Hart R W, Freni S C, Gaylor D W, Gillette J R, Lowry L K, Ward J M, Weisburger E K, Lepore P, Turturro A
Risk Anal. 1986 Jun;6(2):117-54. doi: 10.1111/j.1539-6924.1986.tb00202.x.
The Color Additives Scientific Review Panel considered whether there was information sufficient to perform a carcinogenic risk assessment on the colors D&C Red No. 19 (R-19), D&C Red No. 37 (R-37), D&C Orange No. 17 (O-17), D&C Red No. 9 (R-9), D&C Red No. 8 (R-8) and FD&C Red No. 3 (R-3) and to evaluate the assessments sent to FDA as part of the petitions for use of the colors for drug and external uses by the Cosmetic, Toiletry and Fragrance Association (CTFA). There is a lack of human data concerning the colors for making a human health assessment, so the assessments are based upon the extrapolation of animal data. The risk assessments are determined for exposure to single chemicals. Excluded from consideration are possible effects from exposure to multiple chemicals, such as co-carcinogenesis, promotion, synergism, antagonism, etc. In the light of recent efforts in establishing a consensus in risk assessment, the Panel has determined that the CTFA assessments for R-10, O-17, and R-9 are consistent with present acceptable usages, although it questions some of the assumptions used in the assessments. The Panel identified a number of general assumptions made, and discusses their validity, their impact on total uncertainty, and the potential options to address the gaps in understanding that necessitate the assumption. The Panel also derived revised risk estimates using more "reasonable" assumptions than "worst-case" situations, for 90th percentile and average exposure. For those assumptions that are easily quantifiable, the Panel's estimates are less than an order of magnitude lower than the CTFA risk estimates, indicating that the underestimates and overestimates of the CTFA risk estimates tend to balance each other. The impact of most of the assumptions is not quantifiable. The assessment for R-3 is complicated by the fact that there is no good skin penetrance study for this color. It was assumed that the penetrance is similar to that of another water-soluble xanthene color, R-19. It is expected that the absorption of the color is not likely to exceed that of the smaller molecule, R-19. Therefore, the risk estimates are similar to the CTFA estimates, but with different reasoning. The estimates for R-8 and R-37 are different from the others in that there is a lack of any exposure or toxicological information on these colors.(ABSTRACT TRUNCATED AT 400 WORDS)
颜色添加剂科学审查小组审议了是否有足够信息对D&C红19号（R - 19）、D&C红37号（R - 37）、D&C橙17号（O - 17）、D&C红9号（R - 9）、D&C红8号（R - 8）和FD&C红3号（R - 3）进行致癌风险评估，并评估化妆品、盥洗用品和香料协会（CTFA）作为药物和外用产品颜色使用申请的一部分提交给美国食品药品监督管理局（FDA）的评估报告。由于缺乏用于人类健康评估的关于这些颜色的人体数据，所以评估基于动物数据的外推。风险评估是针对单一化学品暴露进行的。未考虑多种化学品暴露可能产生的影响，如共致癌作用、促进作用、协同作用、拮抗作用等。鉴于近期在风险评估中达成共识所做的努力，小组认定CTFA对R - 10、O - 17和R - 9的评估与目前可接受的用途一致，不过对评估中使用的一些假设提出了质疑。小组确定了一些普遍假设，并讨论了它们的有效性、对总不确定性的影响以及解决因假设而产生的理解差距的潜在选项。小组还使用比“最坏情况”更“合理”的假设得出了第90百分位数和平均暴露情况下的修订风险估计值。对于那些易于量化的假设，小组的估计值比CTFA风险估计值低不到一个数量级，这表明CTFA风险估计值的低估和高估往往相互抵消。大多数假设的影响无法量化。R - 3的评估因缺乏针对该颜色的良好皮肤渗透研究而变得复杂。假设其渗透率与另一种水溶性呫吨染料颜色R - 19相似。预计该颜色的吸收不太可能超过较小分子R - 19的吸收。因此，风险估计值与CTFA的估计值相似，但推理不同。R - 8和R - 37的估计值与其他的不同，因为缺乏关于这些颜色的任何暴露或毒理学信息。（摘要截选至400字）
