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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other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
2010
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

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

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.