Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 4 March 2009 and 29 May 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Recently conducted GLP compliant study using the most recent test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
other: Differential Scanning Calorimetry (DSC)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:

Results and discussion

Melting / freezing point
Melting / freezing pt.:
172 °C

Any other information on results incl. tables

The temperature at which thermal events occur over an increasing temperature between 0 and 240oC increasing steadily over a 45 minute period. The results are provided below

Thermographic Data - Determination 1

 

Thermal Event

  Interpretation    Temperature 
 Endotherm Melting temperature   171.47 oC  445K

Thermographic Data - Dertermination 2

 

Thermal Event

    Interpretation       Temperature 
  Endotherm  Melting Temperature  171.78oC 445K 

Applicant's summary and conclusion

Conclusions:
The melting point has been determined to be 445 ± 0.5K equivalent to 172oC.
Executive summary:

The melting temperature has been assessed using Differential Scanning Calorimetry (DSC) according to EU method A1 in compliance with GLP. Using a calibrated Differential Scanning Calorimeter, the temperature at which an endotherm event equivalent to the melting temperature recorded in duplicate. Taking an average of the recorded melting temperatures, the melting point of the substance has been determined to be 445±0.5K equivalent to 172oC.