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Diss Factsheets
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EC number: 208-291-8 | CAS number: 520-34-3
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral. Weight of evidence. Based on the read across approach from two analogue substances, the LD50 of the test item is not acutely toxic, with an LD50 greater than 4934 mg/kg bw in mice (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:
- key study
- 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:
- GHS criteria not met
- Remarks:
- EU criteria
- 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). Groups of mice were administered a single dose of test item by gavage, at concentrations of 500, 1000 or 10000 mg/kg bw of test item. A log-probit graph paper was used to estimate the LD50 from the results obtained. Under test conditions, the substance was found to be non toxic to mice, with an LD50 ≥ 10000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See 'Attached justification'. - Reason / purpose for cross-reference:
- read-across source
- Limit test:
- no
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 934 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: read-across from analogue substance.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria
- Conclusions:
- Based on the read-across approach, the target substance is deemed to be non toxic, with an LD50 ≥ 4934 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). Groups of mice were administered a single dose of test item by gavage, at concentrations of 500, 1000 or 10000 mg/kg bw of test item. A log-probit graph paper was used to estimate the LD50 from the results obtained. Under test conditions, the substance was found to be non toxic to mice, with an LD50 ≥ 10000 mg/kg bw. Based on the read-across approach, the target substance is deemed to be non toxic, with an LD50 ≥ 4934 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 934 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
Acute toxicity: oral. Weight of evidence.
In an acute oral toxicity study for the analogue substance diosmin on Swiss and NMRI mice (no TG, no GLP), where groups of mice were exposed to either 500, 1000 or 10000 mg/kg bw of test item, the substance was found to be non-toxic to mice, with an LD50 ≥ 10000 mg/kg bw. Based on the read-across approach, the target substance is deemed to have an LD50 ≥ 4934 mg/kg bw.
In an acute oral toxicity of the analogue substance naringin in rats, a limit test was performed, according to the ‘‘Technical Guideline for Acute Toxicity Test of chemical drugs’’(SFDA, 2004, China), similar to OECD 420 (GLP study). The test item was orally administered to 6 male and 6 female Sprague-Dawley rats, at a single bolus dose of 16 g/kg bw, by gavage. The test item was found to be non toxic by oral route, with an LD50 > 16g/kg in rats. Based on the read-across approach, the target substance is deemed to have an LD50 > 8275 mg/kg bw in rats.
Based on the available information for the read-across approach, the test item is deemed to be not acutely toxic, with an LD50 ≥ 4934 mg/kg bw.
Justification for classification or non-classification
Based on the available data (oral LD50 ≥ 4934 mg/kg bw in mice), the substance is not classified for Acute toxicity, according to CLP Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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