In Vitro Genotoxicity Test of m-Phenylenediamine Using the Chromosomal Aberration Assay in Cultured Mammalian Cells

On February 21, 2023, the Ministry of Food and Drug Safety in Korea designated five hair dye ingredients, including m-phenylenediamine, as prohibited substances in cosmetics due to potential genotoxicity, which may cause genetic damage or mutations in humans. Based on the revised regulations, products containing these ingredients have been banned from manufacture and import as of August 22, 2023. However, products manufactured or imported before this date may still be sold until August 21, 2025. Therefore, mphenylenediamine, which has already been verified to exhibit genotoxicity, was selected as the test substance for this study. The chromosomal aberration test was conducted in compliance with OECD TG 473. Mammalian cell lines, specifically the Chinese Hamster Lung (CHL/IU) cell line, were used. The test examined the chromosomal aberration-inducing potential of the test substance with and without metabolic activation. Genotoxicity assessment is not conducted based on a single test; instead, it requires a 3-battery approach, comprising from three different tests. Preliminary studies have shown a positive response in the reverse mutation assay for m-phenylenediamine. This study adds the chromosomal aberration test to compare the results, supporting the validity of a 3-battery approach and suggesting the ethical viability of cell-based toxicity testing to assess chemical hazards.