E&L · Impurities05QSAR Analysis
Quantitative structure-activity relationship modelling for impurity and extractable & leachable safety profiling — reducing costly testing.
Explore serviceWithout Testing
Genotoxicity Prediction
Robust genotoxicity conclusions, faster and without animal testing.
Overview
What is Genotoxicity Prediction?
Genotoxicity is one of the most scrutinised biological endpoints. Traditionally it requires a battery of in-vitro tests, but in many cases a well-argued, prediction-based assessment can address the endpoint.
We combine QSAR predictions, structural alert analysis, chemical characterisation data and literature to reach a defensible genotoxicity conclusion, and identify clearly when confirmatory testing such as an Ames test is still warranted.
The outcome is a faster, more economical route to the same regulatory confidence, with full scientific justification.
FasterThan a full test battery
0Animals used
FullRegulatory justification
When you need it
Typical triggers for this service
- Addressing the genotoxicity endpoint in a biological evaluation
- Assessing compounds identified in extractables studies
- Justifying a test waiver under ISO 10993-3
- Following up equivocal or positive test results
- Material or supplier changes
What you receive
Deliverables
01Structural alert analysis
02QSAR mutagenicity predictions
03Weight-of-evidence assessment
04Waiver justification or test recommendation
05Follow-up strategy for positive alerts
06Report for the BER
Our approach
How we run the engagement
01
Chemistry review
Identification of all compounds relevant to genotoxicity.
02
Alert screening
Structural alerts and QSAR predictions for each compound.
03
Exposure context
Comparison with TTC and compound-specific limits.
04
Weight of evidence
Integration of predictions, data and literature.
05
Conclusion
A justified waiver or a targeted test plan.
Standards & guidance
Aligned with
ISO 10993-3ISO 10993-1:2025ICH M7ISO/TS 21726OECD TG 471
FAQs
Genotoxicity Prediction: common questions
Often, yes, where chemical characterisation and prediction show no concern at the expected exposure. The waiver must be scientifically justified, which is what we provide.
We assess its relevance, compare exposure with acceptable limits and, if needed, recommend a targeted confirmatory test such as a bacterial reverse mutation (Ames) assay.
Yes, when presented as part of a weight-of-evidence approach with expert review and clear documentation.
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Full biological safety assessment per ISO 10993-1:2025 for all device risk classes and patient contact types — from skin contact to long-term implants.
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Need genotoxicity prediction for your device?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
Get In Touch
Do You Have an Enquiry?
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Tell us about your device
Share a few details and a certified toxicologist will get back to you, usually within 2 hours on business days.