OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)

OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)
Author: OECD
Publisher: OECD Publishing
Total Pages: 206
Release: 2018-12-10
Genre:
ISBN: 9264304797

In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...

OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption
Author: OECD
Publisher: OECD Publishing
Total Pages: 692
Release: 2018-09-03
Genre:
ISBN: 9264304746

This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.

Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU

Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU
Author: Gianni Dal Negro
Publisher: Academic Press
Total Pages: 348
Release: 2021-11-18
Genre: Science
ISBN: 0128212527

Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU provides updated information on the EU Directive 2010/63/EU, which is the European Union legislation that protects animals being used in research. EU Directive 2010/63/EU is the European Union (EU) legislation 'on the protection of animals used for scientific purposes' and is one of the most stringent ethical and welfare standards worldwide. - Closes a gap in scientific literature by addressing the need for clear guidance in walking through the multifaced universe of 3Rs - Offers a useful starting point for readers and scientist who approach the 3Rs for the first-time - Gives insights into the harmonization of the animal research legislation across countries

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 442E: In Vitro Skin Sensitisation In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 442E: In Vitro Skin Sensitisation In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation
Author: OECD
Publisher: OECD Publishing
Total Pages: 91
Release: 2024-06-25
Genre:
ISBN: 9264264353

The present Key Event based Test Guideline (TG) addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This TG is proposed to address the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. It provides four in vitro test methods addressing the same Key Event on the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell Line Activation Test or U-SENS, (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay and (iv) the Genomic Allergen Rapid Detection for assessment of skin sensitisers (GARDTMskin). All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The test methods described in this TG either quantify the change in the expression of cell surface marker(s) CD54 and CD86, the cytokine IL-8, or a series of genes (genomic biomarker signature) that are associated with the process of activation of monocytes and DC following exposure to sensitisers.

Organotypic Models in Drug Development

Organotypic Models in Drug Development
Author: Monika Schäfer-Korting
Publisher: Springer Nature
Total Pages: 325
Release: 2021-03-25
Genre: Medical
ISBN: 3030700631

This book provides latest findings in organotypic models in drug development and provides the scientific resonance needed in an emerging field of research in disciplines, such as molecular medicine, physiology, and pathophysiology. Today the research on human-based test systems has gained major interest and funding in the EU and the US has increased over the last years. Moreover, so-called 3R (reduce, replace, refine animal experiments) centres have been established worldwide.

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
Author: OECD
Publisher: OECD Publishing
Total Pages: 22
Release: 2021-06-17
Genre:
ISBN: 9264635289

The Vitrigel-Eye Irritancy Test (EIT) method is an in vitro test method that allows the identification of test chemicals not requiring classification and labelling for eye irritation or serious eye damage. This test measures the eye irritation potential of a test chemical based on its ability to induce damage to the barrier function of the human corneal epithelium (hCE) models used in the Vitrigel-EIT method. It is known that chemicals that are irritating to the eye first destroy tear film and epithelial barrier function of the eye, subsequently induce epithelial cell death, and finally produce stromal degeneration and endothelial cell death, resulting in corneal opacity. Therefore, the change of the epithelial barrier function is a relevant endpoint for detecting eye irritation. In the Vitrigel Eye Irritancy test method , time-dependent changes in the Transepithelial Electrical Resistance (TEER) values are indicative of damage to the barrier function of the corneal epithelium following exposure to a test chemical; this situation is similar to the observed damage of the rabbit cornea following exposure to a test chemical, which is an important mode of action leading to damage of the corneal epithelium and eye irritation. The Vitrigel-Eye Irritancy Test (EIT) method can be used within the limited applicability domain of test chemicals having pH > 5.0 (based on 2.5% weight/volume (w/v) preparation).

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals
Author: OECD
Publisher: OECD Publishing
Total Pages: 84
Release: 2023-07-04
Genre:
ISBN: 9264264361

This Test Guideline describes in vitro assays, which use Androgen Receptor TransActivation (ARTA) to detect Androgen Receptor Agonists and Antagonists. The ARTA assay methods are mechanistically and functionally similar test methods that provide information on the transcription and translation of a reporter gene following the binding of a chemical to the androgen receptor and subsequent transactivation.

Big Data in Predictive Toxicology

Big Data in Predictive Toxicology
Author: Daniel Neagu
Publisher: Royal Society of Chemistry
Total Pages: 303
Release: 2019-12-04
Genre: Medical
ISBN: 1839160829

The rate at which toxicological data is generated is continually becoming more rapid and the volume of data generated is growing dramatically. This is due in part to advances in software solutions and cheminformatics approaches which increase the availability of open data from chemical, biological and toxicological and high throughput screening resources. However, the amplified pace and capacity of data generation achieved by these novel techniques presents challenges for organising and analysing data output. Big Data in Predictive Toxicology discusses these challenges as well as the opportunities of new techniques encountered in data science. It addresses the nature of toxicological big data, their storage, analysis and interpretation. It also details how these data can be applied in toxicity prediction, modelling and risk assessment. This title is of particular relevance to researchers and postgraduates working and studying in the fields of computational methods, applied and physical chemistry, cheminformatics, biological sciences, predictive toxicology and safety and hazard assessment.

Sample Handling and Trace Analysis of Pollutants

Sample Handling and Trace Analysis of Pollutants
Author: Damia Barcelo
Publisher: Elsevier
Total Pages: 638
Release: 2024-10-25
Genre: Science
ISBN: 0323984444

Sample Handling and Trace Analysis of Pollutants: Innovations to Determine Organic Contaminants, Second Edition reviews the latest technologies and challenges in trace analysis of environmental pollutants, from selecting the right approach to tips for performing analytic procedures and measuring and reporting results. Written by internationally renowned experts in environmental analysis from 5 continents and edited by leaders in the field, this completely updated and revised volume presents the latest techniques developed over the past 10 years, such as high-resolution mass spectrometry, biosensors and imaging techniques. Important tools for problem-solving in the determination of environmental pollutants are also discussed.Chapters cover emerging pollutants in the environment, such as nanomaterials, microplastics, metabolites and/or transformation products and antimicrobial resistances. Specific sections describe field sampling techniques and sample preparation in environmental matrices: air, water, soil, sediment and biota, focus on passive samplers, cover the determination of these environmental contaminants based on analytical techniques, such as the use of gas chromatography and liquid chromatography coupled to mass spectrometry, immunoassays, and biosensors as well as advanced analytical methods such as imaging techniques. - Discusses techniques ranging from chromatography coupled to mass spectrometry, to emerging areas such as nanotechnology, immunoassays and biosensors - Covers the characteristics, advantages, limitations and potential of each technique and the current strategies in each method's development and validation - Outlines practical solutions to challenging problems in the analysis of pollutants in environmental matrices, including how to combine techniques for improved efficacy