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Physical & Chemical properties

Flammability

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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 chemical structure of the major constituents (hydrocarbons, esters*) that do not fall into critical categories described in ECHA guidance (e.g. no alkali metal, phosphorous element, Grignard reagent, metal organic substances...), and based on the experience in handling, testing and use of the substance.

* For the major fraction of the UVCB (ca 99.7% non-volatile), direct identification was not achieved, due to technical difficulties. The starting material, beeswax is a complex mixture of saturated and unsaturated linear and complex esters (27 to 40% monoesters, 9 to 23 % hydroxymonoesters, 7 to 16% diesters, 3.9% hydroxydiesters), 11 to 28% hydrocarbons, 1 to 18% saturated, unbranched free fatty acids, 4 to 8% of other substances and < 0.3% free fatty alcohols (EFSA Journal (2007) 615, 1-28). The registered substance Concrete of honeycomb cells of the bee by hexane extraction is anticipated to contain selectively extracted constituents. Hexane being a non-polar solvent, non-hydroxy esters and hydrocarbons are supposed to be predominant in the concrete.
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 chemical structure of the major constituents (hydrocarbons, esters*) that do not fall into critical categories described in ECHA guidance (e.g. no alkali metal, phosphorous element, Grignard reagent, metal organic substances...), and based on the experience in handling, testing and use of the substance.

* For the major fraction of the UVCB (ca 99.7% non-volatile), direct identification was not achieved, due to technical difficulties. The starting material, beeswax is a complex mixture of saturated and unsaturated linear and complex esters (27 to 40% monoesters, 9 to 23 % hydroxymonoesters, 7 to 16% diesters, 3.9% hydroxydiesters), 11 to 28% hydrocarbons, 1 to 18% saturated, unbranched free fatty acids, 4 to 8% of other substances and < 0.3% free fatty alcohols (EFSA Journal (2007) 615, 1-28). The registered substance Concrete of honeycomb cells of the bee by hexane extraction is anticipated to contain selectively extracted constituents. Hexane being a non-polar solvent, non-hydroxy esters and hydrocarbons are supposed to be predominant in the concrete.
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, 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 (UN N4) is not applicable to liquids. Therefore liquids, unless adsorbed, are not classified as self-heating. Similarly, substances with a low melting point (i.e. completely molten up to 160 °C) should not be considered for classification in this class either, since the melting process is endothermic and the substance-air surface is drastically reduced.
Considering that the present substance is a wax-like solid, not under a particulate form, and that the substance has a melting point < 160°C (see IU Section 4.2) the test is considered as NOT necessary.
The hazard class does not apply.
Reason / purpose:
data waiving: supporting information
Endpoint:
flammable solids
Type of information:
experimental study
Adequacy of study:
key study
Study period:
experimental date: 30 November 2017
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. The substance is considered to be adequately characterised. 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:
Manual of Tests and Criteria, Sixth revised edition (2015) Section 33.2.1.4.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht (inspected on 13 & 14 October 2014, 2010 / signed on 08 April 2015)
Specific details on test material used for the study:
Storage conditions: closed original container (metal bottle) at 2 – 8 °C
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

Melting to a yellow-brown liquid was observed. No sign of ignition within two minutes.

Interpretation of results:
not classified based on GHS criteria
Remarks:
GHS and EU-CLP criteria not met
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 as a solid, according to UN N1 guideline, and under GLP.

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

Description of key information

No ignition in contact with a flame: not a flammable solid (CLP/GHS)

Not pyrophoric. No release of flammable gases if contact with water. No self-heating anticipated. (waived)

Key value for chemical safety assessment

Flammability:
not classified

Additional information

As the substance is a solid, the relevant test for flammable properties is the UN N1 test.

A fully reliable experimental study, conducted under GLP, is available. It is considered as a key study, and the result is retained as key data for purpose of classification.

Based on the chemical structure of major constituents, and experience, no flammable properties are anticipated if contact with air or water, or no self-heating as a low melting solid. 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 failed to ignite in the preliminary test, therefore the substance is NOT classified as a flammable solid.