Migration Studies and Endocrine Disrupting Activities: Chemical Safety of Cosmetic Plastic Packaging

The endocrine activity and endocrine disruptor (ED) chemical profiles of eleven plastic packaging materials covering five major polymer types (3PET, 1HDPE, 4LDPE, 2 PP, and 1SAN) were investigated using in vitro cell-based reporter-gene assays and a non-targeted chemical analysis using gas chromatography coupled to mass spectrometry (GC-MS). To mimic cosmetic contact, six simulants (acidic, alkaline, neutral water, ethanol 30%, glycerin, and paraffin) were used in migration assays performed by filling the packaging with simulant. After 1 month at 50 °C, simulants were concentrated by Solid Phase Extraction (SPE) or Liquid-Liquid Extraction (LLE). The migration profiles of seven major endocrine disrupting chemicals detected from GC-MS in the different materials and simulants were compared with Estrogen Receptor (ER) and Androgen Receptor (AR) activities. With low extraction of ED chemicals in aqueous simulants, no endocrine activities were recorded in the leachates. Paraffin was shown to be the most extracting simulant of antiandrogenic chemicals, while glycerin has estrogenic activities. Overall, ED chemical migration in paraffin was correlated with hormonal activity. The NIAS 2,4-di-tert-butyl phenol and 7,9-di-tert-butyl1-oxaspiro (4,5) deca-6,9-diene-2,8-dione were two major ED chemicals present in all polymers (principally in PP and PE) and in the highest quantity in paraffin simulant. The use of glycerin and liquid paraffin as cosmetic product simulants was demonstrated to be relevant and complementary for the safety assessment of released compounds with endocrine activities in this integrated strategy combining bioassays and analytical chemistry approaches.

[1]  Olwenn V. Martin,et al.  Systematic evidence on migrating and extractable food contact chemicals: Most chemicals detected in food contact materials are not listed for use , 2022, Critical reviews in food science and nutrition.

[2]  J. Sobus,et al.  Quantitative non-targeted analysis: Bridging the gap between contaminant discovery and risk characterization , 2021, Environment international.

[3]  M. Marino,et al.  The Peculiar Estrogenicity of Diethyl Phthalate: Modulation of Estrogen Receptor α Activities in the Proliferation of Breast Cancer Cells , 2021, Toxics.

[4]  J. Oehlmann,et al.  Plastic Products Leach Chemicals That Induce In Vitro Toxicity under Realistic Use Conditions , 2021, Environmental science & technology.

[5]  C. Conte‐Junior,et al.  Safety of Plastic Food Packaging: The Challenges about Non-Intentionally Added Substances (NIAS) Discovery, Identification and Risk Assessment , 2021, Polymers.

[6]  Yajing Hu,et al.  Non-targeted analysis and risk assessment of non-volatile compounds in polyamide food contact materials. , 2021, Food chemistry.

[7]  Olwenn V. Martin,et al.  Overview of intentionally used food contact chemicals and their hazards. , 2020, Environment international.

[8]  Test No. 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals , 2020, OECD Guidelines for the Testing of Chemicals, Section 4.

[9]  V. Simon,et al.  Identification of Potential Extractables and Leachables in Cosmetic Plastic Packaging by Microchambers-Thermal Extraction and Pyrolysis-Gas Chromatography-Mass Spectrometry , 2020, Molecules.

[10]  Vasily N. Aushev,et al.  Gene expression profiles for low-dose exposure to diethyl phthalate in rodents and humans: a translational study with implications for breast carcinogenesis , 2020, Scientific Reports.

[11]  H. Hibshoosh,et al.  Gene expression profiles for low-dose exposure to diethyl phthalate in rodents and humans: a translational study with implications for breast carcinogenesis , 2020, Scientific Reports.

[12]  V. Simon,et al.  Development of a HS-SPME-GC-MS method for the analysis of phthalates in glycerin and liquid paraffin: application to safety evaluation of cosmetic packagings , 2020, Analytical and Bioanalytical Chemistry.

[13]  B. van der Burg,et al.  Endocrine activities of phthalate alternatives; assessing the safety profile of furan dicarboxylic acid esters using a panel of human cell based reporter gene assays , 2020 .

[14]  R. Séndon,et al.  Non-target analysis of intentionally and non intentionally added substances from plastic packaging materials and their migration into food simulants , 2019, Food Packaging and Shelf Life.

[15]  T. Ternes,et al.  Benchmarking the in vitro toxicity and chemical composition of plastic consumer products. , 2019, Environmental science & technology.

[16]  S. Mabury,et al.  Unexpectedly high concentrations of 2,4-di-tert-butylphenol in human urine. , 2019, Environmental pollution.

[17]  V. Simon,et al.  Assessment of targeted non-intentionally added substances in cosmetics in contact with plastic packagings. Analytical and toxicological aspects. , 2019, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[18]  N. Xu,et al.  Detection and quantification analysis of chemical migrants in plastic food contact products , 2018, PloS one.

[19]  C. Nerín,et al.  Identification of non volatile migrant compounds and NIAS in polypropylene films used as food packaging characterized by UPLC-MS/QTOF. , 2018, Talanta.

[20]  A. Rodríguez-Bernaldo de Quirós,et al.  GC-MS Screening Analysis for the Identification of Potential Migrants in Plastic and Paper-Based Candy Wrappers , 2018, Polymers.

[21]  Jaeho Ha,et al.  Simultaneous determination of four bioactive compounds in Korean rice wine (makgeolli) by solvent extraction coupled with gas chromatography-mass spectrometry , 2018 .

[22]  M. Chagnon,et al.  Chemical analysis and potential endocrine activities of aluminium coatings intended to be in contact with cosmetic water , 2017, Journal of pharmaceutical and biomedical analysis.

[23]  Julien Veyrand,et al.  Integrating bioassays and analytical chemistry as an improved approach to support safety assessment of food contact materials , 2017, Food additives & contaminants. Part A, Chemistry, analysis, control, exposure & risk assessment.

[24]  Ksenia J. Groh,et al.  In Vitro Toxicity Testing of Food Contact Materials: State-of-the-Art and Future Challenges. , 2017, Comprehensive reviews in food science and food safety.

[25]  M. Chagnon,et al.  Use of bioassays to assess hazard of food contact material extracts: State of the art. , 2017, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[26]  A. Covaci,et al.  Screening of endocrine activity of compounds migrating from plastic baby bottles using a multi-receptor panel of in vitro bioassays. , 2016, Toxicology in vitro : an international journal published in association with BIBRA.

[27]  S. Pirnay,et al.  Evaluation of the content – containing interaction in cosmetic products using gas chromatography–mass spectrometry , 2014, International journal of cosmetic science.

[28]  M. Tacker,et al.  Characterization of Estrogen and Androgen Activity of Food Contact Materials by Different In Vitro Bioassays (YES, YAS, ERα and AR CALUX) and Chromatographic Analysis (GC-MS, HPLC-MS) , 2014, PloS one.

[29]  M. Tacker,et al.  Detection and Identification of Oestrogen‐Active Substances in Plastic Food Packaging Migrates , 2014 .

[30]  M. Aznar,et al.  Migration of residual nonvolatile and inorganic compounds from recycled post-consumer PET and HDPE , 2014 .

[31]  D. Tillitt,et al.  Estrogen and androgen receptor activities of hydraulic fracturing chemicals and surface and ground water in a drilling-dense region. , 2014, Endocrinology.

[32]  Chang-Ju Kim,et al.  2,4-Di-tert-butylphenol from sweet potato protects against oxidative stress in PC12 cells and in mice. , 2013, Journal of medicinal food.

[33]  Qiquan Wang,et al.  Plasticizer contamination in edible vegetable oil in a U.S. retail market. , 2013, Journal of agricultural and food chemistry.

[34]  M. Aznar,et al.  The challenge of identifying non-intentionally added substances from food packaging materials: a review. , 2013, Analytica chimica acta.

[35]  M. Hakkarainen,et al.  Combined chromatographic and mass spectrometric toolbox for fingerprinting migration from PET tray during microwave heating. , 2013, Journal of agricultural and food chemistry.

