Two-Year Carcinogenicity Study of a Novel Plasticizer, bis(2-Ethylhexyl) Cyclohexane-1,4-Dicarboxylate (Eco-DEHCH), by Oral Diet in Han Wistar Rats.

Plasticizers are necessary for the usability of various products, including food contact materials. Exposure to plasticizers is most commonly made through the oral route. Several plasticizers have been reported to have adverse effects on humans and the environment. Thus, the present study aimed to determine the long-term toxicity and carcinogenicity of a novel plasticizer called bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate (Eco-DEHCH), which is an ecofriendly and biologically less harmful replacer. Groups of 50 male and 50 female Han Wistar rats were fed Eco-DEHCH at daily doses of 1,600, 5,000, or 16,000 ppm in their diet for at least 104 weeks. The rats were regularly monitored for mortality, clinical signs, body weight, food consumption, food efficiency, and perceivable mass. All animals were subjected to complete necropsy and histopathological examination. The results indicate that the rats well tolerated chronic exposure to Eco-DEHCH at highest daily doses of 16,000 ppm, with was equivalent to 805.1 mg/kg/day in males and 1,060.6 mg/kg/day in females and did not show signs of toxicity or carcinogenicity. In conclusion, Eco-DEHCH could be a safe and promising alternative plasticizer.

Evaluation of the 52-week chronic toxicity of a novel phthalate-free plasticizer, Eco-DEHCH (bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate), in Han Wistar rats.

Phthalate esters (PEs) are the most widely used class of plasticizers. Several PEs, however, were found to have adverse effects on the health of animals. A new phthalate-free plasticizer, Eco-DEHCH (bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate), was recently developed as an ecofriendly replacement for phthalate plasticizers and to be less harmful to organisms. The present study evaluated the long-term toxicity of Eco-DEHCH in Wistar Han rats to explore adverse effects and predict hazardous potential to humans. Forty male and forty female Wistar Han rats were exposed to Eco-DEHCH in dietary feed for 52 weeks, and their hematologic, coagulation, and serum biochemical parameters were monitored. The rats were subjected to close clinical, ophthalmic, and histopathologic examinations and urinalysis throughout the consumption of Eco-DEHCH. The effects of this plasticizer on food consumption and organ weight were also determined. Chronic exposure to Eco-DEHCH was generally safe, although it also resulted in α2u-globulin accumulation, a parameter with no human relevance. In conclusion, Eco-DEHCH can serve as a safe and promising alternative plasticizer.