17 February 2011

The ICH Expert Working Group (EWG) responsible for the maintenance of the Q3C Guideline has completed its revision of the Permissible Daily Exposure (PDE) for Cumene. With the finalisation of the Q3C Guideline in 1997, it was agreed that the PDE could be modified if reliable and more relevant toxicity data was brought to the attention of the EWG. In line with this and the availability of new toxicity data for Cumene, a reappraisal of the PDE for Cumene was proposed. This reappraisal has resulted in the recommendation from the EWG that Cumene is moved from the Class 3 category, for solvents with low toxic potential, to the Class 2 category, for solvents with inherent toxicity which should be limited in pharmaceutical products.

The revised PDE for Cumene document reached Step 4 of the ICH harmonisation process in February 2011 and has been incorporated as part IV of the core Q3C Guideline which was then renamed Q3C(R5).

The Q3C(R5) Guideline is available for download on the Quality Guideline page.

For more information about the Q3C maintenance process see the ICH Process of Harmonisation page under about us on the ICH website.