Registration Dossier
Registration Dossier
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EC number: 928-806-6 | 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:
- 19 - 20 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Joint Research Center "Particle Size Distribution, Fibre length and diameter Distribution" Guidance document, ECBT/TM/February 1996
- Deviations:
- no
- Remarks:
- There were no amendments to the study plan.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
- - Batch n°: 00403487
- Analytical purity: > 98%
- Expiration date: 31 December 2003
- Storage condition: at room temperature - Percentile:
- other: D5
- Mean:
- 1.8 µm
- St. dev.:
- 0.859
- Percentile:
- D10
- Mean:
- 5.9 µm
- St. dev.:
- 0.861
- Key result
- Percentile:
- D50
- Mean:
- 15.8 µm
- St. dev.:
- 0.587
- Percentile:
- D90
- Mean:
- 29.2 µm
- St. dev.:
- 1.935
- No.:
- #1
- Size:
- 1 µm
- Distribution:
- 3.62 %
- No.:
- #2
- Size:
- 5 µm
- Distribution:
- 8.57 %
- No.:
- #3
- Size:
- 10 µm
- Distribution:
- 22.68 %
- Conclusions:
- The mean mass diameter of the substance T002615 was determined with the laser diffraction method to be 15.8 µm.
Reference
The results obtained during the measurements showed no relevant difference. The MMD mean value of 15.8 um with a standard deviation of +- 0.587 um as reported above. The standard deviation is smaller than 5 %, therefore the study is considered to be valid. In conclusion, using the laser diffraction method to study the particle size of substance T002615 is ranging between 0.3 um and 50 um.
Description of key information
The particle size distribution of T002615 was determined by the laser diffraction method in a Klimisch 1 GLP study (Tognucci, 2003).
The mean mass diameter was determined to be 15.8 µm.
Additional information
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