By NOTOX, The Netherlands, 2000 and 2001.
Genetic toxicology focuses on the process of mutagenesis, that includes the induction of DNA damage and all kinds of genetic changes, ranging from alterations in one or a few DNA base pairs (gene mutations) to gross changes in chromosome structure (chromosome aberrations) or chromosome number. Mutagens are of concern, because genetic damage may contribute to diseases like cancer. Mutagenicity testing should detect the diverse kinds of mutations that are relevant for human health. Therefore a set of tests are needed.
Subacute 28-day oral toxicity with SoyLife COMPLEX by daily gavage in the rat, 2000. 14-day oral range finding with SoyLife EXTRA by daily gavage in the rat. 2001. For both SoyLife COMPLEX and SoyLife EXTRA the maximum dosage administered to the rats was 1000 mg, because the rats were practically not able to eat more than this quantity per day. From the results presented in this report a No Observed Adverse Effect Level (NOAEL) for SoyLife COMPLEX of 1000 mg / kg / day was concluded. For the interpretation of this result, it is important to note that 1000 mg SoyLife / kg / day for rats equals 70 g SoyLife / day for humans. In both studies, no adverse effects were detected with respect to growth, behavior, food & water intake, and organ weights and structure.
SoyLife EXTRA was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli WP2uvrA in two independent experiments. 2000. Part of these tests are better known as “Ames- test”, and is a bacterial test to detect gene mutations (changes in DNA base pairs). Based on the results of this study, it is concluded that SoyLife EXTRA is not mutagenic in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay at a concentration of 5,000μg SoyLife EXTRA per plate. These tests have been carried out in the absence and presence of metabolic activation (the rat liver homogenate S9- mix).
Effect of SoyLife EXTRA on the induction of chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system, 2000.
Gros changes in chromosome structures can be detected by microscopy in human lymphocytes incubated with the compound of interest. SoyLife EXTRA did not produce a biologically relevant or statistically significant increase in the number of cells with chromosome aberrations in the absence and in the presence of S9-mix (metabolic activation) at a dose of 333μg SoyLife EXTRA / ml. From this test it is concluded that SoyLife EXTRA is not clastogenic (the correct term “inducing chromosome aberrations”) in human lymphocytes.
Micronucleus test with SoyLife EXTRA in mice to evaluate its genotoxic effect on erythrocytes in bone. 2000.
This in vivo cytogenetic test involves treating intact animals with SoyLife EXTRA, and the preparation of cell samples for the detection of chromosome abarrations. This test offers the advantage that the mammalian metabolism and distribution of the compound are part of the essay. SoyLife EXTRA was tested in rats to evaluate its genotoxic effect on erythrocytes in bone marrow. Male and female rats were appointed to 2000, 1000 or 500 mg SoyLife EXTRA / kg body weight, or a negative or positive control. The SoyLife EXTRA groups showed no decrease in the ratio of polychromatic to normochromatic erythrocytes compared to the vehicle controls. This reflects the absence of toxic effects of this compound on the erythropoiesis. Based on the results in this study, it is concluded that SoyLife EXTRA is not mutagenic in the micronucleus test.