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EC number: - | 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

Appearance / physical state / colour
Administrative data
- Endpoint:
- appearance / physical state / colour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 October 2017 - 22 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 (Particle size analysis by laser diffraction), Handbook K
- Version / remarks:
- 2007
- Deviations:
- no
- Principles of method if other than guideline:
- According to REACH Article 13(3) tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in regulation (EC) No 440/2008. OECD 110 TG ‘Particle Size Distribution/FibreLength and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s Guidance on information requirements and Chemical Safety Assessment-Chapter R.7a stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. The guidance mentions Laser scattering/diffraction as a method for particles of all kind and makes reference to ISO 13320:2009.
According to Guidance document EUR 20268 (2002), the laser diffraction technique is applicable to particles of respirable and inhalable size. The MMAD can be calculated. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certificate issued: 13 January 2016 (by MHRA UK)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
- Specific details on test material used for the study:
- relative density: 1.39
The substance was tested as received. - Mass median aerodynamic diameter:
- 16.659 µm
- Remarks on result:
- other: standard deviation of the population = 0.133 µm (0.8%)
- Key result
- Percentile:
- D10
- Mean:
- 7.749 µm
- St. dev.:
- 0.077
- Remarks on result:
- other: st.dev. of the population
- Key result
- Percentile:
- D50
- Mean:
- 14.13 µm
- St. dev.:
- 0.113
- Remarks on result:
- other: st.dev. of the population
- Key result
- Percentile:
- D90
- Mean:
- 24.644 µm
- St. dev.:
- 0.248
- Remarks on result:
- other: st.dev. of the population
- No.:
- #1
- Size:
- < 10 µm
- Distribution:
- 22.92 other: vol%
- Conclusions:
- Particle size distribution of the substance: D10= 7.749 µm, D50= 14.13 µm and D90= 24.644 µm. 22.92% by volume was determined to be smaller than 10 µm.
The MMAD was determined to be 16.659 µm. - Executive summary:
The particle size distribution of the substance was determined using laser diffraction analysis (small volume wet module) in a GLP study according to ISO 13320 and CIPAC MT 187.
Each result is the average of five runs:
D10= 7.749 µm, D50= 14.13 µm and D90= 24.644 µm.
22.92% by volume was determined to be smaller than 10 µm.
The MMAD was determined to be 16.659 µm.
VISUAL OBSERVATION
- The substance was observed (by eye) to be a a fine powder which formed into many clusters and lumps.
- At magnification under a microscope using 3.2 objective lens, the particles appeared to be irregular shapes crystals. The smallest individual particle size was approximately < 10 μm and the largest individual size was approximately 38 μm.
- At magnification under a microscope using 40 objective lens, the sample was observed to be made up of single crystalline particles.
DISPERSANT TRIALS
- water: substance not soluble but sample clumped together
- acetone: soluble
- methanol: soluble
- kerosene: substance not soluble and sample well dispersed (for at least 120 minutes; concentrations tested: 1.5 and 5.0 mg/30 mL)
LASER DIFFRACTION ANALYSIS
Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%. These values are within the acceptable limits mentioned in the ISO 13320 standard.
volume weighted mean = 15.353 μm
mode = 14.531 μm
Data source
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Appearance was determined by visual observation.
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical appearance: white powder with lumps
- Test item storage: at room temperature protected from light
Constituent 1
- Specific details on test material used for the study:
- observed as received
Results and discussion
- Physical state at 20°C and 1013 hPa:
- solid
Form / colour / odour
- Key result
- Form:
- solid: particulate/powder
- Colour:
- white
- Odour:
- other: not determined
- Substance type:
- organic
Applicant's summary and conclusion
- Conclusions:
- The substance was visually observed to be a fine white powder with clusters and lumps.
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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