3,20-bis(ethylenedioxy)pregna-5,7-diene

Flammability

Administrative data

Endpoint:

flammability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18/12/2012 - 12/3/2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted following OECD/EU guideline and in accordance with GLP. Study material is well characterized.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.12 (Flammability (Contact with Water))

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,20-bis(ethylenedioxy)pregna-5,7-diene

EC Number:

243-175-0

EC Name:

3,20-bis(ethylenedioxy)pregna-5,7-diene

Cas Number:

19592-55-3

Molecular formula:

C25H36O4

IUPAC Name:

(1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]

Test material form:

solid: crystalline

Details on test material:

Name of test material (as cited in study report): Proketal; pregna-5,7-diene-3,20-dione, cyclic 3,20-bis(1,2-ethanediyl acetal)
- Substance type: Intermediate
- Physical state: Powder
-

Results and discussion

Pyrophoric solids

Test procedure:

ignition time on contact with air

Remarks:

Ignition on contact with air refers to either Pyrophoric solids or Pyrophoric liquids depending on physical state (migrated information).

Remarks on result:

no ignition on contact with air (not further specified)

Remarks:

corresponding to 'no' in migrated source record. | Remarks: | Additional remarks: Based on the results obtained, the test substance is considered ‘not highly flammable’.

Pyrophoric liquids

Test procedure:

ignition time on contact with air

Remarks:

Ignition on contact with air refers to either Pyrophoric solids or Pyrophoric liquids depending on physical state (migrated information).

Remarks on result:

no ignition on contact with air (not further specified)

Remarks:

corresponding to 'no' in migrated source record. | Remarks: | Additional remarks: Based on the results obtained, the test substance is considered ‘not highly flammable’.

Substances / mixtures which in contact with water emit flammable gases

Remarks on result:

no reaction with water observed

Remarks:

corresponding to 'no' in migrated source record.| Remarks: | Additional remarks: Proketal is considered ‘not highly flammable’ in contact with water.

Any other information on results incl. tables

If the test substance does not propagate combustion along 200 mm of the pile within the 4 minutes test period the test substance is considered ‘not highly flammable’.

In contact with the flame of the gas burner the test substance melted, emitted yellow sparks and turned into a yellow residue. White smoke was observed. After removal of the ignition source, no propagation of combustion of the test substance was observed. No propagation of combustion of the test substance along 200 mm length of the pile within 4 minutes was observed. According to the guidelines, performance of the burning rate test is not required. Based on the results obtained, the test substance is considered ‘not highly flammable’.

The test substance does not contain groups that might lead to ignition in contact with water and/or to the evolution of a flammable gas. Moreover the test substance was dissolved in water during the determination of the water solubility (see chapter 10). It demonstrated that the test substance does not ignite spontaneously in contact with water.

Applicant's summary and conclusion

Conclusions:

No propagation of combustion of the test substance along 200 mm length of the pile within 4 minutes was observed. According to the guidelines, performance of the burning rate test is not required. Based on the results obtained, the test substance is considered ‘not highly flammable’.

Proketal is considered ‘not highly flammable’ in contact with water.

Executive summary:

The preliminary screening test was performed for the determination of the flammability of the test substance.

The test substance was loosely filled into an aluminum mould of 250 mm long with a triangular cross-section of inner height of 10 mm and width of 20 mm. On both sides of the mould in a longitudinal direction two metal plates were mounted as lateral limitations that project 2 mm beyond the upper edge of the triangular cross section. The mould was dropped three times from a height of 2 cm onto a solid surface. If necessary, the mould was filled up again. The lateral limitations were removed and the excess substance was scraped off. A non-combustible and nonporous plate was placed on top of the mould. The complete assembly was inverted and the mould removed.

A flame of a gas burner was applied to one end of the test substance pile for 2 minutes. The pile was visually interpreted for propagation of combustion either by burning with a flame or smoldering. If applicable, the time of burning over a distance of 200 mm was measured after the pile had burned a distance of 50 mm.

A test substance is considered highly flammable when it ignites spontaneously in contact with water, or evolves a flammable gas at a minimum rate of ≥ 1 litre/kg of the substance per hour.

The molecular structure of the test substance is shown in paragraph 6.1. The test substance does not contain groups that might lead to ignition in contact with water and/or to the evolution of a flammable gas. Moreover the test substance was dissolved in water during the determination of the water solubility (see chapter 10). It demonstrated that the test substance does not ignite spontaneously in contact with water.

In conclusion, Proketal is considered ‘not highly flammable’ in contact with water.