OECD Updates

The Organisation for Economic Co-operation and Development (OECD) has published several new or updated test guidelines. New test guidelines include the following:

• Test No. 442E: In Vitro Skin Sensitisation (Human Cell Line Activation Test, or h-CLAT)
• Test No. 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals

Updated versions of existing test guidelines include the following:

• Test No. 431: In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method
• Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists
• Test No. 473: In Vitro Mammalian Chromosomal Aberration Test
• Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes
• Test No. 487: In Vitro Mammalian Cell Micronucleus Test
• Test No. 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene

Current draft test guidelines (here) include the following:

• Draft TG on In Vitro Skin Sensitisation: IL-8 Luc assay
• Draft TG on In Vitro Skin Sensitisation: U937 Skin Sensitisation Test (U-SENS^TM)

To stay up-to-date on the latest OECD work, see the 2016 work plan for the Test Guidelines Programme (here). Projects underway include potential new test guidelines for assessing serious eye damage / eye irritation and skin sensitisation, and IATAs for serious eye damage / eye irritation and non-genotoxic carcinogens, among others.

More information on recent OECD updates can be found below, such as the publication of a guidance document on considerations for waiving or bridging of mammalian acute toxicity tests and a new series of documents on adverse outcome pathways (AOPs) for regulatory risk assessment.