scholarly journals An in vitro – in vivo integrated approach for hazard and risk assessment of silver nanoparticles for soil organisms

2016 ◽  
Author(s):  
S.I. Makama
Keyword(s):  
Risk Assessment ◽  
Silver Nanoparticles ◽  
Integrated Approach ◽  
Soil Organisms ◽  
Hazard And Risk ◽  
Hazard And Risk Assessment

scholarly journals Development of the SciRAP Approach for Evaluating the Reliability and Relevance of in vitro Toxicity Data

2021 ◽  
Vol 3 ◽  
Author(s):  
Nicolas Roth ◽  
Johanna Zilliacus ◽  
Anna Beronius
Keyword(s):  
Risk Assessment ◽  
Methodological Quality ◽  
Online Survey ◽  
Human Health Risk ◽  
Reporting Quality ◽  
Test System ◽  
Toxicity Data ◽  
Hazard And Risk ◽  
Hazard And Risk Assessment

Efficient and successful integration of data generated from non-animal test methods must rely on reliable and relevant data. It is important therefore to develop tools and criteria that facilitate scientifically sound, structured, and transparent evaluation of reliability and relevance of in vitro toxicity data to efficiently inform regulatory hazard and risk assessment. The Science in Risk Assessment and Policy (SciRAP) initiative aims to promote such overarching goals. We present the work to develop and refine the SciRAP tool for evaluation of reliability and relevance of in vitro studies for incorporation on the SciRAP web-based platform (www.scirap.org). In the SciRAP approach, reliability evaluation is based on criteria for reporting quality and methodological quality, and is explicitly separated from relevance evaluation. The SciRAP in vitro tool (version 1.0) was tested and evaluated during an expert test round (April 2019-September 2020) on three in vitro studies by thirty-one experts from regulatory authorities, industry and academia from different geographical areas and with various degree of experience in in vitro research and/or human health risk assessment. In addition, the experts answered an online survey to collect their feedback about the general features and desired characteristics of the tool for further refinement. The SciRAP in vitro tool (version 2.0) was revised based on the outcome of the expert test round (study evaluation and online survey) and consists of 24 criteria for evaluating “reporting quality” (reliability), 16 criteria for “methodological quality” (reliability), and 4 items for evaluating relevance of in vitro studies. Participants were generally positive about the adequacy, flexibility, and user-friendliness of the tool. The expert test round outlined the need to (i) revise the formulation of certain criteria; (ii) provide new or revised accompanying guidance for reporting quality and methodological quality criteria in the “test compounds and controls,” “test system,” and “data collection and analysis” domains; and (iii) provide revised guidance for relevance items, as general measures to reduce inter-expert variability. The SciRAP in vitro tool allows for a structured and transparent evaluation of in vitro studies for use in regulatory hazard and risk assessment of chemicals.

The Necessity of Biokinetic Information in the Interpretation of In Vitro Toxicity Data

2002 ◽  
Vol 30 (2_suppl) ◽  
pp. 85-91 ◽  
Author(s):  
Bas J. Blaauboer
Keyword(s):  
Critical Concentration ◽  
In Vitro Toxicity ◽  
Toxicity Data ◽  
Animal Data ◽  
Hazard And Risk ◽  
Hazard And Risk Assessment ◽  
Critical Site ◽  
Dose Metric

Data derived from in vitro toxicity studies are not directly applicable in an assessment of the toxicity of compounds in intact organisms. The major limitation is the lack of knowledge of biokinetic behaviour in vivo. Since the toxicity of a compound will be determined by the critical concentration (or other dose metric) of the critical compound (or a metabolite thereof) at the critical site of toxic action, biokinetic behaviour must be taken into account. Possibilities of biokinetic modelling on the basis of in vitro and other non-animal data are discussed, and the application of the results in hazard and risk-assessment schedules is considered.

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 Effective Safety Management - The tale of the Engineer, Safety Manager and Accountant

2018 ◽  
Author(s):  
P J James ◽  
A Franks
Keyword(s):  
Risk Assessment ◽  
Safety Assessment ◽  
Safety Management ◽  
Integrated Approach ◽  
Building Projects ◽  
Ship Building ◽  
Naval Ship ◽  
Hazard And Risk ◽  
Hazard And Risk Assessment ◽  
Ship Safety

In several recent naval ship building projects, Lloyd’s Register has been looking at methods for integrating statutory compliance with the hazard and risk assessment mandated by some ship building contracts. The Authors have observed that standards are sometimes applied without due regard of operational context. Equally they have spent hours assessing risks for simple reliable equipment designed to rules, codes and standards. As a result, we propose in this paper, an integrated approach for assessing the whole ship safety, with a focus on the safe to operate aspects, building a comprehensive safety argument founded on an agreed standards set which is augmented with a focused safety assessment delivering value and a proportionate risk assessment.

An integrated approach for assessing the in vitro and in vivo redox-related effects of nanomaterials

2021 ◽  
Vol 197 ◽  
pp. 111083
Author(s):  
Periklis Vardakas ◽  
Zoi Skaperda ◽  
Fotios Tekos ◽  
Aikaterini-Flora Trompeta ◽  
Aristidis Tsatsakis ◽  
...  
Keyword(s):  
Integrated Approach

scholarly journals Therapeutic Potentials of Syzygium fruticosum Fruit (Seed) Reflected into an Array of Pharmacological Assays and Prospective Receptors-Mediated Pathways

Life ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 155
Author(s):  
Jannatul Nasma Rupa Moni ◽  
Md. Adnan ◽  
Abu Montakim Tareq ◽  
Md. Imtiazul Kabir ◽  
A.S.M. Ali Reza ◽  
...  
Keyword(s):  
Bioactive Compounds ◽  
Integrated Approach ◽  
Gas Chromatography Mass Spectrometry ◽  
Clot Lysis ◽  
Lipinski’S Rule ◽  
Lysis Activity ◽  
In Silico Studies ◽  
Immobility Time

Syzygium fruticosum (SF), a valuable Bangladeshi fruit, is considered an alternative therapeutic agent. Mainly, seeds are used as nutritional phytotherapy to ease physical and mental status by preventing chronic diseases. Here, we scrutinized the S. fruticosum seed’s fundamental importance in traditional medicine by following an integrated approach combining in vivo, in vitro, and in silico studies. The SF was fractionated with different solvents, and the ethyl acetate fraction of SF (EaF-SF) was further studied. Mice treated with EaF-SF (200 and 400 mg/kg) manifested anxiolysis evidenced by higher exploration in elevated plus maze and hole board tests. Similarly, a dose-dependent drop of immobility time in a forced swimming test ensured significant anti-depressant activity. Moreover, higher dose treatment exposed reduced exploratory behaviour resembling decreased movement and prolonged sleeping latency with a quick onset of sleep during the open field and thiopental-induced sleeping tests, respectively. In parallel, EaF-SF significantly (p < 0.001) and dose-dependently suppressed acetic acid and formalin-induced pain in mice. Also, a noteworthy anti-inflammatory activity and a substantial (p < 0.01) clot lysis activity (thrombolytic) was observed. Gas chromatography-mass spectrometry (GC–MS) analysis resulted in 49 bioactive compounds. Among them, 12 bioactive compounds with Lipinski’s rule and safety confirmation showed strong binding affinity (molecular docking) against the receptors of each model used. To conclude, the S. fruticosum seed is a prospective source of health-promoting effects that can be an excellent candidate for preventing degenerative diseases.

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