Registration Dossier

Administrative data

Description of key information

The acute oral LD50 values of prednisolone is higher than 2000 mg/kg bw. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 857 mg/kg bw

Additional information

The prednisolone LD50 of 3857 mg/kg bw reported by Golubeva, M.I. et al. (2001) was obtained by a single administration of Prednisolone intragastrically to male rats. With prednisolone administration to female rats a related LD50 value of 3879 mg/kg bw was obtained.

This article was reviewed also on RTECS (Registry of Toxic Effects of Chemical Substances) database (TU4152000). The use of secondary sources of data is acceptable when they are based on a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation.

In a supporting study, the acute toxicity by oral route was assessed in mice. Because of it is not the recommended specie for this endpoint, this literature was reported only as supporting study. To note that the obtained value of toxicity in mouse specie is very close to the limit value of 2000 mg/kg bw (Mascitelli-Coriandoli, E. et al. 1970).

Justification for classification or non-classification

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