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Testing methods for nanomaterials in the regulatory framework of chemical safety - BAuA contribution to "Regulatory testing of nanomaterials (NanoReg)" in the 7th EU framework program for research

Project number: F 2325 Institution: Federal Institute for Occupational Safety and Health (BAuA) / Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) Status: Ongoing Project Planned end: 2020-02-29


The 7th EU Framework research project "NANoREG" will work on recommendations to amend existing regulations on chemical safety to the specific properties of nanomaterials. Besides the chemical composition the outer shape (morphology) of nanomaterials has significant relevance when choosing proper test and assessment strategies to determine exposure and human health hazards from nanomaterials. The previously developed "BAuA-Shaker-Method" is to be standardized as a test for morphological characterization of aerosols from nanomaterials. It will be validated by using different types of nanomaterials as a basis for recommendations to categorize them for regulatory purposes. A long-term in-vivo study will serve to experimentally verify hypotheses on the mode of carcinogenic action. In parallel putative systemic effects will be assessed. The study will provide relevant information on chronic effects of these materials in the relevant low-dose range. For the first time resilient results will be available for risk assessment and for the derivation of exposure limits for a group of nanomaterials whose toxicity is exclusively mediated by action of inert dust. The "Cyto-TP", a BAuA development, is currently the most innovative technology to fast gain knowledge on potential health effects of nanoparticles at low cost. It is an early prototype which will be improved. Further open questions on the method will be answered to prepare for a pre-validation-study following internationally accepted test guidelines.


Unit 4.5 "Particulate Hazardous Substances, Advanced Materials"

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