Concrete of Spilanthes acmella (oleracea) obtained from flowers by extraction with organic solvent

Flammability

Link to relevant study record(s)

Reference

Reference 1

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 these constituents that would imply pyrophoric properties. Therefore, the study was considered as unnecessary.

Reference 2

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 March 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. 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:

2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Version / remarks:

2008

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 4,5 and 6 July 2016/ Signed on 10 January 2017

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

Results of the Preliminary Test

The flame from the gas burner was applied to one end of the powder train for 2 minutes but the test item did not ignite. The test item melts in contact with the gas burner and some smoke is emitted.

As no ignition of the test item takes place within two minutes and no propagation of the combustion (flame or smouldering) along 200 mm within four minutes occurs, the test item is classified as not highly flammable, and no further testing is carried out.

Conclusion

The test item is not considered as highly flammable.

Interpretation of results:

GHS criteria not met

Conclusions:

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

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 (GLP). 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 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 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.
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. In addition, no experience in handling and use of the registered substance has been reported, which could cast doubt on the NON-flammability if contact with water of the substance.
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 described as a brown pasty solid (see endpoints 4.1 and 4.2), no test to determine self-heating properties is required.

Description of key information

Flash Point = 162°C (exp) The substance is NOT classified as a FLAMMABLE LIQUID according to Regulation (EC) N°1272/2008 (CLP criteria) and UN Globally Harmonized System (GHS criteria).

No ignition was observed within the 2-min duration of application of the burner flame (exp) => 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

Fully reliable GLP experimental studies are available:

Flammability of solids was evaluated according to UN N1 method, and ispresented under point 4.13. It is considered as the key study.

Based on the chemical structure and experience, no flammable properties are anticipated if contact with air or water, or no self-heating for liquids, therefore studies were deemed unnecessary.

Justification for classification or non-classification

The measured flash point (162°C) is above 60°C, therefore the substance is NOT classified as Flammable liquid according to Regulation (EC) N°1272/2008 (CLP criteria) and UN Globally Harmonized System (GHS criteria).

The result obtained on this kind of substance should be largely influence by small amounts of volatile constituents.

The evaluation of the Flammability of the substance according to UN Test N.1, concluded that no ignition was observed in the preliminary test. Therefore no main test was performed. The substance was not classified as a flammable solid.

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 considering that the substance melts below 160°C, no classification as self-heating substance is anticipated.