Effects of the subchronic exposure to an organomodified clay mineral for food packaging applications on Wistar rats

Organomodified clay minerals have many applications, but their successful technological development should be linked to their safety. There are in vitro toxicological studies that have shown adverse effects induced by organomodified clay minerals in human cell lines. However, in vivo toxicity reports are scarce, particularly those using the oral pathway. The aim of this work was to evaluate the toxicity of an organomodified clay mineral, Clay1, developed from montmorillonite (Mt) and using hexadecyltrimethylammonium bromide as modifier. A repeated dose 90-day oral toxicity study was performed in Wistar rats exposed to 40 mg/kg/day Clay1. The morphological study of the main organ tissues by optic and electronic microscopy did not reveal any adverse effect. Also, blood clinical biochemistry parameters, the reduced/oxidized glutathione (GSH/GSSG) ratio, and interleukin-6 leakage in serum did not show any significant alterations. These results suggest that Clay1 does not cause remarkable toxic effects at the conditions tested.