Derivation of safe health-based exposure limits for potential consumer exposure to styrene migrating into food from food containers
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- 作者：Heinz-Peter Gelbke ; Marcy Banton ; Eric Faes ; Edgar Leibold ; Mark Pemberton ; Sophie Duhayon
- 关键词：AF ; assessment factor ; bw ; body weight ; DNEL ; Derived No Effect Level ; ECETOC ; European Centre for Ecotoxicology and Toxicology of Chemicals ; ECHA ; European Chemicals Agency ; EFSA ; European Food Safety Authority ; EH ; epoxide hydrolase ; EPS ; expanded polystyrene ; GPPS ; general purpose polystyrene ; HED ; human equivalent dose ; HIPS ; high impact polystyrene ; JECFA ; Joint FAO/WHO Expert Committee on Food Additives ; LOAEL ; Low Adverse Effect Level ; LWAE ; lifetime weighted average exposure ; MA ; mandeli
- 刊名：Food and Chemical Toxicology
- 出版年：February, 2014
- 年：2014
- 卷：64
- 期：Complete
- 页码：258-269
- 全文大小：396 K
文摘
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.