Bibra Toxicology Advice & Consulting
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Hazard Characterisation Services
Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities, for example its carcinogenicity, genotoxicity, or ability to disrupt reproduction. We summarise all of the available data in a transparent format, taking into account the needs of our clients – for example, if there is a specific structure or format required to comply with a particular regulation. As experienced risk assessors ourselves we are well placed to ensure that our hazard characterisation – the potential to induce a harm - provides the best possible platform the available data (and budget) will allow for any subsequent risk assessment, a judgement as to whether those harms will actually be seen in a specific circumstance.
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Often, we are asked to assess several compounds that could be of potential health risk to a patient. We have developed a “screening” process where we can prioritise those substances that are more likely to result in a health risk. Compounds present at very low levels, or without inherent toxic hazards, can, with appropriate justification, be excluded from further more detailed and expensive toxicological risk assessment.
More and more computational models are being developed to link a particular toxicological hazard with a chemical structure. This is called (Quantitative) Structure-Activity Relationship ((Q)SAR) modelling. When we are faced with a data-poor chemical, we routinely use (Q)SAR to generate predictions and identify possible areas of concern, or endpoints worthy of further investigation. Even the most sophisticated models still currently require a sanity check and bibra’s experienced toxicologists are ideally placed to provide it.
Often, a toxicological hazard characterisation is the major first step on a pathway leading to 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.