Safety and mutagenicity evaluation of nanoparticulate red mold rice. 2008

Chiun-Chieh Yu, and Jyh-Jye Wang, and Chun-Lin Lee, and Shu-Hui Lee, and Tzu-Ming Pan
Institute of Microbiology and Biochemistry, National Taiwan University, Taipei, Taiwan, Republic of China.

Nowadays, people have recognized the importance of Monascus fermented products due to their many health benefits. A previous study demonstrated a novel formulation approach for the preparation of nanoparticulate red mold rice (NRMR). The aim of this study is to determine the useability of stable NRMR dispersion by evaluating its safety and mutagenicity with the Ames test. The crude red mold rice (RMR) was processed using a wet milling technology in the presence of distilled water to form an aqueous-based nanoparticle dispersion with a mean particle size of 259.3 nm. The formulated diepersion was found to be homogeneous and exhibited unimodal particle size distribution when analyzed by dynamic laser scattering techniques. Ames test results indicated that the equivalent of up to 1 mg of ethanol extract of RMR per plate exhibited no genotoxicity toward Salmonella typhimurium strains TA 98, TA 100, and TA 102. In the feeding toxicity test, the no observed adverse effect level (NOAEL) of NRMR was found to be 1000 mg/kg/day for both male and female rats. In conclusion, red mold rice can be formulated as a stable nanoparticulate dispersion using wet milling technology. In vitro and in vivo safety evaluations of NRMR indicated that no mutagenic or toxic responses were observed in this study.

UI MeSH Term Description Entries
D008297 Male Males
D009152 Mutagenicity Tests Tests of chemical substances and physical agents for mutagenic potential. They include microbial, insect, mammalian cell, and whole animal tests. Genetic Toxicity Tests,Genotoxicity Tests,Mutagen Screening,Tests, Genetic Toxicity,Toxicity Tests, Genetic,Genetic Toxicity Test,Genotoxicity Test,Mutagen Screenings,Mutagenicity Test,Screening, Mutagen,Screenings, Mutagen,Test, Genotoxicity,Tests, Genotoxicity,Toxicity Test, Genetic
D009153 Mutagens Chemical agents that increase the rate of genetic mutation by interfering with the function of nucleic acids. A clastogen is a specific mutagen that causes breaks in chromosomes. Clastogen,Clastogens,Genotoxin,Genotoxins,Mutagen
D010316 Particle Size Relating to the size of solids. Particle Sizes,Size, Particle,Sizes, Particle
D010936 Plant Extracts Concentrated pharmaceutical preparations of plants obtained by removing active constituents with a suitable solvent, which is evaporated away, and adjusting the residue to a prescribed standard. Herbal Medicines,Plant Extract,Extract, Plant,Extracts, Plant,Medicines, Herbal
D004032 Diet Regular course of eating and drinking adopted by a person or animal. Diets
D005260 Female Females
D005285 Fermentation Anaerobic degradation of GLUCOSE or other organic nutrients to gain energy in the form of ATP. End products vary depending on organisms, substrates, and enzymatic pathways. Common fermentation products include ETHANOL and LACTIC ACID. Fermentations
D005511 Food Handling Any aspect of the operations in the preparation, processing, transport, storage, packaging, wrapping, exposure for sale, service, or delivery of food. Food Processing,Handling, Food,Processing, Food
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia

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