Lillicrap Adam, Springer Tim, Tyler Charles R
Norwegian Institute for Water Research (NIVA), Oslo, NO-0349, Norway.
Wildlife International, 8598 Commerce Drive, Easton, MD 21601, USA.
Regul Toxicol Pharmacol. 2016 Mar;75:20-6. doi: 10.1016/j.yrtph.2015.12.012. Epub 2015 Dec 25.
There is currently limited guidance available for regulators and risk assessors on how to use data from non-guideline methods when assessing the bioaccumulation potential of a chemical. Furthermore, bioaccumulation assessments can be more subjective than they need to be due to the lack of a guidance framework on how to use/include the range of information that may be available for a substance. Under some circumstances, in silico, in vitro and/or in vivo non-test guideline data may be sufficient to classify whether a substance is bioaccumulative without the need for further animal testing. Classifying the bioaccumulative potential of a substance is especially difficult when the bioconcentration factor (BCF) is close to the threshold for defining it as bioaccumulative/very bioaccumulative (B/vB), and a more structured process is required to reduce uncertainty in the BCF estimates. In these situations, in silico and in vitro data can, and should, be used to provide greater confidence in classifying these substances. To aid future evaluations of bioaccumulation data, a proposed tiered assessment strategy is presented incorporating all available data on the bioaccumulative properties of a substance. In addition, a revised scheme is recommended for improving the classification of the bioaccumulative potential of a substance.
目前,对于监管机构和风险评估人员而言,在评估化学品的生物累积潜力时如何使用非标准方法得出的数据,可用的指导有限。此外,由于缺乏关于如何使用/纳入某物质可能有的各类信息的指导框架,生物累积评估可能比应有的情况更主观。在某些情况下,计算机模拟、体外和/或体内非测试标准数据可能足以对一种物质是否具有生物累积性进行分类,而无需进一步进行动物试验。当生物浓缩系数(BCF)接近将其定义为具有生物累积性/高度生物累积性(B/vB)的阈值时,对一种物质的生物累积潜力进行分类尤其困难,需要一个更有条理的过程来减少BCF估计值的不确定性。在这些情况下,可以而且应该使用计算机模拟和体外数据,以便在对这些物质进行分类时更有信心。为了帮助未来对生物累积数据进行评估,提出了一种分层评估策略,纳入了关于一种物质生物累积特性的所有可用数据。此外,还建议采用一种修订方案,以改进对一种物质生物累积潜力的分类。