Registration Dossier
Registration Dossier
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EC number: 232-468-9 | CAS number: 8049-47-6
Flammability
Administrative data
- Endpoint:
- flammable solids
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- UN Manual of Tests and Criteria: Test N.1 (Test method for readily combustible solids)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pancreatin
- EC Number:
- 232-468-9
- EC Name:
- Pancreatin
- Cas Number:
- 8049-47-6
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Pancreatin
- Reference substance name:
- Lipids as a constituent of Pancreatin derived from porcine pancreas
- IUPAC Name:
- Lipids as a constituent of Pancreatin derived from porcine pancreas
- Reference substance name:
- Inorganic Salts as a constituent of Pancreatin derived from porcine pancreas
- IUPAC Name:
- Inorganic Salts as a constituent of Pancreatin derived from porcine pancreas
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Unidentified impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and not assigned
- Expiration date of the lot/batch: 2017-12-22
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Results and discussion
Flammable solids
- Key result
- Test procedure:
- burning rate test: preliminary screening test
- Remarks on result:
- substance does not ignite and propagate combustion either by burning with flame or smouldering along 200 mm of the powder train within the 2 minutes test period
Applicant's summary and conclusion
- Interpretation of results:
- not classified based on GHS criteria
- Conclusions:
- This study validly determined that the substance is not classified as a flammable substance according to GHS criteria.
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