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Guidance

New approach methodologies (NAMs) in toxicology

Introduction

New approach methodologies (NAMs) - replacement (full and partial) technologies for use in assessing chemical or drug toxicity - hold great promise in providing useful information for chemical hazard and risk assessment. We are leading projects to increase confidence in the use and application of NAMs for regulatory decision making. This will ultimately reduce the current reliance on animal toxicity tests and improve the science and predictivity of safety testing.

UK chemicals regulation vision

The NC3Rs and British Toxicology Society have identified actions to optimise opportunities presented from exiting the EU to develop a world-leading regulatory framework that firmly embeds the 3Rs in chemical safety testing. Embracing a more flexible, modernised and sustainable approach to UK chemicals regulation will create significant scientific, business and societal benefits, by reducing the reliance on animal-based testing methods to protect human health and the environment.

This work follows on from a workshop we held with Unilever, which brought together over 50 scientists across government departments, large and small industry and academia. The workshop was the first step in building a consensus vision across the UK science base on the future direction of domestic chemicals regulation.

Pathways-based approaches

Using cell-based and computational approaches to investigate how pharmaceuticals and environmental chemicals interact with biological systems, to help predict whether they are harmful to humans and/or the environment. 

You can also read more about our project around applying pathways-based approaches across the biosciences on our project page.

In vitro approaches for carcinogenicity testing

Increasing the use of cell biotransformation assays in regulatory safety assessment to reduce the numbers of in vivo carcinogenicity screens carried out.

You can read more about this project on our project page: In vitro approaches for carcinogenicity testing.

Opportunities and challenges for integrating new in vitro methodologies in nanomaterial hazard testing and risk assessment

Exploring the use of in vitro approaches in the safety assessment of nanomaterials.

You can read more about this project on our project page: Opportunities to apply the 3Rs in the safety assessment of nanomaterials.

Keep up to date with the latest news from the NC3Rs toxicology and regulatory sciences programme.