Document nmoRwxLgmrZQwxg8k7GNb4Qa6
TELOMER RESEARCH PROGRAM 1200 Soputh HrayesiStemet oAingion, Vpigena 2e2202-6050
Feary 14,200
WV : ETE = Clariant CUPON=R Z5 o3n2
MarFy Dominiak
VUEo.ESo.AoEEPnvonierornam5roe8ncttoa3lPrrkohteoctaoionAgency Er onaca@esaor
=a2z 5=52
=z B59
oer TBrehTSromoEersR.1ei5seU7naS8c.h5EP5Ero1g0sa7m8a(1cr0TsoAPmrar)sassetsmcmlaorgreomcoemaop5nrbeAs.,SssHaaotieTGpaSss,)sCoWanh5, oDToeroeansndn8DSAuci,tod, epE mie e nso clpatoispnooBanr.rasbgrhyosoadraeaswrpihonet0 PTpHo.ooTsohtososboeo.optwsrsswseoS,oemaCtoarsy aTe osvywS asss htaaartdtsn,ocfEhaaOSrEaDs DctWVeeAor rf sehseao baso3t(spStaaatrraaerassrDcoStlnoseipabt,osathAfBhodalnsseoTbnocur5 seecewss:oeo"ftHrcyhhl
ma esas arnes se Sa wr ot i Fes a FTeeoeeeTAsP anmvaemaem3taaoecromsrparAreoralsolsrtho,twshoemdeatnka gnaeotaerdefomRoesSsspteupdshrkre crrsirieweit,ts
oe a vo or ho ros TH moscomo
Sets Koti NW n a Rie Katie D. Smythe ~
his docudonmoetonatn TSCA Cl
000043
DR.UNoAGK-LABORATORIM FOR 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 Water Accommodated Fraction (WAF)
acc. to OECD-Guideline No. 201 or Testing of Chemicals (June 1984) TelomerSRpoosneasrocrh Project "AAarnoGmaass OnanCouusTmRES LTD upon
Oirk SAcuhtoheorrbaum
DR.UNoTAoCsKt-FLaAciBlOitRyATORWM FORKAavtGhoE-WPAaNuOiuTsE-SBtl.oLoGIE
31157 Sarstedt
ProjecLtaob.oratory Proj0e2c0t1I0D8CK
Study.No.
sso8etiz
Study Completed On August 07, 2002
Pago 101 3
Orginal 7of 7
000044
Re e1-pDeocanol, 3.34.4:5.Or5.,867N.o7K,G8K.-88L9A.B1O0R.A10T0O-RhIoMpy tFaOdRacAaNfGuEcWroA-NOTE BoLoGE Asi.neGrWoewrnAhcicioommnoTdoasttewdihFrSacceinoendes(mWAuR),s saucco:spOcEaCusD,21012h Lim T~e~t__SPurjtocotN.oS0S2O0B10I8TCSK
Statement of GLP Compliance
Tite
Guidaine Test tom Testing Facitty
GDeLvPiaPtriionncsipflreosm
A1l-gDa,acGornow,t3h.3I.n4.b4i.l65o,n6.T6.o7s.t7,w8i.8h.9S.9c.o10n.e10d.o10suhsepstuabsdpeiccaatfuls.oro721, LimitTest wih the Wale Accomodated Fraction (WAF) EGD-Guidoline No. 201 or Testing of Chemicals (1984) (1B-aDtocchannulm,b3e.r3:.4P.O4.05I,O5T.6).6.7.7,8.8,9.9.10,10,10-heptadecafluoroKORa.the-NPOauAiCuKs--LStArB.O1R,A0T-O3R1I1U5M7FSUaRrAstGeEdtWANOTE BIOLOGIE EForncs:: o(+n4o90s5c6i8a7b0i7n0 Fu. 4) o0geT8o0, None
pWreincdiopclieasroeftGhototdhiLsasbotraytowraysPrcaocntdiuccetaenddatnderneaptoirotneadl iGnLcPormepgaulnactieonwsi2t tshpeecaicftiueadl iOnEtCheOlaw In force,excapt deviations mantoned above.
August 07, 2002
(ik Schearbaum. Stuy Divacior (Thomas Goffe, Scientist) (Or Udo NLoacok, dHe,aodf Testing Fach)
000045
Reon
DR. NOKCK-LABORATORIUM FOR ANGEWANOTE BoLosIE
ay
`ii1g-Dste,cvGanWroloo,lh3o,n3A,i4,ci4,c5n,o5T,m6o,sm6t,w7oi,t7Fdh,r8aaS,cc8tt,ae9re,ne9d,(1o0Ws,Am1u0.,s10sa-uchbecspptOcaEdaeCtcsDa,fi2u10o21r1o,- Lim Tos SPrtoofaaycot.No50820014019C1K2.
Statement of the Quality Assurance Unit
Tite
Guidaine Tost tom Stuy Director
A1l-gDaa,cGanrco,wt3.3I.s4.b45i,n56.T6e.s7t.7w,i8h,8S.c9.o9n.a1d0.o1s0m.u1s0-shoupptsapdieccaaufsl,uoro721, Limi Test wih theWaterAccomodatad Fraction (WAF) (OECD-Guidolino No. 201 for Testing of Chemicals (1984) (1B-aDtocchannculm,be5r..3.4P.O40.I505.061.)6.7.7.8.8,9.9,10.10,10 haptadecatioro-
Dik Scheersaum
The study was varied as follows:
voter woven process based =
aot rept
02002
oor
a
0z0s02
m0azaot0u7 | amonzaorasn
mmzaorzs | meoszaor1ss
pTrhoecerdeuproerst,edarnedssuesrvacactuiroanteslyoarndacccoumrpalteltyelaynrdacfolcmtplhtealryawdedsactraiboefdhne tshtudyr.epAorltso methods. iTshgeuaarcacnotredead.nce of the study with s stucy lan and th principlesof Good Laboratory Pracica
August 07, 2002
.`uBal hMonammai nn K.tabokis 000046
[DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE
R1e-Dpocnanol, 3.3,4,4,65,6,6.77,8,8,9.9,10.10,10-heptadscaiuoro-
Pagedoin
w`Ailtgha,thGerWoawttehrIAnhcicbiotmiomnoTdeasttweidthFSrcacatnioodnas(iWAmFu)sascucb.spOicEaCtuDs,27021h, Limi Test SPtruodjye-cNto-.No5.500280140191C2K
Personnel Involved
Study Director
Dirk Scheerbaum (Biologist)
Scientist:
(TChhoemmaicsalGeEfnkgieneer) cRoenstproonlsainballeysfiosr concentration
Technical Staff:
Ute Kutznor
Quality Assurance Unit: (GBuidolrougnisMt)Ohrmann-Kalabokidis
Doputy:
`Susanne Becker (Biologist)
Head of Testing Facility: Or. Udo Noack (Biologist)
00047
Report
DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE --
1-D0canol, 33,44,55,66,77.8,68.9.10.10.10-heptadecafluoro-
Pages
w`Aigha,thGeroWwaitnernAhicbicioon mTomstowidFharSalccosinodonde(sWArFm)u.sscucbs.piOcaEtCuDs,201 72h,Limit Test SPturdy-oNNo.oj0525e00180c401C1tK2.
Table of Content
Page
Till Pago
1
Statement of GLP Compliance
2
Statement of Qualily Assurance Unit
3
Personne Involvad
.
Table of Content
5
List of Tables.
s
List of Figures,
i
21 `SCuhamrmaactreyrisation Data of the Test lem
97
hi3 RMeestuhlotds
710
aa2 DPerfoilniimtiinvaerTyeTsotst
7 7
a53 VTaslitdiotfytChreitoRreifaerence tem
220
i7 CLointcelrautsuiroen/sReferences
221
9
PGhryaspihcochemical Data
2 2
10 hGaCpt--adAoncalaylsuiosroo-f 1-Decanc, 3.3..4,5,5,6,67.7.8,8.99,10,10,10-
2%
110012 MMeetthhoodd Validation
22
11002212 QLuiannotairftiycation Limit and Dotaction Limit
2 2
11002243 PProeackisSiyonmm(eRetpreyatability)
2277
1100325 RAecscuulrtascy
22
110045 CCahlriobmraattioognrCaumrsv.es
3FY
21" CRearwtfiDcaatlao of 1-Decanl, 3.3.4,4.5.5,6.6.7.7.8.8.99.10,10,10-
3
13 `hGeLpPl-aCdaorctaililcuaotroo-ofAnDaRlyUs.isNOACK-LASORATORIUM
33s
000048
Report
DF.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIoLOGIE
_
--
"Page6orss
A1l-gDao,caGnroolw,th.3I4n4i:b5i,i5on,T6e6s.t7w,7i,h6.S,c9a9n,e1d0a,s1r0m,u1s0s-uhbespptiacdaetcuasf,i7o2ro,-Limit Test wilh ihoWaterAccommodatedFraction(WA),ace: OECD201
SPtroujdeicot.-NoS.0020810611C2K
List of Tables, Page
Tab. 1: NOECILOEC and ECs-Valuos (0-72 h) of Biomass Inhibition
and Rato-Related Inhibition
8
Tab. 2: Preliminary Test Results: Coll Density Values
1"
Tab. 3: NOECILOEC and ECs-Values (0-72 h) of Biomass Inhibition
and Rate-Rolated Inhibition
1.
Tab 4: Coll Densities
1
Tab 5: Evaluation after 72h
1
Tab. 6: EC,-Valuos of Biomass Inhibition and Rate-Related Inhibition of the
Reference liom
20
Tab. 7: Water Parameters
2
Tab.8: Repeatabilty of Injections of Tost lam
27
Tab.S: Mean RecoveryRateof Fortified Samples
2
Tab. 10: Concentrations of the Active Ingrediont 1-Docan,
3.3,4.45.5,6,6.7.7.8,8.9.9.10,10.10-haptadecafuoro-
2
List of Figures
Fig 1: Cell Densitas for Control and Limit Concentration (0-72 h)
2
Fig.2: Calibration Curve of Standard - conconration range 0.01- 0.06 mg/L 3
Fig.3. Calibration Curve of Standard - conconiation range 0.1 - 10 mg/l
at
Fig 4: Calibration Curveof Standard - conconiration range 0.1 - 0.6 malL
at
Fig.5 Chromatogram of Standard
3
Fig.6: Chromatogram of Tost em
P
Fig. 7: Chromatogram of Control
By
000049
Reon
[DR.UNOACK-LABORATORIUM FOR ANGEWANOTE BIoLOGIE
NE
To Param
`1H-iDgao,cGanroolw,in3,n3n.i4b,i45l.o5nT,6e.s6t.1w.i7t,h8.S8c,e9n.9s,d1a0s,1m0u,s10s-uhbospptiacdaetcuasf,l7uor2o,- Limit Test Project-No.020109CK
whieWahter Accommodated Fraction (WAF), acc. OECD 201
StudyNo. 55084112
1 Summary
``TnhuembaecrutPetOo0xIi0c0i1t)yotfo t1h-eD0uGniacneolll,ul3ar.3f.r4e,s4h.w5a.5t.e6r.g6.r7e.e7n.8a,i8g.a9.S9c.a10n,e1d0,e1s0m-uhesplsaudbescpaifclautouros-w(absatch FdoOtReArmNiGnEaWdAaNcDcTorEdiBnIgOLtOtGIhEeinpr3in1c1i5p7lesSaorfstOeEdCt,D-GGeurimdaelniynfero2m01A,praitlD0R. (0N04O,AC2K0-02L.ABORATORIUM
dTehnessittuydoyf nwoamsincaolnldyu1c0tedcelulnsdiemrL.satanicdacownadtiotrioancscoovmmeoradadtureadtifornaoctfio7n2ahsoiumristwciotnhcaenntrinaittiioanc,ell
containing 0.47 mg/L. For suspension with a nominal
the preparation loading of 100
mofg/tLhewwaastesrhaakcecnomfomro9d6alh.ed
fraction
(WAFa)
Tost `were
vessels wero coated with the test tested for the limit concentration
iam and
for 14 days before the replicatesforcontrol.