[36]  Hélène Budzinski,et al.  Effect-directed analysis of endocrine-disrupting compounds in multi-contaminated sediment: identification of novel ligands of estrogen and pregnane X receptors , 2013, Analytical and Bioanalytical Chemistry.

[37]  S. Lacorte,et al.  Migration of phthalates, alkylphenols, bisphenol A and di(2-ethylhexyl)adipate from food packaging , 2012 .

[38]  P. Bonnet,et al.  Analytical method for the identification and assay of 12 phthalates in cosmetic products: application of the ISO 12787 international standard "Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques". , 2012, Journal of chromatography. A.

[39]  C. Nerín,et al.  Analytical tools for identification of non-intentionally added substances (NIAS) coming from polyurethane adhesives in multilayer packaging materials and their migration into food simulants , 2012, Analytical and Bioanalytical Chemistry.

[40]  J. Muncke,et al.  Endocrine disrupting chemicals and other substances of concern in food contact materials: An updated review of exposure, effect and risk assessment , 2011, The Journal of Steroid Biochemistry and Molecular Biology.

[41]  M. Hakkarainen,et al.  Microwave heating causes rapid degradation of antioxidants in polypropylene packaging, leading to greatly increased specific migration to food simulants as shown by ESI-MS and GC-MS. , 2011, Journal of agricultural and food chemistry.

[42]  Sébastien Lê,et al.  Exploratory Multivariate Analysis by Example Using R , 2010 .

[43]  A. Kortenkamp,et al.  The sensitivity of the MDA-kb2 cell in vitro assay in detecting anti-androgenic chemicals--identification of sources of variability and estimation of statistical power. , 2010, Toxicology in vitro : an international journal published in association with BIBRA.

[44]  H. Abdi,et al.  Principal component analysis , 2010 .

[45]  Sébastien Lê,et al.  FactoMineR: An R Package for Multivariate Analysis , 2008 .

[46]  K. Satoh,et al.  Endocrine disruptive effects of chemicals eluted from nitrile-butadiene rubber gloves using reporter gene assay systems. , 2008, Biological & pharmaceutical bulletin.

[47]  M. Biedermann,et al.  Food Contamination with Organic Materials in Perspective: Packaging Materials as the Largest and Least Controlled Source? A View Focusing on the European Situation , 2006, Critical reviews in food science and nutrition.

[48]  A. Albertsson,et al.  Evaluation of long‐term performance of antioxidants using prooxidants instead of thermal acceleration , 2005 .

[49]  I. Skjevrak,et al.  Non-targeted multi-component analytical surveillance of plastic food contact materials: Identification of substances not included in EU positive lists and their risk assessment , 2005, Food additives and contaminants.

[50]  M. Iida,et al.  Estrogenic and Anti-Androgenic Activities of Benzophenones in Human Estrogen and Androgen Receptor Mediated Mammalian Reporter Gene Assays , 2005 .

[51]  L. Gray,et al.  A novel cell line, MDA-kb2, that stably expresses an androgen- and glucocorticoid-responsive reporter for the detection of hormone receptor agonists and antagonists. , 2002, Toxicological sciences : an official journal of the Society of Toxicology.

[52]  V. O. Sheftel.  Indirect Food Additives and Polymers: Migration and Toxicology , 2000 .

[53]  Opinion On.  Scientific Committee on Consumer Safety SCCS , 2014 .

[54]  R Core Team,et al.  R: A language and environment for statistical computing. , 2014 .

[55]  K. Shadan,et al.  Available online: , 2012 .

[56]  Alisa Shekhtman.  Kadi v. Commission: A Case Study of the Development of a Rights-Based Jurisprudence for the European Court of Justice , 2011 .

[57]  J. Pagès,et al.  Analyse factorielle multiple appliquée aux variables qualitatives et aux données mixtes , 2002 .

[58]  Z. Mielniczuk,et al.  Determination of ϵ‐caprolactam migration from polyamide plastics: a new approach , 2001 .

[59]  by the European Commission (EC) , 2022 .