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EC number: 265-967-5 | CAS number: 65894-76-0
- 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:
- 28 July 2017 to 05 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- cascade impaction
- Remarks on result:
- other: 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:
- < 100 µm
- Distribution:
- 58.4 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- 1.28 %
- No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- 0.443 %
- Conclusions:
- Under the conditions of this study the proportion of test item having an inhalable particle size <100 µm determined by sieving was 58.4 %. The proportion of test item having a thoracic particle size <10.0 µm, determined by the cascade impactor was 1.28. % and the proportion of test item having a respirable particle size <5.5 µm, also determined by the cascade impactor was 0.443 %.
- Executive summary:
The particle size distribution of the test material was investigated in accordance with the European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances. The test was performed under GLP conditions.
The test material was first evaluated using a sieving screening test and then using the cascade impactor method.
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 material container for approximately 10 minutes and then sampling from the top (determination 1), middle (determination 2) and bottom (determination 3).
Under the conditions of this study the proportion of test material having an inhalable particle size <100 µm determined by sieving was 58.4 %. The proportion of test material having a thoracic particle size <10.0 µm, determined by the cascade impactor was 1.28. % and the proportion of test material having a respirable particle size <5.5 µm, also determined by the cascade impactor was 0.443 %.
Reference
Sieving Screening Test
Table 2: Results of the Sieving Screening Test
Measurement |
Result |
Mass of test material transferred to sieve |
15.01 g |
Mass of test material passed through sieve |
8.77 g |
Proportion of test material <100 µm |
58.4 % |
Cascade Impactor Method
Table 3: Cascade Impactor Method Determination 1
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
≥10.0 |
86.0025 |
88.8318 |
2.8293 |
Cup 2 |
≥5.5 to <10.0 |
85.4564 |
85.4867 |
0.0303 |
Cup 3 |
≥2.4 to <5.5 |
85.8388 |
85.8461 |
0.0073 |
Cup 4 |
≥1.61 to <2.4 |
85.6099 |
85.6130 |
0.0031 |
Cup 5 |
≥0.307 to <1.61 |
85.7117 |
85.7128 |
0.0011 |
Filter |
<0.307 |
75.6023 |
75.6108 |
0.0085 |
- Mass of test material found in artificial throat: 0.0600 g.
- Total mass of test material recovered from artificial throat, sample cups and filter: 2.9396 g.
Table 4: Cascade Impactor Method Determination 2
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
≥10.0 |
86.0033 |
88.8698 |
2.8665 |
Cup 2 |
≥5.5 to <10.0 |
85.4571 |
85.4809 |
0.0238 |
Cup 3 |
≥2.4 to <5.5 |
85.8395 |
85.8451 |
0.0056 |
Cup 4 |
≥1.61 to <2.4 |
85.6113 |
85.6128 |
0.0015 |
Cup 5 |
≥0.307 to <1.61 |
85.7139 |
85.7166 |
0.0027 |
Filter |
<0.307 |
75.6020 |
75.6023 |
0.0003 |
- Mass of test material found in artificial throat: 0.0500 g.
- Total mass of test material recovered from artificial throat, sample cups and filter: 2.9504 g.
Table 5: Cascade Impactor Method Determination 3
Collection Stage |
Particle Size Range Collected (µm) |
Mass (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
Cup 1 |
≥10.0 |
86.0036 |
88.8501 |
2.8465 |
Cup 2 |
≥5.5 to <10.0 |
85.4573 |
85.4770 |
0.0197 |
Cup 3 |
≥2.4 to <5.5 |
85.8397 |
85.8447 |
0.0050 |
Cup 4 |
≥1.61 to <2.4 |
85.6105 |
85.6121 |
0.0016 |
Cup 5 |
≥0.307 to <1.61 |
85.7151 |
85.7163 |
0.0012 |
Filter |
<0.307 |
75.6041 |
75.6054 |
0.0013 |
- Mass of test material found in artificial throat: 0.1000 g.
- Total mass of test material recovered from artificial throat, sample cups and filter: 2.9753 g.
Table 6: The cumulative amounts of test material found in the three determinations for the individual particle size cut-points
Particle Size Cut-point (µm) |
Cumulative Mass (g) |
Cumulative Percentage (%) |
||||
Det. 1 |
Det. 2 |
Det. 3 |
Det. 1 |
Det. 2 |
Det. 3 |
|
10.0 |
0.0503 |
0.0339 |
0.0288 |
1.71 |
1.15 |
0.968 |
5.5 |
0.0200 |
0.0101 |
0.0091 |
0.680 |
0.342 |
0.306 |
2.4 |
0.0127 |
0.0045 |
0.0041 |
0.432 |
0.153 |
0.138 |
1.61 |
0.0096 |
0.0030 |
0.0025 |
0.327 |
0.102 |
8.4 x 10-2 |
0.307 |
0.0085 |
0.0003 |
0.0013 |
0.289 |
1.0 x 10-2 |
4.4 x 10-2 |
Table 7: The overall cumulative percentage (%) of test material with a particle size less than 10.0 µm and 5.5 µm
Particle Size |
Cumulative Percentage (%) |
|||
Determination 1 |
Determination 2 |
Determination 3 |
Mean |
|
<10.0 µm |
1.71 |
1.15 |
0.968 |
1.28 |
<5.5 µm |
0.680 |
0.342 |
0.306 |
0.443 |
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 material container for approximately 10 minutes and then sampling from the top (determination 1), middle (determination 2) and bottom (determination 3).
Description of key information
Under the conditions of this study the proportion of test material having an inhalable particle size <100 µm determined by sieving was 58.4 %. The proportion of test material having a thoracic particle size <10.0 µm, determined by the cascade impactor was 1.28. % and the proportion of test material having a respirable particle size <5.5 µm, also determined by the cascade impactor was 0.443 %.
Additional information
The particle size distribution of the test material was investigated in accordance with the European Commission Guidance Document EUR 20268 ‘Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances. The test was performed 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 evaluated using a sieving screening test and then using the cascade impactor method.
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 material container for approximately 10 minutes and then sampling from the top (determination 1), middle (determination 2) and bottom (determination 3).
Under the conditions of this study the proportion of test material having an inhalable particle size <100 µm determined by sieving was 58.4 %. The proportion of test material having a thoracic particle size <10.0 µm, determined by the cascade impactor was 1.28. % and the proportion of test material having a respirable particle size <5.5 µm, also determined by the cascade impactor was 0.443 %.
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