C), prolected from moisture. Room tomporature, protected from moisture and light. Atleast 1g has been rotained. Name, batch number and colour Th tost tem and the information concerning the test tm wero provided by tho sponsor. 000045 OR. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-Doorctanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-hsptadecafluoro- Page 1001 32 WFiisthht(hZeeWbraatfiesrh)A, cAccuotemTmoxoicdiFtaryatcTteeisotdn, (StWaAiFc),a9cc6.h,toLOimiEt TCe2sD0t 3 SPruodjyocNto-.No. 0_2FA0Z1B0A9TCIZK 3 Method TEST GUIDELINE TYPE AND PURPOSE TEST SYSTEM, oRfetahseontesotrstyhsetesmelecion origin Holding Water Feeding Food `OECD-Guideline for Testing of Chemicals No. 203 (1952) Determination of the acute toxicity of 1-Decanal, i3n.3a.4l.im4i,t5t.e5s6t.w6i7t.h7,t8h.e8.w9a.t9e.r10a,c1c0o,1m0m-ohdeapttaeddocfarfalcutioorno-(tWoAzFe)b.rafish D`Gaantihoorsetroimoa(,zebPriasfciessh,) Ostelchihyos, Teleoste, Clupeiformes, Cyprinidae According o the his kind of study. guideline Danio rario s suitable for AQUARIUM AM AEG), Feldstr. 7, D-30159 Hannover tAlhlefisusphpluiseer.d i the test will originate from the same delivery of Holding was light 0.1-10 performed at the test faciity u/s, natural photoperiod). at 23 Tho + 2 C and water was diffuse. acdhmainngisetderaetdl.east once per week. No disease treatment was The dissolved oxygen concentration was more than 80 % of the. ai saturation value. Only zebrafish with at east 12 days of acclimatisation and umsoerdaliintth<ye5te%st. within the last 7 days before the study starts was Tapwater of local origin was used for holding and testing. The `2wa4t1er0warsomfoiveerecdhloorninaec.tivated charcoal and aerated for a least Nominal water parameters: Total hardness: 40 - 180 mg CaCOyL p-value: 6.0 - 80 The water regulation. is analysed once a year acc. to German tap water 4F%ooodfwathso pfrioshvibdoeddy3watiimgehst ppeerr fweoeakd.ingThdaey.amTohuentteosft ffiosohdwwials.not be fod until 24 h before the test started. "Trout 40 12; MILKY, D-86666 Burghaim 000046 Report [DFU NOACHK-LABORATORIUM FOR ANGEWANDIE BI0LOGIE Page 116152 F1i-sDhoc(aZneborla,fi3s.h3),,4A,c4,u5t5e,T6o,x6i,c7i,t7y,T8e,s8t9,,9S,t1a0i,c1,09,610h-,hsLipmtiatdsTcoasftluoro- Projoct-No. 020109CK. With thoWaterAccommodated Fraction(WAF)acc.io OECD 203 SudyNo. _FAZBA112 TesT TEM h1e-pDtaacdaneocla,fi3u,o3r,o4-,45,8,6,67,7,8,8.9,9,10,10,10- Pratoatmont of hTohmoogteesntilsaatmiownas heated to 50 C before weighing for TEST CONDITIONS Coatingof the Tost vessels A coating phase of 14 days was carried out. Praparation h1o0p0tamdgec1a-lDloucoarnoo-lL, 3i.l3u.t4i4o.n5.w6a,l6o.r6.