Health risk assessment of container extractables in a topical cream

Client

A pharmaceutical company

Background

Bibra was supplied with an analytical report on extractables and headspace studies, carried out ona container-closure system (lacquered aluminium tubes and HDPE caps) used to store an ointment for topical use. In theory, some or all of the extractables could become leachables in actual use.

Project Goals

The aim was to generate a robust health risk assessment for patients using the ointment.

Approach

Several well-studied extractables were assessed primarily from Expert Group reports (with updated literature searches to capture more recent data). One identified extractable lacked genotoxicity data but contained structural alerts for mutagenicity; thus, it was assessed as a mutagen and the estimated exposure compared with TTC default figures. Several unidentified extractables were also assumed to be mutagens (a health-precautionary approach); again, TTC was invoked (for both threshold and non-threshold toxicity endpoints). Our in-house database TRACE is an unrivalled source for identifying key Expert Group opinions.

Project Outcome

We successfully provided the client with an independent health risk assessment of the extractables. None of the extractables was expected to pose any significant health risks to patients, giving the client confidence to move forward to leachables studies.

Project Leader

Pete Watts

Extractables and Leachables

More recent work Info about us Meet our team