Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcino-GENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US ‘Human Toxicology Project’ consortium).
This is the report of a combined initiative between the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) and the European Centre for the Validation of Alternative Methods (ECVAM), to evaluate triggers and waivers for an extended one-generation reproductive toxicity study, which is being developed as a test guideline by the Organisation for Economic Co-operation and Development (OECD). The initial phase of the work was concerned with reviewing the endpoints evaluated in current regulatory guidelines for developmental and reproductive toxicity and those in newly-published proposals for the evaluation of agrochemicals. In particular, the aim was to design an intelligent testing strategy for reproductive and developmental endpoints, which would be suitable for the evaluation of general industrial chemicals, and to propose triggers and waivers for the investigation of optional modules in an extended one-generation reproduction toxicity study. An additional aim was to describe the extent to which these trigger and waiving criteria could already be considered to be validated, and to propose additional validation steps, if needed.The conclusions of the task force were published as ECETOC Document No. 45 (1), which served as the basis for a multi-stakeholder workshop organised by ECETOC and ECVAM, which took place on 14-15 April 2008, at Barza d'Ispra, Italy. The work-shop participants were drawn from academia, the regulatory community, industry, and contract research organisations. The outcome of the discussions and recommendations agreed upon by the workshop was published as ECETOC Workshop Report No. 12 (2).This report represents the summary findings of the task force, taking into consideration the consensus agreement of the workshop.
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