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Diss Factsheets

Physical & Chemical properties

Melting point / freezing point

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Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12-20 November, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. The substance is adequately identified. Therefore full validation applies.
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
yes
Remarks:
experimental details missing (atmosphere unclear); peak profiles incomplete but acceptable for onset
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
11 March 2011
Type of method:
differential scanning calorimetry
Specific details on test material used for the study:
- Physical state: white crystalline powder.
- Storage condition: Room temperature protected from direct sun light.
Key result
Melting / freezing pt.:
46.1 °C
Decomposition:
no

Table 4.2/1: Melting point – results

Test no.

Start temperature

Heating rate

Onset temperature

1

35 °C

+5 °C/min

46.2 °C

2

30 °C

+5 °C/min

46.1 °C

3

30 °C

+5 °C/min

45.9 °C

Mean ± S.D.

 

 

46.1 °C ± 0.2 °C

 

Three successive tests were retained.

Mean onset for melting occurred at 46.1 °C ± 0.2 °C. The validity criteria were fulfilled: the standard deviation within the three replicate assessments did not exceed 0.5 °C.Therefore the average value is retained as final result.

Executive summary:

The melting point of the test substance was determined under GLP according to EU Method A.1 by using differential scanning calorimetry (DSC).

Three main runs were performed, and the mean final temperature was retained.

The melting temperature of test substance has been determined to be 46.1 °C ± 0.2 °C.

Description of key information

Experimental melting point (i.e. transition from solid to liquid) = 46.1°C.

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:
46.1 °C

Additional information

A fully reliable experimental study, conducted according to a recognized EC method and under GLP, is available. It is considered as key study, and the result is retained as key data.