Assessment of the Acute and Subchronic Toxicity and Mutagenicity of Sideritis scardica Griseb. Extracts.

ABSTRACT

Sideritis scardica Griseb. has a long history of collection from the wild as a traditional remedy for respiratory and gastrointestinal complaints. It has also been investigated for its promising pharmacological activities in the central nervous system. However, its toxicological data is entirely missing. This study investigated the acute and repeated-dose oral toxicity of a S. scardica 20% (v/v) ethanol extract in Sprague Dawley rats, and mutagenicity using the Ames test. No gross pathological abnormalities and no toxicity signs or mortality were detected in animals treated with the dose of 2000 mg/kg bw during 14 days of observation. The tested extract was assigned to category 5 of the GHS. To evaluate a repeated-dose toxicity, an extract has been tested over a 28-day period followed by a 14-day recovery period. No mortality and no changes in body/organ weight or food consumption have been observed. The no-observed-adverse-effect-level of the extract was determined at 1000 mg/kg bw. The results of Ames tests conducted on extracts of different polarity (water; 20% (v/v) ethanol; 50% (v/v) ethanol; n-heptane), were unequivocally negative. The study reveals no toxicity of S. scardica and no concerns for its mutagenic effects, supports its positive safety profile, and confirms the acknowledged traditional medicinal use in human.