PDF(Pubmed)
Abstract：
The European Commission asked EFSA to update its 2011 risk assessment on tetrabromobisphenol A (TBBPA) and five derivatives in food. Neurotoxicity and carcinogenicity were considered as the critical effects of TBBPA in rodent studies. The available evidence indicates that the carcinogenicity of TBBPA occurs via non-genotoxic mechanisms. Taking into account the new data, the CONTAM Panel considered it appropriate to set a tolerable daily intake (TDI). Based on decreased interest in social interaction in male mice, a lowest observed adverse effect level (LOAEL) of 0.2 mg/kg body weight (bw) per day was identified and selected as the reference point for the risk characterisation. Applying the default uncertainty factor of 100 for inter- and intraspecies variability, and a factor of 3 to extrapolate from the LOAEL to NOAEL, a TDI for TBBPA of 0.7 μg/kg bw per day was established. Around 2100 analytical results for TBBPA in food were used to estimate dietary exposure for the European population. The most important contributors to the chronic dietary LB exposure to TBBPA were fish and seafood, meat and meat products and milk and dairy products. The exposure estimates to TBBPA were all below the TDI, including those estimated for breastfed and formula-fed infants. Accounting for the uncertainties affecting the assessment, the CONTAM Panel concluded with 90%-95% certainty that the current dietary exposure to TBBPA does not raise a health concern for any of the population groups considered. There were insufficient data on the toxicity of any of the TBBPA derivatives to derive reference points, or to allow a comparison with TBBPA that would support assignment to an assessment group for the purposes of combined risk assessment.
摘要：
欧盟委员会要求EFSA更新其2011年对四溴双酚A（TBBPA）和五种食品衍生物的风险评估。神经毒性和致癌性被认为是TBBPA在啮齿动物研究中的关键作用。现有证据表明TBBPA的致癌性是通过非遗传毒性机制发生的。考虑到新的数据，CONTAM小组认为设定可容忍的每日摄入量(TDI)是适当的。基于对雄性小鼠社会互动的兴趣下降，我们确定了观察到的最低不良反应水平(LOAEL),即每天0.2mg/kg体重(bw),并选择其作为风险表征的参考点.将默认的不确定性因子100应用于种间和种内变异性，从LOAEL推断为NOAEL的系数为3，TBBPA的TDI为每天0.7μg/kgbw。大约2100年食物中TBBPA的分析结果用于估计欧洲人口的饮食暴露。慢性膳食LB暴露于TBBPA的最重要因素是鱼类和海鲜，肉和肉制品以及牛奶和奶制品。对TBBPA的暴露估计都低于TDI，包括那些估计为母乳喂养和配方喂养的婴儿。对影响评估的不确定因素进行会计处理，CONTAM小组以90%-95%的确定性得出结论,目前的TBBPA饮食暴露不会对所考虑的任何人群造成健康问题.关于任何TBBPA衍生物的毒性的数据不足以得出参考点，或允许与TBBPA进行比较，这将支持分配给评估小组以进行综合风险评估。
