Bibra Toxicology Advice & Consulting 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.

Our scientists know that a robust risk assessment relies upon quality data. We are experienced searchers of the major toxicity databases, databanks and internet. In addition, our in-house database, TRACE, gives us valuable access to Expert Group and primary reports that are not reliably identified via searches the usual range of data sources. All of the documents on TRACE have been selected and indexed by our expert toxicologists, ensuring chemical-specific, reliable and highly efficient retrieval of relevant information. This unique combination is a key part of nearly every project we work on, and the details of our search methods are described in resulting reports with a high degree of transparency.

Central to the understanding of a substance’s toxicity is a consideration of its Absorption, Distribution, Metabolism and Excretion. How efficiently is a substance absorbed by the human body? How is it broken down? Which tissues does it reach and is it likely to bioaccumulate? How does the body eliminate the substance? All this comes under the general heading of toxicokinetics (TK). Generating new TK data in the laboratory involves the use of animals, is time consuming and extremely costly (particularly if radiolabels are required). It is possible, however, to make expert predictions taking into account what is already known about the toxicity of a chemical, its structure and its physico-chemical properties.

It is inevitable that there will be occasions where the existing dataset is not sufficient to allow for a robust hazard characterisation and risk assessment. At other times, a request from a regulator may leave no alternative but to commission additional work. Whatever the context, we can offer advice on a testing programme, from protocol to the final report.