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EC number: 208-288-1 | CAS number: 520-26-3
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 6.4.1989 - 26.4.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented guidline study prior to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Diosmine 90% (consists of 90% diosmin, and 10% hesperidin)
- IUPAC Name:
- Diosmine 90% (consists of 90% diosmin, and 10% hesperidin)
- Reference substance name:
- Diosmin
- EC Number:
- 208-289-7
- EC Name:
- Diosmin
- Cas Number:
- 520-27-4
- Molecular formula:
- C28H32O15
- IUPAC Name:
- 5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4-oxo-4H-chromen-7-yl 6-O-(6-deoxy-alpha-L-mannopyranosyl)-beta-D-glucopyranoside
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- lot No. 23/89
Commercial name Flavonoides 90% Diosmine consisting of 90% diosmin and 10% hesperidin)
Particle size analysis: 5.3% < 1.6 µm, 7.3% < 2.2 µm, 11.5% < 3.0 µm, 29.6% < 5.3 µm; median diameter 8.6 µm
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- A 550 L inhalation chamber was used and test substance concentration, oxygen content and temperature were controlled. Compressed air was used and filtered prior to use for suspension of dust into the chamber. Concentration during exposure was measured as 5.05 ±0.83 g/m3 and median diameter of particles was 8.6 µm. Oxygen concentration was 21% vol and temperature was 25.0-25.3 °C
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.04 g/m3 was used as limit concentration for exposure, measured as 5.05 ±0.83 g/m3
- No. of animals per sex per dose:
- 10 rats were used (5 males and 5 females)
- Control animals:
- yes
- Details on study design:
- Exposure time to test atmosphere was 4 hours and 15 minutes. Thereafter, animals were observed for 14 days and body weight was recorded daily prior to necropsy.
- Statistics:
- no data
Results and discussion
- Preliminary study:
- No mortality was observed, neither in the group of animals exposed to 5.04 g/m3 diosmin nor in the control group. Weight gain of animals during 14 day observation period was normal and did not show abnormalities.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC0
- Effect level:
- > 5.04 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC0
- Effect level:
- > 5.04 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- > 5.04 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.04 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- no mortality was observed throughout the experiment
- Clinical signs:
- other: clinical signs during exposure and observation period were normal (equivalent in test group and control group)
- Body weight:
- body weigth gain was normal for all animals used in the test.
- Gross pathology:
- no macroscopic abnormalities were noted following autopsy of the test animals following the experiment
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a limit test for acute inhalative toxicity to rats using whole body dust exposure no mortality was observed at 5.04 g/m3 and no clinical signs were noted. Following the experiment no macroscopical abnormalities were noted during autopsy. Thus the substance is considered practically nontoxic by inhalative exposire to rats.
- Executive summary:
The tested Flanoides 90% diosmine contains 90% diosmin, a structurally very similar substance to hesperidin and 10% hesperidin.
During the investigation for acute inhalative toxicity to rats following dust exposure no mortality and no clinical signs were noted in any of the animals following exposure to the limit concentration of 5.04 g/m3, exposed to for 4 hours. In addition autopsy did not reveal any abnormalities in the test group in any organs. Thus the tested material is considered practically nontoxic and it can be reasonably assumed that neither diosmin nor hesperidin poses any risk by inhalative exposure to rats.
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