Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: EU guideline, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
2003-02-13
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
description: off white powder
batch number: 0214400005
Received: 13 October 2003
Storage conditions: approximately 4°C in the dark

Results and discussion

Water solubility
Water solubility:
30.2 mg/L
Temp.:
20 °C
pH:
ca. 4.4
Details on results:
3 samples in duplicate

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
The water solubility of the test material has been determined to be 3.02 * 10-2 g/L of solution at 20 +/- 5°C
Executive summary:

The aim of this study was to determine the water solubility of the test item according to the EU A.6, using the flask method.

Analysis were done with HPLC.

The water solubility of the test material has been determined to be 3.02 * 10-2 g/L of solution at 20 +/- 5°C.