Elvig S G, Pedersen P B
Department of Safety & Toxicology, Novozymes A/S, Krogshoejvej 36, Bagsvaerd DK-2880, Denmark.
Regul Toxicol Pharmacol. 2003 Feb;37(1):11-9. doi: 10.1016/s0273-2300(02)00022-3.
An enzyme preparation containing glucanase produced by the fungus Trichoderma harzianum is intended to be used to improve the clarification and filtration of wines. The safety of a glucanase preparation was assessed in a series of toxicological tests to document its safety in use. Oral administration to rats of up to 10 mL/kg bw/day (equivalent to a total organic solids dosage of 1258 mg/kg bw/day or a glucanase dosage of 1882 BGXU/kg bw/day) for 13 weeks did not cause any adverse effect. The test substance was not found to be mutagenic in the bacterial reverse mutation assay, nor did it cause chromosomal aberrations in cultured human lymphocytes. The safety margin for exposure is estimated to be in the range of 2100-72,000 depending on the estimate for daily wine consumption. The results of these studies demonstrate that an enzyme preparation containing glucanase may be considered safe when employed in wine processing.
一种含有由哈茨木霉产生的葡聚糖酶的酶制剂，旨在用于改善葡萄酒的澄清和过滤。在一系列毒理学试验中评估了葡聚糖酶制剂的安全性，以证明其使用安全性。对大鼠口服给药，剂量高达10 mL/kg体重/天（相当于总有机固体剂量1258 mg/kg体重/天或葡聚糖酶剂量1882 BGXU/kg体重/天），持续13周，未引起任何不良反应。在细菌回复突变试验中未发现受试物质具有致突变性，也未在培养的人淋巴细胞中引起染色体畸变。根据每日葡萄酒消费量的估计，接触的安全系数估计在2100至72000之间。这些研究结果表明，含有葡聚糖酶的酶制剂在葡萄酒加工中使用时可被认为是安全的。
