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 october 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: European Commission 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: particulate/powder
Details on test material:
Cream to white powder

Results and discussion

Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
ca. 13.3 %
No.:
#2
Size:
< 10 µm
Distribution:
<= 2.25 %
No.:
#3
Size:
< 5.5 µm
Distribution:
<= 0.14 %

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 13.3%
Percentage of test item with a thoracic particle size <10.0 μm Cascade Impactor ≤ 2.25%
Percentage of test item with a respirable particle size <5.5 μm Cascade Impactor ≤0.14%
Executive summary:

Particle size data was acquired 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:

Measurement                                                                                  Method                        Result

Proportion of test item having an inhalable particle size <100 μm       Sieve                          13.3%

Proportion of test item having a thoracic particle size <10.0 μm       Cascade Impactor       ≤ 2.25%

Proportion of test item having a respirable particle size <5.5 μm       Cascade Impactor       ≤0.14%