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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 03 February 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:
column elution method
Key result
Water solubility:
0.1 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
6.4
Details on results:
The detector calibration was found to be linear over the range 0 to 1 mg/L with a correlation coefficient of 0.9999. Results showed that that the water solubility of the test material is 0.11 ± 0.01 mg/L.
A mean recovery of approximately 71 % was achieved from control samples fortified with the test material at the determined solubility value and there were no significant interfering peaks evident in blank control solutions.

Table 1: Measurements of Water Solubility at 20 °C

Sample number

Solubility (mg/L)

pH

Column flow rate 0.4 mL/minute

0.4A

0.1195

6.2

0.4B

0.1101

6.3

0.4C

0.1229

6.2

0.4D

0.1118

6.2

0.4E

0.09323

6.4

0.4F

0.08423

6.3

Water solubility = 0.11 ± 0.02 mg/L

Column flow rate 0.2 mL/minute

0.2A

0.1158

6.6

0.2B

0.1171

6.6

0.2C

0.1094

6.5

0.2D

0.1174

6.6

0.2E

0.1242

6.6

Water solubility = 0.12 ± 0.01 mg/L

Overall mean water solubility = 0.11 ± 0.01 mg/L

Conclusions:
Under the conditions of this study, the test material was found to have a water solubility of 0.1 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 high performance liquid chromatography (column elution method).

The charged column was connected to an HPLC pump equipped with stainless steel capillaries, and purified water was added to the solvent reservoir. The system was equilibrated at the test temperature of 20 °C. The flow through the column was started at 0.4 mL/minute, and the eluent allowed to run to waste for 25 minutes before sampling commenced. At intervals separated from each other by the passage of at least ten bed volumes, a sample of the eluent (10 mL) was collected in a glass vial and an aliquot (2.5 mL) diluted to volume (5 mL) with acetonitrile for analysis by HPLC.

After six samples had been taken, the flow rate was reduced to 0.2 mL/minute and the eluent allowed to run to waste until collection of a further set of samples. These were processed and analysed as above. All collected samples were examined visually and observed to be clear, colourless and free of particulates.

Under the conditions of this study the test material was found to have a water solubility of 0.1 mg/L at 20 °C.

Description of key 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 high performance liquid chromatography (column elution method). The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).


 


Under the conditions of this study, the test material was found to have a water solubility of 0.1 mg/L at 20 °C.

Key value for chemical safety assessment

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

Additional information