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:
April 2017 - 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
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CIPAC MT 187
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Batch number: 80100005
Expiration date: 13 October 2018
Purity: 99.8%
Stored at Room temperature (nominally 15 to 25C), dark
Physical state/appearance: White solid

Results and discussion

Mass median aerodynamic diameter:
174 µm
Particle sizeopen allclose all
Percentile:
D10
Mean:
79 µm
Remarks on result:
other: No standard deviation
Key result
Percentile:
D50
Mean:
174 µm
Remarks on result:
other: No standard deviation
Percentile:
D90
Mean:
398 µm
Remarks on result:
other: No standard deviation

Any other information on results incl. tables

Table 1. Overall mean values for the 10%, 50% and 90% quantile particle size results for WS-23

 Parameter  Size (µm)
 d(0.1) 79 
 d(0.5) 174 
 d(0.9) 398 

d(0.1): diameter at which 10% of the particle distribution is smaller and 90% is larger.

d(0.5): diameter at which 50% of the particle distribution is smaller and 50% is larger. This value is also known as the Mass Median Diameter (MMD).

d(0.9): diameter at which 90% of the particle distribution is smaller and 10% is larger.

Applicant's summary and conclusion

Conclusions:
Following determination of particle size distribution of WS-23, 10% of the distribution had a diameter of ≤79 µm, 50% had a diameter of ≤174 µm and 90% had a diameter of ≤398 µm. The Median Diameter (MMD) is determined to be 174 µm.
Executive summary:

The size distribution of particles present in the WS-23 was assessed using particle size apparatus based on laser diffraction. Following determination of particle size distribution of WS-23, 10% of the distribution had a diameter of ≤79 µm, 50% had a diameter of ≤174 µm and 90% had a diameter of ≤398 µm. The Mass Median Diameter (MMD) is determined to be 174 µm.