Registration Dossier

Administrative data

Endpoint:
flash point of flammable liquids
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because the flash point is only relevant to liquids and low melting point solids
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 March 2016 - 16 March 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The appearance was determined by visual observation (direct and under a microscope). No guideline was followed for the appearance determination but sufficient details were given in the study report.
GLP compliance:
yes (incl. QA statement)
Remarks:
dd 13 January 2016
Physical state at 20°C and 1013 hPa:
solid
Key result
Form:
solid: particulate/powder
Colour:
Off-white
Odour:
other: not determined
Substance type:
organic

A test substance sample was observed to be a fine off-white powder with some clusters.

From observations using a 3.2 objective lens, the particles appeared to be irregular shaped crystals.

From observations using a 40 objective lens, the sample was observed to be made up of single crystalline particles.

Conclusions:
The substance is an off-white powder at room temperature.
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:
22 December 2017 - 07 June 2018
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:
2016
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.:
242.9 °C
Decomposition:
yes
Decomp. temp.:
> 275 °C

Two experiments were performed to investigate the melting and boiling behaviour of the substance.

DSC EXPERIMENT 1

An endothermic peak was observed between 200°C and 250°C followed by an exothermic effect starting at 275°C (see the illustration below). The extrapolated onset temperature of the first peak was 242.969°C. The endothermic effect was most likely caused by melting of the test item. The exothermic effect was probably caused by reaction and/or decomposition of the test item.

After the experiment, a dark brown molten residue remained in the sample container (original colour: off-white). The change of the colour indicated 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 effect.  The extrapolated onset temperature was 242.887°C. After the experiment, a white 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 melting temperature of Experiment 1 and Experiment 2.

Conclusions:
The melting temperature of the substance was determined to be 242.9°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 242.9°C.

Reaction and/or decomposition of the substance was observed at temperatures > 275°C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion