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Diss Factsheets

Administrative data

Endpoint:
relative self-ignition temperature (solids)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 November 2015 - 23 February 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.16 (Relative Self-Ignition Temperature for Solids)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(1R,4R,6S,7Z,15R,17R)-17-({7-methoxy-8-methyl-2-[4-(propan-2-yl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-13-methyl-2,14-dioxo-3,13-diazatricyclo[13.3.0.0^{4,6}]octadec-7-ene-4-carboxylic acid
EC Number:
618-844-9
Cas Number:
923604-58-4
Molecular formula:
C35H42N4O6S
IUPAC Name:
(1R,4R,6S,7Z,15R,17R)-17-({7-methoxy-8-methyl-2-[4-(propan-2-yl)-1,3-thiazol-2-yl]quinolin-4-yl}oxy)-13-methyl-2,14-dioxo-3,13-diazatricyclo[13.3.0.0^{4,6}]octadec-7-ene-4-carboxylic acid
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): JNJ-38940642-AAA (T003010)
- Physical state: solid
- Appearance: white powder
Specific details on test material used for the study:
- Batch N°: I15AB0298
- Analytical purity: 99.7%
- Expiry date: 22 January 2017
- Storage condition: at room temperature

Results and discussion

Relative self-ignition temperature (solids)
Key result
Remarks on result:
no self-ignition observed up to the melting point

Any other information on results incl. tables

No significant endothermic or exothermic effect of the test item was observed between 20°C and 240.1°C (the melting temperature of the test item was determined at 240.1°C). It demonstrated that the test item is not self-ignitable.

After the experiment, the test item had turned into a charred residue and was collected in a container that was placed below the cube. It indicated that the test item had melted, decomposed and/or reacted during the experiment.

Applicant's summary and conclusion

Conclusions:
Based on the results of the EC A.16 test performed, the test item is considered ‘not self-ignitable’.