SUMILIZER GP

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26-Mar to 13-Apr-2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

GLP compliance:

yes (incl. QA statement)

Remarks:

The Swiss GLP Monitoring Authorities

Type of method:

column elution method

Temp.:

20 °C

pH:

> 6 - < 7.08

Remarks on result:

other: The substance was not stable under test conditions. The substance could not be detected in any of the eluted samples (pH 6.00 - 7.08).

Results

During pre-tests the water solubility of the test item at room temperature was estimated to be below the smallest calibration point of 2.1654 mg/L. 

During the main test six samples were analysed in the first run (0.52 mL/min) and six samples during the second run (0.26 mL/min), each with a sampling interval of one hour. Total elution time was about 68 hours. The quantification was performed by HPLC. The test item could not be detected in any of the eluate samples. In the HPLC chromatograms a peak was detected with a retention time of approximately 7 minutes*. This peak indicated that the test item was not stable under the conditions of the test. Any degradation products were not evaluated as this would be beyond the scope of the study.

* The retention time of the test item in the reference solution (acetonitrile) was approximately 21 minutes.

Description of key information

The substance was not stable in water (the water solubility could not be determined).

Additional information

The substance was not stable under test conditions. The substance could not be detected in any of the eluted samples (pH 6.00 - 7.08).