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:
September 2017 to January 2018
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Deviations:
no
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Principles of method if other than guideline:
Laser diffraction
GLP compliance:
yes (incl. certificate)
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
Details on test material:
MIT.HCl as manufacured has a purity of >99.9% therefore the technical grade and analytical grade are identical
Specific details on test material used for the study:
Batch Number 10013913, Purity >99.9%, Expiry Date 30 November 2018
Analytical grade and technical grade material are identical

Results and discussion

Mass median aerodynamic diameter:
ca. 105 µm
Geometric standard deviation:
ca. 3.7
Particle size
Key result
Percentile:
D50
Mean:
ca. 105.4 µm
St. dev.:
3.7

Applicant's summary and conclusion

Conclusions:
The median particle size L50 of the test item deduced from the particle size distributions was:
105.0 µm.
The GSD deduced from these distributions was:
σg = 3.7