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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:
Feb. 2018 - Apr. 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted 27. Jul. 1995
Deviations:
yes
Remarks:
please refer to "Principles of method if other than guideline"
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
adopted 24 January 2014
Deviations:
yes
Remarks:
please refer to "Principles of method if other than guideline"
Principles of method if other than guideline:
The following deviation from the Guideline was observed:
As the test item is very well soluble in water, it was not possible to weigh the fivefold saturation concentration of the test item in water in order to perform a main test as described in the guidelines.
GLP compliance:
yes (incl. certificate)
Type of method:
flask method
Water solubility:
> 1 000 g/L
Conc. based on:
test mat.
Incubation duration:
24 h
Temp.:
20 °C
pH:
>= 4 - <= 5.85
Details on results:
The dissolution of the test item in the test item solutions with 1 g test item in 1 mL water and 10 g test item in 10 mL water was complete (visual judgement).
Therefore, the water solubility of the test item was stated as > 1000 g/L nominal load.

Observations 1 g test item

Amount Test Item [g]  Volume H2O [mL] Temperature [°C]   pH Value  Observations 
 1.0008  0.1

- *

 -*

not dissolved;

wettability was not complete

 1.0008  1 20.2  4  dissolved
 1.0000  2  20.3  5.18   dissolved
 1.0010  5  20.0  5.44   dissolved
 1.0006 10   20.1  5.85   dissolved

Observations 10 g test item

   Amount Test Item [g]

  Volume H2O [mL]

  Temperature [°C] 

  pH Value

  Observations 
 10.0011  0.1  -*    -*

 not dissolved;

wettability was not complete

 10.0018  1    -*    -*

 not dissolved;

wettability was not complete

 10.0015

 2

   -*

   -*

 not dissolved;

wettability was not complete

 10.0004

 5

 20.0

   -*

 dissolved, very viscous

10.0002 

 10

 19.8

 4.49

 dissolved

* not possible to measure as wettability was not complete

Conclusions:
The solubility of the test item in water was determined as > 1000 g/L.
Executive summary:

The water solubility of the test item was evaluated according to OECD guideline 105 and EU Method A.6 under GLP conditions. After the pre-test, the solubility of the test item in water was determined as > 1000 g/L.

Therefore, it was not possible to weigh the fivefold saturation concentration of the test item in water in order to perform a main test as described in the guidelines. A main test using a simplified flask method with abbreviated equilibration times was performed to evaluate the magnitude of the water solubility of the test item.

The results of the main test confirmed the result of the preliminary test. Therefore, the water solubility of the test item was stated as > 1000 g/L nominal load. In the higher nominal loads the wettability of the test item was not complete.

No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.

Description of key information

The water solubility of the test item was evaluated according to OECD guideline 105 and EU Method A.6 under GLP conditions. After the pre-test, the solubility of the test item in water was determined as > 1000 g/L.

Therefore, it was not possible to weigh the fivefold saturation concentration of the test item in water in order to perform a main test as described in the guidelines. A main test using a simplified flask method with abbreviated equilibration times was performed to evaluate the magnitude of the water solubility of the test item.

The results of the main test confirmed the result of the preliminary test. Therefore, the water solubility of the test item was stated as > 1000 g/L nominal load. In the higher nominal loads the wettability of the test item was not complete.

No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.

Key value for chemical safety assessment

Water solubility:
1 000 g/L
at the temperature of:
20 °C

Additional information

Based the study the water solubility is > 1000 g/L, but for the CSA a value of 1000 g/L is applicable because it shows the high water solubility of the test item.