Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 February 2013 - 28 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed in accordance with the EC.A16 guideline and complied with the principles of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
Version / remarks:
(2008)
Deviations:
yes
Remarks:
The temperature of the oven was increased to 400°C although the melting temperature of the substance is lower.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopyrazine-2-carboxylic acid
EC Number:
226-558-7
EC Name:
3-aminopyrazine-2-carboxylic acid
Cas Number:
5424-01-1
Molecular formula:
C5H5N3O2
IUPAC Name:
3-aminopyrazine-2-carboxylic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Amiloride Compound 5
- Description: Tan powder
- Storage condition of test material: In refrigerator (2-8°C) protected from light, desiccated
- Other: Reactive to light, moisture and oxygen

Results and discussion

Relative self-ignition temperature (solids)
Remarks on result:
no self ignition observed under the test conditions

Any other information on results incl. tables

No endothermic or exothermic reaction between 20°C and 400°C. An exothermic effect was observed at an oven temperature of 400.2°C, the test substance reached a temperature of 428.4°C. After the experiment, no test substance was left in the test cube or container that was placed below the cube. It indicated that the test substance was molten and evaporated during the experiment. This is in line with the melting temperature of the substance (206°C:see endpoint 4.2).

Applicant's summary and conclusion

Conclusions:
The relative self-ignition test was performed (GLP-compliant study in accordance with EC A.16), not resulting in a temperature at which self-ignition of the substance took place.