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Alternatives to animal testing: EURL ECVAM publishes its Recommendation on an in vitro cytotoxicity assay for acute oral toxicity testing

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May 02, 2013
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EURL ECVAM details the performance, applicability and limitations of this 'in vitro' test for acute oral toxicity - one of two remaining health effects currently requiring animal tests at low production levels under REACH Annex VII

Today 02 May 2013 the European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM, hosted by the European Commission Joint Research Centre) published its Recommendation on the scientific validity of the 3T3 Neutral Red Uptake (NRU) in vitro cytotoxicity method for acute oral toxicity testing.

Information on the potential toxicity of chemicals when ingested orally (so called acute oral toxicity) is of fundamental importance: under EU Chemical legislation (REACH), this is one of two health effects requiring animal tests already at low production levels. Until now it has been assessed by a suite of refinement tests conducted in rats and based on lethality. This may change now. EURL ECVAM in its Recommendation details the validity and applicability of the 3T3 Neutral Red Uptake in vitro cytotoxicity assay for acute oral toxicity testing. The method supports identification of chemicals not requiring classification as toxicants (so called "negative" substances) and it appears specifically useful for industrial chemicals under REACH.

EURL ECVAM's Recommendation summarises the overall performance of the 3T3 NRU test method, its applicability and limitation, provides guidance for its proper scientific use, and makes a suite of recommendations in view of tackling some remaining gaps concerning a more complete characterisation of the test method.

To fully address information needs on acute oral toxicity, EURL ECVAM recommends the development of Integrated Testing Strategies building on the integration of 3T3 NRU data with other information sources such as structural alerts, structure-activity relationships and toxicokinetic data. Such strategies ideally should be based on a comprehensive understanding and description of key mechanisms of acute toxicity, summarised, for example, in Adverse Outcome Pathways (AOPs).

Photo: Microscopic observation of cells in a 24-well cell culture plate. Copyright EU 2012.