ISO/TR TECHNICAL REPORT 13014 First edition 2012-05-15 Nanotechnologies Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment Nanotechnologies Directives relatives a la caracterisation physico- chimique des materiaux machinés a I'échelle nanométrique pour I'évaluationtoxicologique Reference number ISO/TR 13014:2012(E) ISO @ ISO 2012 py IHS under lic r networking permitted without license from IHS Not for Resale ISO/TR 13014:2012(E) COPYRIGHTPROTECTEDDOCUMENT ISO 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 · CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland ISO 2012-All rights reserved networking permtted without license from IHS Not for Resale ISO/TR13014:2012(E) Contents Page Foreword ..iv Introduction 1 Scope. 2 Terms and definitions. 3 Symbols and abbreviated terms. .6 4 Importance of physico-chemical properties to toxicological assessment. 6 4.1 Thepurposeoftoxicologicalexperimentation. 6 4.2 General methods of toxicological testing and risk assessment 4.3 Physico-chemical properties of nano-objects... 4.4 Purity and impurity of tested nano-objects.... 9 4.5 When to undertake physico-chemical characterization 4.6 Potential problems with materials assessment.. 10 5 Parameters for the physico-chemical characterization of manufactured nano-objects prior to toxicologicalassessment... 11 5.1 Generalinformation. 5.2 Particle size and particle size distribution .. 11 5.3 Aggregation/agglomeration state in relevant media ... 12 5.4 13 5.5 Surface area / mass-specific surface area / volume-specific surface area 14 5.6 Composition 15 5.7 Surface chemistry. 16 5.8 Surface charge.. 16 5.9 Solubility/dispersibility. 17 6 Expression of measurement results and uncertainties. 19 6.1 General. 19 6.2 Quantifying uncertainty... 19 6.3 Application of uncertainty to nano-objects. .20 6.4 Importance of validation.... 20 7 Reporting. 21 Annex A (informative) Diagram illustrating the use of physico-chemical characterization in toxicological testing .... .23 Annex B (informative) Example measurement methods and standards .24 Bibliography .30 ili thout license from IHS Not for Resale