Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Short description of key information:
In in-vitro genotoxicity studies, propylene oxide exerts a clear, direct-acting positive effect in a wide variety of standard test systems, causing mutations in bacteria and mammalian cells in the absence of exogenous metabolic activation. Negative results were obtained in mouse bone marrow micronucleus tests following oral exposure. In contrast, positive results were obtained for chromosomal aberrations following IP dosing. Therefore, it is clear that propylene oxide is a somatic cell mutagen in vivo. The general toxicological profile for propylene oxide suggests that its potential to produce genetic damage might be expressed only at sites of initial contact.

Given that propylene oxide is a direct-acting mutagen then the possibility that it might express this activity within germ cells cannot be discounted. Classification according to Annex I of Directive 67/548/EC is proposed as follows: Muta. Cat. 2; R46 May Cause Heritable Genetic Damage.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification