Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Testing was conducted between 16 May 2008 and 13 June 2008.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Principles of method if other than guideline:
differential scanning calorimetry (DSC)
GLP compliance:
yes (incl. certificate)
Remarks:
The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Type of method:
other:

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Melting / freezing point
Melting / freezing pt.:
> 633 K
Atm. press.:
other: Not stated
Decomposition:
no
Sublimation:
no

Any other information on results incl. tables

Mean melting temperature: > 633 K

Discussion

The residue in both determinations was observed to be very similar in appearance to the original material.

As the test material was indicated by the Sponsor to be 96% pure and contain water as a known impurity, the wide endotherm at approximately 130°C can be expected to be due to water evaporating from the test samples.

Conclusion

The melting temperature of the test material has been determined to be greater than 633 K.

Applicant's summary and conclusion

Conclusions:
The melting temperature of the test material has been determined to be greater than 633 K.
Executive summary:

The melting temperature of the test material has been determined to be greater than 633 K for substance Na-Na in project number 1307-0436 by differential scanning calorimetry (DSC) using the procedure specified in ASTM E537-86, Method A1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The melting temperature of the test material has been determined to be greater than 633 K.