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Erythrina fusca Lour. is a medicinal plant traditionally used in herbal medicine; however, there are no records of toxicity associated with the ethanol extract of E. fusca fruit (EtEF). The objective of this study was to assess the safety of EtEF through toxicity testing. Four groups of Swiss albino mice were employed, including a control group and three groups administered EtEF at doses of 1000, 3000, and 5000 mg/kg (single dose) and 100, 300, and 500 mg/kg (administered repeatedly for 90 days). Various parameters, including body weight, food and water consumption, hematological and biochemical parameters, relative organ weight, urine composition, and histopathology, were evaluated. No significant differences were observed in the tested groups compared to the control group, and there was no evidence of morphological or histopathological damage in the organs of mice treated with EtEF. This study affirms the safety of EtEF and establishes a foundation for further investigations into its utilization in traditional medicine.

BackgroundUlcer remains a health challenge worldwide with antibiotics and proton pump inhibitors as major management therapy. The study investigated the acute, sub-chronic toxicity and gastrointestinal protective activity of a polyherbal formulation (Mystomate4®) used locally in Nigeria.MethodsOral LD50 and the sub-chronic toxicity test were determined in mice and rats. Mice were grouped into 8 groups of 8 mice each. They were dosed a graded concentration of the formulation (1.28, 2.56; 5.12; 10.24; 20.48; 40.96; 81.92; 163.84 g/kg body weight). The graded dose used was arrived at after an initial pilot study. Thereafter doses were chosen around the dose obtained from the pilot study. Animal were dosed orally and observed for sign of toxicity and number of death recorded after 24 h. The sub-chronic toxicity study was carried out for 3 months in rats at a dose of 2.5 and 5.0 g/kg body weight arrived at by titrating down the LD50 value after which some vital tissues were harvested and assessed for toxicity using relevant biomarkers. Anti-ulcer activity was evaluated in rats using ethanol, indomethacin and pylorus ligation induced ulcer models. Data were analysed with Graph Pad Prism version 5.0 using appropriate statistical method and significant level placed at p ≤ 0.05.ResultsThe acute toxicity study showed an LD50 result of 22,837.21 g/kg. The sub-chronic toxicity study resulted in a significant reduction in body weight due to significant decrease (p ≤ 0.05) in feed consumption. Biochemical analyses of the blood samples showed a significant increase (p ≤ 0.05) in creatinine and albumin level in the 2.5 mg/kg female group. ALT was significantly increased in all the treated rats except in 2 mg/kg female rats. Alkaline phosphatase significantly increased in high dosed male (HM) group while blood urea:creatinine ratio was significantly lowered in all the treated groups. There was a significant increase in serum TGL in all rats while LDL was significantly increased and decreased in HM and high dosed female (HF) respectively.ConclusionMystomate4® showed significant protection against ethanol and indomethacin-induced ulcer models but did not modify the gastric parameters in pylorus ligation-induced ulcer model. The polyherbal formulation is nontoxic with promising potentials for treating experimental peptic ulcer.

The phlorotannin-polycaprolactone-coated endotracheal tube (PP tube) has been developed with the aim of preventing tracheal stenosis that can result from endotracheal intubation, a factor that can lead to a serious airway obstruction. Its preventive efficacy has been assessed through both in vitro and in vivo investigations. However, there is a lack of studies concerning its biocompatibility and sub-chronic toxicity in animal models, a crucial factor to ensure the safety of its usage as a functional endotracheal tube. Thus, this study aimed to evaluate the biocompatibility and sub-chronic (13 weeks) toxicity of the PP tube through L929 cell line and diverse in vivo models. The cytotoxicity testing was performed using the extracts of PP tube on L929 cells for 72 h. Furthermore, other tests conducted on animal models, including ICR mice (acute systemic toxicity), New Zealand white rabbit (intradermal reactivity and pyrogen tests), guinea pig (maximization sensitization), and Sprague Dawley rats (sub-chronic toxicity). In both biocompatibility and sub-chronic toxicity analyses, no significant adverse effects are observed in the groups exposed to the PP tube, when compared to control group. Altogether, the findings suggested that the PP tube exhibits relative non-toxic and safety, supporting its suitability for clinical usage. However, extended periods of intubation may produce mild irritant responses, highlighting the clinical caution of limiting intubation duration to less than 13 weeks.

