Article ID Journal Published Year Pages File Type
5855925 Regulatory Toxicology and Pharmacology 2016 6 Pages PDF
Abstract

•A 7-day dose range-finding study of dietary sodium metabisulphite (SM) was conducted in male Sprague-Dawley rats.•Rat feed with SM at concentrations of 0.25%, 0.5%, 1% or 4% (w/w) was prepared daily.•Resulting group mean sulphite consumptions were 90, 198, 390 and 1478 mg SO2-equivalent/kg bodyweight/day respectively.•Group mean feed consumption was marginally depressed in rats in the 4% group but bodyweight gain was markedly decreased.•There was no histopathological evidence of treatment-related lesions of the gastric mucosa in any rats.•These results challenge the reproducibility of stomach lesions following sulphites ingestion.

Sulphiting agents, such as sodium metabisulphite (SM), are used in food as bleaching agents and to prevent browning reactions. A 1972 repeat dose study in rats found that dietary sulphites caused irritation of the stomach with inflammation, hyperplasia and bleeding. We conducted a 7-day dietary study in rats to confirm that stomach lesions were the most sensitive toxicological endpoint. Rat feed was prepared daily with 0%, 0.25%, 0.5%, 1% or 4% (w/w) SM. Parameters included clinical signs, feed and water intake, bodyweight gain, haematology, serum protein chemistry, necropsy findings and gastrointestinal histopathology. There were no treatment-related clinical signs or gastrointestinal lesions. Mean bodyweight gain was markedly decreased in the 4% (w/w) SM group although feed consumption was marginally depressed. Slightly lower mean values for RBC, Hb, Hct, total WBC and lymphocyte count were observed in the 4% SM group with no evidence of compensatory haematopoiesis. The gastric lesions in rats observed in a 1972 study of dietary SM for 10-56 days could not be replicated. These findings create uncertainty around the most relevant toxicological endpoint to establish a suitable health based guidance value, which can only be overcome if a robust long-term dietary study is undertaken.

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