Resinoid of Commiphora erythraea (Burseraceae) obtained from the gum by ethanol 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:

From 16 June to 11 November 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an internationally recognised method, and under GLP. No deviation affected the quality of the study. The substance is considered to be adequately characterised. 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:

5th revised edition 2009

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP compliance programme (inspected on 05 July 2016 / signed on 28 October 2016)

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

Result of preliminary screening test

The rope failed to ignite during the 2 minutes that the Bunsen flame was applied.

The result of the preliminary screening test obviated the need to perform the main test.

The test item has been determined to be not highly flammable as it failed to ignite in the preliminary screening test.

Interpretation of results:

not classified based on GHS criteria

Conclusions:

The test substance is NOT classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.

Executive summary:

The study was conducted according the procedure Test N.1 of the United Nations Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria, 5th revised edition 2009. The test item failed to ignite during the 2 minutes that the Bunsen flame was applied in the preliminary screening. The result of the preliminary screening test obviated the need to perform the main test.

The test item has been determined to be not highly flammable as it failed to ignite in the preliminary screening test.

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 5 known constituents suggests that there are no chemical groups present in these constituents 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 that do not fall into critical categories described in ECHA guidance.
The information from the surface tension and other aquatic test conducted (fish/algae aquatic toxicity) 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, v4.1 of June 2015:
"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…
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 pasty-solid not under a particulate form and that the substance has a pour point < 160°C (see endpoint 4.2) the test is considered as NOT necessary.

Description of key information

Flash Point=98°C (exp): not a flammable liquid (CLP / GHS)

The result obtained on this kind of substance should be largely influence by small amounts of volatile constituents and this value doesn't represent the major part of the substance.

Not a flammable solid (CLP/GHS).

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

No self-heating anticipated for pasty solid with a melting point < 160°C (waived).

Key value for chemical safety assessment

Flammability:

not classified

Additional information

Fully reliable GLP experimental studies are available:

Flammability of solids was evaluated according to UN N1 method, and is presented under point 4.13. Additionally, as a low melting solid, the substance was also tested for Flash Point according to ISO/EU closed cup method, and is presented under point 4.11. Both are considered as key studies.

Justification for classification or non-classification

According to Regulation (EC) No.1272/2008 (CLP) and UN Globally Harmonised System (GHS) criteria, the substance as solid did not ignite in the preliminary test, the substance is NOT classified as a flammable solid.

The measured flash point result is above the threshold values of 60°C of Regulation (EC) No.1272/2008 (CLP) and of 93°C of UN Globally Harmonised System (GHS), therefore the test substance is NOT considered as a flammable liquid under CLP and under GHS.

Based on low melting point no self-heating is anticipated and based on experience and chemical structure of known constituents, no flammable properties are anticipated if contact with air or water. Therefore additional studies were deemed unnecessary.