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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: reliable, well documented GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction
Deviations:
no
Qualifier:
according to
Guideline:
other: ISO13320-1: Particle Size Analysis - Laser Diffraction Methods
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
ca. 7.8 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
1.2 µm
Percentile:
D50
Mean:
7.8 µm
Percentile:
D90
Mean:
66.7 µm

Any other information on results incl. tables

The percentage of particles < 2 µm is < 16 % and >= 200 µm is < 2.2 %; the substance consists of rod like crystals.

Applicant's summary and conclusion