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First, a bacterial reverse mutation test (Ames test) assessed AOD9604s mutagenic potential using four histidine-dependent auxotrophic mutants of Salmonella typhimurium (TA1535, TA1537, TA98, TA100) and one tryptophan-dependent auxotrophic mutant of Escherichia coli (WP2 uvrA), using both plate incorporation and pre-incubation methods at doses of 0, 1.6, 8, 40, 200, 1,000, and 2,000 g AOD9604/plate

WHC: West Haven Criteria

Mechanism + animal data is hypothesis generation, not clinical validation