Recently, Korean consumers have experienced public health issues as a result of problematic feminine hygiene products. Consumers and local civic groups have urged manufacturers and the Korean government to provide clear information based on comprehensive studies and strengthen related policies. In this study, we collected and compiled information on the relevant regulations and organizations in Korea, the European Union, and the United States to compare the management systems and legal status of feminine hygiene products around the world. We confirmed that the definition of feminine hygiene products is similar for Korea, the EU, and the US; however, they are categorized as quasi-drugs in Korea, general products in the EU, and medical devices in US according to various regulations. Although we cannot completely prevent human exposure to chemicals in modern society, it is vital to establish a management system for the safe use and production of feminine hygiene products in a scientifically and legally sound manner. This research can contribute to the regulatory toxicology and risk assessment fields of feminine hygiene product research.

The Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) 439 is an in vitro test method of reconstructed human epidermis (RhE), which was developed for hazard identification of irritating chemicals in accordance with a primary skin irritation test using rabbits with 4-hr exposure. A regulation for quasi-drugs in Japan requires data from primary skin irritation tests using rabbits to undergo 24-hr exposure, and this is used as an evidence for 24-hr closed patch tests in humans. In this study with the same chemicals, primary skin irritation test data using rabbits undergoing 24-hr exposure and a 24-hr occlusive human patch test data were analyzed by comparing the results obtained with four test methods adopted in OECD TG 439. The performances of in vitro test methods showed a positive predictive value of 72.7-85.7% to predict the results of 24-hr primary rabbit skin irritation test knowing that its positive predictive value was 57.1% against humans only. The prediction factors of in vitro test methods were higher for the human patch test data with a sensitivity reaching 60 to 80%. Three surfactants gave false negatives in some of the RhE methods evaluated with the human patch test, but in each case, they were correctly classified as positive when evaluated at double concentration. Therefore, the approach of setting the margin to 2 was effective in eliminating false negatives. This suggests that in vitro test methods are useful for assessing skin irritation potential without animal testing for the application of quasi-drugs in Japan.