Identifying or deriving a safety benchmark is a critical step in determining the risk of a chemical to human health. These values are estimates of the maximum exposure, generally qualified by route (parenteral, inhalation, oral or dermal), that will pose no significant threat. They are based on evidence from occupational and epidemiological studies, laboratory animal studies, and also, where available, from an understanding of the chemical’s ADME and mechanism.
Expert Groups – both independent and industry-led – will often establish these safe limits as part of their reviews of chemical substances, albeit they have their own nomenclature, for example ADI/TDI, RfD/RfC and MRL, and more surprisingly, different quantitative views on how to account for uncertainty. Where a benchmark is set by the authoritative body in a particular industry sector, this becomes an important influence on a bibra risk assessment for clients in that same business area.
Our in-house database, TRACE, is ideal for the speedy identification of existing safety benchmarks, and provides a reliable and efficient method of data searching and retrieval, to supplement the Expert Group opinion if needed. Our scientists have extensive experience of assessing and recording safety benchmarks from a range of sources, comparing the values, and discussing the approach taken in their derivation.
Where no appropriate Expert Group assessments can be identified, it is sometimes necessary to derive bibra’s own values. This will usually involve identifying a critical data point from a laboratory animal experiment, and adjusting it in line with sector-specific guidance 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.
Our team has an unrivalled level of expertise in deriving safety benchmarks, and we have worked on a large number of projects of this nature across all industry sectors, including those focussed on pharmaceuticals and medical devices, chemicals (particularly toxicity issues generated by REACH), electronic cigarettes, food additives and food-contact materials, and consumer products.
Case study
As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.
Case study
ICH defines a Permitted Daily Exposure (PDE) as a pharmaceutically acceptable intake “protective of public health for all patient populations” and provides specific guidance on the derivation of PDEs for threshold toxins identified as residual solvents (Q3C guideline) and elemental impurities (Q3D guideline) in pharmaceuticals.
Case study
Food-Contact Materials (FCMs) encompass all materials and articles that come into contact with food as it is produced, packaged, stored and consumed. Experts from the European Food Safety Authority (EFSA) have stated that the safety of FCMs must be evaluated to ensure that their potential transfer to foods would not have any adverse effects on consumers . Under EU regulation (EC) 1935/2004, FCMs must not transfer their components into the foods in unacceptable quantities.
Case study
Chemicals that leach into drug products from processing or manufacturing equipment, drug delivery systems and/or packaging may pose a health risk to patients.