(haematological examination, urinalysis, clinical chemistry), as well as necropsy ; Morton, D.; Michael, B.; Roome, N.; Johnson, J.K.; Yano, B.L. Combatting Modern Slavery & Human Trafficking Statement, Copyright ; Richmond, W.; Fu, P.C. In a subchronic toxicity study, the film suspension, at doses of 10, 30 and 75 mg/kg bw for 28 days, were orally administered to rats. uuid:a1da8b51-19ac-4982-bce6-565264ac786a 18 0 obj <>stream This revised Test Guideline 413 (TG 413) has been designed to fully characterize test A collection of nonclinical studies & assays; customization is possible. WHO. Concordance of the toxicity of pharmaceuticals in humans and in animals. -carrageenan was purchased from Karaindo Indonesia (RVN K2), Konjac Glucomannan was purchased from Shannxi Jiahe, Sodium carbonate was purchased from Merck, Glycerin was purchased from PT Sumi asih, Sorbitol solution 70% was purchased from Cargill, Methylparaben was purchased from UENO, and Sorbic acid was purchased from Merck. In Proceedings of the Joint FAO/WHO Expert Committee on Food Additives, 57th Session, Rome, Italy, 514 June 2001.
used. An acute oral toxicity study was performed according to the Organization of Economic Co-operation and Development (OECD) guideline 420 for testing a chemical [, A subchronic oral toxicity study was preformed according to the Organization of Economic Co-operation and Development (OECD) guideline 407 for testing a chemical [. endobj After 28 days, the rats were sacrificed for hematological, biochemical and histological examination. In. evaluations in order to better characterize the toxicity of a test chemical. Published on October 16, 2008Also available in: French, In series:OECD Guidelines for the Testing of Chemicals, Section 4: Health Effectsview more titles, Organisation for Economic Co-operation and Development (OECD). Hall, R.L. Ariffin, S.H.Z. endobj For rodents, at least 20 animals per sex per group should normally be used at Tietz, N.W. OECD OECD Test Guideline 413 The film was prepared by melting the polymers (-carrageenan and konjac glucomannan) in water solution at 8090 C and mixing in other ingredients. 1 A serum was separated and analyzed for biochemical parameters on a Photometer 5010 V5+ based on an enzymatic colorimetric test, including blood glucose, cholesterol, triglyceride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea and blood creatinine. The test substance was a film formulation of -carrageenan added konjac glucomannan for soft capsule shell application. Labcorp is a leading global life sciences company that includes contract research and developmental services to thepharmaceutical,medical technology,crop protectionandchemicalindustries. if it is known that one sex is more susceptible to a given test chemical. Three Enzymatic Determinationof Total Serum Cholesterol. The dose levels were selected based on the dose conversion in soft capsule application. OECD 410/OCSPP 870.3200: Dermal toxicity study (repeated does, 21/28-day), OECD 407/OCSPP 870.3050: Oral toxicity study (repeated dose, 28-Day), OECD 413/OCSPP 870.3465: Inhalation toxicity study (subchronic, 90-day), OECD 408/OCSPP 870.3100: Oral toxicity study (repeated dose, rodents, 90-day), OECD 412: Inhalation toxicity study (subacute, 28-day), OECD 409/OCSPP 870.3150: Oral toxicity study (repeated dose, non-rodents, 90-day), OECD 411/OCSPP 870.3250: Dermal toxicity study (subchronic, 90-day). Further information about the use of cookies can be found in our privacy policy. endobj Three concentrations, at least, should be used. profile of the test substance. Adopted: 17th December 2001. and clinical chemistry), as well as ophthalmology, gross pathology, organ weights, Tel: +49 (0) 25 62 - 81 70-0 - Fax: +49 (0) 25 62 - 81 70-19 | info@vivoscience.de | Imprint | Privacy. Principles of clinical pathology for toxicity studies. endobj Addendum 9. 2022 paper provides an outlook on future directions of research or possible applications. ; Wahab, R.M.A. O.E.C.D. 1 0 obj <>stream ; Senafi, S. Cytotoxicity effect of degraded and undegraded kappa and iota carrageenan in human intestine and liver cell lines. Learn more about our commitment to replacing, reusing and refining nonclinical research models. article toxicity by the inhalation route following repeated exposure for a period
The test compound is administered by gavage Endocrine related measurements, such as thyroid function, are important to consider. IGgrz-qA1 XX|!GJz"2,B'4:0]UWpXGN49wkd6#2Ef^7bR~AI12f.^([cEigbmcusqo"csS<2o&w:PX'v-wJ0n%DV(K6E;EdMuG1{ 0N})Tt4EwbVK8R9YWHw KN1]&,1/aeVOW~t~FI+yO&w~o(`:P9X3'k?~3-?g_WkS#+8S=ThJ*!Mp?>SB0?+ P9u}rILeoM'Ytj,qOEY n1G$k!,Z-jZ'58TZY The body weight of each rat was weighed before the test, weekly during the study and on the day of sacrifice. dX,^U./_/_En7_#Lp"BT^|X?]WBu?_o_N,/_FWUcB#%UELh7p+Vqzj}F9Wv?~~u~\6oJZVM;@]bh* AUUVMw'^OFw{lw=4uk0 NfADvVT|8Q3Yq2lK`pJZ9llae pqj LRw[Ju~)PPw?qJPKX>e3~dKHTG 7U*#.;\K)n`0Suj%do 'ai84a%X"\I7(?$)ra"M-*& S ZO65{dhJ-T?oynQWVV4i )%I22 '-f) (KE) O_/rwya?-X EiL!0>`8T If your test is not listed above, please call us for additional tests. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research. PDF/X-1:2001 The film will be applied for human use as an 8-oblong soft capsule with a 250 mg weight/capsule/day dosage, which is equivalent to 4.166 mg/kg bw. 1 0 obj Nonalcoholic fatty liver disease: A spectrum of clinical and pathological severity. ; Amadou, I.; Qin, X.J. \0FHUT'
4 0 obj I.K.A., S.N.S., and L.D.N.S. Guidelines for Hematoxylin and Eosin Staining. Published on June 27, 2018Also available in: French, In series:OECD Guidelines for the Testing of Chemicals, Section 4: Health Effectsview more titles, Organisation for Economic Co-operation and Development (OECD). stream The target doses for Groups 14 were 0, 10, 30, and 75 mg film/kg bw/day, respectively. or via the diet or drinking water. =K1X1%^dND(+'b~u FmVfSc ]_X`rJ! T rrqWOrNE"BxhsgPr3Zs-g6wr. Visit our dedicated information section to learn more about MDPI. Select one or more items in both lists to browse for the relevant content, Browse the selectedThemes and / or countries. 2009-09-04T13:30:42+02:00 2 0 obj<>>>/CropBox[0.0 0.0 595.32 841.92]/Parent 9 0 R/StructParents 1/Rotate 0/MediaBox[0.0 0.0 595.32 841.92]/TrimBox[0.0 0.0 595.32 841.92]>> dRBD$v]i=:HwR3OXx{?n?pSGRFM`|z3.OPLAdLg!U#Hf=B. Throughout this period, clinical and functional assessments are performed to determine the toxicity and thus health hazard of the chemical. Find support for a specific problem in the support section of our website. Compendium of food additive specifications. Bergmeyer, H.U. Based on the results of the current study, we may conclude that the film formulation that combines -carrageenan and konjac glucomannan was well tolerated up to a 75 mg/kg bw dose when orally administered to Wistar rats. ; Artiss, J.D.
After 14 days of treatment, all tested animals were subjected to gross necropsy with no abnormality of organs observed in the macroscopic observation. At least 20 animals (10 female and 10 male) should be used for each test group. The duration of the exposure period should be 12 months. :okB ]DX}=n bob.o~dW*ozUe 4YkB,.xr-|,xzG) 8snZu 7O6m |F)&' wrote the paper; and I.K.A., and L.D.N.S. This Test Guideline allows the flexibility to include satellite We are one global company innovating for millions together, continuing to bring you more advanced medical breakthroughs. was updated in 2017 to enable the testing and characterisation of effects of nanomaterials ; Rinker, A.D.; Shaw, L.M. Groups of at least 10 male and 10 female rodents are exposed 6 hours per day for 90 Brenner, t.; Wang, Z.; Achayuthakan, P.; Nakajima, T.; Nishinari, K. Rheology and synergy of -carrageenan/locust bean gum/konjac glucomannan gels. x\oFn,5I(;qXEhA(wHt,%&j $y#e]bU]/.oT!BYdbbhwx"XuF=&X5.4c5A\c_lcLpm \V8wa02Su;En3oh=p?[9@7?jZ^J+Pbp4M$0=\xo*Vy| la7=rj)SuXS|I%HL93IpCRc(! endobj ; Perry, R.; Scafer, K. Society of Toxicologic Pathology position paper: Organ weight recommendations for toxicology studies.
The authors declare no conflict of interest. Editors Choice articles are based on recommendations by the scientific editors of MDPI journals from around the world. The body weight measurement resulted in an average body weight of 193.20 7.43, 204.20 8.29, and 211.00 8.83 g for Days 1, 7 and 14, respectively. Department of Pharmaceutics, School of Pharmacy, Institut Teknologi Bandung, Bandung 40132, Indonesia, Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung, Bandung 40132, Indonesia. Martini, F.H. BfIL=@jS0TZvdRnUUD+=K'4D426Bt@A%M7+k*oR+IbUgwzzd7PrHJ1J@|D.8kN};) [gK*d@{+^s||ZvwvPM 2 0 obj OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects, 1 0 obj A number of endocrine-related measurements, particularly relevant to thyoid function have been added in 2018. Some alterations to the relative organ weight and blood biochemistry were observed, but they were considered to be temporary effects and not an indication of toxic effects.
Cumulatively, these data suggest that the film formulation poses a low potential health risk but further study on its chronic toxicity should be undertaken to seek the effect of chronic exposure to film formulation.
permission is required to reuse all or part of the article published by MDPI, including figures and tables. 
Top 5 Design Considerations for Preclinical Immuno-oncology, Core Lead Optimization Toxicology Services, Rabies Vaccine and Antiviral Testing Services. 28 days). Singh, A.; Bhat, T.K. He, X.J. Adobe PDF Library 9.0 articles published under an open access Creative Common CC BY license, any part of the article may be reused without Chearskul, S.; Sangurai, S.; Nitiyanant, W.; Kriengsinyos, W.; Kooptiwut, S.; Harindhanavudhi, T. Glycemic and lipid responses to glucomannan in Thais with type 2 diabetes mellitus. Cholestatic injury is predominantly characterized by initial alkaline phosphatase level elevations that precede or are relatively more prominent than increases in the levels of serum aminotransferases [, The effect of the film suspension on the kidney was investigated by measuring the serum level of urea and creatinine, which are specific indicators of kidney function. Barham, D.; Trinder, P. An Improved Color Reagent for the Determination of Blood Glucose by the Oxidase System. D:20090813160151 In order to be human-readable, please install an RSS reader. IFCC Methods for the measurement of catalytic concentration of enzymes, IFCC Method for Alkaline Phosphatase. This method provides information on health hazard likely to arise from exposure to test substance via oral administration. exposed 5 days per week but exposure for 7 days per week is also allowed. French, https://doi.org/10.1787/9789264070707-en ; Horder, M.; Rey, J. each dose level, while for non-rodents a minimum of 4 per sex per group is recommended. 2 0 obj
No special The Test Guideline focuses on rodents and oral administration. 2010-09-28T08:54:06-04:00 They were acclimatized at room temperature, with 12 h light and 12 h dark cycle, as well as free access to a standard pellet diet and water ad libitum. (LB) for particles, neurologic tests, and additional clinical pathology and histopathological The Feature Paper can be either an original research article, a substantial novel research study that often involves ; Poon, L.S. Normal female Wistar rats were used for acute toxicity study. Tan, C.; Wei, H.; Zhao, X.; Xu, C.; Zhou, Y.; Peng, J. Soluble fiber with hing water-binding capacity, swelling capacity, and fermentability reduces food intake by promoting satiety rather than satiation in rats. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. of 90 days, and to provide data for quantitative inhalation risk assessments. ; Zak, B. <>
; Wang, H.X. 
Frequency of exposure normally is daily, but may vary according to the route chosen Acrobat PDFMaker 9.1 pour Word The animals were observed for toxic symptoms and mortality daily for 14 days. Sood, N.; Baker, W.L. Then, Tukeys post hoc test compared the results with the control group using statistical software SPSS version 23, and. While carrageenan is generally recognized as safe (GRAS) by the United States Food and Drug Administration, the safety of ingested carrageenan remains questionable, as it may be altered by bacteria in the intestine, if the stomach has an acidic condition [, The subchronic 28-day oral toxicity study of the film formulation demonstrated no adverse clinical signs or negative influences on behavior and mortality in the treatment groups. Our toxicity tests will be performed in accordance with theOECD guidelinesthat are used, for example, in theREACHtesting programs. Values are expressed as the mean SD; * significantly different from the control group (p < 0.05). It application/pdf ; Tanvir, E.M.; Islam, A.; Afroz, A.; Ahmed, I.; Saha, M.; Siew, H.G. We also test your food additive and nutrient sources according to the recent Guidance for submission for food additive evaluations of EFSA. OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects,
Analysis of the hematological parameters is important in assessing the toxic effects of test substances, as well as in determining the physiological and pathological status of the body, as variations in these parameters may indicate toxicity associated with the test substances and various diseases and conditions, including anemia, leukemia, reactions to inflammation and infections [, Relative organ weight profiles are essential and widely used for interpreting the effect of a test substance in a toxicity study. ; Bartholomew, E.F. <>
Labcorp Drug Development - All rights reserved. ; Younossi, Z.M. These doses were selected based on the dose level guideline of OECD 407, which states that 24-fold intervals are frequently optimal for setting the descending dose levels. OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects,
Textural and rheological properties of hydrolyzed Konjac Glucomannan and Kappa-Carrageenan: Effect of molecular weight, total content, pH and temperature on the mixed system gels. Swelling characteristics of konjac glucomannan superabsobent synthesized by radiation-induced graft copolymerization. You are accessing a machine-readable page. The test is performed on rats and involves dividing the animals into sub-groups and administering a different fixed dose of the test substance to the groups daily, through gavage or via their food/water, over a period of 90 days. [CDATA[ var google_conversion_id = 1022522455; var google_conversion_language = "en"; var google_conversion_format = "3"; var google_conversion_color ="666666"; var google_conversion_label = "GlqXCKuxuwIQ1-jJ5wM"; var google_conversion_value = 0; // ]]> &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;/p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;div style=display:inline;&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;img height=1 width=1 style=border-style:none; alt= src=http://www.googleadservices.com/pagead/conversion/1022522455/?label=GlqXCKuxuwIQ1-jJ5wM&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;guid=ON&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;script=0/&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;/div&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; Do you want practical support for your project? uuid:26aeae7c-32a7-4e22-b46d-722ce01bf8fb endstream %
%PDF-1.7
9UFb0GAvx%c3 g#D` TU)u3XTrLd7_S6vDA~ 12 0 obj<>>>/CropBox[0.0 0.0 595.32 841.92]/Parent 9 0 R/StructParents 3/Rotate 0/MediaBox[0.0 0.0 595.32 841.92]/TrimBox[0.0 0.0 595.32 841.92]>> [b? The determination of sub-chronic oral toxicity using repeated doses may be carried out after initial information on toxicity has been obtained from acute or repeated dose 28-day toxicity tests. <>
PDF/X-1:2001 The aim is to provide a snapshot of some of the most exciting work a substance in a mammalian species (primarily rodents) following prolonged and repeated Market analysis of encapsulated medications and biologically active dietary supplements indicates that attention need to be paid to the search for alternatives to the traditionally used gelatin. 9789264070707 (PDF). exposure. gobYlF{69D#!qOO^_G 2001 - 2022 vivo Science GmbH | Fabrikstrae 3 - 48599 Gronau - Germany This type of Wua, J.; Deng, X.; Lin, X. This result suggests that the film formulation of -carrageenan with konjac glucomannan was not toxic, after an acute exposure. Access to this content in this format requires a current subscription or a prior purchase. This factor determines the relevance of the development of technology for the production of capsules from hydrocolloids of plant origin [. Just as we have ethical committee oversight for human trials, we have ethical committees overseeing all aspects of our global animal care and use programs. Physical and Chemical Properties of Capsule Shell Based on Plant Analogues of Pharmaceutical Gelatin.
Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes, IFCC method for Alanine Aminotransferase. The results of the subchronic toxicity study show that there were no significant changes observed in the hematology and organ histology. The organs, namely the heart, liver, spleen, lung, kidney, adrenal, testes, seminal vesicles, ovarium, and uterus, were removed from the rats and weighed. histopathology. Feature Papers represent the most advanced research with significant potential for high impact in the field. performed the experiments; N.N.W.S., I.K.A., and L.D.N.S. Allain, C.C. endobj Hj 0 16 0 obj<> An incremental change in these parameters indicates damage to the functional nephrons [, The lipid profile is used to diagnose primary and secondary hyperliproteinemia, triglyceridemia, liver obstruction, and fatty liver disease [, The serum glucose concentration reflects the intestinal glucose absorption, hepatic glucose production, and tissue uptake of glucose [. Prosekov, A.; Petrov, A.; Ulrich, E.; Dyshlyuk, L.; Kozlova, O. Or consider purchasing the publication. 3 0 obj The report of this study will include results
permission provided that the original article is clearly cited. Capsules are an alternative to tablets for the oral delivery of therapeutic compounds. 27 Jun 2018
16
pages
English
Also available in: The results <>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
Males and Visual observation of the test substances indicated that the water suspension of chopped film was stable for 7 days at room temperature without changes viscosity of suspension. Subscribe to receive issue release notifications and newsletters from MDPI journals, You can make submissions to other journals. Antioxidant properties of citrus macroptera fruit and its in vivo effects on the liver, kidney and pancreas in wistar rats. ; Coleman, C.I. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. 2 Neither deaths nor obvious clinical signs of toxicity in the rats were observed for all groups, including the group that received the highest tested dose of 75 mg/kg bw. ; Mazzitelli, C.L. ; Khalil, I.; et al. The films were molded manually in a petri glass with a diameter of 910 mm, and 15 g of mass to provide a film thickness of 0.70.9 mm, then they were aged at an ambient temperature for 3 days to obtain the film, with loss on drying within a range of 2530%. About our nonclinical animal research models: We provide the utmost care for our research animals and actively pursue advances in animal welfare. This Test Guideline is intended primarily for use with rodents (rat preferably). Bartels, H.; Bohmer, M. Micro-determination of Creatinine. The relative organ weight was calculated as follows: Relative organ weight = (organ weight (g) / body weight of the animal on sacrifice day (g)) 100, The following hematological parameters were evaluated on a Medonic M-Series Hematology Analyzer: white blood cell counts, hemoglobin, red blood cell counts, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and hematocrit and platelet counts [, Blood samples were collected from a cardiac puncture in a non-heparinized tube, and then centrifuged at 10,000 rpm for 5 min. Normal male and female Wistar rats were used for the subchronic (28-day) study. The method is based on the repeated oral administration Mc Gowan, M.W. 4 0 obj
measurements, hematology and clinical biochemistry; as well as gross necropsy and x=]8 endobj ; Ariffin, Z.Z.
females are always tested, but they may be exposed at different concentration levels PDF/X-1a:2001 The formula was as follows: -carrageenan 4%, konjac glucomannan 1%, sodium carbonate 0.002%, glycerin 12%, sorbitol solution 7.5%, methyl paraben 0.18%, sorbic acid 0.1% and balance purified water ad 100%. stream ; McCullough, A.J. %PDF-1.5 endobj The statements, opinions and data contained in the journal, 1996-2022 MDPI (Basel, Switzerland) unless otherwise stated. In the acute toxicity study, neither signs of toxicity nor death among the rats were observed for up to 14 days of the experimental period. ; Yeen, W.W.; Abidin, I.Z.Z. OECD iLibrary The method is based on the repeated oral administration of the substance of interest over a prolonged period (one dose level daily during 90 days). and histopathology. At least 10 animals (5 female and 5 male) should be used for each dose level. PDF/X-1:2001 ; Gramlich, T.; Boparai, N.; Liu, Y.C. be expected at a dose of 1000 mg/kg bw/d. The OECD 408: Repeated Dose 90-Day Oral Toxicity Study is used to determine the toxicity of an orally ingested chemical over a prolonged time period. ; Chan, C.S.G. ; Everds, N.E. v6v!4B j #SzV"&9>q@fjTT68t We will call you back! ; Ratziu, V.; Piton, A.; Thibault, V.; Imbert-Bismut, F.; Messous, D.; Charlotte, F.; Di Martino, V.; Benhamou, Y.; et al. You seem to have javascript disabled. Gullapalli, R.P. At least three dose levels should be used in addition to the concurrent control group. Gelatin and Non-Gelatin Capsule Dosage Forms. The glucose, cholesterol and triglyceride changes in the treatment groups were considered to be temporary effects of the film suspension administration, because a normal result was achieved after two weeks of discontinuation of the test substance. of the substance of interest during one limited period (one dose level daily during Published on June 27, 2018Also available in: French, In series:OECD Guidelines for the Testing of Chemicals, Section 4: Health Effectsview more titles, Organisation for Economic Co-operation and Development (OECD). Olson, H.; Betton, G.; Robinson, D.; Thomas, K.; Monro, A.; Kolaja, G.; Lilly, P.; Sanders, J.; Sipes, G.; Bracken, W.; et al. [. Prediction of liver histological lesions with biochemical markers in patients with chronic hepatitis B. Ghabril, M.; Chalasani, N.; Bjrnsson, E. Drug-induced liver injury: A clinical update. Contact our Sales Department for more information by phone: +49 (0) 2562 - 81 70 10.For further information - or written requests - please send us an e-mail to sales@vivoscience.de. For the acute toxicity study, a dose of 2000 mg/kg body weight (bw) of the film suspension was administered orally to rats. The statements, opinions and data contained in the journals are solely (oral, dermal or inhalation) and should be adjusted according to the toxicokinetic False We perform the following tests routinely in rodents: All OECD safety guidelines on health effects can be downloaded here. Organisation for Economic, MOPAN Multilateral Organisation Performance Assessment Network, Biodiversity, water and natural resource management, Consumption, innovation and the environment, Environment in emerging and transition economies, Environmental indicators, modelling and outlooks, Environmental policy tools and evaluation. All articles published by MDPI are made immediately available worldwide under an open access license. conceived and designed the experiments; N.N.W.S. interesting to authors, or important in this field. The organ paraffin section was prepared, stained with hemotoxylin and eosin and processed for a light microscope fitted with an optilab viewer [, Data were expressed as mean standard deviation (SD) and analyzed statistically by a one-way Analysis of Variance (ANOVA). We use cookies on our website to ensure you get the best experience. of the study include measurement and daily and detailed observations (haematology 0 <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 594.96 842.04] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> In all five female testing animals, signs of neither toxicity nor death among the rats were observed during the 14 days of the acute toxicity experimental period, after the administration of a single oral dose of the testing suspension of 2000 mg/kg bw. The test compound is administered by gavage or via the diet or drinking water. The animals were 68 weeks old, and were stabilized for seven days prior to the experiments. Carrageenan has been widely used in food, pharmaceutical and industrial applications. endobj The middle dose was converted by the following calculation: The low and high doses were set as 1/3- and 2.5-fold of the middle dose, respectively.
During acclimatization, the rats were randomized into experimental and control groups. published in the various research areas of the journal. -Carrageenan; Konjac Glucomannan; soft capsule; toxicity, Values are expressed as the mean SD; * significantly different from the control group (. <>/Metadata 1514 0 R/ViewerPreferences 1515 0 R>> 17 0 obj <>stream several techniques or approaches, or a comprehensive review paper with concise and precise updates on the latest Organisation for Economic, MOPAN Multilateral Organisation Performance Assessment Network, Biodiversity, water and natural resource management, Consumption, innovation and the environment, Environment in emerging and transition economies, Environmental indicators, modelling and outlooks, Environmental policy tools and evaluation. For Lipid disorders in diabetes mellitus and current management.
used. An acute oral toxicity study was performed according to the Organization of Economic Co-operation and Development (OECD) guideline 420 for testing a chemical [, A subchronic oral toxicity study was preformed according to the Organization of Economic Co-operation and Development (OECD) guideline 407 for testing a chemical [. endobj After 28 days, the rats were sacrificed for hematological, biochemical and histological examination. In. evaluations in order to better characterize the toxicity of a test chemical. Published on October 16, 2008Also available in: French, In series:OECD Guidelines for the Testing of Chemicals, Section 4: Health Effectsview more titles, Organisation for Economic Co-operation and Development (OECD). Hall, R.L. Ariffin, S.H.Z. endobj For rodents, at least 20 animals per sex per group should normally be used at Tietz, N.W. OECD OECD Test Guideline 413 The film was prepared by melting the polymers (-carrageenan and konjac glucomannan) in water solution at 8090 C and mixing in other ingredients. 1 A serum was separated and analyzed for biochemical parameters on a Photometer 5010 V5+ based on an enzymatic colorimetric test, including blood glucose, cholesterol, triglyceride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea and blood creatinine. The test substance was a film formulation of -carrageenan added konjac glucomannan for soft capsule shell application. Labcorp is a leading global life sciences company that includes contract research and developmental services to thepharmaceutical,medical technology,crop protectionandchemicalindustries. if it is known that one sex is more susceptible to a given test chemical. Three Enzymatic Determinationof Total Serum Cholesterol. The dose levels were selected based on the dose conversion in soft capsule application. OECD 410/OCSPP 870.3200: Dermal toxicity study (repeated does, 21/28-day), OECD 407/OCSPP 870.3050: Oral toxicity study (repeated dose, 28-Day), OECD 413/OCSPP 870.3465: Inhalation toxicity study (subchronic, 90-day), OECD 408/OCSPP 870.3100: Oral toxicity study (repeated dose, rodents, 90-day), OECD 412: Inhalation toxicity study (subacute, 28-day), OECD 409/OCSPP 870.3150: Oral toxicity study (repeated dose, non-rodents, 90-day), OECD 411/OCSPP 870.3250: Dermal toxicity study (subchronic, 90-day). Further information about the use of cookies can be found in our privacy policy. endobj Three concentrations, at least, should be used. profile of the test substance. Adopted: 17th December 2001. and clinical chemistry), as well as ophthalmology, gross pathology, organ weights, Tel: +49 (0) 25 62 - 81 70-0 - Fax: +49 (0) 25 62 - 81 70-19 | info@vivoscience.de | Imprint | Privacy. Principles of clinical pathology for toxicity studies. endobj Addendum 9. 2022 paper provides an outlook on future directions of research or possible applications. ; Wahab, R.M.A. O.E.C.D. 1 0 obj <>stream ; Senafi, S. Cytotoxicity effect of degraded and undegraded kappa and iota carrageenan in human intestine and liver cell lines. Learn more about our commitment to replacing, reusing and refining nonclinical research models. article toxicity by the inhalation route following repeated exposure for a period
The test compound is administered by gavage Endocrine related measurements, such as thyroid function, are important to consider. IGgrz-qA1 XX|!GJz"2,B'4:0]UWpXGN49wkd6#2Ef^7bR~AI12f.^([cEigbmcusqo"csS<2o&w:PX'v-wJ0n%DV(K6E;EdMuG1{ 0N})Tt4EwbVK8R9YWHw KN1]&,1/aeVOW~t~FI+yO&w~o(`:P9X3'k?~3-?g_WkS#+8S=ThJ*!Mp?>SB0?+ P9u}rILeoM'Ytj,qOEY n1G$k!,Z-jZ'58TZY The body weight of each rat was weighed before the test, weekly during the study and on the day of sacrifice. dX,^U./_/_En7_#Lp"BT^|X?]WBu?_o_N,/_FWUcB#%UELh7p+Vqzj}F9Wv?~~u~\6oJZVM;@]bh* AUUVMw'^OFw{lw=4uk0 NfADvVT|8Q3Yq2lK`pJZ9llae pqj LRw[Ju~)PPw?qJPKX>e3~dKHTG 7U*#.;\K)n`0Suj%do 'ai84a%X"\I7(?$)ra"M-*& S ZO65{dhJ-T?oynQWVV4i )%I22 '-f) (KE) O_/rwya?-X EiL!0>`8T If your test is not listed above, please call us for additional tests. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research. PDF/X-1:2001 The film will be applied for human use as an 8-oblong soft capsule with a 250 mg weight/capsule/day dosage, which is equivalent to 4.166 mg/kg bw. 1 0 obj Nonalcoholic fatty liver disease: A spectrum of clinical and pathological severity. ; Amadou, I.; Qin, X.J. \0FHUT'
4 0 obj I.K.A., S.N.S., and L.D.N.S. Guidelines for Hematoxylin and Eosin Staining. Published on June 27, 2018Also available in: French, In series:OECD Guidelines for the Testing of Chemicals, Section 4: Health Effectsview more titles, Organisation for Economic Co-operation and Development (OECD). stream The target doses for Groups 14 were 0, 10, 30, and 75 mg film/kg bw/day, respectively. or via the diet or drinking water. =K1X1%^dND(+'b~u FmVfSc ]_X`rJ! T rrqWOrNE"BxhsgPr3Zs-g6wr. Visit our dedicated information section to learn more about MDPI. Select one or more items in both lists to browse for the relevant content, Browse the selectedThemes and / or countries. 2009-09-04T13:30:42+02:00 2 0 obj<>>>/CropBox[0.0 0.0 595.32 841.92]/Parent 9 0 R/StructParents 1/Rotate 0/MediaBox[0.0 0.0 595.32 841.92]/TrimBox[0.0 0.0 595.32 841.92]>> dRBD$v]i=:HwR3OXx{?n?pSGRFM`|z3.OPLAdLg!U#Hf=B. Throughout this period, clinical and functional assessments are performed to determine the toxicity and thus health hazard of the chemical. Find support for a specific problem in the support section of our website. Compendium of food additive specifications. Bergmeyer, H.U. Based on the results of the current study, we may conclude that the film formulation that combines -carrageenan and konjac glucomannan was well tolerated up to a 75 mg/kg bw dose when orally administered to Wistar rats. ; Artiss, J.D.
After 14 days of treatment, all tested animals were subjected to gross necropsy with no abnormality of organs observed in the macroscopic observation. At least 20 animals (10 female and 10 male) should be used for each test group. The duration of the exposure period should be 12 months. :okB ]DX}=n bob.o~dW*ozUe 4YkB,.xr-|,xzG) 8snZu 7O6m |F)&' wrote the paper; and I.K.A., and L.D.N.S. This Test Guideline allows the flexibility to include satellite We are one global company innovating for millions together, continuing to bring you more advanced medical breakthroughs. was updated in 2017 to enable the testing and characterisation of effects of nanomaterials ; Rinker, A.D.; Shaw, L.M. Groups of at least 10 male and 10 female rodents are exposed 6 hours per day for 90 Brenner, t.; Wang, Z.; Achayuthakan, P.; Nakajima, T.; Nishinari, K. Rheology and synergy of -carrageenan/locust bean gum/konjac glucomannan gels. x\oFn,5I(;qXEhA(wHt,%&j $y#e]bU]/.oT!BYdbbhwx"XuF=&X5.4c5A\c_lcLpm \V8wa02Su;En3oh=p?[9@7?jZ^J+Pbp4M$0=\xo*Vy| la7=rj)SuXS|I%HL93IpCRc(! endobj ; Perry, R.; Scafer, K. Society of Toxicologic Pathology position paper: Organ weight recommendations for toxicology studies.
The authors declare no conflict of interest. Editors Choice articles are based on recommendations by the scientific editors of MDPI journals from around the world. The body weight measurement resulted in an average body weight of 193.20 7.43, 204.20 8.29, and 211.00 8.83 g for Days 1, 7 and 14, respectively. Department of Pharmaceutics, School of Pharmacy, Institut Teknologi Bandung, Bandung 40132, Indonesia, Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung, Bandung 40132, Indonesia. Martini, F.H. BfIL=@jS0TZvdRnUUD+=K'4D426Bt@A%M7+k*oR+IbUgwzzd7PrHJ1J@|D.8kN};) [gK*d@{+^s||ZvwvPM 2 0 obj OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects, 1 0 obj A number of endocrine-related measurements, particularly relevant to thyoid function have been added in 2018. Some alterations to the relative organ weight and blood biochemistry were observed, but they were considered to be temporary effects and not an indication of toxic effects.
Cumulatively, these data suggest that the film formulation poses a low potential health risk but further study on its chronic toxicity should be undertaken to seek the effect of chronic exposure to film formulation.
permission is required to reuse all or part of the article published by MDPI, including figures and tables. Top 5 Design Considerations for Preclinical Immuno-oncology, Core Lead Optimization Toxicology Services, Rabies Vaccine and Antiviral Testing Services. 28 days). Singh, A.; Bhat, T.K. He, X.J. Adobe PDF Library 9.0 articles published under an open access Creative Common CC BY license, any part of the article may be reused without Chearskul, S.; Sangurai, S.; Nitiyanant, W.; Kriengsinyos, W.; Kooptiwut, S.; Harindhanavudhi, T. Glycemic and lipid responses to glucomannan in Thais with type 2 diabetes mellitus. Cholestatic injury is predominantly characterized by initial alkaline phosphatase level elevations that precede or are relatively more prominent than increases in the levels of serum aminotransferases [, The effect of the film suspension on the kidney was investigated by measuring the serum level of urea and creatinine, which are specific indicators of kidney function. Barham, D.; Trinder, P. An Improved Color Reagent for the Determination of Blood Glucose by the Oxidase System. D:20090813160151 In order to be human-readable, please install an RSS reader. IFCC Methods for the measurement of catalytic concentration of enzymes, IFCC Method for Alkaline Phosphatase. This method provides information on health hazard likely to arise from exposure to test substance via oral administration. exposed 5 days per week but exposure for 7 days per week is also allowed. French, https://doi.org/10.1787/9789264070707-en ; Horder, M.; Rey, J. each dose level, while for non-rodents a minimum of 4 per sex per group is recommended. 2 0 obj
No special The Test Guideline focuses on rodents and oral administration. 2010-09-28T08:54:06-04:00 They were acclimatized at room temperature, with 12 h light and 12 h dark cycle, as well as free access to a standard pellet diet and water ad libitum. (LB) for particles, neurologic tests, and additional clinical pathology and histopathological The Feature Paper can be either an original research article, a substantial novel research study that often involves ; Poon, L.S. Normal female Wistar rats were used for acute toxicity study. Tan, C.; Wei, H.; Zhao, X.; Xu, C.; Zhou, Y.; Peng, J. Soluble fiber with hing water-binding capacity, swelling capacity, and fermentability reduces food intake by promoting satiety rather than satiation in rats. A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. of 90 days, and to provide data for quantitative inhalation risk assessments. ; Zak, B. <>
; Wang, H.X. Frequency of exposure normally is daily, but may vary according to the route chosen Acrobat PDFMaker 9.1 pour Word The animals were observed for toxic symptoms and mortality daily for 14 days. Sood, N.; Baker, W.L. Then, Tukeys post hoc test compared the results with the control group using statistical software SPSS version 23, and. While carrageenan is generally recognized as safe (GRAS) by the United States Food and Drug Administration, the safety of ingested carrageenan remains questionable, as it may be altered by bacteria in the intestine, if the stomach has an acidic condition [, The subchronic 28-day oral toxicity study of the film formulation demonstrated no adverse clinical signs or negative influences on behavior and mortality in the treatment groups. Our toxicity tests will be performed in accordance with theOECD guidelinesthat are used, for example, in theREACHtesting programs. Values are expressed as the mean SD; * significantly different from the control group (p < 0.05). It application/pdf ; Tanvir, E.M.; Islam, A.; Afroz, A.; Ahmed, I.; Saha, M.; Siew, H.G. We also test your food additive and nutrient sources according to the recent Guidance for submission for food additive evaluations of EFSA. OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects,
Analysis of the hematological parameters is important in assessing the toxic effects of test substances, as well as in determining the physiological and pathological status of the body, as variations in these parameters may indicate toxicity associated with the test substances and various diseases and conditions, including anemia, leukemia, reactions to inflammation and infections [, Relative organ weight profiles are essential and widely used for interpreting the effect of a test substance in a toxicity study. ; Bartholomew, E.F. <>
Labcorp Drug Development - All rights reserved. ; Younossi, Z.M. These doses were selected based on the dose level guideline of OECD 407, which states that 24-fold intervals are frequently optimal for setting the descending dose levels. OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects,
Textural and rheological properties of hydrolyzed Konjac Glucomannan and Kappa-Carrageenan: Effect of molecular weight, total content, pH and temperature on the mixed system gels. Swelling characteristics of konjac glucomannan superabsobent synthesized by radiation-induced graft copolymerization. You are accessing a machine-readable page. The test is performed on rats and involves dividing the animals into sub-groups and administering a different fixed dose of the test substance to the groups daily, through gavage or via their food/water, over a period of 90 days. [CDATA[ var google_conversion_id = 1022522455; var google_conversion_language = "en"; var google_conversion_format = "3"; var google_conversion_color ="666666"; var google_conversion_label = "GlqXCKuxuwIQ1-jJ5wM"; var google_conversion_value = 0; // ]]> &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;/p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;div style=display:inline;&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;img height=1 width=1 style=border-style:none; alt= src=http://www.googleadservices.com/pagead/conversion/1022522455/?label=GlqXCKuxuwIQ1-jJ5wM&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;guid=ON&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;script=0/&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;/div&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;p&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; Do you want practical support for your project? uuid:26aeae7c-32a7-4e22-b46d-722ce01bf8fb endstream %
%PDF-1.7
9UFb0GAvx%c3 g#D` TU)u3XTrLd7_S6vDA~ 12 0 obj<>>>/CropBox[0.0 0.0 595.32 841.92]/Parent 9 0 R/StructParents 3/Rotate 0/MediaBox[0.0 0.0 595.32 841.92]/TrimBox[0.0 0.0 595.32 841.92]>> [b? The determination of sub-chronic oral toxicity using repeated doses may be carried out after initial information on toxicity has been obtained from acute or repeated dose 28-day toxicity tests. <>
PDF/X-1:2001 The aim is to provide a snapshot of some of the most exciting work a substance in a mammalian species (primarily rodents) following prolonged and repeated Market analysis of encapsulated medications and biologically active dietary supplements indicates that attention need to be paid to the search for alternatives to the traditionally used gelatin. 9789264070707 (PDF). exposure. gobYlF{69D#!qOO^_G 2001 - 2022 vivo Science GmbH | Fabrikstrae 3 - 48599 Gronau - Germany This type of Wua, J.; Deng, X.; Lin, X. This result suggests that the film formulation of -carrageenan with konjac glucomannan was not toxic, after an acute exposure. Access to this content in this format requires a current subscription or a prior purchase. This factor determines the relevance of the development of technology for the production of capsules from hydrocolloids of plant origin [. Just as we have ethical committee oversight for human trials, we have ethical committees overseeing all aspects of our global animal care and use programs. Physical and Chemical Properties of Capsule Shell Based on Plant Analogues of Pharmaceutical Gelatin.
Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes, IFCC method for Alanine Aminotransferase. The results of the subchronic toxicity study show that there were no significant changes observed in the hematology and organ histology. The organs, namely the heart, liver, spleen, lung, kidney, adrenal, testes, seminal vesicles, ovarium, and uterus, were removed from the rats and weighed. histopathology. Feature Papers represent the most advanced research with significant potential for high impact in the field. performed the experiments; N.N.W.S., I.K.A., and L.D.N.S. Allain, C.C. endobj Hj 0 16 0 obj<> An incremental change in these parameters indicates damage to the functional nephrons [, The lipid profile is used to diagnose primary and secondary hyperliproteinemia, triglyceridemia, liver obstruction, and fatty liver disease [, The serum glucose concentration reflects the intestinal glucose absorption, hepatic glucose production, and tissue uptake of glucose [. Prosekov, A.; Petrov, A.; Ulrich, E.; Dyshlyuk, L.; Kozlova, O. Or consider purchasing the publication. 3 0 obj The report of this study will include results
permission provided that the original article is clearly cited. Capsules are an alternative to tablets for the oral delivery of therapeutic compounds. 27 Jun 2018
16
pages
English
Also available in: The results <>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>
Males and Visual observation of the test substances indicated that the water suspension of chopped film was stable for 7 days at room temperature without changes viscosity of suspension. Subscribe to receive issue release notifications and newsletters from MDPI journals, You can make submissions to other journals. Antioxidant properties of citrus macroptera fruit and its in vivo effects on the liver, kidney and pancreas in wistar rats. ; Coleman, C.I. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. 2 Neither deaths nor obvious clinical signs of toxicity in the rats were observed for all groups, including the group that received the highest tested dose of 75 mg/kg bw. ; Mazzitelli, C.L. ; Khalil, I.; et al. The films were molded manually in a petri glass with a diameter of 910 mm, and 15 g of mass to provide a film thickness of 0.70.9 mm, then they were aged at an ambient temperature for 3 days to obtain the film, with loss on drying within a range of 2530%. About our nonclinical animal research models: We provide the utmost care for our research animals and actively pursue advances in animal welfare. This Test Guideline is intended primarily for use with rodents (rat preferably). Bartels, H.; Bohmer, M. Micro-determination of Creatinine. The relative organ weight was calculated as follows: Relative organ weight = (organ weight (g) / body weight of the animal on sacrifice day (g)) 100, The following hematological parameters were evaluated on a Medonic M-Series Hematology Analyzer: white blood cell counts, hemoglobin, red blood cell counts, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and hematocrit and platelet counts [, Blood samples were collected from a cardiac puncture in a non-heparinized tube, and then centrifuged at 10,000 rpm for 5 min. Normal male and female Wistar rats were used for the subchronic (28-day) study. The method is based on the repeated oral administration Mc Gowan, M.W. 4 0 obj
