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Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

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Reference
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
Remarks:
Test method according to European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Leng. GLP study.
Qualifier:
according to guideline
Guideline:
other: European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Leng
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Mean:
< 6.6 µm
Remarks on result:
other: No source field for Standard deviation.
No.:
#1
Size:
>= 0.3 - <= 40 µm
Remarks on result:
other: mass median diameter < 6.6 µm.

In conclusion, using the laser diffraction method to study the particle size of the test substance ranging between 0.3 μm and 40 μm, the mass median diameter (MMD) was determined to be < 6.6 μm.

Conclusions:
In conclusion, using the laser diffraction method to study the particle size of the test substance ranging between 0.3 μm and 40 μm, the mass median diameter (MMD) was determined to be < 6.6 μm.
Executive summary:

The determination of the particle size distribution of the test substance was performed according to the European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the 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 “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction” using the laser diffraction method. In conclusion, using the laser diffraction method to study the particle size of the test substance ranging between 0.3 μm and 40 μm, the mass median diameter (MMD) was determined to be < 6.6 μm.

Description of key information

Key study: According to European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the 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” using the laser diffraction method. GLP study.

In conclusion, using the laser diffraction method to study the particle size of the test substance ranging between 0.3 μm and 40 μm, the mass median diameter (MMD) was determined to be < 6.6 μm.

Additional information

Key study: According to European Commission, Document ECB/TM/February 1996: ”Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document and the 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” using the laser diffraction method. GLP study.

In conclusion, using the laser diffraction method to study the particle size of the test substance ranging between 0.3 μm and 40 μm, the mass median diameter (MMD) was determined to be < 6.6 μm.