Registration Dossier
Registration Dossier
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EC number: 601-489-9 | CAS number: 1176-81-4
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- no
- Type of method:
- column elution method
- Key result
- Water solubility:
- 0 g/L
- Temp.:
- 20 °C
- pH:
- ca. 7
- Remarks on result:
- other: mean value of two determinations
- Water solubility:
- 0 g/L
- Temp.:
- 20 °C
- pH:
- ca. 7
- Remarks on result:
- other: Standard deviation: 0.00000254 g/L; deviation 0.9 %
- Remarks:
- Result of column 1
- Water solubility:
- 0 g/L
- Temp.:
- 20 °C
- pH:
- ca. 7
- Remarks on result:
- other: Standard deviation: 0.00000096 g/L; deviation 0.4 %
- Details on results:
- Difference between both columns: 5 %
- Conclusions:
- Fluocortolon-A-Acetat can be considered as negligibly soluble with a mean solubility of 0.283 mg/L in water at 20 °C.
- Executive summary:
The water solubility of Fluocortolon-A-Acetat was determined according to EU Method A.6 "Water solubility" with the column elution method. Fluocortolon-A-Acetat was eluted with water from a micro-column charged with silica gel, previously coated with an excess of the test item. At 20 °C fractions were collected at a flow rate of 12 mL/h (column 1) and of 24 mL/h (column 2). For each fraction 10 mL were collected. A water solubility of 0.283 mg/L (mean value) was determined for Fluocortolon-A-Acetat at 20 °C. The mean pH-value of the two measurements was approx. 7.
Reference
The validity criterion (mean of both determinations should not differ by more than 30 %) was met.
Validity criteria for the measurement of the water solubility:
| Target condition according to guideline EU Method A.6: | Actual condition according to the study: | Validity criteria met: |
| The test is preferably run at 20 ± 0.5 °C or 30 ± 0.5 °C if preliminary test is used. | the flask had been put into a water bath maintained at 20 °C + 0.5 °. | Yes |
| A substance-specific analytical method is preferred for these determinations, since small amounts of soluble impurities can cause large errors in the measured solubility. Examples of such methods are: gas or liquid chromatography, titration methods, photometric methods, voltametric methods. | HPLC was used for analytical measurements. | Yes |
| The pH of each sample should be recorded. | The pH for each sample is reporte. (mean of three measurements). | Yes |
Description of key information
Fluocortolon-A-Acetat can be considered as negligibly soluble with a mean solubility of 0.283 mg/L in water at 20 °C.
Key value for chemical safety assessment
- Water solubility:
- 0.283 mg/L
- at the temperature of:
- 20 °C
Additional information
The pH-value is not reported for the mean value of 0.2831 mg/L. But the mean pH-value of the two measurements is approx. 7.
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