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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:
2012-02-07 - 2012-05-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: non-GLP guideline study, but test procedure well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ISO 13320-1
Deviations:
no
Qualifier:
according to
Guideline:
other: In-house test method VTA(S)13X11001.01
Deviations:
no
Principles of method if other than guideline:
The particle size distribution is analysed by laser scattering analysis. Laser light interacts with the particles causing diffraction, refraction and absorption, thus producing a characteristic pattern of scattered light. If the particle size is significantly higher than the wavelength of the laser light predominantly diffraction patterns are produced. The information about the particle size is calculated from diffraction angles using the Fraunhofer theory. Using a red Laser Diode and a blue LED light source, the LA-950V2 is able to analyze particles in the range between 0.01 µm and 3,000 µm in diameter.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Physical state: white solid

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
9.4 µm
St. dev.:
0.12
Percentile:
D50
Mean:
50.8 µm
St. dev.:
0.71
Percentile:
D90
Mean:
138.1 µm
St. dev.:
2.26

Applicant's summary and conclusion

Conclusions:
D10 = 9.4 μm ± 0.12 µm
D50 = 50.8 μm ± 0.71 µm= mass median aerodynamic diameter (MMAD)
D90 = 138.1 μm ± 2.26 µm