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 PDF Download
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Author: OECD
Publisher: OECD Publishing
ISBN: 9264635289
Category :
Languages : en
Pages : 22
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Book Description
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).
Author: OECD
Publisher: OECD Publishing
ISBN: 9264635289
Category :
Languages : en
Pages : 22
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Book Description
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).
Author: OECD
Publisher: OECD Publishing
ISBN: 926465609X
Category :
Languages : en
Pages : 30
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Book Description
This Test Guideline proposes defined approaches (DA) combining data generated in vitro methods, with information sources such as physicochemical properties.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264542027
Category :
Languages : en
Pages : 35
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Book Description
This Test Guideline describes an in vitro procedure the identification on its own of chemicals (substances and mixtures) not requiring classification (No Cat), requiring classification for eye irritation (Cat 2) and requiring classification for serious eye damage (Cat 1) according to the UN GHS ocular hazard categories. It makes use of reconstructed human cornea-like epithelium (RhCE) which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium.
Author: OECD
Publisher: OECD Publishing
ISBN: 926418533X
Category :
Languages : en
Pages : 13
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Book Description
This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye. This Test Guideline is intended preferably for use with albino rabbit. The test substance is ...
Author: Frank Dreher
Publisher: CRC Press
ISBN: 1000590623
Category : Medical
Languages : en
Pages : 997
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Book Description
With chapters from experienced and internationally renowned contributors holding positions in research, industry, and clinical practice, this is the fifth edition of what has become the standard reference for cosmetic scientists and dermatologists seeking the latest innovations and technology for the formulation, design, testing, use, and production of cosmetic products for the skin. *Offers in-depth analysis of specific topics in cosmetic science and research *Presents the latest in international research and its translation to practice *Gives an indispensable guide to a hotly competitive area for research and practice
Author: Monika Schäfer-Korting
Publisher: Springer Nature
ISBN: 3030700631
Category : Medical
Languages : en
Pages : 325
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Book Description
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.
Author: Natassa Pippa
Publisher: Elsevier
ISBN: 032391439X
Category : Medical
Languages : en
Pages : 464
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Book Description
From Current to Future Trends in Pharmaceutical Technology explores the current trends of this field and creates a multi-aspect framework for the reader. The book covers topics on pharmaceutics, pharmaceutical engineering, pre-formulation protocols, techniques, innovative excipients, bio-printing techniques, scale-up based on formulas on-a-chip, and regulatory aspects based on new scientific achievements. Modified dosage forms, new aspects on the compatibility of drug excipients interactions, and drug release by various dosage forms are included. Physical pharmacy (physical and biological stability of dosage forms), innovative excipients, patents on innovative formulations and regulatory issues related to the approval process of medicines are also discussed. The book is a valuable resource for a wide audience of academics, industrial researchers and professionals working in this field as the development of efficient and safe medicines is critical to future needs. - Includes innovative excipients/advanced materials in pharmaceutics - Covers modified release delivery platforms - Explores new elements of drug development
Author: P.V. Mohanan
Publisher: Woodhead Publishing
ISBN: 012824173X
Category : Technology & Engineering
Languages : en
Pages : 808
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Book Description
Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. - Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more - Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies - Discusses standardization and ethical hurdles in biomedical product development and how to overcome them
Author: OECD
Publisher: OECD Publishing
ISBN: 9264203869
Category :
Languages : en
Pages : 28
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Book Description
The Isolated Chicken Eye Test (ICE) Method is an in vitro test method that can be used to identify chemicals (substances or mixtures) as either 1) causing “serious eye damage” (category 1 of the Globally Harmonised System for the Classification and ...
Author: OECD
Publisher: OECD Publishing
ISBN: 9264242430
Category :
Languages : en
Pages : 15
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Book Description
This Test Guideline describes a cytotoxicity-based in vitro assay that is performed on a confluent monolayer of Statens Seruminstitut Rabbit Cornea (SIRC) cells, cultured on a 96-well polycarbonate microplate.
