Registration Dossier

Administrative data

Endpoint:
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
the study does not need to be conducted because the substance is a solid which decomposes before boiling
Justification for type of information:
No indication of melting below 300°C
Deomposiiton started at 100 C
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
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
Qualifier:
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:
no
Type of method:
capillary method
Specific details on test material used for the study:
Batch number of test material: D-02-4057
Key result
Melting / freezing pt.:
> 100 °C
Atm. press.:
ca. 1 atm
Decomposition:
yes
Remarks:
Above 100 C
Decomp. temp.:
> 100
Sublimation:
no

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.

Other work performed to attempt drying shows formation of ZrO2 at over 100 C through oxidation processes.

Conclusions:
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.

Executive summary:

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.

Other work performed to attempt drying shows formation of ZrO2 at over 100 C through oxidation processes.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion