Registration Dossier
Registration Dossier
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EC number: 222-860-8 | CAS number: 3637-26-1
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
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:
- Dimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl](3-sulphopropyl)ammonium hydroxide
- EC Number:
- 222-860-8
- EC Name:
- Dimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl](3-sulphopropyl)ammonium hydroxide
- Cas Number:
- 3637-26-1
- Molecular formula:
- C11H21NO5S
- IUPAC Name:
- dimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl](3-sulphopropyl)ammonium hydroxide
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 1.31 µm
- Remarks on result:
- other: standard deviation not available
- Key result
- Percentile:
- D25
- Mean:
- 3.1 µm
- Remarks on result:
- other: standard deviation not available
- Key result
- Percentile:
- D50
- Mean:
- 5.85 µm
- Remarks on result:
- other: standard deviation not available
- Key result
- Percentile:
- D90
- Mean:
- 18.52 µm
- Remarks on result:
- other: standard deviation not available
Applicant's summary and conclusion
- Conclusions:
- Average size of particles = 14.871 μm
D10 = 1.31 μm
D25 = 3.10 µm
D50 = 5.85 μm
D90 = 18.52 μm
The study (no GLP) was performed by laser diffraction based on Mie Scattering on the substance to be registered itself, the test procedure is well documented 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 14.871 µm (D10 = 1.31 µm, D25 = 3.10 µm, D50 = 5.85 µm, D90 = 18.52 µm).
According to the results, the inhalation of particles has to be regarded:
- ~96% are <100 µm (inhalable fraction)
- ~ 74% are <10 µm (thoracic fraction)
- ~34% are < 4µm (respirable fraction)
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