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EC number: 952-026-5 | 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:
- 01 February 2021 - 28 February 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: EUR 20268 EN 2002
- Version / remarks:
- 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)
- GLP compliance:
- yes
- Type of method:
- other: Cascade Impaction and sieving
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier): Imerys
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark - No.:
- #3
- Size:
- < 5.5 µm
- Distribution:
- 0.167 %
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- 0.649 %
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- 96.9 %
- Conclusions:
- Particle size data was acquired, 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). The results are as follows:
Percentage of test item with an inhalable particle size <100 μm - Sieve - 96.9%
Percentage of test item with a thoracic particle size <10.0 μm - Cascade Impactor - 0.649%
Percentage of test item with a respirable particle size <5.5 μm - Cascade Impactor - 0.167% - Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- March 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 5753
- Version / remarks:
- Method for determining the content of respirable particles in a sample of a substance containing
crystalline silica. - GLP compliance:
- not specified
- Type of method:
- other: Size Weighted Respirable Fraction
- Type of particle tested:
- agglomerate
- Type of distribution:
- volumetric distribution
- No.:
- #1
- Distribution:
- 0.1 %
- Remarks on result:
- other: Mean result of 9 runs
- Conclusions:
- Analysis of the particle size distribution via the SWeRF method demonstrates that the substance typically contains <0.1 % respirable crystalline silica and the upper specification limit is <=0.21 %. On this basis, classification is not required.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Particle size distribution on medium grade soda-ash flux calcined kieselguhr was determined using a Coulter model LS 100 particle size analyzer
- GLP compliance:
- no
- Type of distribution:
- counted distribution
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- other: 81.6 %
- Mean:
- < 90 µm
- Conclusions:
- The particle size distribution test indicates that the medium grade material has 81.6% < 90 µm. The substance is therefore considered to be inhalable.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Particle size distribution on fine and coarse grade soda-ash flux calcined kieselguhr was determined using a Coulter model LS 100 particle size analyzer
- Type of distribution:
- counted distribution
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- other: 59.5%
- Mean:
- < 90 µm
- Remarks on result:
- other: Coarse grade
- Percentile:
- other: 99.6%
- Mean:
- < 90 µm
- Remarks on result:
- other: Fine grade
- Conclusions:
- The particle size distribution test shows that the coarse grade has 59.5% < 90µm and the fine grade has 99.6% < 90µm. Both grades of the substance are considered to be inhalable.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-reported study
- Qualifier:
- according to guideline
- Guideline:
- other: The particle size distribution of the calcium silicate is measured using a Leeds and Northrup X100 particle size analyser
- Version / remarks:
- The particle size distribution of the calcium silicate is measured using a Leeds and Northrup X100 particle size analyser (which uses a laser diffraction technique to compute a particle size distribution chart). The data from the particle size analysis are then entered into the SWeRFcs calculation spreadsheet in order to determine the respirable crystalline silica content of the product.
- Deviations:
- no
- Principles of method if other than guideline:
- The particle size distribution was determined using a Leeds and Northrup X100 particle size analyser
- GLP compliance:
- no
- Type of method:
- other: The particle size distribution of the calcium silicate is measured using a Leeds and Northrup X100 particle size analyser
- Remarks:
- laser diffraction technique to compute a particle size distribution chart). The data from the particle size analysis are then entered into the SWeRFcs calculation spreadsheet in order to determine the respirable crystalline silica content of the product.
- Type of distribution:
- volumetric distribution
- Key result
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Key result
- Percentile:
- D50
- Mean:
- 20.805 µm
- Remarks on result:
- other: no data on SD
- Key result
- Percentile:
- D90
- Mean:
- 37.185 µm
- Remarks on result:
- other: no data on SD
- Key result
- Percentile:
- D10
- Mean:
- 11.177 µm
- Remarks on result:
- other: no data on SD
- Conclusions:
- The respirable crystalline silica content determined by entering the output from the particle size distribution analysis into the SWeRFcs calculation spreadsheet was <0.1 %.
- Executive summary:
Particle size analysis of a typical batch of calcium silicate showed the D10, D50 and D90 to be 11.18, 20.81 and 37.19 microns, respectively. Analysis of the data using the SWeRFcs calculation spreadsheet showed the respirable crystalline silica (RCS) content to be < 0.1 %. The specification limit for RCS is 0.9 %.
