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Physical & Chemical properties

Flammability

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Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 November 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. Test substance is 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 13 and 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

In the preliminary screening test following the EU and the UN method, the test item was heated with the flame of a teclu burner.

The test item melted to an orange – light brown liquid. No ignition occurred within two minutes.

Interpretation of results:
not classified based on GHS criteria
Conclusions:
No ignition was observed throughout the course of the test.
The test item should be considered as not highly flammable (for EU regulation) and as non-flammable solid (for UN regulation).
Executive summary:

The study was performed in order to determine the flammability of test item according to UN N1, resp. EU A.10 guideline.

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

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.
A review of the chemical structure of the known constituents of the substance suggests that there are no chemical groups present in these constituents that would imply pyrophoric properties. Moereover, the tests performed on the substance and reported in this dossier showed that the substance clearly does not react with air. Therefore, the study was considered as unnecessary.
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 of the substance suggests that there are no chemical groups present that would imply flammability on contact with water.
Finally,no experience in handling and use of the extract has been reported, which could cast doubt on the NON-flammability if contact with water.
Therefore, the study was considered as unnecessary.
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 October 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. Test substance is 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 13 and 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:

It was observed that the test item burned with a sooting flame. Then it melted and evaporated.

Preliminary screening test:

Melting to a yellow-brown sticky liquid was observed during heating. No ignition occurred within two minutes.

Result:

No ignition was observed throughout the course of the test.

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

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:
No ignition was observed throughout the course of the test.
The test item should be considered as not highly flammable (for EU regulation) and as non-flammable solid (for UN regulation).
Executive summary:

The study was performed in order to determine the flammability of test item according to UN N1, resp. EU A.10 guideline.

No ignition was observed throughout the course of the test.

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

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 of July 2017:
"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 described as a brown solide with a melting point <60°C (see endpoint 4.2) the test is considered as not necessary.

Description of key information

Not a flammable solid (CLP/GHS)

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

Two fully reliable experimental studies, conducted according to EU A10, resp. UN N1 guideline are available.

Both are considered as a key study, and the result is retained as key data.

Justification for classification or non-classification

The tested substance did not ignite in the preliminary test of the UN N1 method and it is NOT classified as a flammable solid according to Regulation (EC) No.1272/2008 (CLP) and UN Globally Harmonised System (GHS) criteria.

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

In addition, based on physical state of the substance (solid with 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.