CinTox, 381, Avenue de Pessicart, F-06100 Nice, France.
Lyondell Chemical Company, 1221 McKinney Street, Houston, TX 77010, USA.
Food Chem Toxicol. 2014 Feb;64:258-69. doi: 10.1016/j.fct.2013.11.039. Epub 2013 Dec 4.
Residual styrene present in polystyrene food packaging may migrate into food at low levels. To assure safe use, safe exposure levels are derived for consumers potentially exposed via food using No/Low Adverse Effect Levels from animal and human studies and assessment factors proposed by European organisations (EFSA, ECHA, ECETOC). Ototoxicity and developmental toxicity in rats and human ototoxicity and effects on colour discrimination have been identified as the most relevant toxicological properties for styrene health assessments. Safe exposure levels derived from animal studies with assessment factors of EFSA and ECHA were expectedly much lower than those using the ECETOC approach. Comparable safe exposure levels were obtained from human data with all sets of assessment factors while ototoxicity in rats led to major differences. The safe exposure levels finally selected based on criteria of science and health protection converged to the range of 90-120 mg/person/d. Assuming a consumption of 1 kg food/d for an adult, this translates to 90 mg styrene migration into 1 kg food as safe for consumers. This assessment supports a health based Specific Migration Limit of 90 ppm, a value somewhat higher than the current overall migration limit of 60 ppm in the European Union.
聚苯乙烯食品包装中残留的苯乙烯可能会以低水平迁移到食品中。为了确保安全使用，通过动物和人体研究中的无/低不良影响水平以及欧洲组织（EFSA、ECHA、ECETOC）提出的评估因素，为潜在通过食物接触的消费者推导了安全暴露水平。大鼠的耳毒性和发育毒性以及人类的耳毒性和对颜色辨别能力的影响已被确定为苯乙烯健康评估中最相关的毒理学特性。使用 EFSA 和 ECHA 的评估因素从动物研究中得出的安全暴露水平预计远低于使用 ECETOC 方法的水平。使用所有评估因素集从人体数据中获得了可比的安全暴露水平，而大鼠的耳毒性导致了重大差异。最终根据科学和健康保护标准选择的安全暴露水平集中在 90-120mg/人/天的范围内。假设成年人每天食用 1 公斤食物，这意味着 1 公斤食物中苯乙烯的迁移量为 90mg 对消费者是安全的。这项评估支持基于健康的特定迁移限量为 90ppm，这一数值略高于欧盟目前的总迁移限量 60ppm。
