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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 July 2016 to 16 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
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:
77 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
5.9
Details on results:
The detector calibration was found to be linear over the range 0 to 71 mg/L with a correlation coefficient of 0.9991.
A mean recovery of approximately 109 % was achieved from control samples fortified with the test material at the determined solubility value, whilst there were no significant interfering peaks evident in blank control solutions.

Table 1: Measurements of water solubility at 20 °C

Sample Number

Time (days) at 20 °C

Concentration (mg/L)

Mean concentration (mg/L)

pH

1A, 1B

1

76.1, 82.7

79.4

6.0, 5.9

2A, 2B

2

78.3, 78.6

78.4

5.9, 5.9

3A, 3B

3

74.3, 74.1

74.2

5.8, 5.8

Mean water solubility = 77.3 ± 3.2 mg/L (determined as the mean of all samples)

C. of V. = 4 %

Conclusions:
Under the conditions of this study, the test material was found to have a water solubility of 77 mg/L at 20 °C.
Executive summary:

The water solubility of the test material was determined in accordance with the standardised guidelines OECD 105 and EU Method A.6 under GLP conditions using the flask method.

Glass-stoppered centrifuge tubes containing approximately 50 mg of test material and 25 mL of purified water were purged with nitrogen, sealed and mixed at 20 °C for periods of 1, 2 and 3 days. After each period, duplicate samples were centrifuged (2500 rpm, 20 ˚C) for 5 minutes and an aliquot (2.5 mL) of supernatant diluted to volume (5 mL) with acetonitrile for analysis by high performance liquid chromatography (HPLC). The pH of each sample was measured.

Under the conditions of this study, the test material was found to have a water solubility of 77 mg/L at 20 °C.

Description of key information

Under the conditions of this study, the test material was found to have a water solubility of 77 mg/L at 20 °C.

Key value for chemical safety assessment

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

Additional information

The water solubility of the test material was determined in accordance with the standardised guidelines OECD 105 and EU Method A.6 under GLP conditions using the flask method. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

Glass-stoppered centrifuge tubes containing approximately 50 mg of test material and 25 mL of purified water were purged with nitrogen, sealed and mixed at 20 °C for periods of 1, 2 and 3 days. After each period, duplicate samples were centrifuged (2500 rpm, 20 ˚C) for 5 minutes and an aliquot (2.5 mL) of supernatant diluted to volume (5 mL) with acetonitrile for analysis by high performance liquid chromatography (HPLC). The pH of each sample was measured.

Under the conditions of this study, the test material was found to have a water solubility of 77 mg/L at 20 °C.

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