Lumina Consulting, L.L.C, Hillsborough, NJ, USA.
ExxonMobil Biomedical Sciences, Inc., Machelen, Belgium.
J Expo Sci Environ Epidemiol. 2023 Nov;33(6):980-993. doi: 10.1038/s41370-022-00510-0. Epub 2023 Jan 21.
The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Targeted Risk Assessment (TRA) Consumer tool was developed to fill in a methodology gap for a high throughput, screening level tool to support industry compliance with the European Union's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation.
To evaluate if the TRA Consumer tool has met its design of being a screening level tool (i.e., one which does not under-predict potential exposures).
The TRA Consumer tool algorithms and defaults were reviewed and performance benchmarked vs. other consumer models and/or empirical data. Findings from existing reviews of the TRA consumer tool were also considered and addressed.
TRA predictions based on its default inputs exceeded measured exposures when available, typically by orders of magnitude, and were generally greater than or similar to those of other consumer exposure tools. For dermal exposure from articles, there was no evidence that a diffusivity approach would provide more appropriate exposure estimates than those of the TRA. When default values are refined using more specific data, the refined values must be considered holistically to reflect the situation being modeled as some parameters may be correlated.
This is the first evaluation of the ECETOC TRA consumer tool in its entirety, considering algorithms, input defaults, and associated predictions for consumer products and articles. The evaluation confirmed its design as a screening level tool.
The ECETOC TRA Consumer tool has been widely applied to generate exposure estimates to support chemical registrations under the EU REACH regulation. This evaluation supports the appropriateness of the TRA as a screening level exposure assessment tool. It also warrants additional measurements of consumer exposure, especially for article use scenarios, to aid the development of consumer exposure tools and chemical risk assessment.
欧洲生态毒理学和化学毒物学中心（ECETOC）的靶向风险评估（TRA）消费者工具是为了填补高通量筛选水平工具的方法学空白而开发的，以支持行业符合欧盟的注册、评估、授权和限制化学物质（REACH）法规。
评估 TRA 消费者工具是否符合其作为筛选水平工具的设计（即不会低估潜在暴露）。
审查了 TRA 消费者工具的算法和默认值，并对其与其他消费者模型和/或经验数据的性能进行了基准测试。还考虑并解决了对 TRA 消费者工具的现有审查结果。
基于其默认输入的 TRA 预测值通常超过了可测量的暴露值，通常超过数量级，并且通常大于或与其他消费者暴露工具相似。对于来自物品的皮肤暴露，没有证据表明扩散方法会提供比 TRA 更合适的暴露估计值。当使用更具体的数据细化默认值时，必须整体考虑细化值，以反映正在建模的情况，因为某些参数可能相关。
这是对 ECETOC TRA 消费者工具的整体首次评估，考虑了算法、输入默认值以及对消费品和物品的相关预测。评估证实了其作为筛选水平工具的设计。
ECETOC TRA 消费者工具已广泛应用于生成暴露估计值，以支持欧盟 REACH 法规下的化学品注册。该评估支持 TRA 作为筛选水平暴露评估工具的适当性。它还需要对消费者暴露进行更多的测量，特别是对于物品使用情况，以帮助开发消费者暴露工具和化学品风险评估。
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