Registration Dossier
Registration Dossier
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EC number: 613-915-0 | CAS number: 66233-43-0
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:
- 12 Jan 2016 to 13 Apr 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- no
- 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:
- ca. 0 g/L
- Loading of aqueous phase:
- 5 other: mL
- Temp.:
- 20 °C
- pH:
- 6.7
- Remarks on result:
- other: mean value of two determinations
- Conclusions:
- The substance can be considered as negligibly soluble with a mean solubility of 0.401 mg/L in water at 20 °C.
- Executive summary:
The water solubility of the substance was determined according to EU Method A.6 "Water solubility" with the column elution method and showed a value of 0.401 mg/L (mean value) at 20 °C (no pH-value was reported). The mean pH-value of the two measurements was 6.7.
Reference
Validity criteria for the measurement of the water solubility:
| Target condition according to guideline OECD 105: | Actual condition according to the study: | Validity criteria met: |
| The test is preferably run at 20 ± 0.5 °C. | The test was performed at 20 °C. | 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 of each sample is reported. | Yes |
Description of key information
DELTA-9(11)-Fluocortolon-Valerat can be considered as negligibly soluble with a mean solubility of 0.401 mg/L in water at 20 °C.
Key value for chemical safety assessment
- Water solubility:
- 0.401 mg/L
- at the temperature of:
- 20 °C
Additional information
The pH-value is not reported for the mean value of 0.401 mg/L. But the mean pH-value of the two measurements is approx. 7.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
