Assessment Factors to Derive DNELs – Critical Evaluation of the Status Quo

2.3 The point of departure (POD) 2.3.1 Identification of the POD The standard information requirements under REACH are described in Annexes VI to X of the regulation and depend on the quantity of the substance that is manufactured or imported into the EU/EEA. [...] REACH TDG Section R.8 provides guidance as to what ECHA expects regarding the assessment of the quality of the human data and refers the registrant to Annex XI of the REACH Regulation setting out the following general criteria for assessing the adequacy of the data for adaptation of the standard testing requirements. [...] In the early 2000s the WHO/IPCS initiated a consultative process aimed at harmonising risk assessment approaches with the objectives of promoting 1) common understanding and encouraging the incorporation of quantitative data in the measurement of dose/concentration–response and 2) research in areas that might lead to more predictive estimates of risk and paved the way to the concept of ‘Chemical-S. [...] TK refers to those factors such as absorption, distribution, metabolism and excretion that determine the concentration of a substance within the body; while TD refers to the molecular, biochemical, and physiological effects of toxicants or their metabolites in biological systems and are result of the interaction of the biologically effective dose of the ultimate (active) form of the toxicant with. [...] 136 22 Assessment Factors to Derive DNELs It has still to be concluded that while ECETOC views its analysis scientifically valid the reality that in the absence of a much larger database on intraspecies variability within humans that the long standing practice of using the default factor of 10 for the general population (and by virtue of this the factor of 5 for the worker) is likely to remain a m.