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:
2017-01-12 - 2017-01-13 (experimental phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
by the Department of Health of the Government of the United Kingdom
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Density: 1.033 g/cm³
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

Results and discussion

Mass median aerodynamic diameter:
18.017 µm
Geometric standard deviation:
0.14
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
6.728 µm
St. dev.:
0.035
Key result
Percentile:
D50
Mean:
17.727 µm
St. dev.:
0.137
Key result
Percentile:
D90
Mean:
43.34 µm
St. dev.:
0.67
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 15 µm
Distribution:
ca. 39.82 %
No.:
#2
Size:
< 50 µm
Distribution:
ca. 91.9 %
No.:
#3
Size:
< 100 µm
Distribution:
ca. 93.4 %

Applicant's summary and conclusion

Conclusions:
Particle size distribution was determined by a scientifically reasonably study according to ISO 13320:2009 and CIPAC MT 187 under GLP, so there is no reason to conclude that the results are not reliable. Particle size distribution of (S)-(4,5-dihydro-5-thioxo-1,3,4-thiadiazol-2-yl)benzenecarbothioate revealed a MMAD of 18.017 µm.
Executive summary:

The results of the laser diffraction test conducted in accordance with ISO 13320:2009 and CIPAC MT 187 to determine the particle size of (S)-(4,5-dihydro-5-thioxo-1,3,4-thiadiazol-2-yl) benzenecarbothioate are summarised below. The analysis was conducted using the small volume (wet) module (SVM) with silicone oil as the dispersant.

 

Particle Size Analysis using small volume (wet) module (SVM)

Average (µm)

Volume weighted mean

27.628

Median

17.727

Mode

18.194

MMAD (mass median aerodynamic diameter)

18.017

d10 - 10 % of material is <

6.728

d50 - 50 % of material is <

17.727

d90 - 90 % of material is <

43.340

volume of sample < 10.00 µm

20.01 %