Incos Boté GmbH, D-55232 Alzey, Friedhofstrasse 6, Germany.
Radiat Res. 2013 Feb;179(2):243-53. doi: 10.1667/RR2914.1. Epub 2013 Jan 14.
Exposure to radiofrequency (RF) electromagnetic fields (EMF) is continuously increasing worldwide. Yet, conflicting results of a possible genotoxic effect of RF EMF continue to be discussed. In the present study, a possible genotoxic effect of RF EMF (GSM, 1,800 MHz) in human lymphocytes was investigated by a collaboration of six independent institutes (institutes a, b, c, d, e, h). Peripheral blood of 20 healthy, nonsmoking volunteers of two age groups (10 volunteers 16-20 years old and 10 volunteers 50-65 years old) was taken, stimulated and intermittently exposed to three specific absorption rates (SARs) of RF EMF (0.2 W/kg, 2 W/kg, 10 W/kg) and sham for 28 h (institute a). The exposures were performed in a setup with strictly controlled conditions of temperature and dose, and randomly and automatically determined waveguide SARs, which were designed and periodically maintained by ITIS (institute h). Four genotoxicity tests with different end points were conducted (institute a): chromosome aberration test (five types of structural aberrations), micronucleus test, sister chromatid exchange test and the alkaline comet assay (Olive tail moment and % DNA). To demonstrate the validity of the study, positive controls were implemented. The genotoxicity end points were evaluated independently by three laboratories blind to SAR information (institute c = laboratory 1; institute d = laboratory 2; institute e = laboratory 3). Statistical analysis was carried out by institute b. Methods of primary statistical analysis and rules to adjust for multiple testing were specified in a statistical analysis plan based on a data review before unblinding. A linear trend test based on a linear mixed model was used for outcomes of comet assay and exact permutation test for linear trend for all other outcomes. It was ascertained that only outcomes with a significant SAR trend found by at least two of three analyzing laboratories indicated a substantiated suspicion of an exposure effect. On the basis of these specifications, none of the nine end points tested for SAR trend showed a significant and reproducible exposure effect. Highly significant differences between sham exposures and positive controls were detected by each analyzing laboratory, thus validating the study. In conclusion, the results show no evidence of a genotoxic effect induced by RF EMF (GSM, 1,800 MHz).
射频(RF)电磁场(EMF)的辐射在全球范围内不断增加。然而,射频 EMF 可能产生遗传毒性的结果仍存在争议。在本研究中,由六个独立研究所(研究所 a、b、c、d、e、h)合作,研究了 RF EMF(GSM,1800MHz)对人类淋巴细胞的可能遗传毒性作用。从 20 名年龄在 16-20 岁和 50-65 岁的健康非吸烟志愿者的外周血中采集样本,刺激并间歇性暴露于三种特定吸收率(SAR)的 RF EMF(0.2W/kg、2W/kg、10W/kg)和假照射下 28 小时(研究所 a)。暴露是在严格控制温度和剂量的条件下进行的,并且采用由 ITIS(研究所 h)设计并定期维护的自动确定波导 SAR 的设置进行。进行了四项具有不同终点的遗传毒性测试(研究所 a):染色体畸变测试(五种类型的结构畸变)、微核测试、姐妹染色单体交换测试和碱性彗星分析(Olive 尾巴矩和%DNA)。为了证明研究的有效性,实施了阳性对照。三个实验室独立评估遗传毒性终点,对 SAR 信息不知情(研究所 c=实验室 1;研究所 d=实验室 2;研究所 e=实验室 3)。研究所 b 进行统计分析。在未拆盲前的数据审查基础上,根据统计分析计划指定了主要统计分析方法和用于多重检测调整的规则。基于线性混合模型的线性趋势检验用于彗星分析的结果,而所有其他结果的线性趋势则采用精确置换检验。确定只有至少两个分析实验室发现具有显著 SAR 趋势的结果表明存在合理的暴露效应怀疑。根据这些规范,没有一个测试 SAR 趋势的九个终点显示出显著且可重复的暴露效应。每个分析实验室都检测到 sham 暴露和阳性对照之间存在显著差异,从而验证了该研究。总之,结果表明,射频 EMF(GSM,1800MHz)没有引起遗传毒性的证据。