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Diss Factsheets

Physical & Chemical properties

Water solubility

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
74.5 g/L
Conc. based on:
test mat.
Incubation duration:
> 24 - < 144 h
Temp.:
20 °C
pH:
4.6
Details on results:
On completion of the equilibration period, all main test sample solutions were hazy, yellow and contained undissolved test item. The solutions were decanted, centrifuged and filtered. Each filtrate was visually observed to be clear, yellow and free from undissolved test item.
It was noted that the analysis of the matrix blank solution produced some peaks in both main test sequences, representing approximately 15% of the response of samples 1 to 3 and approximately 8% of the response of samples 4 to 6. The blank response was rejected from the calibration curve, since it had a detrimental effect on the fit of the trend line. However, it has to be noted that, for each sequence, the matrix blank response affected equally the chromatography of the standards and the samples; therefore, it can be considered that its overall effect on the analysis results was negligible.
The water solubility results from samples 1 to 3 indicated an increase in concentration with shaking time; therefore, three extra samples were prepared using longer equilibration times to ensure saturation. The mean result from samples 4 to 6 has been given as the overall water solubility result. The individual water solubility results from samples 4 to 6 were within ± 15% of the mean, satisfying the criteria specified in the guidelines.
Conclusions:
The water solubility of the test item has been determined to be 74.5 g/L of solution at 20.0 ± 0.5 °C. The test item was also determined to be miscible with water at any proportion equal or greater than 50% w/w.
Executive summary:

The water solubility of the test item has been determined to be 74.5 g/L of solution at 20.0 ± 0.5 °C. The test item was also determined to be miscible with water at any proportion equal or greater than 50% w/w.

Description of key information

The water solubility of the test item has been determined to be 74.5 g/L of solution at 20.0 ± 0.5 °C. The test item was also determined to be miscible with water at any proportion equal or greater than 50% w/w.

Key value for chemical safety assessment

Water solubility:
74.5 g/L
at the temperature of:
20 °C

Additional information