SAFETY EVALUATION OF A LIPASE EXPRESSED IN ASPERGILLUS-ORYZAE

A programme of studies was conducted to establish the safety of a lipa se artificially expressed in Aspergillus oryzae to be used in the dete rgent industry and as a processing aid in the baking industry. Laborat ory animal studies were used to assess general and inhalation toxicity , skin sensitization, and skin and eye irritation. Its potential to ca use mutagenicity and chromosomal aberrations was assessed in microbial and tissue culture in vitro studies. The pathogenicity of A, oryzae, the organism used to produce the lipase, was also assessed in laborato ry animals. Basic ecotoxicity in a variety of test species was studied . General and inhalation toxicity was low. There was evidence of mild skin irritation. There was no evidence of eye irritation, skin sensiti zation, mutagenic potential, chromosomal aberrations, ecotoxicity or n otable pathogenicity. Comparison of these results with human exposure levels and previously published data indicates that the lipase appears safe for consumers in the given applications, requires no special occ upational health precautions in manufacture and is of low environmenta l impact. Furthermore, the organism used in production of the lipase h as no notable pathogenicity.