E&L · Impurities05QSAR Analysis
Quantitative structure-activity relationship modelling for impurity and extractable & leachable safety profiling — reducing costly testing.
Explore serviceTRA · PDE
Toxicological Risk Assessment
Quantitative, science-based assessment of every chemical your device can release.
Overview
What is Toxicological Risk Assessment?
Chemical characterisation tells you what can leach from a device. A toxicological risk assessment (TRA) tells you whether it matters. Following ISO 10993-17:2023, we compare the estimated exposure to each constituent with a tolerable intake derived from the best available toxicity data.
For each extractable or leachable we derive toxicological thresholds, calculate the margin of safety (MoS), and apply the threshold of toxicological concern (TTC) where compound-specific data are missing.
A well-argued TRA can replace systemic toxicity and other biological tests, saving time and cost while giving reviewers the quantitative evidence they increasingly expect.
MoSCalculated for every compound
TTCApplied where data are limited
↓Biological tests waived
When you need it
Typical triggers for this service
- Interpreting extractables & leachables (E&L) data
- Justifying waivers for systemic, subchronic or chronic toxicity testing
- Assessing colourants, additives, residues or process changes
- Answering FDA or notified body questions on chemical safety
- Evaluating impurities, degradants and sterilant residues
What you receive
Deliverables
01Exposure estimation for each constituent
02Tolerable intake (TI) and tolerable contact level derivations
03Margin of safety calculations
04TTC and analytical evaluation threshold review
05Risk conclusion and recommendations
06Report formatted for direct inclusion in the BER
Our approach
How we run the engagement
01
Data review
Assessment of the E&L study design, extraction conditions and analytical evaluation threshold.
02
Hazard identification
Literature, databases and in-silico tools for every identified compound.
03
Dose–response
Point-of-departure selection and tolerable intake derivation with justified modifying factors.
04
Exposure & MoS
Worst-case exposure estimation and margin of safety for each constituent.
05
Conclusion
Clear risk characterisation and next steps where an MoS is below 1.
Standards & guidance
Aligned with
ISO 10993-17:2023ISO 10993-18ISO/TS 21726 (TTC)ICH M7ICH Q3DFDA CDRH guidance
FAQs
Toxicological Risk Assessment: common questions
The margin of safety is the ratio of the tolerable intake of a compound to the estimated patient exposure. A value of 1 or greater generally indicates the exposure is acceptable.
We use read-across from structurally similar compounds, in-silico predictions and the threshold of toxicological concern approach in ISO/TS 21726 to reach a justified conclusion.
We design and review the chemistry and coordinate it with accredited ISO 17025 laboratories, then interpret the data independently.
Related services
Often combined with this service
E&L · Impurities05
No Animal Testing04In-silico Safety Assessment
Computational toxicology tools for rapid, cost-effective chemical safety profiling without animal testing — fully aligned with regulatory expectations.
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Regulatory Compliance02BEP / BER Preparation & Review
End-to-end Biological Evaluation Plans and Reports — regulator-ready, audit-proof, and globally accepted by notified bodies and regulatory authorities.
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Need toxicological risk assessment 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?
We are here to support your safety, compliance & success. Reach out to our certified toxicology experts today.
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.