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Exposure Assessment über den Lebenszyklus von Nanomaterialien nanoToxCom-Kolloquium
2012-07-16
Dr. Matthias Voetz
Bayer Technology Services – a Bayer Subsidiary Holding company Group Management Board Bayer AG
Corporate Center
Business areas
Service areas
Bayer HealthCare
Bayer Business Services
Bayer CropScience
Bayer Technology Services
Bayer MaterialScience
Currenta
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Bayer Technology Services – Full Year 2011
Employees Full Year Sales Global network
2,700* EUR 460 million 20 offices in 10 countries
*
as permanent or fixed-term contracts, in FTE
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Bayer Technology Services – A Leading Technology Company Technology solutions, services, know-how – our core competencies for your success. Competent service partner for value-generating, holistic solutions along the entire life cycle of chemical/pharmaceutical products, processes and plants – we initiate, implement and support technological innovations over the long term from development through engineering and construction to process optimization. Complete technology packages go beyond our spectrum of services.
Technology Development Project Management & Engineering Operation Support & Safety
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Global Network & Local Offices Mexico-City
Leverkusen (global headquarters) Bergkamen, Berlin, Dormagen, Krefeld, Wuppertal, Wendelsheim
Moscow Shanghai
Beijing
Pittsburgh
Berkeley
Antwerp
Baytown
Mumbai
New Martinsville Belford Roxo Dubai
Singapore
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Bayer Technology Services – Mission Sustainable competitive advantage through leading technologies and solutions across the entire life cycle of products, processes and plants for our customers. Bayer Technology Services creates value with three key value drivers:
Delivering innovative technological solutions to sustain the competitiveness of customers’ manufacturing processes Providing prime CAPEX efficiency and economics by complementing customers’ project organizations with project management and lead engineering teams Expertise, methods and tools for safe and reliable operation of processes and plants
Our values of Leadership, Integrity, Flexibility and Efficiency, combined under the term LIFE provide us with guidance as we seek precisely tailored technology solutions, in line with our mission “Bayer: Science For A Better Life.”
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Working Group Nanotechnology bei Bayer: Bayer AG
Group Management Board
Subgroups Bayer HealthCare
Service companies Bayer CropScience
Bayer MaterialScience
Bayer Business Services Bayer Technology Services Currenta
Working Group Nanotechnology Netzwerk innerhalb der Bayer Gruppe: WG-NT ist eine Querschnittsplattform für interne und externe Informationen und Know How Austausch und Koordination der Untergruppen mit Nanotechnologie Aktivitäten : Empfehlungen für F&E im Bereich Nanotechnologie Identifizierung von new business Möglichkeiten Networking und Stakeholder Kontakt; Koordination der internen und externen Kommunikation z.B. Verbänden, Behörden, öffentlichen Hand, öffentlicher Förderung
Nanotechnologie bei Bayer
Nanokomposite Flammgeschütze Kunstoffe: Bayblend FR mit dispergierten Nanopartikeln
200 nm
Nanoobjekte / - additive Carbon nanotubes – Quantendots – BayDots®, Baytubes®
20 nm
93390 : 1
B028202RE109
Nanokomposite für dünne Schichten und Oberflächen Oberflächenmodifikation: Kratzfest, UV-Schutz, Easy-to-Clean Klebtechnik: Haftfestigkeit Thermische Stabilität Verarbeitung
Nanobiotechnologie Liposome, Diagnostics, Drug Delivery
200nm
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Definition „Nanomaterial“ – EU-Kommission „EMPFEHLUNG DER KOMMISSION vom 18. Oktober 2011 zur Definition von Nanomaterialien „
- natural, incidential or manufactured Material - Particles in an unbound state or as aggregate (fused) or agglomerate - 50% or more in the number size distribution, one or more external dimensions in size range 1-100 nm (Nanoobjects nach ISO ) -
included: Fulleren, Graphene, SWCNT
- SSAV > 60m²/cm³ kann zur positiv Bestimmung NM herangezogen werden < 60 Bedarf aber einer Messung der Anzahlverteilung Kommentar: Diese Definition ist messtechnisch nur schwer mit dem Stand der Technik pragmatisch zu erfassen sinngemäß aus: http://ec.europa.eu/environment/chemicals/nanotech/index.htm Page 9
Begriffe 1:
epidemiology insilico
simulation Nachstellung
Risk = Hazard x Exposure invitro
invivo
Messung
( Risk= f(Hazard, Exposure) ) Page 10 • BTS 4:3 Template 2010 • June 2011
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Begriffe 2:
Release: Liberation of material from a matrix
Exposure: “Amount of chemical available at the exchange boundaries of the organism (e.g.; skin, lungs, gut) and available for absorption”.
Release Scenario Operational and/or environmental conditions of any treatment or stress of nanomaterials during all life-cycle phases Description of release of Nanoobject/ composite material into indoor environments, e.g. workplace, residential, and/or environmental compartments, i.e. air, water, soil and sediments Set of parameters to describe the type, form and magnitude of release.
