Mode of Action of carcinogenic constituents of complex mixtures in consumer products

Client

A global company selling consumer products

Background

The company had developed a sophisticated research programme aimed at understanding the true health risks posed by complex chemical mixtures. One part of this process required an understanding of the modes of action underlying the various tumours suspected to be associated with the individual chemical components

Project Goals

The objective was to elucidate the carcinogenic modes of action on what are assumed to be the mixture’s most important chemical constituents. Bibra was asked to provide assistance, by reviewing the relevant literature. Bibra employs a number of experienced, professionally-registered (RSB/BTS/ERT) toxicologists and was commissioned to provide hazard and risk assessment reports on the impurities in question.

Approach

This task involves a good understanding and pragmatic application of the precepts of the IPCS Mode of Action Human Relevance Framework, an approach (now much favoured by the regulators) that aims to bring structure and transparency to an assessment of the human relevance of the cancer findings generated in laboratory animal studies. Bibra scientists scrutinised the published literature for data on cancer, genotoxicity and general/local toxicity that could provide insights into the tumour development process. The identified data (and data gaps) were considered in the light of the IPCS Framework.

Project outcome

Bibra produced substance-specific reports summarising the available relevant data, providing up-to-date position documents on the modes of action of various chemical carcinogens or suspected carcinogens.

Bibra project leader

James Hopkins

• Hazard assessments on individual food additives and contaminants for a global confectionery organisation
• All
• Multi-component Formulations Risk Assessments for the manufacture of inks and adhesives