Oral toxicity and skin sensitisation assessment of scar gels

Project goals

Bibra was asked to evaluate the available data on the constituents of the two products with specific focus on their potential for skin sensitisation and subchronic oral toxicity. The aim was to determine whether testing of the products in laboratory animals for these endpoints could be justifiably avoided.

Background

The company intended to market two scar gels that would come into contact with intact skin on the face and potentially be ingested in small amounts. One of the scar gels contained UV filters.

Client

A pharmaceutical and medical devices company.

Approach

Reliable no-observed-adverse-effect levels (NOAELs) and Expert Group-derived health criteria values (HCVs), together with available studies on skin sensitisation, were identified and summarised following targeted searches of the bibra TRACE database, an unrivalled data-source for identifying Expert Group reports, and several external data sources (PubMed, TOXLINE, RTECS, eChemPortal and the ECHA website).

Project outcome

A summary of the relevant data on each constituent of the two gels was provided to the client, advising them that further toxicity testing with regard to these end-points is indeed not justified based on the good availability of existing data and once animal welfare concerns are taken into account.

Bibra project team

Beth O’Connell

Pete Watts

 

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