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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:
The study was conducted on 24 February 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
other: EUR 20268 EN(2002) reference methods to determine the particle size distribution
Deviations:
not specified
GLP compliance:
not specified
Other quality assurance:
other: This study was conducted following the principles of GLP by experienced and trained personnel using claibrated standards and instrumentation.
Remarks:
Relevant Standard Operating Procedures (SOPs) were followed. The results of this analysis are deemed accurate and correct, and suitable for regulatory purposes
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Lot Number 1004R18708
Mass median aerodynamic diameter:
> 5.87 - < 5.96 µm
Geometric standard deviation:
> 1.39 - < 1.4
Key result
Percentile:
other: 0-100% is in the range 1.981-19.904 µm
Mean:
> 6.14 - < 6.31 µm
St. dev.:
1.41

Particle size distribution data for RD14156 - three determinations

Determination #1 #2 #3
Diameter (µm) Q (%) UnderSize (%) q(%) UnderSize (%) q(%) UnderSize (%)
1.729 0 0 0 0 0 0
1.981 0.126 0.126 0.114 0.114 0.162 0.162
2.269 0.292 0.418 0.271 0.385 0.367 0.529
2.599 0.66 1.078 0.629 1.014 0.8 1.329
2.976 1.419 2.497 1.392 2.406 1.651 2.979
3.409 2.861 5.358 2.878 5.284 3.179 6.158
3.905 5.298 10.656 5.447 10.731 5.619 11.777
4.472 8.801 19.457 9.19 19.921 8.935 20.712
5.122 12.774 32.231 13.436 33.357 12.511 33.223
5.867 15.809 48.04 16.568 49.925 15.117 48.34
6.72 16.372 64.412 16.87 66.795 15.531 63.871
7.697 14.053 78.465 14.018 80.812 13.48 77.351
8.816 10.055 88.52 9.562 90.374 9.939 87.29
10.097 6.143 94.662 5.46 95.834 6.361 93.652
11.565 3.194 97.856 2.636 98.471 3.506 97.157
13.246 1.397 99.253 1.05 99.521 1.666 98.823
15.172 0.544 99.797 0.362 99.883 0.726 99.549
17.377 0.204 100 0.117 100 0.311 99.86
19.904 0 100 0 100 0.14 100
22.797 0 100 0 100 0 100
Conclusions:
European Commission Document EUR 20268 EN (2002) expands on methods as described by OECD 110 and a Horiba LA-950V2 laser diffraction paricle size analyzer was employed in accordance with EUR 20268 EN (2002) reference methods to determine the particle size distribution. The RD14153 powder material under investigaton had a median particle size of 5.93 microns
Executive summary:

European Commission Document EUR 20268 EN (2002) expands on methods as described by OECD 110 and a Horiba LA-950V2 laser diffraction paricle size analyzer was employed in accordance with EUR 20268 EN (2002) reference methods to determine the particle size distribution. The RD14156 powder material under investigaton had a median particle size of 5.93 microns.

Description of key information

European Commission Document EUR 20268 EN (2002) expands on methods as described by OECD 110 and a Horiba LA-950V2 laser diffraction particle size analyzer was employed in accordance with EUR 20268 EN (2002) reference methods to determine the particle size distribution.

A Horiba LA-950V2 laser diffraction particle size analyzer equipped with a dry feeder accessory, model #LY-9505, was used to measure the particle size distribution. All samples were added directly to the dry feeder unit and analyzed against a volume based distribution base. The samples were dispersed with an air pressure of 0.2MPa.

Three determinations were made and the RD14156 powder material under investigation had a median particle size of 5.9 microns.

In a similar study conducted in according to the same procedure the RD14156 powder material also had a median particle size of 5.9 microns.

Additional information