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SCENIHR/002/05
S
CIENTIFIC
C
OMMITTEE ON
E
MERGINGAND
N
EWLY
I
DENTIFIED
H
EALTH
R
ISKS
 (SCENIHR)modified Opinion (after public consultation) onThe appropriateness of existing methodologies to assess thepotential risks associated with engineered and adventitiousproducts of nanotechnologies
Adopted by the SCENIHR during the 10
th
plenary meeting of 10 March 2006after public consultation
EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERALDirectorate C - Public Health and Risk Assessment
C7 - Risk assessment
 
Synthesis report :
 http://ec.europa.eu/health/ph_risk/documents/synth_report.pdf  
Stakeholder comments :
 http://ec.europa.eu/health/ph_risk/documents/stakeholder_comments.zip 
 
 
SCENIHR/002/05
The appropriateness of existing methodologies to assess the potential risks associated with engineered andadventitious products of nanotechnologies
  _______________________________________________________________________ 
2
TABLE OF CONTENTS
EXECUTIVE SUMMARY1.
BACKGROUND
..........................................................................................................52.
TERMS OF REFERENCE
.........................................................................................73.
SCIENTIFIC RATIONALE
........................................................................................73.1 Introduction...................................................................................................................73.2 Definitions and Scope...................................................................................................83.3 Nanoscience and Nanotechnology..............................................................................11
3.3.1
 
 Introduction ...........................................................................................11
 
3.3.2 Examples of Engineered Nanostructures and Materials and Their  Applications ...........................................................................................12
 
3.3.3
 
The essentials of Nanostructure Generation: Top-Down vs. Bottom-UpChemical and Physical Self Assembly...............................................................................12
 
3.3.4
 
 Nanoscale materials properties................................................................................13
 
3.3.5 Conclusions
.
...........................................................................................13
 3.4 Nanoparticles: Physical and Chemical Properties.......................................................13
3.4.1 Nanoparticle - Nanoparticle Interaction..................................................................14
 
3.5.1 Formation of nanoparticles in the liquid phase.......................................................15
 
3.5.2
 
Formation of nanoparticles suspended in the gas phase.........................................15
 
3.5.3
 
 Environmental Sources of airborne Nanoparticles..................................................15
 
3.5.4 Occupational Sources of airborne Nanoparticles....................................................16 
 
3.5.5
 
 Nanoparticles in and from Consumer Products.......................................................17 
 
3.5.6 
 
Conclusions ...........................................................................................17 
 3.6 The Detection and Measurement of Nanoparticles.....................................................18
3.6.1
 
 In situ and on-line detection principles for nanoparticles in gas suspension..........18
 
3.6.2
 
 In situ and on-line detection of particles in a liquid medium...................................19
 3.7 The Potential for Interactions Between Nanoparticles and Living Systems...............20
3.7.1
 
 Introduction ...........................................................................................20
 
3.7.2 Nanoparticles in Living Systems – The Surface Effects...........................................20
 
3.7.3 The Effects of Size, Shape, Surface and Bulk Composition......................................20
 
3.7.4
 
Solubility and Persistence........................................................................................21
 
3.7.5 Conclusions ...........................................................................................21
 3.8 Toxicology of Nanoparticles.......................................................................................22
3.8.1
 
The Mediators of the Toxicity of Particles...............................................................22
 
 
 
SCENIHR/002/05
The appropriateness of existing methodologies to assess the potential risks associated with engineered andadventitious products of nanotechnologies
  _______________________________________________________________________ 
3
3.8.2 Inhaled Particles ...........................................................................................24
 
3.8.3 Particles for Drug Delivery.....................................................................................28
 
3.8.4
 
Toxicological Testing ...........................................................................................32
 
3.8.5 Conclusions ...........................................................................................34
 3.9 Exposure Scenarios.....................................................................................................34
3.9.1 Sampling ...........................................................................................35
 
3.9.2 Exposure Assessment Approaches............................................................................37 
 
3.9.3
 
Conclusions ...........................................................................................41
 3.10 Risk Assessment Methodologies...............................................................................41
3.10.1
 
 Introduction ...........................................................................................41
 
3.10.2 General Exposure Considerations.........................................................................42
 
3.10.3 Hazard Considerations...........................................................................................44
 
3.10.4 Scope of Nanoparticle Risk Assessment.................................................................46 
 
3.10.5 Exposure Assessment Methodology........................................................................48
 
3.10.6 Hazard Identification and Hazard Characterization Methodology.......................51
 
3.10.7 Risk Characterization and Integrated Risk Assessment.........................................53
 
3.10.8 Critical gaps in knowledge required for risk assessment purposes.......................54
 
3.10.9 Regulatory and Other Aspects Related to Risk Assessment...................................55
 
3.10.10 Other Needed Developments................................................................................55
 
3.10.11 Conclusions..........................................................................................................55
 3.11 Prioritisation of Needs in Knowledge.......................................................................564.
COMMITTEE OPINION
...........................................................................................585.
MINORITY OPINION
...............................................................................................62
6. REFERENCES
............................................................................................................637.
ACKNOWLEDGEMENTS
.......................................................................................79
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