test started. Microscopic
Three replicates evaluation of
WhaetecerllqsuaaltittyhepastraratmaentdeeronsfdpoHf-vtaheluIen,cumbeaatsiounrepdearitod0 raenvdea7l2edh,noanmdorrpohoomlotgeimcpaelraatbunroer,maliios.
measured continuously, were determined (0 be within the acceptable limits.
hTohpetacdosnccaefnlturoartoi-onwoafstahneaalcytsievdeaitntghreedileinmitt 1c-oDnacecnatnraa,ti3o,n3.l4e.v4e,la5,t5e,6s,8t, s7t,a7r,t8a,n8d,9,t9e,st10e,n1d0.,1D0e-tails Dofectahnooaln.al3y.t3i.c4a.l4,r5e,s5u.lt6s6,ar7e.7g.i8v.e8n.9in.9P,a1r0t,1100.,1T0h-haoipntiatidaelclyalmueoarsou-rweadsc0o.n4c7emngt/rLa.tAiolofnthe1-end of 1h0ethteesgtltahses cwoanlclesnotfratthiotnesotf vthaesstaelsst itseumnlwikaeslybaeslotwhethwealdlestewcetrieonallrimeiatdoyfp0r.e0-0c9oamtge/dL.foSro1r4ption days before the test has started.
ITnhiteiealflfyemcetasosufr1e-dDeac..ancooln,ce3n.t3r,a4t.i4o5n.5a.r6e.6s,u7m,7m,a8r,i8z,9e,d9.i1n0T,a1b0l,1e01-hepladocafluoro- based on
000050
R Bm ssM sem-- crepes
[] onition of siomass growth mais
Cee TTT
000051
DR.U.NOACK-LABORATORIUM FOR ANGEWANOTE BIOLOGIE 1R-eDpoorcatnol, 3.34,4,5,5,6,6.7.7,8,89,9.10,10,10-hepC tadecafivoro- T Papeso v`Ailtgha,thGeroWwattherInAhicbciotimomnoTdesattewidthFrSaccatnioend(eWsAiRmu)s,asucbcs.piOcEatCuDs,27021 h, Limit Test PStruodjyeecNto-.NoS.500280410181C2K
2 Characterisation Data of the Test item
TEST ITEM
1-Decanol, 3,3,4.4,5,5.6.6.7.7.8,8.9.9,10,10,10-heptadecafluoro-
Batch number
PODIOOT
CASRN
678-397
`Chemical characterizatio/n 3,3.4.4,5,5,6,6,7.7.8,8,9.9.10,10,10-heptadecafluorodecans-1-of
`Active ingredient
(EINECS)
Purity
(sCuBm-peprofrlfuiourooraolaklyklyeltehtahnaonlol999.93.9%%(a(laal)a,)
Appearance
Yellowish solid wax
`Water solubility
134 137
pg gL
at at
12 25
degree degree
C, C,
Std Std
29 53
git, ugiL,
n= (DuPont, 2002) n=17 (DuPont, 2002)
Stabilty in water
Stable at test conditions
Density
Ca. 17 glem"
Expiry date. Recommended storage Storage at testing facility Retention Identification parameter attesting facilty
Unlimited if stored under the recommended conditions. Room temperature (20 C). protected from moisture. Room temperature, protected from moisture and light Atleast 1g has been retained.
Name, batch number and colour.
The tost item and the information concerning the test tem were provided by th sponsor.
000052
Fogo
DR.ULNOAGK-LASORATORIUM FOR ANGEWANDTE BioLoGrE
1-D0canol, 334,4.55,66.1.7.889.9,10,10.10heptadocafiuoro-
Page 10675
wAillghai,neGWraowtnernAiccionmmToodsattweiFnraScctaionno(dWeAsFu)s.saucbespOcEalCuDs,27021h. Lim Test SPtroujdeycNtoN.o.5G52008140181C2K
3 Method TEST GUIDELINE
OTYFPTEHAENSDTUPDUYRPOSE
TEST SYSTEM Tost organism oRfetahsotnofsorstyhsetosmlaction origin
Date of receipt Method of culivation Guture medium TEST mem wPreottreostattmoenmt of
(OaEdGoDp-tGedui7ddluincn,g 1N9o.842)01 for Testing of Chemicals
oAlngog,rogwriohwtahteinatinbdliboinotmeatssfoprroddeutcetrimoinnawtiiotnaofwahteeraffects ac(cLoimmiotdTaotsetd) raion (WAF) of he tot om ovra period of 72
Sconadosmus subspicalus CHODAT SAG 86.81 SAcAcGor6d6i.n8g1o1hseuitgaubildeafionrotSiscaknianddoofssmtuusdsyubspicatus CHODAT `PSllaamnmzleunnpghyvsoinolAolggiesnckhuelstunrsetnu(tSAdGe)r, Universitat Gotingen, Nikolausbarger Weg 18, 0-37073 Gettingen 1997.00.07 IFnrteosnhsitsytoacmkosuwnetroedp3r5e-p7a0reWdEeIv'e+ry5mfoornt2h4ohnpZo-rAgGaary.. Light Nutiont medium Z accordintog LOTIGE of a. (1994), h1o-Dpotcaadneelc,au3o.r3,o4-,45,56,67,7.88,99,10.10,10hTohmeotgeasntiosamtiownas hosted to 0 C befora weighing for
000053
DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE = 1-D0canol, 3.3,44,5,5,667,7,89.9,10,1010-heptadecaE fluoro- EE] Hwiigha,iGnoroWwattherInAhciscioiomnmTdeasttowidthFrSaccteinoend(eWsAmFu)s,saucbcs.piOcEalCuDs,27021, Lit Test PSrotjuecdt.No.5052008140101C2K
Cteosattvinegssoeflsthe
A costing phase of 14 days was carried oul
Proparation
h2e0p0tamdgec1a-flDuaocraon-o1lL, d3i.l3u,t4io.n4,w6a,t5e6r.6(,o7t.7a.v8.o8l9u.m9e,120,L1)0,w1e0r-e shaken n'a otating shaker with 20 rpm for 96 h a1 20 C. 2 -brown glass flasks woro used. Afar phase separation 100 mLportost replicate was ransforrod from the clear liquid phatos25e0 mL Erlanmeyor flasks and closed wih plugs. Dilution water was used forthe preparation of the coating solution.
Coating period
nTohmeinraeladliyl2y3fi+le2d aCndfocrlo1s4eddayEsr.leAnlmtehyeeronfdlaosfksthweorcoeatstionrgepdeartiod the flasks wore emptied and usod for the tost.
Proparation of the test mtreadctiiuonm, (WwAaFte)r accomodated 200 mg 1-Dacanol, 33.4.4,55.6.6.7.7.8.6.9.9,10.10,10-
heptadecafiuoro- L. dilution water (total volum 2 L) were shaken ina rotating shaker with 20 pm for 96h at 20 C. 21 -brown glass flasks wore used. After phase soparation 100 mL per test raplcate were ransfarod from the cloar liquid phase (roprasenting the WAtothFecoa)ted Erlenmeyer flasks.
CONTROL
cSioxndriolpoincsataesst(hweilohsouttrteepslticfatoems.) ware tested under the same test
SELF FLUORESCENCE
No sel fluoresconce was found at the water accomodated fraction.
REFERENCE ITEM AS No.
purty Batch No. Tost concentrations(nom.)
Potassium dichromala p.a. (MERCK) 7778-50-9
002% K 233 78864848 0.1-02-0.4-0.8 18-32 mall
000054
DR.U.NOACK-LABORATORFIOURM ANGEWANDTE BIOLOGIE
R1:Doecanpol,o3,344.5,5,667.7,88,99.10,10,10-hoptadecafluoro-
Page 126130
Awiigha,hGeroWwatehrIAnhcicbiotmiomnToedsattweidhFrSaccatnioendesm(WuAF)s, saucbcs.piOcEalCuDs2,0712, Limit Test ProjectNo.s0s2o01s0191C2K
Rang of validity Experimontal date
00.2600 mmggliLL << EExCCaens((77220)) << 10..0735mmggliLL. November 27 to 30, 2001
TEST CONDITIONS Performance of the fost Exposure duration
Replicates Test container Test volume Oitution water
Static procedure EExxppeerriimmeennttaall cstoamrptldeattieo:nAdpraitle:01A,pr2i0002, 2002 Three replicates for mit concaniration aval, per control Erlenmoyorfasks, 250 mL. with coton wool plugs 100m According to the guideline:
[co| mpcono cenmatir onimgryt|
waTs
wcnewo
7
7]
[ccvamo 1
1]
[somme 7s ]
[o -- 17we
[haemo Tom
[eso amoIe
[we owse
[wowawo [ows
ae
ner
Preculture
chow
sao
[em [e 7 m et e
wwe,Tw
CwTee]
Apferofuorrdmaeyd oinld50pr0ocmuLltEurrelewnamseyuesredflaasskisnwoictuhludmi.lutIinocnuwbaatleiro.n Fwoars h1oresctaeritveofatnheinttieaslt tchaelpcroonccuelntturraetiwoansodfialputperdoxwiitmhatdeilluyti1onx w1a0tor cAlelllasligmaLe iwnetrheefrreoplmictahteess.ame source and have not boen used in a provious study.
000055
DR. NOACK-LABORATORIUM FUR ANGEWANDTE BIOLOGIE
1R-eDpeocratnol, 3.344.5,5,6.6,,7,8,89,9.10,10,10-heptadecafiuoro-
faena
w`Ailgha,thGerWoawttehriAnchciobmimnoTdeasttowdihFSrcacetnieonde(sWAmFu),sascueb.spOicEalCuDs,27021h, Lit Test PSrtoujdeyctoN.o.5G5200180491C1K2.
Application Temperature Agitation Light intensity Light regime KOIFNMDEAANSDURFREEMQEUNETNCY
Equipment
hAtettheestteisttesmt.art fluorescence was measured after application of Nominally 2322 C T`aopsptrocxoinmtaatienleyrs70worrpme.placed on a rotary shaker and oscillated at Nominally 60 - 120 Ems 24 hid ight
C(eelxlcidteantisointyatwa4s35mnema,suermeidssviioanCahtlo6r8o5phnyml).-a-Efalcuhorreespcleicnactee was mofoathseurteesdt 6a-n10dide.veTrhye2c4ahll dFeinlsriattyodwadsilumteioanswuarteedrawtatsheubseegdinansing `ground signal. "The p-value at the begining of the test was measuredoutof `on additional replicateof the imit concentration and control. At the ond it was measured from a poool al replicates. The room tomporature was measurod continuously by a hygrothermograph. Light intensities were measured prior to test start. Microscopic evaluation of the cells was determined at the start uannudsounald coofllthsehaipnecsu,batcioolno.r Adlifgfaerceenllcsesw,edrieffcehraecnckeesdfionrchalnoyroplast morphology. flocculations, adherenocfe algae to test vessols or aggregation of alga cols pH-Molor, pH 191 (WTW) Hygro-thermographe (KLMATHERN) C`Shhiaokreorp,hSylM-i2m5puAls(fBiUuHoLrEoRm)eter (KLEWFELD) Contrifuge: 2K 364, ZiRBUS `IQnvuearnsteummiScernossocrop(eSK(YZEeiIsNsSITMRU2M5E)NTS LT0) FRoltuaotriensgcesnhtatkuebres3,04S0,kGaFLL 36 W / 11-860, daylight (est) Fluorescent tubes, LaNP1 18 W, 60 cm, warmwhite (culture)
000056
'DR.UNOACK-LABORUAMTFOURANGEWAKDTE BIOLOGIE
R1e-Dpectanol, 33,44,5,5,66,77,8,08,9,10,10,10-hoptadecafluoro-
TEE
wAitgha,tGhreoWwatthorinAhicbcitoimonmToodsattweidhFSraccotnioando(WsAmEu).ssaucbcs.piOcEalCuDs,27021 . Limit Test PSrtoujdeycNtoN.o.S052008140191C2K
DETERMINATION OF THE TEST ITEM
The test concentration lavel and control was analytically dveertiafciteidonby(gma/s=zch4r6o3maalnodgr39a5p)hay wittehsmsatsast sapnedcttersotmoenrdi.cAl the nd of the tost replicates with aiga wore analysed. Al dotails of the analytical mathod aro given in part 10.
