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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
Remarks:
Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Qualifier:
no guideline available
Principles of method if other than guideline:
The method was designed to comply with that given in 'Particle Size Distribution, Fibre Length and Diameter Distribution' June 1996 European Commission technical guidance document.
GLP compliance:
yes (incl. QA statement)
Type of method:
determination of fibre length and diameter distributions
Type of distribution:
volumetric distribution
Remarks on result:
not determinable
No.:
#1
Size:
>= 100 µm
Distribution:
ca. 95.8 %
Remarks on result:
other: 4.2% of test material passed through the Sieve aperture of 100µm

By sieve analysis, the proportion of test material found to have a particle size of less than 100 µm was 4.2%

Conclusions:
The proportion of test material found to have a particle size of less than 100µm was 4.2%. The test material is considered essentially non inhalable.
Executive summary:

Method

The determination was made using a method designed to be compatible with that given in 'Particle Size Distribution, Fibre Length and Diameter Distribution' June 1996 European Commission technical guidance document.

Conclusion

By Sieve analysis the proportion of test material found to have a particle size of less than 100µm was 4.2%. The test material is considered essentially non inhalable

Description of key information

The proportion of test material found to have a particle size of less than 100µm was 4.2%. The test material is considered essentially non inhalable.

Additional information

The proportion of test material found to have a particle size of less than 100µm was 4.2%. The test material is considered essentially non inhalable.