Registration Dossier

Diss Factsheets

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 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:
From June 12, 2017 to September 20, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
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.:
>= 9 - <= 29.4 °C
Decomposition:
yes
Decomp. temp.:
> 50 °C

TGA EXPERIMENT (PRELIMINARY TEST)

Starting at 100°C, the weight of the sample decreased significantly: 25% weight loss at 316°C and 70% weight loss at 440°C.

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 substance.

 

DSC EXPERIMENT 1

During cooling two exothermic peaks were observed between 25°C and -25°C, most probably due to crystallisation of the test substance. During heating three endothermic peaks were observed between -25°C and 50°C directly followed by a broad endothermic effect starting at 50°C. The peak max temperature of the first peak was 9.329°C and of the last peak was 29.370°C. The endothermic effects were most likely obtained due to melting of the test substance. After the experiment, a light yellow molten residue remained in the sample container. 

DSC EXPERIMENT 2

In order to investigate whether reaction and/or decomposition of the test substance did already occur during melting, Experiment 2 was stopped at 50°C. Again, endothermic peaks were observed between -25°C and 50°C. The peak max temperature of the first peak was 8.979°C and of the last peak was 19.627°C. After the experiment, an off-white molten residue remained in the sample container. It demonstrated that melting was the reason for the endothermic effect and that reaction and/or decomposition of the test substance did not occur at temperatures up to 50°C. 

DATA HANDLING

The melting temperature was determined as a melting range obtained from the lowest peak max of the first melting temperature (9.0°C) and the highest peak max of the last melting temperature (29.4°C).

Conclusions:
Under the study conditions, from duplicate experiments, the melting range was established between 9.0°C and 29.4°C. Reaction and/or decomposition of the substance occurs at temperatures above 50°C.
Executive summary:

A study was conducted to determine the melting point of the test substance according to OECD 102 Guideline, EU Method A.1 and OPPTS 830.7200. A melting range instead of a well defined melting temperature was determined. Under the study conditions, from duplicate experiments, the melting range was established between 9.0°C and 29.4°C. Reaction and/or decomposition of the substance occurs at temperatures above 50°C (Reingruber, 2017).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion