An evaluation of the genotoxicity of fibre components and processing aids used in its manufacture

Client

A company that produces fibre-based dressings for advanced wound care.

Background

The client asked bibra to advise whether any of the compounds it used in the production of a particular type of fibre was genotoxic.

Project goals

Bibra was asked to identify and review any available genotoxicity data in the literature relating to the component chemicals used by our client in fibre production, to determine whether any of them might exhibit genotoxic properties. The scope of the review included components, pH adjusters, processing aids, bleaching agents and by-products that might be present in the fibres.

Approach

Literature searches were performed, largely based on compound-specific CAS RNs and synonyms, to identify relevant genotoxicity data on each component. A range of data sources was used including the bibra TRACE database (primarily to identify expert group reports and other expert and/or comprehensive reviews), PubMed, and the TOXNET system. Any relevant genotoxicity data was assessed, and summaries were prepared of the available data for each component or contaminant.

Project outcome

Bibra was able to reassure the client that, for most of the compounds, their presence in wound dressings made from the fibres would not pose a genotoxic risk to patients. There was some uncertainty about the genotoxic risk presented by two of the chemicals, and it was suggested that further exploration of the data (including on structurally related compounds) would be possible (and advisable) to clarify the issue.

Bibra project team

Tanya Diver
James Hopkins

 

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