Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08/07/2015-06/18/2015
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
GLP compliance:
yes (incl. certificate)
Type of method:
differential scanning calorimetry

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
100 mL sample received on 08/07/2015.
Presented as a colourless translucent liquid.
Batch number : 100026324
Substance certified 97.5% for isomer 1 of Maderal.
Stored at room temperature protected from direct sunlight

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
>= -75.2 - <= -74.8 °C

Any other information on results incl. tables

Four successive tests were performed. The last ones were retained which fulfilled the validity criteria for repeatability.Mean onset for melting occurred at -75.0°C +/- 0.2°C. the validity criteria were fulfilled: the standatd deviation within t he three replicate assessments did not exceed 0.5°C. Measured onset = 82.5°C.

Applicant's summary and conclusion

Executive summary:

The melting point was performed according to the EU Method A.1 (Melting / Freezing Temperature).

The test substance has the following melting point: -75°C +/-0,2°C