Registration Dossier
Registration Dossier
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Reactions mass of N-{2-[(4-bromo-6-substituted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-methoxyalkyl)amino]phenyl}acetamide) and N-{2-[(4-bromo-6-substiuted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-hydroxy-3-phenoxypropyl)amino]phenyl}acetamide
EC number: - | CAS number: -
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
Description of key information
Determination of the particle size distribution of FAT 41044/A TE.
Additional information
The method used a procedure designed to be compatible with European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of chemical substances’ (2002).
Sieving Apparatus (Screening Test)
Instrument: Pascal Engineering, Inclyno Sieve Shaker, Model No 1
Screening particle size: 100 µm
Test conditions: The test item was sieved for a period of approximately 30 minutes.
Cascade Impactor
Instrument: MSP Corporation, Marple Miller 160 Cascade Impactor
Particle size range: 0.3 to 10 µm.
Discussion
Too few particles were of a size less than 10.0 µm to allow accurate assessment of the mass median aerodynamic diameter.
Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes and then taking aliquots from the top, middle and bottom. However, as a gradient in the particle size distribution was observed for the three samples, the overall values have been reported based on the middle sampling position only, to represent a worst case scenario for risk assessment.
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.
Conclusion
Particle size data acquired for the test item is shown in the following table:
Table 3.18
Measurement |
Method |
Result |
|||
Proportion of test item having an inhalable particle size <100 µm |
Sieve |
17.2 % |
|||
Proportion of test item having a thoracic particle size <10.0 µm |
Cascade Impactor |
≤3.66 % |
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Proportion of test item having a respirable particle size <5.5 µm |
Cascade Impactor |
≤0.721 % |
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