Exploring new approaches to assess safety without animal testing

The 7 Amendment to the EU Cosmetics Directive has made developing non-animal approaches to assure the safety of consumer products a key business need to support future innovation. A substantial research programme was initiated by Unilever in 2004, aimed at critically evaluating the feasibility of a proposed new conceptual approach. The key aspects of this approach are: 1. Developing new risk assessment approaches 2. Developing new computer-based (in silico) and biological (in vitro) models 3. Evaluating the applicability of new data-rich technologies for generating and interpreting information for risk-based safety assessment. We have focussed initially on skin allergy (sensitisation). A new risk assessment framework has been defined and is under evaluation. In collaboration with Entelos Inc., we have developed an in silico model of the induction of skin sensitisation, to help guide our development of new in vitro assays and to provide the biological context for integrating different types of data. New in vitro models are being developed inhouse and through various research partnerships, including via COLIPA and as part of the EU Framework 6 Programme multi-partner research project, Sens-it-iv. The applicability and integration of data from 'omics' technologies are being investigated, including the use of Cytoscape for constructing, visualising and interrogating biological networks in a collaboration with the University of California San Diego. Work is ongoing to evaluate the applicability of this new risk-based approach for skin allergy, and investment is being made in applying the approach to other consumer safety endpoints.