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Diss Factsheets
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EC number: 205-811-5 | CAS number: 152-97-6
- 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:
- 08 Sep - 21 Dec 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Deviations:
- no
- Principles of method if other than guideline:
- In considersation of the relevance of granulometry on toxicological assessment, only the size distribution of the sieved fraction <100 µm were studied in detail.
- GLP compliance:
- no
- Other quality assurance:
- ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
- Type of method:
- sieving
- Type of particle tested:
- primary particle
- Type of distribution:
- mass based distribution
- Mass median aerodynamic diameter:
- 11.95 µm
- Geometric standard deviation:
- 9.74
- Key result
- Percentile:
- D50
- Mean:
- 11.95 µm
- Remarks on result:
- other: spherical volume
- No.:
- #1
- Size:
- >= 3 - <= 5 µm
- Distribution:
- 5.48 %
- Remarks on result:
- other: of the sieve fraction < 100 µm
- No.:
- #2
- Size:
- >= 5 - <= 100 µm
- Distribution:
- 94.43 %
- Remarks on result:
- other: of the sieve fraction < 100 µm
- Conclusions:
- The MMAD (Mass Median Aerodynamic Diameter < 100 µm) has a value of 11.95 µm as spherical particles.
- Executive summary:
According to OECD guideline 110 the particle size distribution of Fluocortolon was determined by scanning electron microscopy method for the sieved fraction (<100 µm was 47.87 % of the total sample) and presented on the basis of calculated mass fractions.
The mean diameter (median) was 9.17 µm with 9.74 µm standard deviation. The median aspect ratio (median) was 1.46 with 0.41 as standard deviation. The median diameter (mass fraction) of the particle size is given for the fraction <100 µm. The value 11.95µm was calculated for spherical particles and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EU 481.
Reference
Result: Sieve Fraction (<100µm):
- weighted sample: 0.7198 g
- weight fraction <100µm: 0.3446 g
- mass fraction <100µm: 47.87 %
The mass fraction <100µm was 47.87 %, and was investigated by scanning electron microscopy. The mean diameter (median) was 9.17 µm with 9.74µm standard deviation. The median aspect ratio (median) was 1.46 with 0.41 as standard deviation.
The median diameter (mass fraction) of the particle size is given for the fraction <100µm. The value 11.95µm was calculated for spherical and the value 13.51µm was calculated for cubical particles.
|
Validity criteria for the measurement of the particle size:
Target condition according to guideline: | Actual condition according to the study: | Validity criteria met: |
Method B: The length and diameter distributions of fibres, if required, should be measured at least twice - using separate samplings and preparations - with at least 70 fibres per histogram. No two values in a given histogram interval should differ by more than 50 % or 3 fibres, whichever is larger. | For the determination of the particle size and the aspect ratio, 2 pictures have been taken by SEM at a magnification of 200 times. | Yes |
Method B: Number of particles per field and total number of fibres measured should be stated. | The total number (1041) is stated. | Yes |
Description of key information
The MMAD (Mass Median Aerodynamic Diameter < 100 µm) of the substance has a value of 11.95 µm as spherical particles.
Additional information
According to OECD guideline 110 the particle size distribution was determined by scanning electron microscopy method for the sieved fraction < 100 µm (47.97 % of total sample) and presented on the basis of calculated mass fractions. The median diameter was 11.95 µm with the main fraction of 41.56 % spherical volume distributing in the range of 10 -100 µm and hence the tested particles with sieved size smaller than 100 µm are mainly dominated by inhalable fraction as defined in EU 481.
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