Additional assessment factors

In cases where where appropriate data or information is scarce or missing, an additional assessment factor is used for extrapolation from the POD to the hazard characterisation in humans. This factor can be used as a worst case value (preferably AF = 100) for inter- and intra-species extrapolation, but it may equally well serve as an additional extrapolation factor next to inter- and/or intra-species extrapolation. In the latter case the factor merely serves to account for differences in for example route to route, metabolic rates in interspecies, completeness and consistency of available data, reliability of alternative data (e.g. read-across) or quality of data in general.