There are many different chemicals and materials in use today. These are subject to stringent regulations, which include a requirement for physico-chemical and toxicity testing. In some countries existing chemicals are also undergoing safety checks. The aim is to determine their hazardous properties and the risks involved in using substances.
Health and safety of the environment and the individual are becoming of prime importance to society and extensive legislation has been developed. To the R&D chemist this is a maze to negotiate when trying to introduce a new material or chemical into a different market place. What tests are required and for which markets? What do the test results mean? Who are the key organisations in each global region? Legislation varies between applications and often the quantity of chemical in use is critical to determining the level of testing required.
A Practical Guide to Chemical Safety Testing describes the different tests that must be performed on new chemicals and other materials to demonstrate to the regulatory authorities that they are safe for use. Tests vary from physico-chemical, measuring properties such as melting point and density, through genetic toxicity studies, to mammalian toxicology and studies to investigate effects on the environment. Animal testing is carried out to look for potential irritants, harmful substances, corrosive agents, allergens, cancer causing potential, etc. Each test type is described here and the validity of the test methods is debated. For example, there are sometimes major differences between simple model systems using cell lines or bacteria, effects in laboratory animals and, most importantly, with effects on humans. This can give rise to misleading interpretation of results.
There is a chapter devoted to alternatives to animal testing for safety evaluation. Many non-animal screening tests are available. It is also becoming increasingly possible to cross-match many new chemicals with existing toxicity data to predict potential carcinogenicity, allergenicity, etc. These approaches can reduce the test requirements for the chemical, although a structural alert showing the presence of a suspect chemical moiety can trigger definitive toxicological assessment.
Ecotoxicological testing is carried out to determine the level of hazard to organisms in the environment. Important properties used to estimate environmental fate include the solubility of the test material in water, its ability to adsorb to soil and its potential for accumulation in animals.
Regulations vary depending on the intended purpose of a material, and this book describes the requirements for general chemicals, polymers, food contact materials, medical devices and biocides. Often the quantity imported into a region determines the stringency of the testing required. The EU, the USA, Japan and other geographical regions each has its own set of regulations. These are outlined here. In some instances approval of a chemical in one country will lead to automatic approval in a second country. In other cases new testing is required. This is a very complex situation. The second half of this book sets out to untangle the web of legal issues facing manufacturers and suppliers.
This book is essential reading for chemical and material manufacturers and suppliers. It describes clearly the process of obtaining approval for use in a variety of global regions and across different applications. It also explains why different tests are performed and the implications of the results.
Dr Derek Knight is the Director of Regulatory Affairs at Safepharm Laboratories Ltd. He is an expert in regulatory requirements, providing advice on testing and document submission to regulatory authorities. He has a doctorate in chemistry from Oxford University and is a Fellow of the Royal Society of Chemistry and the British Institute of Regulatory Affairs. He has published extensively on regulatory issues, alternatives to animal testing, food contact materials and biocides.
Mike Thomas is the Marketing Director for Safepharm Laboratories. He graduated in zoology and chemistry from London University and went on to a career in toxicity testing, including working on a wide range of toxicity studies. Prior to joining Safepharm he was Director of Biological Services at International Consulting and Laboratory Services Ltd., of London.
