Registration Dossier
Registration Dossier
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EC number: 225-751-3 | CAS number: 5053-06-5
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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission 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:
- Fenspiride
- EC Number:
- 225-751-3
- EC Name:
- Fenspiride
- Cas Number:
- 5053-06-5
- Molecular formula:
- C15H20N2O2
- IUPAC Name:
- 8-(2-phenylethyl)-1-oxa-3,8-diazaspiro[4.5]decan-2-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch: 18115637
Results and discussion
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 36.8 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- ca. 7.8 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- ca. 1.9 %
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 36.8%
Percentage of test item with a thoracic particle size <10.0 μm Cascade Impactor 7.8%
Percentage of test item with a respirable particle size <5.5 μm Cascade Impactor 1.9% - Executive summary:
Particle size data was acquired, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of
Chemical Substances' (2002). The results are as follows:
Measurement Method Result
Percentage of test item with an inhalable particle size <100 μm Sieve 36.8%
Percentage of test item with a thoracic particle size <10.0 μm Cascade Impactor 7.8%
Percentage of test item with a respirable particle size <5.5 μm Cascade Impactor 1.9%
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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