European Government-Industry Project Aims to Develop Non-animal Alternatives for Repeated Dose Systemic Toxicity Testing

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In the Spotlight

European Government-Industry Project Aims to Develop Non-animal Alternatives for Repeated Dose Systemic Toxicity Testing

Sherry Ward, AltTox Contributing Editor

Published: March 29, 2011

Repeated dose systemic toxicity testing is one of the many types of toxicity testing required by various government regulatory agencies to estimate the “safety” of chemicals and products. There are no validated alternatives to this type of testing, which involves substantial numbers of animals.

The 7th Amendment to the Cosmetics Directive (Directive 2003/15/EC), adopted by the European Parliament in 2003, imposed deadlines that ban animal testing for cosmetics and cosmetic ingredients to be marketed within EU countries. Finished cosmetic product testing on animals has been banned since September 11, 2004. Animal testing of ingredients has been banned since March 11, 2009 for all toxicity endpoints except those for assessing repeated dose toxicity, reproductive toxicity, and toxicokinetics. The ban on animal testing for these more biologically-complex toxicity endpoints is slated to go into force on March 11, 2013, regardless of the availability of non-animal test methods.

A European Commission (EC) report describing progress made in replacing animal experiments for the safety testing of cosmetic products during the period of 2007 and 2008 concluded that there were still no replacement alternative methods available for the three endpoints subject to the 2013 deadline. Furthermore, none were foreseen to be in place by 2013. This report also described plans for a collaborative project by the EC’s FP7-HEALTH-2010-Alternative Testing programme and the European Cosmetics Association (COLIPA) to jointly fund a €50 million research program to develop replacement methods for repeated dose systemic toxicity testing.

The European research initiative “Safety Evaluation Ultimately Replacing Animal Testing” (SEURAT), as its name implies, is based on the long-term goal of replacing animals in safety testing. The first 5-year phase, SEURAT-1, is the €50 million EC and COLIPA-funded program with the goal of “replacement of current repeated dose systemic toxicity testing in human safety assessment.”

To address this goal, SEURAT-1 is organized into six research projects that will be coordinated for the “development of knowledge and technologies required for repeated dose systemic toxicity testing without animals.”

SEURAT-1 Cluster Projects:

Project Name

Project Topic

Project Coordinator and Organization (Country)

SCR&ToxStem Cells for Relevant efficient extended and normalized ToxicologyProf. Marc Peschanski, INSERM (France)
HeMiBioHepatic Microfluidic BioreactorProf. Catherine Verfaillie, Katholieke Universiteit Leuven (Belgium)
DETECTIVEDetection of endpoints and biomarkers of repeated dose toxicity using in vitro systemsProf. Jürgen Hescheler, Universität zu Köln – Universitätsklinikum (Germany)
COSMOSIntegrated in silico models for the prediction of human repeated dose toxicity of COSMetics to Optimise SafetyProf. Mark Cronin, Liverpool John Moores University (UK)
NOTOXPredicting long-term toxic effects using computer models based on systems characterization of organotypic culturesProf. Elmar Heinzle, Saarland University – Biochemical Engineering Institute (Germany)
ToxBankSupporting integrated data analysis and servicing of alternative testing methods in toxicologyProf. Emilio Benfenati, Istituto di Ricerche Farmacologiche Mario Negri (Italy) and Dr. Barry Hardy, Douglas Connect (Switzerland)

COLIPA announced that almost 100 scientists from over 70 European organizations participated in the SEURAT-1 kick-off meeting on March 1-3, 2011 in Cascais, Portugal.  The purpose of the event, which was limited to project participants, was to introduce project collaborators and provide a platform for discussing proposed research. The main features of the program included the following:

Day 1 – introductions to the sponsoring and research organizations and overviews of the research program and strategy

Day 2 – four focus workshops and a plenary session:
Workshop 1: Mechanisms relevant to repeated dose toxicity
Workshop 2: Data management and analysis
Workshop 3: Definitions and ontology for generation of a common SEURAT-1 database
Workshop 4: Test substances for projects and criteria of chemicals selection
Plenary session: Practical issues related to in vitro toxicity testing

Day 3 – concluded the meeting with 3 sessions: feedback from the focus workshops, the 5-year research strategy for SEURAT-1, and roadmaps for future research

Another EC project, COACH, has been established to provide coordination and optimize cooperation among the SEURAT-1 cluster projects. COLIPA noted that “the installation of a Coordinating Action right from the start of the research initiative is unique; with its coordination mechanisms it will provide a maximum of synergy between participants and therefore optimise the output of this cluster of projects.”

The development of alternative methods to replace animals in repeated dose systemic toxicity testing is a considerable scientific challenge. Stakeholders look forward to the anticipated progress to be made by innovative research programs such as SEURAT-1.