Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by organic solvents extraction.

Melting point / freezing point

Link to relevant study record(s)

Reference

Reference 1

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).

Reference 2

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.

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.