IDEA Workshop on QRA based on NAMs: Building Trust

10 Dec

In the effort towards a QRA on skin sensitization based on new approach methodologies (NAMs) instead of the LLNA, IDEA provides a multi-stakeholder forum to facilitate the generation of a guidance framework based on NAMs to identify a NESIL for fragrance ingredients (FIs).

> Download workshop agenda

> Download final report

Such a framework should focus on deriving a continuous point of departure (PoD) from which the NESIL will be confirmed. This work should be complementary to the achievements that other organizations have already accomplished or activities that they are currently pursuing. The framework should rely on current existing methods and approaches but be open to new methods addressing specific gaps that IDEA perceives exist in current methodologies.

Previous IDEA workshops have focused on the available in vitro tests and the results obtained with them. A key need identified was a benchmark reference chemical potency list for the evaluation of NAMs, which would initially at least be focused on FIs. The workshops also helped identify questions that require attention in the process of building trust in NESILs derived from NAM data.

The aim of this workshop is to start building on the elements already identified previously as being key for confidence assessment of a framework for NESIL identification based on NAMs.

> General discussion - How do we move forward?

> Key Conclusions - Fourth IDEA workshop on QRA based on NAMs: building trust

All presentations and files from the Workshop can be downloaded using the links below.

Here is a list of the presentations:

  • Amaia Irizar (IFRA): Criteria for a reference chemical potency list (RCPL): what’s left to be done?
  • Andreas Natsch (Givaudan) (1): Quality assurance in NAMs (cell viability, cell source, positive controls) and limitations for materials with limited solubility – How are these currently addressed?
  • Andreas Natsch (Givaudan) (2): Weight of individual parameters measured in NAMs: meta-analysis and how it can be applied to NESIL determination – including case studies
  • Anne Marie Api (RIFM):The RIFM sensitization research projects have focused on New Approach Methodologies (NAMs)
  • David Basketter (for Prof Jim Bridges, Chair of the IDEA Supervisory Group): Viable metabolic systems and how to assess pro haptens with NAMs. Summary of the pro haptens workshop and outline of some key criteria to be fulfilled to build confidence in the use of new approach methodologies
  • Roman Liska (Joint Research Centre): How are the variability and knowledge gaps addressed in the LLNA and current DAs – what could be done and learnt for quantifying and managing uncertainty?

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