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:
2008-9-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Official print-out from Coulter LS particle size analyser, and not in the form of a full report.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A standard method using a Coulter LS particle size analyser was used. The model was an optical model Fraunhofer.rf780d (PIDS included). The run length was 62 seconds with pump speed set to 51, obscuration 15% and PIDS obscuration at 73%. The fluid used was methanol.
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Molecular formula of test material: MnS04.H2O

Results and discussion

Particle size
Key result
Percentile:
D50
Mean:
ca. 199.8 µm
Remarks on result:
other: Standard deviation not reported.
Remarks:
Standard deviation not reported.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
ca. 18.7 %
No.:
#2
Size:
< 8 µm
Distribution:
ca. 4.35 %

Any other information on results incl. tables

Please see attached report for tabulated results.

Applicant's summary and conclusion

Conclusions:
The particle size distribution test indicates that 18.7 % of the substance has particles less than 100 microns and therefore can be considered to be potentially inhalable.