Health risk assessment of two chemicals in an intravenous placebo preparation

Client

A bio-pharmaceutical company.

Background

A pharmaceutical company is planning to produce a placebo solution for use in clinical trials which contains two commonly-encountered chemicals .

Project Goals

Bibra was asked to evaluate the toxicological risks posed to subjects by the presence of these substances when infused intravenously.

Approach

Toxicity data searches were performed for both substances using the bibra TRACE database as well as TOXNET, e‑ChemPortal, PubMed and RTECS, with an emphasis on an intravenous route of exposure as both are widely used in foods and much of the available data relate to oral exposure. A human health risk assessment was based on evaluating the most relevant toxicological information.

The first substance was determined to be safe for the intended use in an intravenous solution as there was a reassuring margin of safety between the proposed dose level and the doses showing absence of toxicity in the experimental data. For the second substance, although some mild  effects were seen in volunteers following intravenous injection, the dose was considerably greater than the proposed placebo solution concentration and it was concluded that these effects would be unlikely at the markedly lower dose.

Project Outcome

A health risk assessment report was provided to the client giving reassurance there would be no significant toxicological risk from exposure to the ingredients of the placebo.

Project Team

Anne Edwards

James Hopkins

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