Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August to november 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The determination was carried out by the flask method, using a procedure designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
The test system consisted of purified water with a resistivity of greater than 15MΩ.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
White powder
Specific details on test material used for the study:
Batch 18114773 - Purity > 99.5%

Results and discussion

Water solubility
Key result
Water solubility:
ca. 40.9 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
ca. 6.1

Applicant's summary and conclusion

Conclusions:
On completion of the equilibration period, the samples were clear and colorless with excess test item present at the bottom of the test vessels. The solutions were decanted, avoiding excess test item prior to centrifugation. After centrifugation, the supernatant was taken for analysis. The supernatant was visually observed to be clear/colorless and free from un-dissolved test item.
As the water solubility was determined during the preliminary test to be above 10-2 g/L, the flask shaking test was performed.
All individual water solubility results were within ± 15% of the mean, thus satisfying the criteria specified in the guidelines.

The water solubility of the test item has been determined to be 4.09 x 10-2 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

The water solubility of the test item has been determined to be 4.09 x 10-2 g/L of solution at 20.0 ± 0.5 °C.