Registration Dossier

Administrative data

Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to international accepted guidelines but not GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method A.10 (Flammability (Solids))
Version / remarks:
UN Recommendations on the Transport of Dangerous Goods
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test item: finasteride saturated lactam
Batch No.: M4A085N
Physical state: crystalline powder
Colour: almost white
Storage: at 15-30 °C, protected from light and wet

Results and discussion

Flammable solids
Test procedure:
burning time (test type not further specified)
Remarks:
or specified in description of method (migrated information)
Remarks on result:
other: The burning rate test was not performed because of the result of the preliminary test.
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: According to manufacturing/handling experience.
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: According to manufacturing/handling experience.
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: According to company laboratory instructions.

Any other information on results incl. tables

In the vicinity of the heat source the solid surface is ignited and melted. After removing the heat source the combustion disappeared immediately.

Applicant's summary and conclusion

Interpretation of results:
non flammable
Remarks:
Migrated information
Conclusions:
The substance (finasteride saturated lactam) should not be considered as flammable and no further testing is required. According to the GHS criteria the measured substance cannot be classified.