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Physical & Chemical properties

Particle size distribution (Granulometry)

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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:
other: European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Remarks on result:
not determinable
No.:
#1
Size:
100 µm
Distribution:
15.7 %
Remarks on result:
other: Percentage of test item < 100 µm

Results:

Measurement

Result

Mass of test item transferred to sieve (W1)

15.91

Mass of test item passed through sieve (W3 – W2)

2.49

Percentage of test item less than 100 µm

15.7%
Conclusions:
The percentage of test item with an inhalable particle size < 100 µm is 15.7% (sieved).
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:
mass based distribution
Mass median aerodynamic diameter:
23 µm
Geometric standard deviation:
3
Percentile:
D10
Mean:
5.02 µm
Remarks on result:
other: St. dev not specified
Percentile:
D50
Mean:
24.9 µm
Remarks on result:
other: St. dev not specified
Percentile:
D90
Mean:
82.9 µm
Remarks on result:
other: St. dev not specified

Based on a density value of 1.22 and a shape factor of 1 (based on the assumption that the particles are non-porous, spherical particles), an estimated MMAD value of approximately 23 µm was determined. The volume of the sample <10 µm was determined to be 21.1% and the overall GSD was determined to be 3.0 (sample D GSD = 3.1, sample E GSD = 2.9).

Conclusions:
The test substance was determined to have d10, d50 and d90 values of approximately 5, 25 and 83 µm respectively, with an MMAD value of approximately 23 µm.

Description of key information

Two studies are available assessing particle size. The initial study utilised sieving to give an indication of particle size whilst the subsequent one provide more details via laser diffraction. The test substance was determined to have d10, d50 and d90 values of approximately 5, 25 and 83 µm respectively, with an MMAD value of approximately 23 µm.

Additional information