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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Technical Guidance Document EUR 20268 Determination of Particle Size Distribution
Version / remarks:
The method employed was based on a procedure designed to be compatible with that given in European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances (2002).
Deviations:
no
Principles of method if other than guideline:
The particle size distribution was evaluated based on internationally accepted guidelines. 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.

GLP compliance:
yes
Type of method:
cascade impaction
Type of particle tested:
other: powder
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Mass median aerodynamic diameter:
< 100 µm
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
ca. 22.6 %
No.:
#2
Size:
< 10 µm
Distribution:
< 1 %

Applicant's summary and conclusion

Conclusions:
The proportion of test item having an inhalable particle size of less than 100 μm was determined to be 22.6% by sieve analysis. Cascade impactor analysis identified negligible content (<1.0%) of the test item had a particle size <10 μm.