The OECD Has Published a Number of New or Updated Test Guidelines

The OECD has published a number of new or updated test guidelines (TGs) and a new guidance document (GD) that can be used to replace or reduce the use of animals for regulatory testing.

New TGs and GD

• OECD TG 319A: Determination of In Vitro Intrinsic Clearance Using Cryopreserved Rainbow Trout Hepatocytes (RT-HEP)
• OECD TG 319B: Determination of In Vitro Intrinsic Clearance Using Rainbow Trout Liver S9 Sub-Cellular Fraction (RT-S9)
• GD 280 considers the determination of in vitro intrinsic clearance using cryopreserved hepatocytes (RTHEP) or liver S9 sub-cellular fractions (RT-S9) from rainbow trout and extrapolation to in vivo intrinsic clearance.

Updated TGs

• OECD TG 442D: In Vitro Skin Sensitization Assays Addressing the AOP Key Event on Keratinocyte Activation. The TG was updated to include the LuSens method and an option to use human reagents to achieve xeno-free cell culture.
• OECD TG 442E: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation (TG 442E). The TG describes the human Cell Line Activation Test (h-CLAT) method, the U937 Cell Line Activation Test (U-SENS™), and the Interleukin-8 Reporter Gene Assay. These assays can be used to support the discrimination between skin sensitisers and non-sensitisers.
• OECD TG 492: Reconstructed Human Cornea-Like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage. The TG was updated to include an additional similar method, the LabCyte CORNEA-MODEL24 eye irritation test.
• OECD TG 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage. The TG was updated to include eye histopathology as an endpoint to distinguish UN Globally Harmonisied System (GHS) Category 1 chemicals.