Foronda Natalia M, Fowles Jefferson, Smith Nerida, Taylor Michael, Temple Wayne, Darlington Cynthia
Ministry of Health, Wellington, New Zealand.
Regul Toxicol Pharmacol. 2007 Feb;47(1):29-36. doi: 10.1016/j.yrtph.2006.08.005. Epub 2006 Oct 6.
This paper presents the development of a tolerable daily intake (TDI) for sodium monofluoroacetate (1080) using the quantal myocardial and testicular toxicity end points derived from the traditional NOAEL and newer benchmark dose (BMD) methods. 1080 is a highly toxic vertebrate pesticide that has been proven to be effective in controlling possums and other pests. By convention, the TDIs are derived using the traditional no-observed-adverse-effect-level (NOAEL) and applying appropriate default uncertainty factors (UF). In addition to the default UF, a statistically derived UF was also employed in deriving the TDI. The TDIs derived from the NOAEL and BMD approach, 0.075 and 0.10 mg/kg bw/day, respectively, were compared. The resulting TDI estimates using the BMDL, a statistical lower confidence bound on the BMD, were generally consistently slightly higher than those derived using the NOAEL approach. Based on the best fit of modelled dose-response data, a TDI of 0.03 micro g/kg bw/day is proposed for human health risk assessment of 1080.
本文介绍了使用源自传统无观察到有害作用水平(NOAEL)和更新的基准剂量(BMD)方法的定量心肌和睾丸毒性终点,来制定氟乙酸钠(1080)的每日可耐受摄入量(TDI)。1080是一种剧毒的脊椎动物杀虫剂,已被证明在控制负鼠和其他害虫方面有效。按照惯例,TDI是使用传统的未观察到有害作用水平(NOAEL)并应用适当的默认不确定性系数(UF)来推导的。除了默认的UF外,在推导TDI时还采用了一个统计得出的UF。比较了分别从NOAEL和BMD方法得出的TDI,分别为0.075和0.10毫克/千克体重/天。使用BMDL(BMD的统计下限)得出的TDI估计值通常始终略高于使用NOAEL方法得出的值。基于模拟剂量反应数据的最佳拟合,提出了0.03微克/千克体重/天的TDI用于1080的人体健康风险评估。