Abstract

ABSTRACTMathematical models within the General Unified Threshold models of Survival (GUTS) framework translate time‐variable chemical exposure information into expected survival of animals. The GUTS models are species and compound specific and explicitly describe the internal exposure dynamics in an organism (toxicokinetics) and the related damage and effect dynamics (toxicodynamics), thereby connecting the external exposure concentration dynamics with the simulated mortality or immobility over time. In a recent scientific opinion on toxicokinetic–toxicodynamic (TKTD) models published by the European Food Safety Authority (EFSA), the GUTS modeling framework was considered ready for use in the aquatic risk assessment for pesticides and aquatic fauna. The GUTS models are suggested for use in risk assessment, if they are sufficiently validated for a specific substance–species combination. This paper aims to illustrate how they can be used in the regulatory environmental risk assessment for pesticides for a specific type of refinement, that is, when risks are triggered by lower tiers in acute as well as in chronic risk assessment and mortality or immobility is the critical endpoint. This approach involves the evaluation of time‐variable exposure regimes in a so‐called “Tier‐2C” assessment. The insecticide chlorpyrifos was selected as an example compound because a large data set was available. The GUTS models for 13 different freshwater arthropods and 8 different theoretical aquatic exposure profiles were used to calculate a series of GUTS‐based risk estimates, including exposure profile‐specific multiplication factors leading to 50% mortality or immobility at the end of the tested profile (LP50/EP50) as “margins of safety.” To put the use of GUTS models within the tiered aquatic risk assessment into perspective, GUTS models for the 13 aquatic arthropods were also used to predict the environmental risks of a measured chlorpyrifos exposure profile from an experimental ditch study (Tier‐3 approach), and the results are discussed in the context of calibration of the tiered approach. Integr Environ Assess Manag 2021;17:243–258. © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC)

Highlights

  • Plant protection products (PPPs) are subject to prospective risk assessment procedures before they are authorized for the European market

  • The selected theoretical exposure profiles AEP1 to AEP8 were characterized by the same peak concentration (0.01 μg/L) but decreasing overall exposure when going from AEP1 to AEP8 (Figure 1)

  • AEP5 to AEP7 were characterized by 2 pulsed exposures with the same peak concentrations but different time intervals between pulses, the differences in reduction of environmental risks between AEP5 to AEP7 appeared to be small

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Summary

Introduction

Plant protection products (PPPs) are subject to prospective risk assessment procedures before they are authorized for the European market. In 2018, the Panel on Plant Protection Products and their Residues (PPR) of the European Food Safety Authority (EFSA) concluded that, based on the current state of the art, the mechanistic General Unified Threshold models of Survival (GUTS) modeling framework (Jager et al 2011; Jager and Ashauer 2018) is ready to be used in the aquatic risk assessment for pesticides and aquatic fauna (invertebrates, fish, aquatic stages of amphibians). According to EFSA PPR et al (2018), GUTS models are fit‐for‐purpose to be applied in acute or chronic risk assessment for PPPs and aquatic fauna, under the condition that mortality or immobility is the critical (i.e., most sensitive) endpoint, if risks are triggered by lower tiers.

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