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首页> 外文期刊>Regulatory Toxicology and Pharmacology: RTP >Using urinary solubility data to estimate the level of safety concern of low levels of melamine (MEL) and cyanuric acid (CYA) present simultaneously in infant formulas.
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Using urinary solubility data to estimate the level of safety concern of low levels of melamine (MEL) and cyanuric acid (CYA) present simultaneously in infant formulas.

机译：使用尿液溶解度数据来估算婴儿配方食品中同时存在的三聚氰胺（MEL）和氰尿酸（CYA）含量较低的安全问题。

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摘要

Melamine (MEL) and cyanuric acid (CYA) may occur simultaneously in milk products. There is no health based guidance value for the mixture of MEL+CYA. Limited toxicological data indicate that MEL+CYA toxicity occurs at levels lower than the toxic doses of the single compounds. The key adverse effect of MEL+CYA is the formation of crystals in the urinary tract, which is dependent on the solubility of the MEL+CYA complex. Urinary concentrations resulting from oral doses of MEL+CYA and MEL alone have been calculated from published data from animal studies. A human exposure scenario assuming consumption of infant formula contaminated at a level of 1 ppm of MEL and CYA each (2 ppm of MEL+CYA) was also analyzed. Margins of more than two orders or magnitude were observed between estimated urine concentrations known to be without detectable effects in rats and calculated human urine concentrations. Because the hazard is related to the physico-chemical characteristics of the mixture, there would be a negligible concern associated with crystal formation if the urinary concentration of the complex is within the solubility range. The solubility of MEL+CYA was higher in urine than in water. A strong pH-dependency was observed with the lowest solubility found at pH 5-5.5. The calculated human urinary concentration was about 30 times less than the solubility limit for MEL+CYA in adult human urine. Altogether, these data provide preliminary evidence suggesting that the presence of 1 ppm of MEL and CYA each in infant formula is unlikely to be of significant health concern.
机译：乳制品中可能同时存在三聚氰胺（MEL）和氰尿酸（CYA）。 MEL + CYA的混合物没有基于健康的指导值。有限的毒理学数据表明，MEL + CYA毒性的水平低于单个化合物的毒性剂量。 MEL + CYA的主要不利作用是在尿道中形成晶体，这取决于MEL + CYA复合物的溶解度。根据动物研究的已公布数据，已计算出口服MEL + CYA和仅MEL所产生的尿液浓度。还分析了假设婴儿配方奶的消费量分别受到MEL和CYA 1 ppm（MEL + CYA 2 ppm）污染的人体暴露情况。在估计对大鼠无影响的估计尿液浓度与计算出的人尿液浓度之间，观察到超过两个数量级或数量级的差异。因为危害与混合物的物理化学特性有关，所以如果配合物的尿浓度在溶解度范围内，则与晶体形成有关的问题可以忽略不计。 MEL + CYA在尿液中的溶解度高于在水中的溶解度。观察到强烈的pH依赖性，在pH 5-5.5时发现最低的溶解度。计算得出的人尿液浓度比成人尿液中MEL + CYA的溶解度极限低约30倍。总而言之，这些数据提供了初步证据，表明婴儿配方食品中分别存在1 ppm的MEL和CYA不太可能引起重大健康问题。

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