Sumitomo Chemical Takeda Agro Co., Ltd. TI-435 June 2004

Transcription

1 Section A3 Physical and Chemical Properties of Active Substance Subsection (Anne Point) Method Purity/ Specification Results Remarks/ Justification GLP (Y/N) Reliability Reference Official use only 3.1 Melting point, boiling point, relative density (IIA3.1) Melting point OECD 102 A.1) and result: C The measured melting point was corrected taking into account the reference melting point of two standards. pressure: normal atmospheric pressure Boiling point inhouse method The test substance decomposed before boiling Bulk density/ relative density OECD 109 A.3, pycnometer method) and [g/ml] (at 20 C) CIPAC MT 3 A.3 pycnometer method / OECD 109 and US EPA OPPTS ) 1.59 [g/cm 3 ] (at 20 C)

2 Section A3 Physical and Chemical Properties of Active Substance Subsection (Anne Point) Method Purity/ Specification Results Remarks/ Justification GLP (Y/N) Reliability Reference Official use only 3.2 Vapour pressure (IIA3.2) OECD 104 A.4, effusion method) and Vapour pressure 1 temperature: 25 C result: Pa (etrapolated) Vapour pressure 2 temperature: 20 C result: Pa (etrapolated) Henry s Law Constant (Pt. I-A3.2) Handbook of chemical property estimation methods. Lyman, W.J. et al. (1982) - (calculation) calculated result: Pa m 3 / mol (at 20 C) 3.3 Appearance (IIA3.3) , & and J-MAFF 9-Nousan- No Physical state solid, powder (PAI & TGAI) Colour Munsell Color System: clear and colourless (PAI) 5Y 8.3/6 (TGAI) Odour odourless (PAI & TGAI)

3 Section A3 Physical and Chemical Properties of Active Substance Subsection (Anne Point) Method Purity/ Specification Results Remarks/ Justification GLP (Y/N) Reliability Reference Official use only 3.4 Absorption spectra (IIA3.4) UV/VIS OECD 101 (UV/VIS) and Ma nm in acidic and neutral solution, ma nm in basic solution. IR J-MAFF 9-Nousan-No Absorption peaks (cm -1 ): 3330, 3289, 1633, 1542, 1532, 1463, 1433, 1393, 1346, 1320, 1234, 1181, 1141, 1066, 1044, 949. NMR J-MAFF 9-Nousan-No In agreement with proposed structure. MS J-MAFF 9-Nousan-No In agreement with proposed structure.

4 Section A3 Physical and Chemical Properties of Active Substance Subsection (Anne Point) Method Purity/ Specification Results Remarks/ Justification GLP (Y/N) Reliability Reference Official use only 3.5 Solubility in water (IIA3.5) Water solubility 1 OECD 105 A.6, flask method) and result: g/l temperature: 20 C ph: 10 Water solubility 2 OECD 105 A.6, flask method) result: g/l temperature: 20 C ph: 4 Water solubility 3 result: g/l temperature: 20 C ph: Dissociation constant (-) OECD 112 (spectrophoto-metric method) and pk a = (at 20 C) 3.7 Solubility in organic solvents, including the effect of temperature on solubility (IIIA3.1) OECD 105 A.6, flask method) and in mg/l (at 25 C): heptan <1.04 ylene 12.8 dichloromethane 1320 methanol 6260 octanol 938 acetone ethyl acetate 2030

5 Section A3 Physical and Chemical Properties of Active Substance Subsection (Anne Point) Method Purity/ Specification Results Remarks/ Justification GLP (Y/N) Reliability Reference Official use only 3.8 Stability in organic solvents used in b.p. and identity of relevant breakdown products (IIIA3.2) 3.9 Partition coefficient n-octanol/water (IIA3.6) log Pow 1 OECD 117 A.8, HPLC method) and log Pow 2 OECD 107 A.8, Flask-shaking method) log Pow 3 log Pow 4 result: 0.7 temperature: 25 C result: temperature: 25 C ph: 4 result: temperature: 25 C ph: 7 result: temperature: 25 C ph: 10

6 Section A3 Subsection (Anne Point) 3.10 Thermal stability, identity of relevant breakdown products (IIA3.7) 3.11 Flammability, including autoflammability and identity of combustion products (IIA3.8) Physical and Chemical Properties of Active Substance Method Purity/ Specification Results EEC, A.14 DSC evaluation for thermal analysis showed that the test substance is thermally stabile and does not form breakdown products while heating up to the melting point. Remarks/ Justification GLP (Y/N) Reliability Reference Official use only EEC, A.10 Not highly flammable. X EEC, A.16 No relative self-ignition. X 3.12 Flash-point (IIA3.9) 3.13 Surface tension (IIA3.10) EEC, A.5 and OECD 115 result: 79.6 mn/m temperature: 20 C 3.14 Viscosity (-) 3.15 Eplosive properties (IIA3.11) and EEC, A.14 Not eplosive (when heated and not sensitive to shock and friction) Oidizing properties (IIA3.12) EEC, A.17 and US EPA OPPTS No oidising properties. No reaction with H 2 O, NH 4 H 2 PO 4, Zn, Fe or kerosene; color change from purple to black with KMnO 4.

7 Section A3 Physical and Chemical Properties of Active Substance Subsection (Anne Point) Method Purity/ Specification Results Remarks/ Justification GLP (Y/N) Reliability Reference Official use only 3.17 Reactivity towards container material (IIA3.13) and During storage of TI-435 for 24 months, no peeling, cracking or discoloration of the commercial packaging (polyethylene bag) was observed and no swelling of the container walls occurred. X TI-435 is stable against zinc, iron, aluminium, zinc acetate, iron acetate, and aluminium acetate at least for 14 days at 25 C.

8 Evaluation by Competent Authorities Use separate "evaluation boes" to provide transparency as to the comments and views submitted Evaluation by Rapporteur Member State

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