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Pure Appl. Chem., Vol. 70, No. 9, pp.1671-1683, 1998

    Natural and anthropogenic environmental oestrogens:
    the scientific basis for risk assessment

    Principles of risk assessment

    I.F.H. Purchase and G.L.P. Randall
    Zeneca Central Toxicology Laboratory, Alderley Park, Macclesfield, Cheshire SK10 4TJ, UK.
    E-mail: [email protected]

Importance of risk assessment for risk management
There are a vast number of chemicals, both synthetic and natural, to which man and the environment are exposed. They may have beneficial effects - such as those conferred by vitamins - but all chemicals are toxic when given in a large enough dose. The range of toxicity is over 109 and thus there is a continuing need to define which chemicals represent a risk to health or the environment so that efforts can be directed to controlling those which present the greatest harm to the largest number of individuals.

In the particular context of chemicals which disrupt the endocrine system, there have been many observations of adverse effects occurring in humans or vertebrate species which have been linked to the presence of natural or synthetic chemicals in the environment, frequently without any evidence of causality. There are also observations of chemicals which have oestrogenic properties in human tissue, milk, food or the environment. It is often implied, frequently wrongly, that adverse effects are inevitable from the presence of these contaminants. The use of risk assessment can assist in resolving some of the uncertainties arising from observations of chemical contamination or adverse effects by providing a quantitative assessment of the relationship between the contaminant and the adverse effect.

For commercial organisations, the identification of chemicals which can be used safely is of paramount importance. For some chemicals, where the effect is dependant on the presence of the chemical (for example the treatment of disease with medicines), defining the conditions for safe use is important to protect the consumer. In other cases, the presence of the chemical in the consumer product is adventitious (for example the presence of chemicals in effluent, or the presence of pesticide residues, carcinogenic mycotoxins or oestrogenic compounds in food) and the issue is to what level must the chemical be controlled in order to preserve the environment and health.

The consumer is protected by the regulatory processes which are part of the legal framework for the registration of chemicals for certain uses (e.g. pharmaceuticals, pesticides, food additives, cosmetics or industrial chemicals). Equally the protection of public health requires the identification of toxic natural products and the introduction of the appropriate control measures to minimise risk. For most examples of regulatory action, the assessment of the risk posed by the presence of the chemical is one of the key steps in the decision making process. Eliminating chemicals completely, particularly natural products such as mycotoxins, is practically impossible and the development of high resolution analytical methods has demonstrated the presence of traces of such chemicals in virtually every product. The question is thus the same: To what concentration should the contaminant or natural product be limited in order to allow the benefits of the product (food, medicines etc.) to be realised without undue risk?

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