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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Guideline:
other: European Commission 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:
cascade impaction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Remarks on result:
not determinable
Remarks:
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD).
No.:
#1
Size:
< 10 µm
Distribution:
>= 0.081 - <= 0.174 %
No.:
#2
Size:
< 5.5 µm
Distribution:
>= 0 - <= 0.027 %
No.:
#3
Size:
< 2.4 µm
Distribution:
>= 0 - <= 0.027 %
No.:
#4
Size:
< 1.61 µm
Distribution:
>= 0 - <= 0.027 %
No.:
#5
Size:
< 0.307 µm
Distribution:
>= 0 - <= 0.023 %

Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes and then sampling from the top, middle and bottom.

Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD). The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Particle size cut points (µm)

Cumulative mass (g)

Cumulative percentage (%)

Determination 1

Determination 2

Determination 3

Determination 1

Determination 2

Determination 3

< 10

0.0052

0.0033

0.0023

0.174

0.104

0.081

< 5.5

0.0008

0

0.0001

0.027

0

0.004

< 2.4

0.0008

0

0.0001

0.027

0

0.004

< 1.61

0.0008

0

0.0001

0.027

0

0.004

< 0.307

0.0007

0

0

0.023

0

0

Conclusions:
The percentage of the substance with an inhalable (< 100 µM), thoracic (< 10 µM) and respirable (< 5.5 µM) particle size was determined to be 97.6,

Description of key information

The percentage of the substance with an inhalable (< 100 µM), thoracic (< 10 µM) and respirable (< 5.5 µM) particle size was determined to be 97.6, </= 0.174 and </= 0.027 %, respectively.

Additional information