Referenceopen allclose all
Table 8 Results
Measurement | Result |
Mass of test item transferred to sieve (W1) | 11.04 g |
Mass of test item passed through sieve (W3 – W2) | 10.70 g |
Percentage of test item less than 100 µm | 96.9 % |
Cascade Impactor
The results of the cascade impactor procedure are shown in the following table:
Table 9 Results
Collection Stage | Particle Size Range Collection | Collected Mass (g) | ||
Determination 1 | Determination 2 | Determination 3 | ||
Artificial throat | n/a | 0.91 | 2.21 | 2.50 |
Sample Cup 1 | > 10.0 | 2.0738 | 0.7555 | 0.4699 |
Sample Cup 2 | 5.5 to 10.0 | 0.0122 | 0.0160 | 0.0150 |
Sample Cup 3 | 2.4 to 5.5 | 0.0032 | 0.0039 | 0.0035 |
Sample Cup 4 | 1.61 to 2.4 | 0.0022 | 0.0001 | 0.0003 |
Sample Cup 5 | 0.307 to 1.61 | 0.0005 | 0.0002 | 0.0001 |
Final Filter | <0.3.07 | 0.0003 | 0.0006 | 0.0001 |
Total mass of collected test item | 3.0022 | 2.9863 | 2.9889 | |
Mass of test item added | 2.9930 | 2.9955 | 2.9905 |
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 10 Overall Results
Particle Size Cut Points (µm) | Cumulative Mass (g) | Cumulative Percentage (%) | ||||
Determination 1 | Determination 2 | Determination 3 | Determination 1 | Determination 2 | Determination 3 | |
<10.0 | 0.0184 | 0.0208 | 0.0190 | 0.613 | 0.697 | 0.636 |
<5.5 | 0.0062 | 0.0048 | 0.0040 | 0.207 | 0.161 | 0.134 |
<2.4 | 0.0030 | 0.0009 | 0.0005 | 0.100 | 0.030 | 0.017 |
<1.61 | 0.0008 | 0.0008 | 0.0002 | 0.027 | 0.027 | 0.007 |
<0.307 | 0.0003 | 0.0006 | 0.0001 | 0.010 | 0.020 | 0.003 |
Mean cumulative percentage with a particle size less than 10.0 μm: 0.649% Mean cumulative percentage with a particle size less than 5.5 μm: 0.167%
Mineral Type | Malvern Laser Diff. (wt.%)Mie | Total Quartz (wt.%) XRD | Total Crystalline Silica (wt.%) XRD | Respirable Crystalline Silica wt.% (Calc.) | SWeRF (Sedimentation ) (wt.%) | Quartz in Respirable Fraction (wt.%) XRD | Cristobalite in Respirable Fraction (wt.%) XRD | Crystalline Silica in Respirable Fraction (wt.%) XRD | SWERF Respirable Crystalline Silica (wt.%) (Sedimentation) |
Syn Wollastonite | 35.33 | 1.14 | 1.14 | 0.4 | 1.9 |
|
| 2.5 | 0.05 |
Syn Wollastonite | 45.27 | 1.32 | 1.32 | 0.6 | 2.2 |
|
| 2.1 | 0.05 |
Syn Wollastonite | 6.72 | 1.7 | 1.7 | 0.11 | 2.25 | 1.7 |
| 1.7 | 0.04 |
Syn Wollastonite | 6.37 | 1.35 | 1.35 | 0.09 | 2.75 | 1.35 |
| 1.35 | 0.04 |
Syn Wollastonite | 7.67 | 1.43 | 1.43 | 0.11 | 2.82 | 1.43 |
| 1.43 | 0.04 |
Syn Wollastonite | 47.78 | 0.59 | 0.59 | 0.28 | 41.35 | 0.5 |
| 0.5 | 0.21 |
Syn Wollastonite | 33.39 | 0.85 | 0.85 | 0.28 | 29.77 | 0.7 |
| 0.7 | 0.21 |
Syn Wollastonite | 33.42 | 0.78 | 0.78 | 0.26 | 27.69 | 0.69 |
| 0.69 | 0.19 |
Syn Wollastonite | 58.06 | 0.28 | 0.28 | 0.16 | 33.02 |
| 0.32 | 0.32 | 0.11 |
Mean | 30.4 | 1.04 | 1.04 | 0.26 | 15.97 | 1.06 | 0.32 | 1.25 | 0.10 |
Table 1: Results of particle size analysis
Diameter of particles µm |
Volume % < |
Diameter of particles µm |
Volume % < |
1 |
1.89 |
40 |
56.4 |
1.5 |
3.09 |
50 |
64.1 |
2 |
3.89 |
60 |
69.9 |
3 |
5.12 |
75 |
76.7 |
4 |
6.28 |
80 |
78.5 |
6 |
8.76 |
90 |
81.6 |
8 |
11.5 |
125 |
89.2 |
10 |
14.7 |
160 |
93.2 |
12 |
18.2 |
250 |
97 |
16 |
25.4 |
320 |
98.2 |
20 |
32.2 |
400 |
99.1 |
24 |
38.3 |
500 |
99.7 |
28 |
43.7 |
600 |
99.95 |
Table 1: Results of particle size analysis on coarse grade
Diameter of particles |
Volume % < |
Diameter of particles |
Volume % < |
1 |
0.68 |
40 |
24.4 |
1.5 |
1.18 |
50 |
32.1 |
2 |
1.56 |
60 |
39.5 |
3 |
2.09 |
75 |
50 |
4 |
2.49 |
80 |
53.3 |
6 |
3.18 |
90 |
59.5 |
8 |
3.84 |
125 |
76.4 |
10 |
4.56 |
160 |
86.6 |
12 |
5.39 |
250 |
96.2 |
16 |
7.3 |
320 |
98.3 |
20 |
9.59 |
400 |
99.3 |
24 |
12.2 |
500 |
99.8 |
28 |
15.1 |
600 |
99.98 |
32 |
18.2 |
|
|
Table 2: Results of particle size analysis on fine grade
Diameter of particles |
Volume % < |
Diameter of particles |
Volume % < |
1 |
3.81 |
40 |
98.4 |
1.5 |
6.81 |
50 |
99.1 |
2 |
9.63 |
60 |
99.3 |
3 |
15.7 |
75 |
99.5 |
4 |
22.3 |
80 |
99.5 |
6 |
35.3 |
90 |
99.6 |
8 |
47.4 |
125 |
99.8 |
10 |
58.7 |
160 |
99.9 |
12 |
68.6 |
250 |
99.996 |
16 |
82.7 |
320 |
100 |
20 |
90.3 |
400 |
100 |
24 |
94 |
500 |
100 |
28 |
95.9 |
600 |
100 |
32 |
97.1 |
|
|
The respirable crystalline silica content determined by entering the output from the particle size distribution analysis into the SWeRFcs calculation spreadsheet was <0.1 %.
Description of key information
Particle size distribution analysis of Synthetic wollastonite gave results of 96.9% <100 µm, 0.649% <10 µm and 0.167% < 5.5 µm.
Additional information
Particle size data was acquired, 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).
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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