Elemol-rich fraction of essential oil of Canarium commune (Burseraceae) obtained from exudate by fractional distillation

Melting point / freezing point

Link to relevant study record(s)

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

between March 26th, 2018 and April 05th, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The study wasconducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Version / remarks:

Guideline OECD 102 (1995)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Version / remarks:

European Commission Regulation (EC) No. 440/2008, method A.1.

Deviations:

no

Principles of method if other than guideline:

The melting point / melting range is determined by differential scanning calorimetry (DSC). The test item and the reference are heated up from the starting temperature to the final temperature at a constant heating rate in a defined atmosphere (nitrogen). Open crucibles are used as containers for the test item and as empty reference crucible. The quantity of heat absorbed or released is measured and recorded.

GLP compliance:

yes (incl. QA statement)

Remarks:

inspected on 20 and 21 June 2017 / signed on 04 September 2017

Type of method:

differential scanning calorimetry

Key result

Melting / freezing pt.:

< -20 °C

Atm. press.:

1 013.3 hPa

Remarks on result:

other: The measurements showed no endothermal effect in the temperature range of -80 to 25 °C

No melting point was measured above -80 °C. However, since freezing may be hindered at low temperatures due to supercooling it should only be assumed that no melting point exists above ‑20 °C.

The test item had no melting range/point above -20 °C.

Conclusions:

The test item had no melting range/point above -20 °C.

Executive summary:

The melting point of the test item was determined under GLP according to EU Method A.1 and OECD 102, using DSC method.

 

The test item is liquid at ambient temperature and pressure.

The measurements showed no endothermal effect in the temperature range of -80 to 25 °C.

According to Regulation (EC) No 1907/2006 (REACH) annex VII, column 2 of section 7.2, the determination of the melting / freezing point does not need to be conducted below a lower limit of - 20 °C. Therefore, no additional test was conducted and the melting point is stated as < - 20 °C (< 253.15 K).

Description of key information

Melting point of the registered substance is stated as: < - 20 °C (< 253.15 K)

Additional information

A fully reliable experimental study, conducted according to a recognized OECD/EC method and under GLP, is available. It is considered as a key study.

The test item had no melting range/point above -20 °C.

According to REACH annex VII, column 2 of section 7.2, the determination of the melting- / freezing point does not need to be conducted below a lower limit of - 20 °C. Therefore, the result is expressed as a limit value and cannot be retained as key data for purpose of CSA.