化妆品包装中使用再生高密度聚乙烯的安全性评估基于典型化学污染物的皮肤致敏和系统终点的硅模拟迁移

IF 3.1 Q2 TOXICOLOGY
Ramez Labib , Ripal Amin , Christal Lewis , Valer Toşa , Peter Mercea
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引用次数: 0

摘要

根据欧洲食品安全局(EFSA)发布的关于在食品包装中使用再生塑料的指导方针,对化妆品包装中的再生高密度聚乙烯(rHDPE)进行了安全评估。欧洲食品安全局的指导方针要求证明,因接触食品而产生的再生塑料中选定的代表性化学污染物的浓度低于基因毒性物质的毒理学关注阈值(TTC) 0.0025微克/千克体重/天。为了研究作为化妆品配方替代品从rHDPE包装迁移到食品时不超过遗传毒性TTC的代表性化学污染物的最高浓度(Cmod),我们使用了数学建模软件(MIGRATEST®EXP)。然后将代表性化学污染物的Cmod值与欧洲食品安全局报告的rHDPE中每种污染物的残留浓度(Cres)进行比较。对于评估的每种化妆品/包装组合,我们发现Cmod的模型值明显低于Cres,即回收过程可以有效地将rHDPE的潜在污染物降低到不会导致消费者每日接触化妆品超过遗传毒性TTC的水平。对于皮肤致敏,我们模拟了最坏的情况,并假设每种代表性化学污染物100%从rHDPE迁移到化妆品配方中。然后,我们根据每单位面积的剂量计算了每种污染物的消费者暴露水平,并将其与活性物质的皮肤致敏阈值(DST)(64µg/cm2)进行了比较。在每种情况下,我们都证明了从rHDPE到每种化妆品配方的每种代表性化学污染物的迁移量远低于DST,证实了蛋白质反应性化学物质没有明显的致敏风险。总之,这些数据支持在化妆品包装中安全使用rHDPE,用于免洗和冲洗应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety assessment of the use of recycled high-density polyethylene in cosmetics packaging based on in silico modeling migration of representative chemical contaminants for dermal sensitization and systemic endpoints

A safety assessment of recycled high-density polyethylene (rHDPE) in cosmetic packaging was performed based on guidelines published by the European Food Safety Authority (EFSA) on the use of recycled plastics for food packaging. EFSA guidelines require demonstration that the concentration of selected representative chemical contaminants in recycled plastic resulting from exposure from food is lower than the threshold of toxicological concern (TTC) for genotoxic substances of 0.0025 µg/kg bw/day. To investigate the highest concentration (Cmod) of representative chemical contaminants, that would not exceed the genotoxic TTC, when migrating from rHDPE packaging to foodstuffs, used as cosmetic formulation surrogates, we used mathematical modeling software (MIGRATEST®EXP). The Cmod values of representative chemical contaminants were then compared with the EFSA-reported residual concentration (Cres) of each contaminant in the rHDPE. For each of the cosmetic product/packaging combinations evaluated, we found that the modeled values were clearly lower for Cmod than Cres, i.e., the recycling process could effectively reduce potential contaminants of rHDPE to levels that would not result in daily consumer exposure from cosmetic use exceeding the genotoxic TTC. For skin sensitization, we modeled a worst-case scenario and assumed 100 % of each representative chemical contaminant migrates into the cosmetic formulation from rHDPE. We then calculated the consumer exposure level for each contaminant based on the dose per unit area and compared it with the dermal sensitization threshold (DST) for reactive materials, which is 64 µg/cm2. In each case, we demonstrated that the migration of each representative chemical contaminant from rHDPE into each cosmetic formulation was far below the DST, confirming that there is no appreciable risk of sensitization for protein-reactive chemicals. In conclusion, these data support the safe use of rHDPE in the packaging of cosmetic products for leave-on and rinse-off applications.

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来源期刊
Computational Toxicology
Computational Toxicology Computer Science-Computer Science Applications
CiteScore
5.50
自引率
0.00%
发文量
53
审稿时长
56 days
期刊介绍: Computational Toxicology is an international journal publishing computational approaches that assist in the toxicological evaluation of new and existing chemical substances assisting in their safety assessment. -All effects relating to human health and environmental toxicity and fate -Prediction of toxicity, metabolism, fate and physico-chemical properties -The development of models from read-across, (Q)SARs, PBPK, QIVIVE, Multi-Scale Models -Big Data in toxicology: integration, management, analysis -Implementation of models through AOPs, IATA, TTC -Regulatory acceptance of models: evaluation, verification and validation -From metals, to small organic molecules to nanoparticles -Pharmaceuticals, pesticides, foods, cosmetics, fine chemicals -Bringing together the views of industry, regulators, academia, NGOs
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