Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 February 2011 – 27 April 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-Y110
- Test substance storage: At room temperature protected from light
- Stability under storage conditions: Stable
- Description: Orange powder
- Batch: MB-1
- Expiry date: 23 December 2015

Results and discussion

Water solubility
Water solubility:
>= 405 g/L
Temp.:
20 °C
pH:
7.1
Details on results:
In Preliminary test 2, a mixture at a nominal concentration of 405 g/l was analysed after centrifugation. Concentration measured after two centrifugation steps was 439 g/l. From this it was concluded that all E-Y110 had dissolved and the water solubility is ≥ 405 g/l . The pH of the aqueous sample after two centrifugation steps was 7.1.

No further testing was performed because Preliminary test 1 (nominal end concentration 515 g/l) showed that no aqueous phase required for measurement of water solubility was obtained at higher concentration.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
Water solubility of E-Y110 at 20°C is ≥ 405 g/l. The pH of the aqueous sample after two centrifugation steps was 7.1.