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Diss Factsheets
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EC number: 942-401-1 | 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:
- supporting study
- Study period:
- March 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is well described. However, overestimation of Z-average is possible with this technique. There is a large variation in scattering power and larger particles may mask the presence of smaller particles. In the present study the data quality was too poor and the sample was too polydisperse for distribution analysis. Larger particles (oversizers) were present which hindered the analysis. Furthermore sample fluorescence and sample absorbance (coloured samples) is reported. Therefore the study is considered reliable with restrictions. It can only be used as supporting study.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The particle size distribution was determined by a Dynamic Light Scattering (DLS) method.
- GLP compliance:
- no
- Type of distribution:
- other: intensity
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Conclusions:
- The particle size distribution was determined by a Dynamic Light Scattering (DLS) method. All measured particles that were larger than 100 nm. However, the data quality was poor and the sample was too polydisperse for distribution analysis. Larger particles (oversizers) were present which hindered the analysis. Furthermore sample fluorescence and sample absorbance (coloured samples) is reported. Therefore the study is considered reliable with restrictions. It can only be used as supporting study.
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- no guideline followed
- Version / remarks:
- See remarks under "Principles of method other than guideline"
- Principles of method if other than guideline:
- To determine if Bismuth oxy-iodide/bromide falls under the definition of a nanomaterial as defined in EU recommendation 2011/696/EU, the following investigations were performed:
o Specific surface area analysis by BET (physical adsorption of a gas on the surface of the solid as developed by Brunauer, Emmett and Teller) combined with powder density analysis by use of pycnometer
o Scanning Electron Microscope (SEM) - GLP compliance:
- no
- Type of method:
- microscopic examination
- 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.
- No.:
- #1
- Size:
- < 100 other: nm
- Distribution:
- 43.75 %
- Remarks on result:
- other: Batch 130903 (BiOI0.4Br0.6), n= 48
- No.:
- #2
- Size:
- < 100 other: nm
- Distribution:
- 34.09 %
- Remarks on result:
- other: Batch 130904 (BiOI0.6Br0.4), n= 44
- No.:
- #3
- Size:
- < 100 other: nm
- Distribution:
- 15 %
- Remarks on result:
- other: Batch 130905 (BiOI0.8Br0.2), n= 40
- Conclusions:
- The specific surface area of the measured samples as determined from BET and powder density results is < 60 m2/cm3.
SEM analysis revealed that <50% of the particles had a diameter of <100 nm. Therefore, it is concluded that the substanceshould not be regarded as a nanomaterial under the definition of EU recommendation 2011/696/EU.
Referenceopen allclose all
Particle size distribution based on mean intensity of 278PE:130904 (PA062362-002) treated with the dispersant Novachem 2 % : See attached graph.
The size quality report gave the following remark :
RESULT DOES NOT MEET QUALITY CRITERIA
Multimodal fit error high
* Data quality too poor for distribution analysis
* Sample too polydisperse for distribution analysis
In range figure is low (74%)
* Presence of large or sedimenting particles
* Sample fluorescence
* Sample absorbance (coloured samples)
This means that there are oversizers present, which can be seen in the raw correlation data graph which is given in the attached report.
All the particle size distribution graphs and raw correlation data graphs of all the other samples – whether treated with Novachem 2 % or with MQ water – look the same.
To verify the homogenity of the pigments, the sample preparation is repeated (starting from the weighing) for each pigment.
The average particle size (z-average) was > 100 nm for all samples and all treatments (see Table below).
Every pigment contains oversizers : see raw correlation data graphs in the attached report, very high PdI and PdI width values.
Treatment with Novachem 2 % : ultra sound high energy treatment resulted in smaller Z-average values than only vortex treatment.
Treatment with MQ water : only vortex treatment gave no signal at all (only tested for batch130903).
After ultra sound high energy treatment, Novachem 2 % as dispersant resulted in smaller Z-average values than MQ water as dispersant.
The Z-average values for 1 sample were not reproducible (except for batch130903), this is due to the presence of oversizers, or to inhomogenities in the pigment, or a combination of both.
SEM Results
See above
BET & powder density results
Product |
Batch |
Specific surface area (m2/g) |
Powder Density (g/cm3) |
specific surface area by volume1 (m2/cm3) |
Nanomaterial as defined by point 5 of 2011/696/EU |
278PE |
130903 |
5.51 |
8.00 |
44.08 |
No (<60 m2/cm3) |
278PE |
130904 |
3.59 |
8.02 |
28.79 |
|
278PE |
130905 |
2.51 |
8.01 |
20.11 |
BET & powder density reports are available in the attachments.
1: Specific surface area by volume is obtained by multiplication of powder density and specific surface are
Description of key information
The specific surface area of the measured samples as determined from BET and powder density results is < 60 m2/cm3. SEM analysis revealed that <50% of the particles had a diameter of <100 nm. Therefore, it is concluded that the substance should not be regarded as a nanomaterial under the definition of EU recommendation 2011/696/EU. This issupported by the particle size distribution as determined by a Dynamic Light Scattering (DLS) method. All measured particles were found to be larger than 100 nm.
Additional information
SEM analysis, BET and powder density determinations are available in a report by Cappelle Pigments (2015). The three studies that are part of this report are regarded as key studies. The test results indicate that the majority of the particles have a diameter > 100 nm.
Attempts were also made to determine the particle size distribution with DLS. All measured particles were larger than 100 nm. However, the data quality was poor and the sample was too polydisperse for distribution analysis. Larger particles (oversizers) were present which hindered the analysis. On the other hand, sample fluorescence and sample absorbance (coloured samples) is reported. Therefore the study is considered reliable with restrictions and it is used as supporting study.
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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