Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Melting point / freezing point
Administrative data
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 May 2008 and 02 July 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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. QA statement)
- 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
Constituent 1
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: Greater than 633 ± 0.5 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 contain 12% water as a known impurity, the wide endotherm at approximately 140 to 190°C was anticipated to be due to entrained water evaporating from the test samples.
Applicant's summary and conclusion
- Conclusions:
- The melting/freezing temperature of the test material has been determined to be greater than 633 ± 0.5 K.
- Executive summary:
The determination for substance NDS-Li in project number 1307 -0447 was carried out 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/freezing temperature of the test material has been determined to be greater than 633 ± 0.5 K.
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