Registration Dossier

Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions.
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
no
Type of method:
microscopic examination
Type of distribution:
counted distribution
Key result
Percentile:
D50
Mean:
96.44 µm
Remarks on result:
other: Mass median diameter

The sample was first sieved by a 100 µm sieve.

weighted sample: 4.4558 g

weight fraction <100 µm: 0.166 g

mass fraction <100 µm: 3.73 %

The mass fraction <100 µm was 3.73 %, and was investigated by scanning electron microscopy. The median aspect ratio was 1.41 with 0.41 as standard deviation.

The median diameter of the particle size is given for the fraction <100 µm. The value 96.44 µm was calculated for cubical and for spherical particles.

 particle size  Spherical Volume  Cubical Volume
 < 4 µm  0.074 %  0.049 %
 4 - 10 µm  0.42 %  0.32 %
 10 - 100 µm  64.87 %  63.41 %
 > 100 µm  34.64 %  36.23 %
 Median (diameter)  96.44 µm  96.44 µm
Conclusions:
All particles with a mean diameter less than 100 µm have a mass fraction of 3.73 %. 0.074 % / 0.049 % (spherical/ cubical) particles of this mass fraction have a mean diameter less than 4 µm.

Description of key information

In a particle size study of ZMB2, all particles with a mean diameter less than 100 µm have a mass fraction of 3.73 %.

Additional information

In an OECD guideline 110, the particle size distribution of ZMB2 was determined by scanning electron microscopy method for the sieved fraction (<100 µm, 3.73 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was 96.44 µm with the main fraction of 64 % distributing in the range of 10 to 100 µm; and hence the particle size of ZMB2 is considered inhalable/respirable fraction as defined in EU 481 (Currenta, 2011).