Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 May 2017 - 15 September 2017
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:
2018

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
Type of method:
differential scanning calorimetry

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Batch n°: I16EC2452
- Analytical purity: 100.2% (based on assay; calculated on anhydrous basis)
- Expiration date: 22 November 2020 (retest date)
- Storage condition: at room temperature

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
> 300 °C
Atm. press.:
1 013.25 hPa
Decomposition:
yes
Decomp. temp.:
>= 300 °C
Remarks on result:
other: A black extend charred residue remained after the preliminary and main test, indicating reaction and/or decomposition.

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 300°C. At 534°C the sample weight has decreased by 25%. After the experiment, a black extend charred residue remained in the sample container (original colour: white). Brown residue was observed on the lid of the sample container. The change of the colour indicated reaction and/or decomposition of the test item.

Main tests

The DSC curve obtained with Experiment 1 shows that from 300°C an exothermic effect was observed. The effect was due to reaction and/or decomposition of the test item. After the experiment, a black extend charred residue remained in the sample container. Yellow residue was observed on the lid of the sample container. The change of the colour indicated reaction and/or decomposition of the test item.

The melting temperature of T001492 was not observed below the temperature at which reaction and/or decomposition started. Based on this, the test item has no melting temperature.

Applicant's summary and conclusion

Conclusions:
Reaction and/or decomposition of JNJ-1782820-AAC (T001492) was observed during DSC experiment at temperatures of > 300°C (> 573K). Melting of the test item was not observed below the temperature at which reaction and/or decomposition started. Based on this, the test item has no melting temperature.