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Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

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:
other: GLP with Statement of Compliance in accordance with Directive 2004/9/EC.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
MAN Catalyst FV100 is a a grey/green powder, Lot number 250, with purity >99%, stored at room temperature in the dark. Stability and purity data can be provided by the study sponsor if required.

Results and discussion

Particle size
Percentile:
D50
Mean:
other: Too few particles were of a size < 10 micron to allow an accurate assessment of mass median diameter.
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
<= 99.7 %
No.:
#2
Size:
< 10 µm
Distribution:
<= 5.41 %
No.:
#3
Size:
< 5.5 µm
Distribution:
<= 1.86 %

Any other information on results incl. tables

Representative sampling was ensured by rolling the sample container for approximately ten minutes and sampling from the top (determination 1), middle (determination 2) and bottom (determination 3) prior to definitive testing.

Analysis of the results showed that there was no significance between the three determinations and hence the three sampling points indicated that the test material was homogeneous and the analysis was representative of the sample as a whole.

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 Distribution:
99.7 % < 100 microns (Test Method: Sieve)
5.41 % < 10 microns (Test Method: Cascade Impactor)
1.86 < 5.5 microns (Test Method: Cascade Impactor)
-------------------------------------------------------------
Mass Median Diameter:
Too few particles were of a size < 10 micron to allow an
accurate assessment of mass median aerodymanic diameter.

Applicant's summary and conclusion

Conclusions:
Particle Size Distribution acquired as follows:
99.7 % < 100 microns (Test Method: Sieve)
5.41 % < 10 microns (Test Method: Cascade Impactor)
1.86 < 5.5 microns (Test Method: Cascade Impactor)
Executive summary:

The particle size data of the test material (MAN Cat FV100) was acquired using a procedure designed to comply with the European Comission technical guidance document "Particle Size Distribution, Fibre Lenght and Diameter Distribution". The results are as follows:

- The proportion of test material having an inhalable particle size < 100 microns ise 99.7% (Test Method: Sieve)

- The proportion of test material having a thoracic particle size < 10 microns is 5.41% (Test Method: Cascade Impactor)

- The proportion of test material having a respirable particle size < 5.5 microns is 1.86% (Test Method: Cascade Impactor)