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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:
Testing was conducted between 31 August 2005 and 18 October 2005.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Specific details on test material used for the study:
Sponsor's identification: FSM-005W
Description: white solid
Batch number: 2005-01
Date received: 23 August 2005
Storage conditions: room temperature in the dark under nitrogen over silica gel
The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.
Key result
Percentile:
other: 0.359%
Mean:
< 100 nm
St. dev.:
0
Remarks on result:
other: Proportion of test material having an inhalable particle size less than 100 nm was 0.359% of the test material.
No.:
#1
Size:
< 100 nm
Distribution:
0.359 %
Conclusions:
The result indicated that the test material was essentially non-inhalable.
Executive summary:

Particle size data has been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June 1996), which satisfies the requirements of OECD guideline 110. The results are as follows:

 Measurement Method   Result
 Proportion of test material having an inhalable particle size less than 100 gm  Sieve  0.359%

The result indicated that the test material was essentially non-inhalable.

Description of key information

Proportion of test material having an inhalable particle size less than 100 nm was 0.359%.

The result indicated that the test material was essentially non-inhalable.

Additional information