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Cytotoxicity was evaluated by hemolytic and brine shrimp assays, whereas Ames test (TA98 and TA100) was used for mutagenicity evaluation.
The Ames test was proposed by Ames and coworker [57 59] and have been used for mutagenicity evaluation of tobacco smoke [60], wastewater [61], treated wastewater [44, 45], herbal extracts [62] and toxic chemicals [63].
In this regard, the bioassays (hemolytic and brine shrimp) are the standard tests to evaluate the cytotoxicity, whereas TA98 and TA100 (based on salmonella mutant strains) are the reference tests for mutagenicity evaluation.
The standard Ames test for mutagenicity evaluation is used worldwide [ 10].
JJ carried out all the experiments for the mutagenicity evaluation of SAA, designed the two modified Ames tests, and wrote the paper.
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The negative mutagenicity of SAA evaluation by these two modified methods indicated that the false-positive results obtained by the standard Ames test were eliminated.
TMCU mutagenicity was evaluated in the Ames test.
There are number of analytical methods that have been used widely for the evaluation of mutagenicity and genotoxicity (Egito et al. 2007; Gupta and Ahmad 2012).
The primary objective of this phase of development is to establish the safety profile of the drug candidate before clinical testing, including evaluation of mutagenicity, carcinogenicity and teratogenicity.
No statistical method, however, has been singled out as the method of choice for the evaluation of mutagenicity assay data, although a number of reports on statistical methods to evaluate such data have been published.
Evaluation of the mutagenicity of SAA using the two modified Ames tests indicated that the false-positive results obtained by the standard Ames test were eliminated.
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