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Physical & Chemical properties

Water solubility

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water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016.01.04 - 2016.01.11
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
according to guideline
OECD Guideline 105 (Water Solubility)
according to guideline
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
126 mg/L
Conc. based on:
test mat.
Incubation duration:
24 h
20 °C
Details on results:
The solubility was determined to be in the range of 0.144 - 0.216 g/L. No Tyndall-effect was observed at 0.144 g/L.
For the application dose for the definitive study, approx. 1.1 g/L (= ca. the fivefold) was used.

Detection limits:

The LOD was determined to be 2 mg/L, with a S/N of 3.

The system quantification limit was set to be 10 mg/L (= fivefold of the LOD), SN of 30.


The analytical system gave a linear response in the range of nominal 10 - 500 mg/L with a coefficient of determination for the linear calibration curves (r2) > 0.992.

Limit of quantification:

LOQ was defined corresponding to the study requirements and set to 40 mg/L with a dilution factor of 2, corresponding to a concentration of 20 mg/L in the final samples at 1 x LOQ.

Accuracy and precision:

- Mean recovery rates: 102% for the 1 x LOQ and 102% for the 10 x LOQ

- Precision of both fortification levels showed a coefficient of determination of <= 0.92%

The water solubility was determined after different preincubation times:

pre-incubation time (h) replicate concentration (g/L) mean concentration (g/L)
24 1 126 126
2 126
48 1 126 125
2 124
72 1 127 128
2 129

The mean water solubility (24 -72h) was found to be 126 mg/L.

Deviation (%) (24 -72h): 2.5

The validity criteria were fulfilled.

The water solubility of the test item was determined to be 126 mg/L (20°C, pH 6.1).
Executive summary:

In the current study the water solubility of the test item was determined according to the OECD TG 105 and Method A.6.

The solubility was determined using the flask method at 20 +/- 5°C with pre-incubation at 30 +/- 0.5°C.

The analytical method (HPLC-DAD) was validated for linearity, accuracy, precision and specificity.

The water solubility of the test item was determined to be 126 mg/L (20°C, pH 6.1).

Description of key information

The water solubility of the test item is 126 mg/L at 20 °C and pH 6.1.

Key value for chemical safety assessment

Water solubility:
126 mg/L
at the temperature of:
20 °C

Additional information

One study is avaialble assessing the water solubility of the test item.

In this study the water solubility was determined according to the OECD TG 105 and GLP and was found to be 126 mg/L (20°C, pH 6.1).