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:
Testing was conducted between 1st September to 10th October 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 110 (Sieving / Cascade Impaction method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Too few particles were of a size less than 10.2 pm to allow accurate assessment of mass median aerodynamic 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:
ca. 39.8 %
No.:
#2
Size:
ca. 10.2 µm
Distribution:
ca. 8.47 %
No.:
#3
Size:
ca. 5.4 µm
Distribution:
ca. 1.36 %

Any other information on results incl. tables

Particle Size Distribution:
Proportion of test material having an inhalable particle size less than 100 um = 60.2%
Proportion of test material having a thoratic particle size less than 10.2 um = 8.47%
Proportion of test material having a respirable particle size less than 5.4 um = 1.36%
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Representative sampling was ensured by rolling the sample container for approximately 10 minutes and sampling from the top, middle and bottom prior to definitive testing.

The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.

Applicant's summary and conclusion

Conclusions:
See table in excutive summary
Executive summary:

Introduction:

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 1 10.

Results and conclusions:

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 les than 100µm  sieve  60.2%
 Proportion of test material having a thoracic particle size less than 10.2µm  Cascade Impactor  8.47%
 Proportion of test material having a respirable particle size less than 5.4µm  Cascade Impactor  1.36%