“…If API crosses the epithelial barrier, a battery of six assays of safety and activity that cannot be studied in humans should be included: mutagenicity, carcinogenicity, one (and two)‐generation reproduction toxicity, neurotoxicity, embryotoxicity, and genetic studies (Lard‐Whiteford et al, 2004). Mutagenicity and genetic studies evaluate chromosomal and structural DNA changes, such as duplications, insertions, or translocations (da Silva Dantas et al, 2020; Nakamura et al, 2020; Prado‐Ochoa et al, 2020), and identify gene mutations (Gao et al, 2020; Marcelino et al, 2020; Park et al, 2020). Carcinogenicity studies evaluate tumors' development after 18 in mice or hamsters or 24 months in rats (Dekant et al, 2020; Prado‐Ochoa et al, 2020; Saleh et al, 2020).…”