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

Flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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

Qualifier:

according to guideline

Guideline:

UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)

Version / remarks:

2015

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)

Key result

Test procedure:

burning rate test: preliminary screening test

Remarks on result:

substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period

Safety Pre-Test

The test item burned with an orange, sooting flame, leaving a black residue.

Preliminary Screening Test

In the preliminary screening test following the UN method, the test item was heated with the flame of a teclu burner. The test item melted to an orange-brown liquid. The liquid burned with an orange, sooting flame, leaving a black residue. No ignition occurred within two minutes.

Results and Discussion

No ignition was observed throughout the course of the test.

The test item should be considered as non-flammable solid (for UN regulations).

No observations were made which might cause doubts concerning the validity of the study outcome.

Interpretation of results:

not classified based on GHS criteria

Conclusions:

The test item is not classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP) criteria.

Executive summary:

The substance was tested for its flammable properties, according to UN MTC N1 guideline, and under GLP.

During the preliminary assay, the item could not be ignited within the 2-min duration of application of the burner flame. Therefore no main test was performed.

Reference 2

Endpoint:

pyrophoric solids

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is known to be stable in contact with air at room temperature for prolonged periods of time (days) and hence, the classification procedure does not need to be applied

the study does not need to be conducted because the organic substance does not contain metals or metalloids and hence, the classification procedure does not need to be applied

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with section 1 of REACh Annex XI, study for pyrophoric properties is deemed unnecessary based on the experience in handling, testing and use of the substance and based on the chemical structure of the known constituents of the substance that do not fall into critical categories described in ECHA guidance.
The tests performed on the substance and reported in this dossier showed that the substance clearly does not react with air. Moreover, a review of the chemical structure of the known constituents suggests that there are no chemical groups present in the known constituents of the substance that would imply pyrophoric properties. Therefore, the study was considered as unnecessary.

Reference 3

Endpoint:

substances / mixtures which in contact with water emit flammable gases

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the organic substance does not contain metals or metalloids and hence, the classification procedure does not need to be applied

the study does not need to be conducted because the experience in production or handling shows that the substance does not react with water, e.g. the substance is manufactured with water or washed with water

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with section 1 of REACh Annex XI, study for flammability if contact with water is deemed unnecessary based on the experience in handling, testing and use of the substance and based on the chemical structure of known constituents of the substance that do not fall into critical categories described in ECHA guidance.
Some tests performed using the substance in water and reported in this dossier (partition coefficient, surface tension) showed that the substance clearly does not react with water. Moreover, a review of the chemical structure of the known constituents suggests that there are no chemical groups present that would imply flammability on contact with water. Therefore, the study was considered as unnecessary.

Reference 4

Endpoint:

self-heating substances / mixtures

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is completely molten at 160°C

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING:
According to the Guidance on the Application of the CLP Criteria, v5.0 of July 2017, $ 2.11.4.2:
"the phenomenon of self-heating applies only to solids. The surface of liquids is not large enough for reaction with air and the test method is not applicable to liquids. Therefore liquids are not classified as self-heating… "
In addition,
"Substances or mixtures with a low melting point (< 160 °C) should not be considered for classification in this class since the melting process is endothermic and the substance-air surface is drastically reduced. However, this criterion is only applicable if the substance or mixture is completely molten up to this temperature.". Considering that the test item is a powder (see endpoint 4.1) but that the substance melts below 160°C (see endpoint 4.2), the test is considered as not necessary.

Description of key information

NO ignition in contact with a flame: not a flammable solid (CLP/GHS)

NOT flammable if contact with air or water (waived).

NO self-heating properties anticipated (waived)

Key value for chemical safety assessment

Flammability:

not classified

Additional information

Considering the the substance is a solid (described as a off-white powder in endpoint 4.1), the evaluation of Flammability of the substance according to UN N1 method is considered in this dossier. It is considered as a key study.

Justification for classification or non-classification

During the UN Test N.1, no ignition of the test item was observed within the 2-min duration of application of the burner flame. Therefore, the substance is NOT classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP criteria) and UN Globally Harmonized System (GHS criteria).

Based on the chemical structure of the known constituents and experience in handling, testing and use of the substance, no flammable properties are anticipated if contact with air or water, therefore studies were deemed unnecessary in accordance with section 1 of REACh Annex XI.

Finally the substance is described as a off-white powder (see endpoint 4.1) and it melts below 160°C  (see endpoint 4.2). Therefore no classification as self-heating substance is anticipated.