Tox by Design can develop ERAs of Active Substances ("AS") in a given formulation(s), for one or more countries. We use a 2 phase procedure, according to the adopted guideline:
Phase I estimates the exposure of the environment to the AS on the basis of consumption and "log Kow" (octanol/water partition coefficient - allows for the apprehension of the lipophilic or hydrophilic character of the molecule)
If an environmental exposure or a specific risk was identified in the previous phase, additional studies must be carried out to identify the destination of the product in the environment and its potential impact.
The ratio "PEC" (predicted environmental concentration) / "PNEC" (predicted no effect concentration) = RCR is evaluated in phase II.
You can check Tox by Design methodology for Environmental Risk Assessments, signed by an European Registered Toxicologist expert here.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Tox by Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using this email link to receive a quotation for Environmental Risk Assessments procedure.