Registration Dossier
Registration Dossier
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EC number: 821-185-1 | CAS number: 1777721-63-7
Auto flammability
Administrative data
- Endpoint:
- relative self-ignition temperature (solids)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 November 2016 - 18 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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
- Reference substance name:
- (2S,3S)-3-({5-fluoro-2-[5-fluoro-1-(4-methylbenzenesulfonyl)-1H-pyrrolo[2,3-b]pyridin-3-yl]pyrimidin-4-yl}amino)bicyclo[2.2.2]octane-2-carboxylic acid
- EC Number:
- 821-185-1
- Cas Number:
- 1777721-63-7
- Molecular formula:
- C27H25F2N5O4S
- IUPAC Name:
- (2S,3S)-3-({5-fluoro-2-[5-fluoro-1-(4-methylbenzenesulfonyl)-1H-pyrrolo[2,3-b]pyridin-3-yl]pyrimidin-4-yl}amino)bicyclo[2.2.2]octane-2-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of the test material (as cited in study reports): JNJ-63757109-AAA (T003690)
- Physical state: solid (powder)
- Appearance: white to slightly yellow power
Constituent 1
- Specific details on test material used for the study:
- - Batch n°: I16BD1072
- Analytical purity: 100.0%
- Expiration date: 04 March 2018
Results and discussion
Relative self-ignition temperature (solids)
- Key result
- Remarks on result:
- no self ignition observed under the test conditions
Any other information on results incl. tables
No significant endothermic or exothermic effect of the test item was observed between 20°C and 400°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 partially collected in a container that was placed below the cube. It indicated that the test item had 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’.
Because there were no indications of self-heating observed in this test, the test item was considered ‘not self-heating’ and the main study according to UN N.4 was not performed.
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