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Physical & Chemical properties

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:
November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
other: European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
other: mass of particles with a size below 100 um
Mass median aerodynamic diameter:
>= 100 µm
Remarks on result:
not determinable because of methodological limitations
Key result
Percentile:
other: 99.51%
Mean:
>= 100 µm
Remarks on result:
not determinable because of methodological limitations
No.:
#1
Size:
< 100 µm
Distribution:
0.49 %
No.:
#2
Size:
>= 100 µm
Distribution:
99.51 %
Conclusions:
The particle size of the substance was determined to be bigger than 100 µm for 99.51% of the measured particles.
Executive summary:

The proportion of test item having an inhalable particle size of less than 100 µm was determined by a sieve method to be0.49%. The test item has been considered to be essentially non-inhalable. Particle size data was acquired, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).

Description of key information

Additional information

The proportion of test item having an inhalable particle size of less than 100 µm was determined by a sieve method to be 0.49%. The test item has been considered to be essentially non-inhalable. Particle size data was acquired, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).