ADAMA Deutschland GmbH, Edmund-Rumpler-Str. 6, 51149, Cologne, Germany.
FMC Corporation, Philadelphia, PA, USA.
Arch Toxicol. 2022 Sep;96(9):2429-2445. doi: 10.1007/s00204-022-03320-3. Epub 2022 Jun 15.
Dermal absorption values are used to translate external dermal exposure into potential systemic exposure for non-dietary risk assessment of pesticides. While the Environmental Protection Agency of the United States of America (US EPA) derives a common dermal absorption factor for active substances covering all related products, the European Food Safety Authority (EFSA) requests specific product-based estimates for individual concentrations covering the intended use rates. The latter poses challenges, because it disconnects exposure dose from applied dose in absorption studies, which may not be suitable in scenarios where concentration is not relevant. We analyzed the EFSA dermal absorption database, collected 33 human in vitro studies from CropLife Europe (CLE) companies, where ≥3 in-use dilution concentrations were tested, and 15 dermal absorption triple pack datasets. This shows that absolute dermal absorption correlates with absolute applied dose on a decadic logarithm-scale, which is concordant with the toxicological axiom that risk is driven by exposure dose. This method is radically different from the current European approach focused on concentrations and offers new insights into the relationship of internal and external exposure doses when utilizing data from in vitro studies. A single average dermal absorption value can be simply derived from studies with multiple tested concentrations, by calculating the y-intercept of a linear model on a decadic logarithm scale while assuming a slope of 1. This simplifies risk assessment and frees resources to explore exposure refinements. It also serves as a basis to harmonize dermal absorption estimation globally for use in exposure-driven risk assessments.
皮肤吸收值用于将皮肤外部暴露量转化为非饮食性农药风险评估的潜在全身暴露量。美国环境保护署(EPA)为涵盖所有相关产品的活性物质推导了一个通用的皮肤吸收因子,而欧洲食品安全局(EFSA)则要求针对个别浓度的特定产品估算,涵盖预期使用率。后者带来了挑战,因为它在吸收研究中将暴露剂量与应用剂量断开,在浓度不相关的情况下可能不合适。我们分析了 EFSA 的皮肤吸收数据库,收集了来自 CropLife Europe(CLE)公司的 33 项人类体外研究,其中测试了≥3 种使用中的稀释浓度,以及 15 项皮肤吸收三重数据集。这表明,绝对皮肤吸收与应用剂量的十进制对数呈正相关,这与毒性学公理一致,即风险由暴露剂量驱动。这种方法与当前欧洲专注于浓度的方法截然不同,为利用体外研究数据时内部和外部暴露剂量的关系提供了新的见解。通过在十进制对数尺度上计算线性模型的 y 截距,并假设斜率为 1,可以从具有多个测试浓度的研究中简单地推导出单一的平均皮肤吸收值。这简化了风险评估,释放了资源以探索暴露细化。它还为在基于暴露的风险评估中在全球范围内协调皮肤吸收估算提供了基础。