Ross, B. L. and Paul, K. B. (2024) Genetic toxicity testing of a metal oxide nanoform to meet regulatory requirements: shared experience to aid progress in an evolving scientific and regulatory landscape.

Kai Paul will be presenting a poster he co-authored with Bryony Ross on the challenges associated with conducting genetic toxicity testing with nanoforms.

Date: 12 March 2024

Poster Session: Nanotoxicology in vitro

Time: 09:15 - 11:15 am

Abstract

Guideline in vitro genotoxicity studies have long been used to aid hazard identification for chemicals under various regulatory frameworks, including EU REACH. In the case of substances registered as nanoforms it is necessary to apply additional nano-specific considerations to testing guidelines to ensure relevance and reliability. Over the last 15 years, several guidance documents to support testing on nanoforms have been published to support testing strategy. However, a hallmark of working in the field at present is the accelerating evolution of scientific understanding and need for adaptive regulatory guidance. As such, industry and regulatory authorities need to apply the most up to date knowledge to future-proof studies, supporting their longevity in reliability and relevance.Although some guidance exists on the applicability of standard guideline tests to nanoforms, there is little shared experience in the public domain on the practicalities of its implementation. To address this, we aim to share a summary of the practicability, outcomes, challenges, and learnings on best practice in undertaking a guideline in vitro genetic toxicity test on an inorganic metal oxide nanomaterial (NM) to fulfil information requirements for registration under EU REACH Annex VII (1-10 tonnes per annum).