Fundamental Toxicological Sciences

Paper Details

Fundamental Toxicological Sciences
Vol. 10 No. 3 May 12, 2023 p.113-123
Original Article
A trial to predict skin irritancy of cosmetic products using cytotoxicity tests
  • Minori Mezaki (R&D Laboratories, Self-medication, Taisho Pharmaceutical Co., Ltd. /
Minori Mezaki 1) , Chika Manabe 1) , Junichiro Nagumo 1) , Tomohisa Yoshimura 1) , Tohru Nagahama 1) , Hiroshi Itagaki 2) , Akiko Takaoka 1)
1) R&D Laboratories, Self-medication, Taisho Pharmaceutical Co., Ltd. , 2) ITACS Consulting
Keywords: Skin irritation, Cytotoxicity tests, OECD TG439, OECD TG491, Cosmetic products

Alternatives to animal testing are being used to assess the safety of raw ingredients during the process of developing cosmetics. However, since cosmetic products are composed of a variety of raw ingredients, the safety of the product itself should also be tested. In this study we attempted to evaluate the skin irritation potential of skin lotions by modifying existing alternative test methods. To evaluate the skin irritation potential of commercial skin lotions in the form of an objective indicator, we calculated their Irritation Score (IS) based on the results of searches using keywords related to skin irritation in review statements posted on Japanese cosmetics and beauty websites. We then modified the reconstructed human epidermis (RhE) test method to evaluate irritation by commercial skin lotions. The results showed that exposure to skin lotions with higher ISs tended to result in lower cell viability, and that exposure to many of the lotions with lower ISs resulted in higher cell viability. Next, we tried using an in vitro short-term exposure (STE) test method to assess the skin irritation potential of skin lotions. By changing the test-substance exposure concentrations and exposure times in the STE test method, we were able to obtain results that correlated with those obtained by the modified RhE test method. In conclusion, both alternative methods were helpful for assessing the possibility of developing skin irritation of skin lotions. They may also be useful for screening formulations being developed and as means of evaluation before proceeding to human patch tests.