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Studies of the Toxicological Potential of Capsinoids: V. Genotoxicity Studies of Dihydrocapsiate

SRA International, Inc., Cambridge, Maryland, USA

Eri Watanabe
Terutaka Kodama
Shoji Tsubuku
Akira Otabe

Toxicology and Pathology, Nonclinical Developmental Research Department, Pharmaceutical Research Laboratories, Pharmaceutical Company, Ajinomoto Co., Inc., Kawasaki, Kanagawa, Japan

Madoka Nakajima
Shoji Masumori
Sawako Shimada
Jin Tanaka

Biosafety Research Center, Foods, Drugs and Pesticides, Iwata, Shizuoka, Japan

Takeshi Masuyama

Toxicology and Pathology, Nonclinical Developmental Research Department, Pharmaceutical Research Laboratories, Pharmaceutical Company, Ajinomoto Co., Inc., Kawasaki, Kanagawa, Japan

Correspondence: Address correspondence to Bruce K. Bernard, PhD, President, SRA International, Inc., 5235 Ragged Point Road, Cambridge, MD 21613, USA. E-mail:Bernard{at}sra-intl.com

A series of studies was performed to evaluate the safety of dihydrocapsiate (4-hydroxy-3-methoxybenzyl 8-methylnonanoate; CAS no. 205687-03-2). This study evaluated the potential genotoxicity of this compound using a variety of in vitro and in vivo test systems, including bacterial reverse mutation test, chromosomal aberration test, micronucleus test, gene mutation assay with transgenic rats, and single-cell gel (SCG) assay (Comet assay). In vitro tests (bacterial reverse mutation test and chromosomal aberration test) produced positive results in the absence of metabolic activation, but negative results in the presence of metabolic activation. The in vivo gene mutation assay (with transgenic rats) produced negative results, as did the in vivo mouse micronucleus assay, which failed to induce micronucleated polychromatic erythrocytes. Although the rat SCG assay produced statistically significant increases in the Olive tail moment and % tail DNA of the liver and intestine in the 2000 mg/kg group (compared with the negative-control group), a number of factors caused the authors to question the validity of these findings. Taken together, these results suggest that dihydrocapsiate has a low or extremely low likelihood of inducing genotoxicity.

Key Words: Capsiate • Capsinoids • Clastogenicity • Dihydrocapsiate • Genotoxicity • Mutagenicity

International Journal of Toxicology, Vol. 27, No. 3 Suppl, 59-72 (2008)
DOI: 10.1080/10915810802513536


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