Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Lovastatin did not demonstrate genotoxic potential in the Ames

bacterial mutagenicity assay, an alkaline elution assay using rat or mouse

hepatocytes, a mutation assay in Chinese hamster cells, a chromosomal aberration

assay in hamster cells and an in vivo mouse micronucleus assay.

Computational toxicology summary was prepared by DEREK Nexus version 2.0.2 software, and the result for genotoxicity is negative.


Short description of key information:
Lovastatin did not demonstrate genotoxic potential in the Ames
bacterial mutagenicity assay, an alkaline elution assay using rat or mouse
hepatocytes, a mutation assay in Chinese hamster cells, a chromosomal aberration
assay in hamster cells and an in vivo mouse micronucleus assay

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification