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Melting point / freezing point

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Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05-12 February 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was conducted according to an internationally recognised method, and under GLP. Test substance is adequately characterised. Therefore full validation applies.
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
2008
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
Inspected on 13 and 14 October 2014 / Signed on 8 April 2015
Type of method:
capillary method
Key result
Melting / freezing pt.:
>= 50.1 - <= 55.5 °C
Decomposition:
no

Pre-test 1:

The following values were recorded:

Attempt

Selected temperature*

Melting range in °C

1

120.0

69.6 – 84.6

* Capillary tube containing the test item was set into channel 2 of the instrument

 

The test item melted to a clear yellow sticky mass and solidified after cooling down as a clear yellow solid like original test item.

To prove these melting range additional attempts were performed.

Pre-tests 2 -4:

Attempt

Selected temperature*

Melting range in °C

2

60.0

60.0 – 62.2

3

55.0

55.0 – 56.7

4

52.0

52.3 – 56.8

* Capillary tube containing the test item was set into channel 2 of the instrument

 

In all attempts the test item started to melt immediately after setting in the instrument, therefore for the next trial the selected temperature was reduced.

Main test:

Determination

Selected temperature*

Melting range in °C

1

49.0

50.1 – 55.5

2

49.0

50.0 – 55.5

Result:

The means between both determinations give the following values for the melting range:

Melting range:                                             50.1 to 55.5 °C (323.3 K to 328.7 K)

Standard deviation:                                   0.07 (begin); 0.00 (end)

Estimated accuracy:                                   ± 0.1 °C

Conclusions:
The determination of the melting point of the test item was perforemed with the Melting Point meter MPM-HV2.
The validity criterion “difference between duplicate determinations” was met. The test item showed a melting range, no melting point.
The melting range was detected with: 50.1 to 55.5 °C (323.3 K to 328.7 K).
Executive summary:

The study was performed in order to determine the freezing point of test item according OECD 102, resp. EU A.1 guideline, using the capillary method.

The melting range was determined to be: 50.1 to 55.5 °C (323.3 K to 328.7 K).

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 - 14 February 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was conducted according to an internationally recognised method, and under GLP. Test substance is adequately characterised. Therefore full validation applies.
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Version / remarks:
2008
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
Inspected on 13 and 14 October 2014/ Signed on 8 April 2015
Type of method:
capillary method
Key result
Melting / freezing pt.:
>= 37.8 - <= 46.3 °C
Atm. press.:
1 013 hPa
Decomposition:
no

Pre test 1 with quick heating rate:

The following values were recorded:

Attempt

Selected temperature*

Melting range in °C

1

75.0

39.2 – 64.7

* Capillary tube containing the test item was set into channel 2 of the instrument at 26.7 °C

 

The test item melted to a clear yellow sticky mass and solidified after cooling down as a clear yellow solid.

To prove this melting range an additional attempt was performed.

Pre-test 2 with heating rate of 1°C/min:

Attempt

Selected temperature*

Melting range in °C

2

35.0

37.8 – 46.2

* Capillary tube containing the test item was set into channel 2 of the instrument

The test item melted to a clear yellow sticky mass and solidified after cooling down as a clear yellow solid.

Main test:

The following values were recorded:

Determination

Selected temperature*

Melting range in °C

1

35.0

37.7 – 46.3

2

35.0

37.8 – 46.3

* Capillary tube containing the test item was set into channel 2 of the instrument

Result:

The means between both determinations give the following values for the melting range:

Melting range:                                             37.8 to 46.3 °C (311.0 K to 319.5 K)

Standard deviation:                                   0.07 (begin); 0.00 (end)

Estimated accuracy:                                   ± 0.1 °C

Conclusions:
The determination of the melting point of the test item was perforemed with the Melting Point meter MPM-HV2.
The test item showed a melting range, no melting point.
The melting range was detected with: 37.8 to 46.3 °C (311 K to 319.5 K).
Executive summary:

The study was performed in order to determine the freezing point of test item according OECD 102, resp. EU A.1 guideline, using the DSC method.

The melting range of test item was determined to be 37.8 to 46.3 °C (311 K to 319.5 K).

Description of key information

The melting range was determined as 50.1 -55.5°C or 37.8 -46.3°C, depending the substance tested.

Key value for chemical safety assessment

Additional information

Two fully reliable experimental studies, conducted according to OECD 102/ EU A1 guideline are available.

Both are considered as a key study, and the result is retained as key data.