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TELOMER RESEARCH PROGRAM
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000003
[DUNOAGK-LABOFRUARATNOGERWALNIDTME BOLOGEE
~Report+
1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro-
Fish (Zebrafish), Acute Toxicity Test, Static, 96 h, Limit Test with the Saturated Solution
ace. to OECD-GuideliNnoe. 203forTesting of Chomicals (1992)
TelomerSRpeosnesarocrh Project Asa Guss ATORNA Cunt
DAN INDUSTRIES LTO OuponT.
Author Dirk Scheerbaum
Testing Facility 'DR.U.NOAGK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE
Kithe-Paulus-Str. 1 D-31157 Sarstedt
Laboratory Project ID.
Project-No. Study-Ho.
020103CK FAZ8A111
Page 10f 32
Study Completed August 07. 2002
Orgi7noafl7
000002
RTeepocrtan, 334.4.Dr5U5N,o8A,GC67B.O7O,8N81,0h8ia.pnt5Aa,dvec1cEa0Rt.AiiE1oT0rEo.-Bos00E Fee zors i Eo ChaSmaoirny. ASeotoenToncaoTOoEsCDS2t0a5 38 ne Cm Ton | PSrooncoe, 0_2t0r1z0i8t0
Statement of GLP Compliance
Tie
nroaptnadaac,at3i3o.ro4455667.7.0899.010.10-
WFoinn(nzeotSaeatnryt.eAncStoatTooxnicity Tost, Sa, 9 ii Tost
Guidaine
OECD-GudetneforTesting of Chemicals No. 203
Testom
nDeepaandaoc,at3o3r.4e,4.55857.78888,10.10.10-
(Gato numba, Po001)
Tost Facity
KaDlRoNPoOuAtHLABGS1R.A5T.O4M1U1M57FSORaArNtGoEWANDTE B110IE PEraonte:. (in4f8o)@0n3o0ac6k8ia7bd0e 10. Far (+45) 050 68/708 763
Deviations fm Lp Principles None
WnecidtaecsarofhGaotohdisLatbaoryawtaosPcroancdiutcntaenddahnderaesptratnda iGnLcPomrpelpiaantcoenwsi5h hseocacitiuadl nOEhCDlow fore. oxcot dwiatons mentned avo.
oor 02
Shope
Gi Senora, Say recor
`August 07, 2002
Ropes, 2002
(hemsC Gett , Soni o.r GaLo oowed,,Hosa1 of Tosi Paci)
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wI o AT Amost INAmsa onientraearsierrsmens mcrre
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Statement of the Quality Assurance Unit
i.
coin room rm
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000006
DRUNOAGKLABOFURRAATNGOEWRANUDTME BIOLOGIE
R1e-pDoerctanol, 3,3,4,4,5,5.6,6.7.7,8,8.9.9,10,10,10-heptadocafluoro-
Page 4 of 32
WFiisthht(hZeeSbartafuirsaht)e,dASocluutteioTnoaxcicci.ty10TeOstE,CDSt2a0ti3c, 96 h, Limit Test PSrtojdeyctN:oNo.._F0A2Z0B1A09TC1K
Personnel Involved
Study Director
Dirk Schearbaum (Biologis)
Scientist
Thomas Geffke (RCehsepmoincsailblEenfgoirneceorn)centration control analysis
Technical Staff:
Christian Rebl
Quality Assurance Unit:
Gudrun Mohrmann-Kalabokidss (Biologist)
Deputy Director of tho. Testing Facil.
Susanne Backer (Biologist) Dr. Udo Noack (Biologist)
000007
[DRL NOAGK.LABORATORFIONMRANGEWANDTE BIOLOGEE
Re1p-oDorctanol, 3,3,4.455,6.6.7.7,8,89,9,10,10,10-heptadscafluoro-
Pages 0132
Fish (Zebrafish), Acute Toxicity Test, Staic, 9 h, Limit Test Projoct-No. 020109CK
Winino SaturatedSotionace:0OEC0203_
SwdyNo. FAZBAIT1
Table of Content
Page
Title Page
1
Statement of GLP Compliance
2
`Statement of Quality Assurance Unit
3
Personnel Involved
4
"Table of Content
5
List of Tables and Figures
5
' Summary
7
2
Characterisation Data of the Test item
3 Method
0
4
Results
15
a1 Preliminary Test
1s
az Dofiniive Tost
1s
5 Validity Criteria
"
5 Conclusions.
"
7
Literatur/e Reforences.
7
5
Physicochemical Data
18
81 Water Quality Measurements
1s
s
GC -- Analysis of 1-Decanal, 3,3.4.4,5,5,6.6.7.7.8.89.9, 10,10,10-
heptadecafluoro-
1
01 Method
1
92 Method Validation
2
921 neariy
21
922 Quantification Limit and Detection Limit
2
923 Pracision (Repoatabity)
2
924 Poak Symmetry
2
925 Accuracy
2
03 Results
2%
oe Galbration Curves.
2
95 Chromatograms.
3
10 Gortificato of 1-Decancl, 3.3.4.5.5,6.57.7.8,8.99.10,10,10-
hoptadacauoro- Analysis
a
1"
`GLP-Cartiicato of DR U.NOACK-LASORATORIM
2
000008
DR.NOACKLABORATORIM FOR ANGEWANOTE BI0LOGIE
R1-eDpaocanol, 3,3,4.4,5,56,6,7.7.8,8,99,10,10,10-heptadecafluoro-
Fapeam
FWiisthht(hZeeSbartafuirsaht)e,dSAcaulttooTnoaxcieci.tyloToOsEtC,DSa2f0i3, 96 h, Limit Test PSrtoujdoycNto-.No. 0_2FA0Z1B0A9ITC1K
List of Tables, Page
Tab. 1: LC-Values with 95 % Confidence Intervals
8
Tab.2: Cumulative Mortality in [%] in the Preliminary Test
1s
Tab.3 Observations in the Tost Vessels
1s
Tab. 4: Cumulative Mortaity in [%) in the Test Vessels
Tab. LCi, LCi, NOEC-Values (0-96 0)
1
Tab. 6: LCuValues with 95 % Confidence Intervals
1.
Tab.7: Water Parameters
1
Tab.8: Repeatabiily of Injections of Test Item
2
Tab.9: Moan Recovery Rate of Fortified Samples
2
Tab. 10: Concentrations of the Active Ingredient 1-Dacanol,
3534,4.5,56.6.7.7.8,8.9.9.10,10,10-haptadecafiuoro-
2%
List of Figures Page
Fig.1: Calibration Curve of Standard - concentration range
001-008 mor.
2
Fig.2 Calibration Curva of Standard - concentration range
01-10 mg
2
Fig.3 Calbration Curve of Standard- concentration range
0.1-08 moi.
%
Fig.4: Chromatogram of Standard
2
Fig.5. Chromatogram of Test item
2
Fig.6: Chromatogram of Control
30
000009
R1e-pDoorctanol,
DR. NOAGK-LABORATOFROURM ANGEWANOTE BIOLOGIE 3,3,4.4,5,56,6,7.7,8,89,9,10,10,10-heptadacafluoro-
pa
WiFitshhth(ZeebSraatfuirsahl)e.dASculoe Tloaxcieuc.ittytoTOoisEtC,oDSt2an0i3c, 96 h Limit Test PrSoujdeycNtoN.o. 0_2F0A1Z0B9ACIKT.
1 Summary
Thehpetaadceuctaetfolxuiocriot-yo(fattchhe tnoe.s:t lPOeDmIO1O-TD)octaonfoils,h 3(.z3e.b4r.a4f,i6s.h5).w6.a6s.7d.e7.t8e.r8m.i9n.e9.d1a0,c1c0o,r1d0i-ng to the `D5O.ECD-NGOuAiCdKe-lLiAneBOfRorATTeOsRtIiUnMg FofORChAoNmGiEcWaAlsNDNTo.E 2BI0O3LO(G1I9E9,2)31fr1o5m72S0a0r2st.e0d4t-,02Gterom2an0y0.2-04-a0t6 Ahesttaetsitc ltiemimt tfeosrt1w4adsaycosnbdeufcotreedtwheihtetsthestsaarttuerda.tDedursoaltutiioonnf. tThheetetsetstwvaesss9e6lhw.a3s0ctoeastted with osartguarnaitsemdsswoleurteioenxapossuesdpeonstihoenswaittuhraatneodmsionlaultiloonaadinndgotfhe1c0on0trmolg./LFowrasthsehparkeepnafroatri9o6n ohfatnhed centrifuged. The clear supernatant was used forthe tost. Aanlaleyfsfiesctwvaasluceasrraireod boautsefdoomntthhoetneisitaflloymmeaansdutrheedccoonntcreontvreastsieolnaofttehsestteasrttlaanmd. oGnCd-M(fSo.r r7e.s7u,l8t,s8.s9e.e9.p1a0r,t109..21)0.-hTenpotaidnsitciaaflllyuomreoa-suwraesd0c.o1n8cmegnitLr.atAitonthoef e1n-dDaocfantdhle,te3s.t3t.h4e.4c.o5n.c5e6n.6t,ration ohfehweatsestweilraomawlaresad0y.0p0r6e3-cmoga/tLe.d Sfoorrp1t4iodnbtaftohreagltahesstewsatlhlasosfsttahrteetd,est vessels is unikely as Thohpetaadceuctaetfoixuiocriot-yoisfstuhmematersitsietdemin1-thDeecfaonlollo,wi3n.g3.ta4b.l4e,:5.5,6,6.,7,8.8, 9.9,10,10.10-
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DR.U.NOACK-LABFOORRAANGTEOWARNIDTME BIOLOGE ggg
F1i-sDhoc(aZneobrla,fi3s,h3),,4A.c4u5t.5e,T6o.x6i,c7i7t,y6T,e8s.t9,,9S,ta1t0i,c1,09,h10,-heLipmtiatdsTceasftluoro- Projact-No. 020109CK
Wilh the Saturated Souton ace. 10 OECD 203
StdyNo._FAZBAITY
2 Characterisation Data of the Test Item
TEST mem
1-Decancl, 3.3.4.45.5.6.6,7.7.8,8.9.9,10,10,10-heptadecafluoro-
Batch Number
Pooio0t
cas RN
678307
`Chemical characterization Purity Appearance
3,3.4.4.8,5,6,6,7.7.8,8.9.9.10,10,10-heptadecafluorodecane-1-of (EINECS) sCBu-mperpfelrufourooraolaklyklyeltshtahnoaln:ol9999..39%%((aallaa)). Yellowish sold wax
Water solubity
Stabilty in water Density
134 137
gi gL
at 12 2125
degree degree
C, C.,
Std Std
29 53
gL, gil,
n= (DuPont, 2002) n=17 (DuPont, 2002)
Stable at test conditions.
Ca. 1.7 glem
Expiry date Recommended storage Storage attesting faciity Retention Iadtetnetsitfiincgatfioanciptayrameter
Unlimited if stored under the recommendod conditions Room temperature (20 C), protected from moisture. Room temperature, protected from moisture and light. Atleast 1 g has been retained.
Name, batch number and colour.
Tho tast tom and tho information concerning the test item were provided by the sponsor.
000012
DR.NOACK-LABORATORIFUORM ANGEWANDTE BIOLOGIE
R1e-pDoorctanol, 3,3,4,4,5,5,8,6,7.7,8,8,9.9,10,10,10-hoptadecafiuoro-
Page 100132
W Fishit(hZeeSbat rtafuirsahhl)e,dAScoultuteioTnoxaiccei.ttyoTeOsEtC, DSt2a0i3c, 9 h, Limi Test PSrtoujdepcNto-.No. 0_2F0AZ1B0A9TCIK
3 Method TEST GUIDELINE TYPE AND PURPOSE TEST svsTEM Reason fo the selection of the test system. origin Holding.
Water
Feeding Food
OEC-Guideline for Testing of Chemicals No. 203 (1892) D33a.t4a,r4m,i5n,a5t,i6o.n6.of7.t7h,e8.a8c9u.t9e,1t0o.xi1c0t,y10o-fhe1p-lDaedceacnaafll,uoro10 zebrafish in a mit test with tho saturated solution. DGarnaitohorsetriooma(z,ebPriasfciassh,)Osteichthyes, Telsostel, Clupeiformes, Cyprinidae According to the guideline Danio rerio i suitable for this ind of study. AAQUfAiRshIUuMseAdMiAn CtGhe, tFeesltdswtirll. o7r,igDi-n3at0e15fr9oHmatnhneovsearmedeliveryof the supplier. Holding was performed a the est acilty at 23 42 Canddiffuse fight (01-10 yEimPs. natural photoperiod). The water was cadhmainngisetderaetdl.east once per weak. No disease treatment was The dissolved oxygen concentration was more than 80 % ofthe. ai saturation value Only zebrafish with at east 12 days of acclimatisation and umosretdaliintyt<he 5te%stwithin the last 7days before the study startswas Tap water of loca origin was used for holding and testing. The. water was fered on activated charcoal and aerated for atleast 26 10 remove chlorine. NTootmailnhaalrwdanteesrs:pa4r0am-e1t8er0sm: g CaCONL Tp-hveawlautee:r 6is0a-nal8y.s0ed oncea year acc. 10 German tap water roguiaton. Food was provided 3 times per week. The amount of food was 4%of the ishbodyweight per feeding day. The test fish will not ba fod unt 2 h bafora the tost started "Trouvit 40 12; MLKIVIT, D-86666 Burghaim
000013
Repel
DRUNOAGK-ALABORATORUM FORANGEWANOTE BIOLOGIE PageTora
1Fi-sDhoc(aZenborla,fi3s,h)3,,4,A4c,u5t5e,6T,ox6i,c7i,t7y,8Te,s8t.,9,S9t,a1i0c,,109,610h-hLeipmtiatdeTceasftluoro- Project-No. 020109CK
Withthe SeluraledSoutonsce. Io OECD203
StudyNo. _FAZBATI1
TesT TEM Pretreatment of TEST CONDITIONS Coating of the Tost vassols Preparation
Goating period Proparation of the test medium (saturated solution)
CoNTROL REFERENCE ITEM TEST METHOD,
1-Dacanol, 3,3,4,45,5,6,61,7.8,8,9.9.10,10,10heptadecafluoroThe test lem was heated to 50 C befora weighing for homogenisation.
A coating phaso of 14 days was carried out.
100 mg 1-Decanol, 3.3,445.5.6.6.77,8.8,9.9,10.10,10hSohpatkaednecianfaluroortoa-tiLngdsihtaikoenr wwiatlhe20(trotpaml vfoorlu9m6eh5atx202L)C.we2re -- brown glass flasks were used. After phase separation about 10L por tos roplicate were ransferred from the clear liquid phase to tho glass aquarium and covered with glass tops. Dilution water was used for the preparatioofn the coating solution. Th2eCreafdoirly14fidlaeyds.anAdttchloeseedndaoqfuatrhieucmoawtaisngspteorrieoddatthneomaiqnuaalrliyu2m3 was ompliad and usa for th test.
100 mg 1-Decanal, 334.4,5.5.6.6.7.7,8.899.10,10,10hepladecafluoro- L ition wale (total volume 5 x 2L) were. shaken in a rotating shaker with 20 rom fo96r at 20 C. 2co1nt-ribtruogwend gfolras2s0fmaisnksatw3o0r0e0usrepdm.. T1h0iLspsourspteensstiroenplwicaasteof the "cTlheoarpsraetpuarraatteidonsomleutthioondwhaass tbroaennsfecrhroesdetnowtihtehgrleagsasrdaqtouahrieumt.ost tom properties and in accordwaitnhtchee relevant guidance documents (OECD 2000, BAUA 2001). 3s0amfeishteisntdcilountdiiotniownaste8rs(twhiethtooust treesptlitcaetmes).wero tested under the No referanco tom is recommended fo this test according 10 the guidaline. Ainsittiaatticonlimit ost was performed with ono application a to test
000014
Report
DR. NOAGK-LABORATORUMFORANGEWANOTE BILOGIE gmam
1Fi-sDhoc(aZneborla,fi3s,h3).,4A,4c,u5t,e5T6o.x6i,c7i.t7y.T8e,s0t9,,9S,t1a0i.c1,09,810h-,heLpimtiatdeTcoasftluoro- Projoct-No. 020109CK
Wih the SaturatedSolutionace. to OECD 203
StudyNo._FAZBAN1T
Tost duration Tost vessel Tost volume. Aeration Dilution water Number of test fish Loading, leagthoffish
Repiicates Introduction of fish Foeding of tos fish Water temperature cDoinscsaonltvreadtiooxnygen Light intensity photoperiod
9h Giass-aquaria loosely coveredbyglass tops were used. The test volume was 10Lpervessol Gone aeration was provided. Same as for holding. 30 zebrafish was used por test concentration and control Fish donsity in the tanks was less than 1 g fish por Iter tast `sAolvuetriaogne body lengih at he test start: 277 cm `MAovaesruargienbgovdaylwueesigwehraetdtohteotremsitnsetadrtw:it0h.2f0is.h9{rom the sam batch but not used in the test. One roplicata per test concentration and control Fish were introduced randomltoy individual replicates. The fish wil not be fad during the test n12'C
Not loss than 60% of air saturation value. 0.1-10uE m5 A natural photoperiod occurred during the ost.
KMIENADSAUNRDEMFERNETQUAENNDCY OF OBSERVATIONS.
meWaatseurreqmueanyts
ipnH-avlavleuss,setlesmpaterhaetubreegainnndiongxyogfehnesatteusrtaatinodn ewveerrey m2eahs.ured Tofottahlentaerstancoonstsroolf. tDhuerwiantgetrhweatsestdettheerrmoinoomdtaelmtpheerabteugriennwiansg out recorded continuously with a thermohygrograph.
000015
DRNOACKLABORATORUMFORANGEWANOTE BIOLOGIE
R1e-pDaocanol, 3,3,4,4,5,56.6,7.7,8,89,9,10,10,10-heptadecafluoro-
pmo
FWiisthht(hZeeSbartafuirsaht)e.dSAcouutteonTosxicceity1oToOsEt,CDSt2a0i3c, 98 h, Limit Tost PSrtodjeycNt-oN.o._FA0Z2B01A0I8TCYK
Gritria of effects
Observation intervals Moasuremont of fish size
(F6i:s9h. wilelreovceonrssidmeorveedmdeenatd) fantdheirfetowuacshinnog voifsitbhleecmaouvdaelment p`aebdnuonrcmlaleitpireosd(uec.ge.dlnososorefacteiqouni.libRreicuomr,dsswwiemrmoinkgepbtehofavviiosuibrl,e respiratory function, pigmentation, ol.) Observations were made aftr 24, 48, 72 and 96 h, Antutmebsetrstoafrt7botedsytwfeisihgwhatsadnedteortmailnelde. nTghoetfshae friesphrwesielnntoattibvae used for testing,
TDHEETETREMSITNAITTIEMON OF Sampling and storage
The test concentration lovel and control wero analytically dveortiofciieidonby(giazs=ch46r3omanadto39g5r)aawptihtteyhstmsatasrst aspnedcttersotmeotnrdi.cFor dotais soopart 9.1 w4i0hmgLlatsesstpsloulgustiaonndwesrtoerredanastfa2r-r7ed Ino 5t0hemdLagrklausnstiflaansaklsyscilsosed (test start for 3, test and for 2 days).
EvaLUATION
TLGhyeunc)onac5enwtalrlataisontshelenaodienfgfefco 0leavenld(1N0O0E%C)maofrtetral9y6 (hLwCesrea.nd dLeCtuecrvmailnueedsdhiarevcetlnyoftrtoombtohecatlecstulraetseudlti.n Init ast
COURSE OF THE STUDY
Tsahteurdaetfeidnisiovleutsitouncyawasisngpleerfoosrtmcaodncaosnalraitniitonost with the Osanmeococnotnrdoiltiwointsh waasttehre(twoistthogurtoutpe.s tem) was tested under the 1 the tost concentration and control 30 fish wore (ested. The test fish were not fed during the test. wAfetreer o2b4s,e4r8v,ed7.2 and 86 h mortality and behaviooufr the test fisn Moasurements and observations woro carfod out as described above,
000016
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DRU.NOAGK-LABORATORM FORANGEWANDTE BIL0GE pana
1Fi-sDhoc(aZenborla,fi3sh,)3,,4A,c4u,t55e,T6o,x6i.c7i,t7y,T8e,s8t9,,9S,t1a0i,c1,09,10h-,heLipmtiatdeTceasftluoro- Project:No. 020109CK.
WiththeSaturatedSaltonace. to OECD203
Sudo. FAZBITY
VALIDITY CRITERIA
"DEVIATIONS FROM THE GUIDELINE, DTEHVEISATTUIODNYSPFLRAONM REPORTING ARCHIVING
-~ 0Mo,r-taslaittyuriantitohne c2o6nt0r%ol 5 10%
None
None
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+ all aw data
+ study plan Orin 1612)
+ +
falilnarlerceoprodrst ppearpfeorrcmoepdyb(yOtrhgeaq:u1ally)assurance
programme.
+ siancmlpuldeinogfmtaessttetramschedules
MDi-c3r1o1f5i7msSawrsetreedtr,etained in a safe-depositby Volksbank Sarstedt,
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4 Results
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000019
Repor
RU NOAGK-LABORATORIUMFOR ANGEWANDTE BIOLOGIE Pag17 oef 32
1Fi-sDhoc(aZanborla,fi3s,h)3,,4.A4c,u5t,e5,T6o,x6i,ci1t.y7,T8e,s8t,,9,S9t,a1i0c,,190,610h,-hLeipmtiatdTeecsatfluoro- Project-No. 020109CK
With theSaturSolautitoneacde. to OECD 203
StudyNo._FAZBA111
5 Validity Criteria
The study met the validity criteria of the guideline: + 03 saturation was 60 % + Mortaity in thecontwarso3l%
6 Conclusions aInnytheifsfsetctusdyto1-zeDbercaafnilsh. a3f.t3e.r49.64.hw5.h5,e6.n6.t7e,s7t,e8d,.a9t.t9h.e10i,n1i0ia,l1l0y-mhoepatsaudreceadflcuoonrcoe-ntirdatniootnocfa0u.s1e8 mgiL. The NOEC (0- 96 h) is 0.18 mg/L. (initially measured concentrations).
7 Literature / References
(1) OECD-guideline 203 for testing of chemicals. Fish, Acute Toxicity Test. Adopted July 17,
1992
(2)
OECD (2000): Guidance document on mixtures. OECD series on testing and
aasqsuaetsiscmteonxticintoy.
t2es3tingofdificult
substances
and
(3) BAnAmUeAl,dBuunngdeensannesvtearltStfoafrfAernbaeicthssdcehmutCzhuenmdikAarlbieeintgsemseedtizz.in3.(2i0b0e1r)a:rbLeiittaftaedAnufflarge. (4) DuPont, Determination of physico-chemical parameters of Perfluorooctylathanol, CAS No.
