Acute and long term safety evaluation of zincovit syrup (Nutritional food supplement) in wistar rats

The aim of the present study was to investigate the acute and sub-chronic toxicity associated with Zincovit syrup (Nutritional food supplement) in Wistar rats. Acute toxicity class method (OECD 423 guideline) was employed to determine acute toxicity in Wistar rats. Animals were observed individually after dosing daily for a total of 14 days. Sub chronic toxicity was investigated in normal control (2% gum acacia, 1 ml/kg/day) and Zincovit syrup at 15, 60 and 240 mg/kg/day individually for 3 months in adult female Wistar rats (4 groups, n= 6). Clinical signs, hematological and biochemical parameters were assessed. During the acute toxicity study, according to annex 2a of OECD 423 guidelines, Zincovit syrup falls under Category 4 (>300-2000) of globally harmonized classification system (GHS). For Zincovit syrup, LD₅₀ cut-off among Wistar rats was observed at 1000 mg/kg. There was no significant change in their body weight. During the 90 days of sub-chronic toxicity study, treatment with Zincovit syrup among Wistar rats, the lowest-observed-adverse-effect level (LOAEL) and no-observed-adverse-effect level (NOAEL) was observed at 60 mg/kg/day and 15 mg/kg/day respectively. The present study demonstrated the long term safety of Zincovit syrup at its low dose (15 mg/kg/day) in Wistar rats.