Acute and a 28-repeated dose toxicity study of commercial oleoresin from Copaifera sp. in rodents

Copaifera spp. (copaiba) oleoresin is traditionally used as a medicinal compound since the 16th century, which is primarily indicated for its anti-inflammatory properties being widely sold in free fairs and medicinal herbal houses in Brazil. However, copaiba oleoresin toxicity information is still limited. In this study, we aimed to investigate the acute (in mice and rats) and 28 day—repeated doses (in rats) oral toxicity of commercial copaiba oleoresin. In the acute toxicity test, copaiba oleoresin oral administration at 2000 mg/kg dose did not induce mice or rat lethality. In the subacute toxicity tests, we administered copaiba oleoresin at daily doses of 25, 50, or 100 mg/kg for 28 days. We observed no toxicological effects in body weight gain, feed and water intake, gross necropsy, relative organ weight, histopathology, hematology, or biochemistry parameters. At the three copaiba oleoresin tested doses, we observed an alkaline phosphatase reduction, which might indicate hepatic protection. In conclusion, the commercial copaiba oleoresin has a low risk of toxicity and did not induce treatment-related adverse effects after short-term daily exposures to a dose two thousand times higher than folk use, showing safety doses for further pharmacological investigations.