An Integrated Assessment Scheme for assessing the adequacy of (eco)toxicological data under REACH

Abstract

REACH requires all available (eco)toxicological information, whether protocol studies, other experiments, or non-testing approaches such as read-across or (Q)SAR, to be collected and evaluated. However, guidance documents only limitedly address how adequacy of (eco)toxicological information can be assessed consistently and transparently. We propose an Integrated Assessment Scheme (IAS) for the evaluation of (eco)toxicological data. The IAS consists of three modules: (i) the reliability of the data; (ii) the validity of the methods the data are generated from and; (iii) the regulatory need of the data. Each module is assessed and documented using adjusted OECD principles for the validation of (Q)SARs. These adjusted principles provide a harmonised set of criteria for the evaluation of all types of (eco)toxicological data. Assessment codes, similar to Klimisch codes, are assigned to the evaluated information in each module. The coherent combination of the assessment codes of all three modules determines the overall adequacy of information for fulfilling the information requirement in REACH, and can serve as a weight in a Weight of Evidence procedure as mentioned in REACH Annex XI.