News | Jul 5, 2022
OECD Releases new Test Guidelines for NAMs in 2022
By Eryn Slankster-Schmierer, PhD
On June 30, 2022, the OECD released updates from the 34thMeeting of the Working Group of the National Coordinators of the Test Guidelines Programme held in April 2022. Among the updates are exciting advances for NAMs in the regulatory space.
Last year, the publication of the Defined Approach on Skin Sensitization (Guidline 497) made remarkable strides by offering the first ever defined approach, providing an animal free alternative to skin sensitization assessment by replacing the use of the murine Local Lymph Node Assay with New Approach Methodologies (NAMs). This year, TG 467 follows suit to offer defined approaches to determine eye hazard potential using NAMs. Along with the newly published TG492B on Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification, these guidelines individually provide an approach to complete replacement of animal studies on eye hazard assessment.
To increase awareness of these new adopted guidelines, the OECD will host a webinar on Sep 27, 2022 at 2:00 PM CET/ 8:00 AM in EDT, on Implementation of the first stand-alone NAMs for eye hazard identification into OECD Guidelines: OECD GL 467 and TG 492B.
New Test Guidelines:
- TG 467: Defined Approaches for Serious Eye Damage and Eye Irritation provides a NAMs approach to eye hazard assessment
- TG 492B on Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identificationproposes a new stand-alone method for eye hazard potential using a reconstructed human corneal epithelium
- TG 251 on the Rapid Androgen Disrupter Activity Reporter Assay uses transgenic fish eleutheroembryo in an assay to screen for endocrine activity
Key Corrections and Updates:
- TG 442C: In Chemico Skin Sensitisation includes updates on the amino acid derivative reactivity assay (ADRA) for skin sensitization and includes updated performance standards for the direct peptide reactivity assay (DRPA) and ADRA.
- TG 442E: In Vitro Skin Sensitisation is a set of assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation. It has been updated to feature the GARDSkin assay, breaking ground as the first harmonized method to use gene expression as a regulatory endpoint
- TG 425: Acute Oral Toxicity: Up-and-Down Procedureunderwent text change to encourage group housing, when appropriate.
- TG 442D: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method had minor text corrections to clarify a discrepancy regarding controls
- TG 456: H295R Steroidogenesis Assay underwent significant amendments to the data interpretation procedure, improving the accuracy of this in vitro assay by reducing the number of false positives.