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.

Behavioral and Neurochemical Effects of Extra Virgin Olive Oil Total Phenolic Content and Sideritis Extract in Female Mice

“…Regarding Sideritis, although previously found to be cytotoxic in cancer cell lines [74], our experiments did not reveal toxic effects (distress or death) in animals who received either the low or the high dose of the extract. This comes in line with two previous toxicological studies that proved the safety of S. scardica and S. Taurica [75,76].…”

Plant Growth Regulators and Activated Charcoal Selectively Affect Phenylethanoid and Flavone Glycoside Accumulation in Sideritis scardica Griseb. Tissue Culture

“…Pharmacological studies on different preparations of the species have shown its potential in treating Alzheimer's disease [9], as well as being an anticancer agent [11]. Moreover, studies have shown a lack of toxicity and a favorable mutagenic profile, confirming the safety of the plant, as evidenced in its wide traditional application [12].…”

Aromatic plants rich in phenolic compounds as a valuable basis for dietary supplements in intestinal motility disorders

“…However, the data found for an ethanolic ower extract of Chamomile recutita (synonym of Matricaria chamomile) demonstrated a high safety margin, as the animals tolerated up to 10,000 mg kg body weight of the extract orally in the acute toxicity study and tolerated repeated doses of up to 500 mg kg for 28 days [18]. Regarding Sideritis angustifolia (cat's tail), no animal toxicity studies were found; however, the Sideritis scardica ethanol extract was not toxic after administration of a single dose of 2000 mg/kg bw and repeated doses of 1000 mg/kg bw for 28 days [19]. From the data obtained in our experiments and those reviewed in the literature, we can conclude that these species have a high safety pro le and the dose we used for the intestinal motility assay (300 mg/kg bw) is well below LD50.…”