Toxicological assessment of β-galactosidase shows no adverse effects in vivo and in vitro

A safety assessment for β-galactosidase derived from Aspergillus oryzae (GODO-FAL) was performed. The test article was a concentrated, purified β-galactosidase diluted in glycerin and water with an activity of 10,000 U/mL. A series of genotoxicology tests including micronucleus assay, chromosome aberration assay, and reverse mutagenesis (Ames) assay confirmed that GODO-FAL was not clastogenic or mutagenic at any of the concentrations used, up to 2000 µg/mL for the chromosome aberration assay and 5000 mg per plate in the Ames assay. GODO-FAL was not toxic in acute, repeated oral toxicity, and sub-chronic toxicity assays in Sprague–Dawley rats at any dose used, up to 2000 mg/kg/day. Based on results from the subchronic toxicology assay, the no observed adverse effects level for GODO-FAL was at least 2000 mg/kg/day.

Evaluation by the Ames Assay of the Mutagenicity of UV Filters Using Benzophenone and Benzophenone-1

Ultraviolet absorbing chemicals (UV filters) are widely used in personal care products for protecting human skin and hair from damage by UV radiation. Although these substances are released into the environment during production and consumption processes, little is known about their genotoxicity effects. Our previous studies have shown that benzophenone-type UV filters exhibited acute toxicity on three species of aquatic organisms. Mutagenesis by benzophenone (BP) and benzophenone-1(BP-1) was tested in the present study by the Salmonella typhimurium/reverse mutation assay (Ames assay). All the positive reverse mutations occurred in the absence of the S9 liver extract system for both chemicals. From BP, positive mutation effects on the TA102 strain at doses of 0.05 μg/plate and 0.5 μg/plate were detected. From BP-1, positive mutation effects on the TA97 strain at doses of 0.05 μg/plate and 0.5 μg/plate, and on the TA100 strain at a dose of 0.5 μg/plate, were detected. A mixture of BP and BP-1 exhibited mutagenicity on the TA97 and TA100 strains. For the TA97 strain, the positive mutation results were detected at 10% and 50% of the mixture. For the TA100 strain, the results were detected when the mixture was at 5% and 10%. In the mixture at 5%, the concentrations of BP and BP-1 were 3.5 μg/plate and 14 μg/plate, respectively. In the 10% mixture, the doses of BP and BP-1 were 7 μg/plate and 28 μg/plate, respectively. In the 50% mixture, the doses of BP and BP-1 were 35 μg/plate and 140 μg/plate, respectively. The mixture test results suggested that there was antagonism in mutagenicity between BP and BP-1.