Genetic Toxicity Studies of the Ketogenic Ester Bis Hexanoyl (R)-1,3-Butanediol

This series of studies assessed the genetic toxicity of the ketone ester bis hexanoyl (R)-1,3-butanediol (BH-BD) under OECD guidelines and Good Laboratory Practices. There was no evidence of mutagenic activity in bacterial reverse mutation tests at doses up to 5,000 µg/plate, with or without metabolic activation. BH-BD did not significantly increase micronuclei in human TK6 cells at concentrations up to 100 µg/mL, nor micronucleated polychromatic erythrocytes in Sprague Dawley rats. BH-BD was concluded to be negative in all 3 tests.