HCV calculations for a packaging leachable based on its parent compound

Background

Bibra was asked to derive health criteria values (HCVs) for short-term and long-term exposure to a potential leachable from the packaging of an intravenous pharmaceutical. The leachable also happens to be a key metabolite of a well-studied food additive.

Client

A pharmaceutical company.

Project goals

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

Approach

Initial toxicity data searches using the bibra TRACE database, PubMed, TOXNET and RTECS did not identify sufficient substance-specific data to allow a HCV to be calculated. However, the chemical is also a key metabolite of a well-studied food additive, and it follows that laboratory animals exposed in tests to the food additive would have also been systemically exposed to its metabolite to some extent. Bibra therefore focussed its work on the food additive, using toxicity and metabolism data to come up with suitable HCVs for the potential leachable. The possible increased toxicity of the intravenous route was also considered, given that the vast majority of studies related to the oral route, and appropriate uncertainty factors were applied.

Project outcome

A report defining appropriate HCVs was provided to the client.

Bibra project team

Beth O’Connell
Pete Watts

 

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