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:
20 February 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Laser diffraction method using a Malvern Mastersizer 3000 dry
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

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

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
>= 41.4 - <= 51.5 µm
Remarks on result:
other: range based on 3 runs
Percentile:
D50
Mean:
>= 213 - <= 230 µm
Remarks on result:
other: range based on 3 runs
Percentile:
D90
Mean:
>= 456 - <= 472 µm
Remarks on result:
other: range based on 3 runs

Any other information on results incl. tables

Distribution width: 1.765 -2.017

Applicant's summary and conclusion

Conclusions:
90% of the particles in the sample was > 40 um, which is above inhalable or respirable size.