Assessment of reproductive and developmental toxicity risks of cobalt in medical devices

Abstract

Cobalt metal is an essential trace element that plays a crucial role in various biological processes, with human exposure arising from diverse sources, including diet, dietary supplements, occupational environment, medical devices. Recently, the European Chemicals Agency (ECHA) classified cobalt as a Reproductive Hazard Category 1B. This classification indicates that cobalt is presumed to be a reproductive toxin, primarily due to adverse effects on the testes in male rodents during clinical trials. To evaluate the  significance of this classification. Findings from these evaluations suggest that cobalt-induced reproductive toxicity in rodents is confined to the testes function. The underlying mechanisms of cobalt's reproductive effects, including indirect impacts on testicular function, are discussed in the context of their applicability to human health. Notably, current evidence suggests that the classification of cobalt as a Reproductive Hazard Category 1B may not be entirely appropriate. Instead, a more fitting classification might be as a Reproductive Hazard Category 2, indicating a reproductive toxin. Importantly, for cobalt-containing medical devices, the data do not support its classification as a reproductive hazard, highlighting the need for a refined, evidence-based perspective in regulatory assessments.