Registration Dossier
Registration Dossier
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EC number: 235-019-5 | CAS number: 12057-24-8
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 MAY 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Percentile:
- D10
- Mean:
- 30.006 µm
- Remarks on result:
- other: not more details provided
- Percentile:
- D50
- Mean:
- 69.322 µm
- Remarks on result:
- other: not more details provided
- Percentile:
- D90
- Mean:
- 163.218 µm
- Remarks on result:
- other: not more details provided
- Executive summary:
The particle size distribtuion of the test item was assessed by the sponsor in an in-house non-GLP test via laser diffraction with a Malvern device. The procedure is similar to ISO 13320. It was observed, that the particles have the following sizes and are not existing as nanomaterial:
d10: 30.006 µm
d50: 69.322 µm
d90: 163.218 µm.
Reference
Description of key information
The particle size distribtuion of the test item was assessed by the sponsor in an in-house non-GLP test via laser diffraction with a Malvern device. The procedure is similar to ISO 13320. It was observed, that the particles have the following sizes and are not existing as nanomaterial:
d10: 30.006 µm
d50: 69.322 µm
d90: 163.218 µm.
Additional information
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