(7t.ot7a.l8.v8o.l9u.m9,e10.1x02.1L0)-were shaken i a rotating shaker with 20 rpm for 96 h at 20 C. 2L brown glass flasks were used. After phaso separation about 10 L ptehre golsatssroapqluicaartisuwmearnedtrcaonvsefreerdrewditfhrogmlatshse tcolpesa.rDuiliutdiopnhwaasteerto was used for the proparation of the costing solution Gosling period "2T3h.o2r2eaC lyfofril1e4ddaaynsd.clAotstehdeaaqnudarofiutmhewcaosatsitnogrepdersitodnotmhienally aquarium was emplied and usedfor the tast. Praparaionof the test medium fraction. (water WAF) accomodated 100 mg 1-Decanol, 3,3.4.4,6.5.6.6.7.7.8,8.9.9,10,10,10- `hsehpatkaodnecianfaiuroortoa-tiLn.gdsihlautkioorn wwiatther20(ortpalmvoorl9u6mehatx 220LC.wera fAfrtoemrtphheacsleeasreplairquaitdiopnha1s0oL(rpeoprroessetntrienpglitchaeteWwAeFr)o ttoratnhsefegrlraesds "aTqhuearpiruemp.aration method was choson with ragard to th test tem dproocpuomrteinetssa(ndOEiCn Dac2c0o0r0d,anBcAeUwAil2h00t1h)e.relevant guidance. CONTROL 30 fish n dilution waar (without test tom) wero tested under the same test conditions as the tost opiicales. REFERENCE ITEM No roforence ftom is recommended for his tost according to the. guideline. TEST METHOD Ainisttiaattiiocn.mit tst was porformod with one application a tho test 000047 Report [DF.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Page 120132 F1i-sDhoc(aZneborla,fi3s,h3),,4,A4c,u5t.e5,T6ox,i6c,i7t.y7,T8es,t8,9,S8t,a1i0c,,109,h10,-hLeiptmaidsTceasftluoroWiththeWaterAccommFraoctdiona(WtAFe)adce. io OECD 203 SPrtoujyeNcot.-_No. 0F2A0Z1S0A91C2K Test duration 9h Tost vessel Tost volume (Glass-aquaria loosely covered by glass tops were used. Thetest volume was 10L par vessol Aeration Dilution water Number of ost fish Loading, length of fsh Gentle aeration was provided. Same as for holding. 30 zabrafish was used per test concentration and control. sFoilsuhtidoen,nsity in the tanks was loss than 1 g fish per ler lest ``AAvveerraaggee bbooddyy wloeniggihhtaatttthheetteessttssttaarrtt:: 20..7279cgm bMuetasnuortiunsgevdailnuethsewteersto, determined with fish from the same batch Roplcates. One repicats por test concentration and control. Introductionof fh Faeding of test fish Water temperature Fish wore introduced randomly to individual replicates. The fish wil not bo fed during the test. 2s2'c cDoinscseonltvreadtiooxnygen Not loss than 60% of air saturation value. Light intensity 01-104E/ ms photoperiod Anatural photoperiod occurred during the ost. MKIENADSUANRDEMFERNETQUAENNDCY OF OBSERVATIONS. Water quality measurements iPn-avlallvuees,setlesmpatertahteubreegiannndinogxyogfehnesattousrtaatinodnawveerrey m2e4ah.sured oTfotthaohteastrcodntnrooelf.stDhsuerwianlgotrhweatsestdettheerrmoionemdtaetmptheerabteugriannwians.g out recorded continuously wth a thermohygrograph. 