Toxicological Safety of Nisin

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Acute and Chronic Toxicity: Acute toxicity studies show that Nisin has an LD₅₀ > 5000 mg/kg in rodents (oral administration), indicating extremely low acute toxicity. Long-term chronic toxicity studies (12–24 months) in rats and dogs at doses up to 1000 mg/kg/day show no adverse effects on growth, reproduction, or organ function, with no evidence of carcinogenicity, mutagenicity, or teratogenicity. Allergenicity: Nisin is a small peptide (molecular weight ~3.5 kDa) that is rapidly degraded into amino acids in the gastrointestinal tract by proteases (e.g., pepsin, trypsin), posing minimal allergenic risk. No clinical cases of Nisin-induced allergies have been reported globally, and it is not structurally homologous to common food allergens.

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