Registration Dossier
Registration Dossier
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EC number: 212-216-4 | CAS number: 770-05-8
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- 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
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and D151-1710037
- Expiration date of the lot/batch: 26 October 2019 (retest date)
- Purity test date: 27 October 2017- Mass median aerodynamic diameter:
- >= 46.2 - <= 46.8 µm
- Geometric standard deviation:
- ca. 1.921
- Percentile:
- D10
- Mean:
- ca. 16 µm
- St. dev.:
- 0.112
- Percentile:
- D50
- Mean:
- ca. 39.5 µm
- St. dev.:
- 0.205
- Percentile:
- D90
- Mean:
- ca. 85.7 µm
- St. dev.:
- 0.435
- Conclusions:
- The mass medain aerodynamic diameter was found to be 46.6µm with a standard deviation of 0.216. The distribution of the particle sizes expressed as D10, D50 and D90 was 16, 39.5 and 85.7µm respectively
Reference
See attached document
Description of key information
The mass median aerodynamic diameter was found to be 46.6µm with a standard deviation of 0.216. The distribution of the particle sizes expressed as D10, D50 and D90 was 16, 39.5 and 85.7µm respectively
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