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EC number: 203-271-5 | CAS number: 105-11-3
- 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:
- 09-03-2018 to 26-11-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to recognised guidelines and guidance under GLP. All relevant validity criteria were met.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Version / remarks:
- “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: January 2018 ; signature: September 2018
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- other: particles appeared to be irregular shaped crystals ; some particle agglomerations were present.
- Mass median aerodynamic diameter:
- >= 9.63 - <= 9.92 µm
- Geometric standard deviation:
- >= 3.454 - <= 3.499
- Remarks on result:
- other: average MMAD: 9.77 µm ; where: n=5
- Percentile:
- D10
- Mean:
- >= 1.97 - <= 2.03 µm
- St. dev.:
- 0.021
- Remarks on result:
- other: n=5 ; average D10: 2.00 µm
- Percentile:
- D50
- Mean:
- >= 7.94 - <= 8.18 µm
- St. dev.:
- 0.094
- Remarks on result:
- other: n=5 ; average D50: 8.06 µm
- Percentile:
- D90
- Mean:
- >= 18.7 - <= 19.2 µm
- St. dev.:
- 0.226
- Remarks on result:
- other: n=5 ; average D90: 18.9 µm
- No.:
- #1
- Size:
- < 100 µm
- Distribution:
- > 90 %
- Remarks on result:
- other: The proportion of test item having an inhalable particle size of < 100 μm was determined to be > 90% w/w
- No.:
- #2
- Size:
- < 10 µm
- Distribution:
- 61.37 %
- Remarks on result:
- other: The proportion of test item having an inhalable particle size of < 10 μm was determined to be 61.37 % w/w.
- Conclusions:
- The proportion of test item having an inhalable particle size of <100 μm was determined to be > 90 % w/w using the laser diffraction analysis method. The test item was considered to be inhalable.
- Executive summary:
The test item particle size was evaluated using laser diffraction analysis according to ISO 13320 : 2009 “Particle Size Analysis – Laser Diffraction Methods” and/or CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K (2007) under GLP. Preliminary optical microscope assessment indicated that the brown power, with clusters had particles appeared to be irregular shaped crystals. Under 3.2 object lens, the smallest individual particle size was approximately 3 μm and the largest individual size was approximately 42 μm. Some particle agglomerations were present. At 40 objective lens single crystalline particles were present. Method development indicated 2-propanol was a suitable dispersant and led to acceptable dispersion of the test item. Laser Diffraction analysis using the small volume (wet) module (SVM) indicated that the test item had the following averaged properties following five runs (n=5) :
MMAD (mass median aerodynamic diameter) 9.77 μm
d10 - 10 % of material is < 2.00 μm
d50 - 50 % of material is < 8.06 μm
d90 - 90 % of material is < 18.9 μm
volume of sample < 10.00 μm: 61.34%
All relevant validity criteria were considered to be met. Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. It was considered that the repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard. Applicant assessment indicates: that > 90% of the test item would be considered to be in the inhalable fraction < 100 μm.
Reference
Description of key information
Particle Size Distribution: > 90 % w/w with particle size < 100 μm, ISO 13320 : 2009 - Laser Diffraction Method, 2018
d10 - 10 % of material is < 2.00 μm
d50 - 50 % of material is < 8.06 μm
d90 - 90 % of material is < 18.9 μm
volume of sample < 10.00 μm: 61.34%
The test item was considered to be inhalable
Additional information
The test item particle size was evaluated using laser diffraction analysis according to ISO 13320 : 2009 “Particle Size Analysis – Laser Diffraction Methods” and/or CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K (2007) under GLP. Preliminary optical microscope assessment indicated that the brown power, with clusters had particles appeared to be irregular shaped crystals. Under 3.2 object lens, the smallest individual particle size was approximately 3 μm and the largest individual size was approximately 42 μm. Some particle agglomerations were present. At 40 objective lens single crystalline particles were present. Method development indicated 2-propanol was a suitable dispersant and led to acceptable dispersion of the test item. Laser Diffraction analysis using the small volume (wet) module (SVM) indicated that the test item had the following averaged properties following five runs (n=5) :
MMAD (mass median aerodynamic diameter) 9.77 μm
d10 - 10 % of material is < 2.00 μm
d50 - 50 % of material is < 8.06 μm
d90 - 90 % of material is < 18.9 μm
volume of sample < 10.00 μm: 61.34%
All relevant validity criteria were considered to be met. Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. It was considered that the repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.
Applicant assessment indicates: that > 90% of the test item would be considered to be in the inhalable fraction < 100 μm.
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