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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 June 2018 - 24 July 2018
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 (incl. QA statement)
Type of method:
cascade impaction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Batch Number: TMP1804208
Purity: ≥ 99%
Expiry Date: 19 April 2022
Storage Conditions: Room temperature in the dark
Remarks on result:
other: Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
Percentile:
other: Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
Remarks on result:
not determinable
No.:
#1
Size:
< 100 µm
Distribution:
ca. 86.6 %
Remarks on result:
other: method:sieve
No.:
#2
Size:
< 10 µm
Distribution:
ca. 7.06 %
Remarks on result:
other: Mean cumulative percentage with a particle size less than 10.0 μm
No.:
#3
Size:
< 5.5 µm
Distribution:
ca. 1.24 %
Remarks on result:
other: Mean cumulative percentage with a particle size less than 5.5 μm
Conclusions:
Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes and then sampling from the top, middle and bottom.
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
Executive summary:

Particle size data was acquired for the test substance in a GLP laboratory, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002). The results are as follows:

Proportion of test item having an inhalable particle size <100 μm: 86.6%

Proportion of test item having a thoracic particle size <10.0 μm: 7.06%

Proportion of test item having a respirable particle size <5.5 μm: 1.24%

Description of key information

Particle size data was acquired for the test substance in a GLP laboratory, using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002). The results are as follows:

Proportion of test item having an inhalable particle size <100 μm: 86.6%

Proportion of test item having a thoracic particle size <10.0 μm: 7.06%

Proportion of test item having a respirable particle size <5.5 μm: 1.24%

Additional information