Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- 2 009
- Report date:
- 2009
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)
- Type of distribution:
- other: Cumulative Mass
Test material
- 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
Constituent 1
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
- Size:
- 100 µm
- Distribution:
- 42.6 %
- Size:
- 10 µm
- Distribution:
- 0.259 %
- Size:
- 5.5 µm
- Distribution:
- 0.111 %
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.
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