Application of the acquired knowledge and implementation of the Sens-it-iv toolbox for identification and classification of skin and respiratory sensitizers.
The contribution of the Sens-it-iv project to the reduction and replacement of animal experimentation is 3-fold. The funding of basic research has expanded the existing scientific knowledge thereby strengthening the understanding of the cellular and molecular mechanisms driving skin and respiratory sensitization. Examples are given on how a better understanding was used to improve existing test concepts. This knowledge was also applied to develop novel test systems. While some of test systems did not reach sufficient maturity for being considered for pre-validation others did and entered into the Sens-it-iv toolbox. In the process, developments outside the Sens-it-iv orbit were carefully followed and assessed in order to avoid duplication and to assure synergy between the ongoing activities (e.g. Cosmetics Europe Task Force for Sensitization). Tests from the Sens-it-iv toolbox were submitted to the European Reference Laboratory for Alternative Methods (EuRL-ECVAM) to initiate the rigid procedures for regulatory acceptance by national and international authorities. In spite of not being validated yet, selected tests were already applied in a weight-of-evidence approach in the context of REACH. Furthermore, several chemical, pharmaceutical, cosmetic and consumer product companies are currently assessing selected tests and testing strategies for their value as tools for screening and hazard identification using in house compounds and mixtures. The main points of concern related to transfer to and implementation by industry were cost, through-put and applicability domain, rather than regulatory acceptance. These issues are currently addressed in applied research projects which are financially supported by individual companies, or consortia of companies, representing the various industry sectors.
Department of Toxicology, Novozymes AS, Bagsvaerd, Denmark. elro@novozymes.com
Erwin L
EL
Roggen
D000485:Allergens / Q000633:toxicity*; D000826:Animal Testing Alternatives; D001681:Biological Assay; D017449:Dermatitis, Allergic Contact / Q000209:etiology; D006801:Humans; D012130:Respiratory Hypersensitivity / Q000139:chemically induced; D023422:Skin Irritancy Tests
D000485:Allergens