Genotoxicity

As genotoxicity is defined as the effects of chemical substances, the changes in the genetic material (deoxyribonucleic acid ) of cells trigger. This term is a purely experimental approach, such as substances behave in experiments (in vitro). Substances which were tested here as genotoxic positive, but do not necessarily have mutagen or carcinogen. Determination of the genotoxicity of a substance is part of the determination of toxicity of a substance.

In the context of drug development, pharmaceutical companies are required to carry out a risk assessment on the occurrence of potentially genotoxic impurities in drug more effective. Such impurities can from the synthesis of the drugs come from or arise under certain circumstances during further processing of the drug. The risk assessment shall be submitted to the competent authority with the application for approval of a medicinal product already authorized medicines can occasionally also a risk assessment may be required. General, except for materials from a few to be highly carcinogenic substance known groups (N- nitrosamines, aflatoxins, azoxy compounds ) is considered the maximum daily intake of 1.5 micrograms of potentially genotoxic compound as a toxicologically acceptable risk. This derived from animal experiments value, there is a risk that one of 100,000 patients treated in the course of his life additionally ill ( assuming a lifetime of 70 years ) from cancer. If specific pharmacological- toxicological data are known for appearing as a contaminant, can be justified under certain circumstances, a higher exposure. The maximum allowed amount of such substances, the patient daily by drug intake exposes himself (English: permitted daily exposure PDE) is then calculated on the basis of that concentration limits up to which no harmful effects can be seen in animal studies, the so-called NOEL (English: no observed effect level ).

Detection and quantification of mutagenic substances, the Ames test is used.