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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:
September 07, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Remarks:
and microscopic examination
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
17.388 µm
Key result
Percentile:
D50
Mean:
16.096 µm
St. dev.:
3
Remarks on result:
other: 3%
No.:
#5
Size:
4.446 µm
Distribution:
10 %
No.:
#5
Size:
16.096 µm
Distribution:
50 %
No.:
#5
Size:
46.425 µm
Distribution:
90 %
No.:
#5
Size:
10 µm
Distribution:
29.95 %
Remarks on result:
other:
Remarks:
by volume of sample

Microscopic observations

Standard visual observation: sample observed to be a medium to fine white powder with lumps and clusters.

Observation at 100 x magnification: the particles appeared to be irregular shaped crystals. The smallest individual particle size was

approximately 3 μm and the largest individual size was approximately 80 μm.

Observation at 400 x magnification: the sample was observed to be made up of single crystalline particles with some agglomerations.

Laser diffraction particle size analysis

29.95 % by volume of sample was seen to be < 10.00 μm.

Coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %.

Conclusions:
Under the study conditions, the following particle size distribution measures were found to be: MMAD (Mass Median Aerodynamic Diameter) 17.388 μm; 10 % of material is < 4.446 μm; 50 % of material is < 16.096 μm; 90 % of material is < 46.425 μm; 29.95 % by volume of sample was seen to be < 10.00 μm.
Executive summary:

A study was conducted to determine particle size distributions of the test substance using microscopic observations and laser diffraction particle size analysis according to ISO 13320:2009 and CIPAC MT 187 taking into consideration OECD 110 Guideline, in compliance with GLP. The sample was initially observed to determine whether sieving of the material is required prior to analysis. Subsequently the method development was employed to identify the most appropriate optical properties for the material, the correct dispersant, dispersion pressures and sample compatibility. Once these parameters were obtained the final sample was analysed over the range 0.02 μm to 2000 μm using the Malvern Mastersizer 2000 Laser Diffraction Analyser. 5 runs were completed to ensure repeatability of results. Under the study conditions, the following particle size distribution measures were found to be: MMAD (Mass Median Aerodynamic Diameter) 17.388 μm; 10 % of material is < 4.446 μm; 50 % of material is < 16.096 μm; 90 % of material is < 46.425 μm; 29.95 % by volume of sample was seen to be < 10.00 μm (Younis, 2016).

Description of key information

Determination of the particle size distribution according to ISO 13320:2009 and CIPAC MT 187 taking into consideration OECD Guideline 110 (Younis, 2016).

Additional information

MMAD (Mass Median Aerodynamic Diameter) 17.388 μm; 10 % of material is < 4.446 μm; 50 % of material is < 16.096 μm; 90 % of material is < 46.425 μm; 29.95 % by volume of sample was seen to be < 10.00 μm.