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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 January 2018 to 15 January 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Test material information:
Composition 1
Key result
Water solubility:
12.57 µg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 6 - <= 7
Remarks on result:
other: 12.57 ± 0.48 μg/L
Details on results:
- The deviation among the 5 parallel results of the columns were less than 30 % and random fashioned so all the 10 values were averaged and the standard deviation calculated. The solubility is given as mean ± SD.
- The water solubility of the test material is 12.57 ± 0.48 μg/L at 20±0.5 °C.

Table 1: Results of the solubility measurements

Day

Time

Column 1

Column 2

pH

Test Material Conc.

(μg/L)

Deviation

(%)

pH

Test Material Conc

(μg/L)

Deviation

(%)

4

07.18

6-7

13.03

9.75

6-7

12.79

10.62

4

16.51

6-7

12.63

6-7

12.98

5

09.26

6-7

11.87

6-7

11.92

5

19.31

6-7

12.63

6-7

12.73

7

05.51

6-7

12.00

6-7

13.18

Mean

12.43

 

12.72

 

Conclusions:
Under the conditions of this study, the water solubility of the test material was 12.57 ± 0.48 μg/L at 20 ± 0.5 °C.
Executive summary:

The water solubility of the test material was investigated in accordance with the standardised guideline OECD 105, under GLP conditions.

The test material was dissolved in HPLC tetrahydrofuran and mixed with glass beads. The solvent was evaporated and the covered glass beads were filled into the microcolumns. The bed- and headvolumes were determined and the recirculating pumps set to approx. 25 and 12.5 mL. The systems were equilibrated at 20 °C for 2 hours and five bed volumes of water was discarded. The systems were filled up to head volumes and the recirculation started. After 4 days the sampling started. The samples were filtered through 0.45 μm membrane filter. 150 μL from the filtrate was mixed with 150 μL methanol. Each sample was prepared in duplicate. The pH was measured by indicator strip. The samples were analysed.

Under the conditions of this study, the water solubility of the test material was 12.57 ± 0.48 μg/L at 20 ± 0.5 °C.

Description of key information

Under the conditions of this study, the water solubility of the test material was 12.57 ± 0.48 μg/L at 20 ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:
12.57 µg/L
at the temperature of:
20 °C

Additional information

The water solubility of the test material was investigated in accordance with the standardised guideline OECD 105, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The test material was dissolved in HPLC tetrahydrofuran and mixed with glass beads. The solvent was evaporated and the covered glass beads were filled into the microcolumns. The bed- and headvolumes were determined and the recirculating pumps set to approx. 25 and 12.5 mL. The systems were equilibrated at 20 °C for 2 hours and five bed volumes of water was discarded. The systems were filled up to head volumes and the recirculation started. After 4 days the sampling started. The samples were filtered through 0.45 μm membrane filter. 150 μL from the filtrate was mixed with 150 μL methanol. Each sample was prepared in duplicate. The pH was measured by indicator strip. The samples were analysed.

Under the conditions of this study, the water solubility of the test material was 12.57 ± 0.48 μg/L at 20 ± 0.5 °C.