Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

EFSA Panel on Plant Protection Products and their Residues (PPR)

doi:10.2903/j.efsa.2018.5377

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

EFSA Panel on Plant Protection Products and their Residues (PPR)

Section for Environmental Chemistry and Physics

44 Citations (Scopus)

Abstract

Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species- and compound-specific and can be used to predict (sub)lethal effects of pesticides under untested (time-variable) exposure conditions. Three different types of TKTD models are described, viz., (i) the ‘General Unified Threshold models of Survival’ (GUTS), (ii) those based on the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All these TKTD models follow the principle that the processes influencing internal exposure of an organism, (TK), are separated from the processes that lead to damage and effects/mortality (TD). GUTS models can be used to predict survival rate under untested exposure conditions. DEBtox models explore the effects on growth and reproduction of toxicants over time, even over the entire life cycle. TKTD model for primary producers and pesticides have been developed for algae, Lemna and Myriophyllum. For all TKTD model calibration, both toxicity data on standard test species and/or additional species can be used. For validation, substance and species-specific data sets from independent refined-exposure experiments are required. Based on the current state of the art (e.g. lack of documented and evaluated examples), the DEBtox modelling approach is currently limited to research applications. However, its great potential for future use in prospective ERA for pesticides is recognised. The GUTS model and the Lemna model are considered ready to be used in risk assessment.

Original language	English
Article number	e05377
Journal	EFSA Journal
Volume	16
Issue number	8
Number of pages	188
ISSN	1831-4732
DOIs	https://doi.org/10.2903/j.efsa.2018.5377
Publication status	Published - 2018

Keywords

aquatic organisms
model calibration
model evaluation
model validation
prospective risk assessment
time-variable exposure
Toxicokinetic/Toxicodynamic models

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Scientific Opinion on the state of the art of ToxicokineticToxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organismsFinal published version, 25.5 MBLicence: CC BY-ND

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@article{1d7cc6b22fbb41c3ac6ced3c6430eb9c,

title = "Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms",

abstract = "Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species- and compound-specific and can be used to predict (sub)lethal effects of pesticides under untested (time-variable) exposure conditions. Three different types of TKTD models are described, viz., (i) the {\textquoteleft}General Unified Threshold models of Survival{\textquoteright} (GUTS), (ii) those based on the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All these TKTD models follow the principle that the processes influencing internal exposure of an organism, (TK), are separated from the processes that lead to damage and effects/mortality (TD). GUTS models can be used to predict survival rate under untested exposure conditions. DEBtox models explore the effects on growth and reproduction of toxicants over time, even over the entire life cycle. TKTD model for primary producers and pesticides have been developed for algae, Lemna and Myriophyllum. For all TKTD model calibration, both toxicity data on standard test species and/or additional species can be used. For validation, substance and species-specific data sets from independent refined-exposure experiments are required. Based on the current state of the art (e.g. lack of documented and evaluated examples), the DEBtox modelling approach is currently limited to research applications. However, its great potential for future use in prospective ERA for pesticides is recognised. The GUTS model and the Lemna model are considered ready to be used in risk assessment.",

keywords = "aquatic organisms, model calibration, model evaluation, model validation, prospective risk assessment, time-variable exposure, Toxicokinetic/Toxicodynamic models",

author = "Colin Ockleford and Paulien Adriaanse and Philippe Berny and Theodorus Brock and Sabine Duquesne and Sandro Grilli and Hernandez-Jerez, {Antonio F.} and Bennekou, {Susanne Hougaard} and Michael Klein and Thomas Kuhl and Ryszard Laskowski and Kyriaki Machera and Olavi Pelkonen and Silvia Pieper and Smith, {Robert H.} and Michael Stemmer and Ingvar Sundh and Aaldrik Tiktak and Topping, {Christopher J.} and Gerrit Wolterink and Nina Cedergreen and Sandrine Charles and Andreas Focks and Melissa Reed and Maria Arena and Alessio Ippolito and Harry Byers and Ivana Teodorovic and {EFSA Panel on Plant Protection Products and their Residues (PPR)}",

year = "2018",

doi = "10.2903/j.efsa.2018.5377",

language = "English",

volume = "16",

journal = "EFSA Journal",

issn = "1831-4732",

publisher = "European Food Safety Authority (E F S A)",

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T1 - Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

AU - Ockleford, Colin

AU - Adriaanse, Paulien

AU - Berny, Philippe

AU - Brock, Theodorus

AU - Duquesne, Sabine

AU - Grilli, Sandro

AU - Hernandez-Jerez, Antonio F.

