The REACH registration process: A case study of metallic aluminium,aluminium oxide and aluminium hydroxide

The European Union’s REACH Regulation requires determination of potential health and environmental effects of chemicals in commerce. The present case study examines the application of REACH guidance for health hazard assessments of three high production volume (HPV) aluminium (Al) substances: metallic aluminium, aluminium oxide, and aluminium hydroxide. Among the potential adverse health consequences of aluminium exposure, neurotoxicity is one of the most sensitive targets of Al toxicity and the most critical endpoint. This case study illustrates integration of data from multiple lines of evidence into REACH weight of evidence evaluations. This case study then explains how those results support regulatory decisions on classification and labelling. Challenges in the REACH appraisal of Al compounds include speciation, solubility and bioavailability, application of assessment factors, read-across rationale and differences with existing regulatory standards. Lessons learned from the present case study relate to identification and evaluation of toxicologic and epidemiologic data; assessing data relevance and reliability; development of derived no-effect levels (DNELs); addressing data gaps and preparation of chemical safety reports.     

直肠癌术前同步推量RapidPlan模型用于术后单一处方计划优化的改造测试

目的:测试直肠癌术前同步推量RapidPlan模型用于术后单一处方计划优化的可行性,探索改造和拓展已有模型的应用方法。方法:（1）对现有直肠癌术前同步推量41.8 Gy（PTV）/50.6 Gy（PGTV）RapidPlan模型进行改造;（2）复制直肠癌术后单一PTV处方临床计划18例（45 Gy的7例,50 Gy的11例）,保持布野条件、能量、加速器配置及原有剂量算法等不变,将PTV分别匹配模型中的PGTV和PTV,预测可实现的DVH区间并重新优化;（3）将自动计划靶区剂量归一至与临床计划相似后比较各剂量学参数。结果:单一处方靶区匹配模型中的PTV会导致严重的剂量热区,匹配PGTV的RapidPlan计划质量和临床计划相似或略好,但其危及器官剂量学参数的标准差均小于临床计划。结论:直肠癌术前同步推量RapidPlan模型可用于术后单一处方放疗计划的自动优化并且其质量一致性更好,但需将单一靶区匹配给模型中最高处方剂量对应的靶区结构。