Registration Dossier
Registration Dossier
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EC number: 609-105-1 | CAS number: 35249-62-8
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- 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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Technical Guidance Document EUR 20268 Determination of Particle Size Distribution
- Version / remarks:
- The method employed was based on a procedure designed to be compatible with that given in European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).
- Deviations:
- no
- Principles of method if other than guideline:
- The particle size distribution was evaluated based on internationally accepted guidelines. The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.
- GLP compliance:
- yes
- Type of method:
- cascade impaction
- Type of particle tested:
- other: powder
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- 3-(2-bromo-4,5-dimethoxyphenyl)propanenitrile
- EC Number:
- 609-105-1
- Cas Number:
- 35249-62-8
- Molecular formula:
- C11H12BrNO2
- IUPAC Name:
- 3-(2-bromo-4,5-dimethoxyphenyl)propanenitrile
- Test material form:
- solid
Constituent 1
Results and discussion
- Mass median aerodynamic diameter:
- >= 5.5 - < 100 µm
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 90 %
- No.:
- #2
- Size:
- 0 - < 10 µm
- Distribution:
- 0 - <= 2.07 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- <= 0.6 %
Applicant's summary and conclusion
- Conclusions:
- Percentage of test item with an inhalable particle size <100 μm 90%
Percentage of test item with a thoracic particle size <10.0 μm ≤ 2.7%
Percentage of test item with a respirable particle size <5.5 μm ≤ 0.6%
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