Registration Dossier

Administrative data

Endpoint:
water solubility
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.6 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method

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

Water solubilityopen allclose all
Key result
Water solubility:
ca. 7.4 mg/L
Incubation duration:
ca. 5 h
Temp.:
20 °C
pH:
ca. 7.1
Key result
Water solubility:
ca. 6.8 mg/L
Incubation duration:
ca. 8 h
Temp.:
20 °C
pH:
ca. 7.6

Applicant's summary and conclusion

Executive summary:

The partition coefficient was performed according to the EU Method A.6 (Water Solubility).

The test substance has the following hydrosolubility = 7.1 mg/L