Calculation of HCVs for a packaging leachable

Background

Bibra was asked to calculate health criteria values (HCVs) for a potential leachable from packaging for an intravenous pharmaceutical.

Client

A pharmaceutical company.

Project goals

To consider the critical systemic toxicity data on the potential leachable and to calculate HCVs for short- and long-term exposure.

Approach

Toxicity data searches using the bibra TRACE database, PubMed, TOXNET and RTECS were performed using the specific leachable CAS RN and synonyms, where appropriate. Initial searches indicated a lack of toxicity data on the leachable itself. Therefore several read-across candidates were identified, based on the target’s molecular structure and its likely metabolism in the human body. It was concluded that the target chemical is highly unlikely to possess any in vivo genotoxic potential, therefore it is appropriate to treat it as a threshold toxin.

Intravenous data on the read-across compounds were limited, and the most appropriate points of departure for HCV derivation came from oral studies. However, with the application of appropriate uncertainty factors (including for route-to-route extrapolation), intravenous HCVs could be determined.

Project outcome

A report defining appropriate HCVs was provided to the client.

Bibra project team

Beth O’Connell

James Hopkins

 

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