Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 53, Issue 3, Pages 186-194Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2009.01.002
Keywords
Mortierella alpina; Arachidonic acid; Infant formula; Histopathology; Safety studies
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Funding
- Council of Scientific and Industrial Research (CSIR)
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Safety evaluation of arachidonic acid rich Mortierella alpina biomass was carried out in Wistar rats by acute and subchronic oral toxicity studies. A preliminary acute toxicity study revealed that the biomass was safe at acute doses and that the LD50 exceeded 5000 mg/kg BW, the highest dose used in the study. In subchronic study, rats were fed diet containing 0, 2500, 5000,10,000, 20,000 and 30,000 mg/kg, M. alpina biomass for a period of 13 weeks. Results indicated that biomass fortification had a positive influence on growth with no overt toxic effects on the survival, food consumption and body weight gain throughout the treatment interlude. The statistically significant changes in relative organ weights, serum biochemical and hematological indices in M. alpina fed groups' viz., higher relative weights of spleen, liver, brain and ovary in females, reduced hemoglobin concentration in males, elevated WBC counts at highest dose, reduction in serum triglycerides and increased alkaline phosphatase activity were not concomitant with pertinent histopathological changes and hence toxicologically inconsequential. No microscopic or macroscopic lesions attributable to the treatment were manifested in the experimental groups. The results of the present study strongly advocate the safety of M. alpina biomass in rats at levels used in the study. (C) 2009 Elsevier Inc. All rights reserved.
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