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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:
The study was conducted between 10 June 2005 and 11 August 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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 - Method A: Particle Size Distribution (effective hydrodynamic radius)
GLP compliance:
yes (incl. certificate)
Type of method:
cascade impaction
Type of particle tested:
other: not specified, substance is a crystalline solid
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
Description: white crystalline solid
Lot number: 4172005
Date recieved: 02 June 2005
Storage conditions: room temperature, in the dark

Results and discussion

Remarks on result:
not determinable
Remarks:
Too few particles were of a size less than 10.2 μm to allow accurate assessment of mass median aerodynamic diameter.
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 100 µm
Distribution:
61 %
No.:
#2
Size:
< 10.2 µm
Distribution:
4.24 %
No.:
#3
Size:
< 5.4 µm
Distribution:
0.506 %

Any other information on results incl. tables

Screening test (sieve method)

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)

10.0

Mass of test material passed through sieve (g)

6.1

Test material less than sieve aperture size (%)

61.0

The overall cumulative amounts of test material with a particle size less than 10.2 μm (%) from Determinations 1 to 3 are shown in the following table:

Determination

Cumulative Amount of Test Material Less than 10.2µm (%)

Mean Cumulative Amount of Test Material Less than 10.2µm (%)

1

4.92

 

4.24

2

3.35

3

4.45

The overall cwnulative amounts of test material with a particle size less than 5.4 μm (%) from Determinations 1 to 3 are shown in the following table:

Determination

Cumulative Amount of Test Material Less than 5.4µm (%)

Mean Cumulative Amount of Test Material Less than 5.4µm (%)

1

0.660

 

0.506

2

0.514

3

0.343

Applicant's summary and conclusion

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 less than 100 μm Sieve 61.0%
Proportion of test material having a thoracic particle size less than 10.2 μm Cascade impactor 4.24%
Proportion of test material having a respirable particle size less than 5.4 μm Cascade impactor 0.506%
Executive summary:

Particle size data have been acquired using a procedure designed to comply with the European Commision technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June 1996), which satisifes the requirements of OECD Guideline 110. The results are as follows:

Measurement                                                                                                                  Method                                Result

Proportion of test material having an inhalable particle size less than 100 μm                       Sieve                                  61.0%

Proportion of test material having a thoracic particle size less than 10.2 μm                         Cascade impactor              4.24%

Proportion of test material having a respirable particle size less than 5.4 μm                        Cascade impactor              0.506%