In vivo micronucleus test of 4-butylaniline and N-butylaniline to classify a chemical's mutagenicity according to the globally harmonized system of classification and labelling of chemicals (GHS)

In vivo micronucleus tests were performed to investigate the mutagenic potential of 4-butylaniline and N-butylaniline, which are used in dye intermediates and organic intermediates respectively. Groups of 5 male ICR mice were treated with vehicle or 4-butylaniline for 2 consecutive days by oral gavage at concentrations of 0 (control), 64, 160, 400, and 1000 mg/kg. Statistically significant and dose-dependent increases were found for micronuclei frequencies in male mice (p <0.05). These results suggest that 4-butylaniline can induce genetic effects in the micronuclei of male mouse bone marrow cells. Based on the positive results obtained in cytogenetic analyses of somatic cells in vivo, Globally Harmonized System of Classification and Labelling of Chemicals Category 2 was assigned. N-butylaniline was administered for 2 consecutive days by oral gavage to male ICR mice at dose of 0 (control), 64, 160, 400, and 800 mg/kg. Nbutylaniline tested negative for micronuclei induction in mice, although N-butylaniline was associated with micronucleus induction at the highest dose. Based on the negative results obtained for cytogenetic analyses of somatic cells in vivo, “Not Classified” was assigned.