Concrete of Salvia sclarea L. (Lamiaceae) obtained from leaves, flowers and twigs by apolar hydrocarbon solvent extraction with or without purification by molecular distillation

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:

From 09 to 26 January 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:

6th revised edition 2015

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP compliance programme (inspected on 05 July 2016 / signed on 28 October 2016)

Key result

Test procedure:

burning rate test over 100 mm length

Burning time:

39 s

Results

Preliminary screening test

The rope ignited with a yellow flame and emitted black fumes. Burning rate: 60 seconds (across 200 mm). As the test item ignites and propagates combustion over 200 mm within two minutes , the substance is considered as Flammable and the main test is performed to determine the Hazard category.

Main test

The rope ignited with a yellow flame and emitted black fumes. Flame propagated through the wetted zone. Burning rate: 39 seconds (across 100 mm)

Interpretation of results:

Category 1 (flammable solids) based on GHS criteria

Conclusions:

The test item has been determined to be a FLAMMABLE SOLID Cat.1. according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.

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, 6th revised edition 2015.

First, a safety test was performed. A small amount of the test item was heated on board with a gas burner in order to derive safety precautions. The test item ignited and propagate along 200 mm.

Then, the main test was perfomed.

 

A rope was heated on a board and 1 ml of pure water was placed between 210 and 200 mm along the rope. The rope was burned with a gas burner and the rope ignited with a yellow flame and emitted black fumes.

As the burning time over 100mm is below 45 seconds (39 seconds) and the flame passes the wetted zone, the substance is considered as classified as a FLAMMABLE SOLID, Category 1 according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.

The test item has been determined to be a flammable solid, class 1, as it propagated combustion over the 100 mm of the main test in under 45.

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

Description of key information

Flash Point = 98°C: NOT flammable liquid (CLP/GHS).

The result obtained on this kind of substance should be largely influence by small amounts of volatile constituents and this value doesn't represent the major part of the substance.

Calssified as a FLAMMABLE SOLID Category 1 (CLP/GHS)

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

No self-heating anticipated for solid with a melting point < 160°C (waived).

Key value for chemical safety assessment

Flammability:

flammable

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. Additionally, as a low melting solid, the substance was also tested for Flash Point according to ISO/EU closed cup method, and is presented under point 4.11. Both are considered as key studies.

First, a safety test was performed. A small amount of the test item was heated on board with a gas burner in order to derive safety precautions. The test item ignited and propagate along 200 mm.

Then, the main test was perfomed.

 

The test item should be considered as not highly flammable. A rope was heated on a board and 1 ml of pure water was placed between 210 and 200 mm along the rope. The rope was burned witha gas burner and the rope ignited with a yellow flame and emitted black fumes. Flame propagated through the wetted zone abd the burning rate was of 39 seconds (across 100 mm).

The test item has been determined to be a flammable solid, class 1, as it propagated combustion over the 100 mm of the main test in under 45.

Justification for classification or non-classification

According to Regulation (EC) No.1272/2008 (CLP) and UN Globally Harmonised System (GHS) criteria,the substance has to be classified as FLAMMABLE SOLID Category 1 since burning time over 100mm is below 45 seconds and the flame passes the wetted zone following UN Test N.1.

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

Based on low melting point, no self-heating is anticipated and based on experience and chemical structure of known constituents of the substance, no flammable properties are anticipated if contact with air or water. Therefore additional studies were deemed unnecessary.