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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
other: scanning electron microscopy after the samples was fractionated by a 100 μm sieve
Type of distribution:
mass based distribution
Test material information:
Composition 1
Mass median aerodynamic diameter:
21.91 µm
Remarks on result:
other: as spherical particles (Sieve Fraction nominal < 100μm)
No.:
#1
Size:
< 4 µm
Distribution:
0 %
Remarks on result:
other: respirable fraction; accounting based on the total sample weight
No.:
#2
Size:
>= 4 - < 10 µm
Distribution:
0.06 %
Remarks on result:
other: thoracic fraction; accounting based on the total sample weight
No.:
#3
Size:
>= 10 - < 100 µm
Distribution:
40.11 %
Remarks on result:
other: inhalable fraction; accounting based on the total sample weight
No.:
#4
Size:
> 100 µm
Distribution:
59.83 %
Remarks on result:
other: total (mass & sieve fraction); accounting based on the total sample weight
Conclusions:
Particle size distribution was determined according to OECD 110 under GLP, so there is no reason to conclude that the results are not reliable. The study was assessed to be of high quality and testing is expected to be reasonably performed; results can be considered as reliable. The substance contains 0 % respirable particles (< 4 µm), 0.06 % thoracic particles (4-10 µm) and 40.11 % inhalable particles (10-100 µm).
Executive summary:

The particle size distribution of the test substance was determined by scanning electron microscopy after the sample was fractionated by a 100 μm sieve according to OECD Guideline 110 (GLP).

Sieve Fraction

weighted sample: 0.2561 g

weight fraction < 100 μm: 0.1062 g

sieve mass fraction < 100 μm: 41.47 %

Mass Fraction

Sieve Fraction nominal < 100μm

Particle Size   Spherical Volume  Cubical volume
 < 4 µm (respirable)  0.00 %  0.00 %
 4 -10 µm (thoracic)  0.14 %  0.19 %
 10 -100 µm (inhalable)  96.73 %  96.57 %
 > 100 µm  3.13 %  3.24 %
 Median (diameter)  21.91 µm  22.82 µm

Median diameter corresponds to MMAD (Mass Median Aerodynamic Diameter < 100μm). MMAD has a value of 21.91 μm as spherical particles.

Accounting based on the total sample weight:

   Particle Size [µm]  Spherical Volume [%]
 Mass Fraction  > 100  58.53
 Sieve Fraction  > 100  1.30
 Total (> 100 µm)    59.83
 Sieve Fraction  10 -100 (inhalable)  40.11
 Sieve Fraction  4 -10 (thoracic)  0.06
 Sieve Fraction  < 4 (respirable)  0.00

Description of key information

OECD 110, GLP (2017):

 Particle Size [µm]  Spherical Volume [%]
 Mass Fraction  > 100  58.53
 Sieve Fraction  > 100  1.30
 Total (> 100 µm)    59.83
 Sieve Fraction  10 -100 (inhalable)  40.11
 Sieve Fraction  4 -10 (thoracic)  0.06
 Sieve Fraction  < 4 (respirable)  0.00

Additional information