Registration Dossier
Registration Dossier
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EC number: 478-250-9 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- -
- EC Number:
- 478-250-9
- EC Name:
- -
- Cas Number:
- 62965-37-1
- Molecular formula:
- C26H42N2O4
- IUPAC Name:
- (2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoic acid; N-cyclohexylcyclohexanamine
Constituent 1
Results and discussion
Particle size
- Percentile:
- D50
- Mean:
- >= 0.5 - <= 130 µm
- Remarks on result:
- other: > 125 µm sieved(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- > 125 µm
- Distribution:
- 37.7 %
- Remarks on result:
- other: sieved
- No.:
- #2
- Size:
- > 105 µm
- Distribution:
- 6 %
- No.:
- #3
- Size:
- 60 - 105 µm
- Distribution:
- 24.2 %
- No.:
- #4
- Size:
- 30 - 60 µm
- Distribution:
- 24.7 %
- No.:
- #5
- Size:
- 10.4 - 30 µm
- Distribution:
- 7.2 %
- No.:
- #6
- Size:
- 0.5 - 10.4 µm
- Distribution:
- 0.3 %
Any other information on results incl. tables
The particle size distribution was initially examined using sieve analysis. As greater than 10% by weight of the test substance were found to pass a 75-micron sieve, it was further examined by image analysis
Applicant's summary and conclusion
- Conclusions:
- The results indicated that only 0.3% w/w of the test substance was smaller than 10 µm.
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