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  1. Safety assessment of cultivated fruiting body of Ophiocordyceps sinensis evaluated through subacute toxicity in rats
    Fung SY, Lee SS, Tan NH, Pailoor J
    J Ethnopharmacol, 2017 Jul 12;206:236-244.
    PMID: 28587826 DOI: 10.1016/j.jep.2017.05.037
    ETHNOPHARMACOLOGICAL RELEVANCE: Ophiocordyceps sinensis (Berk.) G.H. Sung, J.M. Sung, Hywel-Jones & Spatafora is one of the most renowned traditional Chinese medicine used as tonic, renal, respiratory and reproductive health, promote longevity and overall improvement in quality of life. Natural production of O. sinensis is limited due to its extreme specificity in host range and confined geographic distribution. Therefore, cultivation of the fungus was developed to meet high demand for commercialization as nutraceutical. O. sinensis fruiting body has recently been successfully cultivated in large scale using rice based solid medium, providing wider source options for consumers and scientific researchers.

    AIMS OF THE STUDY: The present study aims to establish safety profile for the consumption of cultivated fruiting body of O. sinensis (FBOS) by 28-days sub-acute toxicity study in Sprague Dawley rats.

    MATERIALS AND METHODS: Rats were orally administered with cultivated FBOS at three graded doses (250, 500 and 1000mg/kg), once daily for 28 consecutive days. Control group received distilled water. General observations (gross behavioral changes and toxic symptoms) and body weight of each animal were monitored daily. Haematological, serum biochemical and histopathological analysis were carried out at the end of the experiment (Day 29).

    RESULTS: No behavioral changes, toxic symptoms or death was observed in rats throughout the dosing period. Cultivated FBOS treatment up to 1000mg/kg did not cause any adverse effect on the growth of the animals. Results from haematology and serum biochemistry revealed no toxic effect following cultivated FBOS treatment at three graded doses for 28 days. In addition, no treatment related histopathological changes were noted in heart, spleen, kidney, lung and liver of the animals.

    CONCLUSION: The present study revealed that oral administration of cultivated FBOS for 28 days, at dosage up to 1000mg/kg did not pose toxicological concern in rats. Therefore, the no-observed-adverse-effect level (NOAEL) dose of cultivated FBOS in 28-days subacute toxicity study is higher than 1000mg/kg.

    Matched MeSH terms: Toxicity Tests, Subacute*
  2. Acute and repeated dose 28-day oral toxicity of poly(3-hydroxybutyrate-co-4-hydroxybutyrate) nanoparticles in Sprague-Dawley rats
    Leong YH, Isa ASM, Mohamed Mahmood M, Moey CEJ, Utar Z, Soon YI, et al.
    Regul Toxicol Pharmacol, 2018 Jun;95:280-288.
    PMID: 29567329 DOI: 10.1016/j.yrtph.2018.03.011
    This study aimed to investigate the oral acute and subacute toxicity of Poly [3-hydroxybutyrate-co-4-hydroxybutyrate], P(3HB-co-4HB) in the form of nanoparticles in Sprague-Dawley rats. Acute oral administration of P(3HB-co-4HB) nanoparticles was performed as a single dose up to 2000 mg/kg in six female rats for 14 days. Subacute toxicity study via oral administration for 28 days at doses of 0 (control), 500, 1000 and 2000 mg/kg in rats (10 rats in each group, female:male = 1:1) was conducted. The estimated lethal dose (LD50) of P(3HB-co-4HB) nanoparticles was >2000 mg/kg. No mortality, unusual changes in behaviour, adverse clinical signs, abnormal changes in body weights or food consumption were observed on all animals treated with P(3HB-co-4HB) nanoparticles during 14 days of the acute toxicity study. In the subacute test, there was no mortality and toxicologically significant changes in clinical signs, body weights, food consumption, hematology, clinical biochemistry, urinalysis, macroscopic findings, organ weights as well as histopathological examination were observed.
    Matched MeSH terms: Toxicity Tests, Subacute
  3. Evaluation of the sub-acute toxicity of Acacia catechu Willd seed extract in a Wistar albino rat model
    Thangavelu L, Balusamy SR, Shanmugam R, Sivanesan S, Devaraj E, Rajagopalan V, et al.
    Regul Toxicol Pharmacol, 2020 Jun;113:104640.
    PMID: 32169672 DOI: 10.1016/j.yrtph.2020.104640
    Acacia catechu (A. catechu) or Khair (Hindi) is used in several herbal preparations in the Ayurvedic system of medicine in India. Traditionally, this drug is beneficial against several gastrointestinal and stomach related ailments, and leprosy. The present investigation was carried out to evaluate the sub-acute oral toxicity of the ethanolic extract of A. catechu seeds in Wistar albino rats. Results obtained from the quantitative chemical analysis of A. catechu seed extract were compared with commercially available standards. A. catechu seed extract was administered orally at the doses of 250, 500 and 1000 mg/kg b.w. daily for 28 days. General behavior, bodyweight and mortality were examined during the entire study period. At the end of 28 days, hematological and biochemical parameters along with the relative organ weights were determined. It was observed that the extract did not induce death or any significant changes in the body weight, relative weight of vital organs and in hematological parameters for up to a dose of 1000 mg/kg. The oral administration of the plant extract did not produce any significant changes in the levels of glucose. In addition, there were no significant changes in the activity of both hepatotoxic and nephrotoxic marker enzymes in the serum. Oral administration of A. catechu also did not produce any significant changes in the levels of oxidative markers. Furthermore, the findings from the biochemical studies were, well corroborated with the histological findings.
    Matched MeSH terms: Toxicity Tests, Subacute
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