Overview of Toxicological Risk Assessment

Overview of Toxicological Risk Assessment

What is a toxic exposure?

Toxic exposure measures the likelihood of an adverse effect caused by a given compound. This includes effects such as skin irritation from topical treatments with more serious risks such as being lethal if a material is carcinogenic or lethal.

The severity and type of toxicity risk depends to some extent on how the compound will be used. Compounds used in devices used under the skin have a rigorous toxic risk assessment because the toxic exposure is more significant for small concentrations of compounds for internal use.

A toxicological risk assessment should describe all aspects of toxicological exposure, including safe exposure limits in concentration and time. Performing a complete toxicological risk assessment is critical for any new medical device to be approved and can be time-consuming and costly if not handled with specialist care.1

4 Steps to Toxicological Risk Assessment

There are four main steps in a toxicological risk assessment.2 First Hazard Identification. Hazard identification in a toxicological risk assessment means identifying any compound that may pose a risk, no matter how minor.

Part of the hazard identification process in a toxicological risk assessment is also identifying the nature of the hazard – is it carcinogenic, neurotoxic or flammable? The nature of the hazards is essential because, depending on the intended use of the device, various risks must be investigated.

Next in toxic risk assessment is the dose-response assessment. It is about understanding which compound level can cause a toxic reaction and what conditions may be necessary to achieve it.

Risk assessment involves looking at the population that may have been exposed to the chemical undergoing toxic risk assessment. Many medical devices pose only a local risk to the individual patient, but others can potentially come into contact with other people who may also be vulnerable.

The final step of toxic risk assessment is risk characterization. This stage is about understanding how likely the particular hazards are and how severe the impact of the potential hazard can be. Risk characterization is where the results of a toxic risk assessment are expressed and any potential uncertainty in the risk or estimates of the magnitude of the risk.

Important Applications of Toxicological Risk Assessment

Toxicological risk assessment is an essential part of developing any new medical treatment or device. Whether new or existing materials are being used, compounds should be evaluated to see if existing safety data can be used rather than for further testing.

To find a partner to guide you through the toxic risk assessment process, contact Jordi Labs. Jordi Labs has extensive experience in biological safety guidance and toxic risk assessment and can help you navigate the testing process.

To find out how bringing in an expert partner like Jordi Labs can help expedite the creation of your needed toxicological risk assessment, contact Jordi to learn more about the range of testing services and expert advice that Jordi offers. Labs can offer.


  1. FDA (2022) ISO 10993-1, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-andAccessed May 2022
  2. National Research Council (US) Committee on Applications of Toxicogenomic Technologies for Predictive Toxicology. Applications of toxicogenomic technologies to predictive toxicology and risk assessment. Washington (DC): National Academies Press (US); 2007. C, An overview of risk assessment. https://www.ncbi.nlm.nih.gov/books/NBK10201/

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