Press Release: OECD Publishes Test Guideline for ToxTracker®
PRESS RELEASE
New OECD guideline enables regulatory use of ToxTracker® for mechanistic genotoxicity assessment
Oegstgeest, The Netherlands – 6 July 2026 – Toxys, a leading innovator in toxicology solutions, announces the publication of OECD Test Guideline 446A for ToxTracker, its flagship genotoxicity testing platform. ToxTracker is an in vitro assay that identifies genotoxic hazards with high accuracy while providing mechanistic insight into the mode of action of test substances.
The publication of OECD TG 446A marks an important milestone in the adoption of New Approach Methodologies (NAMs) for genetic toxicology and enables the use of ToxTracker within regulatory safety assessment strategies worldwide.
The guideline positions ToxTracker as a follow-up tool for equivocal findings from established in vitro genotoxicity assays and as a method for generating mechanistic information to support the interpretation of positive genotoxicity findings.
“Publication of the OECD Test Guideline for ToxTracker is a defining milestone for Toxys and for the broader adoption of NAMs in toxicology,” said Giel Hendriks, Chief Executive Officer of Toxys. “The guideline enables organizations around the world to incorporate ToxTracker into regulatory testing strategies and represents an important step toward broader acceptance of next-generation safety assessment methods. We look forward to supporting our customers as they implement ToxTracker in their development and regulatory programs.”
The Test Guideline is expected to support broader adoption of ToxTracker across the pharmaceutical, chemical, agrochemical, cosmetics, and food sectors. By providing a harmonized framework for the use of ToxTracker in regulatory safety assessment, the guideline creates new opportunities for organizations seeking scientifically advanced and animal-free approaches to genotoxicity testing.
The publication further strengthens the role of ToxTracker in modern safety assessment and supports ongoing efforts to improve the scientific relevance of genotoxicity testing while reducing reliance on animal studies.
The guideline is available through the OECD Test Guidelines Programme.
Press release is available here.
To help scientists, risk assessors, and regulatory professionals understand the implications of the new guideline, Toxys hosted a webinar on 9 July 2026, which is now available on demand.
The webinar provides an overview of OECD TG 446A, explains where ToxTracker fits within current genotoxicity testing strategies, and discusses practical considerations for regulatory applications.
About ToxTracker
ToxTracker is a unique stem cell-based reporter assay for reliable genotoxicity hazard identification. Unlike conventional genotoxicity assays, ToxTracker provides insight into the genotoxic mode of action by distinguishing between direct DNA reactivity and indirect genotoxicity related to oxidative stress or protein damage. This enables improved interpretation of genotoxic signals and supports more informed decision-making in chemical safety assessment in the pharmaceutical, chemical, cosmetics, and food industries.
About Toxys
Toxys is a global leader in in vitro toxicology, developing innovative New Approach Methodologies (NAMs) for the safety assessment of pharmaceuticals, chemicals, cosmetics, and food-related products. The company specializes in genetic, developmental, and investigative toxicology testing, with a focus on providing mechanistic insight of test substances. With a strong commitment to scientific excellence and sustainability, Toxys is shaping the future of toxicology. The company collaborates with leading research institutions and regulatory bodies worldwide and continues to expand its global footprint through strategic partnerships and product innovation.
Media Contact:
Paula van Rossum
Chief Business Officer
+31 71 3322470
p.vanrossum@toxys.com
