NC3Rs, Gibbs Building, 215 Euston Road, London NW1 2BE, UK.
EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), European Commission - Joint Research Centre (JRC), JRC F3 Chemical Safety and Alternative Methods in JRC Directorate F - Health, Consumers and Reference Materials, Via E. Fermi 2749, I-21027 Ispra, Italy.
Regul Toxicol Pharmacol. 2017 Dec;91:257-266. doi: 10.1016/j.yrtph.2017.10.021. Epub 2017 Oct 22.
Nanomaterials convey numerous advantages, and the past decade has seen a considerable rise in their development and production for an expanse of applications. While the potential advantages of nanomaterials are clear, concerns over the impact of human and environmental exposure exist. Concerted, science-led efforts are required to understand the effects of nanomaterial exposure and ensure that protection goals are met. There is much on-going discussion regarding how best to assess nanomaterial risk, particularly considering the large number of tests that may be required. A plethora of forms may need to be tested for each nanomaterial, and risk assessed throughout the life cycle, meaning numerous acute and chronic toxicity studies could be required, which is neither practical nor utilises the current evidence-base. Hence, there are scientific, business, ethical and legislative drivers to re-consider the use of animal toxicity tests. An expert Working Group of regulators, academics and industry scientists were gathered by the UK's NC3Rs to discuss: i) opportunities being offered in the short, medium and long-terms to advance nanosafety, ii) how to align these advances with the application of the 3Rs in nanomaterial safety testing, and iii) shifting the focus of risk assessment from current hazard-based approaches towards exposure-driven approaches.
纳米材料具有许多优势，在过去十年中，它们的开发和生产得到了极大的发展，应用范围广泛。虽然纳米材料的潜在优势显而易见，但人们对人类和环境暴露的影响仍存在担忧。需要齐心协力，以科学为导向，努力了解纳米材料暴露的影响，并确保实现保护目标。关于如何最好地评估纳米材料风险，人们正在进行大量讨论，特别是考虑到可能需要进行大量测试。可能需要对每种纳米材料进行大量形式的测试，并在整个生命周期内进行风险评估，这意味着可能需要进行大量的急性和慢性毒性研究，这既不切实际，也无法利用当前的证据基础。因此，有科学、商业、伦理和立法方面的驱动因素需要重新考虑动物毒性测试的使用。英国 NC3Rs 召集了监管机构、学术界和行业科学家的专家工作组，讨论了：i）在短期、中期和长期内推进纳米安全性的机会，ii）如何将这些进展与 3R 在纳米材料安全测试中的应用相结合，以及 iii）将风险评估的重点从当前基于危害的方法转向基于暴露的方法。
