This volume provides a brief but important summary of the essential tests that need to be performed on all new compounds--whether they are new drugs, pesticides or food additives--before they can be registered for use in the United Kingdom. These basic tests for mutagenicity, originally drawn up by the United Kingdom Environmental Mutagen Society in 1983 have now been fully revised under the auspices of expert working groups from academia and industry and in collaboration with the UK Department of Health. This volume therefore provides the latest official guidelines and recommendations for all scientists involved in the testing and registration of new compounds not only in the UK, but in wider international context. The four main test procedures for measuring mutagenicity described in this volume are bacterial mutation assays, metaphase chromosome aberration assays in vitro, gene mutation assays in cultured mammalian cells, and in vivo cytogenetics assays. Each of these tests is fully explained and described in practical and procedural detail, with additional information on the presentation and data processing of results.

Originally published in 1993, this volume describes a complementary selection of tests to those described in the companion volume Basic Mutagenicity Tests (Cambridge University Press, 1990). These supplementary tests were used to assess risks of in vitro mutagenicity in those instances where the basic tests were inconclusive. As such, these tests had an important role in the assessment of the safety of compounds, drugs and chemicals. These supplementary test and guidelines, originally drawn up by the United Kingdom Environmental Mutagen Society (UKEMS) were fully revised in this publication to take full account of different regulatory guidelines and scientific advances. This volume will be of value to anyone with aninterest in regulatory affairs, mutagenicity testing and the registration of chemical products in the UK and Europe.

This rigorous and practical account of the interpretation of mutagenicity test data draws upon the expertise of toxicologists and statisticians. Chemicals, such as drugs, food additives and pesticides, all need careful screening to eliminate potentially mutagenic compounds. Although guidelines exist on the performance of these tests, advice on data evaluation is scarce; this volume provides the statistical background necessary for toxicologists to understand, design and interpret mutagenicity tests. In addition to the nine chapters dealing with the different tests employed, there is an introductory chapter on some of the statistical principles involved, a glossary of useful terms and an appendix providing vital information on the availability of computer software. A large team of contributors and editors working under the auspices of the United Kingdom Environmental Mutagen Society (UKEMS) have contributed a wealth of first-hand experience in compiling this immensely practical book of use to both research and industrial toxicologists.

This volume provides a brief but important summary of the essential tests that need to be performed on all new compounds--whether they are new drugs, pesticides or food additives--before they can be registered for use in the United Kingdom. These basic tests for mutagenicity, originally drawn up by the United Kingdom Environmental Mutagen Society in 1983 have now been fully revised under the auspices of expert working groups from academia and industry and in collaboration with the UK Department of Health. This volume therefore provides the latest official guidelines and recommendations for all scientists involved in the testing and registration of new compounds not only in the UK, but in wider international context. The four main test procedures for measuring mutagenicity described in this volume are bacterial mutation assays, metaphase chromosome aberration assays in vitro, gene mutation assays in cultured mammalian cells, and in vivo cytogenetics assays. Each of these tests is fully explained and described in practical and procedural detail, with additional information on the presentation and data processing of results.

The expertise of toxicologists and statisticians to provide a rigorous and practical account of the interpretation of mutagenicity test data has been drawn upon for this volume. Now, chemicals such as drugs, food additives and pesticides all need careful screening to eliminate potentially mutagenic compounds. Although guidelines exist on the performance of these tests, advice on data evolution is scarce. This niche is now filled by providing the statistical background necessary for toxicologists to understand, design and interpret mutagenicity tests. In addition to the nine chapters dealing with the different tests explained, there is an introductory chapter on some of the statistical principles included, a glossary of useful terms and an appendix providing vital information on the availability of computer software.