Barnes D G, Daston G P, Evans J S, Jarabek A M, Kavlock R J, Kimmel C A, Park C, Spitzer H L
United States Environmental Protection Agency, Washington, District of Columbia 20460, USA.
Regul Toxicol Pharmacol. 1995 Apr;21(2):296-306. doi: 10.1006/rtph.1995.1043.
The purpose of the Benchmark Dose Workshop was to assess the feasibility and implications of replacing the no observed adverse effect level (NOAEL) with a benchmark dose (BMD) when deriving reference doses and concentrations (RfDs and RfCs). The workshop participants supported the use of the BMD method to remove many of the limitations inherent in using the NOAEL approach. Participants endorsed in general the use of a BMD for all quantal noncancer health effects and endorsed in particular the BMD for assessing developmental toxicity based on data presented at the workshop. The discussions of implementation recognized the need to demonstrate that changing from a NOAEL to a BMD gives the risk manager more certain information on which to base decisions. Most participants agreed that the current NOAEL-derived RfDs and RfCs are sufficiently protective and should only be changed as data become available for estimating a BMD. It was recognized that to achieve general acceptance of the BMD approach, it will have to be applied to a variety of endpoints.
基准剂量研讨会的目的是评估在推导参考剂量和浓度(RfDs和RfCs)时,用基准剂量(BMD)取代未观察到有害作用水平(NOAEL)的可行性和影响。研讨会参与者支持使用BMD方法来消除使用NOAEL方法时固有的许多局限性。参与者普遍认可将BMD用于所有定量非癌症健康效应,尤其认可根据研讨会上提供的数据将BMD用于评估发育毒性。关于实施的讨论认识到,有必要证明从NOAEL转变为BMD能为风险管理者提供更确定的决策依据信息。大多数参与者一致认为,目前由NOAEL推导得出的RfDs和RfCs具有足够的保护作用,只有在有数据可用于估算BMD时才应进行更改。人们认识到,要使BMD方法得到广泛认可,就必须将其应用于各种终点指标。