Bisphenol A (BPA) Controversy
Blog articles
It is a truth not always recognised that toxicological hazard and risk assessment as currently practiced is a ball-park science, and a health criteria value – a Tolerable Daily Intake (TDI), a Permitted Daily Exposure (PDE) or similar – quoted to 2 significant figures is probably one significant figure more than the data really can confidently support. Occasionally practitioners will let the mask slip...
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
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)
An overlooked aspect of organophosphorus compound neurotoxicity
Blog articles
Organophosphorus compounds (OPs) are widespread in both the natural and industrial worlds. Being major components of DNA and cell membranes, their diverse chemical properties are fundamental for the biology of life. But they also find uses in a range of anthropogenic applications, for example, as flame retardants, plasticisers, antioxidants and, perhaps most famously, as pesticides.
Save yourself the pain of last-minute reformulation with early ingredient screening
Blog articles
Developing a new consumer product? Maybe you’ve come up with the hottest new gadget or e-liquid flavour and are eager to get the product out to market as soon as possible. Prior to mass production, a safety evaluation is key. A preliminary screening assessment of the component ingredients during early development could save you a lot of time and money further down the line.
Exploring Alternative Methods to Animal Toxicity Testing
Blog articles
It has been promised for a heck of a long time, but are we now close to an era when a chemical’s toxic potential can be comprehensively defined without exploiting fellow sentient creatures. As well as this obvious ethical gain, alternative test methods to animal testing have the equally attractive potential to reduce the times and costs associated with safety testing.