Pregn-4-ene-3,20-dione, 21-(acetyloxy)-6-fluoro-11-hydroxy-16-methyl-, (6.alpha.,11.beta.,16.alpha.)-

Flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Jul 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)

GLP compliance:

no

Other quality assurance:

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

Key result

Test procedure:

burning rate test: preliminary screening test

Remarks on result:

substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period

Remarks:

test substance melted

The substance in its delivery state was measured. The test substance melted when approached by the ignition flame. The substance did not burn up. No further testing was required.

Validity criteria for the measurement of the water solubility:

Target condition according to guideline UN Manual Test N.1:	Actual condition according to the study:	Validity criteria met:
A description of the substance to be tested, its physical state including moisture content should be stated.	Description is there, but the moisture content is not stated.	Yes, with restrictions.
Results from the preliminary screening test and from the burning rate test if performed should be stated.	Only a preliminary test was performed.	Yes

 

Interpretation of results:

not classified based on GHS criteria

Conclusions:

Fluocortolon-A-Acetat is in the sense of the CLP-Directive a not flammable solid.

Executive summary:

The test was performed as stipulated in UN test procedure ‘Recommendations on the Transport of Dangerous Goods-Manual of Tests and Criteria’ (UN-MTC), Part III, sub-section 33.2.1.4.1, Test N.1 ‘Test method for readily combustible solids’.

Fluocortolon-A-Acetat was formed into a powder train about 250 mm long by 20 mm wide by 10 mm high on a non-combustible, non-porous and low heat-conducting base plate. 30 – 40 mm beyond the 100 mm timing zone, 1 mL of a wetting solution was added to the pile. A hot flame from a gas burner was applied to one end of the powder train until the powder ignites or for a maximum of 2 minutes. A preliminary screening test was performed to determine if propagation by burning with flame or smoldering occurs without wetted zone.

Fluocortolon-A-Acetat in its delivery state was measured. The test substance melted when approached by the ignition flame. Fluocortolon-A-Acetat did not burn up. No further testing was required.

Fluocortolon-A-Acetat is classified as a not readily combustible solid when tested according to UN-MTC Procedure N.1.

Reference 2

Endpoint:

substances / mixtures which in contact with water emit flammable gases

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the organic substance does not contain metals or metalloids and hence, the classification procedure does not need to be applied

Reference 3

Endpoint:

pyrophoric solids

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is known to be stable in contact with air at room temperature for prolonged periods of time (days) and hence, the classification procedure does not need to be applied

Reference 4

Endpoint:

self-heating substances / mixtures

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: German standard method "VDI 2263, Part 1 ‘Test Methods for the Determination of the Safety Characteristic of Dusts’"

GLP compliance:

no

Other quality assurance:

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

Key result

Test procedure:

other: Grewer oven test

Result:

negative outcome (no effect observed)

Remarks on result:

other: A slight exothermic reaction started at about 242 °C, which was interfered by an endothermic effect

A slight exothermic reaction started at about 242 °C, which was interfered by an endothermic effect. The wire mesh basket was empty after the measurement.

 

Interpretation of results:

GHS criteria not met

Conclusions:

Fluocortolon-A-Acetat is not a self-heating substance in the sense of CLP Annex I, 2.11.

Executive summary:

Appendix 6, point 5.2.2 of UN-MTC test procedure refers to the Grewer oven test. The test was performed as stipulated in test procedure VDI 2263, Part 1 ‘Test Methods for the Determination of the Safety Characteristic of Dusts’.

The sample in its delivery state and an inert reference sample are heated up to 410 °C at a rate of 0.5 K/min in an air flow of about 20 L/h. A slight exothermic reaction started at about 242 °C, which was interfered by an endothermic effect. The wire mesh basket was empty after the measurement.

‘Fluocortolon-A-Acetat' is not a self-heating substance in the sense of CLP Annex I, 2.11. The determination according to UN-MTC Procedure N.4 (Bowes-Cameron-Cage-Test) is not necessary.

Description of key information

a.) Flammability: Fluocortolon-A-Acetat is classified as a not readily combustible solid according to UN-MTC Procedure N.1.

b.) Pyrophoric properties: Fluocortolon-A-Acetat did not deliver indications of pyrophoric properties during the realization of other tests. The determination according to UN-MTC Procedure N.2 is not necessary.

c.) Contact with water: The structural formula contains none of the functional groups quoted in UN-MTC (appendix 6, article 5.3) which may react with water to emit flammable gases. Therefore, it can be concluded by expert judgement that Fluocortolon-A-Acetat does not ignite spontaneously with water and does not liberate gases in hazardous amounts. The determination according to UN-MTC Procedure N.5 is not necessary.

d.) Self-heating substances: Fluocortolon-A-Acetat is not a self-heating substance in the sense of CLP Annex I, 2.11.

Key value for chemical safety assessment

Flammability:

not classified