The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) published new opinions from its Science Advisory Committee (ESAC) on five external validation studies:
- The SkinEthic™ Human Corneal Epithelium Eye Irritation Test: ESAC considers this test appropriate for regulatory use in a tiered assessment strategy and as a first step in bottom-up discrimination of non-irritants or as a confirmatory last step in a top-down approach.
- The U-SENS™ test method for assessing skin sensitisation: Like the human cell line activation test, the U-SENSTM assay addresses the third key event in the skin sensitisation adverse outcome pathway (AOP). ESAC considers the U-SENSTM test method appropriate for regulatory use in the context of an integrated approach to testing and assessment (IATA) for skin sensitisation. It also provides a useful tool for screening and early decision-making during product development.
- The LuSens test method for assessing skin sensitisation: Like the KeratinoSensTM method, the LuSens test method addresses the second key event in the skin sensitisation AOP. ESAC considers the LuSens test method ready for regulatory use in the context of an IATA for skin sensitisation and considers it a useful tool for screening and early decision-making during product development.
- The epiCS® Skin Irritation Test: ESAC considers this test suitable for screening purposes and believes that it also merits consideration for regulatory use.
- The Ocular Irritection® test method for assessing serious eye damage/irritation: ESAC recommends this assay for screening purposes but currently does not consider it appropriate for regulatory testing.