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 decomposes before boiling
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Nov 2017 - 20 Dec 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7200 (Melting Point / Melting Range)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of method:
differential scanning calorimetry
Key result
Melting / freezing pt.:
184.4 °C

TGA EXPERIMENT (PRELIMINARY TEST)

Starting at 275°C, the weight of the sample decreased significantly. At 291°C, the sample weight had decreased by 25%.

After the experiment, a dark brown molten residue remained in the sample container.

The change of the colour indicated reaction and/or decomposition of the test item.

DSC EXPERIMENT 1

A strong endothermic effect was observed between 150°C and 200°C followed by a weak endothermic effect, i.e. gradual decrease of heat flow starting at 225°C. The extrapolated onset temperature of the endothermic peak was 184.619°C. The strong endothermic effect was most likely caused by melting of the test item. The weak endothermic effect was ascribed to reaction and/or decomposition of the test item.

After the experiment, an orange molten residue remained in the sample container. Based on this visual observation, it was concluded that the test item had molten and the change of the colour demonstrated reaction and/or decomposition of the test item.

DSC EXPERIMENT 2

In order to investigate the melting peak, in Experiment 2 heating was stopped directly after the melting peak. The extrapolated onset temperature was 184.126°C. After the experiment, a colourless molten residue remained in the sample container. It demonstrated that melting was the reason for the endothermic effect.

DATA HANDLING

The melting temperature was determined as the mean extrapolated onset temperature of Experiment 1 and Experiment 2.

Conclusions:
The melting temperature of the substance was determined to be 184.4°C.
Executive summary:

Differential Scanning Calorimetry (DSC) experiments were performed in a GLP study according to EC A.1, OECD 102 and OPPTS 830.7200.

The melting temperature of the substance was determined in duplicate obtaining a mean value of 184.4°C.

Reaction and/or decomposition of the substance started at 225°C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion