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Assessment of the dermal sensitisation potency of extractables and leachables using existing data and in silico methods

pdf fileChilton ML; Oliveira A; Patel ML;

There is a recognised need to assess the sensitisation potential of extractable and leachable (E&L) compounds as part of the safety assessment of impurities, alongside other toxicological endpoints of concern. This is typically approached by applying a safety threshold, such as the 5 µg/day threshold for sensitisers /irritants recommended by the PQRI.


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