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Diss Factsheets

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:
31st March 2007 to 01 May 2007
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:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 30th August 2005 Date of signature: 21st November 2005
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification :C-C1
Description : dark blue powder
Lot number : MB-1
Date received : 05 March 2007
Storage conditions :room temperature in the dark, over silica gel

Results and discussion

Particle size
Percentile:
D50
Remarks on result:
other: Too few particles were of a size less than 10.0 µm 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:
10 µm
Distribution:
2.585 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.27 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0445 g.
No.:
#1
Size:
5.5 µm
Distribution:
0.44 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.27 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0445 g.
No.:
#1
Size:
2.4 µm
Distribution:
0.161 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.27 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0445 g.
No.:
#1
Size:
1.6 µm
Distribution:
8.212 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.27 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0445 g.
No.:
#1
Size:
0.307 µm
Distribution:
5.584 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.27 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0445 g.
No.:
#2
Size:
10 µm
Distribution:
2.707 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.15 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0037 g.
No.:
#2
Size:
5.5 µm
Distribution:
0.476 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.15 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0037 g.
No.:
#2
Size:
2.4 µm
Distribution:
0.186 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.15 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0037 g.
No.:
#2
Size:
1.61 µm
Distribution:
0.11 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.15 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0037 g.
No.:
#2
Size:
0.307 µm
Distribution:
5.327 %
Remarks on result:
other: Amount of test material found in artificial throat: 0.15 g. Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0037 g.

Any other information on results incl. tables

Determination #3

Particle Size Cut-points (µm)

Cumulative Amount of Test Material (%)

10.0

2.528

5.5

0.461

2.4

0.176

1.61

9.277 x 10-2

0.307

3.313 x 10-2

Amount of test material found in artificial throat: 0.11 g.
Total amount of test material recovered from impactor cups, filter (0.307µm) and artificial throat: 3.0182 g.

Determination

Cumulative Amount of Test Material

Less Than 5.5 µm (%)

Mean Cumulative Amount of Test Material Less Than 5.5 µm (%)

1

0.440

0.459

2

0.476

3

0.461

Applicant's summary and conclusion

Conclusions:
Based on the sample tested the substance is not considered to contain sufficient particles of inhalable size. Therefore exposure to the substance is unlikley to be through inhalation.
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 of less than 100 µm was found to be 42.5%.

The proportion having a thoracic particle size of less than 10.0 µm was 2.61% and the proportion having a respirable aprticle size of less than 5.5 µm was 0.459%.