Syngenta

Environmental risk assessments for chemicals in the EU rely heavily upon modelled estimates of potential concentrations in soil and water.  A key parameter used by these models is the degradation of the chemical in soil which is derived from a kinetic fitting of laboratory data using standard fitting routines.  Several different types of kinetic can be represented such as: Simple First Order (SFO), Double First Order in Parallel (DFOP), and First Order Multi-Compartment (FOMC). Choice of a particular kinetic and selection of a representative degradation rate can have a huge influence on the outcome of the risk assessment. This selection is made from laboratory data that are subject to experimental error.  It is known that the combination of small errors in time and concentration can in certain cases have an impact upon the goodness of fit and kinetic predicted by fitting software.  Syngenta currently spends in the region of 4m GBP per annum on laboratory studies to support registration of chemicals in the EU and the outcome of the kinetic assessment can adversely affect the potential registerability of chemicals having sales of several million pounds.  We would therefore like to understand the sensitivities involved with kinetic fitting of laboratory studies.  The aim is to provide guidelines for the conduct and fitting of laboratory data so that the correct kinetic and degradation rate of chemicals in environmental risk assessments is used.