PROGRAM OVERVIEW
The OECD Test Guidelines Programme develops internationally harmonized test methods for assessing chemical safety. These guidelines are accepted by all 38 OECD member countries plus partner economies under the Mutual Acceptance of Data (MAD) agreement, eliminating duplicative testing and enabling global market access with single studies.
KEY IN VITRO GUIDELINES
- TG 497: Defined Approaches for Skin Sensitisation—integrated testing strategies
- TG 498: In Vitro Phototoxicity Test using reconstructed human epidermis
- TG 442C/D/E: Skin Sensitisation in chemico and in vitro methods (DPRA, KeratinoSens, h-CLAT)
- TG 439: In Vitro Skin Irritation using reconstructed human epidermis
- TG 492: Reconstructed Human Cornea-like Epithelium for eye irritation
- TG 455: Stably Transfected Transactivation for estrogen receptor agonists
MUTUAL ACCEPTANCE OF DATA (MAD)
Under the 1981 MAD Council Decision, safety data generated using OECD Test Guidelines in one member country must be accepted by all other members. This saves industry an estimated €309 million annually, eliminates redundant animal studies, and accelerates global chemical and pharmaceutical approvals.
VALIDATION PROCESS
New test methods undergo rigorous validation through EURL ECVAM, ICCVAM, or JaCVAM before OECD adoption. The process includes within-laboratory reproducibility, transferability studies, predictive capacity assessment, and formal peer review—typically requiring 5-10 years from method development to guideline adoption.