Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic activity of prednisolone was tested on Salmonella typhimurium TA100, and TA98, following a guideline equivalent or similar to EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria) and OECD Guideline 471 (Bacterial Reverse Mutation Assay). Prednisolone was not mutagenic to either strain with or without S-9 mix, and it was not lethal at doses of up to 33 micrograms/plate. This compound was not tested at concentrations greater than 33 micrograms/plate (Seino, Y. et al. 1978).

Short description of key information:
Prednisolone is not mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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