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
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Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 March 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
Appearance was determined by visual observation, direct and under a microscope. No guideline was followed but sufficient details were given in the study report.
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Physical state at 20°C and 1013 hPa:
solid
Key result
Form:
solid: particulate/powder
Colour:
white
Odour:
other: not determined
Substance type:
organic

The substance as received at the test facility was observed to be a medium, white crystalline powder with clusters. At 32x magnification under a microscope, the particles appeared to be irregular shaped crystals. Many of the larger particles were rectangular in shape, whilst the smaller particles were irregular in shape. At 400x magnification, the sample was observed to be made up of single crystalline particles.  

Conclusions:
The substance is a white powder.
Executive summary:

The substance was visually observed to be a white solid powder. Under a microscope, the substance was observed to be made up of single crystalline particles.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 January 2017 to 16 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
2008
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
Test material information:
Composition 1
Key result
Melting / freezing pt.:
197.1 °C
Decomposition:
yes
Remarks on result:
other: Decomposition started during melting.

TGA EXPERIMENT (PRELIMINARY TEST)

From 190°C upwards the weight of the sample decreased significantly. At 197°C the sample weight had decreased by > 10%. At 293°C the sample weight had decreased by 25%.

DSC EXPERIMENT 1

-Endothermic peak between 175°C and 225°C (extrapolated onset temperature: 197.312°C). Based on the high purity of the substance and the observed weight loss in the TGA experiment, it was concluded that this effect was due to melting and reaction and/or decomposition.

-A second endothermic effect started from 250°C. This effect was due to decomposition and/or reaction of the substance.

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

-DSC curve: see picture below.

DSC EXPERIMENT 2

- Extrapolated onset temperature of the endothermic melting/decomposition peak: 196.813°C.

- At the end of the experiment (at 225°C), there was a colourless molten residue in the sample container. From this it was concluded that melting and reaction/decomposition was the reason for this effect.

Conclusions:
The melting temperature of the substance was determined to be 197°C. Reaction and/or decomposition started during melting.

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 197°C. Reaction and/or decomposition started during melting.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion