Displaying publications 1 - 20 of 24 in total

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  1. Arris FA, Thai VTS, Manan WN, Sajab MS
    Foods, 2020 Nov 29;9(12).
    PMID: 33260330 DOI: 10.3390/foods9121769
    Process-based contaminants in food-particularly in vegetable oils-have been a topic of interest due to their potential health risk on humans. Oral consumption above the tolerable daily intake might result in health risks. Therefore, it is critical to correctly address the food contaminant issues with a proper mitigation plan, in order to reduce and subsequently remove the occurrence of the contaminant. 3-monochloropropane-1,3-diol (3-MCPD), an organic chemical compound, is one of the heat- and process-induced food contaminants, belonging to a group called chloropropanols. This review paper discusses the occurrence of the 3-MCPD food contaminant in different types of vegetable oils, possible 3-MCPD formation routes, and also methods of reduction or removal of 3-MCPD in its free and bound esterified forms in vegetable oils, mostly in palm oil due to its highest 3-MCPD content.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  2. Rovina K, Siddiquee S, Shaarani SM
    Front Microbiol, 2016;7:798.
    PMID: 27303385 DOI: 10.3389/fmicb.2016.00798
    Allura Red AC (E129) is an azo dye that widely used in drinks, juices, bakery, meat, and sweets products. High consumption of Allura Red has claimed an adverse effects of human health including allergies, food intolerance, cancer, multiple sclerosis, attention deficit hyperactivity disorder, brain damage, nausea, cardiac disease and asthma due to the reaction of aromatic azo compounds (R = R' = aromatic). Several countries have banned and strictly controlled the uses of Allura Red in food and beverage products. This review paper is critically summarized on the available analytical and advanced methods for determination of Allura Red and also concisely discussed on the acceptable daily intake, toxicology and extraction methods.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  3. Teh BP, Ahmad N, Ibnu Rasid EN, Zolkifli NA, Sastu Zakaria UR, Mohamed Yusoff N, et al.
    Pharmaceuticals (Basel), 2021 Feb 10;14(2).
    PMID: 33579048 DOI: 10.3390/ph14020142
    A combined polyherbal formulation containing tongkat ali (Eurycoma longifolia) and kacip fatimah (Labisia pumila) aqueous extracts was evaluated for its safety aspect. A repeated dose 28-day toxicity study using Wistar rats was conducted where the polyherbal formulation was administered at doses 125, 500 and 2000 mg/kg body weight to male and female treatment groups daily via oral gavage, with rats receiving only water as the control group. In-life parameters measured include monitoring of food and water consumption and clinical and functional observations. On day 29, blood was collected for haematological and biochemical analysis. The rats were necropsied and the organs were collected for histopathological examination. This study showed that the combined formulation did not induce any significant toxicity effect at any dose level in terms of morbidity, mortality, behaviour, functional observation, body weight, food and water consumption, whole blood haematology and serum biochemistry. However, there were some microscopic changes in the histopathological examinations of some organs given 2000 mg/kg body weight, which may suggest an early response to the polyherbal formulation. From this study, the no observed adverse effect level is estimated to be more than 500 mg/kg body weight but not exceeding 2000 mg/kg body weight. The observed effects at the highest dose indicate the need for further study of longer dosing duration.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  4. Malays J Nutr, 1995;1(1):-.
    MyJurnal
    Food consumption of 50 female students in Universiti Kebangsaan Malaysia was recorded for 7 days. Foods and drinks most frequently consumed were selected for analysis of iron, zinc, copper and lead content. The mean daily intakes of energy, protein, carbohydrate and fat among the students are 6.5±1.4 MJ (1550±335 kcal), 59.8±18.5g. 227. 1±54.6 g and 46.0±11.5 g respectively. This diet contributed 19.6±6.4 mg Fe, 7.0±2.0 mg Zn and 1.6±0.6 mg Cu per day which were lower than the Malaysian RDA for Fe and US RDA for Zn, while Cu is within the recommended range. The main sources of these minerals in the student’s diet were rice, rice products, meat and animal products. Lead concentration in the diet (134±77 ug/day) is below the acceptable daily intake (ADI) value suggested by Codex Alimentarius Commission (1984). This study indicated concern regarding the low intake of the essential trace elements on long term basis among the students.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  5. Kong BH, Tan NH, Fung SY, Pailoor J
    Front Pharmacol, 2016;7:246.
    PMID: 27555822 DOI: 10.3389/fphar.2016.00246
    Lignosus also known as "Tiger Milk Mushroom," is classified in the family Polyporaceae and mainly consumed for its medicinal properties in Southeast Asia and China. The sclerotium is known as the part with medicinal value and often used by the natives to treat a variety of ailments. Lignosus tigris Chon S. Tan, one of the species of the Malaysia Tiger Milk mushroom, has recently been successfully cultivated in laboratory. Earlier studies have demonstrated the L. tigris cultivar E sclerotia exhibited beneficial biomedicinal properties. This study evaluated the potential toxicity of L. tigris E sclerotia in a 28-day sub-acute oral administration in Sprague Dawley (SD) rats. L. tigris E sclerotial powder was administered orally at three different doses of 250, 500, and 1000 mg/kg to the SD rats once daily, consecutively for 28-days. Body weight of the rats was recorded and general behavior, adverse effects, and mortality were observed daily throughout the experimental period. At the end of the experiment, blood hematology and biochemistry, relative organ weights, and histopathological analysis were performed. Results showed that there were no mortality nor signs of toxicity throughout the 28-day sub-acute toxicity study. Oral administration of the L. tigris E sclerotial powder at daily dose up to 1000 mg/kg had no significant effects in body weight, relative organ weight, blood hematological and biochemistry, gross pathology, and histopathology of the organs. L. tigris E sclerotial powder did not cause any treatment-related adverse effect in the rats at different treatment dosages up to 1000 mg/kg. As the lethal dose for the rats is above 1000 mg/kg, the no-observed-adverse-effect level (NOAEL) dose is more than 1000 mg/kg.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  6. Abdul Rohim Tualeka, Juliana Jalaludin
    MyJurnal
    The production of ammonia has been increasing over the past few years. Unfortunately, the production does not follow the safety control of ammonia on workers. Indonesia still adopts chemical standard from other countries. Therefore, it requires an ammonia standard at the highest dose without effect or no observed adverse effect level (NOAEL) in the workplace. This research aims to determine standard at the highest dose of without effect through the expression of CD8 cells as well as analysis of histological alteration CD8 lymphocyte between exposed to ammonia group and control. Methods: The study was a laboratory experimental research with a post-test only control group design. The research used Rattus novergicus species as many as 24. NOAEL was determined by middle dose with a location between the smallest and the largest dose. The doses of ammonia were given through inhalation. The histological alteration of CD8 between ammonia in exposed and the control group were analyzed by using the Kruskal Wallis test. Results: NOAEL was found through CD8 located in group 3 with 0.0154 dose mg/kg body weight. There was a differential expression of CD8 lymphocyte cells in the white mice lung between exposed to ammonia group and control (p=0.042). Conclusion: The expression of CD8 lymphocyte cells in the white mice lung exposed to ammonia differs significantly with the number of the expression of CD8 lymphocyte cells in white mice lung at control group. NOAEL was 0.0154 mg/kg body weight of white mice.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  7. Lee SS, Tan NH, Pailoor J, Fung SY
    Front Pharmacol, 2017;8:594.
    PMID: 28919858 DOI: 10.3389/fphar.2017.00594
    Twenty-eight days subacute toxicity studies performed in rats using sclerotial powder of Lignosus cameronensis cultivar was conducted to assess its safety for consumption prior to other scientific investigations on its medicinal benefits, nutraceutical or pharmaceutical application of the mushroom. The study was conducted at 250, 500, and 1000 mg/kg sclerotial powder of L. cameronensis cultivar (n = 5 for each respective dose, on both male and female groups) while control groups received only distilled water. At the end of the study (29th day), the animals were sacrificed followed by blood and organs collection for analysis. Subacute toxicity studies done shows that sclerotial powder of L. cameronensis cultivar at 250, 500, and 1000 mg/kg did not induce treatment related changes on behavioral patterns, gross physical appearance, growth pattern, body weight gain, values of hematological and clinical biochemical panels as well as histopathological findings on kidney, spleen, heart, lung and liver of the experimental rats. The no-observed-adverse-effect level dose for sclerotial powder of L. cameronensis cultivar in 28-days sub-acute toxicity study is determined to be 1000 mg/kg.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  8. Chuah LO, Yeap SK, Ho WY, Beh BK, Alitheen NB
    PMID: 22924054 DOI: 10.1155/2012/197920
    Obesity is one of the pandemic chronic diseases commonly associated with health disorders such as heart attack, high blood pressure, diabetes or even cancer. Among the current natural products for obesity and weight control, Garcinia or more specifically hydroxycitric acid (HCA) extracted from Garcinia has been widely used. The evaluation of the potential toxicity of weight control supplement is of the utmost importance as it requires long term continuous consumption in order to maintain its effects. Majority of reports demonstrated the efficacy of Garcinia/HCA without any toxicity found. However, a few clinical toxicity reports on weight-loss diet supplements of which some were combinations that included Garcinia/HCA as an active ingredient showed potential toxicity towards spermatogenesis. Nonetheless, it cannot be concluded that Garcinia/HCA is unsafe. Those products which have been reported to possess adverse effects are either polyherbal or multi-component in nature. To date, there is no case study or report showing the direct adverse effect of HCA. The structure, mechanism of action, long history of the use of Garcinia/HCA and comprehensive scientific evidence had shown "no observed adverse effect level (NOAEL)" at levels up to 2800 mg/day, suggesting its safety for use.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  9. Moorthy M, Khoo JJ, Palanisamy UD
    Heliyon, 2019 Aug;5(8):e02333.
    PMID: 31508523 DOI: 10.1016/j.heliyon.2019.e02333
    Despite the lack of its toxicity evaluation, traditional herbal products are being widely used for various health indications. Geraniin, an ellagitannin, is a bioactive compound found in many traditional herbal medicines. In spite its numerous health benefits ranging from anti-inflammatory, anti-hyperglycaemic, hepatoprotective, anti-cancer and anti-microbial, no toxicity data on geraniin is available. The objective of this study is to evaluate the acute oral toxicity of geraniin and an enriched geraniin-extract of Nephelium lappaceum L rind. This study followed the guidelines of the OECD 423 acute oral toxicity test. Subsequent to a single oral administration of the test compounds, the rats were observed for 14 days for signs of toxicity and mortality. Following euthanasia, full blood count, biochemistry of blood and histopathology assessment of organs were carried out. All parameters analysed indicated insignificant difference compared to control. The LD50 cut-off values for both geraniin and geraniin-enriched extract was established to be 2000 mg/kg b. w., following a single oral dose. It was however observed that the hepatocytes of three geraniin-administered rats exhibited a 'foamy appearance'. As such, the no-observed-adverse-effect level of geraniin is below 2000 mg/kg, while that of geraniin-enriched extract is up to 2000 mg/kg. Further detailed toxicity studies are required to establish geraniin or its enriched extract from Nephelium lappaceum L rind safe for human consumption.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  10. Algariri K, Atangwho IJ, Meng KY, Asmawi MZ, Sadikun A, Murugaiyah V
    Trop Life Sci Res, 2014 Aug;25(1):75-93.
    PMID: 25210589 MyJurnal
    The acute and sub-chronic antihyperglycaemic activity, safety margin evaluations and chemical composition of ethanol extract (EE) and fractions of Gynura procumbens (GP) were studied. Streptozotocin (STZ)-induced diabetic rats (SDRs) and the Organisation for Economic Cooperation and Development (OECD) guidelines 425 and 407 were used in the antidiabetic and toxicity studies, respectively. Biochemical and haematological data obtained from both acute and sub-chronic procedures suggest that the extract is safe at the limit test dose (2000 mg/kg); thus, the oral lethal dose (LD50) exceeds 2000 mg/kg. The acceptable daily intake (ADI) was determined to be 700 mg/kg/day. In the acute antihyperglycaemic study, the n-butanol fraction (n-BF) was found to consistently lower glucose levels the most effectively, which was also demonstrated in the 14-day study. Not only did the n-BF show the highest dose-dependent glucose-lowering action (51.2% and 62.0% at 500 mg/kg and 1000 mg/kg, respectively), its effect was the closest to that of metformin (63.6%, p<0.05). The estimated amount of flavonoids in n-BF were 62.90% and 79.68% higher than the ethyl acetate fraction (EAF) and aqueous fraction (AF), respectively (p<0.05), with a corresponding value of 61.22% and 49.33% for phenolics (p<0.05). GP leaves have a no-observed-adverse-effect-level (NOAEL) and antihyperglycaemic activity corresponding to the high content of phenols and flavonoids. Therefore, GP leaves are a promising source of new antidiabetic natural products.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  11. Ahmad SY, Friel JK, MacKay DS
    PMID: 31697573 DOI: 10.1139/apnm-2019-0359
    BACKGROUND: This study aims to determine the effect of pure forms of sucralose and aspartame, in doses reflective of common consumption, on glucose metabolism.

    METHODS: Healthy participants consumed pure forms of a non-nutritive sweetener (NNS) mixed with water that were standardized to doses of 14% (0.425 g) of the acceptable daily intake (ADI) for aspartame and 20% (0.136 g) of the ADI for sucralose every day for two weeks. Blood samples were collected and analysed for glucose, insulin, active glucagon-like peptide-1 (GLP-1), and leptin.

    RESULTS: Seventeen participants (10 females and 7 males; age 24 ± 6.8 years; BMI 22.9 ± 2.5 kg/m2) participated in the study. The total area under the curve (AUC) values of glucose, insulin, active GLP-1 and leptin were similar for the aspartame and sucralose treatment groups compared to the baseline values in healthy participants. There was no change in insulin sensitivity after NNS treatment compared to the baseline values.

    CONCLUSIONS: These findings suggest that daily repeated consumption of pure sucralose or aspartame for 2 weeks had no effect on glucose metabolism among normoglycaemic adults. However, these results need to be tested in studies with longer durations. Novelty: • Daily consumption of pure aspartame or sucralose for 2 weeks had no effect on glucose metabolism. • Daily consumption of pure aspartame or sucralose for 2 weeks had no effect on insulin sensitivity among healthy adults.

    Matched MeSH terms: No-Observed-Adverse-Effect Level
  12. Farsi E, Esmailli K, Shafaei A, Moradi Khaniabadi P, Al Hindi B, Khadeer Ahamed MB, et al.
    Drug Chem Toxicol, 2016 Oct;39(4):461-73.
    PMID: 27033971 DOI: 10.3109/01480545.2016.1157810
    CONTEXT: Clinacanthus nutans (CN) is used traditionally for treating various illnesses. Robust safety data to support its use is lacking.

    OBJECTIVE: To evaluate the adverse effects of aqueous extract of CN leaves (AECNL).

    MATERIALS AND METHODS: The oral toxicity of the AECNL was tested following Organisation for Economic Co-operation and Development (OECD) guidelines. Mutagenicity (Ames test) of AECNL was evaluated using TA98 and TA100 Salmonella typhimurium strains.

    RESULTS: No mortality or morbidity was found in the animals upon single and repeated dose administration. However, significant body weight loss was observed at 2000 mg/kg during sub-chronic (90 d) exposure. In addition, increased eosinophil at 500 mg/kg and decreased serum alkaline phosphatase levels at 2000 mg/kg were observed in male rats. Variations in glucose and lipid profiles in treated groups were also observed compared to control. Ames test revealed no evidence of mutagenic or carcinogenic effects at 500 μg/well of AECNL.

    CONCLUSION: The median lethal dose (LD50) of the AECNL is >5000 mg/kg and the no-observed-adverse-effect level is identified to be greater than 2000 mg/kg/day in 90-d study.

    Matched MeSH terms: No-Observed-Adverse-Effect Level
  13. Jairoun AA, Shahwan M, Zyoud SH
    Sci Rep, 2020 11 02;10(1):18824.
    PMID: 33139833 DOI: 10.1038/s41598-020-76000-w
    A specific safety concern is the possibility that a dietary supplement could be contaminated with heavy metals. This research was undertaken to investigate the daily exposure levels of heavy metals in dietary supplements available in the UAE and to explore the factors associated with the contamination of dietary supplements with heavy metals. A total of 277 dietary supplement samples were collected from the UAE market and prepared for the analysis of selected heavy metal contamination. Inductively coupled plasma mass spectrometry (ICP-MS) was used to determine the presence of heavy metals. The average daily intake of cadmium was 0.73 μg [95% CI 0.61-0.85], compared to the acceptable daily intake (ADI) of 6 μg; the daily intake of lead was 0.85 μg [95% CI 0.62-1.07], compared to the acceptable daily intake (ADI) of 20 μg; and the daily intake of arsenic was 0.67 μg [95% CI 0.57-0.78], compared to the acceptable daily intake of 10 μg. Although the dietary supplements available in the UAE have low levels of heavy metal contamination, numerous individuals are consuming a number of different dietary supplements every day and thereby may experience a cumulative level of toxic exposure. Dietary supplements formulations (Categories), dosage forms and country of origin are strong determents of heavy metal contamination in dietary supplements products.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  14. Leong YH, Azmi NI, Majid MIA, Wen S
    PMID: 34014804 DOI: 10.1080/19440049.2021.1922758
    An average 50 ml breast milk samples were collected from 21 lactating primiparous mothers (range 25 to 45 years, mean 33 years), 4-8 weeks after delivery in Penang Island, Malaysia. The geometric mean concentration of the most toxic congeners, 2,3,7,8-tetrachlorodibenzo-p-dioxin (2,3,7,8-TCDD) was 0.14 pg WHO2005-TEQ g-1 zlipid. The most abundant congeners of PCDD/Fs were octachlorodibenzo-p-dioxin (OCDD) (5.9-75.4%), followed by 1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin (1,2,3,4,6,7,8-HpCDD) (1.1-30.7%). The geometric mean level of total dioxins and dl-PCBs was 2.2 pg WHO2005-TEQ g-1 lipid, significantly lower than those in developed countries or highly contaminated areas. The total dioxins and dl-PCBs in pg WHO2005-TEQ levels in breast milk were significantly correlated with years of residence at potential contaminated site. The average daily intake of 11.8 pg WHO2005-TEQ kg-1 body weight was estimated for a breastfed infant at 6 months of age. This demonstrates the exposure risk to infants, especially from Penang region, to these pollutants from human milk intake are potentially high during the lactation period.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  15. Low BS, Das PK, Chan KL
    Phytother Res, 2014 Jul;28(7):1022-9.
    PMID: 24318772 DOI: 10.1002/ptr.5094
    The roots of Eurycoma longifolia Jack are popularly sought as herbal medicinal supplements to improve libido and general health amongst the local ethnic population. The major quassinoids of E. longifolia improved spermatogenesis and fertility but toxicity studies have not been well documented. The reproductive toxicity, two generation of foetus teratology and the up-and-down acute toxicity were investigated in Sprague-Dawley rats orally treated with quassinoid-rich E. longifolia extract (TAF273). The results showed that the median lethal dose (LD50 ) of TAF273 for female and male rats was 1293 and >2000 mg/kg, respectively. Fertility index and litter size of the TAF273 treated were significantly increased when compared with those of the non-treated animals. The TAF273-treated dams decreased in percentage of pre-implantation loss, post-implantation loss and late resorption. No toxic symptoms were observed on the TAF273-treated pregnant female rats and their foetuses were normal. The no-observed adverse effect level (NOAEL) obtained from reproductive toxicity and teratology studies of TAF273 in rats was 100 mg/kg body weight/day, being more than 10-fold lower than the LD50 value. Thus, any human dose derived from converting the rat doses of 100 mg/kg and below may be considered as safe for further clinical studies.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  16. Ahmad M, Lim CP, Akowuah GA, Ismail NN, Hashim MA, Hor SY, et al.
    Phytomedicine, 2013 Sep 15;20(12):1124-30.
    PMID: 23827665 DOI: 10.1016/j.phymed.2013.05.005
    The present study aims to evaluate the safety of methanol extract of Cinnamomum burmannii (MECB) by acute 14-day (single dose) and sub-chronic 28-day (repeated doses) oral administration to Sprague-Dawley rats. Our results showed that no toxicity was found in either acute or sub-chronic toxicity studies. MECB (containing 0.07% and 0.20% (w/w) of coumarin and trans-cinnamaldehyde, respectively), which was given orally at doses of 500, 1000 and 2000 mg/kg caused neither visible signs of toxicity nor mortality. No significant differences were observed in general condition, growth, organ weight, hematological parameters, biochemical values, or the gross and microscopic appearance of the organs from the treatment groups as compared to the control group. In conclusion, MECB did not cause any mortality nor did it cause any abnormalities in the necropsy and histopathology findings of treated rats. The LD50 for the MECB was found to be more than 2000 mg/kg. No adverse effects were observed in the treated rats at all the doses tested. The no-observed-adverse-effect level (NOAEL) for the 28-day study was determined to be 2000 mg/kg body weight/day.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  17. Budin SB, Siti Nor Ain SM, Omar B, Taib IS, Hidayatulfathi O
    J Zhejiang Univ Sci B, 2012 Oct;13(10):783-90.
    PMID: 23024045
    Litsea elliptica Blume has been traditionally used to treat headache, fever, and stomach ulcer, and has also been used as an insect repellent. The acute and subacute toxicities of L. elliptica essential oil were evaluated orally by gavage in female Sprague-Dawley rats. For the acute toxicity study, L. elliptica essential oil was administered in doses from 500 to 4000 mg/kg (single dose), and in the subacute toxicity test, the following doses were used: 125, 250, and 500 mg/kg, for 28 consecutive days. In the acute toxicity study, L. elliptica essential oil caused dose-dependent adverse behaviours and mortality. The median lethal dose value was 3488.86 mg/kg and the acute non-observed-adversed-effect level value was found to be 500 mg/kg. The subacute toxicity study of L. elliptica essential oil did not reveal alterations in body weight, and food and water consumptions. The haematological and biochemical analyses did not show significant differences between control and treated groups in most of the parameters examined, except for the hemoglobin, mean cell hemoglobin concentration, mean cell volume, mean cell hemoglobin, serum albumin, and serum sodium. However, these differences were still within the normal range. No abnormalities or histopathological changes were observed in the liver, pancreatic islet of Langerhans, and renal glomerulous and tubular cells of all treated groups. In conclusion, L. elliptica essential oil can be classified in the U group, which is defined as a group unlikely to present an acute hazard according to World Health Organization (WHO) classification.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  18. Mohamed EA, Lim CP, Ebrika OS, Asmawi MZ, Sadikun A, Yam MF
    J Ethnopharmacol, 2011 Jan 27;133(2):358-63.
    PMID: 20937371 DOI: 10.1016/j.jep.2010.10.008
    The present investigation was carried out to evaluate the safety of standardised 50% ethanol extract of Orthosiphon stamineus plant by determining its potential toxicity after acute and subchronic administration in rats.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
  19. Lakshmanan H, Raman J, David P, Wong KH, Naidu M, Sabaratnam V
    J Ethnopharmacol, 2016 Dec 24;194:1051-1059.
    PMID: 27816657 DOI: 10.1016/j.jep.2016.10.084
    ETHNOPHARMACOLOGICAL RELEVANCE: Hericium erinaceus is a culinary-medicinal mushroom and has a long history of usage in traditional Chinese medicine as a tonic for stomach disorders, ulcers and gastrointestinal ailments.

    AIM OF THE STUDY: The present investigation was aimed to evaluate the potential toxic effects of the aqueous extract from the fruiting bodies of H. erinaceus in rats by a sub-chronic oral toxicity study.

    MATERIALS AND METHODS: In this sub-chronic toxicity study, rats were orally administered with the aqueous extract of H. erinaceus (HEAE) at doses of 250, 500 and 1000mg/kg body weight (b.w.) for 90 days. Body weights were recorded on a weekly basis and general behavioural changes were observed. The blood samples were subjected to haematological, biochemical, serum electrolyte, and antioxidant enzyme estimations. The rats were sacrificed and organs were processed and examined for histopathological changes.

    RESULTS: No mortality or morbidity was observed in all the treated and control rats. The results showed that the oral administration of HEAE daily at three different doses for 90 days had no adverse effect on the general behaviour, body weight, haematology, clinical biochemistry, and relative organ weights. Histopathological examination at the end of the study showed normal architecture except for few non-treatment related histopathological changes observed in liver, heart and spleen.

    CONCLUSION: The results of this sub-chronic toxicity study provides evidence that oral administration of HEAE is safe up to 1000mg/kg and H. erinaceus consumption is relatively non-toxic.

    Matched MeSH terms: No-Observed-Adverse-Effect Level
  20. Abdalla YOA, Nyamathulla S, Shamsuddin N, Arshad NM, Mun KS, Awang K, et al.
    Toxicol Appl Pharmacol, 2018 10 01;356:204-213.
    PMID: 30138658 DOI: 10.1016/j.taap.2018.08.014
    1'-S-1'-acetoxychavicol acetate (ACA) has been previously reported to reduce tumor volume in nude mice, at an effective dose of 1.56 mg/kg body weight. However, the detailed toxicological profile for ACA has not yet been performed. Herein, we investigated the toxicity of intravenous administration of ACA in male and female Sprague-Dawley rats, both acutely (with single doses of 2.00, 4.00 and 6.66 mg/kg body weight, for 14 days), and sub-acutely (with weekly injections of 0.66, 1.33, and 2.22 mg/kg, for 28 days). In both toxicity studies, treatment with ACA did not affect behavior, food/water intake or body weight, nor did it induce any changes in clinically relevant hematological and biochemical parameters or mortality, suggesting that the LD50 of ACA was higher than 6.66 mg/kg body weight, regardless of sex. Sub-acutely, there was however, mild focal inflammation of kidneys and lobular hepatitis, but these were not associated with significant functional adverse effects. Therefore, the no-observed-adverse-effect level (NOAEL) for intravenous administration of ACA in the present 28-day sub-acute study was 2.22 mg/kg body weight, in both male and female rats. These findings provide useful information regarding the safety of ACA use in a healthy, non-tumor-bearing rat model.
    Matched MeSH terms: No-Observed-Adverse-Effect Level
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