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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

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: There were too few particles to allow accurate assessment of the mass median aaerodynamic diameter(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:
65.3 %
No.:
#2
Size:
> 10 - < 100 µm
Distribution:
19.5 %
No.:
#3
Size:
> 5.5 - < 10 µm
Distribution:
ca. 12.09 %
No.:
#4
Size:
< 5.5 µm
Distribution:
ca. 3.11 %

Applicant's summary and conclusion

Conclusions:
Proportion of testitem having an inhalable particle size less than 100µm (Sieve) is 34.7%. Proportion of testitem having a Thoracic particle size less than 10µm is 15.2%. Proportion of test item having a respirable particle size less than 5.5µm is 3.11%
Executive summary:

Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, fibre length and diameter distribution' (June 1996), which satisfies the requirements of OECD guideline 110