Abstract
SAFETY ASSESSMENTS OF PROTEIN SUPPLEMENT (NRL20195PNV) FOR ACUTE AND 28 DAYS REPEAT DOSE TOXICITY STUDIES AS PER OECD GUIDELINES

Priya Khare, Dr. Omkar Kulkarni*, Dr. Anuj Agrawal, Dr. Gayatri Ganu and Dr. Sohan Chitlange

ABSTRACT

In the present study, we investigated the toxicity of a supplementary protein with micronutrient fortificationin mice for determination of LD50through the acute toxicity study. LD50 values, obtained by single doses were more than 5000 mg/kg body weight. 28 days repeat dose toxicity was studied in rats treated daily with an oral dose of 1000 mg/kg body wt. for 28 days. Hematological and biochemical analyses were carried out together with histological analyses of the liver, heart, kidney and lung tissues etc. As a result, we observed no mortality andnon-significant changes in the biological and hematological parameters in rodents after 28 days of daily dosing, it may be concluded that the NRL20195PNV does not appear to have significant toxicity. The histopathological investigations revealed normal articulate and organ weight of vital tissues with no signs of toxicity. Based on the findings of this study, the no observed adverse effect level (NOAEL) of NRL20195PNV in mice, following oral administration for 28 days was found to be 1000 mg/kg body weight.

Keywords: Repeat dose toxicity, histopathology, acute toxicity, nutraceuticals.


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