Further to reaching Step 4, these PDEs would then be integrated into a complete Q3C(R8) Guideline document. The steps are part of a constant maintenance process to enable the revision and inclusion of new PDEs, as new toxicological data for solvents become available.
In addition, a Step 2 Informational Presentation has been developed by the Maintenance Expert Working Group, showing the establishing process of the PDEs for the three solvents.
The deadline for comments is scheduled for 30 July 2020.
ICH Q3C: Maintenance Website