NanoCRED: A transparent framework to assess the regulatory adequacy of ecotoxicity data for nanomaterials – Relevance and reliability revisited

Abstract

2017. NanoCRED: A transparent framework to assess the regulatory adequacy of ecotoxicity data for nanomaterials-Relevance and reliability revisited. NanoImpact, 6 pp.81-89, http://dx. ABSTRACTEnvironmental hazard and risk assessment serve as the basis for regulatory decisions to protect the environment from unintentional adverse effects of chemical substances including nanomaterials. This process requires reliable and relevant environmental hazard data upon which classification and labelling can be based and Predicted No-Effect Concentration (PNEC) values can be estimated. In a regulatory context ecotoxicological data is often recommended to be generated according to accepted and validated test guidelines, preferably also following Good Laboratory Practice. However, engineered nanomaterials are known to behave very differently in ecotoxicity tests compared to the conventional soluble chemicals, for which most guidelines were developed.Therefore non-guideline tests, or tests following modified test guidelines, can provide valuable information and should not per se be considered less adequate for regulatory use. Here we propose a framework for reliability and relevance evaluation of ecotoxicity data for nanomaterials that take into account the challenges and characterisation requirements associated with testing of these substances. The nanoCRED evaluation criteria, and accompanying guidance, were developed to be used in combination with those developed through the 'Criteria for Reporting and Evaluating Ecotoxicity Data (CRED)' project. This approach can accommodate all types of nanomaterials, all types of aquatic ecotoxicity studies, and qualitative as well as quantitative data evaluation requirements. Furthermore, it is practically feasible to implement and directly applicable in European as well as international regulatory frameworks.

Nanomaterials in the environment: Behavior, fate, bioavailability, and effects—An updated review

“…In the last decade, there have been numerous reviews on the ecotoxicity of NMs (Handy et al 2008a(Handy et al , 2012a(Handy et al , 2012bKlaine et al 2008;Kahru and Dubourguier 2010;Fabrega et al 2011;Levard et al 2012;Schultz et al 2014;Adam et al 2015;Bour et al 2016aBour et al , 2016bGarner et al 2015;Semenzin et al 2015;Hjorth et al 2017a). A number of systematic reviews have discussed ecotoxicity databases and the quality and regulatory adequacy of the data therein (Hartmann et al 2017;Hjorth et al 2017b). Unfortunately, most of the data obtained over the past decade have been for acute effects, with algal bioassays providing the majority of chronic endpoints.…”

Ecotoxicology of manufactured graphene oxide nanomaterials and derivation of preliminary guideline values for freshwater environments

“…Data quality was assessed using a modified Klimisch method , integrated into the assessment tool Toxicological Data Reliability Assessment Tool (ToxRTool) by Schneider et al . ToxRTool was used to assess the reliability of data rather than criteria for reporting and evaluating ecotoxicity data (CRED or NanoCRED) because of the high exclusion rate of studies by the latter methodologies making development of a preliminary SSD impossible. Studies lasting <24 h and unbounded toxicity values (> or ≥) were also not considered in the analysis, and the only additional quality criterion during the selection process was whether the authors reported the size of the GNMs used in the study.…”

Nanomaterials Safer‐by‐Design: An Environmental Safety Perspective

“…Such undertaking facilitated a fast data generation period that focused on creating novel nanomaterials as well as evaluating their hazard potential. These efforts serve as the basis for regulatory decisions to protect the environment from unintended adverse impact caused by nanomaterials and nanotechnology …”