Document ga5JqvBzanwQeawKDvX9pVoyq

po, TELOMER RESEARCH PROGRAM Vw ETE 1200Sui ayo Sit Angin, Vegeia 22025050 Tet (TO4131et1S0604 Fax(7034138111 = Clariant. CPR Fear 14,200 MarF Qonviok Vienn e06 a20180aaor U.S. Environmental Protection Agency EPA East (Mail Code7405M) 1200 PennsylvaniaAvenue NW 2EEg 53 Ss S32R a: ZL F Om = 0 Overby Io Ttaer ResSorhCePEr0ogTammn(sa12p)AmaRsn Ge5Scoumoeoro ostcaom1npoasnbieCs,A,SSAaHsot.t.ElTpsEtS,0sTCh1rs5 aDTookol,atnand3AsDcauoiard E a sana de soaasoenysotrongwio beTaHpF..oThoessLsoseowrtoaetTohs mCo`oosaatatarotmy PP ire hT ee phye sicochemE sincaetlco,haoCrsEaaccvDtaSeeonaocbfoetvhneoCoab3otCouobonprecselsDdodo1oslssoesohosnl.oAbhaoausese.s1tTohuosotuaoBsfnkiToeapssls,8ofwMOoecNy iot asc ome of rt 1 rtsir oe Ooco orSis a ToJe TRu Panntedmaabci oecnod mmepesdo vbmlaetvlil obotrihoi redreaatai gtagliohvrie doiobihsii teesaghsppus oeesraSa wkciopnsi smtrsiwos iioih.e sa a yassoar ho tte TH onaro PS f--" " ~ "KatieWil aStRee0. nSreyr Tisdocumentdssnotcontain TSCA Gol. 000003 'DR.U.NOACK-LABORATORIUM FUR ANGEWANDTE BIOLOGIE 1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro- Alga, Growth Inhibition Test with Scenedesmus subspicatus, 72 h, Limit-Test with the Saturated Solution ace. to OECD-Guidsline No. 201 for Testing of Chemicals (Juno 1884) `Sponsor TelomeArsRwesIeGaUrSchSProject ATORNA Cussunt DAN INDUSTRIES LTD Dupont Dirk SAcuhteheorrvaum DR.U.NTOoAsCtK-FLaAciBlOiRtAyTORIUM FOR ANGEWANDTE BIOLOGIE Kathe-Pauius-Sir. 1 D-31157 Sarstedt Laboratory Project ID. PSrtoujdoyc-tNNo.o. 052500180491C1K1 `Study Completed On August 07, 2002 Page tof 38 Original 7 ot 7 000002 Tapert On. U.NoSK-LasoRATOmUM FO AvcEwANDTE Bota Fonz i-7D2aa..caLCnrioomln,tTh5o.it3,i4o,t4hn.5h5eT8o6S7ta.vi7a.ht88So9cd9Su.r1oa0d.oe1sn0r.su1s0chs.otupobtGsaEdpoGcDaf2i01oro- SProojooc.to. S0a2o0a1a0t91CsK Statement of GLP Compliance Te Guidaine Tost tom Testing Facily GOaPvisPtroinncsipflreosm A1g-Dsa.caGnroolw,t3h,I3n4h,,i5t5o.n6T,e6s.t77w.i8h.,S9c.o,r1a0d.1e0s,r1u0shseupbtsapdieccaaufsi.oro72h, Lini-Test wit the Saturated Souton `OECO-Guidaine No. 201 for Testing ofChemicals (1984) 1(-aDtacchannoumlbe3r4.:.P5O50.I6O,D6T.)7,7,86,99,10.1010heptadecafioroKD1a.theN-OPAaCuKs--LASBtO1R,ADT-O3R1I1U5N7FSUaRrsAtNeGdEtWANOTE BIOLOGIE PCroomnaet: (r40o/0s0i64n754co7. a. (4) 500808 79. None WinecdilcoisaroftGaotohdsLasbtoarcaytowraysPcronaducctaenddatnhd rneaptoirotneadl iGnLcPomrpelgiulaantcieonwsiashsepecaicftiueadl iOnEhCeDaw In frce, except deviations mentioned above. naa August 07, 2002 Bebe (Ok Scheersaum, Study Director (Th_omas GofCfe, lScieons) -- . Udo Noack, Hed of Testing Fac 000005 SENSI i oe a Statementofthe Quality Assurance Unit (Batch number: POO/001) a = == == Te a==ER= || z=== August 07, 2002 Le 000006 R.UU.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-oDrectanl, 33,4,4,55,6.6.77.8,8.9.910.10.10-hoptadecafiuoro- pageagm `7A2gha,, GLirmoitw-tThestn,hiwbiitihotnhTeeSsattwuirahtSedcoSnoeludteisoinmaucse.stuobsOpiEcCalDus2,01 SPrtoujdeycNtoo.._S0S2O0B1a0T9IC1K Personnel Involved Study Director: (DBiirokloSgcihste)erbaum `Scientist: Thomas Geftke (RCehsepmoincsiabllEenfgoirneceorn)centration controlanalysis Technical Staff: Ute Kutzner Quality Assurance Unit: Deputy: Gudrun Mahrmann-Kalabokidls (Biologist) `Susanne Becker (Biologist) Head of Tasting Facilly: O(Bri.oUlodgoistN)oack 000007 Re--Dp--oRrtUNOAKLAGORIORUMFORABNIOLGOGIEE _W_A_Pa_Nge_5O_of_T39_E_ `1A-lgDaa,caGnroolw,t3,I3n,h4b4i,i5o,n5T,e6s.8t,w7i7,h8,S8c9o,9n,d1a0,s1m0u,1s0s-uhbespptiacdaetcuasf,luoro- Projecto. 