Registration Dossier

Administrative data

Endpoint:
thermal stability
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
09.01. - 19.02.2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Differentialthermoanalysis (DSC), Lab method SOP SPZ-420
Version / remarks:
Screening test
Principles of method if other than guideline:
Determination of thermal stability with Differential Scanning Calorimetry (DSC) method
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- State of aggregation: solid

Results and discussion

For thermal stability study

Sublimation:
no
Transformation products:
no

For study on stability to sunlight

Test substance stable to sunlight:
not determined

For study on stability to metals

Test substance stable to metals / metal ions:
not determined

Any other information on results incl. tables

No exothermic reaction observed.

In the measuring range 30 - 400°C, the sample shows endothermic effects in temperature ranges of approx. 115 - 155°C (without loss in mass), 195 - 215°C and 255 - 280°C.

Loss in mass at the end of study is 53%.

Applicant's summary and conclusion