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:
18/08/2008-17/10/2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

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

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)
Remarks:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
See Section 1.2

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 passages
No.:
#1
Size:
<= 100 µm
Distribution:
8.33 %

Any other information on results incl. tables

The results of the sieving procedure are shown in the following table:

Sieve aperture size (µm)

100

Mass of test material transferred to sieve (g)

12.0

Mass of test material passed through sieve (g)

1.0

Test material less than sieve aperture size (%)

8.33

Applicant's summary and conclusion

Conclusions:
The proportion of test material having an inhalable particle size less than 100 µm was 8.33%. The test material has been determined to be essentially non-inhalable.
Executive summary:

The method used is designed to comply with that given in ‘Particle Size Distribution, Fibre Length and Diameter Distribution’, June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 110.

The proportion of test material having an inhalable particle size less than 100 µm was 8.33%. The test material has been determined to be essentially non-inhalable.