Synacinn™: Bacterial reverse mutation test data in five histidine-requiring strains of Salmonella Typhimurium
2021
Zainol, Siti Nurazwa | Fadhlina, Anis | Rentala, Sri Vijaya | Yalaka, Manjula | Vatsavai, Leela Krishna | Pillai, Renuka | Ismail, Hassan Fahmi | Majid, Fadzilah Adibah Abdul
The present data described the analysis of mutagenicity in Synacinnᵀᴹ by assessing the point mutations occurring due to Synacinn™ exposure to five tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100 and TA102), in the presence or absence of an exogenous mammalian metabolic activation system (S9). It was conducted in two Phases - Phase I (Dose Range Finding experiment-DRF) and Phase II (Mutagenicity Assay 1 and 2). DRF and Mutagenicity Assay 1 was conducted employing plate incorporation method, while Mutagenicity Assay 2 was performed using pre-incubation method. Formulation analysis pertaining to Synacinnᵀᴹ was performed for both Mutagenicity Assay 1 and 2. Dose formulations were prepared fresh on each day of the experiment. Adventol 50% v/v in purified water was selected as a suitable vehicle based on the preliminary solubility test. Based on the Phase I analysis, 5 mg/plate was selected as the highest concentration of Synacinnᵀᴹ followed by lower concentrations of 2.5, 1.25, 0.625 and 0.313 mg/plate for the Mutagenicity Assays. Genetic integrity of all the tester strains used was confirmed by performing genotyping before their use. All the data acceptability criteria were fulfilled confirming the validity of the test.
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