Sumizyme PEG, a glucanase/cellulase enzyme preparation produced by Talaromyces versatilis PF8, was investigated to characterize its systemic and genotoxic toxicity profile to support its intended use in food processing applications. A comprehensive toxicological program was conducted in accordance with OECD guidelines, comprising a bacterial reverse mutation (Ames) test, an in vitro chromosomal aberration assay, an in vivo micronucleus test, and a 90-day repeated-dose oral toxicity study in male and female Crl:CD(SD) rats. In the subchronic study, Sumizyme PEG was administered by oral gavage at doses of 107, 1070, and 10,700 U/kg/day. No treatment-related adverse effects were observed across clinical, hematological, biochemical, urinalysis, organ weight, or histopathological endpoints, and the highest dose was identified as the NOAEL. Genotoxic testing showed no consistent mutagenic or clastogenic response across the test battery. A positive in vitro signal was observed in CHL/IU cells; however, this was not reproduced in a human TK6 cell assay or in vivo micronucleus testing, indicating assay-dependent sensitivity within a weight-of-evidence framework. Overall, the integrated dataset does not indicate a consistent treatment-related systemic or genotoxic effect under the conditions of the studies conducted.
Dietrich et al. (Sun,) studied this question.