* Aus NanoRelease Workshop Juni 2012 Washington Page 11 • BTS 4:3 Template 2010 • June 2011
Lifecycle
Recycling
Life-cycle stages ENM synthesis
Fabrication of Masterbatch
Manufacturing
Use
End of life
Release Exposure for Professional Users
Exposure for Consumers
Release to Environment * Aus NanoRelease Workshop Juni 2012 Washington Page 12
• BTS 4:3 Template 2010 • June 2011
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Tiered Approach - Arbeitsplatz
The VCIconcept
e.g.
https://www.vci.de/Downloads/ Tiered-Approach.pdf
Nanoparticle exposure at nanotechnology workplaces: A review Page 13 • BTS 4:3 Template 2010 • June 2011 Kuhlbusch et al.; Particle and Fibre Toxicology 2011; 8:22 , doi:10.1186/1743-8977-8-22
The nanoGEMconcept
Tier 1 – Data Gathering yes
Can the release of nanoscale particles into the workplace air be reasonably excluded during production, handling or prcessing?
? no
SOP M Screening
Tier 2a.1 – Screening
Tier2b – permanent monitoring
(e.g. with CPC)
no
yes
?1
1 Significant increase
of concentration over background?
Maybe Tier 2a.2 – temporary monitoring no
?1
?1 yes
SOP M Sampling
no
yes
Tier 3 – Expert Assessment (e.g. with SMPS, CPC, filter sampler, offline analysis)
no2 2 no ENM
from activity; chemical identity of ENM known; their origin is elsewhere
SOP M Expanded Measurements
Clear evidence of chemcial identity of the ENM?
? yes
Take additional risk management measures to mitigate exposure
Download http://www.nanoGEM.de
Are risk management measures efficient?
? yes
Back to tier 2 no
Document and archive Page 14 • BTS 4:3 Template 2010 • June 2011
Check after 2 years or in case of changes
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Production
Processing
Handling
Weathering
Use
Incineration
Recycling
landfilling
Workplace Measurements/Simulation CarboSafe/NanoGEM Simulation of process CarboLifecycle/NanoGEM Simulation of process ?
Open field
Page 15 • BTS 4:3 Template 2010 • June 2011
Beispiel CNT Komposite - Workplace measurements in production site and compounding - Over 20 measurement campaign in the last years with -
Size distribution on „Nano“ Size distribution „Mikro“ Sampling „Nano“ – TEM Sampling „Mikro“ – REM Sampling „10m³“ – ICP-MS Background: „same procedure without CNT“
- „Use“ simulation in „zero background“ Box - over 10 different CNT-Compounds tested with „sanding“ - over 5 different CNT-Compounds tested with „drilling“ - validation of „sawing process“ in progress -
Size distribution on „Nano“ Size distribution „Mikro“ Sampling „Nano“ – TEM Sampling „Mikro“ – REM
Page 16 • BTS 4:3 Template 2010 • June 2011
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Page 17 • BTS 4:3 Template 2010 • June 2011 Page 17 • Bayer Technology Services • November 2011
Workplace CNT-Production Labscale
SMPS
NAS/TEM
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Sanding of brittle matrix with insufficient dispersed CNT
=> No difference in number with/without CNT Page 19 • BTS 4:3 Template 2010 • June 2011
Sanding of dried CNT-Dispersion
Substrate
Substrate with dried CNTDispersion
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* CNT means here only Baytubes
Conclusion for CNT Composites - abrasion/sanding/drilling of Polymer/CNT Compounds well dispersed and with good connection CNT-Polymer produce no isolated or small agglomerates of CNT - Mechanical stress applied to brittle matrix with not well dispersed CNT could lead to a emission of airborne isolated CNT or small agglomerates - Under normal production or processing conditions no CNT Exposure is detectable -
Handling of CNT-Powder can produce airborne agglomerates, but no isolated CNT
-
Threshold from 50µg/m³ was reached at no time (detected over Co Concentration Page 21 • BTS 4:3 Template 2010 • June 2011
Forschungslandschaft http://www.nanosafetycluster.eu/
D: NanoNature/NanoCare http://www.nanoobjects.info/cms
USA: Nanorelease http://www.ilsi.org/researchfou ndation/pages/nanorelease1.a spx
EU FP7 WP2013 NMP (Call end July): NMP.2013.1.3-1 Safety in nanoscale production and products NMP.2013.1.3-3: Development of a systematic framework for naming and assessing safety of the next generations of nanomaterials being developed for industrial applications. NMP.2013.1.4-3 Development of methods and standards supporting the implementation of the Commission recommendation for a definition of nanomaterial Page 22 • BTS 4:3 Template 2010 • June 2011
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Normung ISO TC 229 Nanotechnology
Page 23 • BTS 4:3 Template 2010 • June 2011
• • Page 24 • BTS 4:3 Template 2010 • June 2011
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CEN 352 Nanotechnology / Mandat M 461 - Methodologies for Nanomaterial characterization in the manufactured form and before toxicity and eco-toxicity testing - Sampeling and measurement of workplace, consumer and environment exposure to nanomaterials - Methods to simulate exposure to nanomaterials
http://ec.europa.eu/enterprise/standards_policy/mandates/database/index.cfm?fuseaction=sea rch.detail&id=443 Page 25 • BTS 4:3 Template 2010 • June 2011
Zusammenfassung Messen kann man viel ……..
……. aber um valide und vergleichbare Ergebnisse zu erhalten bedarf es einer Menge Expertise und “Standardisierung”
Page 26 • BTS 4:3 Template 2010 • June 2011
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Danke für die Aufmerksamkeit Dr. Matthias Voetz BTS-TD-ET-MS 0214/30-25885
[email protected] Page 27
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