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Title: | Report of Sub–chronic toxicity (safety) Evaluation of Prosopis juliflora - Mesocarp in Sprague Dawley rats Volume-Ill |
Other Titles: | Not Available |
Authors: | Not Available |
ICAR Data Use Licennce: | http://krishi.icar.gov.in/PDF/ICAR_Data_Use_Licence.pdf |
Author's Affiliated institute: | ICAR::Central Arid Zone Research Institute NATIONAL INSTITUTE OF NUTRITION (Indian Council of Medical Research) HYDERABAD, INDIA, 500007 |
Published/ Complete Date: | 2014-01-01 |
Project Code: | Not Available |
Keywords: | Sub–chronic toxicity (safety) Evaluation Prosopis juliflora Mesocarp Sprague Dawley rats |
Publisher: | Not Available |
Citation: | Not Available |
Series/Report no.: | Not Available; |
Abstract/Description: | Methodology: The investigation was conducted in sixty Sprague Dawley rats (30M+30F), aged 6- 8 weeks, weighing 180-200g obtained from the National Center for Laboratory Animal Science (NCLAS) after approval of IAEC (No.P8/1–2011/BDK). Test materials: The powdered test material supplied from sponsor has been subjected for compositional analysis. The wheat in the standard pellet diet was replaced with 40% and 80% of test material (Mesocarp) (SOP-Appendix-VIII). The pellet diet with and without test material has been provided to the animals in respective groups (SOP-Appendix-VIII). S.No Group Details Test material administration 1. Control: Standard Diet (NCLAS Pellet diet) 2. PJM-40: wheat flour substituted with 40% of mesocarp 3. PJM-80: wheat flour substituted with 80% of mesocarp Test Material preparation: The test material supplied by the sponsor was Prosopis juliflora – (Mesocarp). based on the exposure level (40% and 80%), the above test material has been substituted to wheat flour in NIN standard diet and prepared as a pellet for oral feeding ‘ad libitum’ as per SOP (No.17 /PHARM /NIN/CO1 /ATI /2007/OL). Diet was autoclaved at 121oC at 15lb/pressure and air dried and canned properly and labeled as Control diet, PJM-40 and PJM-80 respectively and stored at room temperature. Test diet was prepared for every 10 days. Entire procedure was repeated for every 10 days for 3 months. The prepared test material pellet diet was fed daily for 90 days to the respective group animals. Test Material Administration (a) Control Group: The standard NIN pellet Diet was given 20-25 gm to each rat daily for 90 days. (b) PJM-40 Group: The PJM-40 substituted NIN pellet was given 20-25 gm to each ratdaily for 90 days. (c) PJM-80 Group: The PJM-80 substituted NIN pellet was given 20-25 gm to each rat daily for 90 days. Experimental phase: All rats were conditioned for 11 days. The conditioned animals were randomly divided into three groups viz., i. Control (c) ii. PJM-40 (mesocarp-40%) (iii) PJM-80 (mesocarp-80%). The dietary profile was recorded daily for nine days after conditioning period. The test material containing 40% and 80% mesocarp were fed for 90 days to respective groups. Study Parameters: The body weight was recorded twice in a week, whereas feed intake was monitored daily till end of experiment. The live phase, cage side, physical and neurological activity were examined biweekly. The clinical chemistry, hematology, profile was assessed in serum and blood samples after 48hrs of last exposure. Serum IgG2a, & IgE were determined to determine assess allergenicity potential if any. The animals were euthanized 48 hours of last exposure followed gross necropsy and recording of weights of vital organs. All organs were subjected for histopathological evaluation. The data was compiled and analyzed for significant differences between individual groups. Results: All animal were active and no Pre–terminal deaths were recorded in any group of animals. Feed intake has increased significantly in animals received the pellet diet containing test material (mesocarp 40% and 80%) till 8th day. However, from 10th day there was no significant difference in food consumption profile among the groups. The body weight was found significantly reduced till 8th day in test groups. However the gain in body weight was comparable in all animals till end of the experiment. There were no abnormal changes in live phase, physical and neurological activity between the control and test groups throughout the study period. The clinical chemistry profile was normal in all groups except calcium and triglycerides levels which increased in PJM-40 but were in normal historical range as compared to control. There were no significant observations found in hematological parameters. There were no clinical signs suggesting allergic reactions. There were no significant abnormal changes in serum total IgG2a, IgE levels in animals exposed to test material as compared to control group of animals. No gross changes were observed in any of the organs examined during Necropsy. The weight of lungs in 40% mesocarp group significantly decreased as 80% mesocarp. However liver weight in both experimental group were significantly higher as compare to control group in both sex. Histopathological changes were comparable between the groups and not considered significant. Conclusion: All animals were active and there was no mortality in any group of animals which received 40% and 80% mesocarp daily for 90 days. Though there was significant observations in the initial phase of experiment but found to be normal with the duration of experiment in feed intake and body weight gain. Clinical chemistry and hematology profile indicate no abnormal changes in rats expose to PJM-40 and PJM-80. Histopathological changes were comparable between the groups and not considered significant. Study impression: The replacement of Prosopis juliflora mesocarp 40% - 80% with wheat in the standard NIN diet did not induce any morbidity till 90days of study period in experimental animals. |
Description: | Report of Sub–chronic toxicity (safety) Evaluation of Prosopis juliflora - Mesocarp in Sprague Dawley rats Volume-Ill |
ISSN: | Not Available |
Type(s) of content: | Other |
Sponsors: | Not Available |
Language: | English |
Name of Journal: | Not Available |
Volume No.: | Not Available |
Page Number: | 1-271 |
Name of the Division/Regional Station: | Not Available |
Source, DOI or any other URL: | Not Available |
URI: | http://krishi.icar.gov.in/jspui/handle/123456789/39938 |
Appears in Collections: | NRM-CAZRI-Publication |
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