AU - Bennekou, Susanne Hougaard

AU - Klein, Michael

AU - Kuhl, Thomas

AU - Laskowski, Ryszard

AU - Machera, Kyriaki

AU - Pelkonen, Olavi

AU - Pieper, Silvia

AU - Smith, Robert H.

AU - Stemmer, Michael

AU - Sundh, Ingvar

AU - Tiktak, Aaldrik

AU - Topping, Christopher J.

AU - Wolterink, Gerrit

AU - Cedergreen, Nina

AU - Charles, Sandrine

AU - Focks, Andreas

AU - Reed, Melissa

AU - Arena, Maria

AU - Ippolito, Alessio

AU - Byers, Harry

AU - Teodorovic, Ivana

AU - EFSA Panel on Plant Protection Products and their Residues (PPR)

PY - 2018

Y1 - 2018

N2 - Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species- and compound-specific and can be used to predict (sub)lethal effects of pesticides under untested (time-variable) exposure conditions. Three different types of TKTD models are described, viz., (i) the ‘General Unified Threshold models of Survival’ (GUTS), (ii) those based on the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All these TKTD models follow the principle that the processes influencing internal exposure of an organism, (TK), are separated from the processes that lead to damage and effects/mortality (TD). GUTS models can be used to predict survival rate under untested exposure conditions. DEBtox models explore the effects on growth and reproduction of toxicants over time, even over the entire life cycle. TKTD model for primary producers and pesticides have been developed for algae, Lemna and Myriophyllum. For all TKTD model calibration, both toxicity data on standard test species and/or additional species can be used. For validation, substance and species-specific data sets from independent refined-exposure experiments are required. Based on the current state of the art (e.g. lack of documented and evaluated examples), the DEBtox modelling approach is currently limited to research applications. However, its great potential for future use in prospective ERA for pesticides is recognised. The GUTS model and the Lemna model are considered ready to be used in risk assessment.

AB - Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species- and compound-specific and can be used to predict (sub)lethal effects of pesticides under untested (time-variable) exposure conditions. Three different types of TKTD models are described, viz., (i) the ‘General Unified Threshold models of Survival’ (GUTS), (ii) those based on the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All these TKTD models follow the principle that the processes influencing internal exposure of an organism, (TK), are separated from the processes that lead to damage and effects/mortality (TD). GUTS models can be used to predict survival rate under untested exposure conditions. DEBtox models explore the effects on growth and reproduction of toxicants over time, even over the entire life cycle. TKTD model for primary producers and pesticides have been developed for algae, Lemna and Myriophyllum. For all TKTD model calibration, both toxicity data on standard test species and/or additional species can be used. For validation, substance and species-specific data sets from independent refined-exposure experiments are required. Based on the current state of the art (e.g. lack of documented and evaluated examples), the DEBtox modelling approach is currently limited to research applications. However, its great potential for future use in prospective ERA for pesticides is recognised. The GUTS model and the Lemna model are considered ready to be used in risk assessment.

KW - aquatic organisms

KW - model calibration

KW - model evaluation

KW - model validation

KW - prospective risk assessment

KW - time-variable exposure

KW - Toxicokinetic/Toxicodynamic models

U2 - 10.2903/j.efsa.2018.5377

DO - 10.2903/j.efsa.2018.5377

M3 - Journal article

AN - SCOPUS:85053480042

SN - 1831-4732

VL - 16

JO - EFSA Journal

JF - EFSA Journal

IS - 8

M1 - e05377

ER -

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

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Keywords

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