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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
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
Principles of method if other than guideline:
In considersation of the relevance of granulometry on toxicological assessment, only the size distribution of the sieved fraction <100 µm were studied in detail.
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of distribution:
mass based distribution
Mass median aerodynamic diameter:
18.66 µm
Percentile:
D50
Mean:
18.66 µm
Remarks on result:
other: spherical volume
Size:
< 4 µm
Distribution:
0 %
Remarks on result:
other: of the sieve fraction < 100 µm
Size:
>= 4 - <= 10 µm
Distribution:
0.81 %
Remarks on result:
other: of the sieve fraction < 100 µm
Size:
>= 10 - <= 100 mm
Distribution:
99.19 %
Remarks on result:
other: of the sieve fraction < 100 µm

Result: Sieve Fraction:

- weighted sample: 0.3313 g

- weight fraction < 100 μm: 0.2642 g

- sieve mass fraction < 100 μm: 79.75 %

The mass fraction <100 µm was 79.75 %, and was investigated by scanning electron microscopy. The mean diameter (median) was 15.73 µm with 8.82 µm standard deviation. The median aspect ratio (median) was 1.47 with 0.36 as standard deviation.

The median diameter (mass fraction) of the particle size is given for the fraction <100 µm. The value 18.66 µm was calculated for spherical and the value 24.93 µm was calculated for cubical particles.

 Particle Size  Spherical Volume [%]  Cubical Volume [%]
 < 4 µm (respirable)  0.00 %  0.00 %
 4 - 10 µm (thoracic)  0.81 %  0.98 %
 10 - 100 µm (inhalable)  99.19 %  99.02 %
 > 100 µm  0.00 %  0.00 %
 Median (diameter)  18.66 µm  24.93 µm
Conclusions:
The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 18.66 µm as spherical particles.
Executive summary:

According to OECD guideline 110 the particle size distribution of Macrolex Orange R was determined by scanning electron microscopy method for the sieved fraction (<100 µm was 79.75 % of the total sample) and presented on the basis of calculated mass fractions.

The mean diameter (median) was 15.73 µm with 8.82 µm standard deviation. The median aspect ratio (median) was 1.47 with 0.36 as standard deviation. The median diameter (mass fraction) of the particle size is given for the fraction <100 µm. The value 18.66 µm was calculated for spherical particles and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EN 481. The respirable fraction below 4 µm represented 0% of the total sample on the basis of calculated mass fractions.

Description of key information

According to OECD guideline 110 the particle size distribution of Macrolex Orange R was determined by scanning electron microscopy method for the sieved fraction (<100 µm was 79.75 % of the total sample) and presented on the basis of calculated mass fractions.

The MMAD (Mass Median Aerodynamic Diameter < 100 µm) was determined as 18.66 µm as spherical particles.

Additional information

The respirable fraction below 4µm represented 0% of the total sample on the basis of calculated mass fractions.