SAFETY EVALUATION OF BETA-GLUCANASE DERIVED FROM TRICHODERMA-REESEI -SUMMARY OF TOXICOLOGICAL DATA

Barlican, a beta-glucanase enzyme obtained from Trichoderma reesei, wa s produced by a fermentation process and subjected to a series of toxi cological tests to document its safety for use as a feed additive. The enzyme product was examined for general oral toxicity, inhalation tox icity, irritation to eye and skin, skin sensitization and mutagenic po tential. An extensive literature search on the production organism was also conducted. Furthermore, safety for target species was assessed i n a 28-day oral toxicity study with broilers. A strong skin-sensitizin g potential of the beta-glucanase enzyme was detected, but no other ev idence of oral or inhalation toxicity, mutagenic potential, eye or ski n irritancy was found. Feeding of the beta-glucanase enzyme at dietary levels up to 10,000 ppm in the 90-day subchronic toxicity study in ra ts did not induce noticeable signs of toxicity. In addition, no advers e effects were observed when broiler chicks were fed dietary concentra tions of the beta-glucanase enzyme up to eight times the daily recomme nded dose. It is therefore concluded that this beta-glucanase preparat ion is safe for use in feed of the intended target species. However, s ome occupational health precautions should be taken to avoid skin cont act and inhalation, as is the case for almost all enzyme proteins.