Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
other: conclusions drawn from available literature data
Adequacy of study:
weight of evidence
Study period:
compilation of information with reference to melting point/freezing point in February 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
1979
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2014
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2017
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
no guideline required
Guideline:
other: information derived from available literature and handbook data
Deviations:
not applicable
Principles of method if other than guideline:
Published data about the substance group of "bituminosulfonates" are used to derive information about melting point / freezing point. The available data are congruent with the registrant's own laboratory data from daily analysis of the substance as well as long term stability testing.
Type of method:
other: conclusions from literature data

Test material

1
Reference substance name:
Ichthammol
EC Number:
232-439-0
EC Name:
Ichthammol
Cas Number:
8029-68-3
Molecular formula:
unspecified
IUPAC Name:
Ichthammol (UVCB substance)
Test material form:
liquid: viscous
Details on test material:
sample from a batch from regular production released for use as an active pharmaceutical ingredient in medicinal products.
Specific details on test material used for the study:
Availalble published information on the substance group of bituminosulfonates is used to derive information about the melting point / freezing point of Ichthammol which is an ammonium bituminosulfonate.

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
ca. 0 °C
Atm. press.:
ca. 1 013 hPa

Applicant's summary and conclusion

Conclusions:
Ichthammol is distinguished by a melting and boiling point determined by the presence of water. With water removed the remaining dry matter (organic ammonium sulfonate salt) does not melt and does not boil but decomposes at a temperature of about 600°C in a muffle furnace.