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Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- 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
- 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.
Reference
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 |
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.
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