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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:
from 2016-05-25 to 2016-07-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Siemens AG Prozess-Sicherheit, Industriepark Höchst, B 596 & B 598, 65926 Frankfurt am Main, Germany
Type of method:
flask method
Key result
Water solubility:
207 g/L
Conc. based on:
test mat.
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
0.5

Preliminary visual estimation of the water solubility:

In a stepwise procedure, increasing volumes of demineralized water were added at room temperature to a defined amount of the test item. After each addition of an amount of water the mixture was treated with ultrasound for 15 minutes and visually checked for any undissolved particles.

Table 1: Results of the preliminary visual estimation of the water solubility

Amount of test item / mg

Added volume of dist. water / mL

Total volume / mL

Appearance of mixture

98.1

0.1

0.1

dissolved

The preliminary visual experiments showed that the water solubility of the test item is > 10 mg/L. According to the preliminary visual estimation in the main test the water solubility was determined by the flask method.

Flask method

After the equilibration time precipitate was observed in the flasks of the experiments excluding in the blank experiment.

Table 2: Water solubility experiments of the test item

Experiment

24 h experiment

48 h experiment

72 h experiment

Blank experiment (72 h)

Amount of test item / g

20.34

20.24

20.18

-

Amount of demineralized water / mL

20

20

20

20

Stirring time at 30 °C / h

24

48

72

72

pH at 24 °C

0.5

0.5

0.5

5.6

Ce concentration / g/L

76

72

67

-

Water solubility test item / g/L

219

208

193

-

The water solubility of the test item at 20 °C was determined to be 207 g/L (± 13 g/L) (mean values (24-72 h)).

Conclusions:
The water solubility of the test item at 20 °C was determined to be 207 g/L (± 13 g/L).
Executive summary:

The water solubility was determined according to OECD 105 and Regulation (EC) No 440/2008 Part A.6 using the shake flask method with ICP-OES analysis. About 20 g test substance was weighed into 100 mL stoppered Erlenmeyer flasks (nine parallels) according to the estimated solubility based on the Preliminary Test. After the addition of 20 mL demineralized water, the flasks were agitated at 30 °C. After one day, three of the vessels were removed and re-equilibrated at 20 °C for 24 hours. The content of the vessel was then centrifuged for 30 minutes with 15000 rpm at 20 °C and the concentration in the clear aqueous phase was determined by ICP-OES. The other flasks were treated similarly after initial equilibration at 30 °C for two and three days, respectively. The samples were filtered over a 0.2 µm twofold HPLC syringe filter. The pH of each sample was recorded. The water solubility of the test substance was determined to be 207 ± 13 g/L (95 % confidence interval) at 20 °C ± 1 °C (pH 0.5).

Description of key information

The water solubility of the test item at 20 °C was determined to be 207 g/L (± 13 g/L). The result is also applicable for the water free form of the test item.

Key value for chemical safety assessment

Water solubility:
207 g/L
at the temperature of:
20 °C

Additional information

The water solubility was determined according to OECD TG 105 and Regulation (EC) No 440/2008 Part A.6 using the shake flask method with ICP-OES analysis (reference 4.8-1). About 20 g test substance was weighed into 100 mL stoppered Erlenmeyer flasks (nine parallels) according to the estimated solubility based on the Preliminary Test. After the addition of 20 mL demineralized water, the flasks were agitated at 30 °C. After one day, three of the vessels were removed and re-equilibrated at 20 °C for 24 hours. The content of the vessel was then centrifuged for 30 minutes with 15000 rpm at 20 °C and the concentration in the clear aqueous phase was determined by ICP-OES. The other flasks were treated similarly after initial equilibration at 30 °C for two and three days, respectively. The samples were filtered over a 0.2 µm twofold HPLC syringe filter. The pH of each sample was recorded. The water solubility of the test substance was determined to be 207 ± 13 g/L (95 % confidence interval) at 20 °C ± 1 °C (pH 0.5). The result is also applicable for the water free form of the test item.