`COURSE OF THE STUDY
Based on tho rasults of a preliminary range finding tost (NONGLP), the definitive test was porformod with 1 mit concentration vol with 3 replicates Asctoentdroulnwdietrhtdhiolustaiomnawcaotenrdi(lwointshoauts etshettietsetm,grsoxupr.eplicates) was. Afour day-old pracuiure incubated at study conditions was used for the main study. Ghlorophyl-fluorescence was determined at the beginning and after 24,48 and 72. `Other measurements were performed as specified above.
CALCULATIONS AND sTamisTics Couotleouflaftliuoonreosfcceanlcledovnasliuteys
Call desis for each replicate were calculated from the fluorescence values 3.6 (soe raw data). The fluorescence values wore related to coll density values as follows: xx ==6ce3td-enFsqit.y+c3t6u2i5nt 6 =tacocomuomtna10emL Fa = mean fusrescence veeofa elctes po conconvaion S625 =ca cansy cots Comviaton dato Ar 12, 2001 7=03963, 18 The growth rate, the inhiiton of bomass and the rate related ainchciobritdiionngatfoetrhe72fhorwmualraescsaltceudlabtoeldowf.rom the cel density values
000057
DR.U.NOACK-LABORATORIM FOR ANGEWANOTE BIOLOGIE R1-eDeocannol, 3.3,44.65,6.6.7.7.8,8,9,10,10,10-heptadscafivoro- pam w`iAtgha,hGerWowainroAhcibcioimomnoTdeasttewdihFrSaccotnioondo(sWArFm)u,s saucbcs.piOcEatCuDs,27012, Linit Test SPtudry-NooN.oj5025e00180c491C1tK2.
Calculation of biomass integral
Ned Meme
eam
a
NNoo mnoomsinsaelsnunmubmebreorfofccoatmeratattmmaatr.,
[A Lo
tim of
------------ mossurament ator bopming of ast
Calculationof biomass inhibin
IW= a(Ac oAmre)ssAicm)bi+ o1n00%
@
Ae = omaisnth s conttesteernaigncoarm.
Ar = massa in hetotconcanvetonato. ncan
Calculation of growth rate = (In (Na) 10 (Ne) / (tu - 6)
@
bNo == romoemnrasetacorntdienrcsall
Ne = ome stein colimt
tbo awummeaots6e%pmnansnsguortemtaennt ser begin of test
cCaalecurlealtaitoend oifnidition NstOatEiCst,icaLlOaEnCsiyasnids
a= (eww)+ 100%
@
Ve = rout rate of thoconvostern b= rom rate of th est concertos ater nd
OgrnoewtwhayrataenaalnysdisboifomvaasrsiaInncteegr(aAlNs,OVraAs)peacntidveDlUyNwNorEeTTcfaorrsiteodfout fcoormtphaerdeedtetromcionnattrioolnroefplsitcaattiesst.icWalhlyesnigrnuifniicanngt aifoenroanwcaoys.analysis offisvta.riPa-vnacleueasnfoorrmabloitthyntoersmtaalnitdyaanndeqeuqaulalvavrairainacnocetetsetswtsaswedroeno. 0.05. The value for ANOVA and DUNNETT's test (acceptable wparsobaa=b0.i0l5.of incorrectly concluding tht ther is a difference)
000058
DFU. NOACK-LABORATORIUM FORANGEWANDTE BIOLOGIE
R1e-pDoecratnol, 3,3,44,,5,66.77,8.8,98.10,10,10-heptadocafioro-
Ppiea
Awillgha,ihGorWoawttehrInAhcicbioimomnToedsattwedhFrSaccetinoend(eWsAm)u,sascueb:spiOcEatCuDs,27021 h, Limit Test SPturdpNooN.oj5052e0081c4091Ct1K2
Software
VALIDITY CRITERIA
DEVIATIONS FROM THE GUIDELINE DTEHVEISATTUIODNYSPFLRAONM REPORTING. ARCHIVING
Tho data for the tables in this report were computer generated `and have boen roundedforpresentation from tho ful derived dala, Consequently if calculated manually based on the given data minor variations may occur from these figures. C- aSlicgumlaatPiloonts rwee.r2a0c0a0rr(i2e0d00o)u.t SusPiSnSg Isnoc.ftware -- SEixcgemlas2t0a0t0ro(l20020.)0,3 M(I19C9R2O-S1O9F87T)C,OSRPPSOSRAInTcI.ON ~ TInOcX.,SCThAaTyerneln.e3,.W4 Y(1988240)0,1Wa&stDoarvnidEDc.osGuylslteoy,msUnTievcehrnsoiltyogoyf. Wyoming, WY, USA.
Tohpioccaotllesdewnistihtiynh7a2dh1 increase at minimum 16-fold in the conirol Tho temperature during the test had to be in the range of 2Th1e25pH-Cvaclounotrooflltehdeactont.r2olCr.eplicates should not normaly aviato by more than 1.0 unis during th test.
None
None
The fina report is ssued as paper copy (6 originals)and an eloctrnic record (1 origina).
"The following was rotained in the archivo of the tst faiity for
+theallpearwioddaatsa.specified in the operative national GLP regulations:
+ study plan orginal 1612)
+ +
final report all records
ppearpfeorrcmeodpyb(yotrhgenqtualoifty6)assurance
programme
+ sIancmlpuldeinogfmtaessttotrosmchedules
Microfims will bo retained in safo-dapost by
Voksbank Sarstedt, D-31157 Sarstedt.
