Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 - 18 December 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
July 1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
differential scanning calorimetry

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): JNJ-16169374-AAC (T002113)
- Physical state: solid (powder)
- Appearance: off-white powder
Specific details on test material used for the study:
- Batch n°: RT002113G3A231
- Analytical purity: 92.9%
- Expiration date: 01 December 2001
- Storage condition: at room temperature

Results and discussion

Melting / freezing point
Key result
Decomposition:
yes
Decomp. temp.:
> 240 °C
Remarks on result:
not determinable

Any other information on results incl. tables

A small endothermic heat effect was observed starting at about 220°C. An exothermic heat effect started at about 240°C to 400°C (20K/min). After the experiment, the sample had lost about 37% of its mass and the sample was black and carbonized. The degradation started at about 240°C. The test item didn't boil under ambient conditions. A further DSC-run was recorded as main study between about 25°C and 260°C with a heating rate of 10K/min. The endothemic reaction was determined to start at about 210°C. This is not due to the melting of the sample because at the end of the test, the sample was black and carbonized but not melted. The endothermic heat effect might have been caused by a change in crystalline structure. During this run, the sample lost 15% of its mass.

T002113 didn't melt under the conditions of the test.

Applicant's summary and conclusion

Conclusions:
T002113 did not melt under the conditions of the test.