The current scientific and legal status of alternative methods to the LD50 test for botulinum neurotoxin potency testing. The report and recommendations of a ZEBET Expert Meeting.

An Expert Meeting on The Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin (BoNT) Potency Testing was organised by the Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET) at the Federal Institute for Risk Assessment (BfR), and took place on 27–28 April 2009, in Berlin, Germany. The goal of ZEBET is to promote primarily the replacement of legally required animal experiments with valid alternative test methods, to reduce the numbers of test animals used to the absolutely necessary level, and to alleviate their pain and suffering. ZEBET’s tasks are the documentation, assessment and promotion of alternative methods to animal experiments on a national and international level, and the initiation of research and development, including the funding of smaller research projects. The Expert Meeting on alternative methods for Botulinum neurotoxin (BoNT) potency testing was held at the BfR as the result of a decree from the German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), after it was informed by German state authorities about an increase in animal numbers being used in the LD50 potency test in mice for the purposes of BoNT potency testing. Ethical concerns have been raised in both Europe and the United States about the animal suffering involved in this type of testing, especially in the context of BoNT’s aesthetic applications. There had been increased public pressure on the German Government, due to successful campaigning by animal welfare/anti-vivisectionist organisations on the issue of BoNT animal testing. As a result, the BMELV asked ZEBET to assess the status of the different alternative methods to the BoNT LD50 potency test that are cited in the European Pharmacopoeia (EP) 6.0, Monograph 2113, Botulinum Toxin Type The Current Scientific and Legal Status of Alternative Methods to the LD50 Test for Botulinum Neurotoxin Potency Testing