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Diss Factsheets
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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Jul - 16 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Guidance Document EUR 20268 (Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances)
- Version / remarks:
- adopted in 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health, London, UK
- Type of method:
- other: Sieve Screening Test + Cascade Impactor
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
Test material
Constituent 1
- Specific details on test material used for the study:
- 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 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 99.5 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- ca. 1.18 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- ca. 0.33 %
Any other information on results incl. tables
Sieve screening test
The results of the sieving procedure are shown in the following table
Table 2
Measurement |
Result |
Mass of test item transferred to sieve |
12.72 g |
Mass of test item passed through sieve |
12.65 g |
Percentage of test item less than 100 μm |
99.5% |
Cascade impactor
The results of the cascade impactor procedure are shown in the following table
Table 3
Collection stage |
Particle size range collected [μm] |
Collected mass [g] |
||
Determination 1 |
Determination 2 |
Determination 3 |
||
Artificial throat |
n/a |
0.11 |
0.26 |
0.34 |
Cup 1 |
>10.0 |
2.8421 |
2.7082 |
2.6418 |
Cup 2 |
5.5 to 10.0 |
0.0200 |
0.0266 |
0.0302 |
Cup 3 |
2.4 to 5.5 |
0.0041 |
0.0056 |
0.0069 |
Cup 4 |
1.61 to 2.4 |
0.0014 |
0.0028 |
0.0016 |
Cup 5 |
0.307 to 1.61 |
0.0008 |
0.0013 |
0.0014 |
Final filter |
<0.307 |
0.0006 |
0.0016 |
0.0016 |
Total mass of collected test item |
2.9790 |
3.0061 |
3.0235 |
|
Mass of test item added |
3.0055 |
3.0317 |
3.0439 |
The cumulative amounts of test item collected in the three determinations for the individual particle size cut-points are shown in the following table.
Table 4
Particle size cut point [μm] |
Cumulative mass [g] |
Cumulative percentage [%]
|
||||
Determination 1 |
Determination 2 |
Determination 3 |
Determination 1 |
Determination 2 |
Determination 3 |
|
<10.0 |
0.0269 |
0.0379 |
0.0417 |
0.90 |
1.26 |
1.38 |
<5.5 |
0.0069 |
0.0113 |
0.0115 |
0.23 |
0.38 |
0.38 |
<2.4 |
0.0028 |
0.0057 |
0.0046 |
9.4E-02 |
0.19 |
0.15 |
<1.61 |
0.0014 |
0.0029 |
0.0030 |
4.7E-02 |
9.6E-02 |
9.9E-02 |
<0.307 |
0.0006 |
0.0016 |
0.0016 |
2.0E-02 |
5.3E-02 |
5.3E-02 |
Mean cumulative percentage with a particle size less than 10.0 μm: 1.18%
Mean cumulative percentage with a particle size less than 5.5 μm: 0.33%
Discussion
Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes then sampled from the top, middle and bottom.
The overall results from the cascade impactor were taken as limit values due to the variation between the sampling positions; this gives a worst case scenario.
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
The inhalable fraction is defined as the mass fraction of particles which can be inhaled by nose or mouth, the thoracic fraction is defined as the mass fraction of particles that passes the larynx and the respirable fraction is defined as the mass fraction of particles that reaches the alveoli.
Conclusion
Particle size data acquired for the test item is shown in the following table
Table 5
Measurement |
Method |
Result |
Percentage of test item with an inhalable particle size <100 μm |
Sieve |
99.5% |
Percentage of test item with a thoracic particle size <10.0 μm |
Cascade impactor |
1.18% |
Percentage of test item with a respirable particle size <5.5 μm |
Cascade impactor |
0.33% |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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