Safety evaluation of alkaline cellulase.

A programme of studies was conducted to establish the safety of alkaline cellulase, an enzyme used as a processing aid in the food industry. Laboratory animal studies were used to assess general, inhalation and reproduction toxicity, eye irritation and skin irritation and sensitization. Mutagenic potential was assessed in microbial and animal in vivo studies. The pathogenicity of Humicola insolens, the micro-organism used in the production of alkaline cellulase, was also assessed in laboratory animals. Basic ecotoxicity in a variety of test species was studied. General toxicity by a variety of routes was low; there was no evidence of reproductive toxicity. There was evidence of mild skin irritation and some eye conjunctival reddening. There was no evidence of skin sensitization, mutagenic potential, ecotoxicity or notable pathogenicity. When these results are considered along with levels of human exposure and previously published data, it appears that alkaline cellulase is safe for consumers in the given applications, requires no special occupational health precautions in manufacture, and is of low environmental impact. Furthermore, the micro-organism used in production of alkaline cellulase has no notable pathogenicity.