Registration Dossier
Registration Dossier
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EC number: 941-489-9 | CAS number: -
Flammability
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- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.10 (Flammability (Solids))
- GLP compliance:
- yes
Test material
- 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
Constituent 1
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.
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