Ethylenglycol is now listed with a new PDE of 3.1 mg/day and a concentration limit of 310 ppm (before: 6.2 mg/day and 620 ppm).
Furthermore, ICH has published three supporting documents to ICH Q3C which include the summaries of the toxicity data from which PDEs were derived:
Additional information on the current drafting process of ICH Q3C(R8) was also announced at the same time:
The Q3C(R8) EWG is currently undertaking a maintenance of the Guideline, which will result in the future Q3C(R8) version, to develop PDE levels for three solvents
According to the work plan a final version of Revision 8 can be expected by the end of 2019.
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