Registration Dossier
Registration Dossier
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EC number: 212-660-9 | CAS number: 839-90-7
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:
- other: GLP-compliant EC guideline study, performed in recognized contract research organization, no restrictions, fully adequate for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: EUROPEAN COMMISSION, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document, ECB/TM/February 1996.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- other: sieving in combination with laser scattering
- Type of distribution:
- volumetric distribution
- Key result
- Percentile:
- D50
- Mean:
- 334.9 µm
- St. dev.:
- 3.444
- Percentile:
- D10
- Mean:
- 62.5 µm
- St. dev.:
- 5.263
Reference
The particle size distribution was found to range from approximately 0.3 µm to above 2000 µm (88.2% were <2000 µm).
Particles < 10 µm: 1%, <100 µm: 18%.
The mass median diameter (MMD) was determined to be 334.9 µm (i.e. 50% (by mass) of the particles are smaller than 334.9 µm).
Under the microscope (magnification: 100) pebble-like crystalline structures were observed.
Description of key information
MMD: 335 µm; 1% < 10 µm, 18% < 100 µm (European Commission EUR 20268 EN, 2002; European Commission ECB/TM/Feb. 1996)
Additional information
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