Limit values

Toxicological guidance and limit values are one of the key instruments in regulatory toxicology. Their derivation allows a direct comparison with exposure levels and – as a consequence of such comparison – drawing conclusions for risk management (e.g. DNEL derivation in REACH registration dossiers, triggering risk management measures in the chemical safety report). Responsible handling of toxicological guidance values, however, also includes a communication of limitations and uncertainties in relation to their validity.

FoBiG demonstrated the expertise for deriving limit values in many different projects. In this context, various projects on methodological issues have helped us to develop a deeper understanding of options for deriving such values and their validity.

FoBiG’s expertise in this topic

  • DNELs (derived no effect levels) according to ECHA guidance documents as part of our REACH services, permitted daily exposures (PDE, according to the EMA Guideline), e.g. for the evaluation of residues in the course of the cleaning validation for the pharmaceutical industry, tolerable daily intake levels such as TRD values (tolerable absorbed doses), or TDI and ADI values (tolerable/acceptable daily intakes).
  • Limit concentrations for specific compartments such as soil, indoor air, drinking water and groundwater.
  • Exposure-risk relationships for carcinogens at the workplace, DMELs (derived minimal effect levels) for the assessment of carcinogens under REACH.
  • Values characterising ecotoxicological effects: PNECs (predicted no effect concentrations) for freshwater, marine water, sediment and soil according to REACH for REACH registration and authorisation dossiers.

Different regulatory areas require different methodological approaches and guidance values, such as

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