(4aR*, 8aR*)-1-bromo-4a,5,9,10,11,12-hexahydro-3-methoxy-6H-benzofuro[3a,3,2-ef] [2]benzazepin-6-one hydrochloride (1:1)

Auto flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

relative self-ignition temperature (solids)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-06-16 to 2001-11-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

The testing facility indicated that the protocol was followed without deviation.

GLP compliance:

yes (incl. QA statement)

Remarks:

The Federal Office of Public Health, the Swiss Agency for the Environment, Forests and Landscape and the Intercantonal Office for the Control of Medicines with respect to the compliance with the Swiss legislation on Good Laboratory Practice.

Specific details on test material used for the study:

- Batch n°: RT002102G4A311
- Analytical purity: 99.4%
- Expiration date: 25 March 2002
- Storage condition: at room temperature

Relative self-ignition temperature:

ca. 306 °C

The test substance showed an exothermic reaction starting at about 220 deg C. A maximum temperature of about 570 deg C was measured in the sample cube during the exothermic reaction. At the end of the measurement, the test substance was run out of the sample cube and only little red ash remained. T002102 shows a relative self-ignition temperature at about 306 deg C.

Conclusions:

T002102 shows a relative self-ignition temperature at about 306 deg C. T002102 is auto-flammable under the conditions of the test.

Reference 2

Endpoint:

relative self-ignition temperature (solids)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October - 03 November 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Batch n°: M16DB1211
- Analytical purity: 99.7% (base titration)
- Expiration date: 05 April 2017
- Storage condition: at room temperature

Key result

Relative self-ignition temperature:

300 °C

Remarks on result:

other: After the experiment, the test item had turned into a charred residue due to decomposition and/or reaction

A small endothermic or exothermic effect of the test item was observed between 216°C and 232°C. A strong exothermic effect of the test item was observed between 238°C and 335°C. The temperature of the test item reached 400°C at an oven temperature of 300°C. It demonstrated that the self-ignition temperature of the test item is 300°C. After the experiment, the test item had turned into a charred residue. It indicated that the test item had been molten, decomposed and/or reacted during the experiment.

Conclusions:

Based on the EC A.16 test the test item has a self-ignition temperature of 300°C.

Description of key information

The auto-flammability potential of the substance was determined in a K1 GLP study performed according to EU Method A.16 (RCC Ltd., 2001). The substance was concluded to be auto-flammable under the conditions of the test and showed a relative self-ignition temperature at about 306°C.

To investigate if the substance is self-heating, the UN N.4 full-scale test was carried out in a K1 GLP study with the EC A.16 method as screening (Reingruber, 2016). The result of this screening is comparable to the result obtained by RCC Ltd. (2001): the self-ignition temperature was determined to be 300°C.

Key value for chemical safety assessment

Autoflammability / Self-ignition temperature at 101 325 Pa:

306 °C

Additional information

The auto-flammability was determined by 2 tests according to the EU method A.16 and under GLP conditions and was therefore assigned as reliable without restrictions (Klimisch 1 score). During the first test (RCC Ltd., 2001), the substance showed an exothermic reaction starting at about 220 °C. A maximum temperature of about 570 °C was measured in the sample cube during the exothermic reaction. At the end of the measurement, the substance was run out of the sample cube and only little red ash remained. The substance shows a relative self-ignition temperature at about 306 °C.

During the second test (Reingruber, 2016), a strong exothermic effect of the test item was observed between 238°C and 335°C. The temperature of the test item reached 400°C at an oven temperature of 300°C. It demonstrated that the self-ignition temperature of the test item is 300°C. After the experiment, the test item had turned into a charred residue. It indicated that the test item had been molten, decomposed and/or reacted during the experiment.