Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

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.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1992

Materials and methods

Principles of method if other than guideline:
No data on method
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Betahistine
EC Number:
227-086-4
EC Name:
Betahistine
Cas Number:
5638-76-6
Molecular formula:
C8H12N2
IUPAC Name:
methyl[2-(pyridin-2-yl)ethyl]amine
Test material form:
liquid

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.