000048 DR. NOACK-LABORATORIM FOR ANGEWANDTE BioL0GIE Re1p-Doerctanol, 3,3,4,4,55,8,6.77,8,8,8.8,10,10,10-heptadscafluoro- Page 130132 WFiitshh t(hZeebWraatfeirshA,ccAocmutmeodTaotxiecditFyraTcotsti,onS(tWatAiFc), a9c6c.h,(0LiOmEitCTDos2t03 SPrtoujdoycNto-.No._0F2A0Z180A81C1K2. Criteria of effects Obsorvation intervals Moasuremont of fish siza. Fish wore considorod dead I there was no visible movement (0:9 gill covers movemont) and if touchoiftnhge caudal `paebdnuonrcmalleitpireosd(u0c.9e.d lnoossreoafcetqiuoinl.ibRreicuomr,dsswwiemrmeinkgepbtehoafvviiosuirb,le respiratory function, pigmentation, otc.) Obsarvations wore mado aftr 24, 48, 72 and 96 h. Al test start body welght and total length oaf representative nfourmtbeestrionfg 7tot fish was dolormind. Ths fish will not be used DETERMINATION OF THE TEST ITEM Sampling and storage Th tost concontrationlovel and control wero anaiyicaly verifiedbygas chromatography with mass speciromelric dotocton (iz = 463 and 395) a est start and test end. For details see part. 40 mL test solution wero ransforred to 50 mL glass flasks closed with glass plugs and stored at 2-7* in the dark uni analysis ast start for 3. test ondfor 2 days) EVALUATION LThCesc)on2c8enwtlrlataisontshelenaodienfgfe(c0t.0foavenld1(N0O0E%C)maofrttearli9t6y (hLwCesraend otarminod directly from the tost results. . LCurvalues have not to bo calculated in a limit test. `GOURSE OF THE STUDY TahcocodmomfiondtaitveedstfurdayctwiaonsapsorsifnogrlmeetdesatscaonmceinttrLaotsitonw.ith the water One control withwater (without tos tom) was tested under the same conditions as the test group in the tast concentration and control30fish wore tasted. Tho test fish were not fed during the ost. Aftr 24, 48, 72 and 96h mortality and behaviouorf tho ost ish wore obsarved. aMboovaes.uromenatnsd observations wero carriod oul as described 000049 Report DR.U.NOACK-LABORATORIUM - FOR ANGEWANDTE -- BIOLOGIE Pageidoiaz WF1ii-stDhhoc(tahZeneWboarlat,fei3rs,Ah3)c,.c4A,oc4m,um5to,e5d,Ta6ols,ei6c.di7tF,yr7a.Tce8ts,it8,o9n.(S9tW.aA1i0Fc.),1a09c,6e1h.0,-0hLeiOpmtiCatdDTeocas2ft0l3uo_ro_- _ PSrtoujdeycNto-.No. 0_F2A0Z1B0A91C12K VALIDITY CRITERIA TDHEVEIGAUTIIDOENLSIFNREOM DEVIATIONS FROM THE STUDY PLAN REPORTING ARCHIVING -0;- saturation 2 60% ~ Mortality inthe control 10% None None eTlheectfrionnaicrreepocrotrds(1ssourogidnaals.paper copy (6 originals) and an tThheepfeorliloodwiansg swpaescirfeiteadiinnedthien otpheeraarticvheivneoatfiotnhael GesLtParceiglutlyatfioorns: +alslturdaywpldaanta(Orit 1012) + final report paper copy (Origa! 