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Diss Factsheets
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EC number: 948-061-0 | 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
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 November 2016 - 16 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- The determination was performed using a procedure designed to be compatible with the European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’ (2002). No deviation affected the quality of the study. The substance is considered to be adequately characterised. Therefore full validation applies.
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Technical Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances’
- Version / remarks:
- 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP compliance programme (inspected on 05 July 2016 / signed on 28 Octobre 2016)
- Type of method:
- cascade impaction
- Remarks:
- pre-test with Sieving method.
- Type of particle tested:
- other: free-flowing, soft, fine powder, which forms hard clumps (not easily broken down) of various sizes.
- Type of distribution:
- mass based distribution
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- ca. 10 %
- Remarks on result:
- other: Proportion of test item having an inhalable particle size <100 μm
- Remarks:
- Sieving
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- ca. 1.06 %
- Remarks on result:
- other: Proportion of test item having a thoracic particle size <10.0 μm
- Remarks:
- Cascade Impactor
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- ca. 0.044 %
- Remarks on result:
- other: Proportion of test item having a respirable particle size <5.5 μm
- Remarks:
- Cascade Impactor
- Conclusions:
- Proportion of test item having an inhalable particle size <100 μm =10.0%Proportion of test item having a thoracic particle size <10.0 μm=1.06%Proportion of test item having a respirable particle size <5.5 μm= 0.044%
- Executive summary:
The particle size distribution is evaluated based on internationally accepted guidelines. 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. These individual fractions are estimated as follows:
Measurement
Method
Result
Proportion of test item having an inhalable particle size <100μm
Sieving
10.0%
Proportion of test item having a thoracic particle size <10.0μm
Cascade Impactor
1.06%
Proportion of test item having a respirable particle size <5.5μm
Cascade Impactor
4.4 x 10-2%
Reference
Results
Sieving Screening Test
The results of the sieving procedure are:
Mass of test item transferred to sieve 11.85 g
Mass of test item passed through sieve 1.19 g
Proportion of test item <100 μm 10.0%
Cascade Impactor Method
The results of the cascade impactor determinations are shown in the tables on the experimetal report.
(Negligible negative mass differences have not been considered for the calculations and are presented as 0.00 in tables).
Determination 1:
Mass of test item found in artificial throat: 0.17 g.
Total mass of test item recovered from artificial throat, sample cups and filter: 3.0118 g.
Detemination 2:
Mass of test item found in artificial throat: 0.25 g.
Total mass of test item recovered from artificial throat, sample cups and filter: 3.0710 g.
Determination 3:
Mass of test item found in artificial throat: 0.58 g.
Total mass of test item recovered from artificial throat, sample cups and filter: 2.9929 g.
The cumulative amounts of test item found in the three determinations for the individual particle size cut-points are shown in tables in the experimental report.
The overall cumulative percentage (%) of test item with a particle size less than 10.0 μm and 5.5 μm are shown in the following table:
Particle Size | Cumulative Percentage (%) | |||
| Determination 1 | Determination 2 | Determination 3 | Mean |
<10.0 μm | 0.528 | 0.840 | 1.81 | 1.06 |
<5.5 μm | 7 x 10-3 | 7.5 x 10-2 | 5.0 x 10-2 | 4.4 x 10-2 |
Discussion
Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
Sampling for the cascade impactor determinations was performed by rolling the test item container for approximately 10 minutes and then sampling from the top (determination 1), middle (determination 2) and bottom (determination 3).
Description of key information
Proportion of test item having an inhalable particle size <100 μm =10.0%
Proportion of test item having a thoracic particle size <10.0 μm=1.06%
Proportion of test item having a respirable particle size <5.5 μm= 0.044%
Additional information
The particle size distribution is evaluated based on internationally accepted guidelines. 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. These individual fractions are estimated as follows:
Measurement | Method | Result |
Proportion of test item having an inhalable particle size <100μm | Sieving | 10.0% |
Proportion of test item having a thoracic particle size <10.0μm | Cascade Impactor | 1.06% |
Proportion of test item having a respirable particle size <5.5μm | Cascade Impactor | 4.4 x 10-2% |
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