An example of an integrated approach for health and environmental risk assessment: the case of organotin compounds

2000 ◽  
Vol 42 (7-8) ◽  
pp. 305-313
Author(s):  
J. Sekizawa ◽  
G. Suter ◽  
T. Vermeire ◽  
W. Munns
Keyword(s):  
Risk Assessment ◽  
Integrated Approach ◽  
Organotin Compounds ◽  
Health And Environmental Effects ◽  
Environmental Decision Making ◽  
Integrated Risk Assessment ◽  
Toxicological Data ◽  
Potential Risks ◽  
Available Information

Because environmental decision making based solely on simple compilation of toxicological data on either wildlife or humans in isolation can not give effective answers about the nature and levels of risk, an integrated approach for risk assessment of adverse effects of chemicals is required. Integration of available information on health and environmental effects, from in vitro to the level of humans, across various species, across different endpoints, and in combination with integrated exposure data, permits enhanced estimation of the potential risks posed by various agents. Mechanistic and quantitative consideration are the keys in this process. A framework for integrated risk assessment has been proposed by an international workgroup. The value and utility of the integrated approach is shown using the example of organotin compounds.

scholarly journals Integrated Risk Assessment: Case Study of Lithuanian Family Farms

2019 ◽  
Vol 30 (4) ◽  
pp. 402-410
Author(s):  
Sigitas Vaitkevicius ◽  
Vilija Alekneviciene ◽  
Laura Girdziute ◽  
Astrida Miceikiene
Keyword(s):  
Risk Assessment ◽  
Assessment Tool ◽  
Hierarchical Cluster ◽  
Integrated Approach ◽  
Farm Size ◽  
Historical Period ◽  
Family Farms ◽  
Integrated Risk Assessment ◽  
Integrated Risk ◽  
Risk Evolution

This study is designed to develop the tool for risk assessment under the integrated approach. Analyzing risk several problems are encountered: the first one arises at the farm level – assessment of risk in the whole-farm context rather than in a partial context, i.e. an integrated risk assessment tool is necessary. The second problem is related to the dynamic aspect when determining how the risk changes over time and what the main drivers of these changes are. All these problems are solved in the presented research, creating an integrated risk assessment index (IRAI) and testing it in Lithuanian family farms. This index assesses four types of risk: economic, financial, production, and political. The research methodology is developed to make sure that the data collected on the IRAI behavior is as diverse as possible. A model of IRAI variation by farm size illustrating risk evolution at the Lithuanian farms and, at the same time, enabling visual diversification of the dependence of integrated risk on farm size is developed. Hierarchical cluster analysis is applied for identification of the integrated risk evolution models. Assessment of the interaction between the IRAIand output and input using nonparametric Kruskal-Wallis testis used to find out whether the type of integrated risk is based on differential logic. IRAI was tested using official statistical data of 1300 family farms collected in 2004–2013 for institutional purposes. The testing revealed that the designed IRAI allows identifying types of farms by their risk evolvement profiles and the key risk (s) acting on the farm in the historical period. Four meaningful clusters representing the changing pattern of the risk are identified during the testing of IRAI: increasing risk farms; reducing risk farms; relatively constant risk farms; varying risk farms. IRAI can be applied both for macro analysis (at a national, EU or other levels) and microanalysis (at the level of a single farm).

Biokinetic and Toxicodynamic Modelling and its Role in Toxicological Research and Risk Assessment

2003 ◽  
Vol 31 (3) ◽  
pp. 277-281 ◽  
Author(s):  
Bas J. Blaauboer
Keyword(s):  
Risk Assessment ◽  
Molecular Mechanisms ◽  
Animal Experiments ◽  
Integrated Approach ◽  
Animal Data ◽  
Hazard And Risk ◽  
Structural Alerts ◽  
Toxicological Research ◽  
Basal Cytotoxicity

Toxicological risk assessment for chemicals is still mainly based on highly standardised protocols for animal experimentation and exposure assessment. However, developments in our knowledge of general physiology, in chemicobiological interactions and in (computer-supported) modelling, have resulted in a tremendous change in our understanding of the molecular mechanisms underlying the toxicity of chemicals. This permits the development of biologically based models, in which the biokinetics as well as the toxicodynamics of compounds can be described. In this paper, the possibilities are discussed of developing systems in which the systemic (acute and chronic) toxicities of chemicals can be quantified without the heavy reliance on animal experiments. By integrating data derived from different sources, predictions of toxicity can be made. Key elements in this integrated approach are the evaluation of chemical functionalities representing structural alerts for toxic actions, the construction of biokinetic models on the basis of non-animal data (for example, tissue–blood partition coefficients, in vitro biotransformation parameters), tests or batteries of tests for determining basal cytotoxicity, and more-specific tests for evaluating tissue or organ toxicity. It is concluded that this approach is a useful tool for various steps in toxicological hazard and risk assessment, especially for those forms of toxicity for which validated in vitro and other non-animal tests have already been developed.

scholarly journals Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience

2020 ◽  
Vol 94 (10) ◽  
pp. 3581-3592
Author(s):  
M. J. Moné ◽  
G. Pallocca ◽  
S. E. Escher ◽  
T. Exner ◽  
M. Herzler ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Kinetic Modelling ◽  
Mitochondrial Respiratory Chain ◽  
Integrated Approach ◽  
Adverse Outcome Pathway ◽  
Next Generation ◽  
Chemical Safety ◽  
Advisory Boards ◽  
The Eu

Abstract In 2016, the European Commission launched the EU-ToxRisk research project to develop and promote animal-free approaches in toxicology. The 36 partners of this consortium used in vitro and in silico methods in the context of case studies (CSs). These CSs included both compounds with a highly defined target (e.g. mitochondrial respiratory chain inhibitors) as well as compounds with poorly defined molecular initiation events (e.g. short-chain branched carboxylic acids). The initial project focus was on developing a science-based strategy for read-across (RAx) as an animal-free approach in chemical risk assessment. Moreover, seamless incorporation of new approach method (NAM) data into this process (= NAM-enhanced RAx) was explored. Here, the EU-ToxRisk consortium has collated its scientific and regulatory learnings from this particular project objective. For all CSs, a mechanistic hypothesis (in the form of an adverse outcome pathway) guided the safety evaluation. ADME data were generated from NAMs and used for comprehensive physiological-based kinetic modelling. Quality assurance and data management were optimized in parallel. Scientific and Regulatory Advisory Boards played a vital role in assessing the practical applicability of the new approaches. In a next step, external stakeholders evaluated the usefulness of NAMs in the context of RAx CSs for regulatory acceptance. For instance, the CSs were included in the OECD CS portfolio for the Integrated Approach to Testing and Assessment project. Feedback from regulators and other stakeholders was collected at several stages. Future chemical safety science projects can draw from this experience to implement systems toxicology-guided, animal-free next-generation risk assessment.

Concepts in the Netherlands of Risk Assessment of Soil Contamination

1997 ◽  
Vol 16 (4-5) ◽  
pp. 509-518 ◽  
Author(s):  
Rob M. C. Theelen
Keyword(s):  
Risk Assessment ◽  
The Netherlands ◽  
Soil Contamination ◽  
Contaminated Soil ◽  
Risk Assessments ◽  
Soil Protection ◽  
Site Specific ◽  
Toxicological Data ◽  
Potential Risks ◽  
A Site

In 1994, a new Soil Protection Act was implemented in The Netherlands. It states that risk assessments are to be performed if the intervention value is exceeded. The intervention values reflect potential risks of contaminated soil or groundwater for humans or the ecosystem. The Act also describes in detail the methodology to be used. In the case that an intervention value is exceeded by a certain substance, the urgency of remediation has to be defined. This is to be done by a site-specific risk assessment, determining the current risks posed to humans and the ecosystem. In this article, the Dutch system is critically reviewed and compared to a German technique (in development). It is concluded that international harmonization is needed in the field of parameters and toxicological data that are used in the different models.

scholarly journals Key Challenges and Opportunities Associated with the Use of In Vitro Models to Detect Human DILI: Integrated Risk Assessment and Mitigation Plans

2016 ◽  
Vol 2016 ◽  
pp. 1-20 ◽  
Author(s):  
Franck A. Atienzar ◽  
Eric A. Blomme ◽  
Minjun Chen ◽  
Philip Hewitt ◽  
J. Gerry Kenna ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Data Interpretation ◽  
In Vitro Models ◽  
Drug Induced ◽  
Integrated Risk Assessment ◽  
Integrated Risk ◽  
Challenges And Opportunities ◽  
Black Box Warnings ◽  
In Vitro Systems

Drug-induced liver injury (DILI) is a major cause of late-stage clinical drug attrition, market withdrawal, black-box warnings, and acute liver failure. Consequently, it has been an area of focus for toxicologists and clinicians for several decades. In spite of considerable efforts, limited improvements in DILI prediction have been made and efforts to improve existing preclinical models or develop new test systems remain a high priority. While prediction of intrinsic DILI has improved, identifying compounds with a risk for idiosyncratic DILI (iDILI) remains extremely challenging because of the lack of a clear mechanistic understanding and the multifactorial pathogenesis of idiosyncratic drug reactions. Well-defined clinical diagnostic criteria and risk factors are also missing. This paper summarizes key data interpretation challenges, practical considerations, model limitations, and the need for an integrated risk assessment. As demonstrated through selected initiatives to address other types of toxicities, opportunities exist however for improvement, especially through better concerted efforts at harmonization of current, emerging and novel in vitro systems or through the establishment of strategies for implementation of preclinical DILI models across the pharmaceutical industry. Perspectives on the incorporation of newer technologies and the value of precompetitive consortia to identify useful practices are also discussed.

Beauvericin and enniatin B1: an in vitro integrated approach for risk assessment

2021 ◽  
Vol 350 ◽  
pp. S237-S238
Author(s):  
F. Caloni ◽  
Y. Sambuy ◽  
G. Ranaldi ◽  
S. Ferruzza ◽  
E. Torri ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Integrated Approach
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