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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19.-26.01.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
GLP compliance:
no
Type of method:
column elution method
Key result
Water solubility:
< 0.051 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
ca. 6.5
Details on results:
The water solubility of the test item at a temperature of 20 °C was determined to be < 0.051 mg/L.

Preliminary Visual Estimation of the Water Solubility

 

Different amounts of the test item and water were stirred at room temperature until the mixtures appeared dissolved or the water solubility could be estimated to be below 10 mg/L.

Appearance of the test mixtures

Amount of the test item in mg

Total volume in mL

Appearance of mixture

16.4

100

undissolved

7.4

500

undissolved

1.2

500

undissolved

 

The solubility of the test imte in water is below 2.4 mg/L (without correction of the purity). Therefore, the water solubility had to be determined by the "column elution method".

Conclusions:
The water solubility of the test item at a temperature of 20 °C was determined to be the detection limit of 0.051 mg/L.
Executive summary:

The water solubility was determined according to OECD 105 using the column elution method with HPLC analysis. Therefore, two identical columns were prepared; one of them was exposed to a flow rate of about 12.5 mL/h (column 1), the other one to 25.0 mL/h (column 2). Another experiment was performed according to this procedure (flow rate 25.0 mL/h) but without test item. The concentration of test item was determined by means of HPLC. Therefore the aqueous fractions were diluted from 0.25 mL to 1 mL with methanol. The volumes of all fractions were measured. For the analysed fractions the pH values and the temperatures were measured, too. For column 1 the fractions 22 to 26 were evaluated. The water solubility was found to be below the detection limit of 0.051 mg/L. For column 2 the fractions 48 to 52 were evaluated. The water solubility was found to be below the detection limit of 0.051 mg/L. For column 3 the fractions 48 to 52 were evaluated. The water solubility was found to be below the detection limit of 0.051 mg/L For column 2 the fractions 48 to 52 were evaluated. The water solubility was found to be 0.051 mg/L.

The recovery of the recheck samples was between 97.3% and 104.5% indicating a sufficient accuracy of the analytical method. The water solubility at a temperature of 20 °C was determined to be below the detection limit of 0.051 mg/L. 

Description of key information

The water solubility at a temperature of 20 °C was determined to be below the detection limit of 0.051 mg/L. 

Key value for chemical safety assessment

Additional information

The water solubility was determined according to OECD 105 using the column elution method with HPLC analysis. Therefore, two identical columns were prepared; one of them was exposed to a flow rate of about 12.5 mL/h (column 1), the other one to 25.0 mL/h (column 2). Another experiment was performed according to this procedure (flow rate 25.0 mL/h) but without test item. The concentration of test item was determined by means of HPLC. Therefore the aqueous fractions were diluted from 0.25 mL to 1 mL with methanol. The volumes of all fractions were measured. For the analysed fractions the pH values and the temperatures were measured, too. For column 1 the fractions 22 to 26 were evaluated. The water solubility was found to be below the detection limit of 0.051 mg/L. For column 2 the fractions 48 to 52 were evaluated. The water solubility was found to be below the detection limit of 0.051 mg/L. For column 3 the fractions 48 to 52 were evaluated. The water solubility was found to be below the detection limit of 0.051 mg/L For column 2 the fractions 48 to 52 were evaluated. The water solubility was found to be 0.051 mg/L.

The recovery of the recheck samples was between 97.3% and 104.5% indicating a sufficient accuracy of the analytical method. The water solubility at a temperature of 20 °C was determined to be below the detection limit of 0.051 mg/L.