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EC number: 208-289-7 | CAS number: 520-27-4
- 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
Endpoint summary
Administrative data
Description of key information
Weight of evidence: In an acute oral toxicity study of the test item on Swiss and NMRI mice, the LD50 was found to be greater than 10000 mg/kg bw. Other reviews report the substance to be non-toxic, with an LD50 in rats greater than 3000 mg/kg bw, and an absence of substance-related effects. Based on the available information, the LD50 value of 3000 mg/kg bw is taken as a worst case.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Toxicological studies were conducted in mice and rats with respect to the acute symptoms, after single oral administration up to the maximum dose of 3000 mg/kg.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Purity: 90% diosmin + 10% flavonoids expressed as hesperidin. - Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Tested up to 3000 mg/kg.
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths were registered up to 15 days after administration.
- Clinical signs:
- other: No effects observed.
- Gross pathology:
- No substance-related changes were detectable at autopsy.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria.
- Conclusions:
- The LD50 of the test item is greater than 3000 mg/kg bw in rats.
- Executive summary:
An acute oral toxicity study was performed with the test item at doses up to 3000 mg/kg bw on rats. The animals were observed for clinical signs and mortality for up to 15 days. Under test conditions, an LD50 value could not be determined due to the absence of toxic effects. Thus, the LD50 in rats is greater than 3000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1968.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The test item was orally administered to homogeneous groups of Swiss and NMRI male mice, and the LD50 was estimated using the method of Miller and Tainter (1944) (see 'attached background materials'): a log-probit graph paper was used for the estimation of the ED50 and its standard error.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: Swiss and NMRI.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 19-22 g - Route of administration:
- oral: gavage
- Vehicle:
- other: 5% gum tragacanth in water
- Details on oral exposure:
- Oral administration: single dose by gavage, administered to groups of male Swiss mice and groups of male NMRI mice.
- Doses:
- 500, 1000 and 10000 mg/kg.
- No. of animals per sex per dose:
- No data.
- Control animals:
- not specified
- Statistics:
- Method of Miller and Tainter (1944).
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No effects.
- Clinical signs:
- other: No effects.
- Gross pathology:
- No effects.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under test conditions, the substance was found to be non toxic to mice, with an LD50 ≥ 10000 mg/kg bw.
- Executive summary:
The acute oral toxicity was studied for the test substance on Swiss and NMRI mice, using the method of Miller and Tainter (1944) (no TG, no GLP). Under test conditions, the substance was found to be non toxic to mice, with an LD50 ≥ 10000 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Weight of evidence: The acute oral toxicity of the test item on homogeneous groups of Swiss and NMRI mice was determined by Desnoyers (1968) using the method of Miller and Tainter (1944); the LD50 was found to be greater than 10000 mg/kg bw. Reviews by Hitzenberger (1997) and Meyer (1994) report the substance to be non-toxic, with an oral LD50 in rats greater than 3000 mg/kg bw, and the absence of toxic effects. Based on the available information, the LD50 value of 3000 mg/kg bw is taken as a worst case.
Justification for classification or non-classification
Based on the available data (LD50 > 3000 mg/kg bw), the substance is not classified for Acute toxicity, according to CLP Regulation (EC) 1272/2008.
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