Registration Dossier

Diss Factsheets

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
Remarks:
non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Laser diffraction
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(aminoiminomethyl)thio]propanesulphonic acid
EC Number:
244-520-8
EC Name:
3-[(aminoiminomethyl)thio]propanesulphonic acid
Cas Number:
21668-81-5
Molecular formula:
C4H10N2O3S2
IUPAC Name:
3-(carbamimidoylsulfanyl)propane-1-sulfonic acid

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
15.85 µm
Remarks on result:
other: standard deviation not available
Key result
Percentile:
D50
Mean:
99.12 µm
Remarks on result:
other: standard deviation not available
Key result
Percentile:
D90
Mean:
332 µm
Remarks on result:
other: standard deviation not available

Applicant's summary and conclusion

Conclusions:
Average size of particles (volume): 143.788 μm
D10 = 15.85 μm
D50 = 99.12 μm
D90 = 332.00 μm
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.
Executive summary:

The particle size distribution of the test substance was investigated by laser diffraction based on Mie Scattering (non-GLP, 2016) and the average size of particles has been determined to be 143.788 µm (D10 = 15.85 µm, D50 = 99.12 µm, D90 = 332.00 µm).

According to the results, the inhalation of particles has to be regarded as less significant:

- ~ 50% are < 100 µm (inhalable fraction)

- ~ 5 % are < 10 µm (thoracic fraction)

- 0% are < 4µm (respirable fraction)

Categories Display