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.
Assessment of the dermal sensitisation potency of extractables and leachables using existing data and in silico methods
Chilton ML; Oliveira A;
- Apr 2022
- Skin sensitisation assessment