In this case study with the feed additive piperine, we have
successfully used a combination of in vitro/in silico based alternative
methods for the consumer risk assessment. Our approach is based
on (i) read-across techniques to assess metabolism in target animal
complemented with in vitro comparative metabolism work, (ii)
calculated residual concentrations derived from a database thereby
using worst case i.e. highest distributions within the database, and
(iii) comparison of the determined exposure with the derived
Health Based Guidance Value, the respective threshold of the TTC
concept and/or predicted quantitative toxicological endpoints. The
in silico residue modeling used for piperine showed to be a worst
case approach: the modeled residual levels were considerably
higher as compared to the measured residual levels. This strategy
provides an alternative to animal testing without jeopardizing
consumer safety. The use of in vitro/in silico methods may therefore
also serve in future for risk assessment for other feed additives and
was shown that the alternative methods results in conservative
outcomes.