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An environmental quality standard (EQS) is a threshold value applied in regulatory monitoring for retrospective environmental risk assessment. However, an EQS may vary with time and between countries with shared water bodies, challenging coherent risk management. This study aimed to analyze the underlying reasons for changes in EQS values following a revision of previously derived EQSs for 62 substances. Relevant data were retrieved from publicly accessible databases, available literature, registration dossiers, and, in some cases, provided by manufacturers. Ecotoxicological data were assessed regarding reliability and relevance. As in previous studies, EQS derivation followed the European Union guideline. Overall, 61 annual average EQSs (AA-EQS) and 58 maximum acceptable concentration EQSs (MAC-EQS) were derived. Size and completeness of data sets generally increased due to the revision. AA-EQSs increased in 13 cases and decreased in 21 cases. MAC-EQSs increased in 22 cases and decreased in 11 cases. Most EQSs were derived using the deterministic assessment factor (AF) method. The number of substances for which EQSs were derived probabilistically by reference to the species sensitivity distribution (SSD) method increased from 2 to 5 AA-EQSs and from 6 to 11 MAC-EQSs. For AA-EQS derivation, AFs were reduced in 14 cases and increased in 6 cases. For MAC-EQS derivation, AFs were reduced in 9 cases and increased in 2 cases. Results demonstrate that the revisions did not generally lead to either lower or higher EQSs. The majority of EQSs (>93%) changed less than 10-fold. Clearly, EQSs based on small or incomplete data sets with large AFs were more prone to considerable changes in their numeric values when revised than EQSs based on SSDs. Thus, revision can reduce uncertainty and increase robustness of an EQS. In this study, however, available data continued to be insufficient to construct SSDs for the majority of substances. This was mostly due to a lack of reliable data. Integr Environ Assess Manag 2019;00:1-13. © 2019 SETAC., (© 2019 SETAC.)

This study reports the use of the recently developed EASZY assay that uses transgenic cyp19a1b-GFP zebrafish (Danio rerio) embryos to assess in vivo estrogenic activity of 33 surface (SW) and waste water (WW) samples collected across Europe that were previously well-characterized for estrogen hormones and in vitro estrogenic activity. We showed that 18 out of the 33 SW and WW samples induced estrogenic responses in the EASZY assay leading to a significant and concentration-dependent up-regulation of the ER-regulated cyp19a1b gene expression in the developing brain. The in vivo 17β-estradiol-equivalents (EEQs) were highly correlated with, both, the chemical analytical risk quotient (RQ) based on steroidal estrogen concentrations and EEQs reported from five different in vitro reporter gene assays. Regression analyses between the vitro and in vivo effect concentrations allowed us to determine an optimal cut-off value for each in vitro assay, above which in vivo responses were observed. These in vitro assay-specific effect-based trigger values (EBTs), ranging from 0.28 to 0.58 ng EEQ/L define the sensitivity and specificity of the individual in vitro assays for predicting a risk associated with substances acting through the same mode of action in water samples. Altogether, this study demonstrates the toxicological relevance of in vitro-based assessment of estrogenic activity and recommends the use of such in vitro/in vivo comparative approach to refine and validate EBTs for mechanism-based bioassays., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Predicted-no-effect concentrations (PNECs) and environmental quality standards (EQSs) are derived in a large number of legal frameworks worldwide. When deriving these safe concentrations, it is necessary to evaluate the reliability and relevance of ecotoxicity studies. Such evaluation is often subject to expert judgment, which may introduce bias and decrease consistency when risk assessors evaluate the same study. The Criteria for Reporting and Evaluating Ecotoxicity Data (CRED) project attempts to address this problem. It aims to improve the reproducibility, transparency, and consistency of reliability and relevance evaluations of aquatic ecotoxicity studies among regulatory frameworks, countries, institutes, and individual assessors. In the present study, the CRED evaluation method is presented. It includes a set of 20 reliability and 13 relevance criteria, accompanied by extensive guidance. Risk assessors who participated in the CRED ring test evaluated the CRED evaluation method to be more accurate, applicable, consistent, and transparent than the often-used Klimisch method. The CRED evaluation method is accompanied by reporting recommendations for aquatic ecotoxicity studies, with 50 specific criteria divided into 6 categories: general information, test design, test substance, test organism, exposure conditions, and statistical design and biological response. An ecotoxicity study in which all important information is reported is more likely to be considered for regulatory use, and proper reporting may also help in the peer-review process., (© 2015 The Authors. Environmental Toxicology and Chemistry Published by Wiley Periodicals, Inc. on behalf of SETAC.)

In the context of the European Water Framework Directive (WFD) it is fully recognized that pharmaceuticals can represent a relevant issue for the achievement of the good chemical and ecological status of European surface water bodies. The recent European Directive on the review of priority substances in surface water bodies has included three pharmaceuticals of widespread use (diclofenac, 17α-ethinylestradiol (EE2), 17β-estradiol (E2)) in the European monitoring list, the so-called watch list. Endocrine active pharmaceuticals such as EE2 and E2 (also occurring as natural hormone) can cause adverse effects on aquatic ecosystems at very low levels. However, monitoring of these pharmaceuticals within the watch list mechanism of the WFD and national monitoring programs can be difficult because of detection problems of most routine analytical methods. With proposed annual average Environmental Quality Standards (AA-EQS) of 0.035 ng/L and 0.4 ng/L, respectively, the estrogenic pharmaceutical EE2 and the natural hormone E2 are among those substances. Sensitive in vitro bioassays could reduce the current detection problems by measuring the estrogenic activity of environmental samples. In a short review article the application of this approach to screen and assess the risks of endocrine active pharmaceuticals with a focus on estrogenic pharmaceuticals in environmental waters is discussed., (Copyright © 2014 Elsevier B.V. All rights reserved.)