Registration Dossier

Administrative data

Endpoint:
boiling point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
guideline study The study was conducted according to an internationally recognised method, and under GLP. The test substance is adequately characterised. Therefore, full validation applies. Reliability 1.
Cross-reference
Reason / purpose:
reference to same study
Remarks:
4.2
Reference
Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. The substance is considered to be adequately characterised with its purity. Therefore full validation applies. Reliability 1.
Reason / purpose:
reference to same study
Remarks:
4.3
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of method:
differential scanning calorimetry
Key result
Atm. press.:
>= 101 320 - <= 101 330 Pa
Decomposition:
yes
Remarks:
A black residue was observed after the experimentation, an overflowing of this residue was observed. No melting point of the test item was recorded.
Decomp. temp.:
ca. 230 °C
Remarks on result:
other: No melting point was recorded, the test item inflated and darkened.
Conclusions:
No melting point was recorded.
Executive summary:

The melting point of the test substance was tested under GLP according to EU A1 and OECD 102, by differential scanning calorimetry. Three runs were performed under nitrogen atmosphere, and no melting point was recorded.

The test item inflated and darkened sign of decomposition

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.2 (Boiling Temperature)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Type of method:
differential scanning calorimetry

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: beige powder
- Storage: in a dark place at room temperature
- Batch : 16 208
- Manufacturing date: July 26th 2016
- Expiry date: July 26th 2018

Results and discussion

Boiling point
Key result
Atm. press.:
>= 101 320 - <= 101 330 Pa
Decomposition:
yes
Remarks:
A black residue was observed after the experimentation, an overflowing of this residue was observed. No boiling point of the test item was recorded.
Remarks on result:
other: no boiling point was recorded

Applicant's summary and conclusion

Conclusions:
No boiling point was recorded.
Executive summary:

The determination of boiling point test was measured under GLP according to OECD 103 / EU A2 guideline, by differential scanning calorimetry method. Two samples of test substance were placed in crucible with pierced lid and were subjected to a thermal program from 25 -600 °C at 10 °C/min. Two

determinations were performed.

No boiling temperature of the test item has been recorded.