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ISO/TR 19057:2017 Nanotechnologies - Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability >
ISO/TR 19057:2017 Nanotechnologies - Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability, 2017
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Symbols and abbreviated terms
- 5 Background including need for assessing the biodurability of particles
- 6 Aims and objectives
- 7 Approaches for assessment of micrometre mineral particle and fibre biodurability
- 7.1 General
- 7.2 Dissolution of nanomaterials versus their dispersion and biodegradation
- 8 Need for the assessment of nanomaterial biodurability
- 9 Influence of different types of ligands and coatings on nanomaterial biodurability
- 10 Review of methodologies to assess micrometre mineral particle and fibre biodurability
- 10.1 General
- 10.2 In vitro acellular methods
- 10.3 Description of different simulated physiological media
- 10.3.1 General
- 10.3.2 Simulated lung airway lining fluids
- 10.3.3 Simulated lung macrophage phagolysosomal fluid
- 10.3.4 Digestive system (saliva, gastric and intestinal fluids)
- 10.3.5 Simulated sweat (SSW)
- 10.4 Description of different simulated environmental media
- 10.4.1 General
- 10.4.2 Simulated natural freshwaters
- 10.4.3 Simulated seawater
- 10.4.4 Simulated estuarine waters
- 10.5 Description of different test systems to assess dissolution of particles and fibres
- 10.5.1 General
- 10.5.2 Static dissolution system
- 10.5.3 Continuous flow system (CFS)
- 10.5.4 Batch and batch filter systems
- 10.5.5 Tangential flow filtration system
- 10.6 Assessment of dissolved mass concentration post dissolution experiment
- 10.6.1 General
- 10.6.2 Techniques based on physical principles
- 10.6.3 Techniques based on mechanical concepts
- 10.6.4 Techniques based on chemical principles
- 10.6.5 Ultraviolet-visible (UV-Vis) spectroscopy
- 10.6.6 One-dimensional mathematical models
- 10.6.7 Single particle inductively coupled plasma-mass spectrometry (spICP-MS)
- 11 Calculation of micrometre mineral particle biodurability
- 11.1 General
- 11.2 Dissolution kinetics, dissolution rates, and dissolution rate constants
- 11.3 Dissolution kinetics and dissolution rate of larger particles and fibres
- 11.4 Dissolution kinetics and dissolution rate of nanoparticles
- 11.5 Assessment of halftime estimates of particles and fibres
- 11.6 Assessment of lifetime estimates for particles and fibres
- 11.6.1 General
- 11.6.2 Shrinking sphere theory
- 11.6.3 Shrinking fibre theory
- 11.7 Assessment of halftime and lifetime estimates
- 12 Examples of micrometer mineral particles and fibres where biodurability was assessed using in vitro acellular systems
- 12.1 Glass and asbestos fibres
- 12.2 Silicon dioxide (SiO2)
- 12.3 Talc
- 12.4 Tungsten oxide
- 12.5 Beryllium
- 13 Examples of nanomaterials where biodurability was assessed using in vitro acellular systems
- 13.1 SWCNTs and MWCNTs
- 13.2 Silver nanoparticles (AgNPs)
- 13.3 Titanium dioxide (TiO2)
- 13.4 Zinc oxide (ZnO)
- 14 Biodurability of ligands
- 14.1 General
- 14.2 Examples of ligands attached to particles where biodurability has been assessed
- 14.3 Methodologies to assess the biodurability of the attached ligands
- 14.3.1 General
- 14.3.2 Gel permeation chromatography (GPC)
- 14.3.3 Matrix-assisted laser desorption ionization mass spectrometer (MALDI-MS)
- 14.3.4 Attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR)
- 14.3.5 Liquid chromatography coupled with mass spectrometry (LC-MS/MS)
- 15 Relationship with relevant international documents
- 15.1 Simulated sweat
- 15.2 Simulated sebum
- 15.3 Simulated lung fluids
- 15.4 Simulated digestive system fluids
- 16 Assessing the validity of assay/test systems
- 17 Biological relevance of the dissolution assay
- 18 Use of biodurability tests in risk assessment and its limitations
- Annex A (informative) Tables of relevant information
- Bibliography [Go to Page]