000059
Rept
DR. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE pemam
i`1A-ghDae,ichaGonrWooalwt,teh3r.I3nA,hc4ic4b,oi5om,nm5oT,do6sa.tt6.ew7di.hF7r.Sa8cc.ot9in9oo,nd(1b0Ws,A1r0)u,s,1a0scu-behse:ppiOtcEaadtCeuDcs,a2f70o21roh-, Limit Test PSrtoujdeecNtoN.o.5052008140101CK2
4 Results
41 Preliminary Tost
The results of the preliminary test conducted February 25 o 28, 2002 aro prasantad below: Tab. 2: Praliminary Tost Resuite: GollDonsiyValues (2 roiicates oach, contol: 4 rapicates)
1 of towater
Accommodates Fraction
1410 of tho Water
Acconmodstod Fraction
7
Control
2
3
`
Cal density [cotsimi)
on
720
Ties
Sem
10885
sosse
Tear
s51003
1
ssso03
Tez
Ssoais
130
ssaate
10587
26085
11547
s03465
42 Definitive Tost aGorlelgdiavnesniitnosTaabrloelis(tecdalicnulTaatbedloo4u.tEovfalcaulaltidoennssiotfy vbailoumeas)s.s TInhheibgitrioowntahnidnirbaitle-orneoaftfeedctisnhoifbitthieon ost tom aro summarized in Table 3. Microscopic evaluation of the calls at the sart and ondof the incubation poriod ravealad no morphological abnormalities. mWeaatseurrqeudalictoyntpinauourslay,mmoeeflpttHh-eevagrluiusdee,limneearseuqrueidreamet0ntas.nd 72 h, and room temparature,
000060
-E a hsen--" wo
[TT aiotion of bomase row mats
Te Te]
TT| eerste
Te Tw
Sok apices
| onTwnTwnTen |
|ov | ose [sess | weosws|eon |
[oTos[ow von | soon]
000061
Topo
RU NoACK-LABORATORUM FOR ANGEWAOTE BIoLOGIE
1-Dacancl 33,4,45,56,67.7.859.9.10.10.10 haptadecafiuoro-
ETE
Rsiia,nGerWoawonAcpenoTmomowditFahraSicctoeirodande(sWmAPu)s scuebsOpicEosGs,2O7031nLimi Test SPturnN.oo5052j008140e181C2K
Tabs: ESvaalutattioan sstacr a72n0 ferences of biomass inal and Growth rates comparefdo CCoancrlivaaliungarANmaOrVkAed((O)n, WnootyrAincsaysnoofVeanricaencsesa.reDmnaareerss( ndNOWEaswass {oF (00.08). sated on ay mastured concaniaton.
Tost tom
apamraiee [inion
RatTeonrotoioond
[we | 1o% m
1%T)a
oan [a| sae | am
"om
[5] ssw | am
"oss
|EwmETeme Toam]wToae [6 ow |
2] won
130
a
120
[[o5T]]
wen anus
1a 1
a
a
ve ean ogee WSs= esof e
000062
TR ginl33N 4I 4581601a 07s7a, 8pep9ert8s e Bete FSraniCgirdt mo nothCoi rionna Seii tisoRCotesia
s Tomotmrmmmn stn Sn
A
1]
rhiosfSoimaissgoronw
-- ee J.
Reemaswon
5 ValidityCriteria
000063
[DR.U.NOACK-LABORATORIUM FOR ANGEWANOTE BIOLOGIE
R1-eDpoocanol, 3.3,445,5,8,67.7.8,69.9.10.10.10-heptadecafluoro-
reenia
wAilgha,ihGorWoawttehrinAhcicboimonmToedsatteidtFSrcacatnioonda(sWmAu)s saucbes.piOcEatCuDs 20712 , Limit Test SPtruodjyo-cNto-.No.500280140191C2K
6 Conclusions
In this inhibit
study 1-Decanol, the growth of the
f3r,e3s,h4w,4a.t5e,r5g,r6.e6e.n7.a7l.g8a.8S,c9.e9n,e1d0,e1s0m,u10s-hseupbtsapdieccaallulsuotraos-twedaswinthottfhoeuwnadtelor
accommodated fraction (WAF) containing 0.47 mgiL. (intially measured concentration).
7 Literature / References
(1) D39u-P7o,ntU,npDubleistheed rresmuosfi,phUnypsdiaactote-cFiheebm.oic1na5,l2p0ar0a2meters ofPerluorooctyethCaAnScNlo., 676-
(2) EEC Dioctive 92/69/EEC Method C.3, EEC L3834/179 (December, 1992)
(3)
LOTIGE, U, Sch E.,Ln AUGHe,A.e , NAG, ATA, T. (odors, oftheGorman Botanical Society, No. 3 Volume 107 page
1984): BotAactna,iJoucrnaal 111-188 (Juno 1994), THiEME-
Vera.
(4) JO une E 7-. g1u9i8C d4elinD eno. 201 for esting ofchamicalAlsg:a,growth inhibition tast. Adopted (5) OToExCicDtySeTreisetsinognoTfeDsitfifincgulatnSdubAsssteasnscmeesnatn,dNMoix2t3urGeusiEdaNnVc/eJMD/oMconuom(e2no00nt0)A.quaic.
000064
Report
DUNoACKLABORATORIO OR AGEWANDTE Bote FTA
`Ni-DoacinaGenrooWlwa,tt3he3rn,A4oc4o,c5on5m6mT,oo6s7i.ew7id.t8hFS8r8scc9hl.o1nn0a1(0dW1Ae0)r-.hseaucpcbi.aapOdieEccCaalDt,u21o0r12o,-im Tet SPtudryNNoaoS0S2c0O1B0H9tTCK2.
8 Graph
Tove --3o7-- CWaotnetrlAccomadaed Fraction
Zz
5 tos
z
Tors
P
=
Time)
Fi 1 Goll Dantes or onto and Limi Concentration (6.72
000065
-T EE S oE nN e soA omA A mmeuurs oesnospEnE A tor em
9 PhysicochemiDcaatla
r ewe es[] ew]
[orw emo| oor r |soe e]
000066
DR. NoxcK-LABORATORIM FOR ANGEWANOTE BIOLOGIE -Docancl, 334,4,55,6,6.,7,889,C 9.10.10.10-hepladecE afioro- D wAgiah,ihGeroWwaitnerinAhcibciotmonmoTdosattweid FrSaccoinoend(oWsAFm)u.sascueb.spOiEcaCtDs,27021, Limi Tost PSrtoujcoy.NNo.o.5052008140191C2K
10 G10C,1-0,A1n0a-lhyespitsadoefc1a-fDieucoarnoo-l, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,
10.1 Method DMEETTEHROMDINOAFTION
Equipment
`1A-nDaolcyasneosl,of3v.a3r.i4o.u4s.6c.o5n,c6e,n6t.r7a.1t.i8o.n8s.8o,f3.10,10,10-heptadecafluorowSIeLre8ccaapriiloladroycuotlvuimangasuscihnrgoemxatterongarlapsthayndoanrdas.FuDseetdecStiiocnawCaPsperformed witha mass selective detector (MS).
