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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:
2022-01-11 to 2022-04-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7860 (Water Solubility Generator Column Method)
Version / remarks:
1998
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Remarks:
followed by miscibility tests
Key result
Water solubility:
> 5 232 g/L
Conc. based on:
test mat. (dissolved fraction)
Temp.:
22.8 °C
pH:
10.8
Water solubility:
>= 173.5 - <= 1 041 g/L
Conc. based on:
test mat. (dissolved fraction)
Remarks on result:
other: Preliminary test

Preliminary test

The preliminary test at room temperature showed that the water solubility of the test item is 173.5 – 1041 g/L. The observation of the preliminary test is summarized in Table 1. Since during the approach for performing the main test (five times the amount of test item compared to water) the test item was clearly dissolved after 1 min of stirring, the main test could not be carried out. Instead of that, miscibility tests of the test item with water were performed.

Although the main test could not be carried out, the water solubility of the test item can be estimated based on this approach to be > 5232 g/L. The pH value of the approach was determined to be pH = 10.8 at a temperature of 22.8 °C.

Table 1: Results of preliminary test

Amount of test item [mg]

Total volume of added water [mL]

Ultrasonic bath [min]

Remark

104.10

0.1

-

Not dissolved

 

0.6

2

Dissolved

Miscibility tests

The additional tests with test item:water ratios of 10:90, 50:50 and 90:10 % (v/v) showed that the test item was completely soluble in water in all ratios at ambient temperature.

Conclusions:
The estimated water solubility of the test item is > 5232 g/L.
Executive summary:

In a GLP study, conducted according to OECD Test Guideline 105 and EU Method A.6. the water solubility of the test item was determined. The water solubility was too high so that the flask method could not be carried out.

However, the water solubility of the test item can be estimated based on the approach of performing the main test to be > 5232 g/L.The pH value of the approach was determined to be pH = 10.8 at a temperature of 22.8 °C.

Moreover, additional miscibility tests were performed. The test item is miscible with water in the ratios 10:90, 50:50 and 90:10 % (v/v) at ambient temperature.

Description of key information

In a GLP study, according to OECD Test Guideline 105 and EU Method A.6. the water solubility of the test item was determined. The water solubility was too high so that the flask method could not be carried out.


However, the water solubility of the test item can be estimated based on the approach of performing the main test to be > 5232 g/L.The pH value of the approach was determined to be pH = 10.8 at a temperature of 22.8 °C.


Moreover, additional miscibility tests were performed. The test item is miscible with water in the ratios 10:90, 50:50 and 90:10 % (v/v) at ambient temperature.

Key value for chemical safety assessment

Water solubility:
5 232 g/L
at the temperature of:
22.8 °C

Additional information

> 5232 g/L