Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 227-086-4 | CAS number: 5638-76-6
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
