ABSTRACT

Antimicrobial preservatives are used because they are toxic to certain micro-organisms whose pathogenic actions are unacceptable or which cause spoilage or deterioration. The safety of preservative materials has been established by prolonged exposure to humans without adverse comments having been received by the Food and Drug Administration. In order to evaluate the toxicity of any substance, it is necessary to know its acute and cumulative toxicity together with observed 'no effect levels', and also to be aware of its mutagenic, teratogenic and carcinogenic potential. No causal relationship has been shown between any of the commonly used preservatives and reproductive toxicity. Although the route of administration may drastically affect the apparent toxicity of the preservative, the other components of a formulation are also important. The regulatory situation depends on the type of product when a novel preservative substance is used and the country concerned but perhaps the most critical appraisal is reserved for a preservative to be used in a medicine.