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EC number: - | CAS number: -
Water solubility
Administrative data
Link to relevant study record(s)
- 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
- 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
- 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. QA statement)
- 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. - 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.
Reference
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
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.
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