While SEBS-based elastomers are utilized in medical devices, the lack of systemic safety protocols in physiological microenvironments hinders their clinical translation. Furthermore, the intrinsic hydrophobicity of SEBS and the inability of traditional 2D/animal models to replicate human tissue responses necessitate more robust evaluation frameworks. Herein, a SEBS/paraffin oil gel was synthesized via a one-pot method and functionalized with polydopamine (PDA) coatings to enhance hydrophilicity and antimicrobial efficacy. A multiscale safety evaluation framework was established, integrating mechanical characterization, 3D human skin models, in vitro cytotoxicity profiling, and in vivo animal assays. Results demonstrate that the SEBS gel exhibits exceptional toughness and fatigue stability, while the PDA coating achieves high cellular viability (>98%). Crucially, 3D organoid models and animal studies confirmed negligible IL-6 upregulation and an absence of skin irritancy, validating the material's safety at both tissue and organism levels. This work provides a translatable paradigm that unifies materials engineering with human-mimetic evaluation, offering a standardized template for the systematic preclinical assessment of advanced medical elastomers.
Ma et al. (2026) studied this question.