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Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment

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Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment Technical Report No. 133-2 EUROPEAN CENTRE FOR ECOTOXICOLOGY AND TOXICOLOGY OF CHEMICALS Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment Technical Report No. 133-2 Version 1 - March 2020 DISCLAIMER: This Technical Report reflects current experience and knowledge and shall be adapted, amended and refined as new evidence on polymer risk assessment becomes available. Brussels, March 2020 ISSN-2079-1526-133-2 (online) Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment ECETOC Technical Report No. 133-2 © Copyright – ECETOC AISBL European Centre for Ecotoxicology and Toxicology of Chemicals Rue Belliard 40, B-1040 Brussels, Belgium. All rights reserved. No part of this publication may be reproduced, copied, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the copyright holder. Applications to reproduce, store, copy or translate should be made to the Secretary General. ECETOC welcomes such applications. Reference to the document, its title and summary may be copied or abstracted in data retrieval systems without subsequent reference. The content of this document has been prepared and reviewed by experts on behalf of ECETOC with all possible care and from the available scientific information. It is provided for information only. ECETOC cannot accept any responsibility or liability and does not provide a warranty for any use or interpretation of the material contained in the publication. ECETOC TR No. 133-2 Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment Table of contents SUMMARY .....................................................................................................................................................................................................................1 1. INTRODUCTION ..............................................................................................................................................................................................6 2. OVERVIEW OF TEST GUIDELINES, STANDARDS AND SPECIFICATIONS INCLUDED IN THIS REPORT ................. 9 3. ANALYTICAL TOOLS TO DETERMINE STRUCTURAL AND MORPHOLOGICAL DESCRIPTORS AND PHYSICO- CHEMICAL PROPERTIES OF POLYMERS ..................................................................................................................................................... 11 3.1 Weight-average and number-average molecular weight ...................................................................................... 15 3.2 Acid dissociation constant ..................................................................................................................................... 16 3.3 Solubility in water .................................................................................................................................................. 17 3.4 n-Octanol/water partition coefficient ................................................................................................................... 19 3.5 Adsorption/desorption and organic carbon/water partition coefficient .............................................................. 23 3.6 Surface tension ...................................................................................................................................................... 25 3.7 Analytical verification of polymer concentrations in environmental media ......................................................... 27 3.7.1 Cold analytical approaches for polymers .......................................................................................................... 28 3.7.2 Radioanalytical approaches for polymers ......................................................................................................... 28 3.7.3 Stable isotope approaches for polymers ........................................................................................................... 29 4. TEST METHODS TO ASSESS POLYMER ENVIRONMENTAL FATE ........................................................................................ 30 4.1 (Bio)degradation .................................................................................................................................................... 31 4.1.1 Biodegradation screening tests ......................................................................................................................... 32 4.1.2 Simulation biodegradation tests ....................................................................................................................... 40 4.1.3 Abiotic degradation ........................................................................................................................................... 45 4.1.4 Other degradation methods: Industrial composting ......................................................................................... 46 4.1.5 Conceptual framework for polymer (bio)degradation assessment .................................................................. 49 4.2 Bioaccumulation, bioconcentration, biomagnification ......................................................................................... 55 4.2.1 Systemic bioavailability as prerequisite for polymer bioaccumulation............................................................. 56 4.2.2 Test methods for bioaccumulation assessment ................................................................................................ 59 4.2.3 Conceptual framework for polymer bioaccumulation assessment .................................................................. 62 5. MODELS TO ASSESS POLYMER EXPOSURE POTENTIAL .......................................................................................................... 67 5.1 Environmental exposure modelling for polymers ................................................................................................. 67 5.1.1 Exposure in freshwater and freshwater sediment ............................................................................................ 73 5.1.2 Exposure in marine surface water and marine sediment ................................................................................. 75 5.1.3 Exposure in soil.................................................................................................................................................. 76 5.1.4 Exposure via wastewater treatment plants ...................................................................................................... 77 5.2 Human health exposure assessment ..................................................................................................................... 77 5.2.1 Inhalation exposure modelling .......................................................................................................................... 79 5.2.2 Dermal and oral exposure modelling ................................................................................................................ 81 5.2.3 Exposure measurements ................................................................................................................................... 82 6. TEST METHODS TO ASSESS ECOTOXICITY POTENTIAL OF POLYMERS ........................................................................... 85 6.1 Ecotoxicological assessments using aquatic organisms ........................................................................................ 85 6.1.1 Fit-for-purpose polymer identification prior to aquatic toxicity testing ........................................................... 86 ECETOC TR No. 133-2 Applicability of Analytical Tools, Test Methods and Models for Polymer Risk Assessment 6.1.2 Selection of polymer concentrations for aquatic toxicity testing ..................................................................... 87 6.1.3 Preparation of polymers for aquatic toxicity testing ........................................................................................ 88 6.1.4 Verification of polymer concentrations during aquatic toxicity testing ............................................................ 89 6.1.5 Aquatic toxicity test methods ........................................................................................................................... 90 6.2 Ecotoxicity test methods using sediment-dwelling organisms .............................................................................. 94 6.3 Ecotoxicity test methods using terrestrial organisms............................................................................................ 96 6.4 Conceptual framework for polymer ecotoxicity assessment .............................................................................. 100 6.4.1 Tier 0: Identification of ecotoxicity testing needs and of relevant environmental compartment(s) .............. 101 6.4.2 Tier 1: Screening for acute ecotoxicological effects ........................................................................................ 103 6.4.3 Higher-tier follow-up of ecotoxicological screening ....................................................................................... 105 7. TEST METHODS TO ASSESS HUMAN HEALTH TOXICITY POTENTIAL OF POLYMERS ..........................................
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