Registration Dossier
Registration Dossier
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EC number: 239-879-2 | CAS number: 15782-05-5
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Remarks:
- dry method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: draft guidance document EUR 20268 (20029, part 5.2 “Laser scattering /diffraction” for “Particle Size Distribution, Fibre Length and Diameter Distribution”, European Commission, Directorate General JRC)
- Deviations:
- no
- Principles of method if other than guideline:
- Laser granulometry is a measuring technique used to analyse particle size in powders, granulates, suspensions and emulsions, based in the principle of diffraction (= scattering) of a bundled laser beam.
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Key result
- Percentile:
- D50
- Mean:
- 10.06 µm
- Remarks on result:
- other: average of 2 tests
- Key result
- Percentile:
- D10
- Mean:
- 1.45 µm
- Remarks on result:
- other: average of 2 tests
- Key result
- Percentile:
- D90
- Mean:
- 31.27 µm
- Remarks on result:
- other: average of 2 tests
- Conclusions:
- The particle size distribution of test substance was determined to be MMD= 10 µm.
Reference
Description of key information
Dry dispersion:
MMD= 10 µm
D10= 1.4 µm
D90= 31 µm
Additional information
The determination was carried out by laser diffraction method. The measurement of the dry powder was chosen as the key study.
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