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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 February 2006 - 25 April 2006
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method

Test material

Constituent 1
Reference substance name:
No.338 RED
No.338 RED
Details on test material:
Description: red powder
Batch number: 50670

Results and discussion

Water solubility
Water solubility:
< 0 g/L
20 °C
> 6.3 - < 7

Any other information on results incl. tables

Preliminary test:

Since the test substance was of a very fine particle size, not all undissolved test substance was removed by centrifugation, and therefore the sample was also filtrated. However, also with filtration not all undissolved test substance was removed (determined using the Tyndall effect), so the determined water solubility during the preliminary test (7.93 x 10E-4 g/l; only Component 2 was detected in the sample solution) was an overestimation.

Main study:


The linearity of the detector with respect to concentration was assessed over the nominal contrentration range of 0 to 25.0 mg/l. This was satisfactory with a correlation coefficient of >= 0.997 being obtained when assessing the three major components present in the test material on an individual basis.

Recovery of analysis of the sample procedure was assessed and proved adequate for the test (mean recovery 80.4 -90.4% for 0.25 mg/l nominal concentration and 74.0 -96.2% for 0.10 mg/l nominal concentration).

Concentrations have not been corrected for recovery of analysis.


Overall, for all components and for both flow rates, the water solubility was determined to be < 1.0 x 10E-4 g/l at 20.0 +/-0.5°C (pH 6.3 -7.0). The incomplete removal of all excess, un-dissolved test material by the filtration step applied to the sample clean up was confirmed to have no significant impact on the test. This was since any remaining contamination of the sample solutions still resulted in a concentration below that for which the recovery procedure had been succesfully validated, the nominal concentration subsequently used as the reported limit value of solubility.

Applicant's summary and conclusion

Interpretation of results (migrated information): insoluble (< 0.1 mg/L)
The water solubility of the test substance was determined to be < 1.0 x 10E-4 g/l at 20.0 +/-0.5°C (pH 6.3 -7.0), monitoring the three significant components of the test material.