Review of dose setting for the extended one-generation reproductive toxicity studies (OECD TG 443): Considerations on ECHA’s dose level selection recommendations

European Chemicals Agency's (ECHA) dose setting recommendations for the OECD Test Guideline 443 exceed the Maximum Tolerated Dose (MTD), leading to compromised data interpretation and increased animal testing, raising welfare concerns. Current guidance may fail to identify postnatal hazards and does not align with the 3Rs principles (Replacement, Reduction, Refinement). DART experts advocate for revised, science-driven dose selection criteria to produce relevant data ethically and responsibly. They urge ECHA to balance regulatory requirements with scientific pragmatism to better protect human health and animal welfare.

Review of dose setting for the extended one-generation reproductive toxicity studies (OECD TG 443): Considerations on ECHA's dose level selection recommendations. Beekhuijzen et.al., June 2024. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2024.105665

Learn more about the HESI Developmental and Reproductive Toxicology (DART) Committee