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Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances.

ABSTRACT: A SETAC Pellston Workshop® "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)" was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substance (EDS) under review. The workshop additionally considered recent developments in the identification of EDS. Case studies were undertaken on 6 endocrine-active substances (EAS-not necessarily proven EDS, but substances known to interact directly with the endocrine system) that are representative of a range of perturbations of the endocrine system and considered to be data rich in relevant information at multiple biological levels of organization for 1 or more ecologically relevant taxa. The substances selected were 17?-ethinylestradiol, perchlorate, propiconazole, 17?-trenbolone, tributyltin, and vinclozolin. The 6 case studies were not comprehensive safety evaluations but provided foundations for clarifying key issues and procedures that should be considered when assessing the ecotoxicological hazards and risks of EAS and EDS. The workshop also highlighted areas of scientific uncertainty, and made specific recommendations for research and methods-development to resolve some of the identified issues. The present paper provides broad guidance for scientists in regulatory authorities, industry, and academia on issues likely to arise during the ecotoxicological hazard and risk assessment of EAS and EDS. The primary conclusion of this paper, and of the SETAC Pellston Workshop on which it is based, is that if data on environmental exposure, effects on sensitive species and life-stages, delayed effects, and effects at low concentrations are robust, initiating environmental risk assessment of EDS is scientifically sound and sufficiently reliable and protective of the environment. In the absence of such data, assessment on the basis of hazard is scientifically justified until such time as relevant new information is available. Integr Environ Assess Manag 2017;13:267-279. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

SUBMITTER: Matthiessen P

PROVIDER: S-EPMC6069525 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances.

Matthiessen Peter P Ankley Gerald T GT Biever Ronald C RC Bjerregaard Poul P Borgert Christopher C Brugger Kristin K Blankinship Amy A Chambers Janice J Coady Katherine K KK Constantine Lisa L Dang Zhichao Z Denslow Nancy D ND Dreier David A DA Dungey Steve S Gray L Earl LE Gross Melanie M Guiney Patrick D PD Hecker Markus M Holbech Henrik H Iguchi Taisen T Kadlec Sarah S Karouna-Renier Natalie K NK Katsiadaki Ioanna I Kawashima Yukio Y Kloas Werner W Krueger Henry H Kumar Anu A Lagadic Laurent L Leopold Annegaaike A Levine Steven L SL Maack Gerd G Marty Sue S Meador James J Mihaich Ellen E Odum Jenny J Ortego Lisa L Parrott Joanne J Pickford Daniel D Roberts Mike M Schaefers Christoph C Schwarz Tamar T Solomon Keith K Verslycke Tim T Weltje Lennart L Wheeler James R JR Williams Mike M Wolf Jeffrey C JC Yamazaki Kunihiko K

Integrated environmental assessment and management 20170127 2

A SETAC Pellston Workshop<sup>®</sup> "Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)" was held in February 2016 in Pensacola, Florida, USA. The primary objective of the workshop was to provide advice, based on current scientific understanding, to regulators and policy makers; the aim being to make considered, informed decisions on whether to select an ecotoxicological hazard- or a risk-based approach for regulating a given endocrine-disrupting substan ...[more]

PMID: 28127947

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Project description:Endocrine-disrupting substances (EDS) may have certain biological effects including delayed effects, multigenerational effects, and may display nonmonotonic dose-response (NMDR) relationships that require careful consideration when determining environmental hazards. Endocrine disrupting substances can have specific and profound effects when exposure occurs during sensitive windows of the life cycle (development, reproduction). This creates the potential for delayed effects that manifest when exposure has ceased, possibly in a different life stage. This potential underscores the need for testing in appropriate (sensitive) life stages and full life cycle designs. Such tests are available in the Organisation for Economic Co-operation and Development (OECD) tool box and should be used to derive endpoints that can be considered protective of all life stages. Similarly, the potential for effects to be manifest in subsequent generations (multigenerational effects) has also been raised as a potential issue in the derivation of appropriate endpoints for EDS. However, multigenerational studies showing increasing sensitivity of successive generations are uncommon. Indeed this is reflected in the design of new higher tier tests to assess endocrine active substances (EAS) that move to extended one-generation designs and away from multi-generational studies. The occurrence of NMDRs is also considered a limiting factor for reliable risk assessment of EDS. Evidence to date indicates NMDRs are more prevalent in in vitro and mechanistic data, not often translating to adverse apical endpoints that would be used in risk assessment. A series of steps to evaluate NMDRs in the context of endocrine hazard and risk assessment procedures is presented. If careful consideration of delayed, multigenerational effects and NMDRs is made, it is feasible to assess environmental endocrine hazards and derive robust apical endpoints for risk assessment procedures ensuring a high level of environmental protection. Integr Environ Assess Manag 2017;13:293-301. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Project description:In the present study, existing regulatory frameworks and test systems for assessing potential endocrine active chemicals are described, and associated challenges are discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across geographies, but all basically evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or to the environment. Current test systems include in silico, in vitro, and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect apical data to detect possible adverse effects. These test systems are currently designed to robustly assess endocrine activity and/or adverse effects in the estrogen, androgen, and thyroid hormone signaling pathways; however, there are some limitations of current test systems for evaluating endocrine hazard and risk. These limitations include a lack of certainty regarding: 1) adequately sensitive species and life stages; 2) mechanistic endpoints that are diagnostic for endocrine pathways of concern; and 3) the linkage between mechanistic responses and apical, adverse outcomes. Furthermore, some existing test methods are resource intensive with regard to time, cost, and use of animals. However, based on recent experiences, there are opportunities to improve approaches to and guidance for existing test methods and to reduce uncertainty. For example, in vitro high-throughput screening could be used to prioritize chemicals for testing and provide insights as to the most appropriate assays for characterizing hazard and risk. Other recommendations include adding endpoints for elucidating connections between mechanistic effects and adverse outcomes, identifying potentially sensitive taxa for which test methods currently do not exist, and addressing key endocrine pathways of possible concern in addition to those associated with estrogen, androgen, and thyroid signaling. Integr Environ Assess Manag 2017;13:302-316. © 2016 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Project description:The importance of disinfection has recently been emphasized due to the increasing risk of the spread of infections such as coronavirus disease-2019 (COVID-19). In addition, disinfection for preventing the spread of COVID-19 is highly recommended. The increased use of biocidal products raises concerns regarding the potential health risks from exposure among disinfection workers. This study aimed to assess these exposure and health risks using questionnaires targeting disinfection workers who were exposed to the active substances in biocidal products used for disinfection during the COVID-19 pandemic. A follow-up survey was conducted among 271 disinfection workers for 10 working days within two weeks, and exposure factors with reference to disinfection were evaluated through interview-administered questionnaires. An exposure algorithm was used to evaluate the exposure of disinfection workers during disinfection. The hazard index (HI) was calculated by dividing the inhalation concentration obtained using the exposure algorithm and the dermal dose according to occupational exposure limits (OEL). A sensitivity analysis was conducted to identify the exposure factors with the greatest impact on the inhalation and dermal exposure algorithms. A logistic regression analysis was performed to verify the relationship with health effects and sociodemographic and exposure characteristics. The average number of disinfections performed during 10 working days was 17.5 ± 12.3 times. The type of disinfection work was divided into 2806 cases of COVID-19 prevention and disinfection and 1956 cases of regular pesticide application to prevent and remove any pests. The HI was ≥1, indicating a potential health risk, with the use of ethanol (6.50E+00), quaternary ammonium compounds (QACs; 1.49E+01), and benzalkonium chloride (BKC; 1.73E+00). Dermal exposure was more hazardous than inhalation exposure for 6 of the 11 active substances in biocidal products. The weight fraction and exposure time were the factors that most significantly influenced the inhalation and dermal exposure algorithms in the sensitivity analysis. Higher exposure concentrations were more likely to affect health (AOR: 3.239, 95% CI: 1.155-9.082). This study provides valuable information regarding the exposure and risk of disinfection workers to 11 biocidal active substances included in common disinfectants. Our results suggest that the use of ethanol, BKC, and QACs has potential health risks to disinfection workers, with a higher possibility of negative health impacts with increasing exposure concentration.

Project description:ObjectiveOur objective was to provide a scholarly review of the published literature on menopausal hormonal therapy (MHT), make scientifically valid assessments of the available data, and grade the level of evidence available for each clinically important endpoint. PARTICIPANTS IN DEVELOPMENT OF SCIENTIFIC STATEMENT: The 12-member Scientific Statement Task Force of The Endocrine Society selected the leader of the statement development group (R.J.S.) and suggested experts with expertise in specific areas. In conjunction with the Task Force, lead authors (n = 25) and peer reviewers (n = 14) for each specific topic were selected. All discussions regarding content and grading of evidence occurred via teleconference or electronic and written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement.EvidenceEach expert conducted extensive literature searches of case control, cohort, and randomized controlled trials as well as meta-analyses, Cochrane reviews, and Position Statements from other professional societies in order to compile and evaluate available evidence. No unpublished data were used to draw conclusions from the evidence.Consensus processA consensus was reached after several iterations. Each topic was considered separately, and a consensus was achieved as to content to be included and conclusions reached between the primary author and the peer reviewer specific to that topic. In a separate iteration, the quality of evidence was judged using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system in common use by The Endocrine Society for preparing clinical guidelines. The final iteration involved responses to four levels of additional review: 1) general comments offered by each of the 25 authors; 2) comments of the individual Task Force members; 3) critiques by the reviewers of the Journal of Clinical Endocrinology & Metabolism; and 4) suggestions offered by the Council and members of The Endocrine Society. The lead author compiled each individual topic into a coherent document and finalized the content for the final Statement. The writing process was analogous to preparation of a multiauthored textbook with input from individual authors and the textbook editors.ConclusionsThe major conclusions related to the overall benefits and risks of MHT expressed as the number of women per 1000 taking MHT for 5 yr who would experience benefit or harm. Primary areas of benefit included relief of hot flashes and symptoms of urogenital atrophy and prevention of fractures and diabetes. Risks included venothrombotic episodes, stroke, and cholecystitis. In the subgroup of women starting MHT between ages 50 and 59 or less than 10 yr after onset of menopause, congruent trends suggested additional benefit including reduction of overall mortality and coronary artery disease. In this subgroup, estrogen plus some progestogens increased the risk of breast cancer, whereas estrogen alone did not. Beneficial effects on colorectal and endometrial cancer and harmful effects on ovarian cancer occurred but affected only a small number of women. Data from the various Women's Health Initiative studies, which involved women of average age 63, cannot be appropriately applied to calculate risks and benefits of MHT in women starting shortly after menopause. At the present time, assessments of benefit and risk in these younger women are based on lower levels of evidence.

Project description:ObjectiveThe aim was to provide a scholarly review of the published literature on biological, clinical, and nonclinical contributors to race/ethnic and sex disparities in endocrine disorders and to identify current gaps in knowledge as a focus for future research needs. PARTICIPANTS IN DEVELOPMENT OF SCIENTIFIC STATEMENT: The Endocrine Society's Scientific Statement Task Force (SSTF) selected the leader of the statement development group (S.H.G.). She selected an eight-member writing group with expertise in endocrinology and health disparities, which was approved by the Society. All discussions regarding the scientific statement content occurred via teleconference or written correspondence. No funding was provided to any expert or peer reviewer, and all participants volunteered their time to prepare this Scientific Statement.EvidenceThe primary sources of data on global disease prevalence are from the World Health Organization. A comprehensive literature search of PubMed identified U.S. population-based studies. Search strategies combining Medical Subject Headings terms and keyword terms and phrases defined two concepts: 1) racial, ethnic, and sex differences including specific populations; and 2) the specific endocrine disorder or condition. The search identified systematic reviews, meta-analyses, large cohort and population-based studies, and original studies focusing on the prevalence and determinants of disparities in endocrine disorders. consensus process: The writing group focused on population differences in the highly prevalent endocrine diseases of type 2 diabetes mellitus and related conditions (prediabetes and diabetic complications), gestational diabetes, metabolic syndrome with a focus on obesity and dyslipidemia, thyroid disorders, osteoporosis, and vitamin D deficiency. Authors reviewed and synthesized evidence in their areas of expertise. The final statement incorporated responses to several levels of review: 1) comments of the SSTF and the Advocacy and Public Outreach Core Committee; and 2) suggestions offered by the Council and members of The Endocrine Society.ConclusionsSeveral themes emerged in the statement, including a need for basic science, population-based, translational and health services studies to explore underlying mechanisms contributing to endocrine health disparities. Compared to non-Hispanic whites, non-Hispanic blacks have worse outcomes and higher mortality from certain disorders despite having a lower (e.g. macrovascular complications of diabetes mellitus and osteoporotic fractures) or similar (e.g. thyroid cancer) incidence of these disorders. Obesity is an important contributor to diabetes risk in minority populations and to sex disparities in thyroid cancer, suggesting that population interventions targeting weight loss may favorably impact a number of endocrine disorders. There are important implications regarding the definition of obesity in different race/ethnic groups, including potential underestimation of disease risk in Asian-Americans and overestimation in non-Hispanic black women. Ethnic-specific cut-points for central obesity should be determined so that clinicians can adequately assess metabolic risk. There is little evidence that genetic differences contribute significantly to race/ethnic disparities in the endocrine disorders examined. Multilevel interventions have reduced disparities in diabetes care, and these successes can be modeled to design similar interventions for other endocrine diseases.

Project description:The occurrence and distribution of organochlorine pesticides (OCPs) in aquatic systems is a matter of global concern and poses significant toxicological threats to both organisms and human health. Despite the extensive use of OCPs for pest and disease control in southern Africa, relatively few studies have examined the occurrence and toxicological risks of OCP residues in the region. This study investigates the composition, distribution, and potential sources of OCP contamination in sediments from Richards Bay, a rapidly developing industrial port on the northeast coast of South Africa. Surface sediments collected from Richards Bay Harbour and surrounding areas indicate that OCP contamination in the region is widespread. Total concentrations (∑OCP) in surface samples ranged from 135 to 1020 ng g-1, with hexachlorocyclohexanes (∑HCH; 35-230 ng g-1) and dichlorodiphenyltrichloroethanes (∑DDT; 12-350 ng g-1) the dominant contaminant groups detected. Metabolite isomeric compositions indicate that the presence of aldrin and endosulfan likely result from historical agricultural usage, while recent input of γ-HCH, heptachlor, and endrin may be linked to the illegal use of old pesticide stockpiles. Total DDT concentrations were dominated by p,p'-DDT (80 ± 64 ng g-1), which was attributed to its ongoing use in malaria vector control in the region. A 210Pb-dated sediment core revealed that OCP input to the local environment increased dramatically from relatively low concentrations in the mid-1940s (∑OCP, 355 ng g-1) to peak levels (∑OCP, 781 ng g-1) in the 1980s/1990s. An overall decrease in ∑OCP concentration from the mid-2000s is likely related to restrictions on use following the Stockholm Convention in 2004. Despite current restrictions on use, OCP concentrations exceeded sediment quality guidelines in the vast majority of cases, raising concerns for protected estuarine and mangrove habitats in the area, as well as for local fishing and farming communities.

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Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances.

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Recommended approaches to the scientific evaluation of ecotoxicological hazards and risks of endocrine-active substances.

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