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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:
2013-07-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recognised guidelines and guidance under GLP. All relevant validity criteria were met.
Qualifier:
according to guideline
Guideline:
other: EUR 20268 EN
Version / remarks:
According to European Chemicals Agency (ECHA) Guidance R.7a (version 5.0, December 2016): ‘EUR 20268 EN: Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (JRC, 2002)' ISBN 92-894-3704-9; is a primary reference for details of test methods for determining particle size distribution, fibre length and diameter distributions.

The test method was conducted in line with the EUR 20268 EN and the ECHA Guidance R.7a (version 5.0, December 2016) integrated testing strategy for granulometry. This included sieving with 100 μm sieve and/or further testing as defined under the guidelines and literature, as applicable.
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
The proportion of test item passing through a 100 µm sieve was determined using an Incyno sieve shaker.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
inspected: July 2012; signature: November 2012
Type of method:
sieving
No.:
#1
Size:
< 100 µm
Distribution:
6 %
Remarks on result:
other: The proportion of test item having an inhalable particle size of <100 μm was determined to be 6.0 % w/w.

 Table 1.0 - Measurement information

Measurement

Result

Mass of test item transferred to sieve

17.73 g

Mass of test item passed through sieve

1.07 g

Proportion of test item <100 μm

6.0 % w/w

Conclusions:
The proportion of test item having an inhalable particle size of <100 μm was determined to be 6.0 % w/w using the sieving method. The test item was considered to be essentially non-inhalable.
Executive summary:

The proportion of test item having an inhalable particle size of less than 100 μm was determined using sieving method according to European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002) under GLP. The proportion having an inhalable particle size less than 100 μm was 6.0 % w/w. The test item was considered to be essentially non-inhalable.

Description of key information

Particle Size Distribution: < 6.0 % w/w with particle size < 100 μm. The test item was considered to be essentially non-inhalable, EUR 20268 EN: sieving method, 2013

Additional information

 The proportion of test item having an inhalable particle size of less than 100 μm was determined using sieving method according to European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002) under GLP. The proportion having an inhalable particle size less than 100 μm was 6.0 % w/w. The test item was considered to be essentially non-inhalable.

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