Safety Evaluation of Sclerotium from a Medicinal Mushroom, Lignosus cameronensis (Cultivar): Preclinical Toxicology Studies

The purpose of this paper is to provide historical data pertaining to clinical chemistry and haematology parameters, obtained from control Sprague-Dawley rats, used in pre-clinical toxicity studies. Mean, standard deviation, minimum and maximum values for haematological and coagulative profiles, haemato-biochemistry and urine analysis data, and the differences per sex and study duration, 4 versus 13 weeks, are presented. The studies were conducted in agreement with the GLP (Good Laboratory Practice) regulations. Statistically significant differences, at the confidence level of 99%, for the red blood cell (RBC) parameters, the white blood cell (WBC) series parameters, plasmatic albumin/globulin (A/G), alanine amino-transferase (ALT), alkaline phosphatase (ALP), creatinine, globulin, glucose, sodium, total protein, tryglycerides, urea and urine volume were observed in males, when 4-week study values were compared with those obtained from 13-week studies. Female rats showed statistically significant variations, at the confidence level of 99% for RBC number and mean corpuscular haemoglobin (MCH), mean red blood cell volume (MCV), WBCs count and lymphocytes percentage, A/G, albumin, ALT, AST, ALP, creatinine, globulin, and sodium, when 4-week study values were compared to 13-week studies. Similar differences were observed comparing the female with male haematological and biochemical data for the two different times of the sample collection. These data could be useful as a reference for evaluation of background pathology in Sprague-Dawley rats, when used in studies performed to evaluate the toxicological profile of a new chemical entity (NCE) in agreement with requirements from international regulatory agencies.

Lignosus rhinocerus (tiger milk mushroom) is an important medicinal mushroom used in Southeast Asia and China, and its sclerotium can be developed into functional food/nutraceuticals. The nutrient composition, antioxidant properties, and anti-proliferative activity of wild type and a cultivated strain of L. rhinocerus sclerotia were investigated. The sclerotial powder has high carbohydrate but low fat content. Interestingly, the cultivated strain contains higher amounts of protein and water-soluble substances than the wild type. Phenolic content of hot-water, cold-water, and methanol extracts of the sclerotial powders ranged from 19.32 to 29.42 mg gallic acid equivalents g⁻¹ extract, while the ferric reducing antioxidant power values ranged from 0.006 to 0.016 mmol min⁻¹ g⁻¹ extract. The DPPH• , ABTS•⁺ , and superoxide anion radical scavenging activities of the extracts ranged from 0.52 to 1.12, 0.05 to 0.20, and -0.98 to 11.23 mmol Trolox equivalents g⁻¹ extract, respectively. Both strains exhibited strong superoxide anion radical scavenging activity comparable to rutin. The cold-water extracts exhibited anti-proliferative activity against human breast carcinoma (MCF-7) cells, with IC₅₀ values of 206 µg mL⁻¹ and 90 µg mL⁻¹ for the wild type and cultivated strains, respectively. The cultivated L. rhinocerus sclerotium has the potential to be developed into functional food/nutraceuticals. © 2013 Society of Chemical Industry.