2-Methoxy-4-methylphenyl methyl carbonate

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Link to relevant study record(s)

Reference

Reference 1

Endpoint:

relative self-ignition temperature (solids)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09-01-2012 to 12-01-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

Qualifier:

according to guideline

Guideline:

EU Method A.16 (Relative Self-Ignition Temperature for Solids)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

inspected: July 2011; signature: August 2011

Remarks on result:

no self-ignition observed up to the melting point

Remarks:

No relative self-ignition temperature below its melting temperature (64°C) was observed. The substance melted on completion of the study at atm. pressure of 1013.0 hPa

The test item was an extremely pale yellow crystalline solid. Whilst heating the test item, to 64°C no relevant exothermic reaction self-heating of the sample was observed. On completion of the test, the test item had melted.

Conclusions:

The relative self-ignition temperature of the substance was determined using a relevant test method. No relative self-ignition temperature below its melting temperature was observed (at up to 64°C).

Executive summary:

The relative self-ignition temperature for solids was examined using EU Method A.16 under GLP for the test item. This involved the test item being heated in a fine mesh stainless steel cube that is suspended in an oven with a thermocouple placed within the sample and another within the oven. The oven temperature was programmed to increase from ambient to 64 °C (which was approximately 10 °C higher than the melting temperature, determined in a preliminary test), at a rate of 0.5 °C/min. The temperature/time curves relating to the condition in the centre of the sample and the oven were recorded. The test item was an extremely pale yellow crystalline solid. Whilst heating the test item, to 64 °C no relevant exothermic reaction self-heating of the sample was observed. The test item was determined not to have a relative self-ignition temperature below its melting temperature.

Reference 2

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

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI further study of self-heating substances and mixtures does not need to be completed based on weight of available evidence and expert judgement.

The relative self-ignition temperature for solids was examined using EU Method A.16 under GLP for the test item. This involved the test item being heated in a fine mesh stainless steel cube that is suspended in an oven with a thermocouple placed within the sample and another within the oven. The oven temperature was programmed to increase from ambient to 64 °C (which was approximately 10 °C higher than the melting temperature, determined in a preliminary test), at a rate of 0.5 °C/min. The temperature/time curves relating to the condition in the centre of the sample and the oven were recorded. The test item was an extremely pale yellow crystalline solid. Whilst heating the test item, to 64 °C no relevant exothermic reaction self-heating of the sample was observed. The test item was determined not to have a relative self-ignition temperature below its melting temperature.

Applicant assessment indicates that: the classification of self-heating substances and mixtures does not apply and that further testing in a method consistent with the UN Test N.4 test method for self-heating substances is not scientifically necessary. The EU Method A.16 test served as a suitable screening test for self-ignition properties and in accordance with REACH Regulation (EC) No. 1907/2006: Annex VII section 7.12 the test item clearly had a melting point < 160 °C and was entirely molten above 64 °C. Substances which are entirely molten < 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.

Therefore there is sufficient evidence to conclude on classification and labelling and to preclude further testing according to UN Transport of Dangerous Goods Manual of Tests and Criteria: Test N.4.

References:
1. UN Transport of Dangerous Goods Manual of Tests and Criteria, Sixth Edition (2015)
3. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.1.12, July 2017).
4. REACH Regulation (EC) 1907/2006, Annex XI, section 1
5. CLP Regulation (EC) 1272/2008, Annex I, section 2.11
6. ECHA Guidance on Application on the CLP Criteria, section 2.11 (v5.0, July 2017)

Reason / purpose for cross-reference:

data waiving: supporting information

Description of key information

Relative self-ignition temperature for solids: no relative self-ignition below the melting temperature (64 °C) of the substance was observed, 2017

Additional information

In accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI further study of self-heating substances and mixtures does not need to be completed based on weight of available evidence and expert judgement.

 

The relative self-ignition temperature for solids was examined using EU Method A.16 under GLP for the test item. This involved the test item being heated in a fine mesh stainless steel cube that is suspended in an oven with a thermocouple placed within the sample and another within the oven. The oven temperature was programmed to increase from ambient to 64 °C (which was approximately 10 °C higher than the melting temperature, determined in a preliminary test), at a rate of 0.5 °C/min. The temperature/time curves relating to the condition in the centre of the sample and the oven were recorded. The test item was an extremely pale yellow crystalline solid. Whilst heating the test item, to 64 °C no relevant exothermic reaction self-heating of the sample was observed. The test item was determined not to have a relative self-ignition temperature below its melting temperature.

 

Applicant assessment indicates that: the classification of self-heating substances and mixtures does not apply and that further testing in a method consistent with the UN Test N.4 test method for self-heating substances is not scientifically necessary. The EU Method A.16 test served as a suitable screening test for self-ignition properties and in accordance with REACH Regulation (EC) No. 1907/2006: Annex VII section 7.12 the test item clearly had a melting point < 160 °C and was entirely molten above 64 °C. Substances which are entirely molten < 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.

 

Therefore there is sufficient evidence to conclude on classification and labelling and to preclude further testing according to UN Transport of Dangerous Goods Manual of Tests and Criteria: Test N.4.

 

References:

1. UN Transport of Dangerous Goods Manual of Tests and Criteria, Sixth Edition (2015)

3. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.1.12, July 2017).

4. REACH Regulation (EC) 1907/2006, Annex XI, section 1

5. CLP Regulation (EC) 1272/2008, Annex I, section 2.11

6. ECHA Guidance on Application on the CLP Criteria, section 2.11 (v5.0, July 2017)