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Genetics of Speciation

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Related Experiment Video

Updated: Jan 23, 2026

Imaging Approaches to Assessments of Toxicological Oxidative Stress Using Genetically-encoded Fluorogenic Sensors

Imaging Approaches to Assessments of Toxicological Oxidative Stress Using Genetically-encoded Fluorogenic Sensors

Published on: February 7, 2018

Genetic toxicology in silico protocol.

Catrin Hasselgren¹, Ernst Ahlberg², Yumi Akahori³

¹Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.

Regulatory Toxicology and Pharmacology : RTP

|June 14, 2019

Summary

This study introduces the genetic toxicity in silico (GIST) protocol to standardize in silico toxicology assessments for regulatory submissions. The GIST protocol aims to increase confidence and acceptance of computational toxicology methods in chemical hazard evaluation.

Keywords:

(Q)SAR Computational toxicology protocols Expert alerts Expert review Genetic toxicology In silico In silico toxicology

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Area of Science:

Toxicology
Computational Science
Regulatory Science

Background:

In silico toxicology (IST) methods are increasingly used for chemical hazard assessment, particularly for regulatory submissions like REACH and ICH M7.
Key challenges include uncertainty in assessment methodology, defining 'fit-for-purpose', and gaining acceptance from stakeholders and regulatory bodies.

Purpose of the Study:

To address obstacles in IST by developing standardized protocols for various hazard endpoints.
To introduce and describe the genetic toxicity in silico (GIST) protocol.

Main Methods:

Development of a hazard assessment framework for genetic toxicity, detailing key effects and mechanisms.
Review of IST models and data supporting the assessment of gene mutation and clastogenicity.
Defined approaches for integrating information and evaluating assessment confidence.

Main Results:

The GIST protocol provides a structured framework for genetic toxicity assessment using in silico methods.
It incorporates a review of supporting IST models and data.
It includes methods for combining evidence and assessing confidence.

Conclusions:

The GIST protocol facilitates the implementation and acceptance of in silico approaches for genetic toxicity assessment.
Developed by a multi-industry consortium, it aims to enhance consistency and reliability in computational toxicology.
This standardized approach supports regulatory submissions and collaborative efforts in chemical safety evaluation.