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International group develops in silico genotoxicity protocols

An international consortium of regulatory agencies, industry and academia has devised an in silico protocol for predicting genetic toxicity. The protocol is the first from the In Silico Toxicology Protocol Initiative (IST), and aims to boost confidence in computational methods and counts the European Commission's Joint Research Centre (JRC), the US EPA and Health Canada among its partners.

The consortium has identified several issues that have hindered acceptance and large-scale use of the methods. A lack of generally accepted procedures for performing in silico assessments for toxicological endpoints has led to inconsistent approaches across different organisations, industry, and regulatory agencies, according to the project team.

The hope is to boost in silico acceptance and calm regulatory concerns over transparency by developing a set of protocols which outlines how results can be recorded, evaluated, and documented in a uniform, reproducible way.

In addition to a genetic toxicity protocol, IST is close to finalising another for skin sensitisation, while its working groups are also developing protocols for a range of different endpoints, including liver toxicity and carcinogenicity.

These hinge on known toxicity mechanisms and give reliability scores, explains Glenn Myatt from US company called Leadscope, lead author of an IST article in Regulatory Toxicology and Pharmacology.

For some hazard endpoints, such as genetic toxicity and skin sensitisation, there are fairly well-defined approaches, but more complex endpoints, such as carcinogenicity, which typically involve repeated-dose, are "challenging", he said.

"It doesn't mean that you can't look at what the state of the art today is and create a protocol because it is going to improve over time as the science improves."

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