Toxicity assessment of the extractables from multi-layer coextrusion poly ethylene bags exposed to pH=5 solution containing 4% benzyl alcohol and 0.1 M sodium acetate

Jingcong Zhuang; Xuebin Xing; Di Wang; Zhenxia Du; Jianfeng Wang; Yan Dong; Wenlian Yu; Sajid Hussain Siyal

doi:10.1016/j.yrtph.2018.01.015

Toxicity assessment of the extractables from multi-layer coextrusion poly ethylene bags exposed to pH=5 solution containing 4% benzyl alcohol and 0.1 M sodium acetate

Regul Toxicol Pharmacol. 2018 Apr:94:47-56. doi: 10.1016/j.yrtph.2018.01.015. Epub 2018 Jan 28.

Authors

Jingcong Zhuang¹, Xuebin Xing¹, Di Wang¹, Zhenxia Du², Jianfeng Wang³, Yan Dong⁴, Wenlian Yu⁵, Sajid Hussain Siyal⁶

Affiliations

¹ College of Science, Beijing University of Chemical Technology, Beijing 100029, China.
² College of Science, Beijing University of Chemical Technology, Beijing 100029, China; Beijing Key Laboratory of Environmentally Harmful Chemical Analysis, Beijing University of Chemical Technology, Beijing 100029, China. Electronic address: duzx@mail.buct.edu.cn.
³ College of Science, Beijing University of Chemical Technology, Beijing 100029, China; Beijing Engineering Research Center of Food Safety Analysis, Beijing Centre for Physical and Chemical Analysis, Beijing 100089, China.
⁴ Shanghai LePure Biotechnology Company Limited, Shanghai 201600, China.
⁵ Chinese Academy of Inspection and Quarantine, Beijing, China.
⁶ State Key Laboratory of Organic-Inorganic Composite, Beijing University of Chemical Technology, Beijing, 100029, China.

PMID: 29360483
DOI: 10.1016/j.yrtph.2018.01.015

Abstract

A non-target analysis was developed for the analysis of extractables from multi-layer coextrusion bags exposed to 4% benzyl alcohol solution and 0.1 M sodium acetate at pH = 5 for defined periods (15 day, 45 day and 90 day) according to manufacturer instructions based on the ultra-performance liquid chromatography (UPLC) quadrupole-time of flight mass spectrometry (Q-TOF MS). In order to confirm the extractables, principal component analysis (PCA) was used to indicate the differences among samples of different periods. Then, the extractables were identified based on searching the self-built library or online searching. The total content of extractables of 90 day samples was 589.78 μg/L, and the content was in the range of acceptable levels for pharmaceutical manufacturers. The risk assessment of the extractables were evaluated by Toxtree and T.E.S.T. software to avoid the animals bioexperiment.

Keywords: Extractables; Multi-layer coextrusion poly ethylene bag; Risk assessment; UPLC-Q-TOF MS.

MeSH terms

Adult
Animals
Benzyl Alcohol / chemistry*
Chromatography, Liquid / methods
Drug Contamination
Drug Packaging*
Humans
Hydrogen-Ion Concentration
Liquid-Liquid Extraction
Mass Spectrometry / methods
Polyethylene / chemistry*
Polypropylenes / chemistry
Polyvinyls / chemistry
Principal Component Analysis
Risk Assessment
Silica Gel / chemistry
Sodium Acetate / chemistry*
Solutions

Substances

Polypropylenes
Polyvinyls
Solutions
ethylene-vinyl alcohol copolymer
Sodium Acetate
Silica Gel
Polyethylene
Benzyl Alcohol