Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 15, 2007- February 14, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to standard ISO guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: BS ISO 13320-1:1999
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of distribution:
- volumetric distribution
Test material
- Details on test material:
- - Name of test material (as cited in study report): S-500
- Physical state: yellow powder
- Lot/batch No.: MF1456-2345
- Expiration date of the lot/batch: 18 August 2011
- Storage condition of test material: At room temperature in the dark
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Mean:
- 1.452 µm
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- < 0.495 µm
- Percentile:
- D50
- Mean:
- < 1.223 µm
- Percentile:
- D90
- Mean:
- < 4.343 µm
Particle size distribution at different passages
- Size:
- < 10 µm
- Distribution:
- 94.69 %
Applicant's summary and conclusion
- Conclusions:
- The laser diffraction test conducted to determine the particle size analysis resulted in a Mass Median Aerodynamic Diameter of 1.452 µm and 94.69% by volume of the sample was seen to be < 10.00 µm.
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