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Diss Factsheets

Physical & Chemical properties

Melting point / freezing point

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Administrative data

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Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 April to 21 June, 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
The study was conducted according to an internationally recognised method, and under GLP; some experimental details are missing. This is not considered critical for the assessment. Therefore validation applies with acceptable restrictions.
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
not specified
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
GIPC; effective Jan.11, 2011, signed on Mar.11, 2011
Type of method:
differential scanning calorimetry
Specific details on test material used for the study:
- Physical appearance: Light yellow translucent liquid.
- Storage conditions of test material: At room temperature protected from direct sunlight.
Key result
Melting / freezing pt.:
-53.6 °C

Table 1: Observed onset temperature and heating rate:




































Test n°



Start Temperature



Heating rate



Onset temperature



1



-80 °C



+5 °C/min



-53.7 °C



2



-80 °C



+5 °C/min



-53.6 °C



3



-80 °C



+5 °C/min



-53.5 °C



Mean ± S.D.



 



 



-53.6 ± 0.1 °C



 


Three successive tests were retained.


 


Mean onset for melting occurred at -53.6 ± 0.1 °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.

Conclusions:
The melting point of the substance was determined to be -53.6 ± 0.1°C
Executive summary:

A GLP study was conducted to determine the melting point of the test substance by differential scanning calorimeter (DSC) method according to EU method A.1.


Three main runs were performed, and the mean of the three determinations (onset temperature) was retained.


Under the test conditions, the melting point of the substance occured at -53.6 °C ± 0.1 °C.

Description of key information

The melting point of the substance was determined to be -53.6 ± 0.1°C

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:
-53.6 °C

Additional information

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