Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-

Melting point / freezing point

Administrative data

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-04-21 to 2017-10-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Version / remarks:

adopted on 27 July 1995

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Version / remarks:

Council Regulation (EC) No 440/2008; May 30th 2008

GLP compliance:

no

Type of method:

differential scanning calorimetry

Remarks:

In total, 3 methods were used: Capillary Method, Differential Scanning Calorimetry, Thermal Analysis

Test material

Test material information

Constituent 1

Reference substance name:

Ceramide III

IUPAC Name:

Ceramide III

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

The physical state of the test item at 20 °C and 101.3 kPa is a white, crystalline solid. All analyses included in this report have been performed with a batch, which passed the quality control measurements without any irregularity previously. All specifications were met.

Results and discussion

Melting / freezing point

Key result

Melting / freezing pt.:

ca. 124.6 °C

Any other information on results incl. tables

Results

Capillary method 

The melting point / range was determined using a using a melting point system (MP80, Mettler Toledo) according DIN EN ISO 3143 (previous version: DIN 53736). Three runs were done. The onset-temperature is 124 °C. The clear point was reached at 130 °C.

DSC / TGA

As preliminary tests first TGA and DSC runs were performed. As the substance was obviously modified within the first heating period to 250 °C, the DSC main test was focussed on the melting behaviour.

Evaluation 

According to the visual inspection, the test substance starts liquefying at 124 °C. For the determination of the melting point, the main DSC test was performed in triplicate. The melting points were read from the second and the third heating run of each test as the peak top temperature of the allocated melting peak.

After the test procedure, the samples were re-weighed in order to check for a significant sample loss indicating potential interfering non-melting processes. For none of the samples a significant weight loss was recorded (< 0.5 %).

Test Nr.	Peak temperature [°C]	Enthalpy (normalised) [J/g]
1	124.7 124.5 Ø 124.6	115.0 113.6 Ø 114.3
2	124.7 124.5 Ø 124.6	118.9 113.9 Ø 116.1
3	124.6 124.4 Ø 124.5	102.0 94.4 Ø 98.2
Average	124.6	109.5
SD	0.1	9.3
CV (%)	0.10 %	8.5 %

By means of DSC, an average melting point of 124.6 ± 0.1 °C was measured which is in accordance with the one measured by visual observation in the melt microscope (start liquefaction at 124 °C).

Applicant's summary and conclusion

Conclusions:

The average melting point of the test substance was determined to be 124.6 ± 0.1 °C by DSC analysis.

Executive summary:

The melting point of Ceramide III was determined according to OECD Guideline 102 (27 July 1995) and EU Method A.1 (30 May 2008) using differential scanning calorimetry and visual inspection.

According to the visual inspection, Ceramide III starts liquefying at 124 °C. For the determination of the melting point, the main DSC test was performed in triplicate.

The melting points were read from the second and the third heating run of each test as the peak top temperature of the allocated melting peak. For none of the samples a significant weight loss was recorded (< 0.5 %).

By means of DSC for Ceramide III an average melting point of 124.6 ± 0.1 °C was measured which is in accordance with the one measured by visual observation in the melt microscope (start of liquefaction at 124 °C).

Melting point of Ceramide III: 124.6 ± 0.1 °C.