Health-based threshold adi versus mos in toxicology

Abstract

The derivation of health-based threshold values in various fields of regulatory toxicology is based on consented rules laid down in regulatory guidance papers (EFSA EFSA J 8:1325, 2010; ECHA, 2010) Guidance on information requirements and chemical safety assessment Chap. R.8: characterisation of dose [concentration]-response for human health ECHA-2010-G-19-EN). The rules were developed according to the field of application and are improved when scientific evidence became available showing that elements of the framework have to be changed. No principle difference exists in the guidances from several European agencies. The MOS concept applies the same principles; it is however more flexible as it allows to introduce scientific judgement.