tert-butyl {(1S)-2-[(1S,3S,5S)-3-cyano-2-azabicyclo[3.1.0]hex-2-yl]-1-[3-hydroxyadamantan-1-yl]-2-oxoethyl}carbamate

Auto flammability

Administrative data

Endpoint:

relative self-ignition temperature (solids)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

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

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Identification: BMS-528235-01
Description: Off white powder
Batch: 1L63487N
Purity: 98.6%
Structure: Please see Attachment 1.
Expiry / Retest Date: 27 November 2014
Storage Conditions: Room temperature in the dark

Results and discussion

Relative self-ignition temperature (solids)

Relative self-ignition temperature:

> 178 °C

Remarks on result:

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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Conclusions:

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

Executive summary:

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 the center of the oven. A thermocouple was placed in the centre of the sample and another in the oven. The oven temperature was programmed to increase from ambient to178°C (which was approximately 10°C higher than the melting temperatures supplied by the Sponsor) at a rate of 0.5 °C/min. The temperature/time curves relating to the condition in the centre of the sample and the oven were recorded on a two channel chart recorder. Before and after the test the appearance of the test item was recorded.

         

Conclusion

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