Evernia prunastri, ext.

Flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental Phase scheduled: 11 December 2017 - 12 January 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

The study will be conducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised. Therefore full validation should apply. However, considering that the study is still on-going we will consider this study as reliable with restrictions.

Qualifier:

according to guideline

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. QA statement)

Remarks:

a GLP certificate should be included in the final report

Test procedure:

burning rate test: preliminary screening test

Remarks on result:

other: study on-going

study on going

Interpretation of results:

other: study on going

Conclusions:

study on going

Executive summary:

study on going

Reference 2

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.

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 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 (daphnia/algae aquatic toxicity tests performed on oakmoss concrete) showed that the raw material clearly does not react with water. Therefore no reaction is anticipated on the registered substance.
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.

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 a liquid

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.".
The substance is described as a dark brown viscous liquid to sticky pasty substance (see endpoint 4.1) and is was flowable at approximately 80°C(see endpoint 4.4, Laus,2017). Then, the substance is considered as totally molten below 160°C and the test is considered as not necessary.

Description of key information

Flash Point= 110.5°C (exp) => NOT a flammable liquid (CLP/GHS)

Flammability on ignition : study on-going

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

NO self-heating properties anticipated (waived)

Key value for chemical safety assessment

Flammability:

not classified

Additional information

Considering the high viscosity of the substance (described as a dark brown viscous liquid to sticky pasty substance), the evaluation of Flammability of the substance according to UN N1 method is considered in this dossier (study on-going). Additionally, as a liquid, 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 (110.5°C) is above 60°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).

The result obtained on this kind of substance should be largely influence by small amounts of volatile constituents.

The evaluation of the Flammability of the substance accoring to UN Test N.1 is on-going.

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 dark brown viscous liquid to sticky pasty substance. Considering that the substance is a liquid, no classification as self-heating substance is anticipated.