Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 February 2011 – 04 May 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and EC guidelines and in compliance with GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
(1995)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(Official Journal of the European Union no. L142, May 31, 2008)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): E-BW102
- Description: Reddish brown powder
- Batch: MB-1
- Test substance storage: At room temperature protected from light
- Stability under storage conditions: Stable
- Expiry date: 23 December 2015

Results and discussion

Water solubility
Water solubility:
142 g/L
Temp.:
20 °C
Remarks on result:
other: The pH of the aqueous samples could not be measured due to lack of aqueous phase.
Details on results:
In Preliminary test 2, a mixture at a nominal concentration of 106 g/l was analysed after centrifugation. Concentration measured after two centrifugation steps was 112 g/l. From this, it was concluded that all E-BW102 had dissolved. The pH of the aqueous sample after three centrifugation steps was 7.9.

In Preliminary test 3, a mixture at a nominal concentration of 201 g/l was analysed after centrifugation. Concentration measured after two and three centrifugation steps was 141 and 143 g/l. Because Preliminary test 1 (nominal concentration 212 g/l) showed that stirring of the test substance at higher concentrations is not possible, it was decided to stop testing and to report water solubility as 142 g/l i.e. the mean of the two concentrations measured in Preliminary test 3.
The pH of the aqueous samples could not be measured due to lack of aqueous phase.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
Water solubility of E-BW102 at 20°C is 142 g/l. The pH of the aqueous sample could not be measured due to lack of aqueous phase but pH of a nominal 106 g/l sample after three centrifugation steps was 7.9.