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CONSTRUCTION

CONSTRUCTION. PLASTIC PRODUCTS. PHARMA. BIOENERGY. SURFACE TECHNOLOGY. CERTIFICATION. Locations & Scope of Work. Location 1110 Vienna, Brehmstraße. Packaging Pharma & Medical Devices Bio energy Food & Feed analysis. starting summer 2010: New location at TFZ Wr. Neustadt.

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CONSTRUCTION

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  1. CONSTRUCTION PLASTIC PRODUCTS PHARMA BIOENERGY SURFACE TECHNOLOGY CERTIFICATION

  2. Locations & Scope of Work Location 1110 Vienna, Brehmstraße PackagingPharma & Medical Devices Bio energyFood & Feed analysis starting summer 2010: New locationat TFZ Wr. Neustadt Location 1030 Vienna, Arsenal Applied Polymer TechnologySurface TechnologyBuilding & ConstructionSports technology

  3. Our Focus Polymer TechnologyProcessing & application of polymers,elastomers, paints, coatings and adhesives Building & ConstructionBuilding materials, structural monitoring, dehumidification of masonry, sports technology Pharma & PackagingTrace analysis, stability studies,packaging development; food & feed analysis Biomass fuelsManufacturing method, quality assurance,plant design

  4. Agenda What can you expect? • Current discussion • Definition – what are EDCs? • Assay methods and first results • What can we do?

  5. Studies on BPA NTP (NIH) USA 09/2008: At current exposure of the U.S. population: Developmental toxicity to fetuses / infants : „some concern for adverse effects (brain, behavior, prostate)“ Federal Office of Public Health (Switzerland) (2009): „No risk to consumers“ Problem of evasion to other / worse characterized ingredients Statement of the Endocrine Society 06/2009: „EDCs are a significant concern to public health“ Statement of the BfR 10/2009: „No health risk. No risk to infants and young children.“

  6. Actual situation EDCs in contact with food – plastic, paper, laminates, coated metal cans... Effects of EDCs in packaging : Potential danger (but not proven) Currently concentration on a few substances Large number of potential EDCs in packaging Need for action: Analysis (Bioanalytsis; chemical analysis) Toxicological studies There are no comprehensive studies on EDCs in packaging Reduction of the EDC burden of packaging

  7. Definition ED

  8. Endocrine Disruptors (EDCs) Definition: EPA Exogenous substances that act like hormones and disrupt the physiologic function of the endocrine system European comission Exogenous substances that act like hormones, disrupt the physiologic function of the endocrine system and cause adverse health effects.

  9. Effects on the environment Change of sex organs Purple snail (TBT) Alligators (DDT, Dicofol) Accumulation during food chain Example. PCB: Polar bear: 3 billion times the concentration originally found in water

  10. EDCs in plastic Monomers, stabilizers, plasticizers, antioxidants, contaminants ... Bisphenol A Alkylphenols (Nonylphenol) Phthalates Problem: migration out of the plastic into the food

  11. Why estrogens?

  12. Xenoestrogens Act like the primary female sex hormone estrogen Estrogen is involved in the regulation of many sensitive developing steps and metabolism functions in both men and women A disfunction of these mechanisms can cause reproductive problems, developmental disorders or cancer

  13. German study: high estrogenic activity in mineral water Authors assume that plastic bottles are the source BUT: other reasons possible Highly contraversal study Direct analysis of the plastic bottles necessary (PET-Bottle, screw cap)

  14. Selection of bioassays Yeast-Bioassays (YES / YAS) Aspergillus Screen (highly sensitive reportersystem) Cell cultures (breast cancer-, prostate cancer celllines) – E-Screen Reproductiontests with Potamopyrgus antipodarum ...

  15. Bioassays Reporter gene assays: • YES – Yeast Estrogen Screen (2 different strains) • Aspergillus nidulans - Bioassay Principle • Cloned gene for human estrogen receptor • Binding of estrogen or endocrine disruptor (e.g. plastic additive) activates receptor • Expression of ß-Galaktosidase • Conversion of CPRG (yellow) => CPR (red) • Photometric measurement

  16. Effects of estrogens

  17. Reportergen-Assay

  18. Extraction vs. migration Total extraction • ASE – Accelerated Solvent Extraction Food simulants • Water • 3% Acetic acid • 50% Ethanol • Isooctane

  19. 17ß-Estradiol standard curve Limit of detection: 10 pM Limit of quantification: 20 pM

  20. First results *EEQ… 17ß-estradiolequivalent

  21. Plasticadditives Positive HDPE-sample: Bisphenol A:ca. 20 - 40 µg / g sample Benzylbutylphthalat:ca. 200 - 400 µg / g sample

  22. Plasticsamples 12 PET-bottles and PET-bottles preforms 4 PET-foils 13 screw caps 3 recycling flakes  6 positive samples, relatively low activities

  23. Results

  24. Interpretation Estrogen active substances can be found in plastics Low activity, but synthetical estrogens have a higher risk potential than natural estrogens Experiments with food simulants: no activity found In vitro - studies give no information on actual effects in humans

  25. Why bioassays ? Advantages Measurement of known and unknown substances Integration of synergistic effects (mixing effects) Evaluation of the complete package Simple screening tool Evaluation of toxicological effects possible No direct hints on in vivo effects

  26. Bioassays Disadvantages False negative results possible No conclusion about possible in vivo effects only show: hormone binding to receptor Technical problems (solubilities / extracting agents / food simulants ...) No information of whichsubstances are causing the hormone activity  Combination with chemical analytic

  27. Chemical Analysis Chemical analysis Development of testing methods for endocrine disruptors in packaging / food Goal: Development of a multimethode for the 50 most frequent EDCs GC/MS LC/MSn

  28. Next step: E-screen • In-vitro bioassay • Human breast cancer cells (MCF 7 cells) • No genetical modification • Reproduction of the cancer cell line dependents on estrogens • Reproduction of the cells (proliferation) is determined in comparison to a negative control and to estrogenstandards • high sensitivity (ca. 1 pmol/l)

  29. COIN COINprogram line „structure" Funding authority: FFG on behalf of bmvit and BMWFJ Dimension: national Goals of the program Development and improvement of key competences and functions for providers of application-oriented F&E&I-expertise particularly towards the KMU Runtime: 01.09.2010 until 30.08.2014 (48 months) Volume of the project: 1,8 Mio.€

  30. Goal: Establishment of new bioanalytical methods Characterization of the total hormone burden offood contact materials (plastics, coated metal packaging, paper) Bio-Assay-Battery Sensitivity, standardizationand high-throughput-analytic Chemical detection for the 50 most importantEDCs in the ppb-range (preferable GC/MS)

  31. Advisory board International Scientific Advisory Board Toxicologists Food / Packaging analysts Reference laboratory Authorities Project Advisory Committee Project partners (institutions) Participating companies

  32. Partners / Participating Companies The following companies already joined the project: Plastics Europe Deutschland Tetra Holdings GmbH NÖM MAM Babyartikel GmbH Verein für Konsumenteninformation (VKI) REWE Teich AG ALPLA SIG Combibloc The following companies have expressed their interest: Greiner Packaging EREMA Miraplast MM Karton

  33. For any questions please contact: - Hotline DI Dr. Johannes Bergmair (DW 976, E-Mail: johannes.bergmair@ofi.at) • ofiResearch Institute • Brehmstraße 14A • 1110 Vienna • +43-(0)1-798 16 01 -DW • +43-(0)1-798 16 01- 480

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