Genotoxicity testing towards a knowledge-based regulation of nanomaterials
Silva, Maria João
Genotoxicidade Ambiental | Nanomaterials | Regulation
Nanotechnologies are developing very rapidly and the exploitation of manufactured nanomaterials (MNMs) is gaining ascendancy in science, industry and biomedicine. However, comparatively less research has been performed to guarantee their safety for humans and the environment. In the context of risk assessment, solid information about human exposure and hazard is lacking for the vast majority of MNMs, especially related to chronic exposure to low doses that is likely to occur, e.g., in occupational settings or through consumer products. Focusing on hazard characterization, the genotoxic effects of MNMs, which may be linked to carcinogenic effects, are of special concern because cancer has a long latency period and these late effects can be less obvious and more difficult to predict than the acute effects.
The small size, large surface area and unique surface properties of MNMs greatly influence their reactivity in biological systems and trigger some unpredictable cell responses, representing a challenge in terms of hazard assessment. In the context of NANoREG, which is intended to answer regulatory questions and requirements from regulators and legislators, the contribution of PToNANO includes the genotoxicity assessment of well characterized MNMs, using standardized and validated tests and strategies, thereby contributing to the knowledge basis for their regulation. In the future, accommodating the safety evaluation within the innovation process will stimulate the relationship between innovation and risk regulation. This is applicable to the innovation process itself as to the regulation of the resulting products and technologies, in order to promote the benefits from innovation while protecting the public health and the environment.