Extract of Boswellia serrata (Burseraceae) obtained from exudate by solvent extraction

Boiling point

Link to relevant study record(s)

Reference

Endpoint:

boiling point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 September - 23 October 2017

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. The substance is considered to be adequately characterised. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

OECD Guideline 103 (Boiling Point)

Version / remarks:

dated 27. Jul. 1995

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.2 (Boiling Temperature)

Version / remarks:

Regulation (EC) No440/2008 of 30 May 2008, published on 31. May 2008

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

GLP compliance programme (inspected on 13-14 October 2014 / signed on 8 April 2015)

Type of method:

method according to Siwoloboff

Remarks:

and DSC method

Boiling pt.:

205.5 °C

Atm. press.:

>= 100.256 - <= 100.276 kPa

Decomposition:

ambiguous

Decomp. temp.:

>= 95 °C

Results

Pre-test for the boiling point following Siwoloboff

Observations Pre-test for the boiling point following Siwoloboff

Observations	Temperatures
started to slightly shrivel, colour getting darker	95 °C
melted to a slightly yellowish sticky mass and stay for a long time in this state	122 °C
Getting more transparent with a colourless condensate	130 °C
Test item slightly expanded upward with fine foam	Since 140 °C
At the bottom part had more foam than at the top part	160 °C
Bubbles were visible	190 °C
A brown liquid at the bottom with foam at the surface	200 °C
Test item boiled with a lots of foam	250 °C
No foam anymore, test item was a dark brown liquid and boiled	360 °C
Performance of heating and turned off the burner	Up to 400 °C

After cooling down the test item was a dark-brown solid.

Test for boiling point following DSC method

DSC measurements showed only an increase in the heat flow at 359.53 °C. After the test the crucible was visually unchanged, the crucible was opened and a very small amount of whitely to yellow discolored residue was visible. However, no boiling point can be determined using this method.

Finally, the determination of boiling point was conducted using Siwoloboff Method.

Main test : Boiling Point following Siwoloboff method:

Determination	Boiling Point	Atmospheric Pressure
First determination	205.2 °C (478.4 K)	100276 Pa
Second determination	205.7 °C (478.9 K)	100256 Pa

 

Mean ± standard deviation (without correction following Sydney Young)

=205.5 °C ± 0.4 °C (478.6 ± 0.4 K).

 

Observations Boiling Point following Siwoloboff

Observations	First determination	Second determination
Test item melted instantly to a yellow-orange mass under strong expanding and foaming	190 °C	190 °C
Formation of bubbles, the test item was like a very viscous orange-brown liquid caramelised syrup	213 °C	212.9 °C
Strong foaming, boiled with a lots of bubbles. Due to the high viscosity of the test item no rising back into the capillary was visible.	238.4 °C	238 °C
turned off burner, test item was dark brown	247.1 °C	246 °C
No more bubbles	205.2 °C	205.7 °C

 

After cooling down the test item solidified as dark brown mass.

Some of this mass from the second determination was taken to grind, no significant change was visually observed only the test item after the determination seemed to be slightly darker.

We noted potential degradation of the substance starting possibly from 95 °C according to the observations reported in the pre-test.

Conclusions:

The boiling point under possibly decomposition can be stated as 205.5°C (mean value, between 100.256 and 100.276 kPa), with potential decomposition of the substance starting from about 95°C.

Executive summary:

A study was conducted under GLP according to EU Method A.2 and OECD 103, using Siwoloboff method to determine the boiling point of the substance.

Siwoloboff pre-test and DSC measurements were performed to determine the method to be used to determine the initial boiling point of the substance. Finally two independant determinations were conducted using Siwoloboff method and the mean value was used to determine the boiling point of the substance.

Description of key information

The boiling point was determined as 205.5°C (between 100.256 and 100.276 kPa) with potential degradation of the substance starting from about 95 °C

Key value for chemical safety assessment

Boiling point at 101 325 Pa:

205.5 °C

Additional information

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

It is considered as a key study. The result is retained as key data.