Registration Dossier
Registration Dossier
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EC number: 237-731-1 | CAS number: 13951-70-7
Flash point
Administrative data
- Endpoint:
- flash point of flammable liquids
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 2013 to 28 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed to GLP and OECD current guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- capillary method
- Atm. press.:
- ca. 1 atm
- Decomposition:
- yes
- Decomp. temp.:
- ca. 180 °C
- Conclusions:
- The melting temperature of 16alpha-hydroxyprednisolone was not determinable as the test substance was found to decompose at temperatures above approximately 180°C before melting.
In duplicate definitive melting point determinations, the sample was observed to darken from approximately 180ºC, indicating decomposition. A decomposed sample was also noted to rise up the capillary due to evolution of gas when the sample temperature was raised to approximately 245˚C in a preliminary trial.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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