Concrete of Rosa Damascena (Rosaceae) obtained from fresh flowers by extraction with an apolar solvent

Boiling point

Link to relevant study record(s)

Reference

Endpoint:

boiling point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 19 to 25 Octobre 2016

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. No deviation was reported. Test substance is adequately specified. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

OECD Guideline 103 (Boiling Point)

Version / remarks:

1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.2 (Boiling Temperature)

Version / remarks:

2008

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Type of method:

dynamic method

Remarks:

Cottrell pump is used in the main test (pre-test with Siwoloboff method is performed)

Key result

Decomposition:

yes

Decomp. temp.:

ca. 220 °C

Remarks on result:

not determinable

Remarks:

Decomposition

First, a pre-test following Siwoloboff method was performed, but the colour of the test item changed into a darker colour (potentially due to decomposition of the substance). It was not possible to see a boiling chain. Therefore, the Siwoloboff method is not considered as suitable for the main test.

Secondly, the main determination was performed following the dynamic method.

Observations and measured values are presented in the following tables:

Table 4.3.1 Results:

Decomposition	Temperature Cottrell pump	Temperature test item
First determination	194.5°C	243.0°C (516.2K)
Second determination	202.0°C	243.0°C (516.2K)
Mean		243.0°C (516.2K)

Table 4.3.2 Observations:

Observations	Temperature test item
small bubbles	90°C
more bubbles	140°C
colour slightly greenish	220°C
colour greenish	232°C

After cooling down the test item was like wax but stay greenish.

Boiling, indicated by pumping of the Cottrell pump, was observed at 194.5 °C (first determination) and 202 °C (second determination), while the temperature measured in the sample was 243°C.

During the boiling of a pure substance, the temperature in the sample should be the same as the temperature of the Cottrell pump. Otherwise the temperature difference between the thermometers should be a sign of decomposition of the pure substance.

For this complex substance, the thermometer in the Cottrell pump showed a lower temperature than the temperature in the sample, which may be the sign of decomposition. In addition, the colour change of the test item after cooling down indicated clearly decomposition of the test item during the experiment.

Considering the complex nature of the substance, the temperature of initial decomposition of the test item cannot be clearly determined using these methods. However signs of decomposition of the substance (such as change of colour and difference between temperatures of the test item and in the Cottrell pump) were observed from 220°C.

As the test item showed decomposition, the calculation following the equation of Sydney – Young was not necessary.

No observations were made which might cause doubts on the validity of the study outcome. Therefore, the result of the study is considered valid.

Conclusions:

No boiling point was recorded due to decomposition of the substance.

Executive summary:

A study was conducted to determine the boiling point of the test substance under GLP according to OECD 103 / EU A2 guideline.

No boiling point was determined because of decomposition of the test item observed (colour change and temperature difference between test item and the Cottrell pump)

The temperature of initial decomposition of the substance is not clear. Condering the observations reported using Siwoloboff and Cottrell methods, the initial decomposition is considered to be observed from approximately 220°C (colour change).

According to Regulation (EC) No 1907/2006 (REACH) annex VII, column 2 of section 7.3, the determination of the boiling point does not need to be conducted for substances which decompose before boiling (e.g. auto-oxydation, rearrangement, degradation, decomposition, etc...)Therefore no additional test was conducted.

Description of key information

No boiling point was recorded due to the decomposition of the test item before boiling.

Additional information

A reliable GLP experimental study, conducted according to a recognized OECD/EC guidelines is available.

It is considered as a key study.