Pregna-1,4-diene-3,20-dione, 6-fluoro-11-hydroxy-16-methyl-21-[(1-oxopentyl)oxy]-, (6.alpha.,11.beta.,16.alpha.)-

Boiling point

Link to relevant study record(s)

Reference

Endpoint:

boiling point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 Jan to 16 Mar 2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: EU Method A.1 (Melting / Freezing Temperature)

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 102 (Melting point / Melting Range)

GLP compliance:

no

Other quality assurance:

ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)

Type of method:

differential thermal analysis

Remarks:

Differential Thermal Analysis (DTA) / Differential Scanning Calorimetry (DSC)

Specific details on test material used for the study:

Purity not specified

Key result

Decomposition:

yes

Decomp. temp.:

>= 220 - <= 420 °C

Remarks on result:

other: Since there were no further evidences for a boiling point or range it can be stated that the test item has no boiling point

RESULT:

- A melting point of 207 °C could be observed due to the detected endothermal effects

- After the melting of the test item two exothermal phases could be observed between 220 - 310 °C and between 325 - 420 °C

- The exothermic phases indicate transformation and decomposition

Since there were no further evidences for a boiling point or range it can be stated that the test item has no boiling point. No further investigations were made.

 

Validity criteria for the measurement of the boiling point:

Target condition according to guideline 92/69/EWG A.2:	Actual condition according to the study:	Validity criteria met:
The heating rate should not exceed 10 K/min.	Heating rate was 5 K/min.	Yes
The mean of at least two measurements which are in the range of the estimated accuracy (accuracy for this method according to the guideline is +/- 0.5 K up to 600 K) is reported as the boiling temperature.	One value was determined.	No
The measured boiling temperatures and their mean shall be stated and the pressure(s) at which the measurements were made shall be reported in kPa. The pressure should preferably be close to normal atmospheric pressure.	The atmospheric pressure is not stated.	No. Nevertheless, although the pressure is not stated one can assume that the study was performed at atmospheric pressure as the study was performed according to guideline 92/69/EWG A.2, where specifications for the pressure are stated ("the boiling temperature is stated with regard to the ambient pressure during the measurement").

 

Conclusions:

At higher temperatures than melting temperature at 207 °C, two exothermic phases are detected between 220 - 420 °C which indicate transformation and decomposition. Since there were no further evidences for a boiling point or range of the test item, it can be stated that Fluocortolon-21-Valerat has no boiling point.

Executive summary:

A differential thermoanalysis method (DTA/DSC) was used to determine the melting point with test method EC A.1, 'Melting / Freezing Temperature', which corresponds with OECD Guideline 102 'Melting Point / Melting range'.

The sample was weighed in a crucible made of aluminium, cooled down in a DTA/DSC-system to 25 °C and then heated up to 450 °C (heating rate 5 K/min). In comparison with an inert sample (empty crucible) the temperature difference and the heat effect was recorded. Between approx. 190 - 215 °C an endothermic phase could be detected which indicates the melting point of Fluocortolon-21-Valerat. After the melting process two exothermic phases between approx. 220 -310 °C and approx. 325 - 420 °C were detected. These exothermic phases indicate transformation and decomposition.

Since there were no further evidences for a boiling point or range of the test item it can be stated that Fluocortolon-21 -Valerat has no boiling point.

Description of key information

At higher temperatures than melting temperature at 207 °C, two exothermic phases are detected between 220 - 420 °C which indicate transformation and decomposition. Since there were no further evidences for a boiling point or range of the test item, it can be stated that Fluocortolon-21-Valerat has no boiling point.