Registration Dossier
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EC number: 443-930-6 | 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:
- 02 - 20 December 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: European Commision, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission, Directorate General JRC, Joint Research Centre, "Particle Size Distribution, Fibre Length and Diameter Distribution" Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 "Laser scattering / diffraction"
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- sieving
- Type of distribution:
- mass based distribution
- Specific details on test material used for the study:
- - Batch n°: 00467090 (charge 05C0836)
- Expiration date: 04 May 2006
- Purity: 99.9%
- Storage condition of test material: at room temperature at about 20°C - No.:
- #1
- Size:
- 2 000 µm
- Distribution:
- 0.05 %
- Remarks on result:
- other: mean of two sievings
- No.:
- #2
- Size:
- 1 000 µm
- Distribution:
- 4.59 %
- Remarks on result:
- other: mean of two sievings
- No.:
- #3
- Size:
- 500 µm
- Distribution:
- 37.8 %
- Remarks on result:
- other: mean of two sievings
- No.:
- #4
- Size:
- 250 µm
- Distribution:
- 44.98 %
- Remarks on result:
- other: mean of two sievings
- No.:
- #5
- Size:
- 125 µm
- Distribution:
- 12.33 %
- Remarks on result:
- other: mean of two sievings
- No.:
- #6
- Size:
- 75 µm
- Distribution:
- 0.26 %
- Remarks on result:
- other: mean of two sievings
- No.:
- #7
- Size:
- < 75 µm
- Distribution:
- 0 %
- Remarks on result:
- other: mean of two sievings
- Conclusions:
- T002907 is a white crystalline powder. The particle size distribution of T002907 was determined by the sieving test (following European Commission Guidelines). Only about 12.5% of the test item passed the 125 µm sieve. This amount of the test item is insignificant for the evaluation of the particle size distribution. The results of the study can be considered reliable without restriction.
Reference
TIC2782 (T002907) is a white crystalline powder.
The fraction, which passes the 250 μm sieve, is usually used for the measurement using the laser diffraction apparatus. Only about 12.5 % of the test item passed the 250 μm sieve. This amount of test item is insignificant for the evaluation of the particle size distribution.
Description of key information
T002907 is a white crystalline powder. The particle size distribution of T002907 was determined by the sieving test (following European Commission Guidelines). Only about 12.5% of the test item passed the 125 µm sieve. This amount of the test item is insignificant for the evaluation of the particle size distribution.
Additional information
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