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.