ISO/TR TECHNICAL REPORT 18637 Firstedition 2016-12-01 Nanotechnologies Overview of available frameworks for the development of occupational exposure limits and bands for nano- objects and their aggregates and agglomerates (NOAAs) Nanotechnologies - Vue d'ensemble des cadres disponibles pour la definition de limites et bandes d'exposition professionnelle applicables aux nano-objets, a leurs agrégats et agglomérats (NOAA) Reference number ISO/TR 18637:2016(E) ISO International Organization for Standardization @ IS0 2016 d without license from IHS IS0/TR 18637:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, 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 copyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Internatinair PrganizationforStandardization etworking permitted without license from IHS IS0/TR 18637:2016(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 Symbols and abbreviated terms ..3 5 Description of available processes for setting OELs and OEBs .5 5.1 General considerations .5 5.2 Description of evidence-based process. ..6 5.3 Substance-specific OELs .8 5.4 Categorical OELs... 5.5 Initial or default occupational exposure bands .9 6 Substance-specific OELs for nanomaterials .10 6.1 General overview.. .10 6.2 Available substance-specific OELs .10 6.2.1 Carbonnanotubes. .10 6.2.2 Nanoscale Ti02 ..11 6.2.3 Fullerenes. ..12 6.3 Evaluation of OEL methods .12 6.3.1 Similarities and differences .12 6.3.2 Influence of methods on derived OEL values for nanomaterials .13 6.3.3 State of the science in support of risk assessment methods for nanomaterials OELs.. 7 Categorical oELs for nanomaterials .15 7.1 Summary of options proposed. ..15 7.1.1 United Kingdom. ..15 7.1.2 Germany ..15 7.1.3 NIOSH .17 7.1.4 Japan's (AIST's) approaches .17 7.1.5 OECD .18 7.2 Evaluation of categorical OEL .19 7.2.1 Similarities and differences .19 7.2.2 State of the science supporting categorical OELs. .20 8 OEBs and control banding for nanomaterials .21 8.1 Overview of current hazard and control banding schemes 21 8.1.1 Comparison of hazard bands and OEBs as applied to inhaled NOAAs. 22 8.1.2 ISO hazard banding scheme for NOAAs.. .25 8.2 Case studies on banding NOAAs 26 8.3 Evaluation of the evidence for initial (default) OEBs for categories of NOAAs .28 8.3.1 Categorical analyses and read-across .28 8.3.2 Utility of in vitro data in OEL/OEB development for NOAAs ..29 8.3.3 Options for deriving an OEL or OEB for NOAAs. .30 9 Feasibility considerations in the OEL and OEB setting process. .30 Annex A (informative) Standard processes for OEL setting. ..32 Bibliography ..62 iii ed without license from IHS