16 ) + all records performed by th including master schedules quality assurance programme + samplo of test em 0Mi.c3r1o1f5i7msSawrestreedtr,etained ina safe-deposit by Volksbank Sarstedt, 000050 EEE 4 Results TE ee en [oe[ow CammToloo[vo] Measured Effect"| Coo [ow] 000051 _ oTrE useemonA mmeRnme orapnmne e ncn To SkSwen TOtc Spuone" FmRoAsY Initially Measured `Test Curation ih} Tom [oo oo] Smee BO . tpi oral Est mt | pesmi ooom rm | rwomee | 000052 DR.U.NOAGK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE 1R-eDpocanol, 3,3,4.4,5,5,6.6,7.7.8,8.9.9.10.10,10-heptadscafluoro- gram WFishit(hZoetWbraatfheisrh)A,ccAocumtmeodTaotxiecditFyraTcetsito,n S(tWaAiFc,)9a6c.h,foLiOmEitCTDes2t03 SPrwoijyecNto-.No. 0_2FA0Z1B0A81CIZK 5 Validity Criteria The study met the validity criteria of he guideline: + Oy saturation was 2 60 %. + Morality in the control was 3% 6 Conclusions this study 1-Dacanol, any effects to zebrafish a3f,t3e,r49.46.h5w.h5,a8,n6.t7e.s7t.e8d.8t.h8e,9w,a1t0e,r10a,1c0c-ohmepmtoaddaectaefdluforraoc-tidoinod fno0t.c1a4usmeg./L Tho NOEC (0-96 h)is 0.14 mgiL. (initially measured concentrations) 7 Literatur/e References. (1) OECD-guideline 1892 203 for testing of chemical. Fish, Acute Toxicity Test. Adopted July 17, (2) OECD (2000): Guidance document on mixtures. OECDseries on testing and aasqusaetsiscmteonxtinioy. t2es3ting of difficult substances and (3) ABnAmUeAl,duBunngdeensannesutearlSttfforfeArnbaeicthssdcehmutCzhuenmdikAarlbieeintgsemseedtizz.in3. (2001): Leitaden for Gberarbeilete Auflage. (4) DuPont, Determination 678-39-7, Unpublished of physico-chemical result, Update Fab. parameters 16, 2002 of Perfluorooctylethanol, CAS No. 000053 one mpen nser sme Tae mae sn 8 PhysicochemiDcaatla any | Ose| orvatse |remporature| Tota Haraness oComm|| |{oew[Toonn| [5|| TToomwe [ woo w[w orno]] Toorms [ o ow w oenn]] . CCoommme w on[rew |[o|n] [oCroomT {owro e ||rr]] 000054 DR UNOAGK-LABORATORIN FOR ANGEWANDTE BIoLOGIE E 1-Docanol, 33,4.05,5,,67.7.88.9.9.10.10,10-E heptadecafluoroWiFtihst(hZeobWraalfoiarnA)c.cAocmumlootTaolxoidtFyrTacoiso,ntWaAcF,)a9c6e.h,loLiOmEiCTDos2t03 ____SPtruodjyoNctoN.o. 0_P2A0Z1B0A8ICTEK 9 G10C,1-0,A1n0a-lhyespitsadoefc1a-fDiueocraon-l, 3,3,4,4,5,5,6,6,7,7,8,8,9,9, 2.1 Method CEMTEETRHMOIDNAOTFION Eaupment A1n-Daoycsaensolof3v.a3r.i4o.u4s,5c.o5n6c.o6n.t1r.a7t.i8o,n6s.9of.9.10,10,10-heptadecafloroSwIeLr ccaaprielldaroyuctovliuamgnasuscinhgroemxatotmoagrsatapnohdnayrdas.FuDseeldacStiiocnawOaPs. performed witah mass selective detector (MS). AGuatsoscehmvpalmoartograph :CCPT-C38G0o0,miVaPaALn, GTC Acres OSotfetcwtaorre 1SSa,tSuatGurMn 2S000W,orVksatratnion 51, Varn Reagents fert-buty mothy ther 99.8 %, Bath 42337071 31101, FL CONDITIONS OF ANALYSIS Coma CLhOrWomBpLacEkECD/PM-sS,I8LFi(mVAtRhAiNck)n,es3s:0 m0,.2i5:ym0.25 mm, IInnjjaeccttoorr temperatura 2S5p0ilCss (30 pi prassure pus) for 1 min ITnejemcptieornavtoleumep.rogramme Tw perature progr HeaCliinngi ale | Tempecrature [Feline] TTwee [Coo TwTe Ceo 0 50 DCeatrercetrorgas IRounnistaitmoen mode Retention timo Hwasllam 1 mL min column flow E1l5o.3c3tomninonisation (E)) approx. 49min 000055 Report DR. U.NOACI-LABORATORIM FOR ANGEWANDTE BioLOGIE Pago 20 of 32 F1i-sDhec(aZneobrla,fi3s,h3),,4A,c4u5t,5e,T6,o6x,7i7c,8T,e8s,t,9.9S,1t0a,1i90,c1h0,,-heLpitmaidsTceasftluoroWith theWaterAccommodated Fraction (WAF) ace. 0 OECD 203 SPrtoujyo-cNto-.N_o. 0F2AZ0B1A0N9TC2K STANDARD. SPTRAENPDAARRADTSI.ON OF SPRAEMPPALREASTION OF METHOD VALIDATION Peak symmetry Repeatability Accuracy Test item was used as standard iTnwfoots-tbouctkylsomleuttihoyntseotfhetrh,edsitlaunteddar(d9 cofon2c0e0ntmraatiilownsereeacphr)epaanrded uso for calbraton. For calibration range see part 9.2.1 e4t0hamr.LAofftetrhephsaasmeplseepwaerraetiooxntrtahceteoxdtrwaictth w4.a0smiin.jetcotte-dbuditryelctmleythyl into the GOS. mQausasensi6f9c+a3ot9f5toh+en4e6s3t(mfiozm) bwaassecdalocnultahteeedxtbeyrnpaelakstaarndeaardosf.the. oTfhedectaelcitbiroantiaonndprqouacnetdiufriecatainodn ltihmeitpsriwnecrioplafdoarpttheed fdertoemrmDiInNation 32645. Tho method was validated as doscrived below: aPnoaalkytiscyamlmsettarnideasrdwsoraendcatlocsutltatoemd afcrcoomrcdhinrgomoattohgarfaomlslowoifng equation Ts Wewl(2n T+ Wags = PPeosokk wsiydmtmheottry5 % of peak height fmm] 1+ fsinte racotmorthoefppoesakkmwaidxtihm(udmi)d[emdm]by the perpendicular f5rsoumba-ssaimnpglleeshoomf otgheenhoiguhsesstaamnpdlewloowrestancaolncyesnetdr.atMioonanprveaplaureesd. csatlacnudlaartdeddeviations and variations of coefficients ware 51-sDaemcpalneoslw3i.h3.440.4m.5L,5w6a.t6o,r7,w7e.r8e,8s.p9i.k9e.d10w.i1t0h,1a0n-haompoluandetcaoflu8oyrogA(f8t0oirLwaorfds10s0ammpgl/oLs) wtoergieveoxatrfaicntalodcoanscednotsrcartiiboendoafb2ov0e0.gL. 000056 R1-eDpooD cratnolR, 3,U 3,4,4N ,D5R..5,O6,N6O.AA 7C.7K.-8LC,A8B.O.9RK,A1T0O,L R1I0,U1M0A F-FOhOeRpAS tANaNdGGeEcEO WaWAflANuNDoRTroE-BBA lIOoLtOoT GIsEE OPRage I01M52 2WF0iitshhht(tZhoeeWbWraaatfteiesrrh)AA,ccccAoocmmummtoooddTaaoxttieecdditFFyrraaTccettsiioton,n(S(tWWaAAiFFc),)a9acc6oe.h100LiOEmEiCtCOTDe2s2t0033 SSPttruuodcjyyeNcNoto.N.o.