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Creton S.,National Center for the Replacement | Douglas M.,Dow AgroSciences | Wheeler J.R.,Hill International | Hutchinson T.H.,CEFAS - Center for Environment, Fisheries and Aquaculture Science
Toxicology Letters | Year: 2010

Ecotoxicity testing of pesticide active ingredients and formulated plant protection products (PPPs) prior to their commercial use is required by authorities around the world. Such studies are important for the conduct of risk assessments to protect wildlife and the environment, but they should only be conducted when their use is scientifically justified. One test of questionable scientific merit is the chronic fish toxicity test when conducted with formulated PPPs, which is a potential requirement under European legislation: chronic exposure to the formulated product per se rarely occurs in the environment and therefore it is generally not possible to use the data from chronic formulation studies in a meaningful risk assessment. A recent survey of European crop protection companies to explore the scientific merits and regulatory drivers for chronic fish toxicity studies has shown that current practice in deciding on the need for chronic fish toxicity testing of formulated PPPs varies substantially between companies. The most commonly cited reason for conducting such studies was solely to meet regulatory requirements. We conclude that chronic formulation testing is rarely if ever scientifically justified, and recommend that the forthcoming revision of the EU Aquatic Toxicology Guidance Document takes account of this by including a requirement that justification must be provided for conducting the test, rather than the current situation where the onus is on the registrant to provide a justification for not conducting the test. © 2010 Elsevier Ireland Ltd. Source


Creton S.,National Center for the Replacement | Clook M.,Chemicals Regulation Directorate | Wheeler J.R.,Hill International
Chemosphere | Year: 2014

In order to minimise animal testing, this paper explores the feasibility of the "threshold approach" that has been recently developed by the Organisation for Economic Cooperation and Development (OECD). Essentially the approach uses a limit test at a single threshold concentration determined by the results of Daphnia and algae tests. If no mortality is observed in the limit test the fish acute value can be expressed as greater than the threshold value. However, if mortality is observed a full concentration-response test is triggered. In order to assess the applicability of the approach to plant protection products (PPP), a database of 185 products (fish, Daphnia and algae endpoints) was constructed and the threshold approach retrospectively applied. However, this analysis did not take into account the use of the data in the regulatory process. To assess whether the "threshold approach" could be used for PPPs the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) held a workshop in December 2010. This meeting brought together representatives from a number of European regulators and researchers as well as industry to discuss the applicability of the approach. The outcome of this discussion is presented in the paper. © 2013 Elsevier Ltd. Source


Seidle T.,Humane Society International | Seidle T.,University of Konstanz | Robinson S.,Astrazeneca | Holmes T.,Covance | And 4 more authors.
Toxicological Sciences | Year: 2010

Acute systemic toxicity studies are carried out in many sectors in which synthetic chemicals are manufactured or used and are among the most criticized of all toxicology tests on both scientific and ethical grounds. A review of the drivers for acute toxicity testing within the pharmaceutical industry led to a paradigm shift whereby in vivo acute toxicity data are no longer routinely required in advance of human clinical trials. Based on this experience, the following review was undertaken to identify (1) regulatory and scientific drivers for acute toxicity testing in other industrial sectors, (2) activities aimed at replacing, reducing, or refining the use of animals, and (3) recommendations for future work in this area. © The Author 2010. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. Source


Percie Du Sert N.,National Center for the Replacement | Rice A.S.C.,Imperial College London
British Journal of Pharmacology | Year: 2014

Neuropathic pain remains an area of considerable unmet clinical need. Research based on preclinical animal models has failed to deliver truly novel treatment options, questioning the predictive value of these models. This review addresses the shortcomings of rodent in vivo models commonly used in the field and highlights approaches which could increase their predictivity, including more clinically relevant assays, outcome measures and animal characteristics. The methodological quality of animal studies also needs to be improved. Low internal validity and incomplete reporting lead to a waste of valuable research resources and animal lives, and ultimately prevent an objective assessment of the true predictivity of in vivo models. © 2014 The British Pharmacological Society. Source


Creton S.,National Center for the Replacement | Weltje L.,BASF | Hobson H.,Hill International | Wheeler J.R.,Hill International
Chemosphere | Year: 2013

Fish bioconcentration tests are time consuming, expensive, and use many animals. Alternative methods that replace, reduce or refine the use of fish for BCF testing would therefore be of value. Test guidelines generally require that bioconcentration factors (BCFs) are determined at two exposure concentrations. However, recent revisions to the OECD Test Guideline for BCF testing (TG 305) provide the option to use only one exposure concentration, when justification is provided, although two concentrations may still be required for some regulatory purposes. Analysis of 55 studies on plant protection products demonstrates that BCF values do not significantly differ between the two exposure concentrations. This analysis therefore provides evidence to support the revision of OECD TG 305, and in particular provides justification for using the one test concentration approach for plant protection product active substances. © 2012 Elsevier Ltd. Source

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