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

Area of Science:

• Nanomaterial Toxicology
• Regulatory Science
• Risk Assessment

Background:

• Knowledge on engineered nanomaterial (ENM) hazards and risks remains limited.
• Existing regulatory guidance lacks clear articulation of sex/gender-specific responses to ENM exposure.
• This gap hinders precise risk assessment and management of ENMs.

Purpose of the Study:

• To demonstrate the relevance of the sex/gender dimension in characterizing ENM risks and hazards.
• To analyze existing data on sex-related differences in mammalian responses to ENM exposure.
• To provide recommendations for integrating sex/gender into future ENM safety testing.

Main Methods:

• Extensive literature review of in vivo mammalian toxicity studies from PubMed and Web of Science.
• Analysis of data from publications meeting scientific quality criteria using the GUIDEnano approach.
• Systematic evaluation of sex-related differences in ENM toxicity.

Main Results:

• Scientific data confirms significant sex/gender differences in mammalian responses to ENM exposure.
• The sex/gender dimension is critical for accurate hazard and risk characterization of ENMs.
• Current risk assessments may be incomplete without considering sex/gender variations.

Conclusions:

• Integrating the sex/gender dimension into ENM safety testing is essential for precise and reliable hazard and risk assessments.
• Recommendations are provided for incorporating sex/gender considerations into toxicity testing protocols.
• This approach will enhance transparency and accuracy in regulatory decision-making for ENMs.