measurements, hematology and clinical biochemistry; as well as gross necropsy and x=]8 endobj ; Ariffin, Z.Z. females are always tested, but they may be exposed at different concentration levels PDF/X-1a:2001 The formula was as follows: -carrageenan 4%, konjac glucomannan 1%, sodium carbonate 0.002%, glycerin 12%, sorbitol solution 7.5%, methyl paraben 0.18%, sorbic acid 0.1% and balance purified water ad 100%. stream ; McCullough, A.J. %PDF-1.5 endobj The statements, opinions and data contained in the journal, 1996-2022 MDPI (Basel, Switzerland) unless otherwise stated. In the acute toxicity study, neither signs of toxicity nor death among the rats were observed for up to 14 days of the experimental period. ; Yeen, W.W.; Abidin, I.Z.Z. OECD iLibrary The method is based on the repeated oral administration of the substance of interest over a prolonged period (one dose level daily during 90 days). and histopathology. At least 10 animals (5 female and 5 male) should be used for each dose level. PDF/X-1:2001 ; Gramlich, T.; Boparai, N.; Liu, Y.C. be expected at a dose of 1000 mg/kg bw/d. The OECD 408: Repeated Dose 90-Day Oral Toxicity Study is used to determine the toxicity of an orally ingested chemical over a prolonged time period. ; Chan, C.S.G. ; Everds, N.E. v6v!4B j #SzV"&9>q@fjTT68t We will call you back! ; Ratziu, V.; Piton, A.; Thibault, V.; Imbert-Bismut, F.; Messous, D.; Charlotte, F.; Di Martino, V.; Benhamou, Y.; et al. You seem to have javascript disabled. Gullapalli, R.P. At least three dose levels should be used in addition to the concurrent control group. Gelatin and Non-Gelatin Capsule Dosage Forms. The glucose, cholesterol and triglyceride changes in the treatment groups were considered to be temporary effects of the film suspension administration, because a normal result was achieved after two weeks of discontinuation of the test substance. of the substance of interest during one limited period (one dose level daily during Published on June 27, 2018Also available in: French, In series:OECD Guidelines for the Testing of Chemicals, Section 4: Health Effectsview more titles, Organisation for Economic Co-operation and Development (OECD). Olson, H.; Betton, G.; Robinson, D.; Thomas, K.; Monro, A.; Kolaja, G.; Lilly, P.; Sanders, J.; Sipes, G.; Bracken, W.; et al. [. Prediction of liver histological lesions with biochemical markers in patients with chronic hepatitis B. Ghabril, M.; Chalasani, N.; Bjrnsson, E. Drug-induced liver injury: A clinical update. Contact our Sales Department for more information by phone: +49 (0) 2562 - 81 70 10.For further information - or written requests - please send us an e-mail to sales@vivoscience.de. For the acute toxicity study, a dose of 2000 mg/kg body weight (bw) of the film suspension was administered orally to rats. The statements, opinions and data contained in the journals are solely (oral, dermal or inhalation) and should be adjusted according to the toxicokinetic False We perform the following tests routinely in rodents: All OECD safety guidelines on health effects can be downloaded here. Organisation for Economic, MOPAN Multilateral Organisation Performance Assessment Network, Biodiversity, water and natural resource management, Consumption, innovation and the environment, Environment in emerging and transition economies, Environmental indicators, modelling and outlooks, Environmental policy tools and evaluation. All articles published by MDPI are made immediately available worldwide under an open access license. conceived and designed the experiments; N.N.W.S. interesting to authors, or important in this field. The organ paraffin section was prepared, stained with hemotoxylin and eosin and processed for a light microscope fitted with an optilab viewer [, Data were expressed as mean standard deviation (SD) and analyzed statistically by a one-way Analysis of Variance (ANOVA). We use cookies on our website to ensure you get the best experience. of the study include measurement and daily and detailed observations (haematology 0 <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 594.96 842.04] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> In all five female testing animals, signs of neither toxicity nor death among the rats were observed during the 14 days of the acute toxicity experimental period, after the administration of a single oral dose of the testing suspension of 2000 mg/kg bw. The test compound is administered by gavage or via the diet or drinking water. The animals were 68 weeks old, and were stabilized for seven days prior to the experiments. Carrageenan has been widely used in food, pharmaceutical and industrial applications. endobj The middle dose was converted by the following calculation: The low and high doses were set as 1/3- and 2.5-fold of the middle dose, respectively.
During acclimatization, the rats were randomized into experimental and control groups. published in the various research areas of the journal. -Carrageenan; Konjac Glucomannan; soft capsule; toxicity, Values are expressed as the mean SD; * significantly different from the control group (. <>/Metadata 1514 0 R/ViewerPreferences 1515 0 R>> 17 0 obj <>stream several techniques or approaches, or a comprehensive review paper with concise and precise updates on the latest Organisation for Economic, MOPAN Multilateral Organisation Performance Assessment Network, Biodiversity, water and natural resource management, Consumption, innovation and the environment, Environment in emerging and transition economies, Environmental indicators, modelling and outlooks, Environmental policy tools and evaluation. For Lipid disorders in diabetes mellitus and current management.