How safety was evaluated?

A standard range of safety studies normally conducted with all commercially used food ingredients was performed with ACTIVA® TG in vitro or by using laboratory animals, as follows. No adverse toxicological results were found.

• Antibacterial residue test and antifungal activity assay
• Chromosomal Aberration Test (Cultured Mammalian Cells)
• Mutagenicity Test (Reverse Mutation Assay in Bacteria)
• Pathogenicity test (mice)
• Micronucleus Test (mice)
• Skin Sensitization Test (guinea pigs)
• Acute Toxicity Test (rats)
• Thirteen-week Toxicity Test (rats, the no-effect level of TG in this sub-chronic study was considered to be 5.0% (w/w))
• Stability Test (the results suggest that TG is not active in the stomach, which is characterized by acidic pH, and that TG is completely degraded by pepsin)