Abstract

(1) Background: a hybrid black rice rich in β-carotene carrying the psy and crtI genes (HJM) was evaluated in Wistar rats by a 90-day feeding study, aiming to assess its dietary safety. (2) Methods: the HJM rice and its parental line HS were included in rats’ diets at levels of 73.5% and 75.5%, respectively. The AIN-93 diet was administered as a nutritional control. No adverse effects on animal behavior or weight gain were observed during the study. Blood samples were collected and analyzed, and standard hematological and biochemical parameters were compared. (3) Results: Some parameters were found to be significantly different, though they remained within the normal range for rats of this breed and age. In addition, upon sacrifice, various organs were weighed, and macroscopic and histopathological examinations were performed, with only minor changes to report. (4) Conclusions: HJM rice exhibited no adverse or toxic effects in Wistar rats in this 90-day study.

Highlights

  • Rice is one of the most important crops, serving as the staple food for nearly half of the global population [1]

  • The safety assessment of transgenic crops is based on the principle of substantial equivalence that has been originally proposed by the OECD [9]

  • This principle focuses on comparing a transgenic crop to its non-transgenic counterpart using compositional analysis to determine whether the insertion of a gene leads to an imbalance of nutrition constituents

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Summary

Introduction

Rice is one of the most important crops, serving as the staple food for nearly half of the global population [1]. In this toxicology study, a transgenic rice line (HJM) rich in β-carotene and its parental line (HS) were compared. The safety assessment of transgenic crops is based on the principle of substantial equivalence that has been originally proposed by the OECD [9]. This principle focuses on comparing a transgenic crop to its non-transgenic counterpart using compositional analysis to determine whether the insertion of a gene leads to an imbalance of nutrition constituents. In this study, we performed a subchronic feeding experiment to examine the potential adverse effects of the transgenic rice HJM rich in β-carotene

Test Materials
Diet Formulation and Feeding
Animals and Housing
Study Method
Statistical Analysis
Diet Nutritional Composition
Hematology
Serum Biochemistry
Histopathologic
Discussion
Conclusions
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