Registration Dossier

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 February 2018 to 17 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: New Zealand Pharmaceuticals, 68 Weld Street, Palmerston North 4472, New Zealand (Batch No. 2216242)
- Expiration date of the lot/batch: 07 November 2021
- Purity: 91.2 % (07 November 2016)

Results and discussion

Relative self-ignition temperature (solids)
Key result
Relative self-ignition temperature:
> 158.8 °C
Remarks on result:
no self-ignition observed up to the melting point

Applicant's summary and conclusion

Conclusions:
No self-ignition observed up to the melting point 158.8°C.
Executive summary:

A preliminary test according to EU Method A.16 (Relative Self-Ignition Temperature for Solids) was carried out on the test substance ( Bile, Hydrolyzates) to determine the melting point of the test item ( 158.8°C). The temperature was raised up to 158.8°C at a rate of 0.5°C/minute. The test item does not self-ignite up to 158.8°C.