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  • A review to support the der...
    Gimeno-Benito, Irene; Giusti, Anna; Dekkers, Susan; Haase, Andrea; Janer, Gemma

    Regulatory toxicology and pharmacology, February 2021, 2021-Feb, 2021-02-00, Letnik: 119
    Journal Article

    Data on dermal penetration of nanoparticles (NPs) was reviewed with the goal to establish a worst-case dermal penetration value for NPs. To this aim, the main focus was on studies providing quantitative dermal penetration data (29 studies). In vivo dermal penetration studies and ex vivo studies based on skin explants were included. These studies used NPs with different compositions, dimensions, and shapes. The overall results showed that skin is an efficient barrier for NPs, indistinctly of their properties. However, some studies reported that a small percentage of the applied NP dose penetrated the skin surface and reached deeper skin layers. The integrity of the skin layer and the product formulation were more critical determinants of dermal penetration than the NP properties. Most quantitative studies were based on elemental analysis such that it cannot be concluded if detected levels are attributable to a dissolved fraction or to the penetration of particles as such. Results of qualitative imaging studies suggest that at least a fraction of the levels reported in quantitative studies could be due to particle penetration. Altogether, based on the data compiled, we propose that 1% could be used as a worst-case dermal penetration value for nanoparticles within the boundaries of the properties of those included in our analysis. •Variations in test design along with NP properties, hindered interstudy comparisons.•A trend towards lower dermal penetration with increasing size was observed.•No clear conclusions can be derived on the role of shape or coating.•Existing studies probably overestimate dermal penetration of NPs in their particulate form.•The worst-case dermal penetration value in healthy skin was 1% of the applied dose.