News | Jul 18, 2023

OECD Releases new Test Guidelines for NAMs in 2023

By Eryn Slankster-Schmierer, PhD

On July 4, 2023, the OECD released updates from the 35thMeeting of the Working Group of the National Coordinators of the Test Guidelines Programme (WNT) held in April 2023. 

For two years in a row, substantial progress was made with  the consecutive release of Defined Approaches to Skin Sensitization (TG 497) and eye damage and irritation (TG 467), each providing complete replacements of the respectivetraditional animal tests. This year, two new publications are sure to advance toxicity testing towards non-animal methods indevelopmental neurotoxicity and immunotoxicity.

Test guideline TG 444a outlines the use of a T cell line in the first OECD in vitro assay to be published to address immunotoxicity. Additionally, the Developmental Neurotoxicity (DNT) In Vitro Battery (IVB) is being published as an “initialrecommendation” to highlight that it is an evergreen document. The document itself makes clear its limitations and transferability and is expected to be subject to revision. The uptake of this document within the OECD sets a clear message to regulators within OECD member countries that non-animal tests ought to be prioritized, and it signals to chemical manufacturers that these experiments should be considered in lieu of animal tests.

In addition to endorsing the release of guidance documents, every year the OECD’s WNT accepts new projects into the work plan. This year, ICAPO members are proud to co-lead a new project accepted into the work plan. This project is to develop a detailed review paper (DRP) to facilitate the development of test methods to predict the respiratory sensitisation potential of substances. A DRP is a state-of-the-science report aiming tobring the WNT up to speed on a regulatory need. This is often a necessary first step before drafting meaningful test guidelines for prospective uptake into the Test Guidelines Programme. 

New Publications

• Initial recommendations on evaluation of data from Developmental Neurotoxicity (DNT) In Vitro Battery (IVB)

• TG 444A:  In vitro immunotoxicity, the IL-2 Luc assay

Updates or Revisions: 

• TG 442E: Revised TG 442E skin sensitisation on IL-8 Luc assay

• TG 442C: In chemico skin sensitisation assays addressing the Adverse Outcome Pathway Key Event on Covalent Binding to Proteins

• TG 458 : Androgen receptor transactivation (ARTA) test guideline of similar in vitro methods

• TG 487: : In Vitro Mammalian Cell Micronucleus Test

• TG 491: Short Time Exposure In Vitro Test Method For Eye Hazard Potential  

• TG 492B: Updated Performance Standards 216 for TG 492B RhCE methods for eye hazard potential

• TG 442E: Validation and Peer-review reports for EpiSensA

• Guideline 497: Defined Approaches for Skin Sensitisation

These updates can be found on the OECD Test Guidelines for Chemicals page. You can find all OECD Test Guideline publications on the Series on Testing and Assessment page.