1.
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.
2.
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.
3.
4.
Beronius, A., et al.
(författare)
Improving the transparency of data evaluation in risk assessment of endocrine disrupting compounds-Implications from the bisphenol A case study
2011
Ingår i: Toxicology Letters. - : Elsevier BV. - 0378-4274 .- 1879-3169. ; 205, s. S256-S256
Tidskriftsartikel (övrigt vetenskapligt/konstnärligt) abstract
The complex biology and toxicology of endocrine disrupting compounds (EDCs) makes toxicity testing as well as evaluation of data for risk assessment difficult. Standardized test guidelines have previously been questioned as to their applicability for evaluating EDC toxicity. However, several guidelines have been updated and enhanced in an effort to better cover EDCs. Also, EDC toxicity is a very active research field and a lot of toxicological data are generated in research studies NOT conducted according to standardized guidelines. Our previous work indicates that differences in how the reliability and relevance of toxicity studies are judged may vary greatly between risk assessments of the same compound and may result in different conclusions about the size and nature of health risks. Further, the process of data evaluation is in many cases in-transparent. The purpose of this on-going study is to contribute to making health risk assessments of EDCs more transparent, systematic, and predictable. The investigation is conducted as a literature study using the EDC bisphenol A (BPA) for a case study. We scrutinize and compare the strengths and weaknesses of both guideline and non-guideline studies evaluating developmental neurotoxicity of BPA. One goal is to further assess the applicability of standardized guidelines in this case. Another aim is to propose improvements in the process of data reporting of non-guideline studies and recommend criteria for the evaluation of data in order to facilitate risk assessment of EDCs.
5.
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.
6.
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.
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8.
Hansson, Sven Ove, et al.
(författare)
The substitution principle
2011
Ingår i: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 59:3, s. 454-460
Tidskriftsartikel (refereegranskat) abstract
According to the substitution principle, hazardous chemicals should be replaced by less hazardous alternatives. In this paper, the major issues concerning the more precise definition of the principle are analyzed, and a general purpose definition is proposed. It is claimed that the priority between reducing hazard, functionality and economical considerations in the application of the substitution principle is a matter for adjustment in each particular case that cannot be settled beforehand. None of these objectives can have absolute priority over the others, but the substitution principle is aimed at increasing the priority given to the reduction of hazards to human health and the environment. Major methods to promote and implement the principle are summarized, current legislative approaches are discussed, and proposals for efficient implementation are made. It is emphasized that the primary responsibility for avoiding hazardous substances and processes rests with industry.
9.
Molander, Linda, et al.
(författare)
Combining web-based tools for transparent evaluation of data for risk assessment : developmental effects of bisphenol A on the mammary gland as a case study
2017
Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 37:3, s. 319-330
Tidskriftsartikel (refereegranskat) abstract
Different tools have been developed that facilitate systematic and transparent evaluation and handling of toxicity data in the risk assessment process. The present paper sets out to explore the combined use of two web-based tools for study evaluation and identification of reliable data relevant to health risk assessment. For this purpose, a case study was performed using in vivo toxicity studies investigating low-dose effects of bisphenol A on mammary gland development. The reliability of the mammary gland studies was evaluated using the Science in Risk Assessment and Policy (SciRAP) criteria for toxicity studies. The Health Assessment Workspace Collaborative (HAWC) was used for characterizing and visualizing the mammary gland data in terms of type of effects investigated and reported, and the distribution of these effects within the dose interval. It was then investigated whether there was any relationship between study reliability and the type of effects reported and/or their distribution in the dose interval. The combination of the SciRAP and HAWC tools allowed for transparent evaluation and visualization of the studies investigating developmental effects of BPA on the mammary gland. The use of these tools showed that there were no apparent differences in the type of effects and their distribution in the dose interval between the five studies assessed as most reliable and the whole data set. Combining the SciRAP and HAWC tools was found to be a useful approach for evaluating in vivo toxicity studies and identifying reliable and sensitive information relevant to regulatory risk assessment of chemicals. Copyright (c) 2016 John Wiley & Sons, Ltd. The present paper explores the combined use of the Science in Risk Assessment and Policy toxicity study evaluation method and the Health Assessment Workspace Collaborative tools for identification of reliable data relevant to health risk assessment. Combining the Science in Risk Assessment and Policy and Health Assessment Workspace Collaborative tools was found to be a useful and transparent approach for evaluating in vivo toxicity studies and identifying reliable and sensitive information relevant to regulatory risk assessment of chemicals.
10.
