Risk Assessment
Our work
The health risk of a chemical is not only related to the toxicological hazards but also to exposure. If this is very low, then the hazards are entirely academic. As exposures increase, the toxic potential can be realised and adverse health effects can occur. With increasing doses, toxic effects will be seen at a higher frequency and a greater severity.
In our health risk assessments, we convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure. Most health effects are only seen above a certain dose (a toxicological “threshold”), and so we are able to conclude with confidence about the quantitative health risk that a particular exposure might pose.
Exposure estimation
Once a chemical’s toxicological hazards have been characterised, it is crucial to understand what the potential human exposure might be. This can be relatively simple to estimate – for example, an impurity present in a drug product at a constant level and subject to a defined treatment regimen – or can be very complex – such as a colouring present in several different foods with consumers of different ages.
We always treat exposure estimation as a collaborative process, guiding our clients to identify the information necessary for a robust health risk assessment. We are familiar with many of the key software tools for exposure estimation, including ECHA’s Chesar, EasyTRA, EUSES and ConsExpo.
Sectors
The science of health hazard and risk assessment is the same no matter the context of the report:
Hazard x Exposure = Risk.
We always present our hazard and risk assessments in the format that is most appropriate for the sector in which our clients operate, including a risk assessment conducted in line with the relevant regulatory guidance. Our years of experience with a wide range of product types has given us an unrivalled insight into the specific toxicological requirements of regulators and Competent Authorities worldwide.
Safety Benchmarks
To carry out a risk assessment, it is often necessary to derive a health-based guidance value. Such a value is an estimate of the maximum exposure, generally qualified by route (parenteral, inhalation, oral or dermal), that will pose no significant threat to human health. It will usually be based on data from laboratory animal experiments, adjusted to account for the likely differences in how humans and the other species (usually a rodent) is likely to respond to chemicals in general or (much more rarely) to that specific test chemical.
Some industries we work in
Extractables + Leachables
We provide valuable support to the pharmaceutical, medical device and processing equipment industries by producing screening reports and, if warranted, full risk assessment reports relating to extractables and leachables (E&L).
Medical Devices
We are adept at conducting biocompatibility assessments and biological safety evaluations of medical devices in compliance with ISO 10993, FDA and European guidelines, to help bring your device to market.
Pharmaceuticals
Our team is adept at preparing critical toxicological reports - we regularly provide assessments of novel or unexpected impurities, excipients and other intentionally-added substances, and extractables and leachables.
