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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: beige powder
- Storage: in a dark place at room temperature
- Batch : 16 208
- Manufacturing date: July 26th 2016
- Expiry date: July 26th 2018
Specific details on test material used for the study:
- Particle size: non spherical
- Particle size refractive index: 1.532 (measured by refractometer)
- Particle size absorption index: 0.010
- Approximate density of the powder: 1 g/cm3

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D50
Mean:
ca. 18.5 µm
Remarks on result:
other: RSD = 2.54%
Key result
Percentile:
D10
Mean:
ca. 7.2 µm
Remarks on result:
other: RSD = 1.70%
Key result
Percentile:
D90
Mean:
ca. 38.6 µm
Remarks on result:
other: RSD = 2.88%

Applicant's summary and conclusion

Conclusions:
The particle size distribution of the test substance was determined by laser diffraction according to ISO 13320-2009.
The test item has a median particle size D50 = 18.7 µm.

Executive summary:

The particle size distribution of the test substance was determined by laser diffraction according to ISO 13320-2009 in an appropriate dispersive solvent (isopropanol).

The MIE diffusion model was used to obtain the volumetric distribution of the test substance.

5 measurements were made during the passage of the powder in the apparatus, the following parameters were determined:

D10 = 7.2 µm (RSD = 1.70%)

D50 = 18.7 µm (RSD = 2.54%)

D90 = 38.6 µm (RSD = 2.88%)

All the RSD were below the limits definied by the ISO 13320, these measurements are considered to comply with the International Standard.