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Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals: a proposal to improve evaluation criteria and reporting
Stockholm University, Faculty of Science, Department of Applied Environmental Science (ITM). Karolinska Institute, Sweden.
Stockholm University, Faculty of Science, Department of Applied Environmental Science (ITM).
Stockholm University, Faculty of Science, Department of Applied Environmental Science (ITM).
2014 (English)In: Journal of Applied Toxicology, ISSN 0260-437X, E-ISSN 1099-1263, Vol. 34, no 6, 607-617 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2014. Vol. 34, no 6, 607-617 p.
Keyword [en]
chemicals, relevance, reliability, study evaluation, reporting guidelines, OECD, Health risk assessment, non-standard studies
National Category
Biological Sciences Pharmacology and Toxicology
Research subject
Applied Environmental Science
Identifiers
URN: urn:nbn:se:su:diva-104117DOI: 10.1002/jat.2991ISI: 000334955100003OAI: oai:DiVA.org:su-104117DiVA: diva2:721006
Note

AuthorCount:4;

Available from: 2014-06-03 Created: 2014-06-03 Last updated: 2017-12-05Bibliographically approved
In thesis
1. Chemicals in consumer products: Bridging the gap between academic research and chemicals regulation
Open this publication in new window or tab >>Chemicals in consumer products: Bridging the gap between academic research and chemicals regulation
2015 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Exposure to chemicals emitting from consumer products, such as clothes, electronic devices, toys and kitchen-ware, has emerged as an issue of public health and environmental concern. The use of chemicals having endocrine disrupting properties in commercial products is receiving particular attention as low dose exposures of such chemicals have been associated with adverse effects in both human and wildlife populations. Current chemicals regulation has been criticized for not providing adequate protection of human health and the environment with regard to consumer products. The aim of this thesis has been to provide new insights and methods related to the risk assessment and risk management of chemicals in consumer products in order to ensure a safer and more sustainable use.

The comparative analyses of different EU regulatory frameworks targeting the use of chemicals in articles identified a number of shortcomings and inconsistencies in how chemicals in articles are regulated. One main conclusion from Paper I was that product specific rules are important complements to REACH as they can more easily be tailored for certain uses and exposure scenarios. In Paper II it was investigated whether the regulation of chemicals in articles according to REACH is sufficient for meeting EU environmental goals, which include rectifying environmental problems at the source. It was concluded that the prioritization of substances to be targeted by restrictions and other requirements under REACH to a greater extent should take into account substances that have been identified as posing a risk to or via the environment.

With the aim to facilitate the use of all reliable and relevant toxicity information in regulatory health risk assessment of chemicals, a method for systematic and transparent evaluation of non-standard research studies, as well as reporting guidance for such studies, were developed in Paper III. It has for example been emphasized that non-standard research studies can provide valuable information with regard to endocrine disrupting effects. Such effects are not systematically tested for in standardized studies commonly preferred in regulatory risk assessments. In Paper IV, the method for study evaluation proposed in Paper III was combined with recently developed web-based tools that aid summarizing and visualizing toxicity data extracted from several studies. The combined use was found to comprise a promising methodology for identifying reliable and sensitive information from in vivo toxicity studies of relevance to consider in the risk assessment process.

The new methods and tools proposed and evaluated in this thesis will hopefully help improve the use of non-standard studies for risk assessment purposes and thereby strengthen the link between academic research and chemicals policy. In my view, this would be an important step towards improving public health protection with regard to the use of chemicals in consumer products.

Place, publisher, year, edition, pages
Department of Environmental Science and Analytical Chemistry, Stockholm University: Stockholm University, 2015. 42 p.
Keyword
consumer products, articles, chemicals, chemicals regulation, REACH, risk management, health risk assessment, non-standard toxicity studies, study evaluation, reporting guidance, endocrine disrupting compounds, bisphenol A, low dose effects
National Category
Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-120285 (URN)978-91-7649-244-4 (ISBN)
Public defence
2015-10-06, Nordenskiöldsalen, Geovetenskapens hus, Svante Arrhenius väg 12, Stockholm, 10:00 (English)
Opponent
Supervisors
Note

At the time of the doctoral defense, the following paper was unpublished and had a status as follows: Paper 4: Manuscript.

Available from: 2015-09-17 Created: 2015-09-04 Last updated: 2015-09-16Bibliographically approved

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