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EC number: 209-567-0 | CAS number: 585-88-6
- 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:
- May 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: European Pharmacopeia
- Principles of method if other than guideline:
- The diffraction of a lazer beam by the particules was analysed by the apparatus. The intensity and the picture of the diffraction are a fonction of the size of the particules. The computer treatment of the pictures gives the granulometric distributions.
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Mass median aerodynamic diameter:
- 244 µm
- Geometric standard deviation:
- 8
- No.:
- #1
- Size:
- 32 µm
- Distribution:
- 4 %
- No.:
- #2
- Size:
- 63 µm
- Distribution:
- 5 %
- Remarks on result:
- other: Cumulative fraction : 9%
- No.:
- #3
- Size:
- 80 µm
- Distribution:
- 4 %
- Remarks on result:
- other: Cumulative fraction: 13%
- No.:
- #4
- Size:
- 100 µm
- Distribution:
- 5 %
- Remarks on result:
- other: Cumulative fraction: 18%
- No.:
- #5
- Size:
- 160 µm
- Distribution:
- 16 %
- Remarks on result:
- other: Cumulative fraction: 34%
- No.:
- #6
- Size:
- 200 µm
- Distribution:
- 10 %
- Remarks on result:
- other: Cumulative fraction: 44%
- No.:
- #6
- Size:
- 250 µm
- Distribution:
- 13 %
- Remarks on result:
- other: Cumulative fraction: 57%
- No.:
- #7
- Size:
- 315 µm
- Distribution:
- 14 %
- Remarks on result:
- other: Cumulative fraction: 71%
- No.:
- #8
- Size:
- 500 µm
- Distribution:
- 23 %
- Remarks on result:
- other: Cumulative fraction: 94%
- No.:
- #9
- Size:
- 800 µm
- Distribution:
- 5.8 %
- Remarks on result:
- other: Cumulative fraction: 99.8%
- No.:
- #10
- Size:
- > 800 µm
- Distribution:
- 0.2 %
- Conclusions:
- The particle size distribution of Maltitol was determined according to the European Pharmacopeia with a Laser Diffraction Granulometer (dry phase). The mean particle diameter was calculated to be 244 µm ± 8 µm .
- Executive summary:
The particle size distribution of Maltitol was determined according to the European Pharmacopeia. The particule size was determined with a lazer diffraction granulometer in dry phase.
The lazer beam is diffracted by the particules and the intensity and the picture of the diffraction are a fonction of the size of the particules. The granulometric distribution is provided for the following mean diameters : 32, 63, 80, 100, 160, 200, 250, 315, 500, and 800 µm and it gives the following values 4, 5, 4, 5, 16, 10, 13, 14, 23, 5.8 and 0.2 % respectively.
The mean particle diameter was calculated to be 244 µm ± 8 µm.
Reference
Description of key information
The particle size distribution of Maltitol was determined according to the European Pharmacopeia with a Laser Diffraction Granulometer (dry phase). The mean particle diameter was calculated to be 244 µm ± 8 µm .
Additional information
The particle size distribution of Maltitol was determined according to the European Pharmacopeia. The particule size was determined with a lazer diffraction granulometer in dry phase.
The lazer beam is diffracted by the particules and the intensity and the picture of the diffraction are a fonction of the size of the particules. The granulometric distribution is provided for the following mean diameters : 32, 63, 80, 100, 160, 200, 250, 315, 500, and 800 µm and it gives the following values 4, 5, 4, 5, 16, 10, 13, 14, 23, 5.8 and 0.2 % respectively.
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