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Table 1 Overview of the possibilities for further improvements of the ECHA guidance identified in the current appendices and the changes that we suggest

From: Revising REACH guidance on information requirements and chemical safety assessment for engineered nanomaterials for aquatic ecotoxicity endpoints: recommendations from the EnvNano project

ECHA TG Section in ECHA TG Page Room for improvement in the current text Section in this paper addressing this issue EnvNano recommendation(s) related to this issue
Nanospecific Appendix R.7a v2 1.1 General advice on how to perform nanomaterials ecotoxicity and fate testing 6 No mentioning of the importance of understanding and considering the pros and cons of various characterization methods in the listed prerequisites – Appropriate nanomaterial dispersion is key for reliable ecotoxicity testing – Quantifying nanomaterial dissolution is crucial for disclosing ecotoxic effects – Nanomaterial surface reactivity is important as toxicity indicator EnvNano recommendation # 1 on dispersion EnvNano recommendation # 2 on dissolution EnvNano recommendations # 3 on ROS
Nanospecific Appendix R.7a v2 1.1 General advice on how to perform nanomaterial ecotoxicity and fate testing 7 No mentioning of the importance of preparation of the stock solution to minimize agglomeration/aggregation – Nanomaterial dispersion is key for reliable ecotoxicity testing EnvNano recommendation # 1 on dispersion
Nanospecific Appendix R.7b v2 1.2.1 Aquatic pelagic toxicity 8 Could be more specific with regard to how to determine whether an NP dissolves fast or not – Quantifying nanomaterial dissolution is crucial for disclosing ecotoxic effects EnvNano recommendation # 2 on dissolution
Nanospecific Appendix R.7b v2 1.2.1.1 Test guidelines specificities for aquatic toxicity 9 Not sufficiently specific regarding OECD TG 201 on algal growth inhibition testing – A shortened exposure may reduce nanomaterial transformations in ecotoxicity tests and elucidate nanomaterial-specific effects and exposure dynamics – Using freshly prepared nanomaterial-suspensions may underestimate toxicity – It is important to distinguish between physical and chemical effects in aquatic toxicity tests EnvNano recommendation # 4 for acute algal tests with nanomaterials EnvNano recommendation # 5 on not only using a freshly nanomaterial-suspensions EnvNano recommendation # 6 on shading and physical effects
Nanospecific Appendix R.7b v2 1.2.1.1 Test guidelines specificities for aquatic toxicity 9 Not sufficiently specific regarding OECD TG 202 on daphnia magna acute toxicity testing – Uptake and depuration depend on nanomaterial functionalization – It is important to distinguish between physical and chemical effects in aquatic toxicity tests EnvNano recommendation # 8 for acute daphnia tests with nanomaterials EnvNano recommendations # 6 on shading and physical effects
Nanospecific Appendix R.7b v2 1.2.1.1 Test guidelines specificities for aquatic toxicity 9 Could be more specific regarding OECD TG 211 on daphnia magna chronic toxicity testing – Toxicity and uptake is feeding dependent EnvNano recommendation # 7 for long-term daphnia tests with nanomaterials
Nanospecific Appendix R.7c v2 2.1.1. Aquatic bioaccumulation 7 No consideration of integration of the nanomaterials into food sources and potential trophic transfer – Trophic transfer is an important uptake pathway for nanomaterials EnvNano recommendation # 9 for bioaccumulation tests with nanomaterials
R.7b Endpoint specific guidance 7.8.2 Information requirements for aquatic pelagic toxicity 15 Limited nanospecific relevance of existing general information requirements – Appropriate nanomaterial dispersion is key for reliable ecotoxicity testing – Quantifying nanomaterial dissolution is crucial for disclosing ecotoxic effects – Nanomaterial surface reactivity is important as toxicity indicator EnvNano recommendation # 1 on dispersion EnvNano recommendation # 2 on dissolution EnvNano recommendation # 3 on ROS
7.8.4.1 Evaluation of available information on aquatic pelagic toxicity 22–23 Klimisch scoring does not take nanospecific properties into account – Data selection for dose–response assessment derivation should be structured, reproducible and transparent and support use on non-guideline data EnvNano recommendation # 10 on evaluation of data