1H-Pyrazolo[3,4-c]pyridine-3-carboxylic acid, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)phenyl]-, ethyl ester

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Link to relevant study record(s)

Reference

Endpoint:

relative self-ignition temperature (solids)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 20 February and 21 February 2012.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method A.16 (Relative Self-Ignition Temperature for Solids)

Version / remarks:

using a procedure designed to be compatible with Method A16 Relative Self-Ignition Temperature for Solids of Commission Regulation (EC) No 440/2008 of 30 May 2008.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Relative self-ignition temperature:

> 193 °C

Remarks on result:

other: The test item has been determined not to have a relative self-ignition temperature below its melting temperature.

     

Results

Whilst heating the test item,no relevant exothermic reaction was observed. The temperature/time curve is shown in

Attachment 2. On completion of the test, the cube was empty, a brown liquid was observed beneath the cube.

Conclusions:

The test item has been determined not to have a relative self-ignition temperature below its melting temperature.

Executive summary:

Test System Testing was conducted using a procedure designed to be compatible with Method A16 Relative Self-Ignition Temperature for Solids of Commission Regulation (EC) No 440/2008 of 30 May 2008. Principle of the Test The test item is heated in a fine mesh stainless steel cube that is suspended in an oven. The temperature/time-curves of both test item and oven are recorded. Performance of the Test The cube was completely filled with the test item and placed in the center of the oven at room temperature.A thermocouple was placed in thecenterof the sample and another in the oven. The oven temperature was programmed to increase from ambient to193°C (which was approximately10°C higher than the melting temperature, determined as part of Harlan Laboratories Ltd study number 41200037) at a rate of 0.5 °C/min. The temperature/time curves relating to the condition in thecenterof the sample and the oven were recorded on a data logger. The appearance of the test item after the test was recorded. Data Handling The self-ignition temperature, as obtained by this method, is the minimum ambient temperature expressed in [°C] at which a certain volume of a substance ignites under defined conditions.

 

Temperature measurement data and any heat effects observed between room temperature and 193 °C were evaluated.

 

If an exothermic reaction of the test item appears, the sample thermocouple shows a sharp temperature rise above the oven temperature. The temperature of the oven at which the sample reaches 400 °C by self-heating is stated as the self-ignition temperature of the test item.

Results Whilst heating the test item,no relevant exothermic reaction was observed.The temperature/time curve is shown in Attachment 2. On completion of the test, the cube was empty, a brown liquid was observed beneath the cube.

          

Conclusion

The test item has been determined not to have a relative self-ignition temperature below its melting temperature.

Description of key information

The test item has been determined not to have a relative self-ignition temperature below its melting temperature.