Registration Dossier
Registration Dossier
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EC number: 617-393-5 | CAS number: 82834-12-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August to November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Type of particle tested:
- agglomerate
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- (2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]amino]propanoic acid
- EC Number:
- 617-393-5
- Cas Number:
- 82834-12-6
- Molecular formula:
- C10 H19 N O4
- IUPAC Name:
- (2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]amino]propanoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- White powder
Constituent 1
- Specific details on test material used for the study:
- Batch: 18128093
Results and discussion
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 89.7 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- <= 4.3 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- <= 0.78 %
Applicant's summary and conclusion
- Conclusions:
- Particle size data acquired for the test item is shown in the following table:
Measurement Method Result
Percentage of test item with an inhalable particle size <100 μm Sieve 89.7%
Percentage of test item with a thoracic particle size <10.0 μm Cascade Impactor ≤4.3%
Percentage of test item with a respirable particle size <5.5 μm Cascade Impactor ≤0.78%
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