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EC number: 227-086-4 | CAS number: 5638-76-6
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral. Supporting study: Based on the available data the oral LD50 for betahistine was determined to be 2920 mg/kg in mouse.
Acute toxicity: oral. Supporting study: Based on the available data the oral LD50 for betahistine was determined to be 6110 mg/kg in rat.
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- No data on method, no data on GLP.
- Principles of method if other than guideline:
- No data on method
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 920 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No data available.
- Clinical signs:
- No data available.
- Body weight:
- No data available.
- Gross pathology:
- No data available.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 in mouse is 2920 mg/kg.
- Executive summary:
The acute oral toxicity of the test substance was evaluated on mice. According to the results, the oral LD50 is 2920 mg/kg body weight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- No data on method, no data on GLP.
- Principles of method if other than guideline:
- No data on method
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 6 110 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No data available.
- Clinical signs:
- No data available.
- Body weight:
- No data available.
- Gross pathology:
- No data available.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 in rats is 6110 mg/kg.
- Executive summary:
The acute oral toxicity of the test substance was evaluated on rats. According to the results, the oral LD50 is 6110 mg/kg body weight.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 920 mg/kg bw
- Quality of whole database:
- Diverse oral LD50 are reported from a secondary source. The results of the whole database lead to the same classification of the substance according to CLP regulation.
Additional information
Acute toxicity: oral. Supporting study. The acute oral toxicity of the test substance was evaluated on mice. GLP study not specified. According to the results, the oral LD50 is 2920 mg/kg body weight.
Acute toxicity: oral. Supporting study. The acute oral toxicity of the test substance was evaluated on rats. GLP study not specified. According to the results, the oral LD50 is 6110 mg/kg body weight.
Justification for classification or non-classification
Based on the available data the oral LD50 was determined to be 2920 mg/kg in mouse. Betahistine has not to be classified for Acute oral toxicity according to CLP Regulation (EC) no. 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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