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:
02/12/2008 to 17/02/2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with recognised guideline.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
25.2 %
No.:
#2
Size:
< 10 µm
Distribution:
0.477 %
No.:
#3
Size:
< 5.5 µm
Distribution:
0.148 %

Any other information on results incl. tables

Particle size data acquired for the test material are shown in the following table:

Measurement

Method

Result

Proportion of test material having an inhalable particle size less than 100 µm

Sieve

25.2%

Proportion of test material having a thoracic particle size less than 10.0 µm

Cascade

Impactor

0.477%

Proportion of test material having a respirable particle size less than 5.5 µm

Cascade

Impactor

0.148%

Applicant's summary and conclusion

Conclusions:
The test material was shown to contain 25.2 % of particles to be <100 µm, 0.477% of particles to be <10 µm and 0.148% of particles to be <5.5 µm.
Executive summary:

In a determination of general physico-chemical properties study (Harlan project number: 0959/0224) the test material was shown to contain 25.2 % of particles to be <100 µm, 0.477% of particles to be <10 µm and 0.148% of particles to be <5.5 µm.