Saccharomyces cerevisiae, lysate

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:

From 05/02/2018 to 06/03/2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Version / remarks:

Method A.1, Official Journal of the European Union L 142 of 31 May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Version / remarks:

Adopted July 27, 1995

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

capillary method

Key result

Melting / freezing pt.:

> 400 °C

Atm. press.:

ca. 1 013 hPa

Decomposition:

yes

Decomp. temp.:

>= 150 - <= 250 °C

Remarks on result:

other: The test item became black

The following preliminary tests were performed:

- from 30°C to 400°C at 10°C/min heating rate with three parallel samples:

At about 150°C the test item began to become brown, then black at about 250°C. The test item seemed as if it was charred. Nevertheless, at about 300°C it has a wet appearance visually, but melting did not occur during this test. The preliminary test was repeated with a slower heating rate to obtain more accurate results.

- from 160°C to 255°C at 5°C/min heating rate with three parallel samples:

At about 160°C the colour of test item already began to became dark continuously, at about 240°C the test item was very dark brown and at about 245°C the test item became to uniformly black.

In the first preliminary test slightly wetness was observed at about 300°C, for further examination of this, the test was repeated from a higher initial temperature with different heating rate:

- from 300°C to about 330°C at 2°C/min heating rate, then from 330°C to 400°C at 20°C/min with three parallel samples:

At about 300°C the test item became black, it appeared to be shiny and slightly wet. At about 305°C the test item blackened further continuously, it seemed slightly wet, but not melted. At about 330°C the test item was apparently charred, a part of test item disappeared. From this temperature, the gradient was increased from 2°C/min to 20°C/min. The test item began to smoke, the test item was black and a ‘burnt’ odour was apparent.

Main test

Based on the results of different preliminary tests, the 240-255°C as temperature range was selected to the Main test.

For the main test three capillaries containing test item were placed into the apparatus, the block was heated from 240°C to 255°C at 0.5°C/min heating rate. The transformations of the test item were observed, visually through the magnifying glass.

Two parallel experiments were carried out and in each case three parallel samples were measured. The observations were same in both experiments:

At about 240°C the test item began to become dark, at about 244°C the test item was black (appearing to be burned) but melting was not observed.

Conclusions:

The test item has no melting point up to 400°C, because degradation of test item appears to occur between 150-250°C according to visual observation.

Executive summary:

The melting point was determined according to the Method A.1 of the Commission Regulation (EC) No 440/2008 of 30 May 2008 and in compliance with the GLP. The capillary method using a metal block was applied.

The degradation of the test item appears to occur between 150 -250°C according to visual observation. The test item became black but no melting point was observed.

The test item, Saccharomyces cerevisiae, lysate has no melting point up to 400°C.

This melting point study is classified as acceptable, and satisfies the guideline requirements of the EU method A.1.

Description of key information

The test item has no melting point up to 400°C, because degradation of test item appears to occur between 150-250°C according to visual observation.

Additional information

The melting point was determined according to the Method A.1 of the Commission Regulation (EC) No 440/2008 of 30 May 2008 and in compliance with the GLP. The capillary method using a metal block was applied.

The degradation of the test item appears to occur between 150 -250°C according to visual observation. The test item became black but no melting point was observed.

The test item, Saccharomyces cerevisiae, lysate has no melting point up to 400°C.