Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 15 February and 03 March 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:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
using a procedure designed to be compatible with Method A1 Melting/Freezing Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 102 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
Deviations:
no
GLP compliance:
yes
Type of method:
other: Differential scanning calorimetry (DSC)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: BMS-589154-01
Description: Off white powder
Batch: 1M49303NA
Purity: Not supplied
Expiry / Retest Date: Not supplied
Storage Conditions: Room temperature in the dark

Results and discussion

Melting / freezing point
Decomposition:
yes
Decomp. temp.:
>= 170 °C
Sublimation:
no
Remarks on result:
other: The test item has been determined to decompose with melting from approximately 170 °C (443 K).

Any other information on results incl. tables

Results

Thermograms and thermographic data for Determinations 1 to 3 are shown in Attachment 1.

Applicant's summary and conclusion

Conclusions:
The test item has been determined to decompose with melting from approximately 170 °C (443 K).
Executive summary:
Principle of the Test A phase transformation, e.g. melting or evaporation, or a reaction, e.g. dissociation, usually is associated with a heat effect. In the calorimeter, two identical crucibles, one filled with the test item and the other empty (used as a reference), are heated at a constant rate. During the experiment, the heat effect, i.e. the difference in heat flow between the sample crucible and the reference crucible, is registered. Performance of the Test Calibration The temperature accuracy of the DSC was assessed using an indium reference standard (purity*: 100 %). The melting temperature was determined to be 156.69 ºC and within the defined tolerance (156.6 ± 0.5 ºC). The DSC was therefore considered acceptable for use.

*Value quoted by supplier.

Conclusion

The test item has been determined to decompose with melting from approximately 170 °C (443 K).