Since 2020 REACH has made explicit that nanoforms have to be registered. The registrants are required to provide a specific hazard dataset for each nanoform or set of nanoforms and to characterised them. This includes particle size distribution and other physical-chemical properties. Moreover, all toxicological (considering health effects) and ecotoxicological testing of chemicals (considering effects on biotic systems; such as OECD Test Guideline (TG) 201, 202 and 203) need to be adjusted to the behaviour of nanomaterials (see OECD Guidance Document (GD) 317). However, to do appropriate adaptations to the behaviour of nanomaterials the dispersion stability (OECD Test Guideline (TG) 318) and the dissolution rate (no OECD TG available; based on OECD GDs 29 and 318) should be known. Scientifically sound studies are necessary, especially if no TG is available.
Important points to consider during dispersion stability studies are for example,
For dissolution rate studies it is important to know, that
Although the guidance documents, as well as the available test guidelines, help laboratories to find an appropriate way to generate the required data for REACH registrations, there might be big variations between laboratories regarding the study design. Moreover, the laboratories take the responsibility to conduct scientifically sound studies until a practical TG is available. The practicability of TGs is of high importance. Since the studies need to be feasible at many labs and the results should be highly comparable on an interlaboratory level. That's why round robin tests (interlaboratory test performed independently several times) are performed during TG development. Historically testing started with metal and metal oxide nanomaterials mainly due to practical reasons and therefore the development of TGs for organic nanomaterials with all the challenges they represent is currently still lacking behind. That leads to open questions (and sometimes inapplicability) if other materials need to be assessed for registration. Of course, not every potential issue can be clarified during round robins and nanomaterials are a very broad group of materials with different properties and challenges, therefore it seems to be of high importance that these studies are conducted by experienced scientific personnel.
The last seven years I dedicated to the establishment of the laboratory nEcoTox GmbH, which offers contract research services (analytics, laboratory tests for REACH, such as OECD 318) for the chemical industry. In the course of this, I combine expert knowledge with huge amount of experience and practice in the laboratory. The focus of nEcoTox is on nanomaterials (such as pigments), therefore I specialized on studies for the characterization and environmental behaviour of nanomaterials newly required by the ECHA. Thus, I have always kept up to date with regulatory requirements, guidance documents and the development of new test guidelines in recent years.
2015: PhD thesis at the Institute for Environmental Sciences, University of Koblenz-Landau, Germany (Thesis: Combined toxicity of nanoparticulate titanium dioxide products and heavy metals considering various environmental parameters.).
2011: M.Sc. (Ecotoxicology) at the Institute for Environmental Sciences, University of Koblenz-Landau, Germany (Thesis: Do TiO2 nanoparticles alter heavy metal toxicity? - A factorial approach using Daphnia magna)
2010: B.Sc. (Environmental Sciences) at the Institute for Environmental Sciences, University of Koblenz-Landau, Germany (Thesis: Effect of titanium dioxide nanoparticles (nTiO2) on lipid content, as energy reserve, in Daphnia magna)
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