Annex B 

Spirotetramat 

B.2 Physical and chemical properties 

Reviewed by: 

PMRA, Canada 

Peer-reviewed by: 

US EPA, USA 

AGES, Austria 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

B.2.1 Physical and chemical properties of the active substance (Annex IIA 2) 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

 Melting point and boiling point IIA 2.1 

B.2.1.1 Melting point, freezing point or solidification point, purified a.s. IIA 2.1.1 

EC A.1, OECD 102 

BYI 08330, mix-batch 08045/0003, purity 99.2 % 

The melting point of Spirotetramat at atmospheric pressure is 142 °C. 

The result is acceptable Y Franke, J.; 2004 

M-063268-01-1 

B.2.1.2 Boiling point of purified active substance IIA 2.1.2 

EC A.2, OECD 103 

BYI 08330, mix-batch 08045/0003, purity 99.2 % 

Spirotetramat has no boiling point at atmospheric pressure. Spirotetramat decomposed at a temperature of 235 °C. 

The test material is a solid. Y Franke, J.; 2004 

M-063268-01-1 

B.2.1.3 Temperature at which decomposition or sublimation occurs IIA 2.1.3 

OECD 113 BYI 08330, 

mix-batch 08045/0003, purity 99.2 % 

Spirotetramat showed an endothermic effect in the temperature range 135 – 165 °C (melting) and a two exothermal effects in the temperature range 200 – 300 °C and 380 – 450 °C with a maximum overall energy of 246 J/g. 

The result is acceptable Y Franke, J.; 2004 

M-063268-01-1 
- 3 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

Relative density of purified active substance IIA 2.2 

B.2.1.4 Relative density of purified active substance IIA 2.2 

EC A.3, OECD 109 (pycnometer method) EC A.3, OECD 109, OPPTS 830.7300 (pycnometer method) 

BYI 08330, mix-batch 08045/0003, purity 99.1 % BYI 08330, PFV0586001, purity 97.5 % 

Active substance, pure: D420 = 1.23 

Active substance as manufactured: D420 = 1.22 

The results are acceptable Y 

Y 

Muehlberger, B., Lemke, G.; 2004 M-063293-01-1 Bogdoll, B., Lemke, G.; 2006 M-270041-01-1 

Vapour pressure and volatility IIA 2.3 

B.2.1.5 Vapour pressure of purified active substance IIA 2.3.1 

EC A.4, OECD 104 effusion method (vapour pressure balance) 

BYI 08330, mix-batch 08045/0003, purity 99.2 % 

Extrapolated: 5.6 x 10-9 Pa for 20 °C 

1.5 x 10-8 Pa for 25 °C 1.5 x 10-6 Pa for 50 °C 

The gas saturation method should be used instead of vapour pressure balance method. 

Y Franke, J.; 2004 

M-066171-01-1 

B.2.1.6 Henry's law constantIIA 2.3.2 

Calculation Henry's law constants at 20 °C at 

different pH values: at pH 4: 6.24 x 10-8 Pa x m3 x mol-1

at pH 7: 6.99 x 10-8 Pa x m3 x mol-1at pH 9: 1.09 x 10-7 Pa x m3 x mol-1

The results are acceptable N Bogdoll, B.; 2005

M-262215-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

Appearance IIA 2.4 

B.2.1.7 B.2.1.8 Description of the physical state and colour, pur. and techn. a.s. IIA 2.4.1 

OPPTS 830.6302,OPPTS 830.6303OPPTS 830.6302,OPPTS 830.6303 

BYI 08330, mix-batch 08045/0003, purity 99.1 % BYI 08330, PFV0586001, purity 97.5 % 

Active substance, pure: light beige powder Active substance as manufactured: white powder 

The results are acceptable Y 

Y 

Muehlberger, B.; 2003 M-103239-01-1 Bogdoll, B., Lemke, G.; 2006 M-270051-01-1 

B.2.1.9 Description of the odour - purified and technical active substance IIA 2.4.2 

OPPTS 830.6304OPPTS 830.6304 

BYI 08330, mix-batch 08045/0003, purity 99.1 % BYI 08330, PFV0586001, purity 97.5 % 

Active substance, pure: no characteristic odor Active substance as manufactured: no characteristic odor 

Acceptable Y 

Y 

Muehlberger, B.; 2003 M-103239-01-1 Bogdoll, B., Lemke, G.; 2006 M-270051-01-1 

Spectra and molecular extinction at relevant wavelengths IIA 2.5 Spectra for purified active substance IIA 2.5.1 

B.2.1.10.1 UV/VIS IIA 2.5.1.1 

 BYI 08330, 

M26802, purity 99.2 % 

UV (acetonitrile) The UV spectrum of BYI 08330 is shown in Figure 1. 

Acceptable spectra were provided Spectra in alkaline and acid media are required 

Y Kaussmann, M.; 

2004 M-182543-02-1 

B.2.1.10.2 IIA 2.5.1.2 IR 

 BYI 08330, 

M26802, purity 99.2 % 

The IR spectrum for BYI 08330 (Figure 2) was obtained using Bruker FTIR-Spectrometer TENSOR 37. Absorption bands and assignments are given in Table 1. 

Key bands are consistent with the structure. The results are acceptable 

Y Kaussmann, M.; 

2004 M-182543-02-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

B.2.1.10.3 IIA 2.5.1.3 NMR

 BYI 08330, 

M26802, purity 99.2 % 

1H and 13C spectra were obtained 

using a Bruker Avance 400 spectrometer.

1H-NMR (400.13 MHz, CDCl3) 

13C-NMR (100.61 MHz, CDCl3) 

The structure and the assignement of chemical shifts of carbons and protons in ppm are given in Figure 3 and tables 2 and 3 

The spectra are consistent with the structure of BYI 08330. 

Y Kaussmann, M.; 

2004 M-182543-02-1 

B.2.1.10.4 IIA 2.5.1.4 MS 

 BYI 08330, 

M26802, purity 99.2 % 

LC-MS/ESI+ was performed using 

HPLC Agilent 1100 with DAD and autosampler coupled to Waters ZMD MS with ESI Z-Spray source. The results showed the [M+H]+ ion m/z 

374.3 and [2M+H] + ion m/z 747.4. 

These are consistent with a molecular weight of 373.48 (Figure 4). 

MS confirmed the structure of BYI 08330. 

Y Kaussmann, M.; 

2004 M-182543-02-1 

IIA 2.5.1.5 Wavelengths at which UV/VIS molar extinction occurs, max >290 nm 

 BYI 08330, 

M26802, purity 99.2 % 

Peak maxima molar absorptivity  [nm] [1000 cm2/mol]  211 22.0 x 103

 276 0.8 x 103

The results are acceptable Y Kaussmann, M.; 

2004 M-182543-02-1 

B.2.1.10.5 Optical purity IIA 2.5.1.6 

 Not relevant as the active substance 

is not a resolved optical isomer 

B.2.1.11 Spectra for impurities IIA 2.5.2 

IIA 2.5.2.1 UV/VIS 

 No data presented None of the impurities present in 

the active substance as manufactured is of toxicological or environmental significance 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

IIA 2.5.2.2 IR No data presented None of the impurities present in 

the active substance as manufactured is of toxicological or environmental significance 

IIA 2.5.2.3 NMR No data presented None of the impurities present in 

the active substance as manufactured is of toxicological or environmental significance 

IIA 2.5.2.4 MS No data presented None of the impurities present in 

the active substance as manufactured is of toxicological or environmental significance 

B.2.1.12 Solubility of purified active substance in water (pH 4-10) IIA 2.6 

B.2.1.12 Solubility of purified active substance in wate r (pH 4-10) IIA 2.6 

EC A.6, OECD 105 (Flask method) EC A.6, OECD 105, OPPTS 830.7840 

BYI 08330, mix-batch 08045/0003, purity 99.1 % BYI 08330, SPT0378-1, purity 99.4 % 

pH 4 33.5 mg/L at 20°C pH 7 29.9 mg/L at 20°C pH 9 19.1 mg/L at 20°C The HPLC chromatograms shows that the test item is unstable in aqueous solution at pH 9 (formation of a degradation product). The degradation does increase with longer stirring time. In distilled water: pH 6.0 - 6.3 33.4 mg/L at 20°C 

The results are acceptable Y 

Y

Muehlberger, B., Strunk, B.; 2003 M-103256-01-1 Bogdoll, B., Lemke, G.; 2006 M-270060-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

IIA 2.7 Solubility in organic solvents at 15 to 25°C 

B.2.1.13 Solubility in organic solvents at 15 to 25°C IIA 2.7 

EC A.6, OECD 105 (Flask method) 

BYI 08330, mix-batch 08045/0003, purity 99.1 % 

 [g/L at 20 °C] ethanol 44 n-hexane 0.055 toluene 60 dichloromethane > 600 acetone 100 - 120 ethyl acetate 67 dimethyl sulfoxide 200 - 300 

The results are acceptable Y Muehlberger, B., 

Eyrich, U.; 2004 M-122802-01-1 

Partition coefficient IIA 2.8 

B.2.1.14 n-Octanol/water partition coefficient IIA 2.8.1 

EC A.8, OECD 117 (HPLC-method) 

BYI 08330, mix-batch 08045/0003, purity 99.1 % 

Determination of the partition coefficient of Spirotetramat in 1-octanol / water at 20 °C  Pow log Pow pH 7 324 2.51 

The results are acceptable Y Lemke, G., 

Muehlberger, B.; 2003 M-103244-01-1 

Effect of pH (4 to 10) on the n-octanol/ water partition coefficient IIA 2.8.2 

EC A.8, OECD 117 (HPLC-method) 

BYI 08330, mix-batch 08045/0003, purity 99.1 % 

The partition coefficient (1-octanol / water) of Spirotetramat different pHvalues was:  Pow log Pow pH 4 324 2.51 pH 7 324 2.51 pH 9 316 2.50 

The results are acceptable Y Lemke, G., 

Muehlberger, B.; 2003 M-103244-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

Hydrolysis and photolysis IIA 2.9 

B.2.1.15 Hydrolysis rate at pH 4, 7 and 9 under sterile and dark conditions IIA 2.9.1 

OECD 111, EPA 161-1, DACO 8.2.3.2, MAFF 8147 

[Azaspirodecenyl-3-

14C]-cis-BYI 08330, 

radiochemical purity > 99 %, specific 

radioactivity 3.71 MBq/mg [Azaspirodecenyl-5-

14C]-cis-BYI 08330, 

radiochemical purity 98 %, specific radioactivity 4.03 MBq/mg 

BYI 08330 is hydrolytically labile under acidic, neutral and alkaline conditions at ambient temperature. The fastest degradation was observed at pH 9. The experimental half-lives of the test substance at pH 7 were 8.6 days (25 °C) and 13 days (20 °C). The test substance also was unstable under acidic conditions (half-lives of 32.5 days (25 °C) and 48 days (20 °C) at pH 4) and degraded with a half-life of 7.6 hours at pH 9 (25 °C). The hydrolytic degradation was strongly temperature dependent. One major degradation product occurred in the total pH range tested the formation of BYI 08330-enol as a common hydrolysis product was observed (for structure see appendix 1). 

