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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Laser diffraction
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D10
Mean:
1.15 µm
Remarks on result:
other: standard deviation not available
Key result
Percentile:
D50
Mean:
4.1 µm
Remarks on result:
other: standard deviation not available
Key result
Percentile:
D90
Mean:
9.64 µm
Remarks on result:
other: standard deviation not available
Conclusions:
Average size of particles = 4.848 μm,
D10 = 1.15 μm,
D50 = 4.10 μm,
D90 = 9.64 μm.
The study was performed in accordance with generally accepted scientific standards and described in sufficient detail and therefore reliability of Klimisch 2 has been assigned.
Executive summary:

The particle size distribution of the test substance was investigated by laser diffraction based on Mie Scattering (non-GLP, 2013) and the average size of particles has been determined to be 4.848 µm (D10 = 1.15 µm, D50 = 4.10 µm, D90 = 9.64 µm).

According to the results, the inhalation of particles has to be regarded:

- ~ 100% are <100 µm (inhalable fraction)

- ~ 90% are <10 µm (thoracic fraction)

- ~50% are < 4µm (respirable fraction)

Description of key information

Average particle size of the test substance = 4.848 µm (D10 = 1.15 µm, D50 = 4.10 µm, D90 = 9.64 µm) [by laser diffraction, no guideline followed]
According to the results, the inhalation of particles has to be regarded:
- ~ 100% are <100 µm (inhalable fraction)
- ~ 90% are <10 µm (thoracic fraction)
- ~50% are < 4µm (respirable fraction)

Additional information