Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
flammable solids
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.10 (Flammability (Solids))
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Prednisolone
EC Number:
200-021-7
EC Name:
Prednisolone
Cas Number:
50-24-8
IUPAC Name:
11,17,21-trihydroxypregna-1,4-diene-3,20-dione
Details on test material:
- Name of test material (as cited in study report): Prednisolone
- Substance type: Organic
- Physical state: White or almost white, crystalline powder
- Analytical purity: >99% w/w
- Batch No.: 1153320
- Expiration date of the lot/batch: 2 year
- Stability under test conditions: stable

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: There is no flame propagation.
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.
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.

Applicant's summary and conclusion

Interpretation of results:
non flammable
Remarks:
Migrated information
Conclusions:
There is no flame propagation. Prednisolone is not able to mantain the flame. Based on the proposed read-across strategy, 9β,11β-epoxy-6α-fluoro-17,21-dihydroxypregna-1,4-diene-3,20-dione 21-acetate should be considered not flammable.