Mutagenicity of DigeZyme® was evaluated using Bacterial Reverse Mutation Assay in-house, as per OECD guidelines. DigeZyme® was tested at different concentrations (39.07–5000 µg/plate) against Salmonella typhimurium tester strains, such as TA98, TA100, TA102, TA1535, and TA1537 using plate incorporation method.
DigeZyme® gave a negative response in the presence and absence of Aroclor 1254-induced rat liver S9 in the assay up to 5000 µg/plate.
Overall, it was concluded that DigeZyme® was non-mutagenic and found to be safe in bacterial reverse mutation assay.