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EC number: 700-222-4 | CAS number: 1065519-44-9
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15.12.2008-17.03.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EUR 20268: draft EU Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002)
- GLP compliance:
- yes
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
- EC Number:
- 700-222-4
- Cas Number:
- 1065519-44-9
- Molecular formula:
- C22H28N6O7S
- IUPAC Name:
- N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
- Details on test material:
- - Name of test material (as cited in study report): No. 408 Yellow
- Physical state: yellow powder
- Analytical purity: 98.6%
- Lot/batch No.: 081105-1
- Expiration date of the lot/batch: 04.11.2009
- Storage condition of test material: room temperature (10 to 30°C)
- Other: A copy of the Certificate of Analysis is included in the study report
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Percentile:
- D50
- Mean:
- ca. 8.898 µm
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- ca. 2.498 µm
- Percentile:
- D50
- Mean:
- ca. 7.54 µm
- Percentile:
- D90
- Mean:
- ca. 36.13 µm
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- > 0 - <= 0.417 µm
- Distribution:
- ca. 0.02 %
- No.:
- #2
- Size:
- > 0 - <= 2.512 µm
- Distribution:
- ca. 10.13 %
- No.:
- #3
- Size:
- > 0 - <= 3.802 µm
- Distribution:
- ca. 23 %
- No.:
- #4
- Size:
- > 0 - <= 5.754 µm
- Distribution:
- ca. 39.21 %
- No.:
- #5
- Size:
- > 0 - <= 7.586 µm
- Distribution:
- ca. 50.21 %
- No.:
- #6
- Size:
- > 0 - <= 10 µm
- Distribution:
- ca. 60.4 %
- No.:
- #7
- Size:
- > 0 - <= 15.136 µm
- Distribution:
- ca. 73.12 %
- No.:
- #8
- Size:
- > 0 - <= 26.303 µm
- Distribution:
- ca. 85.1 %
- No.:
- #9
- Size:
- > 0 - <= 45.709 µm
- Distribution:
- ca. 93.1 %
- No.:
- #10
- Size:
- > 0 - <= 158.489 µm
- Distribution:
- ca. 98.8 %
Any other information on results incl. tables
An averaged distribution set was constructed on the base of eleven measurements. It is the unimodal distribution over the size range from approximately 0.3 to 160 μm.
The mass median aerodynamic diameter (MMAD) is calculated as the product of the particle size representing the mid-point in the distribution [d(0.5)] and the square root of the relative density. The geometric standard deviation (GSD) is similarly calculated as the product of the standard deviation of percentage distribution (for positive data records) and the square root of the relative density. The relative density of No. 408 Yellow was determined to be 1.3899 (see Key, Covance, 2009, RL1) and this was used to calculate the MMAD and GSD values. The calculations resulted in values:
MMAD= 8.8975 μm and GSD=2.297 μm.
In performed measurements the coefficient of variability around the median was 0.55% and at the extremities was 0.86% for the 10% point and 3.14% for the 90%. The values are within the requirements.
Applicant's summary and conclusion
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