The pharmacological effects of have been extensively documented. A solid self-microemulsifying drug delivery system (SMEDDS) has been developed to address limitations such as poor water solubility and low bioavailability. This study evaluated the safety and anti-aging efficacy of the solid SMEDDS containing extract (KPS-SMEDDS) in rats. A sub-chronic toxicity study was performed to assess the safety of KPS-SMEDDS. Healthy rats (  = 10/group) received oral doses of 125, 250, or 500 mg/kg body weight daily for 90 days. Clinical signs, body weight, hematological and biochemical parameters, and major organ histopathology were evaluated. Separately, the anti-aging effects of KPS-SMEDDS were investigated in a different cohort of rats (  = 9/group) with D-galactose-induced aging. Rats received intraperitoneal D-galactose (50 mg/kg/day) and oral KPS-SMEDDS at the same doses for 60 days. Oxidative stress markers, hormone levels, histopathology, and the expression of proteins related to aging, apoptosis, and inflammation were assessed. No significant changes were observed in clinical signs, body weight, organ weights, hematological or biochemical parameters, or histopathology in KPS-SMEDDS-treated rats, indicating its safety. KPS-SMEDDS treatment significantly improved testicular weight, reduced malondialdehyde levels, normalized hormone levels, and restored testicular structure in rats with D-galactose-induced aging. Additionally, it upregulated SIRT-1 and Bcl-2, downregulated SA-β-gal, p53, and caspase-3, and modulated inflammatory cytokines (TNF-α, IL-6, and IL-10). KPS-SMEDDS was well-tolerated in rats and exerted protective effects against D-galactose-induced aging. These findings support its potential as a safe, natural anti-aging agent and highlight the value of formulation enhancement in traditional herbal medicine.

Background Quercetin is an organic flavonoid present in several fruits and vegetables. The anti-inflammatory, antiviral, antioxidant, cardio-protective, anti-carcinogenic and neuroprotective properties demonstrated by this dietary supplement endorses it as a possible treatment for inflammatory diseases and cancer. Unfortunately, conflicting research has cast uncertainties on the toxicity of quercetin. The main purpose of this study was to determine if quercetin has any toxic properties in mice at doses that have shown efficacy in pre-clinical studies regarding cancer, cancer therapy, and their off-target effects. Methods A sub-chronic toxicity study of quercetin was examined in male and female CD2F1 mice. Three different doses of quercetin (62, 125, and 250 mg/kg of diet) were infused into the AIN-76A purified diet and administered to mice ad libitum for 98 days. Body weight (BW), food consumption, water intake, body composition, blood count, behavior, and metabolic phenotype were assessed at various timepoints during the course of the experiment. Tissue and organs were evaluated for gross pathological changes and plasma was used to measure alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT). Results We found that low (62 mg/kg of diet), medium (125 mg/kg of diet), and high (250 mg/kg of diet) quercetin feeding had no discernible effect on body composition, organ function, behavior or metabolism. Conclusions In summary, our study establishes that quercetin is safe for use in both female and male CD2F1 mice when given at ~ 12.5, 25, or 50 mg/kg of BW daily doses for 14 weeks (i.e. 98 days). Further studies will need to be conducted to determine any potential toxicity of quercetin following chronic ingestion.

Elsholtzia ciliata essential oil (E. ciliata) has been reported to have an impact on the cardiovascular system. However, its toxicity remains unknown. Therefore, the objective of this investigation was to evaluate the toxicological aspects of the E. ciliata extract. Male Balb/c mice were subjected to either acute (a single dose administered for 24 h) or sub-chronic (daily dose for 60 days) intraperitoneal injections of the E. ciliata extract. The mice were assessed for blood hematological/biochemical profiles, mitochondrial functions, and histopathological changes. Additionally, in vitro cytotoxicity assessments of the E. ciliata extract were performed on immobilized primate kidney cells (MARC-145, Vero) and rat liver cells (WBF344) to evaluate cell viability. The control groups received an equivalent volume of olive oil or saline. Our results demonstrated no significant detrimental effects on hematological and biochemical parameters, mitochondrial functions, cellular cytotoxicity, or pathological alterations in vital organs following the intraperitoneal administration of the E. ciliata extract over the 60-day sub-chronic toxicity study. In general, E. ciliata displayed no indications of toxicity, suggesting that the E. ciliata extract is a safe natural product with a well-defined therapeutic and protective index (found to be 90 and 54, respectively) in Balb/c mice.

Monosodium glutamate (MSG) is the sodium salt of glutamic acid (GLA), used as a flavour enhancer. MSG is considered a controversial substance. It is incriminated in disturbing the antioxidant system, but also has beneficial effects, as GLA metabolism plays a crucial role in homeostasis. This study highlights which positive or negative aspects of MSG sub-chronic consumption are better reflected in subjects potentially affected by advanced age. Daily doses of MSG were administered to four groups of two-year-old Wistar rats for 90 days: (I) 185 mg/kg bw, (II) 1500 mg/kg bw, (III) 3000 mg/kg bw and (IV) 6000 mg/kg bw, compared to a MSG non-consumer group. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, direct and total bilirubin, total cholesterol, triglycerides, creatinine and urea levels were analysed; stomach, liver and kidney samples were subjected to histopathological analysis. Although, in most cases, there were no statistical differences, interesting aspects of the dose–effect relationship were observed. After MSG sub-chronic consumption, the positive aspects of GLA seem to be reflected better than the negative ones. The hormesis effect, with low-level reactive oxygen species’ protective effects and GLA metabolism, may represent the hypothesis of a potential defence mechanism triggered by MSG sub-chronic consumption in ageing rats.

