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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
Study period:
From the 17th to the 20th of September, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to SOP STR 071 analytical method.Test conducted according to internationally accepted testing guidelines.
Qualifier:
according to guideline
Guideline:
other: SOP STR 071
Principles of method if other than guideline:
The analysis was performed with and without 1 and 2 minutes of ultrasonics.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
28.806 µm
Remarks on result:
other: after 1 minute of ultrasonic treatment
Percentile:
D50
Mean:
71.206 µm
Remarks on result:
other: after 1 minute of ultrasonic treatment
Percentile:
D10
Mean:
23.36 µm
Remarks on result:
other: after 2 minutes of ultrasonic treatment
Percentile:
D50
Mean:
60.256 µm
Remarks on result:
other: after 2 minutes of ultrasonic treatment

After 1 minute of ultrasonic treatment:

Specific Weighted mean D (3,2): 49.995 µm

Vol. Weighed mean D (4,3): 75.843 µm

After 2 minutes of ultrasonic treatment:

Specific Weighted mean D (3,2): 42.162 µm

Vol. Weighed mean D (4,3): 65.169 µm

See graph for details.

Conclusions:
Particle size after 1 minute of ultrasonic treatmentD10 ca. 30.2 µmD50 > 69.183 < 79.433 µm (mean value 71.206 µm)D90 > 120.226 < 138.038 µmParticle size after 2 minutes of ultrasonic treatment D10 > 22.900 < 26.303 µm D50 > 60.256 < 69.183 µm (mean value 60.501 µm) D90 > 104.713 < 120.226 µm
Executive summary:

Granulometry of the sample was performed with SOP-STR 071 method without and with 1 and 2 minutes of ultrasonic treatment.

Particle size after 1 minute of ultrasonic treatment

D10 ca. 30.2 µm

D50 > 69.183 < 79.433 µm (mean value 71.206 µm)

D90 > 120.226 < 138.038 µm

Particle size after 2 minutes of ultrasonic treatment

D10 > 22.900 < 26.303 µm

D50 > 60.256 < 69.183 µm (mean value 60.501 µm)

D90 > 104.713 < 120.226 µm

Description of key information

D50 mean 71.206 µm (1 minute of ultrasonics)
D50 mean 60.501 µm (2 minute of ultrasonics)

Additional information

Granulometry of the sample was performed with SOP-STR 071 method without and with 1 and 2 minutes of ultrasonic treatment.

Particle size after 1 minute of ultrasonic treatment

D10 ca. 30.2 µm

D50 > 69.183 < 79.433 µm (mean value 71.206 µm)

D90 > 120.226 < 138.038 µm

Particle size after 2 minutes of ultrasonic treatment

D10 > 22.900 < 26.303 µm

D50 > 60.256 < 69.183 µm (mean value 60.501 µm)

D90 > 104.713 < 120.226 µm

Granulometry is of considerable importance for the toxic properties of a substance as it influences aspects such as the route of exposure of humans and toxicity by inhalation: the choice of route of administration for animal testing, the efficiency of uptake in an organism and the distribution in the environment.

For this purpose fractions can be divided in:

• Inhalable fraction (the mass fraction of particles that can be inhaled by nose and mouth. Particles > 100 μm are not included in the inhalable convention;

• Thoracic fraction (the mass fraction of the inhaled particles that passes the larynx). The convention for thoracic fraction sets that 50 % of the particles in air with an aerodynamic diameter of 10 μm belong to the thoracic fraction;

• Respirable fraction (the mass fraction of the inhaled particles that reaches the alveoli) The convention for respirable fraction sets that 50 % of particles with an aerodynamic diameter of 4 μm belong to the respirable fraction.

The substance to be registered presented a granulometry (D50 after 2 minutes of ultrasonic treatment) that can be considered as an inhalable fraction.