Health risk assessment of a potential wound dressing leachable

Client

A leading manufacturer of advanced wound care products and medical grade materials.

Background

The client wished to add a certain antimicrobial compound into their wound dressings at a low ppm w/w concentration and so, taking appropriate precautions, asked bibra to assess whether or not this compound could pose any significant toxicological risks to patients if present at concentrations as high as 100 ppm w/w.

Project goals

To assess whether or not the compound in question could pose any significant risk to users (wound dressing leachable) at such a concentration.

Approach

Bibra estimated “worst-case” exposure levels of the potential wound dressing leachable to the compound and then conducted a thorough search for any existing information regarding its toxicity. In this case, no substance‑specific toxicological data were identified and so a number of appropriate surrogate compounds were identified so that an assessment could be carried using the “read-across” approach.

Using this approach it was possible to carry out a full, detailed health risk assessment by assessing the relevant toxicological endpoints of structurally similar and representative, worst-case analogues. Bibra adopted the health-precautionary assumption that 100% would leach from the dressing and enter the patients’ bloodstream via the wound, but also considered the compound’s potential for local toxicity.

Project outcome

Despite the lack of substance specific data for this potential wound dressing leachable, bibra was able to reach reassuring conclusions that the estimated exposure to the compound of interest were unlikely to give rise to any local or systemic toxicity, even at concentrations as high as 100 ppm.

Bibra project team

Pete Watts

Charlie Johnson

 

Medical Devices

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