Bletilla formosana (Hayata) Schltr. is an important economic medicinal and edible plant in China. Its tubers (BFTs) are traditionally consumed as a beverage and canned foods for promoting human health. In this paper, the nutrients, the contents of total phenol, flavonoids, and polysaccharides, and the safety and toxicity of BFT are determined. The chemical analysis reported that BFT is rich in proteins, polysaccharides, polyphenols, flavonoids, and trace elements. The acute (14 days), subacute (28 days), and sub‐chronic (90 days) toxicities of BFT were evaluated for the first time in female and male rats. An acute toxicity study showed that the female rats by single oral administrations of BFT with 10,000 mg/kg body weight (BW) did not have behavioral changes and mortality, indicating that 50% lethal dose (LD50) of BFT was over 10,000 mg/kg BW. Similarly, BFT at 5000 mg/kg BW for consecutive 28 and 90 days in rats was also not toxic for rats after the analysis of physiological and biochemical parameters. Additionally, there are no significant differences on the histopathological changes of the heart, liver, spleen, lung, kidney, ovary, or testis between the control and BFT groups. Our findings revealed that BFT with concentration of less than 5000 mg/kg BW are safe for the female or male rats, indicating that BFT could be regarded as a safe food source. The nutrients analysis of Bletilla formasana tuber and its investigations on the acute, subacute, and sub‐chronic toxicity in rats.

Rauwolfia vomitoria has recently been reported as a promising phytomedicine for benign prostatic hyperplasia (BPH). It has a wide range of therapeutic advantages intermingled with diverse controversies of toxicities, necessitating the need to proceed on a long‐term investigation to determine the safety of R. vomitoria . The study is aimed at determining the subchronic toxicity of R. vomitoria. Rats were randomised into four (4) groups, which included the normal control group (C), R. vomitoria root bark aqueous extract (RVRAE), low dose (LD, 10 mg/kg bwt.), medium dose (MD, 25 mg/kg bwt.) and high dose (HD, 50 mg/kg bwt.). The experimental set‐up included daily administration of plant extracts for a period of 90 days. Relative organ weights, haematological and renal function revealed no significant differences across the treatment groups. However, for liver function, whilst most liver analytes remained unchanged, a significant increase in alkaline phosphatase (ALP) was observed across treatment groups. C and LD values were C = 144.2 ± 29.3 and LD = 246.4 ± 66.9 (IU) ( p = 0.008). Total bile acids (TBAs) reduced in a dose‐dependent manner; C = 27.9 ± 7.6, LD = 19.0 ± 5.5, MD = 18.6 ± 4.3, HD = 116.8 ± 16.8 μ mol/L. The most prominent significant value among others occurred between the C and HD groups ( p = 0.004). Absolute and relative organ weights of lungs decreased in a dose‐dependent manner. However, only the absolute organ weight was significant ( p < 0.05) with values of C = 2.13 ± 0.12, LD = 1.81 ± 0.05, MD = 1.77 ± 0.15, HD = 0.62 ± 0.17 g. PSA levels in the study did not show significant differences ( p > 0.05). However, a decline was observed with the high dose group. No significant histopathological alterations were observed in the kidneys, confirming the absence of renal toxicity. However, some histoarchitecture alterations were observed in the liver and lungs, which require further investigation. The safety of the root bark extract remains doubtful, with the lungs and the liver adversely affected even at lower doses of 10 mg/kg bwt.

Averrhoa carambola is a species of tree native to tropical Southeast Asia. It possesses antioxidant and anti-hyperlipidemia effects and has traditionally been used to treat a variety of ailments. However, the presence of oxalic acid in its fruits might restrict its consumption by individuals suffering from kidney disease, and caramboxin can cause neurotoxicity. In this study, we evaluated the acute and sub-chronic toxicity of the methanolic extract of A. carambola leaves (MEAC) in male and female rats. In the acute study, female rats were given a single oral dose of 5000 mg/kg of MEAC and closely examined for distinct indications of toxic effects during the first 4 h, periodically for 48 h, and daily thereafter for 14 days. Rats of both sexes were employed in the sub-chronic investigation for the 28-day repeated dose oral toxicity study. Results of the acute study revealed the safety of MEAC up to a dose of 5000 mg/kg where the rats did not show changes or signs of toxicity. In the sub-chronic toxicity study, MEAC (250, 500, and 1000 mg/kg) administration did not affect the body weight, food, and water consumption, motor coordination, behavior, or mental alertness in the treated rats. In addition, no variations in hematological or biochemical markers were found in MEAC-treated rats. In conclusion, these findings pinpoint the safety of MEAC at doses up to 5000 mg/kg. The leaves of A. carambola could be safely consumed by people with kidney disease to treat other ailments.