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EC number: 203-120-3 | CAS number: 103-53-7
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:
- 21.07 - 16.12.2015
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- column elution method
- Key result
- Water solubility:
- 0.523 mg/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- 7
- Conclusions:
- The water solubility was determined to be 0.523 mg/L (20°C, pH 7).
- Executive summary:
In the current study the water solubility of the test item was determined according to OECD guideline 105 (1995) and Council Regulation (EC) No. 260/2014, Method A.6. The study is GLP.
The solubility of the test item was determined using the column elution method at 20 ± 0.5 °C.
The analytical method (HPLC-DAD, external standard) was validated and tested with satisfactory results in regard to linearity, accuracy, precision and specificity.
The water solubility was determined to be 0.523 mg/L (20°C, pH 7).
Reference
The results of the solubility assessment are:
Sample |
1st run at 0.4 mL/min |
2nd run at 0.2 mL/min |
| 1 | 0.504 | 0.500 |
| 2 | 0.511 | 0.544 |
| 3 | 0.520 | 0.508 |
| 4 | 0.529 | 0.541 |
| 5 | 0.570 | 0.505 |
| mean | 0.527 | 0.519 |
| Deviation (%) | 13 | 8.7 |
| SD +/- | 0.026 | 0.021 |
| Overall mean | 0.523 | |
| Deviation (%) | 1.4 | |
Validity criteria:
The validity criteria were fulfilled:
- The test item concentration of five consecutive fractions was constant within 30% for both flow rates.
- The mean values obtained from two tests with different flow rates did not differ by more than 30%.
- Temperatures were kept constant at 20 +/- 0.5°C.
Description of key information
The water solubility of the test substance was determined to be 0.523 mg/L.
Key value for chemical safety assessment
- Water solubility:
- 0.523 mg/L
- at the temperature of:
- 20 °C
Additional information
Two studies are available assessing the water solubility of the test item.
In the key study this was done according to OECD 105 and Method A.6, and GLP. The solubility of the test item was determined using the column elution method. The water solubility was determined to be 0.523 mg/L (20°C, pH 7).
The second study was a screening test via DOC-Analysis. The study was not GLP. The mean value of the results after 24 and 72 hours was calculated and determined to be 1 mg/L at 20 +/- 2°C.
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