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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: no guideline specified
Principles of method if other than guideline:
Diffraction particle size distribution
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
>= 61.62 - <= 74.25 µm
Remarks on result:
other: six samples tested
Percentile:
D50
Mean:
>= 414.5 - <= 468.1 µm
Remarks on result:
other: six samples tested
Percentile:
D90
Mean:
>= 653 - <= 868.9 µm
Remarks on result:
other: six samples tested

Applicant's summary and conclusion

Conclusions:
The study was performed in accordance with generally accepted scientific standards and described in sufficient detail and therefore reliability of Klimisch 2 has been assigned.
The particle size distribution was investigated based on the theory of laser diffraction with the following results:
D10: 61.62 - 74.25 μm
D50 (mass median diameter, MMD): 414.5 - 468.1 µm
D90 = 653.0 - 868.9 μm
Executive summary:

The particle size distribution of the test substance was investigated (non-GLP, 2019) based on the theory of laser diffraction with the following results:

D10: 61.62 - 74.25 μm

D50 (mass median diameter, MMD): 414.5 - 468.1 µm

D90 = 653.0 - 868.9 μm

The inhalation of particles has to be regarded as follows:

- ca. 16% are <100 µm (inhalable fraction)

- 0% are <10 µm (thoracic fraction)

- 0% are < 4µm (respirable fraction)