The results are acceptable. Y Heinemann, O.; 

2004 M-093124-01-2 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

B.2.1.16 Direct phototransformation in sterile water using artificial light IIA 2.9.2 

EPA 162-1, DACO 8.2.3.3.2 

[Azaspirodecenyl-3-

14C]-BYI 08330, 

radiochemical purity > 98 %, specific radioactivity 3.67 MBq/mg [Azaspirodecenyl-5-

14C]-BYI 08330, 

radiochemical purity > 98 %, specific radioactivity 4.03 MBq/mg 

Spirotetramat was degraded in sterile aqueous 0.01 M acetate buffer pH 5 under conditions of direct phototransformation. Four major phototransformation products were found and identified as products of re-arrangement reactions (for structures see appendix 2). P6 was the main metabolite and increased to max. 39.2 % of the AR at DAT-7; P7 was max. 22.1 % at DAT-4; P8 increased to 11.1 % after 3 days exposure to light and decreased then to 5.3 % at the end; P9 was max. 18.2 % of the AR at DAT-6. Based on the experimental DT50 of 2.7 days for BYI 08330 the predicted environmental DT50 is calculated to be e.g. 12.9 solar summer days at Phoenix, AZ, USA or 19.9 summer days at Athens, Greece. Under dark conditions the half life under experimental conditions is 26 days, which is regarded as hydrolysis half-life, and BYI 08330-enol is formed, only. 

The results are acceptable. Y Stupp, H.-P.; 

2005 M-266695-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

B.2.1.17 Quantum yield of direct phototransformationIIA 2.9.3 

ECETOC, EPA 161-1 

BYI 08330, batch M26802, purity 99.2 % 

A degradation of BYI 08330 of approx. 56 % was measured by HPLC-UV during the maximum irradiation period of 240 minutes in water. This indicates that BYI 08330 is not stable against direct phototransformation in aqueous solution relative to other compounds irrated under the same study conditions. Using the UV absorption data and the degration kinetics of both the experiments a mean quantum yield of Φ = 0.00571 was calculated. 

Estimates based on two different arithmetic models (GC-Solar and Frank & Kloepffer) by means of the resulting quantum yield and the light absorption in a range of wavelengths relevant for the environment are given. They are well comparable when considering identical marginal conditions. “Environmental direct phototransformation half-lives” of BYI 08330 of 0.5 days to about one week during the period of main use can be assessed. However, this assessment does not consider any indirect mechanisms, which may enhance the photodegradation in natural water and which compete with the direct phototransformation to a great extent. This is addressed in more detail in chapter IIA 7.6. 

The results are acceptable. Y Heinemann, O.; 

2004 M-092941-01-2 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

B.2.1.18 Lifetime in the top layer of aqueous systems (calculated and real) IIA 2.9.4 

ECETOC, EPA 161-2 EPA 162-1, DACO 8.2.3.3.2 

BYI 08330, batch M26802, purity 99.2 % [Azaspirodecenyl-3-

14C]-BYI 08330, 

radiochemical purity > 98 %, specific radioactivity 3.67 MBq/mg [Azaspirodecenyl-5-

14C]-BYI 08330, 

radiochemical purity > 98 %, specific radioactivity 4.03 MBq/mg 

This point is covered by point IIA 2.9.3 and in more detail also considering natural water by point IIA 7.6. 

The result is acceptable. Y 

Y 

Heinemann, O.; 2004 M-092941-01-2 Stupp, H-.P.; 2005 M-266753-01-1 

B.2.1.19 Dissociation in water of purified active substance IIA 2.9.5 

OECD 112 (spectrophotometric method) 

BYI 08330, mix-batch 08045/0003, purity 99.1 % 

The dissociation constant of Spirotetramat was: pKa = 10.7 

The result is acceptable. Y Muehlberger, B., 

Eyrich, U.; 2005 M-261598-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

Estimated photochemical oxidative degradation IIA 2.10 

B.2.1.20 Estimated photochemical oxidative degradation IIA 2.10 

Calculation according to Atkinson 

 The chemical lifetime of 

spirotetramat in the air is assessed based on the calculation according to Atkinson by AOPWIN (version 1.91). A value of at the most 3 hours corresponding to a half-life of approx. 2 hours results, with respect to the OH radical and ozone reaction, only. Based on these values no longrange transport and no accumulation in air are expected for spirotetramat. Reaction with OH radicals and ozone contribute to the degradation of spirotetramat in the air to a high extent. The chemical stability of spirotetramat in air is not determined by an attack at one single site, but at different parts of the molecule. This should result in the formation of various primary radicals leading to secondary oxidation products, which can be eliminated from the air by wet and/or dry deposition. 

The results are acceptable. N Hellpointner, E.; 

2004 M-092840-01-1 

Flammability including auto-flammability IIA 2.11 

B.2.1.21 Flammability of the active substance as manufactured IIA 2.11.1 

EC A.10 BYI 08330, 

PFV0586001, purity 97.5 % 

Spirotetramat is not a highly flammable solid in the sense of EC guideline A.10. 

The results are acceptable. Y Smeykal, H.; 

2006 M-269989-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

B.2.1.22 Auto-flammability of the active substance as manufactured IIA 2.11.2 

EC A.16 BCC-Test 

BYI 08330, PFV0586001, purity 97.5 % BYI 08330, PFV0586001, purity 97.5 % 

No self-ignition temperature was observed up to the melting point or up to the maximum test temperature of 401 °C. Spirotetramat is not classified in Division 4.2 (a negative result was obtained in the test using a 10 cm cube sample at 140 °C). 

The results are acceptable. The study is considered as additional information by EU 

Y Y 

Smeykal, H.; 2006 M-270010-01-1 Smeykal, H.; 2006 M-270036-01-1 

Flash point of the active substance as manufactured IIA 2.12 

B.2.1.23 Flash point of the active substance as manufactured IIA 2.12 

 Not applicable. The active substance 

is a solid; its melting point is > 40 °C. 

The results are acceptable. 

Explosive properties of the active substance as manufactured IIA 2.13 

B.2.1.24 Explosive properties of the active substance as manufactured IIA 2.13 

EC A.14 BYI 08330, 

PFV0586001, purity 97.5 % 

Not explosive in the sense of EC guideline A.14. 

The results are acceptable. Y Smeykal, H.; 

2006 M-269992-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

Surface tension of the active substance as manufactured IIA 2.14 

B.2.1.25 Surface tension of the active substance as manufactured IIA 2.14 

EC A.5, OECD 115 EC A.5, OECD 115 

BYI 08330, mix-batch 08045/0003, purity 99.1 % BYI 08330, PFV0586001, purity 97.5 % 

Pure substance: 61.65 mN/m at 20°C Technical substance: 60.5 mN/m at 20°C the concentration used: 90% of the saturation concentration 

Spirotetramat is classified to be non-surface active according to EC Guideline A.5. This study is considered as additional information by EU This study is not required by Canada (PMRA) The study is accepted by EU. 

Y Y 

Muehlberger, B., Lemke, G.; 2004 M-063303-01-1 Muehleberger, B., Lemke, G.; 2004 M-063303-01-1 Bogdoll, B., Lemke, G.; 2006 M-270037-01-1 

Oxidizing properties of the active substance as manufactured IIA 2.15 

B.2.1.26 Oxidizing properties of the active substance as manufactured IIA 2.15 

EC A.17 BYI 08330, 

PFV0586001, purity 97.5 % 

Spirotetramat has no oxidizing properties in the sense of EC guideline A.17. 

The result is acceptable. Y Smeykal, H.; 

2006 M-270029-01-1 

pH IIA 2.16 

B.2.1.2.27 pH IIA 2.16 

OPPTS 830.7000 BYI 08330, 

batch SPT0378-1, purity 99.4 % BYI 08330, batch PFV0586001, purity 97.5 % 

Pure substance: 6.3 (1 % suspension in distilled water) Technical substance: 6.3 (1 % suspension in distilled water) 

The result is acceptable This study is not required according to directive 91/414. 

Y Bogdoll, B., 

Lemke, G.; 2006 M-269907-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

Stability IIA 2.17 

B.2.1.2.28 Storage stability IIA 2.17.1 

OPPTS 830.6317 BYI 08330, 

mix-batch 08045/0014, purity 97.75 % 

The results from a twelve months 30 °C stability study showed Spirotetramat to be stable in Polypropylene and Polyethylene containers. After completion of the accelerated storage test no decomposition of Spirotetramat could be established. There are no visible corrosive effects on the containers themselves after twelve months of storage. 

This study is not required by Canada (PMRA) This study is not required according to directive 91/414. 

Y Olenik, B.; 2006 

M-272433-03-1 

B.2.1.2.29 Stability (temperature, metals) IIA 2.17.2 

OPPTS 830.6313 BYI 08330, 

mix-batch 08045/0014, purity 97.7 % 

The results from a two weeks 54 °C stability study showed Spirotetramat to be stable in presence of the metals and metal ions. After completion of the accelerated storage test no decomposition of Spirotetramat could be established. In the presence of metals (iron and aluminum) changes in color during the test period could not be observed.

The deviation of the analytical measurement of the samples with aluminum flakes are based on the inhomogeneity of these samples. 

The result is acceptable This study is not required according to directive 91/414. 

Y Olenik, B.; 2006 

M-271221-02-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP

Y/N 

Reference 

Other/special studies IIA 2.18 

B.2.1.2.30 Other/special studiesIIA 2.18 Oxidation or reduction properties OPPTS 830.6314 BYI 08330, batch PFV0586001, 

purity 97.5 %

Technical BYI 08330 was found to be non-reactive with ammonium dihydrogen phosphate, metallic iron or aqueous solution of 0.1N potassium permanganate in terms of significant temperature increase or evolution of gas. No significant temperature increase was observed for all applied test mixtures, i.e. the temperature increase was clearly below 5 °C in the course of the experiments and never exceeded ambient conditions. 

This study is not required by Canada (PMRA) This study is not required according to directive 91/414. 

Y Bogdoll, B., 

Lemke, G.; 2006 M-270048-01-1 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 

B.2.1.3 Summary and evaluation of points 2.1 to 2.18 IIA 2.19 (not reviewed by 

Canada (PMRA) 

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

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

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

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

degradation is strongly temperature dependent and the 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 competition of hydrolysis and indirect photo-reactions is 

strong and leads to a thorough degradation. Its flammability, 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

HO

CH3

CH3

CH3

 
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Spirotetramat – Volume 3, Annex B.2, Physical and chemical 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

CH3

H

O

CH3

HO

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

CH3

H

O

CH3

H HO
- 19 - 

Spirotetramat – Volume 3, Annex B.2, Physical and chemical 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-oxo-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

CH3

H

O

CH3

H O

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-methoxy-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

CH3

H

O

CH3

O

O O

CH3

H
- 20 - 

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

Figure 1. 

UV spectrum 
- 21 - 

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

Figure 2. 

IR spectrum 
- 22 - 

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

Table 1. Interpretation of the IR spectrum 
- 23 - 

Spirotetramat – Volume 3, Annex B.2, Physical and chemical properties April 2008 
- 24 - 

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

Figure 3. 

A. 13C-NMR 
- 25 - 

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

B. 1H-NMR 
- 26 - 

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

Table 2. Interpretation of the 13C-NMR 
- 27 - 

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

Table 3. Interpretation of the 1H-NMR 

Figure 4. MS spectrum 
- 28 - 

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

B.2.2 Physical, chemical and technical properties of the plant protection product (Annex IIIA 2) Table 1. Summary of the physical and chemical properties of the plant protection product Movento 240 SC Insecticide Movento 240 SC is not evaluated for EC. 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Physical state of the preparation and its colour and odour IIIA 2.1 

B.2.2.1 Physical state of the preparation and its colour and odour IIIA 2.1 

Visual Olfactory 

Batch–Number: 07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Physical state: suspension Colour: white Odour: aromatic 

Aceptable N Gueldner, W., 2006 

M-266718-01-1 

Explosivity and oxidizing properties IIIA 2.2.1 

B.2.2.4 Explosive properties of the preparation IIIA 2.2.1 

EC A.14 Batch–Number: 

07218/0062(0062); 243.40 g/L spirotetramat. The specification and purity are given under point 1.4. 

Not explosive in the sense of EC Guideline A.14 

Aceptable Y Heitkamp, D., 2005 

M-259836-01-1 

B.2.2.5 Oxidizing properties of the preparation IIIA 2.2.2 

EC A.21 Batch–Number: 

07218/0062(0062); 243.40 g/L spirotetramat. The specification and purity are given under point 1.4. 

Not oxidizing in the sense of EC Guideline A.21 

Acceptable Y Heitkamp, D., 2005 

M-259836-01-1 
- 29 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Flash point & other indication of flammability or spontaneous ignition IIIA 2.3.1 

B.2.2.6 The flash point of the preparation IIIA 2.3.1 

EC A.9 Batch–Number: 

07218/0062(0062); 243.40 g/L spirotetramat. The specification and purity are given under point 1.4. 

No flash point up to the boiling point Acceptable Y Heitkamp, D., 2005 

M-259836-01-1 

B.2.2.7 The flammability of the preparation IIIA 2.3.2 

 Not flammable Acceptable 

B.2.2.8 The autoflammability of the preparation IIIA 2.3.3 

EC A.15 Batch–Number: 

07218/0062(0062); 243.40 g/L spirotetramat. The specification and purity are given under point 1.4. 

Auto ignition temperature: 415 °C 

Acceptable Y Heitkamp, D., 2005 

M-259836-01-1 

Acidity/alkalinity and if necessary pH value IIIA 2.4 

B.2.2.9 Acidity or alkalinity and pH value IIIA 2.4.1 

 Not applicable 

(4 ≤ pH ≤ 10) 
- 30 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.10 pH of a 1% aqueous dilution, emulsion or dispersion IIIA 2.4.2 

CIPAC MT 75.3 (electrometric determination) 

Batch–Number: 07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

4.6 (1 % in CIPAC D water under N2-atmosphere and room 

temperature) 

Acceptable Y Gueldner, W., 2006 

M-266718-01-1 

Viscosity and surface tension IIIA 2.5 

B.2.2.11.1 Kinematic viscosity of the preparation IIIA 2.5.1 

 Calculated: 

shear rate 20 s-1

ν = 

η / ρ = 2.25⋅10-4 m2/s at 20 °C 

ν = 

η / ρ = 1.90⋅10-4 m2/s at 40 °C 

shear rate 100 s-1

ν = 

η / ρ = 0.72⋅10-4 m2/s at 20 °C 

ν = 

η / ρ = 0.60⋅10-4 m2/s at 40 °C 

Acceptable Y Gueldner, W., 2006 

M-266718-01-1 

B.2.2.11.2 Dynamic viscosity of the preparation and details of the test conditions IIIA 2.5.2 

OECD 114 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

shear rate 20 s-1

η = 0.242 Pa s at 20 °C η = 0.203 Pa s at 40 °C shear rate 100 s-1

η = 0.0773 Pa s at 20 °C η = 0.0640 Pa s at 40 °C 

Acceptable Y Gueldner, W., 2006 

M-266718-01-1 

B.2.2.12 Surface tension of the preparation IIIA 2.5.3 

OECD 115 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

σ = 44 mN/m at 25 °C (undiluted) classified as surface-active 

This study is not required by Canada (PMRA) 

Y Gueldner, W., 2006 

M-266718-01-1 
- 31 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Relative density and bulk density IIIA 2.6 

B.2.2.13 Relative density of the preparation IIIA 2.6.1 

OECD 109 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

D420 = 1.075 

D440 = 1.069 

Acceptable Y Gueldner, W., 2006 

M-266718-01-1 

B.2.2.14 Bulk or tap density of the preparation IIIA 2.6.2 

 Not applicable as the 

preparation is a suspension 

Storage stability and shelf-life IIIA 2.7 

B.2.2.15 Stability after storage for 14 days at 54 °C IIIA 2.7.1 

CIPAC MT 46.3 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Stable for 2 weeks at 54 °C in HDPE This study is not 

required by Canada (PMRA) 

N Gueldner, W., 2006 

M-265475-01-1 

B.2.2.16 Stability after storage for other periods and/or temperature IIIA 2.7.2 

 A one year storage stability study is 

expected to be completed in December 2007 

Not provided 
- 32 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.17 Minimum content after heat stability testing IIIA 2.7.3 

CIPAC MT 46.3 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

The active substance content did not decline to less than 95 % of the content prior to the test (packaging material: HDPE) 

This study is not required by Canada (PMRA) 

N Gueldner, W., 2006 

M-265475-01-1 

B.2.2.18 Effect of low temperature on stability IIIA 2.7.4 

CIPAC MT 39.3 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

< 0.01 % residue on a 75 μm sieve after 7 days at 0 °C in HDPE 

This study is not required by Canada (PMRA) 

N Gueldner, W., 2006 

M-265475-01-1 

B.2.2.19 Shelf life following storage at ambient temperature IIIA 2.7.5 

GIFAP Monograph No. 17 

Batch–Number: 07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

 Study in progress 

(Scheduled end of storage 2007-12-03) 

N Gueldner, W., 2006 

M-265475-01-1 

B.2.2.20 Shelf life in months IIIA 2.7.6 

 The active substance 

is expected to be stable for 24 months (see IIIA 2.7.5) This study is not required by Canada (PMRA) 
- 33 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Technical characteristics of the product IIIA 2.8 

B.2.2.21 Wettability IIIA 2.8.1 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.22 Persistent foaming IIIA 2.8.2 

CIPAC MT 47.2 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

0.3 % in CIPAC D water: after 10 sec 45 mL after 1 min 38.5 mL after 3 min 33 mL after 12 min 23.5 mL 

This study is not required by Canada (PMRA) 

N Gueldner, W., 2006 

M-266718-01-1 

Suspensibility and suspension stability IIIA 2.8.3B.2.2.23 Suspensibility IIIA 2.8.3.1 

CIPAC MT 184 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

0.03 % of the preparation in CIPAC D water: Spirotetramat assay: 99 % 0.3 % of the preparation in CIPAC D water: Spirotetramat assay: 99 % 

This study is not required by Canada (PMRA) 

N Gueldner, W., 2006 

M-266718-01-1 

B.2.2.24 Spontaneity of dispersion IIIA 2.8.3.2 

CIPAC MT 160 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

5 % of the preparation in CIPAC D water: Spirotetramat assay: 96 % 

This study is not required by Canada (PMRA) 

N Gueldner, W., 2006 

M-266718-01-1 
- 34 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.25 Dilution stability IIIA 2.8.4 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

Sieve test IIIA 2.8.5 B.2.2.26 Dry sieve test IIIA 2.8.5.1 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.27 Wet sieve test IIIA 2.8.5.2 

CIPAC MT 185 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Residue on a 75 μm sieve: < 0.01 % 

This study is not required by Canada (PMRA) 

N Gueldner, W., 2006 

M-266718-01-1 

Particle size distribution IIIA 2.8.6 
- 35 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.28 Size distribution of particles – Normal size range of granules IIIA 2.8.6.1 IIIA 2.8.6.2 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.29 Dust content IIIA 2.8.6.3 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.30 Particle size of dust IIIA 2.8.6.4 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.31 Friability and attrition characteristics of granules IIIA 2.8.6.5 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

Emulsion characteristics IIIA 2.8.7 
- 36 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.32 Emulsifiability IIIA 2.8.7.1 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.33 Emulsion stability IIIA 2.8.7.2 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.34 Re-emulsifiability IIIA 2.8.7.3 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.35 Stability of dilute emulsions IIIA 2.8.7.4 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

Flowability, pourability and dustability IIIA 2.8.8 
- 37 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.36 Flowability IIIA 2.8.8.1 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

B.2.2.37 Pourability (including rinsed residue) IIIA 2.8.8.2 

CIPAC MT 148 Batch–Number: 

07218/0062(0062); 242.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Residue: 2.10 % Rinsed residue: 0.16 % 

This study is not required by Canada (PMRA) 

N Gueldner, W., 2006 

M-266718-01-1 

B.2.2.38 Dustability following accelerate storage IIIA 2.8.8.3 

 Not applicable as the 

preparation is a suspension This study is not required by Canada (PMRA) 

Physical compatibility with other products IIIA 2.9

B.2.2.39 Physical and chemical compatibility of tank mixes IIIA 2.9 

 Not applicable (tank 

mixtures with other pesticides are not recommended) This study is not required by Canada (PMRA) 
- 38 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Distribution and adherence to seed IIIA 2.10 

B.2.2.40 Adherence and distribution to seeds IIIA 2.10 

 Only applicable for 

seed treatment in cereals This study is not required by Canada (PMRA) 

Miscibility IIIA 2.11 

B.2.2.41 Miscibility IIIA 2.11 

Not required by Directive 91/414/EEC 

 Not applicable as the 

product is not to be diluted with petroleum solvents. 

Dielectric breakdown voltage IIIA 2.12 

B.2.2.42 Dielectric breakdown voltage IIIA 2.12 

Not required by Directive 91/414/EEC 

 Not applicable as the 

product is not intended for use around electrical equipment. 

Corrosion characteristics IIIA 2.13 

B.2.2.43 Corrosion characteristics IIIA 2.13 

Not required by Directive 91/414/EEC 

 The product is not excpected to be 

corrosive to the packaging material. 

The applicant will be requested to provide a one year corrosion characteristics study with a one year storage stability study.
- 39 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Container Material IIIA 2.14 

B.2.2.44 Container Material IIIA 2.14 

Not required by Directive 91/414/EEC 

 HDPE 1 L to 200 L 

Other/special studies IIIA 2.15 

B.2.2.45 Other/special studiesIIIA 2.15 

Not required by Directive 91/414/EEC 
- 40 - 

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

Table 2. Summary of the physical and chemical properties of the plant protection product Movento 150 OD Insecticide 

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Physical state of the preparation and its colour and odour IIIA 2.1 

B.2.2.1 Physical state of the preparation and its colour and odour IIIA 2.1 

Visual Olfactory 

Batch–Number: 08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Physical state: suspension Colour: light brown Odour: weak mouldy 

Acceptable N Gueldner, W., 2006 

M-266815-01-1 

Explosivity and oxidizing properties IIIA 2.2.1 

B.2.2.4 Explosive properties of the preparation IIIA 2.2.1 

EC A.14 Batch–Number: 

08030/0233(0152); 148.3 g/L spirotetramat. The specification and purity are given under point 1.4. 

Not explosive in the sense of EC Guideline A.14 Exothermic decomposition energy 17 J/g 

Acceptable This study is not required by Canada (PMRA). 

Y Rexer, K.; Bittner, P., 2006

M-264101-01-1 

B.2.2.5 Oxidizing properties of the preparation IIIA 2.2.2 

EC A.21 Batch–Number: 

08030/0233(0152); 148.3 g/L spirotetramat. The specification and purity are given under point 1.4. 

Not oxidizing in the sense of EC Guideline A.21. 

Acceptable Y Rexer, K.; Bittner, P., 2006

M-264101-01-1 
- 41 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Flash point & other indication of flammability or spontaneous ignition IIIA 2.3 

B.2.2.6 The flash point of the preparation IIIA 2.3.1 

EC A.9 Batch–Number: 

08030/0233(0152); 148.3 g/L spirotetramat. The specification and purity are given under point 1.4. 

Higher than 100 °C Acceptable Y Rexer, K.; Bittner, P., 2006

M-264101-01-1 

B.2.2.7 The flammability of the preparation IIIA 2.3.2 

 Not flammable Acceptable 

B.2.2.8 The autoflammability of the preparation IIIA 2.3.3 

EC A.15 Batch–Number: 

08030/0233(0152); 148.3 g/L spirotetramat. The specification and purity are given under point 1.4. 

Auto ignition temperature: 410 °C 

Acceptable Y Rexer, K.; Bittner, P., 2006

M-264101-01-1 

Acidity/alkalinity and if necessary pH value IIIA 2.4 

B.2.2.9 Acidity or alkalinity and pH value IIIA 2.4.1 

 Not applicable 

(4 ≤ pH ≤ 10) 
- 42 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.10 pH of a 1% aqueous dilution, emulsion or dispersion IIIA 2.4.2 

CIPAC MT 75.3 (electrometric determination) 

Batch–Number: 08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

4.5 (1 % in CIPAC D water under N2-atmosphere and room 

temperature) 

Acceptable Y Gueldner, W., 2006 

M-266815-01-1 

Viscosity and surface tension IIIA 2.5 

B.2.2.11.1 Kinematic viscosity of the preparation IIIA 2.5.1 

 Calculated: 

shear rate 20 s-1

ν = 

η / ρ = 8.07⋅10-4 m2/s at 20 °C 

ν = 

η / ρ = 5.41⋅10-4 m2/s at 40 °C 

shear rate 100 s-1

ν = 

η / ρ = 5.47⋅10-4 m2/s at 20 °C 

ν = 

η / ρ = 2.76⋅10-4 m2/s at 40 °C 

Acceptable Y Gueldner, W., 2006 

M-266815-01-1 

B.2.2.11.2 Viscosity of the preparation and details of the test conditions IIIA 2.5.2 

OECD 114 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

shear rate 20 s-1

η = 0.801 Pa s at 20 °C η = 0.532 Pa s at 40 °C shear rate 100 s-1

η = 0.543 Pa s at 20 °C η = 0.271 Pa s at 40 °C 

Acceptable Y Gueldner, W., 2006 

M-266815-01-1 

B.2.2.12 Surface tension of the preparation IIIA 2.5.3 

OECD 115 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

σ = 27 mN/m at 25 °C (undiluted) classified as surface-active 

This study is not required by Canada (PMRA) The study is accepted by EU. 

Y Gueldner, W., 2006 

M-266815-01-1 
- 43 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Relative density and bulk density IIIA 2.6 

B.2.2.13 Relative density of the preparation IIIA 2.6.1 

OECD 109 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

D420 = 0.993 

D440 = 0.983 

Acceptable Y Gueldner, W., 2006 

M-266815-01-1 

B.2.2.14 Bulk or tap density of the preparation IIIA1 2.6.2 

 Not applicable as the 

preparation is an oil dispersion 

Storage stability and shelf-life IIIA 2.7 

B.2.2.15 Stability after storage for 14 days at 54 °C IIIA 2.7.1 

CIPAC MT 46.3 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Stable for 2 weeks at 54 °C in HDPE, COEX/EVOH and COEX/PA 

This study is not required by Canada (PMRA) The study is accepted by EU. 

N Gueldner, W., 2006 

M-266311-01-1; Gueldner, W., 2006 M-266300-01-1; Gueldner, W., 2006 M-266306-01-1 

B.2.2.16 Stability after storage for other periods and/or temperature IIIA 2.7.2 

 A one year storage stability study is 

expected to be completed in March 2008. 

Not provided Not relevant for EU as the formulation is stable for 2 weeks at 54 °C. 
- 44 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.17 Minimum content after heat stability testing IIIA 2.7.3 

CIPAC MT 46.3 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

The active substance content did not decline to less than 95 % of the content prior to the test (packaging material: HDPE, COEX/EVOH and COEX/PA) 

This study is not required by Canada (PMRA) The result is accepted by EU. 

N Gueldner, W., 2006 

M-266311-01-1; Gueldner, W., 2006 M-266300-01-1; Gueldner, W., 2006 M-266306-01-1 

B.2.2.18 Effect of low temperature on stability IIIA 2.7.4 

CIPAC MT 39.3 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

0.04 % residue on a 75 μm sieve after 7 days at 0 °C in HDPE, COEX/EVOH and COEX/PA 

This study is not required by Canada (PMRA) The result is accepted by EU. 

N Gueldner, W., 2006 

M-266311-01-1; Gueldner, W., 2006 M-266300-01-1; Gueldner, W., 2006 M-266306-01-1 

B.2.2.19 Shelf life following storage at ambient temperature IIIA 2.7.5 

GIFAP Monograph No. 17 

Batch–Number: 08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

The formulation is expected to be stable for at least 2 years at ambient conditions in HDPE, COEX/EVOH and COEX/PA 

Study in progress (Scheduled end of storage 2007-12-03) 

N Gueldner, W., 2006 

M-266311-01-1; Gueldner, W., 2006 M-266300-01-1; Gueldner, W., 2006 M-266306-01-1 

B.2.2.20 Shelf life in months IIIA 2.7.6 

 The active substance 

is expected to be stable for 24 months (see IIIA1 2.7.5) This study is not required by Canada (PMRA) This point depends on the outcome of the shelf life study at ambient temperature (see B.2.2.19). 
- 45 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Technical characteristics of the product IIIA 2.8 

B.2.2.21 Wettability IIIA 2.8.1 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.22 Persistent foaming IIIA 2.8.2 

CIPAC MT 47.2 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

0.5 % in CIPAC D water: after 10 sec 25 mL after 1 min 0 mL after 3 min 0 mL after 12 min 0 mL 

This study is not required by Canada (PMRA) EU: The study has to be performed with the highest application dose (i.e. 0.64 %). 

N Gueldner, W., 2006 

M-266815-01-1 

Suspensibility and suspension stability IIIA 2.8.3B.2.2.23 Suspensibility IIIA 2.8.3.1 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.24 Spontaneity of dispersion IIIA 2.8.3.2 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 
- 46 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.25 Dilution stability IIIA 2.8.4 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

Sieve test IIIA 2.8.5 B.2.2.26 Dry sieve test IIIA 2.8.5.1 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.27 Wet sieve test IIIA 2.8.5.2 

CIPAC MT 185 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Residue on a 75 μm sieve: < 0.01 % 

This study is not required by Canada (PMRA) The result is accepted by EU. 

N Gueldner, W., 2006 

M-266815-01-1 

Particle size distribution IIIA 2.8.6 
- 47 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.28 Size distribution of particles – Normal size range of granules IIIA 2.8.6.1 IIIA 2.8.6.2 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.29 Dust content IIIA 2.8.6.3 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.30 Particle size of dust IIIA 2.8.6.4 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.31 Friability and attrition characteristics of granules IIIA 2.8.6.5 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

Emulsion characteristics. IIIA 2.8.7 
- 48 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.32 Emulsifiability IIIA 2.8.7.1 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.33 Emulsion stability IIIA 2.8.7.2 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.34 Re-emulsifiability IIIA 2.8.7.3 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.35 Stability of dilute emulsions IIIA 2.8.7.4 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 
- 49 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.35 Stability of emulsions IIIA 2.8.7.5 

CIPAC MT 180 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

0.01 % prep. in CIPAC A water. Dispersion after: 0 min completely 30 min sediment: trace  oil/cream: 0.0 mL Redispersibility after: 24 h completely 24.5 h sediment: trace  oil/cream: 0.0 mL 0.5 % prep. in CIPAC A water. Dispersion after: 0 min completely 30 min sediment: 0.2 mL  oil: 0.0 mL  cream: < 0.05 mL 

Dispersion stability of suspo-emulsion This study is not required by Canada (PMRA) EU: The test should be performed at the lowest and highest application dose which is 0.04 and 0.64%. 

N Gueldner, W., 2006 

M-266815-01-1 
- 50 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.35 Stability of emulsions (cont.) IIIA 2.8.7.5 

CIPAC MT 180 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Redispersibility after: 24 h completely 24.5 h sediment: 0.3 mL  oil: 0.0 mL  cream: < 0.05 mL 0.01 % prep. in CIPAC D water. Dispersion after: 0 min completely 30 min sediment: trace  oil/cream: 0.0 mL Redispersibility after: 24 h completely 24.5 h sediment: 0.0 mL  oil/cream: 0.0 mL 0.5 % prep. in CIPAC D water. Dispersion after: 0 min completely 30 min sediment: 0.05 mL  oil: 0.0 mL  cream: < 0.05 mL Redispersibility after: 24 h completely 24.5 h sediment: 0.2 mL  oil: 0.0 mL  cream: trace 

Dispersion stability of suspo-emulsion This study is not required by Canada (PMRA) EU: The test should be performed at the lowest and highest application dose which is 0.04 and 0.64%. 

N Gueldner, W., 2006 

M-266815-01-1 
- 51 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

Flowability, pourability and dustability IIIA 2.8.8 B.2.2.36 Flowability IIIA 2.8.8.1 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

B.2.2.37 Pourability (including rinsed residue) IIIA 2.8.8.2 

CIPAC MT 148 Batch–Number: 

08030/0233(0152); 148.95 g/L spirotetramat. The specification and purity are given under point 1.4. 

Residue: 3.61 % Rinsed residue: 0.20 % 

This study is not required by Canada (PMRA) The result is accepted by EU. 

N Gueldner, W., 2006 

M-266815-01-1 

B.2.2.38 Dustability following accelerate storage IIIA 2.8.8.3 

 Not applicable as the 

preparation is an oil dispersion This study is not required by Canada (PMRA) 

Physical compatibility with other products IIIA 2.9 

B.2.2.39 Physical compatibility of tank mixes IIIA 2.9.1 

 Not applicable (tank 

mixtures with other pesticides are not recommended) This study is not required by Canada (PMRA) 
- 52 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.39 Chemical compatibility of tank mixes IIIA 2.9.2 

 Not applicable (tank 

mixtures with other pesticides are not recommended) This study is not required by Canada (PMRA) 

Distribution and adherence to seed IIIA 2.10 

B.2.2.40 Distribution (seed treatment) IIIA 2.10.1 

 Only applicable for 

seed treatment in cereals This study is not required by Canada (PMRA) 

B.2.2.40 Adhesion (seed treatment) IIIA 2.10.2 

 Only applicable for 

seed treatment in cereals This study is not required by Canada (PMRA) 

Miscibility IIIA 2.11 

B.2.2.41 Miscibility IIIA 2.11 

Not required by Directive 91/414/EEC 

 Not applicable as the 

product is not to be diluted with petroleum solvents. 

Dielectric breakdown voltage IIIA 2.12 
- 53 - 

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

Test or Study & Annex point 

Guideline and method 

Test material purity and specification 

Findings Comments GLP 

Y/N 

Reference 

B.2.2.42 Dielectric breakdown voltage IIIA 2.12 

Not required by Directive 91/414/EEC 

 Not applicable as the 

product is not intended for use around electrical equipment 

Corrosion characteristics IIIA 2.13 

B.2.2.43 Corrosion characteristics IIIA 2.13 

Not required by Directive 91/414/EEC 

 The product is not expected to be 

corrosive to the packaging material 

The applicant will be requested to provide a one year corrosion characteristics study with a one year storage stability study. 

Container Material IIIA 2.14 

B.2.2.44 Container Material IIIA 2.14 

Not required by Directive 91/414/EEC 

HDPE jug or tote, 1 L to 200 L

Other/special studies IIIA 2.15 

B.2.2.45 Other/special studiesIIIA 2.15 

Not required by Directive 91/414/EEC 
- 54 - 

Spirotetramat – Volume 3, Annex B.2, Physical and chemical 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 point 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 practical and commercial conditions. Its technical properties 

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

A shelf-life (2 year) storage stability study is currently in progress. The end of storage is scheduled for 

2007-12-03. 

No physical/chemical classification is proposed. 
- 55 - 

Spirotetramat – Volume 3, Annex B.2, Physical and chemical 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 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 2.1.2 /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 chemical 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 state 

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 state 

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 state 

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 chemical 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 chemical 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 chemical 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 chemical 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 chemical 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 chemical 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 chemical 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 and shelf life of spirotetramat Yes BCS 
- 64 - 

Spirotetramat – Volume 3, Annex B.2, Physical and chemical 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 chemical 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