4-(2-hydroxyethyl)-1-piperazinepropanesulphonic acid

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:

2020-12-16

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)

Version / remarks:

2019

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

Preliminary Test

The test item did not ignite at room temperature using a flame as ignition source being applied for at least 2 minutes. The test item only melted and turned black.

 

Main Test

In the preliminary test the test item could not be ignited by a flame. Thus, the performance of the main test was not necessary.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not ignite at room temperature using a flame as ignition source being applied for at least 2 minutes. The test item only melted and turned black.

Executive summary:

A study was conducted according to UN Manual of Tests and Criteria, Seventh revised edition, Test N.1. Therefore, the test item was formed into a powder train. It was ignited by a gas flame and the burning rate is determined. The test item did not ignite at room temperature using a flame as ignition source being applied for at least 2 minutes. The test item melted and turned black. As the preliminary test the test item could not be ignited by a flame, the performance of the main test was not necessary.

Reference 2

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 3

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 4

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 5

Endpoint:

self-heating substances / mixtures

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2020-12-16 to 2020-12-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2019

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: VDI guideline 2263, Part 1, 1990: Test Methods for the Determination of the Safety Characteristic of Dusts, 1.4.1 Test according to Grewer

Version / remarks:

1990

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Key result

Test procedure:

100 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 an endothermic effect was detected in the temperature range of approx. 230 – 260 °C. No exothermic process was detected up to the test end temperature of approx. 410 °C. A black residue remained in the wire basket after the test.

For the test item in mixture with Kieselguhr an exothermic effect was observed starting at a temperature of 245 °C, which led to a maximum temperature of approx. 535 °C (approx. 200 °C above the corresponding temperature of the reference material). A grey residue remained in the wire basket after the test.

Experiment	Onset self- ignition / °C	Maximum temperature / °C
Pure test item	-	-
Test item in mixture with Kieselguhr (1:1)	245	535

The pure test item indicated no self-ignition at atmospheric pressure.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item does not have to be classified as self-heating substance.

Executive summary:

A study was conducted to determine the self-ignition of the test item according to VDI 2263 Sheet 1 Grewer Oven (1990). In the investigation of self-ignition in the Grewer Oven for the pure test item an endothermic effect was detected in the temperature range of approx. 230 – 260 °C. No exothermic process was detected up to the test end temperature of approx. 410 °C. A black residue remained in the wire basket after the test. It can be assumed that the test item would not indicate a self-heating up to a temperature of 140 °C in a 1 L wire basket. Therefore, the test item does not have to be classified as self-heating substance.

Reference 6

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 substance is known to be soluble in water to form a stable mixture

Description of key information

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

Key value for chemical safety assessment

Flammability:

not classified

Additional information

Flammable gases (reference 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.

 

Flammable liquid (reference 4.11-1)

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 flammable liquid.

 

Flammable solids (reference 4.13-1)

A study was conducted according to UN Manual of Tests and Criteria, Seventh revised edition, Test N.1. Therefore, the test item was formed into a powder train. It was ignited by a gas flame and the burning rate is determined. The test item did not ignite at room temperature using a flame as ignition source being applied for at least 2 minutes. The test item melted and turned black. As the preliminary test the test item could not be ignited by a flame, the performance of the main test was not necessary.

 

Pyrophoric 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 flammable liquid.

 

Pyrophoric solids (reference 4.13-4)

In accordance with section 2.10.4 Annex I of Regulation (EC) No 1272/2008 and ECHA guidance on the application of CLP Criteria section 2.10.4.1 the classification procedure for pyrophoric solids needs not to be applied when experience in manufacture or handling shows that the solid does not ignite spontaneously on coming into contact with air at normal temperatures (i.e. the solid is known to be stable at room temperature for prolonged periods of time (days)). Based on the experience in handling and use the substance is not known to ignite spontaneously when coming into contact with air at normal temperatures. 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 to determine the self-ignition of the test item according to VDI 2263 Sheet 1 Grewer Oven (1990). In the investigation of self-ignition in the Grewer Oven for the pure test item an endothermic effect was detected in the temperature range of approx. 230 – 260 °C. No exothermic process was detected up to the test end temperature of approx. 410 °C. A black residue remained in the wire basket after the test. It can be assumed that the test item would not indicate a self-heating up to a temperature of 140 °C in a 1 L wire basket. Therefore, the test item does not have to be classified as self-heating substance.

 

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

In accordance with column 2 of REACH Annex VI and with Regulation (EC) No 1272/2008 Annex I section 2.12.4 and ECHA guidance on the application of CLP Criteria section 2.12.4.2 the classification procedure for this hazard class needs not to be applied. The substance is known to be soluble in water to form a stable mixture and in addition the test substance is not pyrophoric. Thus, no study was conducted and the substance was not considered for classification.

 

Flammable Aerosols

Section 2.4.2 of Guidance on the application on the CLP Criteria state as follows: “Aerosols, this means aerosol dispensers, are any non-refillable receptacles made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state." Thus, as the substance does not meet the definition for aerosol, the test for aerosols was waived. Consequently the substance has not to be considered for classification for this hazard class.

 

In conclusion, the substance has not to be considered as flammable gas, flammable liquid, flammable solid, flammable in contact with water, flammable aerosol, pyrophoric solid, pyrophoric liquid or self-heating substance.

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 2.7, Section 2.9, Section 2.10 Section 2.11, Section 2.12 of Regulation (EC) No 1272/2008, as amended for the seventeenth time in Regulation (EU) 2021/849, and UN GHS Rev 8 (2019) the test item has not to be classified as, readily combustible solid in class 4 Division 4.1, flammable liquid, self-heating substance in Class 4 Division 4.2, substances which in contact with water emit flammable gases in Class 4 Division 4.3, pyrophoric liquid, pyrophoric solid in class 4 Division 4.2, flammable gases in class 2 or as aerosol in class 2.