Registration Dossier

Diss Factsheets

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

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.

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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion