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Reference
Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019-01-22 to 2019-01-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
Version / remarks:
Version of 31 May 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
OGYÉI- National Institute of Pharmacy and Nutrition (21.04.2016)
Specific details on test material used for the study:
The test item was used in its initial form.
Remarks on result:
no self-ignition observed up to the melting point
Conclusions:
In the course of this study the test item did not self-ignite up to the melting point (192 °C, based on Certificate of Analysis, provided by the Sponsor). Thus, no self-ignition temperature could be stated.
Executive summary:

The Determination of the relative self-ignition temperature of the test item was conducted following the EU method A.16, under GLP compliance.

A certain volume of the test item under the assay was placed into an oven at ambient temperature; the temperature/time curve was recorded while the temperature of the oven was increased up to the melting point, at a rate of approximately 0.5 °C/min. For the purpose of this test, the temperature of the oven at which the sample temperature reaches 400 °C by self-heating is called the self-ignition temperature.

Three replicate tests were performed.

In the course of this study the test item did not self-ignite up to the melting point. Thus, no self-ignition temperature could be stated.

Description of key information

The determination of the relative self-ignition temperature of the test item was conducted following the EU Method A.16, under GLP compliance.

A certain volume of the test item under the assay was placed into an oven at ambient temperature; the temperature/time curve was recorded while the temperature of the oven was increased up to the melting point, at a rate of approximately 0.5 °C/min. For the purpose of this test, the temperature of the oven at which the sample temperature reaches 400 °C by self-heating is called the self-ignition temperature.

Three replicate tests were performed.

In the course of this study the test item did not self-ignite up to the melting point. Thus, no self-ignition temperature could be stated.

Key value for chemical safety assessment

Additional information