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Reference
Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 March 2019
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)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Name: LEVOTHYROXINE ACID
Batch No.: B486066
Expiry date: 27 August 2020
Storage condition: at room temperature, protected from light
Appearance: white slightly creme, powder
Key result
Relative self-ignition temperature:
> 400 °C
Remarks on result:
no self ignition observed under the test conditions
Conclusions:
Three consecutive tests were performed. A temperature-time curve can be seen in Figure 1.
In the course of this study the test item LEVOTHYROXINE ACID did not self-ignite up to 400 °C. Thus, no self-ignition temperature could be stated.
Executive summary:

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 400 °C, 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 LEVOTHYROXINE ACID did not self-ignite up to 400 °C. Thus, no self-ignition temperature could be stated.

Description of key information

Three replicate tests were performed.

In the course of this study the test item LEVOTHYROXINE ACID did not self-ignite up to 400 °C. Thus, no self-ignition temperature could be stated.

Key value for chemical safety assessment

Additional information