Registration Dossier

Administrative data

Description of key information

The oral toxicity of betamethasone on mouse was reported to be greater than 4500 mg/kg bw.
Moreover, to support this value, some data on oral toxicity of structural related analogues in mouse or rat are reported. Most of them are direct precursors of betamethasone, who, once given, are quickly transformed into betamethasone alcohol, but dexamethasone.
Dexamethasone is the most related compund as epimer of betamethasone.

Key value for chemical safety assessment

Additional information

The acute oral LD50 values of betamethasone is higher than 2000 mg/kg bw, limit threshold for classification.

Oral toxicity of betamethasone is absent, even as pointed out by the absence of toxicity of its analogues.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and Regulation 1272/2008/EC, classification is not necessary for acute oral toxicity based on the available data.