Updates to OECD In Vitro and In Chemico Test Guidelines

The Organisation for Economic Co-operation and Development (OECD) has published several new or updated in vitro test guidelines.

The following new in vitro test guidelines were published:

  • Test 467: Defined Approaches for Serious Eye Damage/Eye Irritation and supporting document. This is the second test guideline for defined approaches. It describes defined approaches for serious eye damage and eye irritation based on both a) physicochemical properties and in vitro data from TGs 492 and 437 for neat non-surfactant liquids and b) in vitro data from TGs 491 and 437 for neat and/or diluted non-surfactant liquids or solids dissolved in water. The defined approaches can be used to identify chemicals causing serious eye damage (i.e. UN GHS Category 1), eye irritation (i.e. UN GHS Category 2), and test chemicals not requiring classification (i.e. UN GHS No Category).
  • Test 492B: Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Eye Hazard Identification. The SkinEthicTM Human Corneal Epithelium (HCE) Time-to-Toxicity Test (TTT) on liquids (TTL) and on solids (TTS) allows the identification of chemicals not requiring classification (No Cat), requiring for eye irritation classification (Cat 2) and requiring serious eye damage classification (Cat 1).

Updated versions of existing test guidelines include the following:

  • Test 442E: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation. The Genomic Allergen Rapid Detection (GARDTM) Skin method has been included.
  • Test 442C: In Chemico Skin Sensitisation Assays Addressing the Adverse Outcome Pathways Key Event on Covalent Binding to Proteins. The Amino Acid Derivative Reactivity Assay (ADRA) method has been included.

Furthermore, new and updated in vivo test guidelines have been published, including the following:

  • New Test 251: Rapid Androgen Disruption Activity Reporter (RADAR) assay and validation report. This assay uses transgenic Medaka eleutheroembryos to detect chemicals active on the androgen axis. (Note: animal embryos are used, therefore this test should be used only if replacing a regulatory requirement for a live-animal test using later life stages.)
  • Updated Test 488: Transgenic Rodent Assay. The updated TG allows more flexibility in the age of the animals used in the test to minimise the breeding of animals who are bred but not used in procedures, clarification that full studies should not be conducted with an atypical solvent which has not been previously assessed and minimisation of the use of concurrent controls.