Registration Dossier
Registration Dossier
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EC number: 232-369-0 | CAS number: 8008-63-7 Extractives and their physically modified derivatives such as proteins, lipids, carbohydrates, nucleic acids, inorganic ions, etc. obtained from mammalian bile.
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:
- from 2018-05-23 to 2019-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Key result
- Water solubility:
- > 1 730 g/L
- Conc. based on:
- test mat.
- Incubation duration:
- 72 h
- Temp.:
- 20 °C
- pH:
- 7.1
- Conclusions:
- The water solubility of the test item was determined at 20 °C to be >1730 g/L.
- Executive summary:
The water solubility was determined according to OECD 105, Regulation (EC) No. 440/2008 method A.6 and OPPTS 830.7840 using the shake flask method. A preliminary test was performed to determine the range of the water solubility of the test item. The solubility of the test item in water at room temperature was estimated to be > 64.5 g/L and < 171.9 g/L. Therefore, the flask method was performed. For the main test three flasks were prepared with around 85.5 g of test item and 50 mL water, and one flask only with water. After 24, 48 and 72 h at 30 °C and further 24 h at 20 °C the mixtures could not be homogenized anymore. Since no homogenization of the mass could be assured, no analytical measurements of the masses were performed. In the main test, about 86.5 g of the test item could be dissolved in 50 mL water (1730 g/L). This amount formed a very viscous mass, which could not be homogenized anymore. The water solubility was estimated to be >1730 g/L at 20 °C and pH 7.1.
Reference
Preliminary Test
The preliminary test at room temperature showed, that the water solubility of the test item was between 64.5 and 171.9 g/L. Therefore, the flask method was performed.
Preliminary test for the water solubility
| Amount of test item [mg] | Total volume of added water [mL] | Ultrasonic bath [min] | Remark |
| 103.14 | 0.1 | -- | not dissolved |
| 103.14 | 0.6 | 2 | not dissolved |
| 103.14 | 1.6 | 1 | dissolved |
Main Test
For the main test three flasks were prepared with an amount of test item and water, and one flask only with water. After 24, 48 and 72 h at 30 °C and further 24 h at 20 °C the mixtures could not be homogenized anymore. Since no homogenization of the mass could be assured, no analytical measurements of the masses were performed. In the main test, about 86.5 g of the test item could be dissolved in 50 mL water (1730 g/L). This amount formed a very viscous mass, which could not be homogenized anymore.
Description of key information
The water solubility of the test item was determined at 20 °C to be >1730 g/L.
Key value for chemical safety assessment
- Water solubility:
- 1 730 g/L
- at the temperature of:
- 20 °C
Additional information
The water solubility was determined according to OECD 105, Regulation (EC) No. 440/2008 method A.6 and OPPTS 830.7840 using the shake flask method. A preliminary test was performed to determine the range of the water solubility of the test item.The solubility of the test item in water at room temperature was estimated to be > 64.5 g/L and < 171.9 g/L. Therefore, the flask method was performed. For the main test three flasks were prepared with around 85.5 g of test item and 50 mL water, and one flask only with water. After 24, 48 and 72 h at 30 °C and further 24 h at 20 °C the mixtures could not be homogenized anymore. Since no homogenization of the mass could be assured, no analytical measurements of the masses were performed. In the main test, about 86.5 g of the test item could be dissolved in 50 mL water (1730 g/L). This amount formed a very viscous mass, which could not be homogenized anymore. The water solubility was estimated to be >1730 g/L at 20 °C and pH 7.1.
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