Synacinn™: Bacterial reverse mutation test data in five histidine-requiring strains of Salmonella Typhimurium
Siti Nurazwa Zainol,
Anis Fadhlina,
Sri Vijaya Rentala,
Manjula Yalaka,
Leela Krishna Vatsavai,
Renuka Pillai,
Hassan Fahmi Ismail,
Fadzilah Adibah Abdul Majid
Affiliations
Siti Nurazwa Zainol
Proliv Life Sciences Sdn Bhd, D-1-15, Residensi Bistaria, Jln Ulu Kelang, Taman Ukay Bistari, 68000 Ampang, Selangor Darul Ehsan, Malaysia
Anis Fadhlina
Institute of Marine Biotechnology, Universiti Malaysia Terengganu, 21030 Kuala Nerus, Terengganu Darul Iman, Malaysia; Faculty of Pharmacy, International Islamic University Malaysia, Bandar Indera Mahkota, 25200 Kuantan, Pahang, Malaysia
Institute of Marine Biotechnology, Universiti Malaysia Terengganu, 21030 Kuala Nerus, Terengganu Darul Iman, Malaysia
Fadzilah Adibah Abdul Majid
Proliv Life Sciences Sdn Bhd, D-1-15, Residensi Bistaria, Jln Ulu Kelang, Taman Ukay Bistari, 68000 Ampang, Selangor Darul Ehsan, Malaysia; Institute of Marine Biotechnology, Universiti Malaysia Terengganu, 21030 Kuala Nerus, Terengganu Darul Iman, Malaysia; Corresponding author at: Institute of Marine Biotechnology, Universiti Malaysia Terengganu, 21030 Kuala Nerus, Terengganu Darul Iman, Malaysia
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.
