The JRC participated in an expert group of regulators, academics and industry to discuss the way forward in nanotoxicology, concluding that there is a strong potential for use of alternative methods that will impact the reduction, refinement and replacement (3Rs) of animal testing.
Nanomaterials (NM) are increasingly being developed and produced for a wide array of applications. It is therefore crucial to understand any potential adverse effects of NM exposure on humans and the environment to ensure adequate levels of protection. However there are ongoing discussions within scientific and regulatory communities on how to best assess any potential risks of the many different NM forms throughout their lifecycle, considering the large number of tests that may be required under different regulatory frameworks. Moreover, traditional toxicity testing approaches that rely heavily on animal studies are not only undesirable from an ethical perspective but often have significant limitations in terms of time, cost and relevance.
The expert group discussed the many scientific, legislative, societal, and business drivers to move towards 21st century, animal-free approaches in nanotoxicology through the utilisation of non-traditional methods such as in vitro tests and computational modelling. Recommendations included: proper consideration of the limitations and uncertainties of both animal-based and alternative approaches; clarity about which adverse effects can be covered by current safety assessment practice and which require further research; and emphasis on the fact that 'one size doesn't fit all' and thus different integrated systems will be required for assessing different types of NM against different potential adverse effects. In addition, experts expressed a preference for the design of safety assessment approaches that are exposure-driven.
Read more in:
N. Burden et. al.: Aligning nanotoxicology with the 3Rs: What is needed to realise the short, medium and long-term opportunities. Regulatory Toxicology and Pharmacology, 91 (2018) 257-266
- 2 Februar 2018