0201090K 72,LimitTest, with th Saturaled Solution act lo OECD 201 StudyNo._SSOBT11 Table of Content Page Tits Page. 1 Statement of GLP Compliance 2 Statemenotf Quality Assurance Unit 3 Personnel Involved 4 Table of Content 5 Listof Tables, 5 List of Figures 5 1 `Summary 7 23 MCehtahraocdterisation Data of the Test lam 10 +a1 RePsruellitmsinary Test "7" 2a3 TDeefsitniotfivteheToRsetference ftom Eia" 55 CoVanlcildiutsyiCornitseria 2210 87 GLritaoprhature / References 221 o10 `PGhCys-icAoncalhyesmiiscaolf D1a-Dteacanol, 3.3.4.4,5.5.6,67.7,8.899, 10,10,10- 2 101 hMeeptthaoddecaluoro- 22 1100221 LMienteharoidtyVaidation 22 11002223 QPuraenctiisfiiocnat(iRoenpeLaitmaibtialtnyd)Detection Limit 227 11002245 APcecaukraScyymmetry 22 110043 CRaelsiublrtastion Curves 3209 1n05 CRharwomDaattaograms E3ls Cheorpttiafdiecactaefloufor1o--DaAcnaalnyls,is3,3.4.4,5,6.6.6..7.8.89.9.10,10,10- as 3 `GLP-Carticate of DR.U.NOACK-LASORATORIUM 3 000008 DF U.NOACK-LABORATORIUM FOR ANGEWANDTE BIoLOGIE Re1-pDoercatnol, 33445,5,667,7.8,99,10.10,10-heptadecafluoro- Page 60138 7g2a0,LGirmoiwttThosnth,bwiitbhotnhTeeSsattuwriatheSdcaSnoolduelsornmaucsseutbospOiEcaCtDus201 PrSotjuedcptNNoo.._S0S2O0B140I91C1K List of Tables, Pago Tab. 1: NOECILOEC and ECs, Values (0-72) of Biomass Inhibition and Rate-Rolated Inhibition 8 Tab.2: Preliminary Test Results: Cell Density Values " Tab. 3 NOEGILOEC and ECs-Values (0-72 h) of Biomass Inhibition and Rata-Rolated Inhibition 1 Tab.4 Call Densitios 1 Tab.5: Evaluation after 72h 9 Tab.5: ECu-Valuoefs Biomass Inhibition and Rato-RelatedInhibitionof the Reference ftom 2 Tab.7: Water Parameters 2 Tab.6: Repeatabiity of Injections of Test tem 27 Tabs: Mean Recovery Rat of Fortified Samples 2 Tab. 10: Concentrations of the Active Ingredient 1-Decanol, 33.4,4,5,5,66.7.7.8,8,9.9.10,10,10-noptadecafluoro- 2 List of Figures Fig. 1: Call Densities for Control and Limit Concentration (0-72 h) 2 Fig.2. Calibration Curve of Standard - concontation range 0.01 -0.06 mglL 0 Fig.3: Calibration Curve of Standard - conconiration rang 0.1 - 10 mg/L. at Fig. 4: Callbation Curveof Standard - concentration range 0.1 0.6 mgiL 31 Fig.5 Chromatogram of Standard 3 Fig.6 Chromatogram of Test item PA Fig.7: Chromatogram of Control 3 000009 Report DR. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE -- Page Tol30 7A12g-haD,,ecLGairnmooiwltToh3s.it3n,h,wi4ib4it.thi5to5nhT,e6eS6sa.tt7wu.i7r.an8tS,e8dc,Sa9onl,ou1td0i,eo1sn0ra,uc1se0-.shtueobpsOtpaEidcCealcDuasf2,l0u1oro- PSriojdecot:.No. 0S20510098CK 1 Summary nTuhmebaecrutPeODtoIx0iOciTt)ytoof t1h-eDaunciacneolll,ul3a3r,f4r.e4s,h5w,a5l6o.r6.g7r,e7e.n8,a8l,g9a9S.1c0a,n1e0d,1e0s-mhuesptsaudbascpaifclautourso-w(absatch dFeUtRerAmNiGnEeWdAaNcDcToErdBinIgOL1OGIthEeinpr3in1c1i6p7leSsaorfstOoEdCl,D-GGeurimdaenliynfor2o0m1A,praiilD0F1.tU.o0N4O,AC2K0-02L.ABORATORIUM dTehnesistytuodfy wnoamsincaolnldyu1c0tecdelulnsdiemrLsatnatdicacosnadtiutriaotnesdosvoelrutaidounraastiiomniocfo7n2cehnoturartsiwoint,hcaontaiinniitnalg.cell 01.0200mmgg/iLL.waFsorsthhaekpernepfaorr9at6ihoan nofdthceenstaitfuurgaetde.d Tsohleutciloenarassuupsaprennastiaonntiwtahsausneodmifonralthleoatdesitn,g of wTeosrtevteesssteeldsfowotrhecmoiattecdownciehnttrhaetitoesntaintdem forrep1l4icdaateyssfboerfcoornetrtohle Ttehset sttaasrttetda. mThwraesecrleepalrilcyates Idinscsuoblavteidontpherroiuogdhoruetvetahleetdesnto. mMoircprhooslcoogpiiccaolvaalbunatoiromnaoifst.haWcaatllesratqutahle stapratraanmdetaenrdsooff pthHedVaoltuaer,mimneeadsutroebdo awtit0hianntdhe72ach,ceapntdabrleoommittse.mperature, measured continuously, were h"Tehpetacdoonccaelnutorraot-iwooofnrethaenaacltyisveediantgrtehdeielnimtit1-cDoanccaennotrla,t3i,o3n.4l.o4v.e5a.5.t6.t6,7s.t7a.t8,a8n.9d.9t.es1t0,e1n0d,.10DDeetcaainlosl,of3t.h3e.4a.n4al,y5t5i.c6a.l8,r7e.s7u.l8l,8a.r9o.9g.i1v0e,n10in,1P0a-rhtap0t.adTehcoaflinutoiraoll-ywmaesas0u.r20edglco.nceAnLtrtahteieonndofof11h0ethteesgtltahsascwoanlclesnotfratthieontoesft vtheostseaslts iisteumnlwikaeslybaeslotwhetwhaldlestewcetrieonallirmeiatodyfp0r.o0-0c8oamtLad.foSro1r4ption ays bofore the test has started ITnhiteialelfyfemcetassoufr1e-dDeac.anccoln,co3n.i3r.a4t4i,o5n,5a.r6e,6s.u7.m7m.a8r.i8,z9e.d9,i1n0T,1a0b.i10-1.heptadecafluoro- based on 000010 oB E g eTnR eE s ee we [[ roietionof somass growin mi I ET ot apptcavle CeTw 000011 DR.U NOACK-LABORATORIM FOR ANGEWANOTE BIOLOGIE Re1p:Doarctanol, 3344,5,56.67.7.8899.10.10,10-heptadecafluoro- Page gf 39 7#i2gha,, LGirmoiwtt-ThesItnhiwbiitthitonhTeeSsattwuirahteSdcSeonleudieosnamcucs.sutbosOpiEcaCtDus,201 PrSohjiedcotN.o. 0S2S0O1B0A9TCIK1 2 Characterisation Data of the Test Item TEST TEM 1-D6canol, 3.3.4.4,5.56.6.7.7.8,8.9.9.10,10,10-hoptadscafluoro- Batch number PO0I001 CASRN 67830.7 Chemical characterizatio|n 3.3.4,4.5.5.6.6.7.7,6,8,9.9,10,10,10-heptadecafluorodecane-1-oi Active ingredient (EINECS) purity Cs8u-mpeprefrifulourooraolakiyklyeltehtahnaonlol999.93.9%%(a(faal)s.) Appearance Yellowish sold wax Water solubiity 134 gi at 12 degree C, Std 20 gL, n=8 (DuPont, 2002) 137 gi at 25 degres C, Sid 53 gil, n=17 (DuPont, 2002) `Stabilty in water Stable at test conditions. Density Ca. 1.7 glam' Expiry date. Recommended storage Storage at testing faciity Retention Identification parameter at testing faciity Unlimited f stored undsr the recommended conditions. Room temperature (20 C), protected from moisture. Room temperature, protected from moisture and light. Atleast 1.9 has been retained. Name, batch number and colour. Th test itam and the information concerning tho tost item were provided by tho sponsor. 000012 [OR.U.NOACI-LABORATORIUM FR ANGEWANDTE BIOLOGIE Re1-pDoarctanol, 3.344:5.5,6,6.,7.8,699,10,10,10-heptadscafiuoro- Page 100138 A7l2gah, GLrowithminhiwibiithitotnhTeeS-sattwuTirahteeSdcSosonleudttaosnma,ucse.sutobsOpiEcCaDtu2s,01 PSrtoujdeycNto.N_o. 0S2S0O1B0A81CIK1 3 Method TEST GUIDELINE `OECD-Guideline No. 201 for Testing of Chemicals (adopted 7.une, 1984) TYPE AND PURPOSE OF THE STUDY. Alga. growth inhibition tast for determination of the offacts o`fonthgertoewtsh rate and biomass production with a saturated temover a period of 72h (Limit Test). solution TesT sysTEM Tost organism Reasonforthe selection of the test system origin Date of receipt Mathod of cultivation Culture medium `Scenedesmus subspicatus CHODAT SAG 86.81 According to the guideline Scanedosmus subspicatus CHODAT SAG 86.81 is suitable for this kind of study. `PHSlaamnmzleunnpghyvsoinolAolggiesrckhuelstuIrnesnit(tSAdGe)r,Universitat Gottingen. Nikolausberger Weg 18, D-37073 Gattingen 1997.08.07 Frosh stocks wore propared evary month on Z-Agar. Light intensity amounted 35-70 WET?- for 24 h par day. Nutrient medium Z according to LOTTE of a. (1994). TesT mem Pthretrteesatttmoonmt of 1h-eDpotcaadnsccla,fi3u,o3r,o4.-45,5,6,6.7.7.88.9.9,10,10.10Thohmeotgeesnitseamtowna.s heated 10 50 C before weighing for 000013 DR. NOACK-LABORATORIM FOR ANGEWANDTE BIOLOGIE Re1pDoocratnol, 3.3,445,5,867.7,88,99.10,10,10-heptadecafiuoro- Page 110139 A7i2ga,. LGirmoiwttThesItn, hwbiitohtnhTeeSsattwuriahteSdcSaonluotdieosn maucs.sfuobsOpiEcCalDus2,01 PSrtodjyeNcot.o. 052500180491C1K1 Coating of the test vessols Proparation Coating period Proparation of the test medium (saturated solution) A coating phase of 14 days was carried out. 200 mg 1-Decancl, 3.3.4.4,5,56.67.7.8.899.10.10,10haptadecafiuoro-IL dilution water (otal volume 2 L) were shaken ina rotatingshakerwith 20 rpmfor 96h at 20 C. 2L ~brown glass flasks woro used. Afer phase separation 100 mL. par test rEerplloincamteeyowrasflraasnkssfaonrdrocdlofsroodmwtihtohcplleuagsr.quDiil!utpiohnawseatro 2w5a0smuLsed for the preparation of tho coating solution. "nTohmeinraelaldyiy23fi+l2ed aCndfocrl1o4seddayEsr.leAnlmtehyeerenfdlaosfksthweorcoeasttionrgepdeartiod the flasks were emptied and used for the test. h2o0p0tamdgac1a-fDioucoarnoo-lL, 3d.i3lu.t4i,o4n,w5a5t.6e.r6(.t7.a7l.8v8o9l,u9m.e102.1L0),w10e-re shaken i21nbarotoawtinnggslhaasskefrlawsiktshw2e0rerpumsefdo.r 9T6hihs as1us2p0enCs.ion was. Gentrituged for 20minat 300r0m. 100 mL par tost replicate of tEhrelacnlmeaoryosratfulraasktse.d solution was transferred(0 tho coated "The proparation method was chosen with regard to the test tam properties and in accordance wih the relevant guidance documents (OECD 2000, BAUA 2001), conTROL CSioxndriotpioincsataosst(hweitthaosuttrtaepsictatoems). wor tested undar the same test SELF FLUORESCENCE No salf florescenco was found at the saturated solution "REFERENCE ITEM CAS No. purty Baten No. Tostconcentrations (nom) Potassium dichromate p.a. (MERCK) 7778-50-09 1002% K 233 76864546 0.1-0.2-0.4-08-16-32mol 000014 OR.U.NOAGK-LABORATORIUM FOR ANGEWANOTE BIOLOGIE Ra1p-Doerctanol, 33445,5,66.7,7,8.898,10,10,10-heptadecafiuoro- Page 120130 A72gha., LGriomwiiThositnhwiibintTeosSattwuriahtSecdoSneodoslrmauucscts.utbiosOpoiEcCnaDts2.01 SPrtodjyecNtoN.o. 505200814019C1K1 Rangeof valiity Experiments! dato 00.2600 mmalgl<<iEE..CCLuysa ((7210)2<<101..)7035 mmaalill November 27 0 30, 2001 TEST CONDITIONS Performance of the test Exposure duration Roplicates Test container Test volume Ditton water Static procodure EExxppeorriimmeennttaal sctoamtpldeattis:onAdpartiel:01,Apr2i00024, 2002 Three replicates fo limit concentration lave, per control Erenmeyerfasks, 250 mL. with cotton wool plugs 100m According to the guideline: preculture [com 1 po concenn tratione mgst| weTw1] [wowemo1 0] [eovzmo [ww 7] [wso 17 rw wso ] [wo [ee 1 [ Fenemo[ow1] [wee 1 omz 0 mo1] wee ows [wewawe70ms ze me [vomwoorzme[oer [_co1 o-- nwe suvom r o1] [cemamo 7 waeTM [ wwoo,Te CeTere] fpeorufrordmaady oinld5p0r0ecmuLltuErrelewnamseyuesredflaassksinwociuhludmi.lutIinocnuwbaatteiro.nFwoasr. tothresatcaaritveofatnheniteaslt ctohlel pcroenccuelnutrerwataisofndilauptperdoxwiimhatdeiluyi1onxw1a0ter AGlelali/gma.siwnetrhoa frreopmlithcea.samesource and have not boen used In 2 previous study. 000015 DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE 1R-oDpaocratnol, 3,34.4,5,6,67,7,8.9,9,10,10,10-haptadecafluoro- Page 130139 7g2a0, LGirmoiwttThesItn,hwiibititohnTeeSsattuwriahteSdcSaonoldoasnramcuseSulobsOpiEcCalDus2,01 PSrtoujdeycNtoo,. 0_2S0S1O0B8IC1K1 Application Temperature Agiation Light intensity Light regime Athtethteesttotstoms.tart fluorescence was measured aftr application of Nominally 23 2 C Tapopsrtocxoinmtaatienleyrs70werrpem.placed on arotary shaker and osclialod at Nominally 60 - 120 yE/'5 24 wa ight KIND AND FREQUENCY OF MEASUREMENT Equipment Coll density was measured via Chiorophylla-fluorescence (meexacsituarteiodn6a.1104103.5Tnhm,e cmoillssdeinosnitaytw6a8s5mnem)a.suEraecdhartotphiecabteogiwnansi.ng of the test and overy 24 h. Filvaled dilution water was used 35 ground signal The p-value at the beginning of the test was measured out of one addtional replicate of the limit concentration and conlrol. AL the and it was moasured from a pool of all repicates. The room temperature was measured continuously by a hygronermograph. Light intensities were measured prio o tes start aMincdroosncdopofictheevailnucautbiaotinoonf.Athlegaccaallslswawserdeetcohromciknedd afortahney.start umonrupshuoallocgayl,l sfhlaocpceusl.atcoonlso,r daidfhoerraannccaos,ofdiaffleregntcoaetseesintcvheisosreolpslaosrt aggregation of alga cel. pH-Meter, pH 191 (WTW) HChyigorroo-pthhye-rimmopgurlaspfhleuo(rKoLmMeAtToHrE(RKML)ENFELO) SCohnatkretru,goS:M22K5 3A64(,BOZiWoEuRs). QInuvaenrtseummiScernossocrop(eSK(Y2E1I5sNSITMRU2M5)ENTS LTO) RCoonttartfiungges:ha2kKer36340,40Z,ivGoFuLs FFlluuoorreesscceenntt ttuubbeess,, OLASWRPAIM18L3W6,6W0/c1m1,-8w6e0r,mdwayhliitght(c(ueltsutr)e) 000016 DR. NOACK-LABORATORIUM FOR ANGEWANOTE BIOLOGE Re1pDoarctanol, 3,3445,5,667,7,8.,99,10.10,10-heptadecafuoro- Fags 140130 A7l2gha,,LGirmoiwttThostI,nnwiiothonthToeSsattwuirahteSdcoSonloudtbiosnmaucs:su{0bsOpEcaClDus2.01 PrSojteoct.No. 0S2S0O1B0A9TCIK1 DETERMINATION OF THE TEST ITEM Th test conceniration evel and control was analytically verified by gas chromatography with mass spectrometric ontdooctfiothne(tmes/t=zre4pl6i3caatneds w3i9t5h)aaitgatswtersetaratnaalnydsetde.st end. At the All dotals of the analytical method aro given in part 10. `GOURSE OF THE STUDY GBLaPs)e.dtohne tdhoefirnestuvletsesoftawaprselpiemrifnoarrmyerdanwigtehfi1nldiimnigt fcoosntce(nNtOrNat-ion level with 3 rapicates. A control with dilution water (without test tem, six replicates) was. tested undor the same conditions as the test group. Afofrotuhredmaayi-onlsdtupdrye.culture incubated at study conditions was used Chlorophyllfisoroscance was determined at the beginning and aftor 24, 48 and 721. Other measurements wore performed as spaced above. CALCULATIONS AND sTamsTICS Calculation of coll donsity outof fluorescence values Call donsiios for each replicate were calculated from th fluorescence values 3.6 (see raw data). The fluorescence values. wore related to cell density values as follows: x =63 + Fa + 3525 x6 =fcooclcdeonymcomliun.rtaeolmL Fa. = p mean fuy orescance vale of al epctes por concentration 3625 =can conay cain. Corrolaion does Ar 12.2001, +0.9863, 8 Tha growth rate, the nhisitiofn biomass and the rate elated aicnchoirbdiinngatfotetrh7e2fhowremurleasclailsctueldabteeldowf.rom th cell density values. 000017 DR. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1-pDoerctanol, 3.3,4/45,5,6,67.7,8,889,10,10,10-hoptadecafluoro- Page 150139 7A2gha,, LGirmoitwtThesitn,hwiibtihiotnTheeSsattwurianteSdoSoonleutdisosnmaucse.stuobsOpiEcCalDus2,01 stProjecto. S032008140191C1K Cianltceugrlaaltionofbiomass AtMe t eeenee e [--t . t (1) A am Ne = mossured umber of catmt at ma LIW um= uemeoofff"rstmmosseraamenst usttoorrroepigmnggeoofnfesetts.t. Cablicoumlaastsioinnohfibin nW= (=AbAoncm)esA-iQn)oi+io1n0%0% @ AAre == blloommaasststeeggsailatthh cootncsontcearnnetdoinn sceorlinndt cots. Calculoaftgrioowtnh rate b1 =(I=n (Nroy-Im)n r(aNeec)ot(dte-ns6)i Ne bom sta ta in count NWo =stbmleomoatssseagymmnncgootlilomnt Lume measurement str begining of est Calculation of rate rolatod inhibition he= (ed a) + 100% @ brown oeof necontol8 Brom aeof ne test concentra ator ns. NOEC, LOEC ang statistical analysis OWnie nwasy analysis of variance (ANOVA), DUKKETY's and test of growth rate and biomass integrals, respectively wero. carried outforthe determination of statistically significant wdiafyeraenanlcyessiscoofmpvaarrieadncteo caonntorromlalrietpyiclaesttesa.ndWhaenneqruuanlnivnagriaanocnee.. tost was done first. P-values for both normality and equal vteasrtia(naccecetpetsatbslweeprreo0b.a05b.lyTohf ian-cvoarlrueectfloyrcAonNcOluVdAinagntdhaDtUtNNhEoTrTi'ss a difference) was a=0.05. 000018 [DR.U.NOACK-LABORATUOMR FUR ANGEWANDTE BIOLOGIE R1e-pDoerctanol, 3.344,55,66.77.8,88,9,10.10,10-heptadscafluoro- age 160130 Alga, Growih inhibit Tost ihSconodosmussubspicatus, ProjectNo. 020100CK ZZ, Limi Toot,wibSoSaturatedSolvionoor ORCD201 Swov-No. SSOBHVY Software "aTnhde hdaavtaefboeretnherotaubnldeesdinfothipsrorseepnotrattwieonrercoommptuheteurllgednereirvaetded data. Consequenty if calculated manually based on the given data minor variations may occur from these figures. G-aSlicgumlaatPiloontsrwlo.r2e00ca0rr(i2e0d00o)u,t $u9siSnsgIsco.ftware -- SExicgemlaS2t0a0t0r(ol2.0020.)0,3 M(i19c9R20-3109F9T7)C,OSRpPsOsRAnTcI.ON ~ TInOcX.,SCThAeTyernon.e3,.W4 Y(1988240)0.1Wa&sDtaevridEDc.osGyulslteey,msUnTievcehrnsoiltoygoyf. `Wyoming, WY, USA. VALIDITY CRITERIA Tho call density had to increase at minimum 16-1old in the control rTehpolitcaetmepserwaitthuirne7d2urhing the testhad tba in the range of 2T1h.e25pHeCvaclounetoroflltehed actontr2olCreplicates should not normally doviate by more than 1.0 unis during the test. DEVIATIONS FROM None. THE GUIDELINE DTEHVEISATTIUODNYSPFLRAONM REPORTING ARCHIVING TPuhroitpyHw.-avsalCu8e-patortfhleuobreogsiinknyilnagthoafnct!he99o.s3t wa(salms)e.asured out of omnge,adrdetsipoencailverleyp.licTahtee.seLOdeDviaantdioLnsOhGawdenroo i0m.p0a0c9taonndt0h.e02qu7ality and ntogeity of the study. "The final report i issuedas papercopy (6 originals) and an electronic record (1 origina). The folowing was retained In the archive of the tes failty for t+heallpecraiwoddaatsaspecified in the operative national GLP regulations: + study plan (Osgioa 1 42 ++ aflilnarlerceoprodrstppearpfeorrcmeodpyb(yOtrhegsqua1loifty6)assurance programme + sianmclpuldoinogfmtaosstetrosmchedules MVioclrkosfbiamnsk wSialrlsbteodtr,eta0i-n3e1d1i5n7 Sasrasfot-eddetposit by 000019 OR U.NOACK-LABORATUOMR FOR ANGEWANDTE BIoLOGIE Re1-pDoerctanol, 3.3,44,55,6,6,77,8,,8.9,10,10,10-heptadecafluoro- Page ire A72gha,, LGiromwitThesitn,witiitontTheeSsattuwriahteSdoSeolnuotdioonsmauces.stuobsOpEicCaDtu2s,01 SPiroujdoycNtoNo.. 0525001840191C1K 4 Results 41 Proliminary Test The results of the preliminary test conducted February 25 to 28, 2002 are prasantsd below: Tab.2: Preliminary Tost Resule: Coll Dansity Valuss (2 rpicates each. contol: 4 rapicates) can donsity [cost] on 72 11 of tho saturated sloton 110080987 earr1ao0s0 1110 ofth saturated solution 1138 T Treas ET Control 2 11390 sass 3 1os87 s20085 " 1147 ssausa No sll fuorsconce wa found at to ssurtd solution 42 Dofinitive Tost Goll dansitos are listed in Table4. Evaluatioonfs biomass inhibition and rate-related inhibition aorsotgtiovemnairnoTsaubmlema5ri(czaeldcuilnaTteadbloeut3.of cal density values). Tho growth inhibitionoffects of the Microscopic evaluationofthe cells at the start and andof the Incubation period ravealed no `morphological abnormalities. Water quality parametors of pH-value, measured at 0 and 72 h, and room temperature, measured continuously. met the guideline requirements. 000020 B SwerETn S Be Ri E I, ee pe wn [riofo omens rn owinmots | Te ew] Rate-related inhibition [mg/L] Mo Ion Ta T aa sm m wan | Toe |swwer |aooes|ooaoms| [oJ ws |own| vmeoro|evaos | [ovToms T iow | roots |soos| 000021 oooan, EO 3344583850180, 8apa7doc7eti8os- -- Foo Sp mAA EA IAmA p P i--v--s J a tm nTaarsdeemseAanAR STomES E-- = p-- Tw os om |--7 ]| "1s2o3t8 0i3ns [To] ws a pron re 8 rc enrnegpo 000022 n D = R T T S NOIILRE Eopcane osc a Same Sommer Se an C1] ee hiboif bltomaissgorownth ew -- Te Tatoraated Iniion ew contre art CE Er ey res o--a-- ong SA 5 Validity Criteria 000023 DR.U.NOACK-LABORATORIM FOR ANGEWANDTE BIOLOGIE R1o-pDoerctanol, 3.3,44,55,6,67,7,8,89,9,10.40.10-heptadecafluoro- Page 210138 7A2lg1a,, LGriomwttThesinth,iwniitihotnhTeeSsattuwriantSecdaSnoeldutaisornmaucses.utbospOiEcCatDu2s0,1 SPtruoojyeNcot.o. 0$2500180491C1K1 6 Conclusions In this study 1-Docana, 3.3.4.4.5.5.6,6.7.7.8,8.9.9,10.10,10-heptadocafluoro- was not found to inhibit the growth of the freshwatargraon alga Scanadasmus subspicatus tested with a `saturated solution, containing 0.20 mg/L (initially measured concentration). 7 Literature / References (1) ABnAmAe,ldBuunngdeensannesutearltStGorffAernbaeicthssdcehmutCzhuenmdikAarlibeentgsemseedtizz.in3.(2l0b0e1r):arbLeeiittsaedeAnuffliarge. (2) 3D9u-P7o,ntU,npDubalisthesd reesumlotfsi,phUnypsdiaactots-Fciahebmo.ic1na5,l2p0a0r2ametersof PefuorooctethCAaSnNdo,. 676(3) EECDirective 92/6/EEC MethodC.3, EEC L3834179 (December, 1992) (8) oLf tUho GTUor,ImSaCnGHNBEoEtPaFn,,iEc.al,SLociAetyU, GNAo..,HN3ALVGoATlIAu,m,eT.10(7ediptaogrse, 1119194-)1:88Bo(tJaunnioca1A9c94t)a,,TJioeurwnea-l Vesus. (5) JOuneE7-,g1uC9i8de4lDine no. 201for tesoftcheimincalgs: Alga, growth inhibition test. Adopled (6) OToExiCciDtySeTreisetsinognoTfeDsitfifnicgulatnSdubAsstsaenscsemsenatn,dNMoix2t3urGeusiEdNanVcIeJMDIoMcounmoen(t20o0n0A)q.uatic 000024 Report Or. Noxcx-LABORATORM FOR ANGEWANDTE BiokoGE Poe Zor 71A2-iDgha.ciaGnmrcilo,Twe33sn4tnw.b4ii.bh5ot5nh,T8So6sa.tt7wr.ia7ht8e8Sd8cS9ao.n1ue0td.oo1ns0sr,c1ss.huetbopstOapEdCceDacla2sf0u1cro- SPruoedckao. 0S205100901K 8 Graph tors a cCoovame 2 B tees : 3 3 tors P 7 Tinh Fo. 1: Goll Denisfor Conte and Limi Concentration (072 h) 000025 wE S mr aTsAse R agSee peemwso 9 -- PhysicochemiDcaatla =r] 000026 OR. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p-Doerctanol, 33,44,5,5,66.1.7.8.599,10.10,10-heptadecafluoro- Page 240135 A72gha,,LGirmoiwiTnesitn,iwbiitihotnhTeeSsattwuriahteSdcSoonloudioosnramcues.stuobsOpEicCaDtu2s,01 PSrtodjye-cNtoo.._S0S2O0B10A9ICTKT 10 1G0C,1-0,A1n0a-lhyespitsadofec1a-fDleucoarnoo-l, 3,3,4,4,5,5,6,6,7,7,8,8,9,9, 10.1 Method METHOD OF DETERMINATION Equipment Analyses of various concentrations of w1o-Draeccaanrcrli,ed3.o3u.t4v.i4a.5g,a5s,6c,h6r.7o.m7a.8t,o8g.r8.a9p.oh1n0y,1a0,F1u0s-endepStialdiceacaCoPr-oSIL 8capilary column using external standards. Detection was performed wih a mass selective detector (MS). Gas chromatograph: CP-3800, VARAn Autosampler GTC Combi PAL, CTC AvaLyics Detector MS, Saturn 2000, VARIAN Software `Saturn GCIMS Workstation 5.51, VARIAN Reagents ort butyl methyl enor 99.8%, Batch 42337011 31101, Fuk CONDITIONS OF ANALYSIS Column Injector Injector temperature Injaction volume Chrompack CP-SIL 8 (VARIAN), 30 m, 1.0. 0.25 mm LOW BLEE/D MS, Fim thickness: 0.25 pm `Spiess (30 psi prassure pul) for 1 min 250C To TomperalLe PIOGIANMY (caCliimnign)rate| Temprecr)ature | Holdimning)te [C=Tw 1 00 [CoTw T70-- CeT2050] Garter gas. Doentiescattoiron mode Run time. Rotontion time Hollum 1 mL/min column flow MElso.ctron ionisation (E1) 15.33 min approx. 4.9 min 000027 DR. NOACK-LABORATORIM FOR ANGEWANDTE BIOLOGIE Re1p-oDorctanol, 33,44.6,5,6,67.7,8,889,10.10,10-heptadecafluoro- Pago 250139 A7l2gha,,LGirmiotwiTnesitn,wiibitlhotnhTeeSsattrwaithodScSoonloudtaisornamcucs.sutbosOpEicCatDu2s,01 SPtruodjyeNcot.o. 0S2S0O1B0A0TCIK1 STANDARD PREPARATION OF STANDARDS PREPARATION OF SAMPLES METHOD VALIDATION Peak symmetry Ropeatabity Accuracy Test fom was used as standard Two stock solutions of the standard of 200 mg/L wore prapared uinsefodrtf-obrutcayllibmraetitonh. tFhoerr,caldiiburtaetdio(n9rcaonngceensteraatpiaornts1e0a.c2.h1) and 40 mLof the sample were extracted with 4.0 mi. for butyl mathyt othor. After phase separation the extract was injected directly into the GCM. Qmuaasnsieisfi6ca9to+n3o9f5t+he4t6e3st(liezm) bwaassedcaolcnultahteeedxbtoyrpnaelakstaarnedaarodfst.he "The calibrationprocedure and the principle for the datermination of detection and quaniiication limits ware adapted from DIN 32645. The method was validated as described below: Paak symmatries wero calculated from chromatograms of analytical standards and lest tom according to th following oquation: Ts Wem T+ pas symmetry Woss == Pfrasstksowcitdotrhoaftp5e%akowf iashk(dhieviigdhetd[bmyn]tho porpondicuiar iin from the peak maximum [mm] 5 sub-samples of the highest and lowest concentration prepared rstoamndaarsdindgalveihaioomnosgeannoduvsarsiaatimonps owfercoeefafniacliyesnetds.weMreoan values. calculated 51-sDaemcpanloels,w3i,t3h44,04,m5.L5,w6a,t6e7r,w7,e8r,e8.s9p9i,k1e0d,w1i0t,h10a-nheapmtoaudenctafoflu8oryogA(8f0tperLwoafrds10s0ammpgle)stwoegrioveexatrfaicntaledcoanscednetsrcartiiboendoafb2o0v0e gil. 000028 DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Re1p:Doorctanol, 3.34,45,5,66.1,7.8.8,99,10.10,10-haptadecafluoro- Page 260130 742igah, LGirmoiwttThosItn,hwiiblihiohneTeSsattwuriahteSdcSaonloutdiaosnraucse.sutobsOpEicCaDtu2s01 PStruodjeeNcot.o. 0552008140191K1 10.2 Method Validation The method was validated and tested with satisfactory results wit respect to tinarity ~~ ppreeackissiyonmm(eretpreyatability) ~ adoctceurrmaicnyation init and detection limit 1021 Linearity 3T3h.e6,a4n.a5l,yt5i.c6a.l6.s1y.s7t.e8.m8,g9a.9v,1l0i.n1e0r,1r0e-shoppotnasdeecianftlhoeror-a.ngTeohfe c0a.l1ib-ra1t0iomngciuLrvofe 1a-nDdecanal, Chromatograms obtained for standard and ost tem are given n figures 2-7. For atermination and detection limits see part 10.3 1022 Quantification LimitandDetection Limit vTahleuelimmiettohfoqduadnetsicfriciabteidonIn(DLIONQ)32a6nd45li"miNtaocfhdweotlesc-tiuonnd(BLeOstDi)mwmeurngescgarlecnuzlea"te.d using the blind TthheeLLODO)D. was datermined to be 0.009 mo/L. and tharafore the LOQ was. 0.027 mg (threefold 000029 a = 34Sio44r4a 295e10m108 oOy s4cao7 rseSaPpT--e 72h,Limit Test,with the Saturated Solution ace. to OECD201 StudyNo._SSOB4111 025 Pmcnnoeeasiy = eEs , E oT Co oo [oe| [ oo2 | vases | [oT om [wom| -- 1 =1 =a so | [veon=s|o zooae|swsaitesazezrass| 1024 Poko 000030 Raper D8. OADLusoraromu ro Avcewore Boro FT 1-RTEDencCarnoool,3t,v3,4wo,4,in5,e5,a,S6o,7ui.7r.i8S,s8,S9,9po,1n0,1so0,.10-1dh0EeGpstEapedDeaca.0fl1uoro- SPrtoysnee. aS20o109s0K 1025 Accumey Tab.5. Maan Recovery RaofFtorte samples J ioner "oars. Sota. arseseinmns |J = t [=uoi] Ce [ oso [[w|x wms]| -- [To -- |a w-- s| [TT o [ m o|a