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:
March 2005 - April 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted using a method which complies with that specified in "Particle Size Distribution, Fibre Lenght and Diameter Distribution" (june 1996 European Commission technical guidance document), which satifies the requirements of OECD Guideline 110. Carries out in accordance with GLP. Study material is well characterized.

Data source

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

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
Type of method:
sieving
Remarks:
Screening test was carried out with sieving
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 passages
No.:
#1
Size:
< 100 µm
Distribution:
5.38 %

Any other information on results incl. tables

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

 Sieve Aperature Size (um) 100
 Massof test material transferred to sieve (g)  10.08
 Masss of test material passed through sieve (g) 0.54 
 Test material less than sieve aperature size (%) 5.38 

Applicant's summary and conclusion

Conclusions:
The test material is considered to be of a particle size that is essentially non-inhalable
Executive summary:

The Proportion of the test material having an inhalable particle size less than 100 um is 5.38%. The test material is considered to be of a particle size that is essentially non-inhalable.