Enzymatic hydrolysis products of Ophiopogon japonicus, Liliaceae, root

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:

From 18 to 20 April 2016

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. No deviation was reported. Test substance is adequately specified. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: UN Method N1, 2009: “Test method for readily combustible solids”

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

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

RESULTS

- Safety Pre-Test

The test item burned with a yellow flame and bloated to a black mass on the magnesia groove.

- Preliminary Screening Test

The test item burned with yellow flame and bloated to a black mass. The flame died when the burner was removed. No signs of flammability were observed within two minutes.

- Results and Discussion

No ignition was observed throughout the course of the test.

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

No observations were made which might cause doubts concerning the validity of the study outcome.

Interpretation of results:

non flammable

Remarks:

Migrated information

Conclusions:

The test item is NOT classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP) and UN GHS criteria.

Executive summary:

The test substance was tested for its flammable properties following UN TDG Method N.1.

The test substance melted on application of the ignition source and burned with a hot flame of the gas burner. The test item burned with yellow flame and bloated to a black mass. The flame died when the burner was removed.No signs of flammability were observed within two minutes.

The test substance was found not flammable solid because no ignition was observed throughout the course of the test.

Reference 2

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 that does not fall into critical categories described in ECHA guidance, and based on the experience in handling, testing and use of the substance.

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

the study does not need to be conducted because the substance is known to be soluble in water to form a stable mixture

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 constituents of the substance that does not fall into critical categories described in ECHA guidance, and based on the experience in handling, testing and use of the substance.

Description of key information

For substance in its solid form : No ignition in contact with flame. No propagation in contact with a flame: not a flammable solid (CLP/GHS)

For substance marketed in a liquid form (aqueous solution) : No Flash point is anticipated due to the nature of the substance (not flammable solid) and its high water content.

Key value for chemical safety assessment

Flammability:

non flammable

Additional information

A reliable experimental study was conducted on the solid test item andaccording to standard method (UN N1Test and EU method A10) under GLP.

The test item to propagate combustion in the preliminary test (identical in EC A10 and UN N1 tests), shows that the substance is non flammable.

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 propagate combustion in the preliminary test (identical in EC A10 and UN N1 tests), therefore the substance is NOT classified as a flammable solid.

The substance can be marketed in aqueous solution (see '1.2-Composition') but in this marketed form, it is very unlikely to exhibit a flash point due to the nature of the substance (not flammable solid) and its high water content. Therefore, the flash point was waived and the substance is not classified as a flammable liquid.

Based on the chemical structure of the constituents of the substance and experience in handling and use of the substance, no flammable properties are anticipated if contact with air or water, therefore studies were deemed unnecessary.

Finally , the substance is not considered as classified in these hazard classes.