wos| -- oo| EP [lowoammen | |oo ewm[e]s|] CShees 2) r= e I gloeItv nre Sses,es iB a f CE omc R me 360031 I or on Nose npomonu si-- nAvaswyore Bisco FoToS a as soso raatmest ipogpehs. con 13 fosune eon? | ror | Toren J a [Surt| ol2s00ah20s4ma 0n5ra s|egi:Ta2a0y0i200Ts400i5s| eose Teere | prs [oo | ow vn dB3Fh I ET EEES aSA------ 000032 FfE ot on Noroapomroan osenvmeaeBnot -- Fo Ea eraseSsonast2ai3n3,1 PSoohea. aGzoe08ycK 104 Caran curves TToe ctbnratan ces shown ors aba or fan cocaration ang nd a - I CalGubrvrof Faluotwe!i200o206n04 we I~ J oo + 21000 "0 3 -- e-- n | Te om co wmnots om mom ee -------------------------- FT Cmtteateen Cnue Sents coer ang 1-408 mt 000033 Taper D8. NoAGLasFoRRAvAcETANDOTERBoUtMe EZELES 7K5oacaeinmoo,T3es3e,4e,wl4i.o5n58T.So7a.7ii.nn8S8s9e9S1ao01or0n.a1sc0desheuo0stbaGsrdEesCuacDasf2v1oro- SProhpaahto, Sos2o0a1a0t00tKs | Calibration Curve of Fluowet (2002-04-10) | "o"oonmeo _ 7 00000 | Sid wl-- - | x A y=44250x- 2011.7 || toehomoo]n R=0.0008 | | o : : : Tw -- Fo. 5 (dCaatebdr20a02C.04u.1o0frStvandeard -concanvation ange 1-10 mall { GalGubrverof Faluotwet(i2002o-06-n19) I | wom i| f 20000 || E3 o150n00 | | . oe | g --8 | oTob yaamosn20019 | oz oa os os os 1 Cone ima | Fo + (dCaatlberda2t0a0n2C.06.u1o9fSrtandeard concanraton rings 0.10.6 mall 000034 DRU.NOACK-LABORATORUM FOR ANGEWANDTE BIOLOGIE 1Re-pDoerctanol, 33445,5,66.77,8.89.9,10,10,10-heptadscafluoro- Page 320130 Rig, Grown nnbiion Testwih Sconodasrmus subspicalus, Projecto. 020109CK "mTgh/eL)frswtascalniobtrabtriooandcuarnvoeuwghastoesbteabulsiesdhefdor2a0l02t-e0s4ts-0r4unbniunlg.theThceornecfeonrteratthieonsercaonngde c(0u.r0v1e- 0.06 n(i20s0t2e-st0.4-T1h0o) wchoinccehntcroavteirosnacamlucuclhatwiiodnesruasinnggeth(e0.t1w-o1d0ifmfegr/eLn)t cwuarsveusseddofnoortthiefecralmcualraetitohnasnin T1h0e%caflriobmraetiaocnhcoutrhveerfrom 2002.06-19with concontration range of 0.1 - 0.8 gi. shows that the GGIMS systom has a good stabilty over a long period of timo. 000035 RFE ar rt 334A 4554670710A8pm4ne d9c9Eav1rE0s REJE ee anssono E3831 Boe J-- mo am aan Fire Em mem = Enetan To a i| JE mma he i. | | E---- - i def 1 Dh i | rrr] ets Sr omeoa nes 000036 Wr AT lI i|h Wy -- TT | | | fi Jl | ih | | i li rms ---- TE 000038 Report DR. NOACK-LABORATORIVM FOR ANGEWANDTE BIOLOGIE Page 360139 {H7i-2gDaho.cLaGinrmcolTw,th3o3i4nn4wsb5ii,ih5tot6hn,eT7e.Ss7at8twu8ri,an9t3eSd1cS0ao,n1lo0do.on1s0am-cuhcso.sptutobasOpdiEeccCaatDufsi2,v01oro- PSrtodjyeNcok.o. 052500180491C1K1 11 Raw Data Forscance stestsagioniog P pa como pan sons Er TsnrweenTewTwnTe TesTowTwnToe) [---- En rn pan can - poms acne 0 = BT EE EEEEEHE ET 000039 Roport DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE Page dToiso A1l:gDao,caGnroolw,th3.i3n4h4i,b5i,o5nT,e6s6.t7w.i7h,8S.c,a9n9o,d1e0s1i0m1u0s-hsaubpstpaidceactaufs,iuoro72h.Limi Testwith theSaturated Solution ac. {o OECD 201 PSrtoujdeycNtNo.o. 0_S2S0O1B0A9TCIK1 Fisorsscanceshar 481 pa oe [EmalrAlsAww ean[ewe [wa| Feel atammTownreeTemTome) Fusorsscasntcaer 20 pu moe TEREEEEEEET 000040 Ropar DFU NOACK-LABORATORIM FOR ANGEWANOTE BioL001E EXE] 7T2g-Da.acGCarinootwliTn5oe.t34iw,i4nh.5h8eT7So.sa7rw.ai8i.h9S.eS9a.no1e0do1on0s.ms1uc0esh.up1bt0daOpdEcaCecDta2si0.u1ors- SPruojreoct.o. 0S2S0o1019101K 12 Cheerpttiafdiecactaefloufo1r-oD-eAcnaanloyls,is3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10' FER = Clariant 000041 oBFaanrrirSnae, 3o4o4o5or5U6is6ne7rSo7LnBa,odm8oTa81OrDsR9Ues8Yppl.rdoaa1cMt,aeu1Erwo0-ore BotcpoEene.Fcrauese 7aCo.Tat, ie SetiSons 0 CECD201 Se Soar 13 GLP-Certificate of DR.U.NOACK-LABORATORIUM pfoerde] LSP essetca hSteatemnuenatioefGgLoPcuComnpliagnce orremopacnerytos EBEO.E Ien SRIITTNSNE fon.xironfc e LaAROr sRsToOM 0pSxe.se sAoCmKLsnABtOReATORY aSreise pSreiresat tegenttos f ie Pi1ted mehaeneeBeerrntrtomteegdeanae-naatr3Scootern1So ncrrOecBn rereGbntpsionr79 J Ena Srs nc A--o--r i esa aeOns 3 Auntos2mrgmt stm in|t oumm meo5v1 p27S1p 1, 00 gE------------ ETr r ERE m RREAT E EEE FURTEEIETIEE TT sont r= e RRSN Yor o onl 000042