DL-thyroxin

Auto flammability

Link to relevant study record(s)

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.