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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
Study period:
03-26 May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Also according to GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Principles of method if other than guideline:
Sieve, Cascade Impactor
GLP compliance:
yes (incl. QA statement)
Remarks:
2005-11-21
Type of method:
cascade impaction
Type of distribution:
mass based distribution
No.:
#1
Size:
< 100 µm
Distribution:
91.7 %
Remarks on result:
other: Sieve
No.:
#2
Size:
< 10 µm
Distribution:
4.08 %
No.:
#3
Size:
< 5.5 µm
Distribution:
0.312 %

Screening method:

Sieve aperture size (µm)

100

Mass of test material transferred to sieve (g)

10.56

Mass of test material passed through sieve (g)

9.68

Test material less than sieve aperture size (%)

91.7

Definitive test (cascade impactor method):

Determination 1

Cup number

Particle size cut points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10.0

0.0843

2.853

3

5.5

0.0048

0.162

4

2.4

0.0005

1.69x10-2

5

1.61

0.0000

0.000

Filter

0.307

0.0000

0.000

Dtermination 2

Cup number

Particle size cut points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10.0

0.1322

4.42

3

5.5

0.0142

0.474

4

2.4

0.0028

9.35x10-2

5

1.61

0.0018

6.01x10-2

Filter

0.307

0.0015

5.01x10-2

Determination 3

Cup number

Particle size cut points (µm)

Cumulative Mass of Test Material (g)

Cumulative Amount of Test Material (%)

2

10.0

0.1728

4.97

3

5.5

0.0104

0.299

4

2.4

0.0007

2.01x10-2

5

1.61

0.0001

2.88x10-3

Filter

0.307

0.0001

2.88x10-3

Too few particles were of size less than 10.0 µm to allow accurate assessmnet of mass median aerodynamic diameter.

Conclusions:
Too few particles were of size less than 10.0 µm to allow accurate assessment of mass median aerodynamic diameter.
Executive summary:

Particle size data have been acquired following the OECD Guideline 110 and GLP.

Inhalable particles (< 100 µm): 91.7%

Thoracic particles (< 10 µm): 4.08%

Respirable particles (< 5.5 µm): 0.312%

Description of key information

91.7% < 100 µm
4.08% < 10 µm
0.312% < 5.5 µm

Additional information

The particle size distribution (granulometry) of the substance was determined using sieve and cascade impactor. The method applied is considered equivalent to OECD Guideline 110.