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Physical & Chemical properties

Water solubility

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Dec 2017 to 15 Jan 2018
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:
equivalent or similar to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes
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:
0.15 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
ca. 7
Remarks on result:
other: mean value of both columns
Water solubility:
0.15 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7
Remarks on result:
other: Column 1
Remarks:
Standard deviation: 0.00000266 g/L
Water solubility:
0.15 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
ca. 7
Remarks on result:
other: column 2
Remarks:
Standard deviation: 0.00000169 g/L
Details on results:
The result of the preliminary test was 0.00006 g/L.

The validity criterion (mean of both determinations should not differ by more than 30 %) was met (Difference between both columns: 0 %).


 


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

 

Conclusions:
The water solubility of Fluocortolon-21-Valerat at 20 °C was determined as 0.15 mg/L measured at a mean pH-value of 7.
Executive summary:

The water solubility of Fluocortolon-21-Valerat at 20 °C was determined using the column elution method according to OECD Guideline 105, which is in all relevant parts equivalent to EC Guideline A.6. For the main test the test item was eluted with water from a micro-column which was 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. After dilution with acetonitrile the concentration of the test item in the solutions was determined by HPLC-UV-analysis. The water solubility of Fluocortolon-21-Valerat was determined as 0.15 mg/L.

Description of key information

The water solubility of Fluocortolon-21-Valerat at 20 °C is determined as: 0.00015 g/L.

Key value for chemical safety assessment

Water solubility:
0.15 mg/L
at the temperature of:
20 °C

Additional information