Registration Dossier
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EC number: 233-031-5 | CAS number: 10024-93-8
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:
- 4 July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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’
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- sieving
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 0.27 %
- Conclusions:
- Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 µm was determined to be 0.27 %. The test material has been considered to be essentially non-inhalable.
- Executive summary:
The particle size distribution of the test material was determined in accordance with the standardised guideline:European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ under GLP conditions using the sieving method.
An aliquot of test material was added to a 100 µm sieve fitted onto a receiver pan of known mass. A lid was then secured onto the sieve and the assembled apparatus placed on a sieve shaker for a period of approximately 30 minutes. Following the shaking period, the mass of the receiver pan and collected test material was recorded and the percentage of test material with a particle size less than 100 µm calculated.
Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 µm was determined to be 0.27 %. The test material has been considered to be essentially non-inhalable.
Reference
The percentage of test material having an inhalable particle size of less than 100 µm was determined to be 0.3%.
Description of key information
Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 µm was determined to be 0.27 %. The test material has been considered to be essentially non-inhalable.
Additional information
The particle size distribution of the test material was determined in accordance with the standardised guideline:European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ under GLP conditions using the sieving method. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
An aliquot of test material was added to a 100 µm sieve fitted onto a receiver pan of known mass. A lid was then secured onto the sieve and the assembled apparatus placed on a sieve shaker for a period of approximately 30 minutes. Following the shaking period, the mass of the receiver pan and collected test material was recorded and the percentage of test material with a particle size less than 100 µm calculated.
Under the conditions of the study the percentage of test material having an inhalable particle size of less than 100 µm was determined to be 0.27 %. The test material has been considered to be essentially non-inhalable.
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