Resinoid of Styrax tonkinensis (Styracaceae) obtained from exudate by ethanol extraction

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:

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.
The information from 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 3

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 September 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:

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:

GLP certificate (inspected on 13 and 14 October 2014 / signed on 08 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

Findings

Safety Pre-Test

It was observed that the test item melted to a clear brown- yellow liquid. The liquid burned with an orange flame.

Preliminary Screening Test

The test item melted to a brown liquid. It was observed, that the liquid burned 1 second after removing of the teclu burner. No ignition occurred within two minutes was observed.

 

Results and Discussion

No ignition was observed throughout the course of the test.

The test item should be considered as not highly flammable (for EU regulations) and. non-flammable solid (for UN regulations), resp.

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).

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 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:

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 to dark brown solid with a melting point < 160°C (see endpoint 4.2) the test is considered as not necessary.

Description of key information

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

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

No self-heating 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 is presented 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

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.

Based on experience and chemical structure of known constituents of the substance, no flammable properties are anticipated if contact with air or water.

Based on low melting point, no self-heating is anticipated.