Safety evaluation of SoyLife

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”