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EC number: 231-162-2 | CAS number: 7440-54-2
- 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
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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:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Particle size investigated using laser diffraction technology.
- GLP compliance:
- not specified
- Type of method:
- Laser scattering/diffraction
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- No particle size measurements were available because the test material was soluble in water.
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- no particle size measurements were available because the test material was soluble in water.
- Conclusions:
- Under the conditions of the study, no particle size measurements were available because the test material was soluble in water.
- Executive summary:
The analysis was carried out on a Microtrac S3500 which uses laser diffraction technology. 500 µL of detergent (TSPP 5 %) was added to improve the distribution of the material in the solvent distilled water. The suspension of the material was treated ultrasonically to destroy potential agglomerates. Particle size determination was conducted in triplicate and the average taken.
Under the conditions of the study, no particle size measurements were available because the test material was soluble in water.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 August 2017 to13 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- Too few particles were of a size less than 10.0 μm to allow accurate assessment of the mass median aerodynamic diameter.
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- <= 0.81 %
- No.:
- #2
- Size:
- < 5.5 µm
- Distribution:
- <= 0.239 %
- Conclusions:
- Under the conditions of this study, the proportion of test material having an inhalable particle size <100 μm was 99.7 % from the sieving method. The overall cumulative percentage with a thoracic particle size less than 10.0 μm: ≤ 0.810 % and the overall cumulative percentage with a respirable particle size less than 5.5 μm: ≤ 0.239 %.
- Executive summary:
The particle size distribution of the test material was determined in accordance with the standardised guideline of the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, under GLP conditions.
The test material was first subjected to a screening test using sieving apparatus and then a cascade impactor was used for the main test.
Sampling for the cascade impactor determinations was performed by rolling the test material 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.
The proportion of test material having an inhalable particle size <100 μm was 99.7 % from the sieving method. The overall cumulative percentage with a thoracic particle size less than 10.0 μm: ≤ 0.810 % and the overall cumulative percentage with a respirable particle size less than 5.5 μm: ≤ 0.239 %.
Referenceopen allclose all
Table 2: Results of the Sieving Screening Test
Measurement |
Result |
Mass of test material transferred to sieve (W1) |
10.72 g |
Mass of test material passed through sieve (W3 – W2) |
10.69 g |
Percentage of test material less than 100 μm |
99.7 % |
Table 3: Results of the Cascade Impactor
Collection Stage |
Particle Size Range Collected (µm) |
Collected Mass (g) |
||
Determination 1 |
Determination 2 |
Determination 3 |
||
Artificial Throat |
N/A |
0.39 |
0.16 |
0.14 |
Sample Cup 1 |
>10.0 |
2.4879 |
2.7548 |
2.6385 |
Sample Cup 2 |
5.5 to 10.0 |
0.0177 |
0.0063 |
0.0124 |
Sample Cup 3 |
2.4 to 5.5 |
0.0040 |
0.0009 |
0.0028 |
Sample Cup 4 |
1.61 to 2.4 |
0.0004 |
0.0000 |
0.0027 |
Sample Cup 5 |
0.307 to 1.61 |
0.0000 |
0.0001 |
0.0006 |
Final Filter |
<0.307 |
0.0014 |
0.0012 |
0.0006 |
Total mass of collected test material |
2.9014 |
2.9233 |
2.7976 |
|
Mass of test material added |
3.0209 |
2.9866 |
3.0109 |
Table 4: Table to show the cumulative amounts of test material collected in the three determinations for the individual particle size cut-points
Particle Size Cut Points (μm) |
Cumulative Mass (g) |
Cumulative Percentage (%) |
||||
Determination 1 |
Determination 2 |
Determination 3 |
Determination 1 |
Determination 2 |
Determination 3 |
|
<10.0 |
0.0235 |
0.0085 |
0.0191 |
0.810 |
0.291 |
0.683 |
<5.5 |
0.0058 |
0.0022 |
0.0067 |
0.200 |
0.075 |
0.239 |
<2.4 |
0.0018 |
0.0013 |
0.0039 |
0.062 |
0.044 |
0.139 |
<1.61 |
0.0014 |
0.0013 |
0.0012 |
0.048 |
0.044 |
0.043 |
<0.307 |
0.0014 |
0.0012 |
0.0006 |
0.048 |
0.041 |
0.021 |
- Overall cumulative percentage with a particle size less than 10.0 μm: ≤ 0.810 %
- Overall cumulative percentage with a particle size less than 5.5 μm: ≤ 0.239 %
Sampling for the cascade impactor determinations was performed by rolling the test material 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.
Table 5: Summary of Results
Measurement |
Method |
Result |
Percentage of test material with an inhalable particle size <100 μm |
Sieve |
99.7 % |
Percentage of test material with a thoracic particle size <10.0 μm |
Cascade Impactor |
≤0.810 % |
Percentage of test material with a respirable particle size <5.5 μm |
Cascade Impactor |
≤0.239 % |
Description of key information
Fox, 2018
The proportion of test material having an inhalable particle size <100 μm was 99.7 % from the sieving method. The overall cumulative percentage with a thoracic particle size less than 10.0 μm: ≤ 0.810 % and the overall cumulative percentage with a respirable particle size less than 5.5 μm: ≤ 0.239 %.
Additional information
Fox, 2018
The particle size distribution of the test material was determined in accordance with the standardised guideline of the European Commission Technical Guidance Document EUR 20268 Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
The test material was first subjected to a screening test using sieving apparatus and then a cascade impactor was used for the main test.
Sampling for the cascade impactor determinations was performed by rolling the test material 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.
The proportion of test material having an inhalable particle size <100 μm was 99.7 % from the sieving method. The overall cumulative percentage with a thoracic particle size less than 10.0 μm: ≤ 0.810 % and the overall cumulative percentage with a respirable particle size less than 5.5 μm: ≤ 0.239 %.
Flatschacher, 2017
The analysis was carried out on a Microtrac S3500 which uses laser diffraction technology. 500 µL of detergent (TSPP 5 %) was added to improve the distribution of the material in the solvent distilled water. The suspension of the material was treated ultrasonically to destroy potential agglomerates. Particle size determination was conducted in triplicate and the average taken.
Under the conditions of the study, no particle size measurements were available because the test material was soluble in water.
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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