Bile, extract

Flammability

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

flammable gases

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because the substance is a solid

Reference 2

Endpoint:

pyrophoric liquids

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because the substance is a solid

Reference 3

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

Reference 4

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 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

Reference 5

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2018-05-23 to 2018-11-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

Remarks:

result will be given later

In the preliminary test, the test item ignited by the flame, but the flame extinguished after approx. 10 s (burning distance <20 mm). Therefore, no main test was performed. The test item is not classified as readily combustible solid of Class 4 Division 4.1 and does not need to be classified as a flammable solid according to GHS/CLP Regulation 1272/2008.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not a flammable solid and does not need to be classified according to CLP.

Executive summary:

A preliminary test according to UN N.1 was performed to determine the flammability of the test substance. The test item was formed into a powder train. The flame from a gas burner was applied to one end of the powder train. The burning of the pile was observed. In the preliminary test the test item ignited but the flame extinguished after approx. 10s (burning distance <20 mm). Based on the results of the preliminary test, no main test was performed. The test item is considered as a not readily combustible solid of Division 4.1. and is not a flammable solid.

Reference 6

Endpoint:

self-heating substances / mixtures

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2018-05-23 to 2018-11-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

UN Manual of Tests and Criteria: Test N.4 (Test method for self-heating substances)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: VDI 2263 (1990), sheet 1, Grewer Oven

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Key result

Test procedure:

25 mm sample cube at 140°C

Result:

negative outcome (no effect observed)

In the investigation of self-ignition in the Grewer Oven for the pure test item a first small endothermic process was detected starting at approx. 60 °C and a second, starting at approx. 200 °C. After the test, only half of the test item volume was present in the wire basket. The residue in the wire basket was black. No self-heating or self-ignition could be observed up to 400 °C.

Interpretation of results:

GHS criteria not met

Conclusions:

No self-heating or self-ignition could be observed up to 400 °C.

Executive summary:

A study was conducted according toVDI 2263, part 1 1990, test methods for the determination of the safety characteristics of dusts; UN Transport Regulations, Appendix 6, Screening Procedures (Substances which may be liable to spontaneous combustion (Division 4.2))to determine the self-heating properties of the test item. The test item was filled in a small wire basket of a volume of 8 cm3 and this wire-basket was placed into the oven. In this oven, the self-ignition behavior of five samples can be determined simultaneously. An additional basket was filled with a reference material (graphite). The temperature of the oven was increased with a constant heating rate (1.2 K/min) in an air stream of 100 to 120 L per hour and the temperature of the sample was recorded as a function of time at intervals of 10 seconds. In the investigation of self-ignition in the Grewer Oven for the pure test item a first small endothermic process was detected starting at approx. 60 °C and a second, starting at approx. 200 °C. After the test, only half of the test item volume was present in the wire basket. The residue in the wire basket was black. No self-heating or self-ignition could be observed up to 400 °C.

Description of key information

The substance has not to be classified as flammable gas, flammable liquid, flammable solid, pyrophoric solid, pyrophoric liquid, flammable in contact with water, flammable aerosol or self-heating substance.

Key value for chemical safety assessment

Flammability:

not classified

Additional information

Flammable solids (reference 4.13-1)

A preliminary test according to UN N.1 was performed to determine the flammability of the test substance. The test item was formed into a powder train. The flame from a gas burner was applied to one end of the powder train. The burning of the pile was observed. In the preliminary test the test item ignited but the flame extinguished after approx. 10s (burning distance <20 mm). Based on the results of the preliminary test, no main test was performed. The test item is considered as a not readily combustible solid of Division 4.1. and is not a flammable solid.

 

Flammable liquids (reference 4.11-1)

In accordance with column 2 Annex VII section 7.9 of Regulation (EC) No 1907/2006 (REACH), the test on flash point does not need to be conducted as the test substance is solid.

 

Flammable gases (4.13-2)

The test item is a solid at ambient conditions. This hazard class is only applicable for gases. Thus, the substance was not considered for classification as flammable gas.

 

Pyrophoric properties of liquids (reference 4.13-3)

The test item is a solid at ambient conditions. This hazard class is only applicable for liquids. Thus, the substance was not considered for classification as pyrophoric liquid.

 

Pyrophoric properties of solids (reference 4.13-4)

In accordance with section 2.10.4.1, Annex I of Regulation (EC) No 1272/2008, the classification procedure for pyrophoric solids need not to be applied when experience in manufacture or handling shows that the substance or mixture does not ignite spontaneously on coming into contact with air at normal temperatures (i.e. the substance is known to be stable at room temperature for prolonged periods of time (days)). Thus, no study was conducted and the substance was not considered for classification as pyrophoric solid.

 

Self-heating substances and mixtures (reference 4.13-5)

A study was conducted according toVDI 2263, part 1 1990, test methods for the determination of the safety characteristics of dusts; UN Transport Regulations, Appendix 6, Screening Procedures (Substances which may be liable to spontaneous combustion (Division 4.2))to determine the self-heating properties of the test item. The test item was filled in a small wire basket of a volume of 8 cm3 and this wire-basket was placed into the oven. In this oven, the self-ignition behavior of five samples can be determined simultaneously. An additional basket was filled with a reference material (graphite). The temperature of the oven was increased with a constant heating rate (1.2 K/min) in an air stream of 100 to 120 L per hour and the temperature of the sample was recorded as a function of time at intervals of 10 seconds. In the investigation of self-ignition in the Grewer Oven for the pure test item a first small endothermic process was detected starting at approx. 60 °C and a second, starting at approx. 200 °C. After the test, only half of the test item volume was present in the wire basket. The residue in the wire basket was black. No self-heating or self-ignition could be observed up to 400 °C.

 

Substances which, in contact with water, emit flammable gases (4.13-6) 

In accordance with column 2 of REACH Annex VII and with Regulation (EC) No 1272/2008 Annex I, section 2.12.4.1(b) the classification procedure for this hazard class need not be applied. Based on the experience in handling and use the substance does not react with water and in addition the test substance is not pyrophoric. Thus, no study was conducted and the substance was not considered for classification.

 

Flammable Aerosols

In accordance with Annex I of Regulation (EC) No. 1272/2008, section 2.3 the classification procedure for this hazard class does not apply, since the test substance is not used as an aerosol. Thus, no study was conducted and the substance was not considered for classification.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

In accordance with Annex I section 2.2, section 2.3, section 2.6, section 2.7, section 2.9, section 2.10, section 2.11 and section 2.12 of Regulation (EC) No. 1272/2008, as amended for tenth time in Regulation (EU) No 2017/776, and UN GHS Rev 7 (2017) the test item has not to be classified as flammable liquid, readily combustible solid in class 4, Division 4.1, self-heating substance in Class 4, Division 4.2, substance which in contact with water emits flammable gases in Class 4, Division 4.3, pyrophoric liquid, pyrophoric solid in class 4, Division 4.2, flammable gas in class 2 or as aerosol in class 2.