| 1. |
- Ågerstrand, Marlene, et al.
(författare)
-
A call for action : Improve reporting of research studies to increase the scientific basis for regulatory decision-making
- 2018
-
Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 38:5, s. 783-785
-
Tidskriftsartikel (refereegranskat)abstract
- This is a call for action to scientific journals to introduce reporting requirements for toxicity and ecotoxicity studies. Such reporting requirements will support the use of peer-reviewed research studies in regulatory decision-making. Moreover, this could improve the reliability and reproducibility of published studies in general and make better use of the resources spent in research.
|
|
| 2. |
- Beronius, Anna, et al.
(författare)
-
Bridging the gap between academic research and regulatory health risk assessment of Endocrine Disrupting Chemicals
- 2014
-
Ingår i: Current opinion in pharmacology (Print). - : Elsevier BV. - 1471-4892 .- 1471-4973. ; 19, s. 99-104
-
Tidskriftsartikel (refereegranskat)abstract
- Regulatory risk assessment is traditionally based primarily on toxicity studies conducted according to standardized and internationally validated test guidelines. However, health risk assessment of endocrine disrupting chemicals (EDCs) is argued to rely on the efficient integration of findings from academic research. The aim of this review was to provide an overview of current developments to facilitate the use of academic research in regulatory risk assessment of chemicals and how certain aspects of study design and reporting are particularly important for the risk assessment process. By bridging the gap between academic research and regulatory health risk assessment of EDCs, scientific uncertainty in risk assessment conclusions can be reduced, allowing for better targeted policy decisions for chemical risk reduction.
|
|
| 3. |
- Beronius, Anna, et al.
(författare)
-
Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals : a proposal to improve evaluation criteria and reporting
- 2014
-
Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 34:6, s. 607-617
-
Tidskriftsartikel (refereegranskat)abstract
- To improve data availability in health risk assessment of chemicals and fill information gaps there is a need to facilitate the use of non-standard toxicity studies, i.e. studies not conducted according to any standardized toxicity test guidelines. The purpose of this work was to propose criteria and guidance for the evaluation of reliability and relevance of non-standard in vivo studies, which could be used to facilitate systematic and transparent evaluation of such studies for health risk assessment. Another aim was to propose user friendly guidance for reporting of non-standard studies intended to promote an improvement in reporting of studies that could be of use in risk assessment. Requirements and recommendations for the design and execution of in vivo toxicity studies were identified from The Organisation for Economic Co-operation and Development (OECD) test guidelines, and served as basis for the data evaluation criteria and reporting guidelines. Feedback was also collected from experts within the field of toxicity testing and risk assessment and used to construct a two-tiered framework for study evaluation, as well as refine the reporting guidelines. The proposed framework emphasizes the importance of study relevance and an important aspect is to not completely dismiss studies from health risk assessment based on very strict criteria for reliability. The suggested reporting guidelines provide researchers with a tool to fulfill reporting requirements as stated by regulatory agencies. Together, these resources provide an approach to include all relevant data that may fill information gaps and reduce scientific uncertainty in health risk assessment conclusions, and subsequently also in chemical policy decisions.
|
|
| 4. |
|
|
| 5. |
- Beronius, Anna, et al.
(författare)
-
Health risk assessment procedures for endocrine disrupting compounds within different regulatory frameworks in the European Union
- 2009
-
Ingår i: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 55:2, s. 111-122
-
Tidskriftsartikel (refereegranskat)abstract
- In this study we have investigated how different regulatory frameworks in Europe cope with identification and risk assessment of endocrine disrupting compounds (EDCs). Four regulatory groups were selected for the investigation: existing industrial chemicals, environmental pollutants in food, pharmaceuticals and plant protection products. The legislation and guidelines for each of these groups were scrutinized and compared in detail. In addition, one recent European risk assessment document each for three identified EDCs, i.e. bisphenol A, dioxins and vinclozolin, were reviewed and compared. We found that the requirements for toxicity testing and availability and scope of risk assessment guidelines varied between the four regulatory frameworks. Also, the general principles regarding the human relevance of the mode of action identified in animal tests differed in the different risk assessments. In conclusion, there is little conformity in the risk assessment processes between these groups of chemicals. Because of the complicated nature of endocrine disruption, test methods, principles and criteria for data interpretation traditionally used might not be directly applicable to EDCs and further development of a transparent and reliable risk assessment process for this type of substances is needed.
|
|
| 6. |
- Beronius, Anna
(författare)
-
Risk assessment of endocrine disrupting compounds
- 2013
-
Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- During the past decade a growing number of chemicals have been identified as having endocrine disrupting properties in laboratory studies. Also, associations between exposure to such substances and endocrine-related health effects in the general population, as well as in wildlife, have been increasingly reported. This implies that past chemical regulation has failed to adequately protect human health and the environment. Endocrine disrupting compounds (EDCs) have lately been identified as substances of very high concern that should be phased out in new European (EU) legislations for e.g. industrial chemicals, plant protection products and biocides. There is thus an increased pressure on regulatory agencies to be able to efficiently and reliably identify, characterize and risk assess EDCs. However, risk assessment of EDCs has proven complicated, in part due to the complex toxicity exhibited by substances that can interact with the endocrine system, and also because there are currently no generally agreed upon criteria within the EU or internationally that direct how to specifically identify compounds with endocrine disrupting properties. The aim of this thesis project has been to identify how scientific uncertainties concerning the toxicity of EDCs can be reduced or handled to make health risk assessments of EDCs more transparent, systematic, and reliable. To that end literature studies were conducted that investigated the risk assessment process for EDCs within different regulatory frameworks in the EU, as well as the underlying toxicity data available to risk assessors and how the use of all available toxicity data can be improved. The much debated EDC bisphenol A (BPA) was used for a case study in a large part of this work. A comparison of different regulatory frameworks within the EU showed that the regulatory risk assessment process, including underlying policies, criteria and requirements may differ for EDCs belonging to different regulatory groups, e.g. industrial chemicals, plant protection products or pharmaceuticals. The investigations within this project also showed that non-standard research studies, i.e. studies not conducted according to standardized regulatory test guidelines, fill data gaps and contribute information that could be particularly important for the identification and risk assessment of EDCs. However, non-standard studies were often criticized for having methodological limitations or being insufficiently reported, limiting their use in regulatory risk assessment. Regulatory agencies commonly gave more weight to standard than non-standard studies in risk assessment of BPA, despite the growing amount of research indicating that toxic effects at low doses were being overlooked. A framework of criteria and guidelines intended to enable transparent and systematic evaluation of non-standard research studies, as well as guidance for how to report in vivo research to meet the requirements for regulatory risk assessment, was proposed. These tools are intended to facilitate the use of non-standard research studies in regulatory risk assessment and hopefully improve the reliability of risk assessment conclusions for EDCs.
|
|
| 7. |
- Beronius, Anna, et al.
(författare)
-
Risk to all or none? A comparative analysis of controversies in the health risk assessment of Bisphenol A
- 2010
-
Ingår i: Reproductive Toxicology. - : Elsevier BV. - 0890-6238 .- 1873-1708. ; 29:2, s. 132-146
-
Tidskriftsartikel (refereegranskat)abstract
- Bisphenol A (BPA) is an endocrine disruptor for which health risk assessment has proven controversial. Conclusions regarding health risks of BPA vary between assessments from "there is no risk to any part of the population" to "there is risk to the entire population". We have carried out a literature study investigating what might be the scientific and/or policy-related reasons for these differences. Ten risk assessments for BPA were scrutinized and several factors were compared between assessments, including estimations of exposure levels, identification of critical study and NOAEL, assessment factors and significance attributed to reports of low-dose effects. Differences in conclusions were mainly influenced by the evaluation of low-dose effects and the uncertainties surrounding the significance of these data for health risk assessment. The results illustrate the impact of differences in risk assessment policy and expert judgment on the risk assessment process and highlight the importance of transparency in this process.
|
|
| 8. |
- Beronius, Anna, et al.
(författare)
-
Testing and refining the Science in Risk Assessment and Policy (SciRAP) web-based platform for evaluating the reliability and relevance of in vivo toxicity studies
- 2018
-
Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 38:12, s. 1460-1470
-
Tidskriftsartikel (refereegranskat)abstract
- The Science in Risk Assessment and Policy (SciRAP) web-based platform was developed to promote and facilitate structure and transparency in the evaluation of ecotoxicity and toxicity studies for hazard and risk assessment of chemicals. The platform includes sets of criteria and a colour-coding tool for evaluating the reliability and relevance of individual studies. The SciRAP method for evaluating in vivo toxicity studies was first published in 2014 and the aim of the work presented here was to evaluate and develop that method further. Toxicologists and risk assessors from different sectors and geographical areas were invited to test the SciRAP criteria and tool on a specific set of in vivo toxicity studies and to provide feedback concerning the scientific soundness and user-friendliness of the SciRAP approach. The results of this expert assessment were used to refine and improve both the evaluation criteria and the colour-coding tool. It is expected that the SciRAP web-based platform will continue to be developed and enhanced to keep up to date with the needs of end-users.
|
|
| 9. |
- Beronius, Anna, et al.
(författare)
-
The influence of study design and sex-differences on results from developmental neurotoxicity studies of bisphenol A, implications for toxicity testing
- 2013
-
Ingår i: Toxicology. - : Elsevier BV. - 0300-483X .- 1879-3185. ; 311:1-2, s. 13-26
-
Tidskriftsartikel (refereegranskat)abstract
- Developmental neurotoxicity (DNT) of bisphenol A (BPA) has been investigated in a large number of studies. However, there are discrepancies in the results reported between the studies. The aim of this study was to identify and analyze factors that may contribute to these differences and to assess whether there are sex-differences in the sensitivity of certain endpoints or tests used in DNT-studies. Forty-four DNT studies of BPA were identified from the open literature. Details about study design and results from each study, as well as the criteria for DNT testing according to the standardized OECD test guideline (TG) 426, were collected in a database. This enabled systematic and detailed comparisons between studies as well as to the criteria and recommendations stated in TG 426. Multivariate analyses were also used to investigate how different factors of the study design contributed to differences in study results. The analyses showed behavioral effects were often observed for endpoints that are not required according to OECD TG 426, such as anxiety-related, social and sexual behaviors, especially at very low doses and in female offspring. On the other hand relatively few studies observed any effects on motor activity, which is commonly used in screening for neurotoxic effects in regulatory testing. However, varied and to some extent seemingly contradictory results have been reported in these studies, especially for endpoints related to motor activity and anxiety and exploration. Many studies were also poorly reported, limiting these analyses. No strong conclusions could be drawn from the multivariate analyses. A few factors of study design, such as the size of the dose and number of dose levels used and the use of litter or individual pup as statistical unit seemed to have some influence on study results. In conclusion, this analysis suggests that DNT-studies conducted according to the standardized OECD TG 426 may overlook sensitive effects of BPA, and possibly other potential endocrine disruptors, especially in female offspring.
|
|
| 10. |
- Beronius, Anna, et al.
(författare)
-
Using systematic reviews for hazard and risk assessment of endocrine disrupting chemicals
- 2016
-
Ingår i: Reviews in endocrine and metabolic disorders (Print). - : Springer Science and Business Media LLC. - 1389-9155 .- 1573-2606. ; 16:4, s. 273-287
-
Forskningsöversikt (refereegranskat)abstract
- The possibility that endocrine disrupting chemicals (EDCs) in our environment contribute to hormonally related effects and diseases observed in human and wildlife populations has caused concern among decision makers and researchers alike. EDCs challenge principles traditionally applied in chemical risk assessment and the identification and assessment of these compounds has been a much debated topic during the last decade. State of the science reports and risk assessments of potential EDCs have been criticized for not using systematic and transparent approaches in the evaluation of evidence. In the fields of medicine and health care, systematic review methodologies have been developed and used to enable objectivity and transparency in the evaluation of scientific evidence for decision making. Lately, such approaches have also been promoted for use in the environmental health sciences and risk assessment of chemicals. Systematic review approaches could provide a tool for improving the evaluation of evidence for decision making regarding EDCs, e.g. by enabling systematic and transparent use of academic research data in this process. In this review we discuss the advantages and challenges of applying systematic review methodology in the identification and assessment of EDCs.
|
|
