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Physical & Chemical properties

Melting point / freezing point

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Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 03 November 2011 and 24 December 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid and conclusive guideline study under GLP
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
Commission Regulation (EC) No. 440/2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: ASTM E537-86
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Department of Health of Government of the U.K., inspection 19-21 July 2011
Type of method:
thermal analysis
Remarks:
- Differential Scanning Calorimetry (DSC)
Melting / freezing pt.:
ca. 24 - ca. 45 °C
Atm. press.:
ca. 101.3 kPa
Decomposition:
no
Sublimation:
no
Remarks on result:
other: Ambient pressure assumed as no value is stated in the report, the extrema of both measurements are taken
Melting / freezing pt.:
ca. 297 - ca. 318 K
Atm. press.:
ca. 101.3 kPa
Decomposition:
no
Sublimation:
no
Remarks on result:
other: Converted from °C measurement

Table 2: Thermographic Data – Determination 1

 Thermal Event  Interpretation  Temperature
 [°C]  [K]
 Endotherm  Onset of melting  24.04  297.19
 Endset of melting  42.81  315.96

Table 3: Thermographic Data – Determination 2

 Thermal Event  Interpretation  Temperature
 [°C]  [K]
 Endotherm  Onset of melting  24.10  297.25
 Endset of melting  44.84  317.99
Conclusions:
Melting range 24 to 45 °C (297 to 318 K)
Executive summary:

The melting behaviour of the test item was investigated in a GLP-compliant study by Differential Scanning Calorimetry (DSC) according to the ASTM E537-86 protocol, which is compatible to EU A.1 (2008) and OECD TG 102 (1995) standards. The experiment is deemed valid, conclusive and thus suitable for assessment without restrictions.

The test system indicated melting as endothermic effect in the range 24 to 45 °C (297 to 318 K).

Description of key information

Melting range 24 to 45 °C (297 to 318 K)(OECD 102)

Key value for chemical safety assessment

Melting / freezing point at 101 325 Pa:
24 °C

Additional information

The melting behaviour was investigated in a GLP-compliant study (Fox & White 2012, Harlan Report no. 41103263) by Differential Scanning Calorimetry (DSC) according to the ASTM E537-86 protocol, which is compatible to EU A.1 (2008) and OECD TG 102 (1995) standards. The experiment is deemed valid, conclusive and thus suitable for assessment without restrictions.

The test system indicated melting as endothermic effect in the range 24 to 45 °C (297 to 318 K, mean 34.35 °C = 307.5 K). Due to the fact that the submission item is a complex mixture the finding of a melting range is not surprising. The submission item is a viscous material at standard conditions (ISO 5011, i.e. 20 °C and 101.3 kPa) and has no crystalline structure.

In conclusion the submission item should be regarded a non-solid however the melting range starts above the temperature considered for standard conditions.