Registration Dossier
Registration Dossier
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EC number: 244-520-8 | CAS number: 21668-81-5
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Laser diffraction
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- 3-[(aminoiminomethyl)thio]propanesulphonic acid
- EC Number:
- 244-520-8
- EC Name:
- 3-[(aminoiminomethyl)thio]propanesulphonic acid
- Cas Number:
- 21668-81-5
- Molecular formula:
- C4H10N2O3S2
- IUPAC Name:
- 3-(carbamimidoylsulfanyl)propane-1-sulfonic acid
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 15.85 µm
- Remarks on result:
- other: standard deviation not available
- Key result
- Percentile:
- D50
- Mean:
- 99.12 µm
- Remarks on result:
- other: standard deviation not available
- Key result
- Percentile:
- D90
- Mean:
- 332 µm
- Remarks on result:
- other: standard deviation not available
Applicant's summary and conclusion
- Conclusions:
- Average size of particles (volume): 143.788 μm
D10 = 15.85 μm
D50 = 99.12 μm
D90 = 332.00 μm
The study was performed in accordance with generally accepted scientific standards and described in sufficient detail and therefore reliability of Klimisch 2 has been assigned. - Executive summary:
The particle size distribution of the test substance was investigated by laser diffraction based on Mie Scattering (non-GLP, 2016) and the average size of particles has been determined to be 143.788 µm (D10 = 15.85 µm, D50 = 99.12 µm, D90 = 332.00 µm).
According to the results, the inhalation of particles has to be regarded as less significant:
- ~ 50% are < 100 µm (inhalable fraction)
- ~ 5 % are < 10 µm (thoracic fraction)
- 0% are < 4µm (respirable fraction)
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