ISO/TR TECHNICAL REPORT 16197 First edition 2014-05-15 Nanotechnologies Compilation and description of toxicological screening methods for manufactured nanomaterials Nanotechnologies - Compilation et description des méthodes de criblage toxicologiques pour les nanomateriaux manufacturés Reference number IS0/TR 16197:2014(E) ISO @IS02014 mitted without license from IHS NotforF IS0/TR 16197:2014(E) COPYRIGHT PROTECTED DOCUMENT @IS02014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form 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 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 @ IS0 2014 - All rights reserved 44001,User=sharabiani, shahramfs IS0/TR 16197:2014(E) Contents Page Foreword ..iv Introduction .V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions ..1 4 Symbols (and abbreviated terms) ..3 5 Background. 5.1 Role and relevance of toxicological screening for the safety evaluation of manufacturedNMs. 3 5.2 Toxicological screening as part of tiered approaches to toxicological assessment of manufactured NMs. 4 5.3 Discussion of relevant dosing for toxicological screening. 5 5.4 Discussion of the relationship between this Technical Report and ISO/DTR 16196, Compilation and description of sample preparation and dosing methods for manufactured NMs 5.5 Discussion of the relationship between this Technical Report and IS0/TR 13014, Nanotechnologies - - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicological assessment. 6 5.6 Review of other relevant international activities and published documents 6 6 Methods for toxicological screening related to human health .7 6.1 General. .7 6.2 Positive and negative controls for nanomaterial toxicity testing .7 6.3 Relevant methods for in vitro toxicological screening of manufactured NMs ..8 6.4 Relevant methods for in vivo toxicological screening of manufactured NMs. ..19 Methods for toxicological screening related to the environment. .20 7.1 Introduction 20 7.2 Environmental fate and distribution 20 7.3 Environmentaldegradation andtransformation 21 7.4 Environmental biopersistence and bioaccumulation 21 Bibliography .22 ii thout license from IHS