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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
Study period:
2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
other: SAV. 038: Medianwert-Bestimmung (PartikelgrÖssen-Verteilung)
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Principles of method if other than guideline:
Laser diffraction on particles placed in a suspension
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
- Lot/batch No.: 407940
Key result
Percentile:
D90
Mean:
58.94 µm
St. dev.:
0
Remarks on result:
other: St. dev. not determined
Key result
Percentile:
D50
Mean:
23.64 µm
St. dev.:
0
Remarks on result:
other: St. dev. not determined
Key result
Percentile:
D10
Mean:
3.234 µm
St. dev.:
0
Remarks on result:
other: St. dev. not determined
Remarks on result:
other: not determined in this assay
Conclusions:
The particles size distribution has been determined by laser diffraction. 90% of the particles size stands below 58.94 µm; 50% below 23.64 µm and 10% below 3.234 µm. MMAD is expected to be much less than 100 µm (less than 50 µm)
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline required
Principles of method if other than guideline:
Sieving method
GLP compliance:
no
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
- Lot/batch No.: 407940
Mass median aerodynamic diameter:
< 50 µm
No.:
#1
Size:
> 500 µm
Distribution:
0 %
No.:
#2
Size:
> 250 - < 500 µm
Distribution:
0.2 %
No.:
#3
Size:
> 125 - < 250 µm
Distribution:
16.6 %
No.:
#4
Size:
> 63 - 125 µm
Distribution:
27.6 %
No.:
#5
Size:
> 36 - < 63 µm
Distribution:
37.2 %
No.:
#6
Size:
< 36
Distribution:
18.2 %
Conclusions:
83 % of the total sample has a particule size less than 125 µm and 55.4% has a particule size less than 63µm. So most probably the MMAD is less than 50 µm.

Description of key information

Both studies performed led to the conclusion that MMAD is most probably below 50 µm.

Additional information

The particle size distribution determined by laser diffraction (key study) showed that 90% of the particle size stands below 58.94 µm. Another measurement method, sieving method (supportive study), led to the conclusion that 55.4 % of the total sample tested had a particle size less than 125 µm.

These two studies enable to conclude that MMAD is most probably below 50 µm.