The discovery or development of novel chemicals or materials creates a demand of new knowledge as regards the related potential biological effects and health hazards. Before such materials are launched for different uses, they must be evaluated for safety without any risks to health according to the legal requirements in the different countries. In Germany these are for example chemicals ordinance, the medicinals products act, the food regulations, the cosmetics and detergents ordinances, and various other regulations. These requirements are also valid for and applied to smart or nanomaterials.
Since additional issues, however, must be considered to find out, for example, whether the particular properties of the nanovariant of a material may influence or change the material’s behaviour in biological systems on a physical, chemical or on any other level, the nanomaterials are analysed toxicologically. There are two basically different methods, i.e. in vitro or in vivo, that toxicologists, mostly chemists, medical scientists or biologists, may choose for conducting such studies.
In addition to assessing the possible biological effects of innovative materials or nanomaterials inside the human body, it is important to evaluate the materials’ epidemiological impacts, i.e. their effects on the health of the overall population. Workplace hazards, for example, are among the risks that need to be studied. Additionally, the influence of innovative materials such as engineered nanoparticles on all organisms in our environment has to be considered and studied. Does an environmental “pollution” with nanoparticles exert similar effects compared to chemicals?
For all that, it is important to point out that the health hazards of any chemical substance almost always depend on the concentration. According to Paracelsus (1493-1541), “all things are poison; there is nothing without poison; only the dose makes a thing non-poisonous”. It has remained valid until the present day that any substance has a biological/toxicological effect. Only the concentration (or dose) that is taken up by the organism decides whether that effect is negative or not. However, there are exceptions from this rule, especially carcinogenic substances or endocrine disruptors may induce biological effects without a clear concentration- or dose dependency.