__F0AP2AZ0ZB1BA0ATA9I1CZ2K 92 Method Validation The me= thoidnwaarsyvalkiatad and testod with satisfactory resuls with respect to +- ppreeackissiyonmm(ertsrpeystabilty) adectceurrmaicnyation limit and dotoction mit 921 Linearity "3T.h3e.0a4n,a5i.y5t,i6c,a6l.s1y.s7,t8e.m8,g8a.v3,e10l,i1ne0a,r10r-ehseppotandsoecailnltuhoeror-a.ngTehoafc0a.l1ib-ra1t0iomnglcLu.rovf 1a-nDdecanl, cdohtroormmaitnaotgiroanmasnodbtdaeitneecdtifoonrlsitmaitnsdasredeapnadrotst9.3.tom are given in figures 1 - 6. For 9.22 Quantification Limit and Detection Limit "vTahleuleimmietothfoqduadneisicfrciabteidonin(DLIONG)32a6nd45im"iNaocfhwdoeitse-ctuinodn (BLeOsDt)imwmeurnegcsaglcrualnazt"ed using the blind The LOD the LOD). was determined to be 0.009 mg/L and therefore the LOQ was 0.027 mgl. (threefold 000057 eTrpan, 1ny 3Ao4oin Y4eon8ncer8on7p7kem8o10g3bmepntT0aAdvA1AccaeItm0uEueOo,rse-isOoOs to. Tro agorcoCK i trAma acs AEoolo cm Sine Beck 523 Precision (Rapestbit) The entofte epastaitysar gtd te el eo. Tons Aenps aotntogorooet a t asTie ap nnsyre ComTo T wo | [mowe esa s mess os| [2Ta| oas es | TT em [we| CesT s | weer | 5 1 ase | ssw | 524 Puak Symmes e Tio asv k rma an hn oe Voc, ARSE TABI 000058 Raport D8. NoAcrAABORNTORIM FOR AncEwANDTE Botoc 1-Docanol, 3.3,448,666.7.7.089.9,10.100haptadecafluoro- Fae ToT WFiitshh h(ZeeWbartaefirsAh.cAuctooTomxmcPyaocToidsoin,al(WaiAlPo,)a9dc6 e1,10LiOmEiCTDo2s0t9 ~~ SPrtjuocytoN.o._F0a2z0a1a00nCsK 925 Accuracy Tab 9: Mean RecoveryRate of Forted Samples coenFanomiroaatnon |33.445S86Te67oa75r8nr38,.101010 oe = [reosssesinmatn)fpa oo] t] m [ons [o em e | uwna|] [Cromenes foTm| |o oa w | os|| [roms|oe a Tw| --| on |rweee| oom |ow [ee|] EGerT reaase ET -- I Sovtdom 1) Grom clu mae ey 5a Ci a- Bien rte an =coathocflvareiantiton 000059 orogiior poe. mom 2s ro on Toa --| -- a a--is | wr on or |owwo]] [[oeoamm [ T o o om m| eat (71 g BEB J ee iEomSyE mEmee I -- . 000060 DUNoASK LABORATORUM FOR AGEWRNDTE BLOG RDFoiaspchoar(tnzoelb,ra3s3),,4.A4c5ut5e,8T6o7x.ie7t.y.8Te9s,i1,0S.t1a0i,c106-heh,ptLiamdietcTaofsitvore- Fam z5 01% PrjactNo. 020109CK Wh tno WotorAccommodate racton (WA) ace.ioOECD203 ___ Stuyor_FAZBANTS 9.4 Calibration Curves Tdihoorcaanltibmraetison curves shown war asablishd for diferent concentration ranges and at | | 2500 | | Fgiso Tom | S00 | o0 Calibration Curveof Fluowet (2002-04-04) : __ < & Reo y=32263x- 79.967 om om om om oo om Gone mot Fo 1. C(oalultat2i0o0n2C040u8)ofrStavndaerd concentration range0.91 0.08 mpl 000061 oa r , IN 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro- ET [ Calibration CurveofFluowet (2002-04-10) || fret 500000 i 350000 F 300000 3 250000 _ oo | Foo a_i 150000 = | so] RY 209996 | | = ret | | 2 4 5 8 10 | Br Es a-------------------------------- CatGarreofhaett 5o020n879 whs : | woB =f2i0o00m0 = 10000 _8 -- yess | | | 0 re-e, Ce mm amon 000062 (ORL NOACK-LABORATORIUM FOR ANGEWANDTE BIoLOGIE Ro1p-oDorctanol, 3,3,4,4,5,5.6,6,7.7.8,8.9.9,10.10,10-heptadecafluoro- Pago 270132 FWiilshht(hZeebWraatfeirsh)A,ccAocmumlsodTaoxtiecdiFtryaTcetsito,n(StWaAtiFc),a9c6c.h,0LiOmEitCTDe2s0t3 ___ PStruodjye-cNto-.No. 0_F2A0Z1B0A91012K "mTihel)frswtacsalniobtrabtriooandcuernvoeugwhasoesbteabulsiesdhfeod 2a0l02t-e0s4s-0r4unbnuintg.theThcoornecfeonrtoratthioonsorcaonngde (c0u.r0v1e-0.06 (2002-04-10) which covers a much wider range (0.1 - 10 mg/L) was usedfo the calculations in his test. The concontration calculations using the wo differnt curves donotdiffer moro than 10% from each othor. The calibration curve from 2002:06-w1it9h conconiration range of 0.1 - 0.6 gi. shows that the GC/MS systemhas a good stabillyoveralong period of time. 000063 RDoapcorhtnol, 33.4.45D,R5.6U..6N7o.A7C.K08L.A9s9O,R10A.T0O.R1U0-MhFaOpRtaAdGeEcaWfAiNuDoTroE-BoL0GIE Fama iFahnionebrWaatoernA:ccAotmomoTdioeduFroTcoiso,n S(aWkA,)a3c6ehetoCOmECTDo2s0t3 PSruceac.to. 0_F2A0Z1B0A01CY2K 5.5 Chromatograms sve EEE Ea BE Em em = oe = weje-r HER em a- || IT |! I "~~ b[SyER Ze Tr |rart = Fiat: 0C1hmrg.o(mtotdoo0f0gst2ra.n0ada1mr0d 000064 Rpreno, 33P 44845A 8515010180N hee8pCAA ad7nTcoe tau7O ro-BruPcreoce.e02m010o00 en hcn baci oAF sEs CD303 Suv Pagans EE ERB Eo ee em em fm. - He Fae " | IANHI | HiH | TH | | IN | i | ! Tots Somat esietaanm HATA HH ASHE 000065 oE2ERA 325eA nC 4To07oA n1SS 8eO8S pee0sn4S 1 pBoptme,rsoEep mm Em BSem oemes -EB tt a a I| 1 Hg Ta I fil | fn Re | [I jf J| [mSa S I me 000066 Rew DR.UNOACK-LABORATORUM FOR ANGEWANOTE Biot0ciE rmesiew WDFoiicneiaZneacblWra,atto3or3n,A,4c4Ac,oc5m5om,o6T6do7au.t7ce,l8yFr8aT9co.ts9i,o,n1S0(.Na1Ac0F,)19a0ch-eh.e1pLstiEamdCioDcT2easf0tl3uo_ro_- _ PSrtoujaeyctoo.._FA02Z0B1S019102K \ 10 Certificate of 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10heptadecafluoro- Analysis Ee = Clariant 000067 eaptairtno, 39.4455D88..6.N7o.k7c.x8.a9g9o,1m0r.o10n10-FeupntAadsaEcvaimvTroE-Biosoc Pa ioen rrtnegAcAosmtamaTnodusaocmaSWlAToa98 hlsmECTDos2t00 PSrotjeycto. 0E2A0Zo1A0r9eGsK 11 GLP-Certificate of DR.U.NOACK-LABORATORIUM LPBesScheansgusntaofaGtL.PaCommpelinancte FA erp p --m o---- , Ee Cramaiaeoeistc bow. Rcharia SARE e--a xPotesoTnetre eensn vacant LS retro Sr oma tt etn e 1Pe n eg tren e e at me eBoeCee ormmae eeoea omeLoomOoyn"nd F eneengve totese wt raionhos mats tS ss ttosnE stta2.k30oe1,50 rr om mot nwe JE ELSCSe EETEEmns summa A fLro ,CN w Le a 000068