Optimising testing strategies for classification of human health and environmental hazards – A proof-of-concept study

Emilie Da Silva,Anders Baun,Elisabet Berggren,Andrew Worth

doi:10.1016/j.toxlet.2020.10.008

Emilie Da Silva, Anders Baun + Show 2 more

Open Access

https://doi.org/10.1016/j.toxlet.2020.10.008

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Abstract

This paper outlines a new concept to optimise testing strategies for improving the efficiency of chemical testing for hazard-based risk management. While chemical classification based on standard checklists of information triggers risk management measures, the link is not one-to-one. Toxicity testing may be performed with no impact on the safe use of chemicals . Each hazard class and category is not assigned a unique pictogram and for the purpose of this proof-of-concept study, the level of concern for a chemical for the population and the environment is simplistically considered to be reflected by the hazard pictograms. Using active substances in biocides and plant protection products as a dataset, three testing strategies were built with the boundary condition that an optimal approach must indicate a given level of concern while requiring less testing (strategy B), prioritising new approach methodologies (strategy C) or combining the two considerations (strategy D). The implementation of the strategies B and D reduced the number of tests performed by 6.0% and 8.8%, respectively, while strategy C relied the least on in vivo methods. The intentionally simplistic approach to optimised testing strategies presented here could be used beyond the assessment of biocides and plant protection products to gain efficiencies in the safety assessment of other chemical groups, saving animals and making regulatory testing more time- and cost-efficient.

Highlights

In the European Union (EU), the manufacture, import, distribution, use and disposal of chemicals is regulated by more than 40 pieces of legislation in a complex interplay [1]
The intentionally simplistic - approach to optimised testing strategies presented here could be used beyond the assessment of biocides e and plant protection products to gain efficiencies in the safety assessment of other chemical groups, saving r animals and making regulatory testing more time- and cost-efficient. l P Keywords: chemical safety; hazard identification; risk management; CLP Regulation; alternative methods. a Abbreviations: Biocidal Products Regulation (BPR) (Biocidal Product Regulation), CLP (Classification, Labelling and Packaging), CMR n (Carcinogenic, Mutagenic, toxic to Reproduction), European Chemicals Agency (ECHA) (European Chemical Agency), EU (European Union), r GHS (Globally Harmonized System), NAMs (New Approach Methodologies), OECD (Organisation for Economic u Co-operation and Development), Protection Products Regulation f (PPR) (Plant Protection Products Regulation), quantitative structure activity relationship (QSAR) (Quantitative Structure Jo Activity Relationship), REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), STOT
Testing is not explicitly requested for the - purpose of classification and labelling, it is conducted under other regulatory programmes, which often e indirectly leads to risk management based on classification and labelling. r Traditionally, both the hazard and risk-based regulatory approaches are established on toxicity and l P ecotoxicity data that involve animal testing

Summary

Introduction

In the European Union (EU), the manufacture, import, distribution, use and disposal of chemicals is regulated by more than 40 pieces of legislation in a complex interplay [1]. R Traditionally, both the hazard and risk-based regulatory approaches are established on toxicity and l P ecotoxicity data that involve animal testing. While this historical precedent is often seen as a barrier for the uptake of non-animal methods [3], there are in principle no legal barriers for inclusion of so-called new a approach methodologies (NAMs, [4]) not relying on animal testing [5]. According to the horizontal Directive rn 2010/63/EU on the protection of animals for scientific purposes [6], animal testing should only be conducted u as a last resort, with the ambition to eventually replace it completely and the Globally Harmonized System Jo for Classification and Labelling of Chemicals (GHS) is updated to include any relevant non-animal methods

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