The uncertainty with nanosafety: Validity and reliability of published data.

Use and production of chemicals and new materials are always reasons for concern especially with regard to human health and the environmental impacts. Over the past few decades occupational safety is a greater focus for toxicologists and of national and international registration programs for new products. Thus, the careful investigation of the biological effects of new chemicals and materials is critical. However, the hype around "The Nanotechnology" has boosted a competition for public funds and thereby the number of publications on this "nanotoxicology" topic has exploded. For more than two decades the public discussion around the special effects of nanomaterials or nanoparticles is ongoing without a final conclusion regarding an existing issue of a "nano-specific effect". Facing the situation of a dramatic increase in the number of publications (>4400 PubMed references in 2017 alone!); the quality of the findings appears to be questionable, particularly with regard to the implementation of risk assessment for nanomaterials. Most of the published nanotoxicology studies are associated with fundamental deficiencies in the experimental design of these investigations, including 1) a lack of rigorous and adequate physicochemical characterization of the test materials; 2) the absence of adequate particle controls; and 3) the implementation of high dose experiments, designed to produce toxicological effects - which are publishable (and sensational). As a consequence, the "toxicology" results have limited utility, and therefore must be critically (re)evaluated. This service is provided by the internet knowledge base DaNa (www.nanoobjects.info). On this website a criteria catalogue for the re-evaluation of scientific publications has been published and if these criteria are utilized > 60 70% of reported study findings are not acceptable and cannot be taken into consideration for risk assessment criteria.