Our work
Over the past few years, the assessment of cannabinoids has been the fastest growing sector of our business. There is huge consumer demand for products containing cannabinoids, driven largely by the public interest in cannabidiol (CBD) – the major non-psychoactive component of hemp and cannabis plants. Companies are adding CBD and other cannabinoids to a plethora of consumer products (including foods, e-cigarettes, and cosmetics), and there is also much interest in the therapeutic benefits of CBD by our pharmaceutical clients. We have been tasked with assessing the safety of these products, flagging any toxicological concerns and identifying potential risks (for example to vulnerable sub-populations).
Food
Food producers and formulators are adding cannabinoids, primarily CBD, to their products, including confectionary, beverages, and “well-being” products (e.g. oral drops), which are available to the general public. This potentially poses a health risk to the consumer, as certain of these cannabinoids are associated with adverse effects. Indeed, there is some evidence that CBD is associated with adverse effects on reproduction and on liver function; as such it is advised that individuals that are pregnant, breast-feeding or taking medication should refrain from taking CBD. Further, food companies must apply for authorisation to add their CBD-containing products to the EU and UK markets. We can help with these activities.
Pharmaceuticals
CBD and THC are currently approved for use in the treatment of certain conditions (e.g. epilepsy). We have helped our pharmaceutical clients assess the ADME, pharmacology, and toxicity of CBD for medicinal applications. For example, we recently revised and updated an Investigational Brochure (IB) setting out the key pharmacological and toxicological issues concerning oral administration of CBD to patients. This IB review was submitted to the US Food and Drug Administration (FDA) and will be used by health care professionals running clinical trials in the US.
E-cigarettes and Vaping
As companies look to innovate their e-cigarette product portfolio, Research & Development (R&D) has focused on replacing nicotine (which is highly addictive) in the e-liquid with CBD (e.g. as a nicotine cessation aid). We are experienced at assessing the potential hazards and consumer risks of inhaling CBD in the aerosol of e-cigarettes. The focus of these assessments is usually the available (albeit limited) studies in humans involving the inhalation of CBD, where adverse effects (e.g. on the respiratory tract) are recorded along with effects, for example, on mood and measures of anxiety. However, the majority of the available data involves the oral route of exposure, and therefore these assessments require consideration of route-to-route extrapolation (i.e. from the largely oral toxicity dataset to the consumer inhalation exposure).
Cosmetics
Cosmetic companies are adding CBD to a myriad of their products (for example to moisturisers, shampoos, deodorants, and toothpastes), the use of which may contribute to CBD exposure via dermal absorption. We can assist with the estimation of CBD bioavailability following use in leave-on and rinse-off dermally-applied cosmetics, estimating the likely pharmacologically/therapeutically active dose of the cannabinoid, and assessing the potential risks to the consumer. A lot of relevant human data exists, notably involving the application of synthetic CBD gels to the skin of various patient groups.
Our expertise in this area
Hazard Characterisation
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.
Risk Assessment
Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.
Literature Searching
Robust risk assessments rely upon quality data. We are experienced searchers of major toxicity databases, giving us valuable access to Expert Group and primary reports.
Some of our case studies in this area
Making sense of skin sensitisation
Blog articles
From cosmetics to cleaning products, skin allergy (sensitisation) is a prominent feature of our modern chemical-centric world. Put simply, this hazard is an abnormal reaction of the immune system which makes certain individuals overly sensitive to particular chemicals. Read more in our blog, to help you make sense of sensitisation.
Knowledge is key. Part 2: The bibra TRACE database (and supporting databank)
Blog articles
In Part 1, Peter Watts gave a potted history of his personal early experience in literature searching and toxicity data identification. Along with our colleagues of the same 'fine vintage', he weathered the storms of change, progressing from a time of back-strain (from carrying huge texts around) and index finger wear (turning pages) to dial-up and then to web-based searching. With your indulgence, Pete would now like to expand a little regarding TRACE and its value to clients and the bibra toxicologists.
Knowledge is key. Part 1: Toxicity literature searching, a personal history
Blog articles
Our Toxicology Director, Peter Watts, has written a very interesting article focussing on toxicity literature searching, from his own perspective (having been at bibra for 40+ years)
