Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2016
Reliability:
1 (reliable without restriction)
Justification for type of information:
The determination was carried out using the flask method, 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
Batch Number : 18113833
The test system consisted of purified water with a resistivity of greater than 15MΩ.

Results and discussion

Water solubility
Key result
Water solubility:
>= 12 - <= 13 other: %w/w
Conc. based on:
test mat. (total fraction)
Temp.:
20 °C
pH:
ca. 5
Details on results:
Preliminary test :
Results of the preliminary estimate of water solubility are shown in the table 9 of the joint document WK38GS.
Preliminary test result: water solubility in the range 10 to 15 %w/w at 20.0 ± 0.5ºC.
Definitive Test :
The results of the definitive test for the water solubility are shown in the table 10 of the joint document WK38GS.
Water solubility in the range 12 to 13 %w/w at 20.0 ± 0.5 ºC.

Any other information on results incl. tables

Water solubility in the range 12 to 13 %w/w at 20.0 ± 0.5 ºC.

Applicant's summary and conclusion

Conclusions:
The standard EC method A6 and OECD method 105 was not applicable to this test item due to the high indeterminable saturation levels produced. It was therefore not possible to prepare samples at five times the saturation level as recommended in the guidelines. No analysis could be performed due to the high solubility producing unfilterable mixtures. Therefore the water solubility was determined based on visual inspection. Throughout testing the test item/water mixtures have been shown to be single phase homogenous solutions at concentrations below 15.0% w/w, with significant absorbance of the water above 20.0 %w/w.
Executive summary:

The water solubility of the test item has been determined to be in the range of 12 to 13% w/w of solution at 20.0 ± 0.5 °C.