Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- May to October 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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).
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- sieving
- Remarks:
- A Cascade Impactor was also used
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- Remarks on result:
- other: 97.2% Proportion of test item having an inhalable particle size <100 μm(Sieve Method)
- Remarks:
- ≤ 0.200% Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor) ≤ 0.066% Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor)
- Percentile:
- D95
- Mean:
- < 100 µm
- Remarks on result:
- other: 97.2% Proportion of test item having an inhalable particle size <100 μm(Sieve Method)
- Remarks:
- ≤ 0.200% Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor) ≤ 0.066% Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor)
- Conclusions:
- Results are as follows:
97.2% Proportion of test item having an inhalable particle size <100 μm(Sieve Method)
≤ 0.200% Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor)
≤ 0.066% Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor) - Executive summary:
Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 2 ½ minutes, allowing to settle, and then sampling from the top, middle and bottom.
The overall results from the cascade impactor were taken as limit values due to the variation between the sampling positions; this gives a worst case scenario.
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.
Results are as follows:
97.2% Proportion of test item having an inhalable particle size <100 μm(Sieve Method)
≤ 0.200% Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor)
≤ 0.066% Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor)
Reference
Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 2 ½ minutes, allowing to settle, and then sampling from the top, middle and bottom.
The overall results from the cascade impactor were taken as limit values due to the variation between the sampling positions; this gives a worst case scenario.
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.
Results are as follows:
97.2% Proportion of test item having an inhalable particle size <100 μm(Sieve Method)
≤ 0.200% Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor)
≤ 0.066% Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor)
Description of key information
Results are as follows:
97.2% Proportion of test item having an inhalable particle size <100 μm(Sieve Method)
≤ 0.200% Proportion of test item having a thoracic particle size <10.0 μm (Cascade Impactor)
≤ 0.066% Proportion of test item having a respirable particle size <5.5 μm (Cascade Impactor)
Additional information
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