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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:
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:
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 3434.15
Mass median aerodynamic diameter:
> 5.76 - < 6.03 µm
Geometric standard deviation:
> 1.39 - < 1.4
Key result
Percentile:
other: 0-100% is in the range 1.981-17.377 µm
Mean:
> 6.08 - < 6.34 µm
St. dev.:
1.4

Particle size distribution data for RD14153 - three determinations

 Determination     1     2     3
 Diameter (microns)  Q (%)  Undersize (%)  Q (%)  Undersize (%)  Q (%)  Undersize (%)
 1.729  0  0  0  0  0  0
 1.981  0.116  0.116  0.107  0.107  0.141  0.141
 2.269  0.268  0.384  0.251  0.359  0.033  0.47
 2.599  0.605  0.989  0.576  0.935  0.747  1.217
 2.9.76  1.309  2.298  1.265  2.2  1.603  2.82
 3.409  2.667  4.965  2.318  4.818  3.211  6.031
 3.905  5.007  9.972  4.987  9.805  5.882  11.913
 4.472  8.452  18.424  8.522  18.327  9.608  21.521
 5.122  12.474  30.988  12.687  31.014  13.629  35.15
 5.867  15.687  46.589  16.012  47.026  16.373  51.523
 6.72  16.487  63.073  16.782  63.808  16.352  67.875
 7.697  14.344  77.417  14.152  78.26  13.454  81.328
 8.816  10.4  87.817  10.267  88.557  91.77  90.505
 10.097  6.453  94.27  6.222  94.779  5.299  95.804
 11.565  3.398  97.668  3.178  97.956  2.599  98.403
 13.246  1.505  99.173  1.352  99.308  1.069  99.741
 15.172  0.597  99.77  0.508  99.873  0.391  99.862
 17.377  0.23  100  0.184  100  0.138  100
 19.904  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 5.9 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 RD14153 powder material under investigaton had a median particle size of 5.9 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 RD14153 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