Registration Dossier
Registration Dossier
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EC number: 273-997-5 | CAS number: 69430-20-2
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Administrative data
- Endpoint:
- relative self-ignition temperature (solids)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 February 2018 to 17 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- Bile, hydrolyzates
- EC Number:
- 273-997-5
- EC Name:
- Bile, hydrolyzates
- Cas Number:
- 69430-20-2
- Molecular formula:
- Unspecified
- IUPAC Name:
- Bile, hydrolyzates
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: New Zealand Pharmaceuticals, 68 Weld Street, Palmerston North 4472, New Zealand (Batch No. 2216242)
- Expiration date of the lot/batch: 07 November 2021
- Purity: 91.2 % (07 November 2016)
Results and discussion
Relative self-ignition temperature (solids)
- Key result
- Relative self-ignition temperature:
- > 158.8 °C
- Remarks on result:
- no self-ignition observed up to the melting point
Applicant's summary and conclusion
- Conclusions:
- No self-ignition observed up to the melting point 158.8°C.
- Executive summary:
A preliminary test according to EU Method A.16 (Relative Self-Ignition Temperature for Solids) was carried out on the test substance ( Bile, Hydrolyzates) to determine the melting point of the test item ( 158.8°C). The temperature was raised up to 158.8°C at a rate of 0.5°C/minute. The test item does not self-ignite up to 158.8°C.
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