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. 2021 May 16;13(5):732.
doi: 10.3390/pharmaceutics13050732.

In Vitro and Clinical Safety Assessment of the Multiple W/O/W Emulsion Based on the Active Ingredients from Rosmarinus officinalis L., Avena sativa L. and Linum usitatissimum L

Ugne Zlabiene  1 , Juste Baranauskaite  2 , Dalia M Kopustinskiene  1 , Jurga Bernatoniene  1   3
Affiliations

In Vitro and Clinical Safety Assessment of the Multiple W/O/W Emulsion Based on the Active Ingredients from Rosmarinus officinalis L., Avena sativa L. and Linum usitatissimum L

Ugne Zlabiene et al. Pharmaceutics. .

Abstract

The multiple W/O/W emulsion supplemented with the extracts of Rosmarinus officinalis L., Avena sativa L. and Linum usitatissimum L. was prepared in the study, its active compounds were determined by HPLC and its safety was evaluated in vitro by the means of reconstituted human skin model EpiDerm™ for the assessment of its irritation, phototoxicity and early skin inflammation effects and by the 48 h human skin patch test for its skin irritation and allergenic potential. The microbiological challenge test of W/O/W emulsion was performed to ensure its preservation efficiency. The results showed that the W/O/W emulsion loaded with self-preserving plant-based bio-actives had no irritant potential, was not phototoxic and did not provoke skin inflammation or sensitization and thus could be used as a safe base for cosmetic products. Furthermore, our results demonstrate that the safety evaluation of cosmetic ingredients of natural or organic origin could be easily performed using reconstructed human skin model EpiDerm™ similar to the well-defined chemicals used in the cosmetics industry.

Keywords: EpiDerm™; microbiological challenge test; multiple emulsion; patch test; phototoxicity; skin irritation.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
The influence of W/O/W emulsion on the cell viability during in vitro skin irritation test. N = 4 * p < 0.05 vs. negative control and W/O/W emulsion.
Figure 2
Figure 2
The view of the cell tissues during the in vitro skin irritation test after 18 h of incubation and cell viability determination by MTT. (A)—negative control, (B)—positive control, (C)—W/O/W emulsion.
Figure 3
Figure 3
The influence of W/O/W emulsion and chlorpromazine on the cell viability during in vitro phototoxicity test. N = 4 * p < 0.05 vs. UV−.
Figure 4
Figure 4
The influence of W/O/W emulsion on the inflammation marker IL-1α release in vitro. N = 4 * p < 0.05 vs. negative control, W/O/W emulsion and untreated tissue.
See this image and copyright information in PMC

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