Registration Dossier

Diss Factsheets

Administrative data

boiling point
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is a solid which melts above 300°C
Justification for type of information:
no indication of melting below 300°C
Reason / purpose for cross-reference:
data waiving: supporting information
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
Using recognised methods described incompany report. This also corrolates with published data suggesting no melting point < 300 C
equivalent or similar to guideline
EU Method A.1 (Melting / Freezing Temperature)
Principles of method if other than guideline:
Melting point estimate was carried out using a Maplelab Scientific Melting Point Device MPD02 up to 300 C
GLP compliance:
Type of method:
capillary method
Specific details on test material used for the study:
Batch number of test material: C-04-3584
Key result
Melting / freezing pt.:
> 100 °C
Atm. press.:
ca. 1 atm
Above 100 C
Decomp. temp.:
> 100

Substance does not melt .The substance decomposes > 100 C.

The MPD02 equipment could only go up to 300 C and at this temperature no physical or colouration changes were observed in the crystalline sample placed in the glass capillary tube.

A 1 g sample was heated in a carbolite furnace to 900 C after which it has changed to a dark ash, therefore decomposition had occurred.

Results: Substance does not melt .The substance decomposes >300 °C.

During normal use and handling, and certainly under biological and environmental conditions, the substance will remain solid.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion