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:
01 December 2008 to 10 March 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols with no deviations from standard test guidelines and/or minor methodological deficiences which do not affect the quality of the relevant results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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)
Type of distribution:
other: Cumulative Mass

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): INK BH11 M
- Substance type: dark red powder
- Lot/batch No.: MB-1A
- Storage condition of test material: room temperature in the dark

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 passagesopen allclose all

Any other information on results incl. tables

Too few particles were of a size less than 10.0 µm to allow accurate assessment of mass median aerodynamic diameter.

Measurement

Method

Result

Proportion of test material having an inhalable particle size less than 100 pm

Sieve

42.6%

Proportion of test material having a thoracic particle size less than 10.0 pm

Cascade

Impactor

0 259%

Proportion of test material having a respirable particle size less than 5.5 pm

Cascade

Impactor

0.111%

Applicant's summary and conclusion

Conclusions:
The test material was shown to contain 42.6 % of particles to be <100 μm, 0.259% of particles to be <10 μm and 0.111% of particles to be
<5.5 μm.
Executive summary:

In a determination of general physico-chemical properties study (Harlan project number: 0959/0234) The substance was shown to contain 42.6 % of particles to be <100 μm, 0.259% of particles to be <10 μm and 0.111% of particles to be <5.5 μm.