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Österreichisches Forschungsinstitut

für Chemie und Technik

Austrian Research Institute for Chemistry & Technology CONSTRUCTION BIOENERGY PLASTIC PRODUCTS SURFACE TECHNOLOGY PHARMA CERTIFICATION

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Locations & Scope of Work

Location

1030 Vienna, Arsenal

Location

1110 Vienna, Brehmstraße

Applied Polymer Technology Surface Technology Building & Construction Sports technology

starting summer 2010:

New location at

TFZ Wr. Neustadt

Packaging Pharma & Medical Devices Bio energy Food & Feed analysis Member of

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Our Focus

Polymer Technology

Processing & application of polymers, elastomers, paints, coatings and adhesives

Building & Construction

Building materials, structural monitoring, dehumidification of masonry, sports technology

Pharma & Packaging

Trace analysis, stability studies, packaging development; food & feed analysis

Biomass fuels

Manufacturing method, quality assurance, plant design Member of

Agenda

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 

What can you expect?

  Current discussion Definition – what are EDCs?

Assay methods and first results What can we do?

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Studies on BPA

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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 .“ Member of

Actual situation

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   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

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Definition ED

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Endocrine Disruptors (EDCs)

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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

.

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Effects on the environment

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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 Member of

EDCs in plastic

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Monomers, stabilizers, plasticizers, antioxidants, contaminants ...

Bisphenol A Alkylphenols (Nonylphenol) Phthalates Problem: migration out of the plastic into the food Member of

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Why estrogens?

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Xenoestrogens

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 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 Member of

German study: high estrogenic activity in mineral water

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 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) Member of

Selection of bioassays

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• • Yeast-Bioassays (YES / YAS) Aspergillus Screen (highly sensitive reportersystem) • Cell cultures (breast cancer-, prostate cancer celllines) – E-Screen • Reproductiontests with

Potamopyrgus antipodarum

• ...

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Bioassays

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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 Member of

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Effects of estrogens

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Reportergen-Assay

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Extraction vs. migration

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Total extraction

• ASE – Accelerated Solvent Extraction

Food simulants

• Water • • • 3% Acetic acid 50% Ethanol Isooctane Member of

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17ß-Estradiol standard curve Limit of detection

: 10 pM

Limit of quantification

: 20 pM Member of

First results

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Materials

PP Yeast strain 1 Yeast strain 2 HDPE Yeast strain 1 Yeast strain 2 PET Yeast strain 1 Yeast strain 2

*EEQ… 17ß-estradiolequivalent

total negative positive (pg EEQ* / g sample) Limit of detection [pg EEQ/g sample] 23 23 22 23 1 0

400 120

13 13 12 12 1 1

2000 1000 6

19 19 17 14 2 5

10 / 50 50 - 80 Member of

Plasticadditives

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Positive HDPE-sample:  Bisphenol A: ca. 20 40 µg / g sample  Benzylbutylphthalat: ca. 200 400 µg / g sample Member of

Plasticsamples

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    12 PET-bottles and PET-bottles preforms 4 PET-foils 13 screw caps 3 recycling flakes  6 positive samples, relatively low activities Member of

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Results

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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 Member of

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Why bioassays ?

   

Advantages

  Measurement Integration of of known and unknown substances synergistic effects (mixing effects) Evaluation of the complete package Simple screening tool Evaluation of toxicological effects No direct hints on in vivo effects possible Member of

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Bioassays

Disadvantages

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

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Chemical Analysis

Chemical analysis

• Development of testing methods disruptors in packaging / food for endocrine • Goal: Development of a frequent EDCs multimethode for the 50 most • • GC/MS LC/MS n Member of

Next step: E-screen

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    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 estrogen standards  high sensitivity (ca. 1 pmol/l) Member of

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Member of

COIN

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

COIN program 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.

€ Member of

Goal:

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  Establishment

of new bioanalytical methods

 Characterization of the total hormone burden of food contact materials (plastics, coated metal packaging, paper)  Bio-Assay-Battery Sensitivity, standardization and high-throughput-analytic Chemical detection for the 50 most important EDCs in the ppb-range (preferable GC/MS) Member of

Advisory board

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International Scientific Advisory Board • • • • Toxicologists Food / Packaging analysts Reference laboratory Authorities Project Advisory Committee • Project partners (institutions) • Participating companies Member of

Partners / Participating Companies

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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 Member of

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For any questions please contact: DI Dr. Johannes Bergmair

(DW 976, E-Mail: [email protected])

- Hotline

ofi Research Institute

Brehmstraße 14A 1110 Vienna 

+43-(0)1-798 16 01 -DW



+43-(0)1-798 16 01- 480

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