678-307, Unpublished result, Update Fab. 15, 2002
000020
sy xopempesoncer im
EN
I
8 PhysicochemiDcaatla
Initially
Oxygen.
Value remperature| Total Hardness
Ceomwm |[o wo [ro[Tnow ie| | ] . TowTw ew [we] - ew ww[wo] - ow ow [wo | -[oCmoe T[ oTw e[m weai]]
000021
Report
ORUNOAGK-LAFOBRAONGREAWATTEOBR11U0GME Page 195132
1F.iBnac(aZneoblr,af3i,s3h,,4A,c4u,t55o,T6o,x6i.c1it.y7.T8e,s8t9,.9S,t1i0c.,109,610h-heLipmtiatdeTcoasftluoro- Projecto. 020109CK
Withthe SaturtedSolutionace. o OECD203
StudyNo._FAZBANT
9 G10C,1-0,A1n0a-lhyespitsadoefc1a-fDleucoarnoo-l, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,
9.1 Method DMEETTEHROMDINOAFTION
Equipment
A1n-aDlaycsaensl,of3v,a3r4i.o4u5s.5co,n5c.e6n.t7r7a.t8i,o8n.s9,of9.10.10.10-hoptadecaflorowSeILre8 ccaarpriileldaroyuctovliuamgnasuscihnrgoemxatteorgarlapsthayndoanrdas.FuDsoetdecStiicona wCaPsporformed with mass selective detector (MS).
AGuatosscahmrpolmeartograph
GP-3800, VAAN CTC Cambi PAL, CTC AuaLyics
DSeotfetcwtaorre
+ MSaSt,urSnatGuCrn/M2S000W,orVkAsRtIaAtNion 5 51, VAAN
Reagents
{ort-butyt methyt ether 99.8 %, Batch 42397011 31101, FLua
CONDITIONS OF ANALYSIS
Column
CLhOrWomBpLacEkECD/P.MSSI,LF8il(mVAtRhIiAckNn,es3s0:m0,.215.p0m.25 mm,
IInnjjeeccttoorr temperature S2p5i0ieCss (30 pi prossure puis) or 1 min
ITnejmepcpteeirraoatnutrevuroe pmrporoggramme.
Ti Heating ats| Temperatura| Holding me
"Cimin)
Q
mi]
[=Tw T7700 7]
[o1e m0
CT 20 1 "50
DCetaerctrorgas lRounnsattiimoen mode Retention me
Hweslium 1 mL. min column flow E1l5e.c3t9rmoinnionisation (EI) approx. 43 min
000022
Report
DRU.NOAGK-LABORATORUM FORANGEWANDTE BLOG hamaw
1Fi-sDhac(aZneborla,fi3s.h3),,4A,c4u,t5e5,T6o,x6i,c7i.t7y,T8e,s8t9,.9S,t1ai0c,,109,610,-heLipmtiatdsTceasftluoro- ProjoctNo. 020109CK
With the Ssturalsd Soluton ace. to OECD 203
StudyNo._FAZBAIT
STANDARD PSRTEAPNADRAARTDISON OF PSRAEMPPALREASTION OF METHOD VALIDATION Peak symmetry
Repeatability Accuracy
Tost tom was used as standard Tinwtoots-tbouctkyslomluettihoynlseotfhetrh,eusttaenddar(d9 ocfon2c0e0ntmrgat/iLonwsoreeacphr)epaanrded used for calibration. For calibration range see part 8.2.1, 4ot0hmerLof the sampla were extracted with 4.0 mL tort-butl methyl "ATfhetexpthraascotiosnopsatreaptieonncltoheseesxtarnacetnwraicshimnejnetctbeydfdaicrteocrtl1y0,into the Gos.
