ABSTRACT
National Centre for Documentation and Evaluation of Alternative Methods to Animal Experiments (ZEBET) was established in 1989 at the Federal Health Office (BGA) in Berlin as the National German Centre for Documentation and Evaluation of Alternatives to Animal Testing. ZEBET’s mission is to reduce animal testing for regulatory purposes. The only concept available in 1989 to reduce testing in animals was the Three Rs principles of Russell and Burch (Russell and Burch, 1959)
In the process of producing chemicals it is the goal of regulatory toxicology to ensure the occupational safety of workers, to ensure the safety of food and beverages, to protect patients against possible hazards represented by drugs and medical devices, and to protect humans and the environment against possible hazards posed by residues of chemicals, e.g. pesticides. The standard approach in regulatory toxicology to assess the toxicity of chemicals is the determination of toxic properties in standardized animal tests, as described in the OECD Guidelines for Testing of Chemicals (OECD, 1983). This information is then used by regulators to classify each chemical according to internationally harmonized guidelines in the first step, e.g. as harmful, toxic, irritant. The second step is to label each chemical according to European Union (EU) risk (R) phrases, e.g. ‘R-41: risk of serious damage to the eye’. The consequences of classification and labeling are the restricted use of the tested chemical in finished products (depending on exposure), and safety and labeling recommendations.
