Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 June 2016 - 29 November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7200 (Melting Point / Melting Range)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
differential scanning calorimetry

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study reports): JNJ-7928531-AAA (T001481)
- Physical state: liquid
- Appearance: Colourless, light yellow to brown liquid
Specific details on test material used for the study:
- Batch n°: M16AB0419
- Expiration date: 23 September 2016
- Purity: 102.5% (based on GC assay)
- Storage condition of test material: at room temperature

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
-65.5 °C
Atm. press.:
1 013.25 hPa
Decomposition:
yes
Decomp. temp.:
> 175 °C
Remarks on result:
other: During the test no melting was observed.
Remarks:
Glass transition temperature is reported

Any other information on results incl. tables

Preliminary test

From the TGA curve it could be derived that the weight of the sample decreased significantly at 175°C. At 265°C the sample weight has decreased by 25%.

After the experiment it was observed that the test item was evaporated from the sample container.

Main tests

During cooling a glass transition was observed between -85°C and -60°C. During heating a glass transition between -75°C and -50°C was observed. The inflection point of the glass transition was -65.417°C. An endothermic peak between 200°C and 300°C was observed. The extrapolated onset temperature of the peak was 276.807°C. The effect was most likely obtained due to boiling of the test item. After the experiment it was observed that the test item was evaporated from the sample container.

Experiment 2 was performed to investigate the boiling point and is explained in the next section.

Experiment 3 was performed to investigate reaction and/or decomposition of the test item and was therefore

stopped at 280°C. At approximately 110°C a small signal was observed: it was most likely an artefact. From 175°C the baseline deviated in the endothermic direction. After the experiment, a light yellow residue remained in the sample container which demonstrated that reaction and/or decomposition of the test item probably took place over the temperature range.

The glass transition temperature was determined as the average glass transition temperature obtained from experiment 1 (-65.417°C) and experiment 2 (-65.586°C). No melting was observed.

Applicant's summary and conclusion

Conclusions:
The glass transition temperature of JNJ-7928531-AAA (T001481) was determined at -65.5°C (207.6K) by using DSC.