Registration Dossier
Registration Dossier
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EC number: 941-489-9 | CAS number: -
Auto flammability
Administrative data
- Endpoint:
- auto-flammability
- 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- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
- other: ASTM E2021-09: Standard Test Method for Hot-Surface Ignition Temperature of Dust Layers
- 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
Auto-ignition temperature (liquids / gases)open allclose all
- Auto-ignition temperature:
- ca. 280 °C
- Atm. press.:
- 101.3 kPa
- Remarks on result:
- other: Carbonization of prednisolone.
- Auto-ignition temperature:
- ca. 290 °C
- Atm. press.:
- 101.3 kPa
- Remarks on result:
- other: Prednisolone melts with decomposition.
Relative self-ignition temperature (solids)open allclose all
- Relative self-ignition temperature:
- ca. 280 °C
- Remarks on result:
- other: Carbonization of prednisolone.
- Remarks:
- at atm. press. of 101.3 kPa
- Relative self-ignition temperature:
- ca. 290 °C
- Remarks on result:
- other: Prednisolone melts with decomposition.
- Remarks:
- at atm. press. of 101.3 kPa
Applicant's summary and conclusion
- Conclusions:
- By the Layer Ignition Temperature analysis it was observed a beginning of carbonization of prednisolone at 280 °C that proceeded by melting and decomposition at 290 °C. There is no flammability of prednisolone either by direct contact with 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 auto flammable.
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