In the second part of the study, the substances without (adequate) literature data were tested in vitro in a bacterial reverse gene mutation test (i.e.,
Ames test).
There was no evidence of mutagenic or genotoxic potential for BT-11 up to tested limit doses using an
Ames test, chromosomal aberration assay in human peripheral blood lymphocytes, or micronucleus assay in rats.
Profilers relevant to genetic toxicity and carcinogenicity deriving from structural alerts associated with toxicity include carcinogenicity (genotoxic and nongenotoxic) by ISS, DNA alerts for Ames by OASIS, DNA alerts for CA and MNT by OASIS, in vitro mutagenicity (
Ames test) by ISS, in vivo chromosomal mutation, and OncoLogic primary classification.
In general, the first test to assess the toxicity of chemical compounds is the Salmonella/Microsome test, or
Ames test, which shows patterns of mutation in DNA structure.
If an
Ames test is conducted, the second study in the tier should evaluate the hazard potential to mammalian cells.
The
Ames test was specifically designed to detect a wide range of mutagenic chemicals.
He developed the "
Ames test" that remains in wide use to determine if a chemical is a mutagen (a potential carcinogen).
Ames test on back mutation action of the strain using both TA98 and TA100 strains showed negative results.
While the statistical evaluation of the results of the
Ames test is under discussion (Kim and Margolin, 1999; Mortelmans and Zeiger, 2000) and depends also from the historical data achieved in the individual testing site, the responsible laboratory considered a test item showing a positive response, if the number of revertants was significantly increased (p < 0.05, U-test according to Mann and Whitney, Colquhoun, 1971) (ranges see Table 3) to at least 2-fold of the respective solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both of the independent experiments.
Various aspects associated with the safety of probiotic bacteria can be studied using in vitro and in vivo methods (e.g., the
Ames test, animal models, and humans) [2, 3].
This method has been accepted by several international organizations and these organizations occasionally suspend research on new products simply because the product in question produced a positive result on the
Ames test [8-12].
Ames (University of California-Berkeley) for inventing the
Ames test of mutagenicity
