Beth O Connell

Beth O’Connell

Principal Toxicologist

UKRT/ERT

About Beth

Beth has an MA (Cantab) in Natural Sciences from the University of Cambridge, an MSc in Forensic Science from King’s College London, and is a Registered Toxicologist. She has been a toxicologist at bibra for 14 years, and is skilled in searching for and consolidating data on the mammalian toxicology of chemicals, and assessing these data in the context of human health.

Beth has worked for government agencies, and clients from a range of industrial sectors, including consumer products, food, pharmaceuticals, medical devices and cosmetics. Beth has worked to establish the modes of action (MoAs) of chemical carcinogens, and regularly derives tolerable human exposures by different routes (oral, inhalation, dermal, injection) for both genotoxic and non-genotoxic substances. Over the years, Beth has performed risk assessments on hundreds of chemicals, including additives, flavourings, pharmaceutical impurities, degradants, extractables, leacahles and excipients. She has evaluated the safety of a range of different medical devices in compliance with ISO 10993, and has assisted both with REACH work on industrial chemicals and pre-manufacture notice (PMN) submissions for compliance with the US Toxic Substance Control Act (TSCA). Another area of interest is the cosmetics sector, for which Beth has drafted cosmetic product safety reports (CPSRs) under the European Cosmetics Regulation ((EC) 1223/2009), assessing the toxicological properties of individual cosmetics ingredients to ensure that products are safe for human use.

Beth also helps peer review Toxicology and Regulatory News, bibra’s monthly publication summarising critical developments and reports relevant to the field of mammalian toxicology.

Outside of work Beth attends both creative writing and life drawing classes, and is training for her purple stripe belt in kickboxing!

Beth's case studies and blog posts

PDE for a leachable in an intravenous pharmaceutical

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.

Determining a suitable read-across surrogate for a pharmaceutical impurity

Case study

Following analytical studies on an intravenous drug product, an organic leachable from the container closure system (CCS) was detected, identified and quantified.

Derivation of a dermal HBEL for a hormone ester

Case study

Health-Based Exposure Limits (HBELs) are used to control risk when different medicinal products are manufactured in shared facilities.

Want to read more case studies and blog posts that Beth has been involved in? Click below to read more.

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