カラメルIの変異原性試験

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Caramel color, a food additive which is widely used as a food color for beverages, seasonings, confectionery and many food products, is obtained by heat-treating food-grade carbohydrates including starch hydrolysates, molasses, or saccharides. Caramel color is classified into Caramel I, Caramel II, Caramel III, and Caramel IV according to each manufacturing method. As part of a series of studies to evaluate the safety of caramel color A, which is made from the raw materials containing molasses and is classified into Caramel I, its mutagenicity was examined by mutagenicity studies (a reverse mutation test, a chromosome aberration test, and a micronucleus test). In the reverse mutation test, the chromosome aberration test, and the micronucleus test, the mutagenicity of caramel color A was found to be negative at the highest concentrations specified in the Guidelines for Designation of Food Additives and for Revision of Standards for Use of Food Additives. Specifically, negative results were obtained at 5000μg/plate by the method without metabolic activation and with metabolic activation in the reverse mutation test. In a cell growth inhibition test performed prior to the chromosomal aberration test, the 50% cell growth inhibition concentration (IC_<50>) of caramel color A was found to be 5000μg/mL or higher by the method with metabolic activation in the presence of S9 mix, and 3309μg/mL by the direct method. In the chromosomal aberration test, negative reactions were noted at 5000μg/mL by the method with metabolic activation and at 3500μg/mL by the direct method. Caramel color A at 4000μg/mL, a dose inducing overt cytotoxicity, caused chromosomal aberrations, but the aberration potential was weak without dose-dependency. Negative results were obtained at 2000 mg/kg, the highest dosage level, in the micronucleus test, and the maximal tolerated dose is estimated at 2000 mg/kg or higher. Based on the above results and considering the human intake, it can be concluded that there is no potentiality caramel color A causes gene mutations or chromosomal aberations in a living body.
2000-04-30

カラメルIの変異原性試験

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