Hello again it’s me Dr Candice Johnson. The E&L conference took place on May 17th – 18th and it was so nice meeting colleagues and hearing about all the developments in the E&L field.

The E&L community is eagerly anticipating the changes that the ISO-10993-17 standard and the ICH Q3E guideline will bring. Several presentations highlighted the importance of defined procedures for the identification and toxicological evaluation of E&L. Instem delivered a presentation on the chemical classification of E&L chemicals and identified chemical classes which are the most commonly seen as E&Ls as well as the prevalence of mutagens and potent skin sensitizers in the dataset. This work reproduces an important finding by Parris et al.1, that the prevalence of potent sensitizers in E&L is very low using an expanded dataset of E&L structures. Further, the degree of structural classification of E&L chemicals opens an interesting area of research on the feasibility and utility of setting class-based limits.  

Please get in touch if you would like to hear more about this work or receive a recording of a presentation summarizing our activities related to E&L (candice.johnson@instem.com).

  1. Parris et al., Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis (2022) being submitted