F2024C00396 Rework skin sensitivity test results required per Guidelines 6.14.2

[Mike Dewhirst]

The change in the Guidelines removes ...

• if the human health exposure band is 3 - all of the following:
  • a suitable in silico prediction indicating that the chemical and its metabolites (if any) do not cause skin sensitisation, and
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 2nd key event in skin sensitisation, with a non-sensitising prediction, and
  • test results from an in vitro study on the chemical or from suitable read across information, conducted following an acceptable test guideline for the 3rd key event in skin sensitisation, with a non-sensitising prediction, or

and inserts ...

• results from a defined approach (combination of tests) described in OECD TG 497, with a non-sensitising prediction¹⁶

¹⁶ Note that negative results only with key event 1 and key event 2 adverse outcome pathway (AOP) assays will not rule out skin sensitisation potential for some weak skin sensitisers and pre-/pro-hapten fragrance chemicals when using the "2 out of 3" (2o3) defined approach and hence this should be considered when determining an appropriate testing methodology. For further information see:
ENV/CBC/MONO(2021)11. Supporting Document to the OECD Guideline 497 on Defined Approaches for Skin Sensitisation (​https://one.oecd.org/document/ENV/CBC/MONO(2021)11/en/pdf)