OECD Test Guidelines for NAMs

The Organisation for Economic Co-operation and Development (OECD) develops internationally agreed test methods for chemical and pharmaceutical safety assessment. OECD Test Guidelines (TGs) are the gold standard for validated alternative methods, with over 150 guidelines including numerous in vitro NAMs.

      Mutual Acceptance of Data: OECD Test Guideline data generated in any OECD member country must be accepted by all other members, eliminating duplicate testing and accelerating global regulatory acceptance.
    

Validated In Vitro Test Guidelines

Skin Sensitization

TG Number	Method	Description
TG 442C	DPRA	Direct Peptide Reactivity Assay - chemical reactivity
TG 442D	KeratinoSens	Keratinocyte activation (Nrf2 pathway)
TG 442E	h-CLAT	Human Cell Line Activation Test - dendritic cells
TG 497	DA/ITS	Defined Approach integrating multiple methods

Eye Irritation

TG Number	Method	Description
TG 437	BCOP	Bovine Corneal Opacity and Permeability
TG 438	ICE	Isolated Chicken Eye test
TG 460	FL Assay	Fluorescein Leakage test
TG 491	STE	Short Time Exposure using rabbit cornea cells
TG 492	RhCE	Reconstructed human Cornea-like Epithelium

Genotoxicity

TG Number	Method	Description
TG 471	Ames Test	Bacterial reverse mutation assay
TG 473	Chromosome Aberration	In vitro mammalian cell assay
TG 476	Gene Mutation	Mammalian cell gene mutation (HPRT/TK)
TG 487	Micronucleus	In vitro mammalian cell micronucleus test

Emerging OECD NAMs Projects

Organ-on-Chip Guidance

OECD is developing guidance documents for microphysiological systems:

Liver-on-chip for hepatotoxicity assessment
Lung-on-chip for inhalation toxicity
Multi-organ systems for systemic toxicity
Good In Vitro Method Practices (GIVIMP) application

Defined Approaches

OECD Defined Approaches combine multiple information sources:

Integrated Testing Strategies (ITS)
Weight-of-Evidence frameworks
(Q)SAR model integration
Read-across approaches

OECD Validation Process

Test Development - Initial method development and optimization
Pre-validation - Protocol refinement and transferability assessment
Validation - Multi-laboratory ring trials with reference chemicals
Peer Review - Independent scientific review by OECD expert group
Regulatory Acceptance - Adoption as official OECD Test Guideline

Submitting NAMs to OECD

To propose a new Test Guideline or Guidance Document:

Submit Standard Project Submission Form (SPSF) to OECD
Include validation data package
Demonstrate international relevance
Identify lead country sponsor
Timeline typically 2-4 years from submission to adoption

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Educational content created by J Radler for the biotech and scientific community. Last updated: February 4, 2026.

Free to share for educational purposes with attribution.