Registration Dossier
Registration Dossier
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EC number: 225-443-9 | CAS number: 4851-50-7
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:
- 2017
- 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)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Other quality assurance:
- ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
- Type of method:
- column elution method
- Key result
- Water solubility:
- < 3 µg/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- ca. 7
- Conclusions:
- The water solubility determined by the column elution method at 20 °C was lower than 3 μg/L.
- Executive summary:
The water solubility was determined using the method (OECD Guideline 105, EC Guideline A.6).
The water solubility of the test item, given by the sponsor, was lower than 10 mg/L. Therefore, the column elution method was chosen for the determination of the water solubility. For the main test the test item was eluted with water from a micro-column which is charged with silica gel, previously coated with an excess of the test item. At 20 °C twenty fractions were collected at a flow rate of 12 mL/h (column 1) and ten fractions at a flow rate of 24 mL/h (column 2). For each fraction 10 mL were collected. After dilution with acetonitrile the concentration of Solvent Green 28 in the solutions was determined by HPLC-analysis.
The water solubility determined by the column elution method at 20 °C was lower than 3 μg/L.
Reference
| Column 1 (12 mL/h) | Column 2 (24 ml L/h) | ||||
| Fraction no. | pH value | Concentration | Fraction no. | pH value | Concentration |
| [β] = g/L | [β] = g/L | ||||
| 11 | 7.3 | < 3 | 1 | 6.4 | < 3 |
| 12 | 7.4 | < 3 | 2 | 6.3 | < 3 |
| 13 | 7.1 | < 3 | 3 | 6.5 | < 3 |
| 14 | 7.3 | < 3 | 4 | 6.6 | < 3 |
| 15 | 7.0 | < 3 | 5 | 6.7 | < 3 |
| 16 | 7.2 | < 3 | 6 | 6.7 | < 3 |
| 17 | 7.5 | < 3 | 7 | 6.5 | < 3 |
| 18 | 6.7 | < 3 | 8 | 6.5 | < 3 |
| 19 | 7.4 | < 3 | 9 | 6.6 | < 3 |
| 20 | 6.8 | < 3 | 10 | 6.6 | < 3 |
Description of key information
The water solubility determined by the column elution method at 20 °C was lower than 3 μg/L.
Key value for chemical safety assessment
- Water solubility:
- 1.2 µg/L
- at the temperature of:
- 20 °C
Additional information
The mean value determined with column 1 was 1.82 μg/L and the value determined with column 2 was 0.56 μg/L. For this reason, a mean value (1.19 μg/L) from these two values is used as a basis for assessing the chemical safety assessment.
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