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EC number: 943-665-0 | CAS number: -
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 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
- 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.
Reference
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 |
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
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