ISO/TR TECHNICAL REPORT 19057 First edition 2017-10 Nanotechnologies Use and application of acellular in vitro tests and methodologies to assess nanomaterial biodurability Nanotechnologies-Utilisation et application destests invitro sur cellules et méthodes pour évaluer la biodurabilité des nanomateriaux Reference number IS0/TR 19057:2017(E) ISO @IS02017 IS0/TR 19057:2017(E) COPYRIGHTPROTECTEDDOCUMENT @IS0 2017,Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax+4122 74909 47 [email protected] www.iso.org ii @ IS0 2017 - All rights reserved IS0/TR 19057:2017(E) Contents Page Foreword .V Scope .1 2 Normative references .1 3 Terms and definitions ..1 4 Symbols and abbreviated terms .2 5 Background including need for assessing the biodurability of particles. .4 6 Aims and objectives. .6 7 Approaches for assessment of micrometre mineral particle and fibre biodurability .6 7.1 General 6 7.2 Dissolution of nanomaterials versus their dispersion and biodegradation .7 8 Need for the assessment of nanomaterial biodurability .7 9 Influence of different types of ligands and coatings on nanomaterial biodurability .8 10 Review of methodologies to assess micrometre mineral particle and fibre biodurability...8 10.1 General 8 10.2 In vitro acellular methods. 8 10.3 Description of different simulated physiological media 9 10.3.1 General 9 10.3.2 Simulated lung airway lining fluids 9 10.3.3 Simulated lung macrophage phagolysosomal fluid 10 10.3.4 Digestive system (saliva, gastric and intestinal fluids) 10 10.3.5 Simulated sweat (SSW) 11 10.4 Description of different simulated environmental media .11 10.4.1 General 11 10.4.2 Simulated natural freshwaters 11 10.4.3 Simulated seawater. 11 10.4.4 Simulated estuarine waters. 11 10.5 Description of different test systems to assess dissolution of particles and fibres 11 10.5.1 General 11 10.5.2 Static dissolution system 12 10.5.3 Continuous flow system (CFS) 12 10.5.4 Batch and batch filter systems 12 10.5.5 Tangentialflowfiltrationsystem 12 10.6 Assessment of dissolved mass concentration post dissolution experiment. 13 10.6.1 General. 13 10.6.2 Techniques based on physical principles. 13 10.6.3 Techniques based on mechanical concepts 14 10.6.4 Techniques based on chemical principles.. 15 10.6.5 Ultraviolet-visible (UV-Vis) spectroscopy 16 10.6.6 One-dimensional mathematical models. 16 10.6.7 Single particle inductively coupled plasma-mass spectrometry (spICP-MS) .16 11 Calculation of micrometre mineral particle biodurability .17 11.1 General 17 11.2 Dissolution kinetics, dissolution rates, and dissolution rate constants. 18 11.3 Dissolution kinetics and dissolution rate of larger particles and fibres. 18 11.4 Dissolution kinetics and dissolution rate of nanoparticles. 20 11.5 Assessment of halftime estimates of particles and fibres. .20 11.6 Assessment of lifetime estimates for particles and fibres. 21 11.6.1 General 21 11.6.2 Shrinking sphere theory 21 11.6.3 Shrinking fibre theory. .22 @ IS0 2017 - All rights reserved ii