Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Bismuth metal is not acutely toxic via oral, dermal or inhalation route. 

Key value for chemical safety assessment

Additional information

In an acute oral toxicity test in rats with bismuth (mean particle diameter was 10 µm), no deaths occurred at a dose of 2000 mg/kg body weight. Therefore the LD50 is >2000 mg/kg bw for both sexes.

An acute dermal toxicity study with bismuth metal is considered to be scientifically unjustified.

An acute inhalation study with bismuth metal powder is considered to be technically not feasible, since it was not possible to generate a stable aerosol atmosphere with a mass median aerodynamic diameter (MMAD) of < 4 µm.

Justification for classification or non-classification

In an acute oral toxicity test in rats with bismuth, the LD50 was determined to be >2000 mg/kg bw.

An acute dermal toxicity study with bismuth metal is considered to be scientifically unjustified.

An acute inhalation study with bismuth metal powder is considered to be technically not feasible.

The available information indicates that bismuth metal is not acutely toxic or harmful. Therefore, classification of bismuth metal for acute toxicity is not warranted.

Categories Display