Safety evaluation of an ink in a wound dressing

Background

The client manufactures a wound dressing which is printed with an ink comprising several chemical substances.

Client

A leading manufacturer of wound care and surgical products.

Project goals

To identify and briefly review the critical published studies relating to the toxicity of ten potential ink constituents (some of which are themselves mixtures), and to evaluate, in a screening exercise, the toxicological health risks posed to patients exposed through breached or compromised skin.

Approach

Bibra estimated “worst-case” exposure levels of the ink constituents, adopting the health-precautionary assumption that 100% may leach from the dressing into the patients’ systemic circulation. Local toxicity potential was also considered. Expert Group-derived health criteria values (HCVs) and reliable laboratory animal data were identified for the majority of chemicals (or chemical mixtures) through literature searches using appropriate names, CAS RNs and synonyms. The threshold of toxicological concern (TTC) principal was also considered for the less well-studied compounds. Critical points of departure were identified and compared to calculated exposures, enabling bibra to conclude on risk.

Project outcome

There were no safety concerns for the majority of the evaluated ink constituents, but the possibility of allergic skin reactions could not be entirely ruled out for two, and no definitive conclusions could be made on a further (mixed) constituent without further knowledge of its specific composition.

Bibra project team

Beth O’Connell
Pete Watts

 

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