mQuaasnsteifsi6c9at.i+on3o9f5t+he4t6e3st(1t/o2m) bwaassedcaolcnultahteeedxtbeyrnpaelakstaarndeaardofs.the. "oTfhdeetcealcitbiroantiaonndpqruoacnetdiufirceaatinodn tlhimeitpsriwnecripoleadfoarpttheeddfertoemrmDiInNation 32645. The method was validated as described below: aPnaaalyktiscyamlmsottarnidoasrdwseraondcatlecsutlaitteedm afcrcoomrcdihnrgotmoatthoegfrolalomowsfing equation: Te Wewi2h) T= Pessymmoty WTom== fPrasstkswoicdotrhoaftpse%okowf phask(dhieviigdhetdfbmym]tho perpendicular
in from the peak maximum) mm] 5frsomuabsi-nsgalemhopoflmteohgesenhoiguhsesstaamnpdlelwoweerset acnoanlcyesnetdr.atMioenanprveaplaureesd. scatlacnudlaartdeddeviations an variations of coeficients were 51-sDaemcpalncels w3i.t3h.4406,m5.L5,w6a,t6e7r.w7.e8r,e8,s0p.i9k.e1d0w,i1t0h,1a0n-haempotaudnotcaoffl8oyrog`(A8f0te4rLwaorfds10s0ammpgle)s twoerioveexatfriancatlodcoasncdeonstcrriavteidoofanbo2v0e0. gil.
000023
DR.UNOAGK-LABORATOFROIRMANGEWANDTE BIOLOGIE
Ra1p-Doorctanol, 3,3,4,4,5,5,6,6.7.7,8,89,9,1010,10-heptadecafluoro-
Page 21 0152
FWiisthht(hZeoSbartaufriaht)e,dSAocltutsioTnoaxicceityoTOesEtC,DSt2a0ti3c, 96 h, Limit Test SPrtoujedcyt-NNoo._FA0Z2B01A0N9I0TK
92 Method Validation
The me~ thotdinwoaarstyvalidated and tested with satisfactory results wil respect to
~ -
pproeackissiyonmm(erteprayatabiity)
- accuracy
determination imit and detection limit.
9:24 Linearity The analytical system gave linear response in the range of 0.1 - 10 mL of 1-Decanal, 3C.h3r.o4m,a4.t5o.g5r,a6,m6s.7o.b7t,a8i.n8e.d8:f.or10s,t1a0n,d1a0r-dheaptnaddetceatlutoerom-.areThgeivceanliibnraftiigounrecsur1 v-es6. aFnodr Getermination and detection mils soepart 9.3,
9.22 Quantification Limit and Datection Limit "The limit of quantification (LOQ) and limit of detection (LOD) were calculated using the bind value method described in DIN 32645 "Nachweis- und Bestmmungsgrenze" Tho LOD was determined to be 0.009 mg/L and therefore the LOQ was 0.027 mglL. (hvesfold the LOD)
000024
onus Acomvore Bont LE SASeSnOeOroNs SITTIN a pg, noon 223 smoon ape
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000025
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028 Accuracy Ton5 Wenn Recovery Rate of Fated Samples cnrFoanitee |ssesass"aoaioirin:gsa0s00
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000026
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000027
DU NoAGKLABOFOMRAAGTEWOAMOTAE Biotoae RBoecannol, 3.34.4:5,56,67.7.889.9,10,101-heptadscafluoro-
Paemon
WFiiet(Shzaabtrartsena),dASoconToaxcic.tlyoTeOsEtC,DSa2t0e3, 98h, Limit Test PSruodjeycNtoo._FA02Z0B1I0I9CTK
2.4 Catlration Curves fTheeracanltibmraotison curves shown were stabishedfo ferent concenraion ranges and at
Calibration Curve of Fluowet (2002-04-04)
|
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000028
FTaBroocnanol 3.34.45D5a6,t67o.7s.8889B,o1m0.T1O0R1I0-MhFeRptAacdoEcMaMtEloTrEo-Boos Ere iEonanSmootdaSowToa u0TOoEsCDS2a0,3 90h Lint Ton SPrhoej"o. 0F2a0z1m09iCnK
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000029
Report
'DR.UNOACK-LABORATORUM FORANGEWANDTE BIOLOGIE Page 27 of 32
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000030
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