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EC number: 229-662-0 | CAS number: 6642-31-5
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:
- 2002-07-08 - 2002-07-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution", Guidance Document, using the sieving method.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- sieving
- Type of particle tested:
- agglomerate
- Type of distribution:
- mass based distribution
- Specific details on test material used for the study:
- - Storage condition of test material: at room temperature (at about 20 °C)
- Key result
- Percentile:
- D50
- Mean:
- 500 µm
- St. dev.:
- 0
- Remarks on result:
- other: no St. dev. can be given
- Remarks:
- Determination was made via sieve test. The sieves had 75 µm, 125 µm, 250 µm, 500 µm, 1000 µm and 2000 µm mesh size, those are absolute values and no STD can be given.
- Percentile:
- other: D2
- Mean:
- <= 250 µm
- St. dev.:
- 0
- Remarks on result:
- other: no St. dev. can be given
- Remarks:
- Determination was made via sieve test. The sieves had 75 µm, 125 µm, 250 µm, 500 µm, 1000 µm and 2000 µm mesh size, those are absolute values and no STD can be given.
- No.:
- #1
- Size:
- <= 500 µm
- Distribution:
- ca. 50 %
- Conclusions:
- The GLP study was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution", Guidance Document, using the sieving method.
The particles of 1,3-Dimethyl-4-aminouracil form various size agglomerates. The main agglomerate size was found in the range of 250 µm to 2000 µm. 50 % of the test item agglomerates exceeded 500 µm. - Executive summary:
The GLP study was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution", Guidance Document, using the sieving method.
Based on the visual observation, the sieving method was selected to determine the particle size of the test substance.
In conclusion it can be stated that the particles of 1,3-Dimethyl-4-aminouracil form various size agglomerates. The measurement of the single particles was not possible. The amount of test item with a particle size below 250 µm was only about 2 %. This amount is too small and not relevant for the particle size distribution. The main agglomerate size was found in the range of 250 µm to 2000 µm. 50 % of the test item agglomerates exceeded 500 µm.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP
- Guideline:
- other: laser diffraction according to ISO 13320-1, with evaluation according to Fraunhofer.
- GLP compliance:
- yes (incl. QA statement)
- Other quality assurance:
- other: ISO 13320-1
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Percentile:
- D10
- Mean:
- 19 µm
- Remarks on result:
- other: No source field for Standard deviation.
- Percentile:
- D50
- Mean:
- 106 µm
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D90
- Mean:
- 1 020 µm
- Remarks on result:
- other: No source field for Standard deviation.
- No.:
- #1
- Size:
- 7.095 µm
- Distribution:
- 0.09 %
- No.:
- #2
- Size:
- 10 µm
- Distribution:
- 1.25 %
- No.:
- #3
- Size:
- 20 µm
- Distribution:
- 11.7 %
- No.:
- #4
- Size:
- 44.774 µm
- Distribution:
- 31.85 %
- No.:
- #5
- Size:
- 100 µm
- Distribution:
- 48.95 %
- No.:
- #6
- Size:
- 2 000 µm
- Distribution:
- 100 %
Referenceopen allclose all
In conclusion it can be stated that the particles of 1,3-Dimethyl-4-aminouracil form various size agglomerates. The measurement of the single particles was not possible. The amount of test item with a particle size below 250 µm was only about 2 %. This amount is too small and not relevant for the particle size distribution. The main agglomerate size was found in the range of 250 µm to 2000 µm. 50 % of the test item agglomerates exceeded 500 µm.
Description of key information
Granulometry
- D10 = 19 µm, D50 = 106 µm, D90 = 1020 µm (volumetric distribution, laser diffraction according to ISO 13320-1)
- D2 <= 250 µm, D50 = 500 µm (mass based distribution, sieving method)
Additional information
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