Toxicological evaluation of an Allium-based commercial product in a 90-day feeding study in Sprague–Dawley rats

• The safety of Proallium AP®, an Allium sp. extract, has been proved in a 90-day oral toxicity study in male and female rats.
• The doses of Proallium assayed (25, 100, 400 mg/kg/d) did not induce adverse clinical signs or changes in general conditions.
• Any haematological, biochemical or histopathological changes were detected in rats.
• The NOAEL found for Proallium AP® was 400 mg/kg/day in the conditions assayed.

Proallium AP® is a commercial Allium extract intended to be used in active food packaging as the antibacterial and antioxidant effects of some organosulfur compounds are well known. However, there is little information on its toxicity and the Scientific Committee on Food (UE) requires the safety assessment of substances used in food contact materials. Thus, the aim of this study was to conduct for the first time a subchronic oral toxicity study of Proallium AP® with groups of 10 males and 10 females Sprague–Dawley rats fed a diet containing 0, 25, 100, 400 mg/kg/d for 90 days. No treatment-related clinical signs or mortality were noted. Besides, no treatment-related effects with regard to any of the toxicological biomarkers considered were observed, including biochemical, haematological and histopathology parameters. In conclusion, the non-observed-adverse-effect-level (NOAEL) for Proallium AP® in rats was determined to be a dietary dose of 400 mg/kg/d under the present experimental conditions, a value 500-fold higher than the exposure derived from its potential use in active packaging.