AuGtaossacmhprloemratograph GCPT-C36C0o0,mbViaPRAALN, CTC Avauymics
SDoefttewcatorre
MSSa,turSnaGtCu/M20S00W,orVkasrtiaatinon 5.51, VARIAN
Reagents
tert-butyl methyl ther 99.8 %, Batch 42337011 31101, Fuura
`CONDITIONS OF ANALYSIS
Column
CLhOrWomBpLaEcEkDGPM-SSI,LF8i(mVtahRic)k,nes3s0:m0,.2i5d.pm0.25 mm.
IInnjjeoccttoorr temperature S25p0ieCss (30 psi prossure puis) for 1 min
iTnejmepcpeteratureiroantvuorleupmreogprogramme.
Tat Heating ato | Temperature | Holding ime
(Cimin
rg
min)
[=140 T7700
[Co1s 170
Cm
20
50
DeGteacrtiorgas Rfounnistaitmioen mode Retention time
Hmeslium 1 mL min column flow E1l6e.c3t3romninonisaon (E)) approx. 49 min
000067
'OR.UNOACK-LABORATORIUMFOR ANGEWANOTE BIOLOGIE
Re1-pDoocratnol, 33,4,,5.5,6.6.77,8,89.9,10.10,10-heptadecafluoro-
Papmo
iAltgha,hGerWoawttehriAnhcicbiobmomnoTdeasttwoidthFrSaccetinoend(eWsAmFu)s, saucbcs.piOcEalCuDs,27021h Limi Test PSrtoujdeycNtoN.o.505200814091C1K2.
STANDARD PREPARATION OF STANDARDS PREPARATION OF SAMPLES METHOD VALIDATION Peak symmetry,
Repoatabilty Accuracy
Test tom was used as standard.
"Two stock solutions of the standard of 200 mg/L wore prepared
in tort-butyl methyl used for calibration.
eFthoerr,cadliilburtaetdio(n9rcaonngceenstaraatpiaornts
1o0a.2c.h1)
and
40 mL of the sample wero extracted wih 4.0 mL fort butyl methyl tinhtoor.thAefGtOerIMpSh.ase separation the extract was injected directly
Qmuaasnsiiefsic6a9ti+on3o9f5t+he4t6e3st(imtze)m bwaassecdaolcnutlahteeedxtbeyrnpaelskstaarndeaarodfs.the o`Tfhdaectaelcitbiroantiaonndprqouacnetdiufriecaatinodn ltihmeitpsriwnocirpleadfaorpttehed dfertoemrmDiInNation 32645. The method was validated as described below: Peak symmatrios wero calculated from chromatograomfs analytical standards and tast tom according to the following `equation T= Weml(2) WToes== PPeeskkwsiydimhmea1ty5 % ofpeak height fmm) f= fst soctor of peak wih ( vided by tho perpendicular
ine trom tho peak maximum) (mm) 5 sub-samopfltehse highost and lowest concentration prepared from a single homogenous sample wore analysed. Mean values, scatlacnudlaatredd.deviations and variationsof coefficients ware 51-s0a0m6pNl0o1s,w3i.t3h4440,m5,L5.6w,a6t,a7r.7w.o8r,e8,s9p.i9k,e1d0,w1i0t,h10a-nhoapmtoaudnectafoflv8oryog(`A8f0toprLwaorfds10s0ammpglieLs) wfoergieveexatrfaicntalodcoanscednotsrcartiiboond aofbo2v0e0.gil.
000068
'OR.U.NOACK-LABORATORIUM FUR ANGEWANOTE BIOLOGIE
R1-eDpeocanol, 3,3,44,5,5,6.6,77,8,8,9,,10,10,10-heptadecafluoro-
Paema
w`iAtlgha,hGerWoawttehrnhAicbcioomnmToedsattweidthFrSaccotinoond(eWsAmFu)s, saucbc.sOpicEaluCs2,D0721h, Limi Test P`rSotjudeyc-tNoN.o.S052008140181C2K
102 Method Validation `The me~ tholidnewaaristyvalidated and tested with satisfactory results with respect to
~ ppreeackissiyomnm(erterpyoatabily) + accuracy ~ determination mit and detection limi
1024 Linearity The analytical system gave linear respons in the rangeof0.1 - 10 mgiL of 1-Decanol, 3.3,4,8,5.5,6,6.7.7,8,8.9.9,10,10.10-hopladecafluoro- The calibration curve and chromatograms obtainedforstandard and test item aro given in figure2s - 7. For determination and detection limits soe part 10.3
10.22 Quantification Limit and Detection Limit `The limit of quantification (LOQ) and limit of detection (LOD)were calculated using the bind value method described in DIN 32645 "Nachwais- und Bestimmungsgranze'. The LOD was determined to be 0.009 mgiL and therefore the LOG was 0.027 mg/L (threefold the LOD),
000069
Bein 134455D4n67.eo7sA8e4s081p010o10npaiocnnuRsawtcOrew-eTrsBonao pE ro me Cok y ep Tot SPrejosogaaOmReCK 12s stron prey Tou renotftshe pus ar grin atta
Tn: --pen--a -- tonsofTet tm [OKTrTTHrE
[ei|nceentr|
[21 aos | vases | 1
1
= [meso 2 [n ws|me a masres aes|| ComTw| 1524 Tos y pThorpoettsaymmmetirynfhee st om 1-Docanl, 344550477889910.10.10
000070
=Enmore -- sm
EomE [al Ce EE mee| 2 or] ENE |roms a]
[sa] [ee]
amet | oor
eig E==e EE m EEEEmm [o1 om ooo m u1
000071
Bene] 134455467784981010oapasec[ atro-he me TT a -- mas Eaeen ok Tot PSrs Noo20t 10t00
oe---- T or |T Toren
proms ae
r--
a toaTon |
SEE
ow ow a oSoorm?) Tome|
JLi2EmT
Js---- ------ EE=Emu
rari
iy
000072
RDaopcaanc, 34.4.8.8D.8R7.N7o.8K9G9H.L1A0B.O1R0A.T0ORhUpMiaFdOeRcAautsvEowrM-DTE Boo Fae iKia: GaroawtthoAickoomnmoTdosalwislhSsccoinoandeAsuFs)ssues.apOcEaCsOs,27031 iTm ostStPynreNoSoCs200814c0101C5K
10.4 Caibraion Curves ATtheercanativmaetsn curves shown wera asablihedfo arant concanration ranges anda
|
Calibration Curve of Fluows (2002.04.04)
|
200
| 20
]
Zz1500
13Tow PY
| o0
L
*
--~
3
[a
yesRzizseoosesssser
on om om oe om oo conc. tot)
Fo. 2 (Cianelsv2a0n0C2u.0r0e)of Stan-codncaanvratidon ange 0.01 0.08 mat
000073
wg A RS et Siem
CalibrationCurveofFluowet (2002-04-10)
peoew 500000
250000
Li ooem 4om0me%
i1
~~
S a= O R090
ee es
{
Bat
| cation GareofFm 808
wwenr
i
=20000
_
|
2fo0e -
aznsn
\
|
Cone.(mail)
000074
DR.U.NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE
R1o-pDeocannol, 3,3,44,65,66.17.8.80.9,10,10,10-heptadacafiuoro-
Page 320130
Aig, Growth inhibiton TostwihSconodasrussubspicalus, 72, Limit Test ProjectNo.020109CK.
iththo WaterAccommodatedFraction(WAP). acc.OECD201____Study-No.SS084112_
The frst calibration curve was established 2002-04-04 but he concentration range (0.01 -0.08 mgIL) was not broad enough t be used foral tess running. Thorofore the second curve (2002:04-10) which covers a much wider rango (0.1 - 10 mg/L) was used for the calculations in his tast. The concentration calculations using the tw different curves do not differ moro than T10ha%caflriobmraetiaocnhoctuhrevra.from 2002:06-19 with a concentration range of 0.1 - 0.6 mgiL. shows that tho GC/MS systom has a good stabilly over along pariod of time.
000075
FTaecoan, 13445D,6r86N118o89A610L,10A10bBeptOFaOdeMcAatrTuocrOoe- eRBUtooMr: ETE] Kon CrowantnA ahnm Tosim sSeannao Sd AESsoepSiEaD,2113hLik Tas s Prjoci koQ20n 106CK 105 Chromatograms
Eo om
BTEaw
US,
a Hen -
No : | es Lo[PRR
||
|
f= TEE
12 I HnET
| J|
|" IM
|g !
WL
II! J
rn) !
1.5: CroaetmeaotsofgSarnatrmd
000076
E"I r J AS SYvo soTnEe
SrToh os ict
a
a
Ee Ba oo om ap ssvese. =
Cdl
|
iI]
AHIl
| i I|nt
|I I
= |
oSnisrentet msismansosn
000077
wEi= ssx ssrnrsi aemEsmamsTnetens ems sey wea was
a E = D mB Koad" mms
Sane ae
ily i I
ERT
i LI' | h
|
SS
000078
Report
ORV NOAGK-LABORATORIUM FOR ANGEWANDTE BioLoGIE Page 360135
1Ri-gDao,cGarnoolwn33I4n.h4b5i5l,o6n6T.e1s.t7w.i88S,9c8a,n1o0d.o10s.m1u0s-hseupbtspaidceactaufs,lu7o2ro,-Limi Test ProjectNo 020106CK
wih ne WatorAccommoFradcioont(WeAd)ac OECD201
StugyNo. 55084112
11 Raw Data [I------
po ax
EE elswwweTew wen [ee
[r--
[Er --
[EaralswwweeTew wmTe
= 0 rn 7 2
000079
DR. NOACK-LABORATORIUM FOR ANGEWANDTE BIOLOGIE
W1-eDelcanol, 33,44.55,66.77,8,69.9,10.10,10-hoptadscafiuoro-
Papwow
`iAlhga,thGarWoawttehrnhAicbcioimonmToedsattewdihFrSaccoinoond(eWsArFm)us,ascubes.piOcEatCuDs,27021h. Limit Test PSrtoujdeyc-NtoN.o505200810491C1K2.
[-- Ew
J-- |
=ivw
Frorescance star720 on
Er re sw wr2
pan amex pr son rn |
[Emalr AmawwTennTewTwn eee)
000080
OLUNOACK-LABORATORIM FOR ANGEWADTE BOLOGIE
R`1eiDgeeocaGdnroolw,n33n4i45i,o5,n6T8o7s.7w,i8h89S.e9a1n0e,d1o0a.m1u0s-sha uabpdtpaidceectasf,u7ow r2o.- imiTosa ProjoNo0 20109CK
"iheWater AccommFraacntiodn(aWAtP)e,sdc.OECD201
Sto. SSOBTT2
12 Cheerpttiafdieccataefioufo1r-oD-eAcnaanloyls,is3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
LZ
= Clariant
000081
ORNokLASoMTORMFUR AsewmeTE BoLcoe Theol 34.45,66677.8899,1010.10hotadacaiuoro-
=
iKonnGraou ocnaTsei ioFSresariansiB enotsA eeoBpEF aDt2n3 Lmk Test tProepctNos0a20o1n0r0CsK
13 GLP-Certificate of DR.U.NOACK-LABORATORIUM
GLPBpesocomhteeabisrnaGgiounsnagt/AoeSfutLbarcittCnoesmmplaianncte Bfr,ESTpeWe,R3AMOrEeLsEtt ST emO menssr:e
ore .xrNonka LAgRORTAoTtORtMy C3oPm r.sse tcKTORnATORY
SoXo
Sa--, --
vtegreenoreToagay Pmirreaon a-- seeBeiere e-- roooa sea -- mao ry-- at dS eCea-- ttp cee nr7-- dre OatmCtr Tpm-- rainnn S + Fa otoy s egenPottsr wevtoum strateSours
[I antPlSomer esSoe at 1.0 gEmmmermy rms EECETETEmIE summa
me: @ ent rel \ 3J
000082