A Systematic Review on Molecular Toxicology and Omics-Based Risk Assessment of Pigments Used in Dermal Implantation Procedures: Implications for Somatology and Somatic Therapy Practice.

Pigment implantation (semi-permanent make-up, microblading and cosmetic tattooing) introduces complex pigment mixtures into the dermis, resulting in direct exposure of keratinocytes, fibroblasts and resident immune cells to metals, organic dyes and nanoparticles. Within Somatology and Somatic therapy practice, an allied health discipline concerned with evidence-based care of the skin and body, Somatic Therapists operate at the interface of dermal intervention, molecular exposure and occupational health, underscoring the relevance of mechanistic toxicology for risk-informed professional practice. This PRISMA-guided systematic review synthesises molecular toxicology and omics-based evidence, emphasising oxidative stress generation, inflammatory signalling via NF-κB/MAPK pathways, apoptosis and genotoxicity, T-cell-mediated type IV hypersensitivity reactions associated with modern red azo pigments, and dermal-to-lymphatic transport of particulate matter. Transcriptomic and metabolomic studies consistently demonstrate pigment-specific inflammatory responses and wound-healing gene signatures, supporting mechanism-driven biocompatibility profiling. Regulatory frameworks, including EU REACH Annex XVII Entry 75 and recent FDA guidance on microbial contamination, have strengthened compliance requirements; however, surveillance continues to identify mislabelling, restricted pigments and microbial contamination in some inks. For Somatology and Somatic therapy practice, these findings highlight the importance of evidence-based pigment selection, traceable sourcing, aseptic technique, ventilation, personal protective equipment and informed consent addressing pigment migration and delayed adverse reactions. The integration of molecular outcomes with omics technologies and regulatory oversight provides a next-generation risk assessment framework to advance safe cosmetic practice and public health.