Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because the substance is marketed or used in a non solid or granular form
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 Jun - 22 Aug 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Visual interpretation
Reference:
Composition 0
Qualifier:
no guideline followed
GLP compliance:
no
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 605803
- Physical state: White waxy solid
2
Flammability_KEY_REACH3813
- Analytical purity: 98.4%
- Expiration date of the lot/batch: 31 December 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Physical state at 20°C and 1013 hPa:
solid
Key result
Form:
other: waxy solid
Colour:
White
Conclusions:
MTDID 15670 is a white, waxy solid.
Executive summary:

MTDID 15670 is a white, waxy solid.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 Jun - 22 Aug 2016
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)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7200 (Melting Point / Melting Range)
Deviations:
no
GLP compliance:
yes
Type of method:
differential scanning calorimetry
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 605803
- Physical state: White waxy solid
- Analytical purity: 98.4%
- Expiration date of the lot/batch: 31 December 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Key result
Melting / freezing pt.:
24 °C
Decomposition:
no

The DSC-curves obtained during the two experiments are included in attachments. During the cooling in the first experiment, an exothermic peak between -30 °C and 15 °C was observed. The effect was obtained due to crystallization of the test item. During heating two endothermic peaks between -25 °C and 50 °C were observed. A first broad peak followed by a sharp second peak. The peak maximum of the first peak was 24.68 °C and its extrapolated onset temperature was 9.08°C. The peak maximum of the second peak was 35.99°C. It was assumed that the first peak was due to melting of the test item. The source of the second effect was unknown.

In order to investigate the peaks between -25 °C and 50 °C, a repeated heating cycle was applied in the second experiment. With the first heating, the peak maximum of the first peak was 23.92 °C and its extrapolated onset temperature was 9.29 °C. The peak maximum of the second peak was 35.23 °C. With the second heating, the first peak had a maximum of 24.07 °C and an extrapolated onset temperature was 18.68 °C. The second peak had a maximum of 33.08 °C.

Conclusions:
The melting point of MTDID 15670 was determined to be 24 °C by the EU Method A.1.
Executive summary:

The melting point of MTDID 15670 was tested using differential scanning calorimetry (DSC). The melting temperature was determined to be 24 °C. The study was conducted in accordance with EU Method A.1 and was GLP compliant; therefore the study is considered reliable without restrictions.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion