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Physical & Chemical properties

Flammability

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Endpoint:
pyrophoric liquids
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.
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 paste (see endpoint 4.1) but that the substance is considered to melt between 12.9 and 15.1°C (see endpoint 4.2) and to be flowable at 65°C (see endpoint 4.4), the test is considered as not necessary.
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, the information from aquatic test conducted on the raw material (fish/algae aquatic toxicity tests performed on labdanum gum) showed that the raw material clearly does not react with water. Therefore no reaction is anticipated on the extracts of this substance.
Finally,no experience in handling and use of the extract has been reported and which could cast doubt on the NON-flammability if contact with water.
Finally, Therefore, the study was considered as unnecessary.
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. No deviation was reported. Test substance is adequately specified. Therefore full validation applies.
Qualifier:
according to
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. certificate)
Remarks:
GLP compliance programme (inspected on 15-16 November 2017 / signed on 15 May 2018)
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

Melting was observed during the test. The liquid burned with an orange flame

 

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 just melted to a brown liquid. 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.

Description of key information

Flash Point= 149°C (exp) => NOT a flammable liquid (CLP/GHS)

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 considering the low melting point of the substance (waived).

Key value for chemical safety assessment

Flammability:
not classified

Additional information

Considering the high viscosity of the substance (described as a paste), the evaluation of Flammability of the substance according to UN N1 method is considered in this dossier and is presented under the endpoint 4.13. Additionally, the substance may be handled as a liquid. Then the substance was also tested for Flash Point according to ISO/EU equilibrium closed cup method, and is presented under point 4.11. Both are considered as key studies.

Justification for classification or non-classification

The measured flash point (149°C) is above 60°C and above 93°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).

During the UN Test N.1, no ignition was observed within the 2-min duration of application of the burner flame. Therefore, the substance is NOT classified as a flammable solidaccording 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 paste or as a very viscous and sticky, almost not flowable liquid (see endpoint 4.1) with a low melting point < 160°C (see endpoint 4.2). Therefore No classification as self-heating substance is anticipated.