4,4'-methylenebis(2,6-xylidine)

Flammability

Link to relevant study record(s)

Reference

Reference 1

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 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. In particular, in Water solubility testing presented under IUCLID Section 4.8, or in ecotoxicity testing under Section 6, though the substance is of low solubility, no particular reaction, hazardous or not, was observed when mixing.
The hazard class does not apply.

Reason / purpose for cross-reference:

data waiving: supporting information

Reference 2

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 December 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. No deviation affected the quality of the study. The substance is considered to be adequately characterised with its purity. 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:

2015

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Version / remarks:

2008

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

GLP certificate (inspected on 13 and 14 October 2014 / signed on 08 April 2015)

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

Findings

 Safety Pre-Test

The test item melted with yellow-orange flame. Yellow liquid and purple and pink residue was observed.

Preliminary Screening Test

In the preliminary screening test following the EU and the UN method, the test item was heated with the flame of a teclu burner for two minutes. The test item melted into a clear yellow liquid. After cooling down the liquid hardened and a brown-yellow solid residue was observed. No signs of ignition were observed.

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 as non-flammable solid (for UN regulations).

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

Interpretation of results:

not classified based on GHS criteria

Remarks:

GHS and EU-CLP criteria not met

Conclusions:

The test item is NOT classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP) 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 (GLP). The test item failed to ignite during the 2 minutes that the Bunsen flame was applied in the preliminary screening. The result of the preliminary screening test obviated the need to perform the main test.

The test item has been determined to be not highly flammable as it failed to ignite in the preliminary screening test.

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

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.
The hazard class does not apply.

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:
"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 (UN N4) is not applicable to liquids. Therefore liquids are not classified as self-heating…"
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 substance has a melting point < 160°C (see IU Section 4.2) the test is considered as NOT necessary.
The hazard class does not apply.

Reason / purpose for cross-reference:

data waiving: supporting information

Description of key information

NO ignition in contact with a flame: not a flammable solid (CLP/GHS)

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

A fully reliable, GLP, experimental study is presented under point 4.13 for flammability of solids. It is considered as a key study.

Based on the chemical structure and experience, no flammable properties are anticipated if contact with air or water, or no self-heating as a low melting solid, therefore studies were deemed unnecessary.

Justification for classification or non-classification

During the UN Test N.1, no propagation of a flamme was observed within the 2-min duration of application of the burner flame. Therefore, the substance is NOT classified as a flammable solid according to Regulation (EC) N°1272/2008 (CLP criteria) and UN Globally Harmonized System (GHS criteria).

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 powder (see endpoint 4.1) and it melts below 160°C  (see endpoint 4.2). Therefore no classification as self-heating substance is anticipated.