Sex and Gender Dimensions in Hazard and Risk Assessment of Engineered Nanomaterials.

The knowledge on hazards and risks connected to human exposure to engineered nanomaterials (ENMs) is still very limited, despite several decades of research and regulatory efforts at the international level. In particular, sex/gender-related responses to such exposure have not been clearly articulated so far in any of the existing guidance documents or regulatory relevant opinions provided to the parties involved in the risk assessment and risk management of ENMs. We aimed to demonstrate the relevance of the sex/gender dimension for the characterization of the risks and hazards associated with ENMs by analyzing existing scientific data on sex-related differences in response to ENMs exposure. This was achieved by performing an extensive review of in vivo mammalian toxicity studies published in PubMed and Web of Science databases. Further analysis was performed only for data reported in publications that satisfied scientific quality criteria assessed using the GUIDEnano approach. Finally, we demonstrated the importance of the sex/gender dimension for safety testing of ENMs in the future and provided recommendations on how to include the sex/gender dimension in toxicity testing of ENMs to ensure precise, transparent, and reliable conclusions in the process of hazard and risk assessments. This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Toxicology of Nanomaterials Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine.