BASF Corporation, 11750 Katy Freeway, Houston, TX, 77079, United States.
BASF SE, Carl-Bosch-Strasse 38, Ludwigshafen am Rhein, D-67056, Germany.
Food Chem Toxicol. 2022 Jun;164:112984. doi: 10.1016/j.fct.2022.112984. Epub 2022 Apr 20.
Several non-ortho phthalate plasticizers, including ATBC, DEHA, DINCH, DOTP, and ESBO, are currently used in flexible PVC applications for food packaging and processing. The aim of this review is to summarize the available toxicity, migration, and human biomonitoring data. Available assessments from US CPSC, EFSA, other governmental and non-governmental organizations, and published toxicology studies were used to show that these plasticizers are generally well-studied and demonstrate low toxicity with a focus on potential carcinogenicity, reproductive, developmental, and endocrine related adverse effects as well as biodegradation, aquatic toxicity, and bioaccumulation. Seven other plasticizers, 2EHESBO, ASE, COMGHA, DBT, DEHCH, PETV, and TOTM, have at least some recent but limited food contact clearances; assessments from CPSC, EFSA, and robust summaries in the REACH dossiers were reviewed for these products. Data gaps were found for some of these; however, there were no concerns raised by the existing data, and they for now have limited use in food contact applications. Migration of ASE, COMGHA, DINCH, DOTP, DEHCH, and TOTM in simulants for aqueous and low alcohol foods ranged from <0.02 to 0.165 mg/kg, which showed they are below established migration limits and well-suited for these applications. Human biomonitoring data are available for DINCH, DOTP, DEHA, DINA, and TOTM, and are essential for determining exposure from all uses.
几种非邻苯二甲酸酯类增塑剂,包括 ATBC、DEHA、DINCH、DOTP 和 ESBO,目前用于食品包装和加工的柔性 PVC 应用中。本综述的目的是总结现有的毒性、迁移和人体生物监测数据。美国消费品安全委员会 (CPSC)、欧洲食品安全局 (EFSA)、其他政府和非政府组织以及已发表的毒理学研究的可用评估被用来表明,这些增塑剂通常研究得很好,并且表现出低毒性,重点是潜在的致癌性、生殖、发育和内分泌相关的不良影响以及生物降解、水生毒性和生物累积。另外七种增塑剂,2EHESBO、ASE、COMGHA、DBT、DEHCH、PETV 和 TOTM,至少有一些最近的但有限的食品接触许可;对这些产品的 CPSC、EFSA 和 REACH 档案中的稳健摘要进行了评估。发现其中一些存在数据差距;然而,现有数据并未提出任何担忧,并且它们目前在食品接触应用中的使用有限。ASE、COMGHA、DINCH、DOTP、DEHCH 和 TOTM 在水相和低酒精食品模拟物中的迁移量从<0.02 到 0.165mg/kg 不等,这表明它们低于既定的迁移限量,非常适合这些应用。DINCH、DOTP、DEHA、DINA 和 TOTM 的人体生物监测数据可用,对于确定所有用途的暴露情况至关重要。