Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August to November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: European Commission Technical Guidance Document EUR 20268 'Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances' (2002)
GLP compliance:
yes (incl. certificate)
Type of method:
cascade impaction
Type of particle tested:
agglomerate
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
White powder
Specific details on test material used for the study:
Batch: 18128093

Results and discussion

Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
ca. 89.7 %
No.:
#2
Size:
< 10 µm
Distribution:
<= 4.3 %
No.:
#3
Size:
< 5.5 µm
Distribution:
<= 0.78 %

Applicant's summary and conclusion

Conclusions:
Particle size data acquired for the test item is shown in the following table:

Measurement Method Result
Percentage of test item with an inhalable particle size <100 μm Sieve 89.7%
Percentage of test item with a thoracic particle size <10.0 μm Cascade Impactor ≤4.3%
Percentage of test item with a respirable particle size <5.5 μm Cascade Impactor ≤0.78%