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EC number: - | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-03-03 to 2021-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187: Particle size analysis by laser diffraction
- Version / remarks:
- 2007
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- other: Medium Volume Distribution
Test material
- Reference substance name:
- 4-chloro-N-[2-methoxy-4-(morpholin-4-yl)-5-nitrophenyl]pyrimidin-2-amine
- Cas Number:
- 2270944-70-0
- Molecular formula:
- C15H16ClN5O4
- IUPAC Name:
- 4-chloro-N-[2-methoxy-4-(morpholin-4-yl)-5-nitrophenyl]pyrimidin-2-amine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: I20CD1048
- Purity: 100%
- Purity test date: 2020-05-11
- Expiry date: 2022-03-22 (retest date)
- Physical Description: Light yellow to dark orange solid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions and during storage: not indicated
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: not indicated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: not indicated
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
No treatment
Results and discussion
- Mass median aerodynamic diameter:
- 11.52 µm
- Geometric standard deviation:
- 2.334
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 3.28 µm
- St. dev.:
- 0.012
- Remarks on result:
- other: standard deviation of the population
- Key result
- Percentile:
- D50
- Mean:
- 9.6 µm
- St. dev.:
- 0.029
- Remarks on result:
- other: standard deviation of the population
- Key result
- Percentile:
- D90
- Mean:
- 20.6 µm
- St. dev.:
- 0.053
- Remarks on result:
- other: standard deviation of the population
Any other information on results incl. tables
The particle size distribution of the test item was analysed over the range 0.01 µm to 3500 µm.
Applicant's summary and conclusion
- Conclusions:
- The particle size distribution of the test item was determined by means of Laser Diffraction
Analysis using the Aero S dry powder module.
The D50 of the test item was determined to be 9.60 µm, the D10 was 3.28 µm and the
D90 was 20.6 µm. The MMAD of the test item, for the relative density and the mean d50,
was calculated to be 11.52 µm.
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