[No public or meaningful name is available]

Auto flammability

Administrative data

Endpoint:

relative self-ignition temperature (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 a solid having a melting point <= 160°C

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACh Annex VII column 2, the study does not need to be conducted for solids, if the substance has a melting point ≤ 160 °C, or if preliminary results exclude self-heating of the substance up to 400 °C.
Based on the melting point of 46°C (refer to IUCLID section 4.2), testing for self-ignition can be waived.
For the same reason, self-heating does not apply, and self-heating test, under IU section 4.13, is recommended by ECHA R7a guidance (v6.0, July 2017, §R7.1.10.7), instead of relative self-ignition of solids based on EU A16 guideline under the present IU section 4.12, because the new UN N4 test is the standard used for CLP classification purpose.
Moreover, considering the ignition failure in the UN N1 flammability test, in the presence of a flame (see 4.13), self-ignition seems unlikely for the substance.
Therefore, the experimental study (A16) was deemed unnecessary, and no additional information is required.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12-20 November, 2012

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. The substance is adequately identified. Therefore full validation applies.

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Deviations:

yes

Remarks:

experimental details missing (atmosphere unclear); peak profiles incomplete but acceptable for onset

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

11 March 2011

Type of method:

differential scanning calorimetry

Specific details on test material used for the study:

- Physical state: white crystalline powder.
- Storage condition: Room temperature protected from direct sun light.

Key result

Melting / freezing pt.:

46.1 °C

Decomposition:

no

Table 4.2/1: Melting point – results

Test no.	Start temperature	Heating rate	Onset temperature
1	35 °C	+5 °C/min	46.2 °C
2	30 °C	+5 °C/min	46.1 °C
3	30 °C	+5 °C/min	45.9 °C
Mean ± S.D.			46.1 °C ± 0.2 °C

 

Three successive tests were retained.

Mean onset for melting occurred at 46.1 °C ± 0.2 °C. The validity criteria were fulfilled: the standard deviation within the three replicate assessments did not exceed 0.5 °C.Therefore the average value is retained as final result.

Executive summary:

The melting point of the test substance was determined under GLP according to EU Method A.1 by using differential scanning calorimetry (DSC).

Three main runs were performed, and the mean final temperature was retained.

The melting temperature of test substance has been determined to be 46.1 °C ± 0.2 °C.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

flammable solids

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 January 2013

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.

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EU Method A.10 (Flammability (Solids))

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

11 April 2011

Specific details on test material used for the study:

- Appearance: White powder
- Storage conditions: Test item was stored in a closed vessel at room temperature away from light and humidity.

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 started immediately to melt und burned with a yellow, sooting flame leaving no residue on the magnesia groove.

Preliminary Screening Test:

The test item melted immediately after contact with the flame, but didn't burn within 2 minutes. If the completely molten test item is strongly heated for longer than the 2 minutes sometimes partial ignition of the molten mass could be observed, but the flame died immediately after removal of the burner. After cooling down, the melted test item had turned slightly yellow.

 

Results and discussion:

In the preliminary screening test the test item melted immediately after contact with the flame, but no ignition occurred within two minutes.

Therefore, the test item should be considered as not highly flammable.

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 substance was tested for its flammable properties as a solid, according to EU-Method A.10 and UN N1 guideline, and under GLP.

 

In the preliminary screening test, the test item melted immediately after contact with the flame, but no ignition occurred within two minutes. Therefore no main burning rate test was performed.

 

The test item has been determined to be NOT highly flammable.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

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, 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 (UN N4) is not applicable to liquids. Therefore, liquids are not classified as self-heating… (similarly) substances or mixtures with a low melting point (< 160 °C) should not be considered for classification in this class (either) 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 test item has a melting point of 46°C (see IU Section 4.2) the test is considered as NOT necessary.
Moreover, the chemical structure does not contain metals or metalloïds, which are typically self-heating substances.

Reason / purpose for cross-reference:

data waiving: supporting information