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Diss Factsheets
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EC number: 432-820-3 | 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:
- Testing was conducted between 01 August 2002 and 17 October 2002.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: February 28th 2000, Date of signature: April 26th 2000
- Type of distribution:
- counted distribution
Test material
- Details on test material:
- Sponsor's identification :S178207
Description : white powder
Batch number : NBZ 0155/44
Date received : 18 July 2002
Storage conditions :room temperature, in the dark
Constituent 1
Results and discussion
Particle size
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- > 0 - < 100 µm
- Distribution:
- 48.1 %
- No.:
- #1
- Size:
- > 0 - < 10 µm
- Distribution:
- 36.2 %
Any other information on results incl. tables
Screening test (sieve method)
The results of the sieving procedure are shown in below.
Sieve Aperture Size (µm) |
100 |
Mass of test material transferred to sieve (g) |
10.00 |
Mass of test material passed through sieve (g) |
4.81 |
Test material less than sieve aperture size (%) |
48.1 |
Definitive test (cascade impactor method)
Determination 1
The results of the cascade impactor method are shown below.
Determination 1
Cup Number |
ParticleCollected (µm) |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10 |
86.8523 |
86.9256 |
0.0733 |
2 |
5 – 10 |
86.0138 |
86.0331 |
0.0193 |
3 |
2.5 – 5 |
86.4909 |
86.4962 |
0.0053 |
4 |
1.25 - 2.5 |
86.1840 |
86.1868 |
0.0028 |
5 |
0.625 - 1.25 |
86.3706 |
86.3721 |
0.0015 |
Filter |
<0.625 |
75.6420 |
75.6623 |
0.0203 |
Amount of test material found in artificial throat: 0.0733 g.
Total amount of test material recovered from impactor cups, filter and
artificial throat: 0.1225 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown below.
Determination 1
Cup Number |
Particle Size Cut-points (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10 |
0.0492 |
40.2 |
3 |
5 |
0.0299 |
24.4 |
4 |
2.5 |
0.0246 |
20.1 |
5 |
1.25 |
0.0218 |
17.8 |
Filter |
0.625 |
0.0203 |
16.6 |
Determination 2
The results of the cascade impactor method are shown below.
Determination 2
Cup Number |
ParticleCollected (µm) |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10 |
86.8512 |
86.9618 |
0.1106 |
2 |
5 – 10 |
86.0143 |
86.0326 |
0.0183 |
3 |
2.5 – 5 |
86.4884 |
86.4943 |
0.0059 |
4 |
1.25 - 2.5 |
86.1843 |
86.1875 |
0.0032 |
5 |
0.625 - 1.25 |
86.3686 |
86.3703 |
0.0017 |
Filter |
<0.625 |
75.6424 |
75.6611 |
0.0187 |
Amount of test material found in artificial throat: 0.1106 g.
Total amount of test material recovered from impactor cups, filter and
artificial throat: 0.1584 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown below.
Determination 2
Cup Number |
Particle Size Cut-points (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10 |
0.0478 |
30.2 |
3 |
5 |
0.0295 |
18.6 |
4 |
2.5 |
0.0236 |
14.9 |
5 |
1.25 |
0.0204 |
12.9 |
Filter |
0.625 |
0.0187 |
11.8 |
Determination 3
The results of the cascade impactor method are shown below.
Determination 3
Cup Number |
ParticleCollected (µm) |
Cup Masses (g) |
||
Pre-sampling |
Post-sampling |
Difference |
||
1 |
>10 |
86.8498 |
86.9514 |
0.1016 |
2 |
5 – 10 |
86.0144 |
86.0429 |
0.0285 |
3 |
2.5 – 5 |
86.4882 |
86.4958 |
0.0076 |
4 |
1.25 - 2.5 |
86.1851 |
86.1889 |
0.0038 |
5 |
0.625 - 1.25 |
86.3685 |
86.3703 |
0.0018 |
Filter |
<0.625 |
75.6419 |
75.6630 |
0.0211 |
Amount of test material found in artificial throat = 0.1016 g.
Total amount of test material recovered from impactor cups, filter and
artificial throat = 0.1644 g.
The cumulative amounts found for the individual particle size cut-points (µm) are shown below.
Determination 3
Cup Number |
Particle Size Cut-points (µm) |
Cumulative Mass of Test Material (g) |
Cumulative Amount of Test Material (%) |
2 |
10 |
0.0628 |
38.2 |
3 |
5 |
0.0343 |
20.9 |
4 |
2.5 |
0.0267 |
16.2 |
5 |
1.25 |
0.0229 |
13.9 |
Filter |
0.625 |
0.0211 |
12.8 |
The overall cumulative amounts of test material with a particle size less than 10 µm (%) from Determinations 1 to 3 are shown ibelow.
Determination |
Cumulative Amount of Test Material Less Than 10 µm (%) |
Mean Cumulative Amount of Test Material Less Than 10 µm (%) |
1 |
40.2 |
36.2 |
2 |
30.2 |
|
3 |
38.2 |
Particle size data acquired for the test material are shown below.
Measurement |
Method |
Result |
Proportion of test material having a particle size less than 100 µm |
Sieve |
48.1% |
Proportion of test material having a particle size less than 10 µm |
Cascade Impactor |
36.2% |
Applicant's summary and conclusion
- Conclusions:
- The results indicate that the proportion by mass of particles which, if inhaled, can be expected to achieve pulmonary deposition is at least 30%. This indicates that there is potential for the test material to be hazardous by inhalation depending on toxicity and use pattern.
- Executive summary:
Particle Size Distribution. Particle size data have been acquired using a procedure designed to comply with the European Commission technical guidance document 'Particle Size Distribution, Fibre Length and Diameter Distribution' (June 1996), which satisfies the requirements of OECD Guideline 110. The results are shown below.
Measurement
Method
Result
Proportion of test material less than 100 µm
Sieve
48.1%
Proportion of test material less than 10 µm
Cascade Impactor
36.2%
The results indicate that the proportion by mass of particles which, if inhaled, can be expected to achieve pulmonary deposition is at least 30%. This indicates that there is potential for the test material to be inhaled.
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.
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