Challenging the requirement for chronic fish toxicity studies on formulated plant protection products

Creton, Stuart; Douglas, Mark; Wheeler, James R.; Hutchinson, Thomas H.

doi:10.1016/j.toxlet.2010.08.019

Cited by 4 publications

(3 citation statements)

References 2 publications

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“…A critical review of global data requirements may also be useful to identify potentially redundant requirements for testing and to ensure greater international harmonisation. For example, a recent survey of European crop protection companies indicates that chronic fish toxicity testing of formulated PPPs (plant protection products) -a potential requirement under EU legislation -is rarely, if ever scientifically justified, as chronic exposure to the formulation per se rarely occurs in the environment (Creton et al, 2010). For bird testing, there are a number of international variations in terms of preferences for the use of particular species or protocols, leading to a number of tests on the same endpoint being conducted for one substance.…”

Section: Revision Of Test Designs and Risk Assessment Schemesmentioning

confidence: 99%

A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment

Scholz

Sela²,

Bláha

et al. 2013

Regulatory Toxicology and Pharmacology

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153

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Tests with vertebrates are an integral part of environmental hazard identification and risk assessment of chemicals, plant protection products, pharmaceuticals, biocides, feed additives and effluents. These tests raise ethical and economic concerns and are considered as inappropriate for assessing all of the substances and effluents that require regulatory testing. Hence, there is a strong demand for replacement, reduction and refinement strategies and methods. However, until now alternative approaches have only rarely been used in regulatory settings. This review provides an overview on current regulations of chemicals and the requirements for animal tests in environmental hazard and risk assessment. It aims to highlight the potential areas for alternative approaches in environmental hazard identification and risk assessment. Perspectives and limitations of alternative approaches to animal tests using vertebrates in environmental toxicology, i.e. mainly fish and amphibians, are discussed. Free access to existing (proprietary) animal test data, availability of validated alternative methods and a practical implementation of conceptual approaches such as the Adverse Outcome Pathways and Integrated Testing Strategies were identified as major requirements towards the successful development and implementation of alternative approaches. Although this article focusses on European regulations, its considerations and conclusions are of global relevance.

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Section: Revision Of Test Designs and Risk Assessment Schemesmentioning

confidence: 99%

A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment

Scholz

Sela²,

Bláha

et al. 2013

Regulatory Toxicology and Pharmacology

Self Cite

153

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“…In 2008, the NC3Rs began a dedicated program of work in the area of ecotoxicology, supported by a working group of experts in the field across academia, government agencies (including regulators), contract research organizations, and industry (principally agrochemicals, personal care products, and petrochemicals). The projects initiated within the NC3Rs Ecotoxicology Working Group over the past 6 y have largely focused on reducing the use of fish in the safety assessment of industrial chemicals and agrochemicals (Creton et al 2010;Creton et al 2013;Burden et al 2014;Creton et al 2014), and build on the earlier 3Rs-related work of some members of the group (Douglas et al 1986;Hutchinson et al 2003;Jeram et al 2005). This paper summarizes discussions held at a recent workshop of the NC3Rs Ecotoxicology Working Group, which considered the future of animal use in the ecotoxicity testing required for product or substance registration.…”

Section: Introductionmentioning

confidence: 99%

Advancing the 3Rs in regulatory ecotoxicology: A pragmatic cross‐sector approach

Burden

Benstead

Clook

et al. 2015

Integr Environ Assess Manag

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The ecotoxicity testing of chemicals for prospective environmental safety assessment is an area in which a high number of vertebrates are used across a variety of industry sectors. Refining, reducing, and replacing the use of animals such as fish, birds, and amphibians for this purpose addresses the ethical concerns and the increasing legislative requirements to consider alternative test methods. Members of the UK-based National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) Ecotoxicology Working Group, consisting of representatives from academia, government organizations, and industry, have worked together over the past 6 y to provide evidence bases to support and advance the application of the 3Rs in regulatory ecotoxicity testing. The group recently held a workshop to identify the areas of testing, demands, and drivers that will have an impact on the future of animal use in regulatory ecotoxicology. As a result of these discussions, we have developed a pragmatic approach to prioritize and realistically address key opportunity areas, to enable progress toward the vision of a reduced reliance on the use of animals in this area of testing. This paper summarizes the findings of this exercise and proposes a pragmatic strategy toward our key long-term goals-the incorporation of reliable alternatives to whole-organism testing into regulations and guidance, and a culture shift toward reduced reliance on vertebrate toxicity testing in routine environmental safety assessment. Integr Environ Assess Manag 2016;12:417-421. © 2015 SETAC

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“…Conversely, for those active substances that are not toxic to birds (typically defined as those not causing mortality at a limit dose of 2000 mg active substance/kg body wt), dilution in a formulation is even less likely to lead to measurable toxicity (median lethal dose [LD50] < 2000 mg formulated product/kg body wt). These principles have been previously demonstrated to apply in regard to fish toxicity testing of active substances and their formulated products [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Saving two birds with one stone: using active substance avian acute toxicity data to predict formulated plant protection product toxicity

Maynard

Edwards

Wheeler

2014

Enviro Toxic and Chemistry

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Environmental safety assessments for exposure of birds require the provision of acute avian toxicity data for both the pesticidal active substance and formulated products. As an example, testing on the formulated product is waived in Europe using an assessment of data for the constituent active substance(s). This is often not the case globally, because some countries require acute toxicity tests with every formulated product, thereby triggering animal welfare concerns through unnecessary testing. A database of 383 formulated products was compiled from acute toxicity studies conducted with northern bobwhite (Colinus virginianus) or Japanese quail (Coturnix japonica) (unpublished regulatory literature). Of the 383 formulated products studied, 159 contained only active substances considered functionally nontoxic (median lethal dose [LD50] > highest dose tested). Of these, 97% had formulated product LD50 values of >2000 mg formulated product/kg (limit dose), indicating that no new information was obtained in the formulated product study. Furthermore, defined (point estimated) LD50 values for formulated products were compared with LD50 values predicted from toxicity of the active substance(s). This demonstrated that predicted LD50 values were within 2-fold and 5-fold of the measured formulated product LD50 values in 90% and 98% of cases, respectively. This analysis demonstrates that avian acute toxicity testing of formulated products is largely unnecessary and should not be routinely required to assess avian acute toxicity. In particular, when active substances are known to be functionally nontoxic, further formulated product testing adds no further information and unnecessarily increases bird usage in testing. A further analysis highlights the fact that significant reductions (61% in this dataset) could be achieved by using a sequential testing design (Organisation for Economic Co-operation and Development test guideline 223), as opposed to established single-stage designs. Environ Toxicol Chem 2014;33:1578–1583.

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Challenging the requirement for chronic fish toxicity studies on formulated plant protection products

Cited by 4 publications

References 2 publications

A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment

A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment

Advancing the 3Rs in regulatory ecotoxicology: A pragmatic cross‐sector approach

Saving two birds with one stone: using active substance avian acute toxicity data to predict formulated plant protection product toxicity

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