Registration Dossier

Administrative data

Endpoint:
vapour pressure
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the melting point is above 300°C
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:
2017-11-21 - 2017-11-24 (experimental phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
adopted by the Council on 27th July 1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: in-house test procedure VTA(S)31X93001.02: "Melting temperature determination (Tm) of solid and liquid substances by means of DSC"
Deviations:
no
GLP compliance:
yes
Type of method:
differential scanning calorimetry
Key result
Decomposition:
yes
Decomp. temp.:
ca. 159 °C
Remarks on result:
other: no melting point has been determined between -90 and 300 °C
Conclusions:
The melting point was determined in a GLP study according to EU method A.1 without deviations on the registered substance itself. Hence, there is no indication given that the results are not reliable. The test item shows no melting of crystalline subcomponents in a temperature range between -90 °C and 300 °C (at ambient temperature the test item is solid). The cooling run shows no crystallization. The 3rd heating run shows a second endothermic effect with an onset temperature of ca. 159 °C, which can be recognized as decomposition.
Executive summary:

The melting point was determined according to EU method A.1 in a study classified as Klimisch 1. The test item shows no melting of crystalline subcomponents in a temperature range between -90 °C and 300 °C (at ambient temperature the test item is solid). The cooling run shows no crystallization. The 3rd heating run shows a second endothermic effect with an onset temperature of ca. 159 °C, which can be recognized as decomposition.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion