# Annex B



# Spirotetramat

B.2 Physical and chemical properties

Reviewed by:

PMRA, Canada

Peer-reviewed by:

US EPA, USA

AGES, Austria- 2 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008B.2.1 Physical and chemical properties of the active substance (Annex IIA 2)Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceMelting point and boiling point IIA 2.1B.2.1.1Melting point,freezing point orsolidification point,purified a.s.IIA 2.1.1EC A.1,OECD 102BYI 08330,mix-batch08045/0003,purity 99.2 %The melting point of Spirotetramat atatmospheric pressure is 142 °C.The result is acceptable Y Franke, J.; 2004M-063268-01-1B.2.1.2Boiling point ofpurified activesubstanceIIA 2.1.2EC A.2,OECD 103BYI 08330,mix-batch08045/0003,purity 99.2 %Spirotetramat has no boiling point atatmospheric pressure. Spirotetramatdecomposed at a temperature of235 °C.The test material is a solid. Y Franke, J.; 2004M-063268-01-1B.2.1.3Temperature atwhich decompositionor sublimationoccursIIA 2.1.3OECD 113 BYI 08330,mix-batch08045/0003,purity 99.2 %Spirotetramat showed an endothermic effect in the temperaturerange 135 – 165 °C (melting) and atwo exothermal effects in thetemperature range 200 – 300 °C and380 – 450 °C with a maximumoverall energy of 246 J/g.The result is acceptable Y Franke, J.; 2004M-063268-01-1- 3 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceRelative density of purified active substance IIA 2.2B.2.1.4Relative density ofpurified activesubstanceIIA 2.2EC A.3,OECD 109(pycnometermethod)EC A.3,OECD 109,OPPTS 830.7300(pycnometermethod)BYI 08330,mix-batch08045/0003,purity 99.1 %BYI 08330,PFV0586001,purity 97.5 %Active substance, pure:D420= 1.23Active substance as manufactured:D420= 1.22The results are acceptable YYMuehlberger, B.,Lemke, G.; 2004M-063293-01-1Bogdoll, B.,Lemke, G.; 2006M-270041-01-1Vapour pressure and volatility IIA 2.3B.2.1.5Vapour pressure ofpurified activesubstanceIIA 2.3.1EC A.4,OECD 104effusion method(vapour pressurebalance)BYI 08330,mix-batch08045/0003,purity 99.2 %Extrapolated:5.6 x 10-9Pa for 20 °C1.5 x 10-8Pa for 25 °C1.5 x 10-6Pa for 50 °CThe gas saturation method shouldbe used instead of vapour pressurebalance method.Y Franke, J.; 2004M-066171-01-1B.2.1.6Henry's law constantIIA 2.3.2Calculation Henry's law constants at 20 °C atdifferent pH values:at pH 4: 6.24 x 10-8Pa x m3x mol-1at pH 7: 6.99 x 10-8Pa x m3x mol-1at pH 9: 1.09 x 10-7Pa x m3x mol-1The results are acceptable N Bogdoll, B.; 2005M-262215-01-1- 4 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceAppearance IIA 2.4B.2.1.7B.2.1.8Description of thephysical state andcolour, pur. andtechn. a.s.IIA 2.4.1OPPTS 830.6302,OPPTS 830.6303OPPTS 830.6302,OPPTS 830.6303BYI 08330,mix-batch08045/0003,purity 99.1 %BYI 08330,PFV0586001,purity 97.5 %Active substance, pure:light beige powderActive substance as manufactured:white powderThe results are acceptable YYMuehlberger, B.;2003M-103239-01-1Bogdoll, B.,Lemke, G.; 2006M-270051-01-1B.2.1.9Description of theodour - purified andtechnical activesubstanceIIA 2.4.2OPPTS 830.6304OPPTS 830.6304BYI 08330,mix-batch08045/0003,purity 99.1 %BYI 08330,PFV0586001,purity 97.5 %Active substance, pure:no characteristic odorActive substance as manufactured:no characteristic odorAcceptable YYMuehlberger, B.;2003M-103239-01-1Bogdoll, B.,Lemke, G.; 2006M-270051-01-1Spectra and molecular extinction at relevant wavelengths IIA 2.5Spectra for purified active substance IIA 2.5.1B.2.1.10.1UV/VISIIA 2.5.1.1BYI 08330,M26802,purity 99.2 %UV (acetonitrile)The UV spectrum of BYI 08330 isshown in Figure 1.Acceptable spectra were providedSpectra in alkaline and acid mediaare requiredY Kaussmann, M.;2004M-182543-02-1B.2.1.10.2IIA 2.5.1.2 IRBYI 08330,M26802,purity 99.2 %The IR spectrum for BYI 08330(Figure 2) was obtained using BrukerFTIR-Spectrometer TENSOR 37.Absorption bands and assignmentsare given in Table 1.Key bands are consistent with thestructure. The results areacceptableY Kaussmann, M.;2004M-182543-02-1- 5 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.1.10.3IIA 2.5.1.3 NMRBYI 08330,M26802,purity 99.2 %1H and13C spectra were obtainedusing a Bruker Avance 400spectrometer.1H-NMR (400.13 MHz, CDCl3)13C-NMR (100.61 MHz, CDCl3)The structure and the assignement ofchemical shifts of carbons andprotons in ppm are given in Figure 3and tables 2 and 3The spectra are consistent with thestructure of BYI 08330.Y Kaussmann, M.;2004M-182543-02-1B.2.1.10.4IIA 2.5.1.4 MSBYI 08330,M26802,purity 99.2 %LC-MS/ESI+was performed usingHPLC Agilent 1100 with DAD andautosampler coupled to Waters ZMDMS with ESI Z-Spray source. Theresults showed the [M+H]+ion m/z374.3 and [2M+H]+ion m/z 747.4.These are consistent with amolecular weight of 373.48 (Figure4).MS confirmed the structure ofBYI 08330.Y Kaussmann, M.;2004M-182543-02-1IIA 2.5.1.5Wavelengths atwhich UV/VIS molarextinction occurs,max >290 nmBYI 08330,M26802,purity 99.2 %Peak maxima molarabsorptivity[nm] [1000 cm2/mol]211 22.0 x 103276 0.8 x 103The results are acceptable Y Kaussmann, M.;2004M-182543-02-1B.2.1.10.5Optical purityIIA 2.5.1.6Not relevant as the active substanceis not a resolved optical isomerB.2.1.11 Spectra for impurities IIA 2.5.2IIA 2.5.2.1UV/VISNo data presented None of the impurities present inthe active substance asmanufactured is of toxicological orenvironmental significance- 6 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceIIA 2.5.2.2 IRNo data presented None of the impurities presentinthe active substance asmanufactured is of toxicological orenvironmental significanceIIA 2.5.2.3 NMRNo data presented None of the impurities present inthe active substance asmanufactured is of toxicological orenvironmental significanceIIA 2.5.2.4 MSNo data presented None of the impurities present inthe active substance asmanufactured is of toxicological orenvironmental significanceB.2.1.12 Solubility of purified active substance inwater (pH 4-10) IIA 2.6B.2.1.12Solubility of purifiedactive substance inwate r (pH 4-10)IIA 2.6EC A.6,OECD 105 (Flaskmethod)EC A.6,OECD 105,OPPTS 830.7840BYI 08330,mix-batch08045/0003,purity 99.1 %BYI 08330,SPT0378-1,purity 99.4 %pH 4 33.5 mg/L at 20°CpH 7 29.9 mg/L at 20°CpH 9 19.1 mg/L at 20°CThe HPLC chromatograms showsthat the test item is unstable inaqueous solution at pH 9 (formationof a degradation product). Thedegradation does increase withlonger stirring time.In distilled water:pH 6.0 - 6.3 33.4 mg/L at 20°CThe results are acceptable YYMuehlberger, B.,Strunk, B.; 2003M-103256-01-1Bogdoll, B.,Lemke, G.; 2006M-270060-01-1- 7 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceIIA 2.7 Solubility in organic solvents at 15 to 25°CB.2.1.13Solubility in organicsolvents at 15 to25°CIIA 2.7EC A.6,OECD 105 (Flaskmethod)BYI 08330,mix-batch08045/0003,purity 99.1 %[g/L at 20 °C]ethanol 44n-hexane 0.055toluene 60dichloromethane > 600acetone 100 - 120ethyl acetate 67dimethyl sulfoxide 200 - 300The results are acceptable Y Muehlberger, B.,Eyrich, U.; 2004M-122802-01-1Partition coefficient IIA 2.8B.2.1.14n-Octanol/waterpartition coefficientIIA 2.8.1EC A.8,OECD 117(HPLC-method)BYI 08330,mix-batch08045/0003,purity 99.1 %Determination of the partitioncoefficient of Spirotetramat in1-octanol / water at 20 °CPow log PowpH 7 324 2.51The results are acceptable Y Lemke, G.,Muehlberger, B.;2003M-103244-01-1Effect of pH (4 to 10)on the n-octanol/water partitioncoefficientIIA 2.8.2EC A.8,OECD 117(HPLC-method)BYI 08330,mix-batch08045/0003,purity 99.1 %The partition coefficient (1-octanol /water) of Spirotetramat different pHvalues was:Pow log PowpH 4 324 2.51pH 7 324 2.51pH 9 316 2.50The results are acceptable Y Lemke, G.,Muehlberger, B.;2003M-103244-01-1- 8 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceHydrolysis and photolysis IIA 2.9B.2.1.15Hydrolysis rate atpH 4, 7 and 9 understerile and darkconditionsIIA 2.9.1OECD 111,EPA 161-1,DACO 8.2.3.2,MAFF 8147[Azaspirodecenyl-3-14C]-cis-BYI 08330,radiochemical purity>99 %, specificradioactivity 3.71MBq/mg[Azaspirodecenyl-5-14C]-cis-BYI 08330,radiochemical purity98 %, specificradioactivity 4.03MBq/mgBYI 08330 is hydrolytically labileunder acidic, neutral and alkalineconditions at ambient temperature.The fastest degradation was observedat pH 9. The experimental half-livesof the test substance at pH 7 were8.6 days (25 °C) and 13 days(20 °C). The test substance also wasunstable under acidic conditions(half-lives of 32.5 days (25 °C) and48 days (20 °C) at pH 4) anddegraded with a half-life of 7.6 hoursat pH 9 (25 °C). The hydrolyticdegradation was stronglytemperature dependent. One majordegradation product occurred in thetotal pH range tested the formationof BYI 08330-enol as a commonhydrolysis product was observed(for structure see appendix 1).The results are acceptable. Y Heinemann, O.;2004M-093124-01-2- 9 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.1.16Directphototransformationin sterile water usingartificial lightIIA 2.9.2EPA 162-1,DACO 8.2.3.3.2[Azaspirodecenyl-3-14C]-BYI 08330,radiochemical purity> 98 %, specificradioactivity 3.67MBq/mg[Azaspirodecenyl-5-14C]-BYI 08330,radiochemical purity> 98 %, specificradioactivity 4.03MBq/mgSpirotetramat was degraded in sterileaqueous 0.01 M acetate buffer pH 5under conditions of directphototransformation. Four majorphototransformation products werefound and identified as products ofre-arrangement reactions (forstructures see appendix 2).P6 was the main metabolite andincreased to max. 39.2 % of the ARat DAT-7;P7 was max. 22.1 % at DAT-4;P8 increased to 11.1 % after 3 daysexposure to light and decreased thento 5.3 % at the end;P9 was max. 18.2 % of the AR atDAT-6.Based on the experimental DT50 of2.7 days for BYI 08330 the predictedenvironmental DT50 is calculated tobe e.g. 12.9 solar summer days atPhoenix, AZ, USA or 19.9 summerdays at Athens, Greece.Under dark conditions the half lifeunder experimental conditions is 26days, which is regarded as hydrolysishalf-life, and BYI 08330-enol isformed, only.The results are acceptable. Y Stupp, H.-P.;2005M-266695-01-1- 10 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.1.17Quantum yield ofdirectphototransformationIIA 2.9.3ECETOC,EPA 161-1BYI 08330,batch M26802,purity 99.2 %A degradation of BYI 08330 ofapprox. 56 % was measured byHPLC-UV during the maximumirradiation period of 240 minutes inwater. This indicates that BYI 08330is not stable against direct phototransformation in aqueous solutionrelative to other compounds irratedunder the same study conditions.Using the UV absorption data andthe degration kinetics of both theexperiments a mean quantum yieldofΦ= 0.00571 was calculated.Estimates based on two differentarithmetic models (GC-Solar andFrank & Kloepffer) by means of theresulting quantum yield and the lightabsorption in a range of wavelengthsrelevant for the environment aregiven. They are well comparablewhen considering identical marginalconditions. “Environmental directphototransformation half-lives” ofBYI 08330 of 0.5 days to about oneweek during the period of main usecan be assessed. However, thisassessment does not consider anyindirect mechanisms, which mayenhance the photodegradation innatural water and which competewith the direct phototransformationto a great extent. This is addressed inmore detail in chapter IIA 7.6.The results are acceptable. Y Heinemann, O.;2004M-092941-01-2- 11 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.1.18Lifetime in the toplayer of aqueoussystems (calculatedand real)IIA 2.9.4ECETOC,EPA 161-2EPA 162-1,DACO 8.2.3.3.2BYI 08330,batch M26802,purity 99.2 %[Azaspirodecenyl-3-14C]-BYI 08330,radiochemical purity> 98 %, specificradioactivity 3.67MBq/mg[Azaspirodecenyl-5-14C]-BYI 08330,radiochemical purity> 98 %, specificradioactivity 4.03MBq/mgThis point is covered by point IIA2.9.3 and in more detail alsoconsidering natural water by pointIIA 7.6.The result is acceptable. YYHeinemann, O.;2004M-092941-01-2Stupp, H-.P.;2005M-266753-01-1B.2.1.19Dissociation in waterof purified activesubstanceIIA 2.9.5OECD 112(spectrophotometric method)BYI 08330,mix-batch08045/0003,purity 99.1 %The dissociation constant ofSpirotetramat was: pKa = 10.7The result is acceptable. Y Muehlberger, B.,Eyrich, U.; 2005M-261598-01-1- 12 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceEstimated photochemical oxidative degradation IIA2.10B.2.1.20EstimatedphotochemicaloxidativedegradationIIA 2.10Calculationaccording toAtkinsonThe chemical lifetime ofspirotetramat in the air is assessedbased on the calculation according toAtkinson by AOPWIN (version1.91). A value of at the most 3 hourscorresponding to a half-life ofapprox. 2 hours results, with respectto the OH radical and ozone reaction,only. Based on these values no longrange transport and no accumulationin air are expected for spirotetramat.Reaction with OH radicals and ozonecontribute to the degradation ofspirotetramat in the air to a highextent. The chemical stability ofspirotetramat in air is not determinedby an attack at one single site, but atdifferent parts of the molecule. Thisshould result in the formation ofvarious primary radicals leading tosecondary oxidation products, whichcan be eliminated from the air by wetand/or dry deposition.The results are acceptable. N Hellpointner, E.;2004M-092840-01-1Flammability including auto-flammability IIA 2.11B.2.1.21Flammability of theactive substance asmanufacturedIIA 2.11.1EC A.10 BYI 08330,PFV0586001,purity 97.5 %Spirotetramat is not a highlyflammable solid in the sense of ECguideline A.10.The results are acceptable. Y Smeykal, H.;2006M-269989-01-1- 13 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.1.22Auto-flammability ofthe active substanceas manufacturedIIA 2.11.2EC A.16BCC-TestBYI 08330,PFV0586001,purity 97.5 %BYI 08330,PFV0586001,purity 97.5 %No self-ignition temperature wasobserved up to the melting point orup to the maximum test temperatureof 401 °C.Spirotetramat is not classified inDivision 4.2 (a negative result wasobtained in the test using a 10 cmcube sample at 140 °C).The results are acceptable.The study is considered asadditional information by EUYYSmeykal, H.;2006M-270010-01-1Smeykal, H.;2006M-270036-01-1Flash point of the active substance as manufacturedIIA 2.12B.2.1.23Flash point of theactive substance asmanufacturedIIA 2.12Not applicable. The active substanceis a solid; its melting point is > 40°C.The results are acceptable.Explosive properties of the active substance as manufactured IIA 2.13B.2.1.24Explosive propertiesof the activesubstance asmanufacturedIIA 2.13EC A.14 BYI 08330,PFV0586001,purity 97.5 %Not explosive in the sense of ECguideline A.14.The results are acceptable. Y Smeykal, H.;2006M-269992-01-1- 14 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceSurface tension of the active substance as manufactured IIA 2.14B.2.1.25Surface tension ofthe active substanceas manufacturedIIA 2.14EC A.5,OECD 115EC A.5,OECD 115BYI 08330,mix-batch08045/0003,purity 99.1 %BYI 08330,PFV0586001,purity 97.5 %Pure substance:61.65 mN/m at 20°CTechnical substance:60.5 mN/m at 20°Cthe concentration used: 90% of thesaturation concentrationSpirotetramat is classified to benon-surface active according toEC Guideline A.5.This study is considered asadditional information by EUThis study is not required byCanada (PMRA)The study is accepted by EU.YYMuehlberger, B.,Lemke, G.; 2004M-063303-01-1Muehleberger, B.,Lemke, G.; 2004M-063303-01-1Bogdoll, B.,Lemke, G.; 2006M-270037-01-1Oxidizing properties of the active substance as manufactured IIA 2.15B.2.1.26Oxidizing propertiesof the activesubstance asmanufacturedIIA 2.15EC A.17 BYI 08330,PFV0586001,purity 97.5 %Spirotetramat has no oxidizingproperties in the sense of ECguideline A.17.The result is acceptable. Y Smeykal, H.;2006M-270029-01-1pH IIA 2.16B.2.1.2.27pHIIA 2.16OPPTS 830.7000 BYI 08330,batch SPT0378-1,purity 99.4 %BYI 08330,batch PFV0586001,purity 97.5 %Pure substance:6.3 (1 % suspension in distilledwater)Technical substance:6.3 (1 % suspension in distilledwater)The result is acceptableThis study is not required accordingto directive 91/414.Y Bogdoll, B.,Lemke, G.; 2006M-269907-01-1- 15 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceStability IIA 2.17B.2.1.2.28Storage stabilityIIA 2.17.1OPPTS 830.6317 BYI 08330,mix-batch08045/0014,purity 97.75 %The results from a twelve months30 °C stability study showedSpirotetramat to be stable inPolypropylene and Polyethylenecontainers. After completion of theaccelerated storage test nodecomposition of Spirotetramatcould be established. There are novisible corrosive effects on thecontainers themselves after twelvemonths of storage.This study is not required byCanada (PMRA)This study is not required accordingto directive 91/414.Y Olenik, B.; 2006M-272433-03-1B.2.1.2.29Stability(temperature,metals)IIA 2.17.2OPPTS 830.6313 BYI 08330,mix-batch08045/0014,purity 97.7 %The results from a two weeks 54 °Cstability study showed Spirotetramatto be stable in presence of the metalsand metal ions. After completion ofthe accelerated storage test nodecomposition of Spirotetramatcould be established.In the presence of metals (iron andaluminum) changes in color duringthe test period could not be observed.The deviation of the analyticalmeasurement of the samples withaluminum flakes are based on theinhomogeneity of these samples.The result is acceptableThis study is not required accordingto directive 91/414.Y Olenik, B.; 2006M-271221-02-1- 16 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceOther/special studies IIA 2.18B.2.1.2.30Other/special studiesIIA 2.18Oxidation orreduction propertiesOPPTS 830.6314BYI 08330,batch PFV0586001,purity 97.5 %Technical BYI 08330 was found tobe non-reactive with ammoniumdihydrogen phosphate, metallic ironor aqueous solution of 0.1Npotassium permanganate in terms ofsignificant temperature increase orevolution of gas.No significant temperature increasewas observed for all applied testmixtures, i.e. the temperatureincrease was clearly below 5 °C inthe course of the experiments andnever exceeded ambient conditions.This study is not required byCanada (PMRA)This study is not required accordingto directive 91/414.YBogdoll, B.,Lemke, G.; 2006M-270048-01-1

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# B.2.1.3 Summary and evaluation of points 2.1 to 2.1 8 IIA 2.19 (not reviewed by

Canada (PMRA)

Spirotetramat is a tetramic acid insecticide. Its v apour pressure and volatility are very low. The

solubility in water is 33.5 mg/L at pH 4 and 29.9 m g/L at pH 7. With < 3 its log Pow is not critical i n

respect to ecological and environmental aspects. Sp irotetramat is hydrolytically labile under acidic,

neutral and to a high extent under alkaline conditi ons at ambient temperature. The hydrolytic

degradation is strongly temperature dependent and t he BYI 08330-enol is the only degradate. Via

direct phototransformation of spirotetramat in pure buffer of pH 5 four major re-arrangement products

are formed. However, in natural water the competiti on of hydrolysis and indirect photo-reactions is

strong and leads to a thorough degradation. Its fla mmability, explosive and oxidizing properties are

not critical.

Appendix 1:

Hydrolysis product

1

chemical name (IUPAC): cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-

methoxy- 1-azaspiro[4.5]dec-3-en-2-one

chemical name (CA): 1-azaspiro[4.5]dec-3-en-2-one, 3-(2,5-

dimethylphenyl)-4-hydroxy-8-methoxy-, cis

trivial name:

code name: BYI 08330-enol

AE 1302944

CAS No.: 203312-38-3

structural formula:



# H

O

NH

O O H

CH

3



# CH

3 

# CH

3

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Appendix 2:

Direct phototransformation products (pure buffer pH 5)

1

chemical name (IUPAC): (1s,4s)-8'-hydroxy-4-methoxy-5'-methyl-2'Hspiro[cyclohexane-1,1'-indeno[1,2-c]pyrrol]-

3'(8'H)-one

chemical name (CA): spiro[cyclohexane-1,1'(2' H )-indeno[1,2- c ]

pyrrol]-3'(8' H

)-one, 8'-hydroxy-4-methoxy-5'-

methyltrivial name:

code name: BYI 08330-photo-cyclopentyl

P6

CAS No.: not allocated

structural formula:



# NH

O

CH

3 

# H

O CH

3



# O H

2

chemical name (IUPAC): (5s,8s)-3-[2-(hydroxymethyl)-5-methylphenyl]-

8-methoxy-1-azaspiro[4.5]dec-3-en-2-one

chemical name (CA): 1-azaspiro[4.5]dec-3-en-2-one, 3-[2-

(hydroxymethyl)-5-methylphenyl]-8-methoxytrivial name:

code name: BYI 08330-photo-2-hydroxymethyl

P7

CAS No.: not allocated

structural formula:



# NH

O

CH

3 

# H

O CH

3



# H O H

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Appendix 2 (continued):

Direct phototransformation products (pure buffer pH 5)

3

chemical name (IUPAC): 2-[(5s,8s)-8-methoxy-2-oxo-1-

azaspiro[4.5]dec-3-yl]-4-methylbenzaldehyde

chemical name (CA): benzaldehyde, 2-(8-methoxy-2-o xo-1-

azaspiro[4.5]dec-3-yl)-4-methyltrivial name:

code name: BYI 08330-photo-2-formyl

P8



# CAS No.: not allocated

structural formula:



# NH

O

CH

3 

# H

O CH

3



# O H H

H

4

chemical name (IUPAC): Ethyl 2-[(5s,8s)-8-methoxy-2-oxo-1-

azaspiro[4.5]dec-3-en-3-yl]-4-methylbenzyl

carbonate

chemical name (CA): carbonic acid, ethyl [2-(8-met hoxy-2-oxo-1-

azaspiro[4.5]dec-3-en-3-yl)-4-methylphenyl]methyl ester

trivial name:

code name: BYI 08330-photo-2-methylcarbonate

P9



# CAS No.: not allocated

structural formula:



# NH

O

CH

3 

# H

O CH

3



# O O O CH

3



# H

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Figure 1

. UV spectrum

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Figure 2

. IR spectrum

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Table 1 . Interpretation of the IR spectrum

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

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Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Figure 3

.

A. 13 

# C-NMR

# - 25 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# B. 1 

# H-NMR

# - 26 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Table 2 . Interpretation of the 13 

# C-NMR

# - 27 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# Table 3 . Interpretation of the 1 

# H-NMR

Figure 4 . MS spectrum- 28 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008B.2.2 Physical, chemical and technical propertiesof the plant protection product (Annex IIIA 2)Table 1. Summary of the physical and chemical properties of the plant protection product Movento 240SC InsecticideMovento 240 SC is not evaluated for EC.Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferencePhysical state of the preparation and its colour and odour IIIA 2.1B.2.2.1Physical state of thepreparation and itscolour and odourIIIA 2.1VisualOlfactoryBatch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Physical state: suspensionColour: whiteOdour: aromaticAceptable N Gueldner, W., 2006M-266718-01-1Explosivity and oxidizing properties IIIA 2.2.1B.2.2.4Explosive propertiesof the preparationIIIA 2.2.1EC A.14 Batch–Number:07218/0062(0062);243.40 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Not explosive in the sense of ECGuideline A.14Aceptable Y Heitkamp, D., 2005M-259836-01-1B.2.2.5Oxidizing propertiesof the preparationIIIA 2.2.2EC A.21 Batch–Number:07218/0062(0062);243.40 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Not oxidizing in the sense of ECGuideline A.21Acceptable Y Heitkamp, D., 2005M-259836-01-1- 29 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceFlash point & other indication of flammability or spontaneous ignition IIIA 2.3.1B.2.2.6The flash point of thepreparationIIIA 2.3.1EC A.9 Batch–Number:07218/0062(0062);243.40 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.No flash point up to the boiling pointAcceptable Y Heitkamp, D., 2005M-259836-01-1B.2.2.7The flammability ofthe preparationIIIA 2.3.2Not flammableAcceptableB.2.2.8The autoflammability of thepreparationIIIA 2.3.3EC A.15 Batch–Number:07218/0062(0062);243.40 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Auto ignition temperature:415 °CAcceptable Y Heitkamp, D., 2005M-259836-01-1Acidity/alkalinity and if necessary pH value IIIA2.4B.2.2.9Acidity or alkalinityand pH valueIIIA 2.4.1Not applicable(4≤pH≤10)- 30 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.10pH of a 1% aqueousdilution, emulsion ordispersionIIIA 2.4.2CIPAC MT 75.3(electrometricdetermination)Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.4.6 (1 % in CIPAC D water underN2-atmosphere and roomtemperature)Acceptable Y Gueldner, W., 2006M-266718-01-1Viscosity and surface tension IIIA 2.5B.2.2.11.1Kinematic viscosityof the preparationIIIA 2.5.1Calculated:shear rate 20 s-1ν=η/ρ= 2.25⋅10-4m2/s at 20 °Cν=η/ρ= 1.90⋅10-4m2/s at 40 °Cshear rate 100 s-1ν=η/ρ= 0.72⋅10-4m2/s at 20 °Cν=η/ρ= 0.60⋅10-4m2/s at 40 °CAcceptable Y Gueldner, W., 2006M-266718-01-1B.2.2.11.2Dynamic viscosity ofthe preparation anddetails of the testconditionsIIIA 2.5.2OECD 114 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.shear rate 20 s-1η= 0.242 Pa s at 20 °Cη= 0.203 Pa s at 40 °Cshear rate 100 s-1η= 0.0773 Pa s at 20 °Cη= 0.0640 Pa s at 40 °CAcceptable Y Gueldner, W., 2006M-266718-01-1B.2.2.12Surface tension ofthe preparationIIIA 2.5.3OECD 115 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.σ= 44 mN/m at 25 °C (undiluted)classified as surface-activeThis study is notrequired by Canada(PMRA)Y Gueldner, W., 2006M-266718-01-1- 31 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceRelative density and bulk density IIIA 2.6B.2.2.13Relative density ofthe preparationIIIA 2.6.1OECD 109 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.D420= 1.075D440= 1.069Acceptable Y Gueldner, W., 2006M-266718-01-1B.2.2.14Bulk or tap densityof the preparationIIIA 2.6.2Not applicable as thepreparation is asuspensionStorage stability and shelf-life IIIA 2.7B.2.2.15Stability afterstorage for 14 daysat 54 °CIIIA 2.7.1CIPAC MT 46.3 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Stable for 2 weeks at 54 °C in HDPE This study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-265475-01-1B.2.2.16Stability afterstorage for otherperiods and/ortemperatureIIIA 2.7.2A one year storage stability study isexpected to be completed inDecember 2007Not provided- 32 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.17Minimum contentafter heat stabilitytestingIIIA 2.7.3CIPAC MT 46.3 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.The active substance content did notdecline to less than 95 % of thecontent prior to the test (packagingmaterial: HDPE)This study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-265475-01-1B.2.2.18Effect of lowtemperature onstabilityIIIA 2.7.4CIPAC MT 39.3 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.< 0.01 % residue on a 75 μm sieveafter 7 days at 0 °C in HDPEThis study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-265475-01-1B.2.2.19Shelf life followingstorage at ambienttemperatureIIIA 2.7.5GIFAPMonograph No.17Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Study in progress(Scheduled end ofstorage 2007-12-03)N Gueldner, W., 2006M-265475-01-1B.2.2.20Shelf life in monthsIIIA 2.7.6The active substanceis expected to bestable for 24 months(see IIIA 2.7.5)This study is notrequired by Canada(PMRA)- 33 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceTechnical characteristics of the product IIIA 2.8B.2.2.21WettabilityIIIA 2.8.1Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.22Persistent foamingIIIA 2.8.2CIPAC MT 47.2 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.0.3 % in CIPAC D water:after 10 sec 45 mLafter 1 min 38.5 mLafter 3 min 33 mLafter 12 min 23.5 mLThis study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-266718-01-1Suspensibility and suspension stability IIIA 2.8.3B.2.2.23SuspensibilityIIIA 2.8.3.1CIPAC MT 184 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.0.03 % of the preparation in CIPACD water:Spirotetramat assay: 99 %0.3 % of the preparation in CIPAC Dwater:Spirotetramat assay: 99 %This study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-266718-01-1B.2.2.24Spontaneity ofdispersionIIIA 2.8.3.2CIPAC MT 160 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.5 % of the preparation inCIPAC D water:Spirotetramat assay: 96 %This study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-266718-01-1- 34 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.25Dilution stabilityIIIA 2.8.4Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)Sieve test IIIA 2.8.5B.2.2.26Dry sieve testIIIA 2.8.5.1Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.27Wet sieve testIIIA 2.8.5.2CIPAC MT 185 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Residue on a 75 μm sieve:< 0.01 %This study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-266718-01-1Particle size distribution IIIA 2.8.6- 35 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.28Size distribution ofparticles – Normalsize range ofgranulesIIIA 2.8.6.1IIIA 2.8.6.2Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.29Dust contentIIIA 2.8.6.3Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.30Particle size of dustIIIA 2.8.6.4Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.31Friability andattritioncharacteristics ofgranulesIIIA 2.8.6.5Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)Emulsion characteristics IIIA 2.8.7- 36 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.32EmulsifiabilityIIIA 2.8.7.1Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.33Emulsion stabilityIIIA 2.8.7.2Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.34Re-emulsifiabilityIIIA 2.8.7.3Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.35Stability of diluteemulsionsIIIA 2.8.7.4Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)Flowability, pourability and dustability IIIA 2.8.8- 37 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.36FlowabilityIIIA 2.8.8.1Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)B.2.2.37Pourability(including rinsedresidue)IIIA 2.8.8.2CIPAC MT 148 Batch–Number:07218/0062(0062);242.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Residue: 2.10 %Rinsed residue: 0.16 %This study is notrequired by Canada(PMRA)N Gueldner, W., 2006M-266718-01-1B.2.2.38Dustability followingaccelerate storageIIIA 2.8.8.3Not applicable as thepreparation is asuspensionThis study is notrequired by Canada(PMRA)Physical compatibility with other products IIIA 2.9B.2.2.39Physical andchemicalcompatibility of tankmixesIIIA 2.9Not applicable (tankmixtures with otherpesticides are notrecommended)This study is notrequired by Canada(PMRA)- 38 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceDistribution and adherence to seed IIIA 2.10B.2.2.40Adherence anddistribution to seedsIIIA 2.10Only applicable forseed treatment incerealsThis study is notrequired by Canada(PMRA)Miscibility IIIA 2.11B.2.2.41MiscibilityIIIA 2.11Not required byDirective91/414/EECNot applicable as theproduct is not to bediluted with petroleumsolvents.Dielectric breakdown voltage IIIA 2.12B.2.2.42Dielectricbreakdown voltageIIIA 2.12Not required byDirective91/414/EECNot applicable as theproduct is notintended for usearound electricalequipment.Corrosion characteristics IIIA 2.13B.2.2.43CorrosioncharacteristicsIIIA 2.13Not required byDirective91/414/EECThe product is not excpected to becorrosive to the packaging material.The applicant will berequested to provide aone year corrosioncharacteristics studywith a one yearstorage stability study.- 39 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceContainer Material IIIA 2.14B.2.2.44Container MaterialIIIA 2.14Not required byDirective91/414/EECHDPE 1 L to 200 LOther/special studies IIIA 2.15B.2.2.45Other/special studiesIIIA 2.15Not required byDirective91/414/EEC- 40 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Table 2. Summary of the physical and chemical properties of the plant protection product Movento 150OD InsecticideTest or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferencePhysical state of the preparation and its colour and odour IIIA 2.1B.2.2.1Physical state of thepreparation and itscolour and odourIIIA 2.1VisualOlfactoryBatch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Physical state: suspensionColour: light brownOdour: weak mouldyAcceptable N Gueldner, W., 2006M-266815-01-1Explosivity and oxidizing properties IIIA 2.2.1B.2.2.4Explosive propertiesof the preparationIIIA 2.2.1EC A.14 Batch–Number:08030/0233(0152);148.3 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Not explosive in the sense of ECGuideline A.14Exothermic decomposition energy 17J/gAcceptableThis study is notrequired by Canada(PMRA).Y Rexer, K.; Bittner, P., 2006M-264101-01-1B.2.2.5Oxidizing propertiesof the preparationIIIA 2.2.2EC A.21 Batch–Number:08030/0233(0152);148.3 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Not oxidizing in the sense of ECGuideline A.21.Acceptable Y Rexer, K.; Bittner, P., 2006M-264101-01-1- 41 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceFlash point & other indication of flammability or spontaneous ignition IIIA 2.3B.2.2.6The flash point of thepreparationIIIA 2.3.1EC A.9 Batch–Number:08030/0233(0152);148.3 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Higher than 100 °C Acceptable Y Rexer, K.; Bittner,P., 2006M-264101-01-1B.2.2.7The flammability ofthe preparationIIIA 2.3.2Not flammableAcceptableB.2.2.8The autoflammability of thepreparationIIIA 2.3.3EC A.15 Batch–Number:08030/0233(0152);148.3 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Auto ignition temperature:410 °CAcceptable Y Rexer, K.; Bittner, P., 2006M-264101-01-1Acidity/alkalinity and if necessary pH value IIIA2.4B.2.2.9Acidity or alkalinityand pH valueIIIA 2.4.1Not applicable(4≤pH≤10)- 42 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.10pH of a 1% aqueousdilution, emulsion ordispersionIIIA 2.4.2CIPAC MT 75.3(electrometricdetermination)Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.4.5 (1 % in CIPAC D water underN2-atmosphere and roomtemperature)Acceptable Y Gueldner, W., 2006M-266815-01-1Viscosity and surface tension IIIA 2.5B.2.2.11.1Kinematic viscosityof the preparationIIIA 2.5.1Calculated:shear rate 20 s-1ν=η/ρ= 8.07⋅10-4m2/s at 20 °Cν=η/ρ= 5.41⋅10-4m2/s at 40 °Cshear rate 100 s-1ν=η/ρ= 5.47⋅10-4m2/s at 20 °Cν=η/ρ= 2.76⋅10-4m2/s at 40 °CAcceptable Y Gueldner, W., 2006M-266815-01-1B.2.2.11.2Viscosity of thepreparation anddetails of the testconditionsIIIA 2.5.2OECD 114 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.shear rate 20 s-1η= 0.801 Pa s at 20 °Cη= 0.532 Pa s at 40 °Cshear rate 100 s-1η= 0.543 Pa s at 20 °Cη= 0.271 Pa s at 40 °CAcceptable Y Gueldner, W., 2006M-266815-01-1B.2.2.12Surface tension ofthe preparationIIIA 2.5.3OECD 115 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.σ= 27 mN/m at 25 °C (undiluted)classified as surface-activeThis study is notrequired by Canada(PMRA)The study is acceptedby EU.Y Gueldner, W., 2006M-266815-01-1- 43 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceRelative density and bulk density IIIA 2.6B.2.2.13Relative density ofthe preparationIIIA 2.6.1OECD 109 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.D420= 0.993D440= 0.983Acceptable Y Gueldner, W., 2006M-266815-01-1B.2.2.14Bulk or tap densityof the preparationIIIA1 2.6.2Not applicable as thepreparation is an oildispersionStorage stability and shelf-life IIIA 2.7B.2.2.15Stability afterstorage for 14 daysat 54 °CIIIA 2.7.1CIPAC MT 46.3 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Stable for 2 weeks at 54 °C inHDPE, COEX/EVOH andCOEX/PAThis study is notrequired by Canada(PMRA)The study is acceptedby EU.N Gueldner, W., 2006M-266311-01-1;Gueldner, W., 2006M-266300-01-1;Gueldner, W., 2006M-266306-01-1B.2.2.16Stability afterstorage for otherperiods and/ortemperatureIIIA 2.7.2A one year storage stability study isexpected to be completed in March2008.Not providedNot relevant for EU asthe formulation isstable for 2 weeks at54 °C.- 44 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.17Minimum contentafter heat stabilitytestingIIIA 2.7.3CIPAC MT 46.3 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.The active substance content did notdecline to less than 95 % of thecontent prior to the test (packagingmaterial: HDPE, COEX/EVOH andCOEX/PA)This study is notrequired by Canada(PMRA)The result is acceptedby EU.N Gueldner, W., 2006M-266311-01-1;Gueldner, W., 2006M-266300-01-1;Gueldner, W., 2006M-266306-01-1B.2.2.18Effect of lowtemperature onstabilityIIIA 2.7.4CIPAC MT 39.3 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.0.04 % residue on a 75 μm sieveafter 7 days at 0 °C in HDPE,COEX/EVOH and COEX/PAThis study is notrequired by Canada(PMRA)The result is acceptedby EU.N Gueldner, W., 2006M-266311-01-1;Gueldner, W., 2006M-266300-01-1;Gueldner, W., 2006M-266306-01-1B.2.2.19Shelf life followingstorage at ambienttemperatureIIIA 2.7.5GIFAPMonograph No.17Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.The formulation is expected to bestable for at least 2 years at ambientconditions in HDPE, COEX/EVOHand COEX/PAStudy in progress(Scheduled end ofstorage 2007-12-03)N Gueldner, W., 2006M-266311-01-1;Gueldner, W., 2006M-266300-01-1;Gueldner, W., 2006M-266306-01-1B.2.2.20Shelf life in monthsIIIA 2.7.6The active substanceis expected to bestable for 24 months(see IIIA1 2.7.5)This study is notrequired by Canada(PMRA)This point depends onthe outcome of theshelf life study atambient temperature(see B.2.2.19).- 45 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceTechnical characteristics of the product IIIA 2.8B.2.2.21WettabilityIIIA 2.8.1Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.22Persistent foamingIIIA 2.8.2CIPAC MT 47.2 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.0.5 % in CIPAC D water:after 10 sec 25 mLafter 1 min 0 mLafter 3 min 0 mLafter 12 min 0 mLThis study is notrequired by Canada(PMRA)EU: The study has tobe performed with thehighest applicationdose (i.e. 0.64 %).N Gueldner, W., 2006M-266815-01-1Suspensibility and suspension stability IIIA 2.8.3B.2.2.23SuspensibilityIIIA 2.8.3.1Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.24Spontaneity ofdispersionIIIA 2.8.3.2Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)- 46 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.25Dilution stabilityIIIA 2.8.4Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)Sieve test IIIA 2.8.5B.2.2.26Dry sieve testIIIA 2.8.5.1Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.27Wet sieve testIIIA 2.8.5.2CIPAC MT 185 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Residue on a 75 μm sieve:< 0.01 %This study is notrequired by Canada(PMRA)The result is acceptedby EU.N Gueldner, W., 2006M-266815-01-1Particle size distribution IIIA 2.8.6- 47 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.28Size distribution ofparticles – Normalsize range ofgranulesIIIA 2.8.6.1IIIA 2.8.6.2Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.29Dust contentIIIA 2.8.6.3Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.30Particle size of dustIIIA 2.8.6.4Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.31Friability andattritioncharacteristics ofgranulesIIIA 2.8.6.5Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)Emulsion characteristics. IIIA 2.8.7- 48 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.32EmulsifiabilityIIIA 2.8.7.1Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.33Emulsion stabilityIIIA 2.8.7.2Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.34Re-emulsifiabilityIIIA 2.8.7.3Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.35Stability of diluteemulsionsIIIA 2.8.7.4Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)- 49 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.35Stability ofemulsionsIIIA 2.8.7.5CIPAC MT 180 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.0.01 % prep. in CIPAC A water.Dispersion after:0 min completely30 min sediment: traceoil/cream: 0.0 mLRedispersibility after:24 h completely24.5 h sediment: traceoil/cream: 0.0 mL0.5 % prep. in CIPAC A water.Dispersion after:0 min completely30 min sediment: 0.2 mLoil: 0.0 mLcream: < 0.05 mLDispersion stability ofsuspo-emulsionThis study is notrequired by Canada(PMRA)EU: The test should beperformed at thelowest and highestapplication dosewhich is 0.04 and0.64%.N Gueldner, W., 2006M-266815-01-1- 50 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.35Stability ofemulsions (cont.)IIIA 2.8.7.5CIPAC MT 180 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Redispersibility after:24 h completely24.5 h sediment: 0.3 mLoil: 0.0 mLcream: < 0.05 mL0.01 % prep. in CIPAC D water.Dispersion after:0 min completely30 min sediment: traceoil/cream: 0.0 mLRedispersibility after:24 h completely24.5 h sediment: 0.0 mLoil/cream: 0.0 mL0.5 % prep. in CIPAC D water.Dispersion after:0 min completely30 min sediment: 0.05 mLoil: 0.0 mLcream: < 0.05 mLRedispersibility after:24 h completely24.5 h sediment: 0.2 mLoil: 0.0 mLcream: traceDispersion stability ofsuspo-emulsionThis study is notrequired by Canada(PMRA)EU: The test should beperformed at thelowest and highestapplication dosewhich is 0.04 and0.64%.N Gueldner, W., 2006M-266815-01-1- 51 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceFlowability, pourability and dustability IIIA 2.8.8B.2.2.36FlowabilityIIIA 2.8.8.1Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)B.2.2.37Pourability(including rinsedresidue)IIIA 2.8.8.2CIPAC MT 148 Batch–Number:08030/0233(0152);148.95 g/Lspirotetramat.The specification andpurity are givenunder point 1.4.Residue: 3.61 %Rinsed residue: 0.20 %This study is notrequired by Canada(PMRA)The result is acceptedby EU.N Gueldner, W., 2006M-266815-01-1B.2.2.38Dustability followingaccelerate storageIIIA 2.8.8.3Not applicable as thepreparation is an oildispersionThis study is notrequired by Canada(PMRA)Physical compatibility with other products IIIA 2.9B.2.2.39Physicalcompatibility of tankmixesIIIA 2.9.1Not applicable (tankmixtures with otherpesticides are notrecommended)This study is notrequired by Canada(PMRA)- 52 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.39Chemicalcompatibility of tankmixesIIIA 2.9.2Not applicable (tankmixtures with otherpesticides are notrecommended)This study is notrequired by Canada(PMRA)Distribution and adherence to seed IIIA 2.10B.2.2.40Distribution (seedtreatment)IIIA 2.10.1Only applicable forseed treatment incerealsThis study is notrequired by Canada(PMRA)B.2.2.40Adhesion (seedtreatment)IIIA 2.10.2Only applicable forseed treatment incerealsThis study is notrequired by Canada(PMRA)Miscibility IIIA 2.11B.2.2.41MiscibilityIIIA 2.11Not required byDirective91/414/EECNot applicable as theproduct is not to bediluted with petroleumsolvents.Dielectric breakdown voltage IIIA 2.12- 53 -Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008Test or Study &Annex pointGuideline andmethodTest materialpurity andspecificationFindings Comments GLPY/NReferenceB.2.2.42Dielectricbreakdown voltageIIIA 2.12Not required byDirective91/414/EECNot applicable as theproduct is notintended for usearound electricalequipmentCorrosion characteristics IIIA 2.13B.2.2.43CorrosioncharacteristicsIIIA 2.13Not required byDirective91/414/EECThe product is not expected to becorrosive to the packaging materialThe applicant will berequested to provide aone year corrosioncharacteristics studywith a one yearstorage stability study.Container Material IIIA 2.14B.2.2.44Container MaterialIIIA 2.14Not required byDirective91/414/EECHDPE jug or tote, 1 L to200 LOther/special studies IIIA 2.15B.2.2.45Other/special studiesIIIA 2.15Not required byDirective91/414/EEC

# - 54 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# B.2.3 Summary and evaluation of points 2.2.1 to 2.2 .45 of the formulation (not

reviewed by Canada (PMRA)

The plant protection product Movento OD 150 appears as a light brown to whitish suspension and has

weak mouldy odour. The preparation has a flash poin t higher than 100 °C and has a self ignition

temperature of 410 °C.

It is not explosive and has no oxidizing properties . Its pH is within the range that naturally occurs e.g.

in soil. Its stability allows storage under practic al and commercial conditions. Its technical propert ies

indicate that no particular problems have to be exp ected, when it is used as recommended.

A shelf-life (2 year) storage stability study is cu rrently in progress. The end of storage is schedule d for

2007-12-03.

No physical/chemical classification is proposed.

# - 55 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008



# B.2.4 References relied on

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

Annex II Data and Information

KIIA 2.1.1 /01 Franke, J. 2004 BYI 08330, Mix-Batch 0 8045/0003 - Melting

point, boiling point, thermal stability

Siemens Axiva GmbH & Co. KG, Frankfurt am

Main, Germany

Bayer CropScience AG,

Report No.: 20040156.01,

Edition Number: M-063268-01-1

Date: 26.03.2004

GLP, unpublished Yes BCS

KIIA 2.1.2 /01 Franke, J. 2004 BYI 08330, Mix-Batch 08045/0003 - Melting

point, boiling point, thermal stability

Siemens Axiva GmbH & Co. KG, Frankfurt am

Main, Germany

Bayer CropScience AG,

Report No.: 20040156.01,

Edition Number: M-063268-01-1

Date: 26.03.2004

GLP, unpublished Yes BCS

KIIA 2.1.3 /01 Franke, J. 2004 BYI 08330, Mix-Batch 08045/0003 - Melting

point, boiling point, thermal stability

Siemens Axiva GmbH & Co. KG, Frankfurt am

Main, Germany

Bayer CropScience AG,

Report No.: 20040156.01,

Edition Number: M-063268-01-1

Date: 26.03.2004

GLP, unpublished Yes BCS

KIIA 2.2 /01 Muehlberger, B.;

Lemke, G. 2004 BYI 08330 (AE 1302943) - Relative density

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA03/039,

Edition Number: M-063293-01-1

Date: 02.04.2004

GLP, unpublished Yes BCS

KIIA 2.2 /02 Bogdoll, B.;

Lemke, G. 2006 Relative density of BYI 08330 - Technical

substance

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA06/025,

Edition Number: M-270041-01-1

Date: 13.04.2006

GLP, unpublished Yes BCS

# - 56 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

KIIA 2.3.1 /01 Franke, J. 2004 BYI 08330, Mix-Batch 08045/0003 - Vapour

pressure

Siemens Axiva GmbH & Co. KG, Frankfurt am

Main, Germany

Bayer CropScience AG,

Report No.: 20040156.02,

Edition Number: M-066171-01-1

Date: 26.04.2004

GLP, unpublished Yes BCS

KIIA 2.3.2 /01 Bogdoll, B. 2005 Henry's law constant of BYI 08330(AE

1302943) at pH 7 and pH 9

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: AF05/085,

Edition Number: M-262215-01-1

Date: 08.12.2005

Non GLP, unpublished Yes BCS

KIIA 2.4.1 /01 Muehlberger, B. 2003 BYI 08330 (AE 1302943) - Physical

characteristics color, appearance and odor

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA03/035,

Edition Number: M-103239-01-1

Date: 03.11.2003

GLP, unpublished Yes BCS

KIIA 2.4.1 /02 Bogdoll, B.;

Lemke, G. 2006 Physical characteristics - Color, physical stat e

and odor of BYI 08330 - Technical substance

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA06/026,

Edition Number: M-270051-01-1

Date: 20.04.2006

GLP, unpublished Yes BCS

KIIA 2.4.2 /01 Bogdoll, B.;

Lemke, G. 2006 Physical characteristics - Color, physical stat e

and odor of BYI 08330 - Technical substance

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA06/026,

Edition Number: M-270051-01-1

Date: 20.04.2006

GLP, unpublished Yes BCS

KIIA 2.4.2 /02 Bogdoll, B.;

Lemke, G. 2006 Physical characteristics - Color, physical stat e

and odor of BYI 08330 - Technical substance

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA06/026,

Edition Number: M-270051-01-1

Date: 20.04.2006

GLP, unpublished Yes BCS

# - 57 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

KIIA 2.5.1.1

/01 Kaussmann, M. 2004 Spectral data set of BYI 08330 (Spirotetramat)

-

Amendment no. 1

Bayer CropScience AG,

Report No.: 15-600-2244,

Edition Number: M-182543-02-1

Date: 02.12.2004, Amended: 28.08.2006

GLP, unpublished Yes BCS

KIIA 2.5.1.2

/01 Kaussmann, M. 2004 Spectral data set of BYI 08330 (Spirotetramat)

-

Amendment no. 1

Bayer CropScience AG,

Report No.: 15-600-2244,

Edition Number: M-182543-02-1

Date: 02.12.2004, Amended: 28.08.2006

GLP, unpublished Yes BCS

KIIA 2.5.1.3

/01 Kaussmann, M. 2004 Spectral data set of BYI 08330 (Spirotetramat)

-

Amendment no. 1

Bayer CropScience AG,

Report No.: 15-600-2244,

Edition Number: M-182543-02-1

Date: 02.12.2004, Amended: 28.08.2006

GLP, unpublished Yes BCS

KIIA 2.5.1.4

/01 Kaussmann, M. 2004 Spectral data set of BYI 08330 (Spirotetramat)

-

Amendment no. 1

Bayer CropScience AG,

Report No.: 15-600-2244,

Edition Number: M-182543-02-1

Date: 02.12.2004, Amended: 28.08.2006

GLP, unpublished Yes BCS

KIIA 2.5.1.5

/01 Kaussmann, M. 2004 Spectral data set of BYI 08330 (Spirotetramat)

-

Amendment no. 1

Bayer CropScience AG,

Report No.: 15-600-2244,

Edition Number: M-182543-02-1

Date: 02.12.2004, Amended: 28.08.2006

GLP, unpublished Yes BCS

KIIA 2.6 /01 Muehlberger, B.;

Strunk, B. 2003 BYI 08330 (AE 1302943) - Water solubility at

pH4, pH7 and pH9 (Flask method)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA03/034,

Edition Number: M-103256-01-1

Date: 21.11.2003

GLP, unpublished Yes BCS

KIIA 2.6 /02 Bogdoll, B.;

Lemke, G. 2006 Water solubility of BYI 08330 (AE 1302943)

in distilled water (Flask Method)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA06/033,

Edition Number: M-270060-01-1

Date: 20.04.2006

GLP, unpublished Yes BCS

# - 58 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

KIIA 2.7 /01 Muehlberger, B.;

Eyrich, U. 2004 BYI 08330 (AE 1302943) - Solubility in

organic solvents

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA03/033,

Edition Number: M-122802-01-1

Date: 17.02.2004

GLP, unpublished Yes BCS

KIIA 2.8.1 /01 Lemke, G.;

Muehlberger, B. 2003 BYI 08330 (AE 1302943) - Partition coefficient

1-octanol/water (HPLC-method)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA03/036,

Edition Number: M-103244-01-1

Date: 13.11.2003

GLP, unpublished Yes BCS

KIIA 2.8.2 /01 Lemke, G.;

Muehlberger, B. 2003 BYI 08330 (AE 1302943) - Partition coefficient

1-octanol/water (HPLC-method)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA03/036,

Edition Number: M-103244-01-1

Date: 13.11.2003

GLP, unpublished Yes BCS

KIIA 2.9.1 /01 Heinemann, O. 2004 [Azaspirodecenyl-3-14C]- and

[azaspirodecenyl-5-14C]BYI08330: Hydrolytic

degradation

Bayer CropScience AG,

Report No.: MEF-04/176,

Edition Number: M-093124-01-2

Date: 08.09.2004

GLP, unpublished Yes BCS

KIIA 2.9.2 /01 Stupp, H. - P. 2005 BYI08330: Phototransformation of BYI08330

in sterile water

Bayer CropScience AG,

Report No.: MEF-05/206,

Edition Number: M-266695-01-2

Date: 15.11.2005

GLP, unpublished Yes BCS

KIIA 2.9.3 /01 Heinemann, O. 2004 BYI08330: Determination of the quantum yield

and assessment of the environmental half-life of

the direct photodegradation in water

Bayer CropScience AG,

Report No.: MEF-04/080,

Edition Number: M-092941-01-2

Date: 28.09.2004

GLP, unpublished Yes BCS

# - 59 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

KIIA 2.9.4 /01 Heinemann, O. 2004 BYI08330: Determination of the quantum yield

and assessment of the environmental half-life of

the direct photodegradation in water

Bayer CropScience AG,

Report No.: MEF-04/080,

Edition Number: M-092941-01-2

Date: 28.09.2004

GLP, unpublished Yes BCS

KIIA 2.9.5 /01 Muehlberger, B.;

Eyrich, U. 2005 BYI 08330 (AE 1302943) - Determination of

the dissociation constant

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: M-261598-01-1,

Edition Number: M-261598-01-1

Date: 24.11.2005

GLP, unpublished Yes BCS

KIIA 2.10 /01 Hellpointner, E. 2004 Calculation of the chemical lifetime of BYI

08330 in the troposphere

Bayer CropScience AG,

Report No.: MEF-04/400,

Edition Number: M-092840-01-1

Date: 14.09.2004

Non GLP, unpublished Yes BCS

KIIA 2.11.1

/01 Smeykal, H. 2006 BYI 08330 (Spirotetramat); Substance,

technical Flammability (Solids) A.10.

Siemens AG, Frankfurt am Main, Germany

Bayer CropScience AG,

Report No.: 20060305.01,

Edition Number: M-269989-01-1

Date: 26.04.2006

GLP, unpublished Yes BCS

KIIA 2.11.2

/01 Smeykal, H. 2006 BYI 08330 (Spirotetramat); Substance,

technical - auto – flamma-bility (solids -

determination of relative self-ignition

temperature) A.16.

Siemens AG, Frankfurt am Main, Germany

Bayer CropScience AG,

Report No.: 20060305.03,

Edition Number: M-270010-01-1

Date: 26.04.2006

GLP, unpublished Yes BCS

KIIA 2.13 /01 Smeykal, H. 2006 BYI 08330 (Spirotetramat); Substance,

technical - Explosive properties A.14.

Siemens AG, Frankfurt am Main, Germany

Bayer CropScience AG,

Report No.: 20060305.02,

Edition Number: M-269992-01-1

Date: 26.04.2006

GLP, unpublished Yes BCS

# - 60 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

KIIA 2.14 /02 Bogdoll, B.;

Lemke, G. 2006 Surface tension of BYI 08330 - Technical

substance

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: PA06/024,

Edition Number: M-270037-01-1

Date: 13.04.2006

GLP, unpublished Yes BCS

KIIA 2.15 /01 Smeykal, H. 2006 BYI 08330 (Spirotetramat); Substance,

technical - Oxidizing properties A.17

Siemens AG, Frankfurt am Main, Germany

Bayer CropScience AG,

Report No.: 20060305.04,

Edition Number: M-270029-01-1

Date: 26.04.2006

GLP, unpublished Yes BCS

# - 61 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

Annex III Data and Information

KIIIA1 2.1 /01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.2.1

/01 Rexer, K.; Bittner

P. 2006 Safety relevant technical properties of BYI

08330 oil dispersion 150 g/litre - Recipe Code:

30-00364846 - Material number: 06424376 -

Batch code: 08030/0233(0152)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: FOR0842(PC)01,

Edition Number: M-264101-01-1

Date: 20.01.2006

GLP, unpublished Yes BCS

KIIIA1 2.2.2

/01 Rexer, K.; Bittner

P. 2006 Safety relevant technical properties of BYI

08330 oil dispersion 150 g/litre - Recipe Code:

30-00364846 - Material number: 06424376 -

Batch code: 08030/0233(0152)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: FOR0842(PC)01,

Edition Number: M-264101-01-1

Date: 20.01.2006

GLP, unpublished Yes BCS

KIIIA1 2.3.1

/01 Rexer, K.; Bittner

P. 2006 Safety relevant technical properties of BYI

08330 oil dispersion 150 g/litre - Recipe Code:

30-00364846 - Material number: 06424376 -

Batch code: 08030/0233(0152)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: FOR0842(PC)01,

Edition Number: M-264101-01-1

Date: 20.01.2006

GLP, unpublished Yes BCS

KIIIA1 2.3.3

/01 Rexer, K.; Bittner

P. 2006 Safety relevant technical properties of BYI

08330 oil dispersion 150 g/litre - Recipe Code:

30-00364846 - Material number: 06424376 -

Batch code: 08030/0233(0152)

Bayer CropScience GmbH, Frankfurt am Main,

Germany

Bayer CropScience AG,

Report No.: FOR0842(PC)01,

Edition Number: M-264101-01-1

Date: 20.01.2006

GLP, unpublished Yes BCS

KIIIA1 2.4.2

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG, Yes BCS

# - 62 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished

# - 63 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

KIIIA1 2.5.1

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.5.2

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.5.3

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.6.1

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.7.1

/01 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material: HDPE] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-01,

Edition Number: M-266311-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.1

/02 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material:

COEX/EVOH] - Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-03,

Edition Number: M-266300-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.1

/03 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material: COEX/PA] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-02,

Edition Number: M-266306-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.3 Gueldner, W. 2007 Storage stability an d shelf life of spirotetramat Yes BCS

# - 64 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

/01 OD 150 G - [Packaging material: HDPE] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-01,

Edition Number: M-266311-01-1

Date: 26.03.2007

Non GLP, unpublished

KIIIA1 2.7.3

/02 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material:

COEX/EVOH] - Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-03,

Edition Number: M-266300-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.3

/03 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material: COEX/PA] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-02,

Edition Number: M-266306-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.4

/01 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material: HDPE] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-01,

Edition Number: M-266311-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.4

/02 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material:

COEX/EVOH] - Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-03,

Edition Number: M-266300-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.4

/03 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material: COEX/PA] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-02,

Edition Number: M-266306-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.5

/01 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material: HDPE] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-01,

Edition Number: M-266311-01-1

Date: 26.03.2007 Yes BCS

# - 65 -

Spirotetramat – Volume 3, Annex B.2, Physical and c hemical properties April 2008

Annex point/

reference

number Author(s) Year Title

Source (where different from company)

Company, Report No

GLP or GEP status (where relevant)

Published or not Data

Protection

Claimed

Y/N-R/NR Owner

Non GLP, unpublished

KIIIA1 2.7.5

/02 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material:

COEX/EVOH] - Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-03,

Edition Number: M-266300-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.7.5

/03 Gueldner, W. 2007 Storage stability and shelf life of spirotetramat

OD 150 G - [Packaging material: COEX/PA] -

Interim report (52 weeks)

Bayer CropScience AG,

Report No.: 2005-002629-02,

Edition Number: M-266306-01-1

Date: 26.03.2007

Non GLP, unpublished Yes BCS

KIIIA1 2.8.2

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.8.5.2

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.8.7.5

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS

KIIIA1 2.8.8.2

/01 Gueldner, W. 2006 Physical, chemical and technical properties of

BYI 08330 OD 150 G

Bayer CropScience AG,

Report No.: 14 1050 5392,

Edition Number: M-266815-01-1

Date: 06.02.2006

GLP, unpublished Yes BCS