Beth O’Connell's case studies
Cannabinoids – preparation of several inhalation focused toxicity profiles
Case study
The client requested the production of a series of urgent toxicity profiles for more than a dozen different cannabinoids, to support and inform their Research & Development (R&D) of new inhalable (non nicotine) consumer products (including their possible incorporation as ingredients into e liquids).
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.
Cosmetic Product Safety Report (CPSR) on a skin cream
Case study
Under Regulation (EC) 1223/2009, cosmetics within the European Union should not be placed on the market if they are harmful to health under normal or reasonably foreseeable conditions of use. Bibra was asked to produce a CPSR on a skin cream with multiple ingredients.
N-Nitrosamines risk assessment for a pharmaceutical product
Case study
Bibra was asked to investigate two N-nitrosamines extracted from stoppers for vials used within the pharmaceutical sector.
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.
Literature monitoring for an industry group
Case study
The scientific literature can provide an early indicator of potential changes in the regulatory status of chemical substances. Organisations representing different chemical sectors may therefore provide services to their members that keep them up to date with the latest relevant publications on the toxicology of their chemicals in humans and other animals, as well as their persistence in the environment.
Evaluation of the safety of two complex cosmetics ingredients
Case study
The client was interested in extending the conditions of use of two of its manufactured surfactants to cosmetics and requested a risk assessment in order to evaluate their safety in a range of rinse-off and leave-on products. The two surfactants are each a mixture of several different structurally-related chemicals.
Derivation of a Tolerable Daily Intake (TDI) for a chemical in Food Contact Materials (FCMs)
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.
Derivation of an intravenous PDE for a common leachable
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.
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.