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  1. Alternatives to animal testing and safety assessment of chemicals

    Chemical safety assessment has traditionally been based on animal testing but the EU has been promoting for many years the replacement, reduction, and refinement of animal testing. Further it is also considered that traditional risk assessment approaches ...

    30 April 2014

  2. Performance Standards and Alternative Assays: Practical Insights From Skin Sensitization

    To encourage the development and validation of alternative toxicity test methods, the effort required for validation of test methods proposed for regulatory purposes should be minimised. Performance standards (PS) facilitate efficient validation by requir ...

    30 April 2014

  3. Training needs for toxicity testing in the 21st century: a survey-informed analysis

    Current and future training needs on the use of alternative methods in predictive toxicology, including new approaches based on mode of action (MOA) and adverse outcome pathway (AOP) concepts, are expected to evolve rapidly. In order to gain insight into ...

    30 April 2014

  4. QSAR and Metabolic Assessment Tools in the Assessment of Genotoxicity

    In this chapter, a range of computational tools for applying (Q)SAR and grouping/read-across methods are described, and their integrated use in the computational assessment of genotoxicity is illustrated through the application of selected tools to two ca ...

    30 April 2014

  5. Frontiers in pluripotent stem cells research and therapeutic potentials- Chapter titile: Stem Cell Technologies and their Application in Modern Toxicology- Current State of the Art

    Chemicals produced by various industrial sectors such as drugs, cosmetics, agrochemicals and industrial chemicals are obliged to undergo a rigorous safety assessment before their entry into the market. Today the standard information requirements providing ...

    30 April 2014

  6. Comparative analysis of eight cytotoxicity assays evaluated within the ACuteTox project

    A comparative analysis of eight cytotoxicity assays [the 3T3 and normal human keratinocytes Neutral Red Uptake (NRU) assay, the primary rat hepatocytes, human HepG2 and 3T3 MTT assay, and the human A.704, SH-SY5Y and HepG2 cells propidium iodide (PI) assa ...

    30 April 2014

  7. Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

    Acute systemic toxicity data (LD50 values) and hazard classifications derived in the rat following oral administration and dermal application have been analysed to examine whether or not orally-derived hazard classification or LD50 values can be used to d ...

    30 April 2014

  8. Objective scoring of transformed foci in BALB/c 3T3 cell transformation assay by statistical image descriptors

    In vitro cell transformation assays (CTAs) have been shown to model important stages of in vivo carcinogenesis and have the potential to predict carcinogenicity in humans. Advantages of CTAs are their ability of revealing both genotoxic and non-genotoxic ...

    30 April 2014

  9. Prediction of dose-hepatotoxic response in humans based on toxicokinetic/toxicodynamic modeling with or without in vivo data: A case study with acetaminophen

    In the present legislations, the use of methods alternative to animal testing is explicitly encouraged, to use animal testing only 'as a last resort' or to ban it. The use of alternative methods to replace kinetics or repeated dose in vivo tests ...

    30 April 2014

  10. EURL ECVAM progress report on the development, validation and regulatory acceptance of alternative methods (2010-2013)- Prepared in the framework of Directive 76/768/EEC and Regulation (EC) No 1223/2009 on cosmetic products

    Provisions of Regulation No 1223/2009 on cosmetic products require that the European Commission reports on a yearly basis to the European Parliament and Council on the progress made in the development, validation and regulatory acceptance of alternative m ...

    30 April 2014

  11. EURL ECVAM Recommendation on the 3T3 Neutral Red Uptake Cytotoxicity Assay for Acute Oral Toxicity Testing

    Acute oral toxicity is currently being assessed by a suite of refinement test methods based on the traditional LD50 lethality test and is, besides skin sensitisation, the only remaining animal test required under REACH Annex VII. In view of assessing the ...

    30 April 2014

  12. ECVAM prevalidation study on in vitro cell transformation assays: General outline and conclusions of the study

    The potential for a compound to induce carcinogenicity is a key consideration when ascertaining hazard and risk assessment of chemicals. Among the in vitro alternatives that have been developed for predicting carcinogenicity, in vitro cell transformation ...

    30 April 2014

  13. Metabolomics in Toxicology and Preclinical Research

    Metabolomics, the comprehensive analysis of metabolites in a biological system, provides detailed information about the biochemical/physiological status of a biological system, and about the changes caused by chemicals. Metabolomics analysis is used in ma ...

    30 April 2014

  14. A rule for designing safer nanomaterials: do not interfere with the cellular redox equilibrium

    A comprehensive evaluation of the biological and toxicological effects of nanomaterials is necessary for the design of safe products. Attempts to describe and predict these effects are increasingly taking mechanistic considerations into account, shifting ...

    30 April 2014

  15. Non-invasive monitoring of cytotoxicity based on kinetic changes of cellular autofluorescence

    A quantitative, non-destructive cellular autofluorescence based in vitro imaging assay has been developed and applied to study the cytotoxicity of Sodium Lauryl Sulfate (SLS) and HgCl2 chemical compounds on Balb 3T3 cell culture. A phenomenological double ...

    30 April 2014

  16. The 3T3 neutral red uptake phototoxicity test: Practical experience and implications for phototoxicity testing- The report of an ECVAM/EFPIA workshop

    This is the report from the?ECVAM-EFPIA workshop on 3T3 NRU Phototoxicity Test: Practical Experience and Implications for Phototoxicity Testing?, jointly organized by ECVAM and EFPIA and held on the 25-27 October 2010 in Somma Lombardo, Italy. The Europea ...

    30 April 2014

  17. ECVAM-Coordinated Prevalidation Study of Three Cell Transformation Assays for Chemical Carcinogenicity Testing

    A formal prevalidation study of the Syrian hamster embryo (SHE) Cell Transformation Assays (CTAs) performed at pH 6.7 and pH 7.0 and the BALB/c 3T3 CTA was coordinated by ECVAM. The study was designed to complement the findings of the OECD detailed review ...

    30 April 2014

  18. Guidance on classification for reproductive toxicity under the globally harmonized system of classification and labelling of chemicals (GHS)

    With a wider remit, the United Nations formulated a classification and labelling system for universal application, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The GHS was first published in 2003 (UN, 2003) and subseq ...

    30 April 2014

  19. Comet assay in reconstructed 3D human epidermal skin models? investigation of intra- and inter-laboratory reproducibility with coded chemicals

    Reconstructed 3D human epidermal skin models are increasingly being used for safety testing of chemicals. Based on EpiDerm? tissues, an assay was developed in which the tissues were topically exposed to test chemicals for 3h followed by cell isolation and ...

    30 April 2014

  20. Human Bioaccumulation Potential simulated in R and implemented in the KNIME Interface

    The assessment of human bioaccumulation potential is an important element in the risk assessment of chemicals. Tonnelier et al. (Arch Toxicol (2012) 86: 393?403) developed a generic physiologically based toxicokinetic (PBTK) model which, based on in vitro ...

    30 April 2014

  21. Adverse Outcome Pathway-based Screening Strategies for an Animal-free Safety Assessment of Chemicals

    Currently the assessment of risk to human health from exposure to manufactured chemicals is mainly based on experiments performed on living animals (in vivo). Substantial efforts are being undertaken to develop alternative solutions to in vivo toxicity te ...

    30 April 2014

  22. The SEURAT-1 Research Strategy: Proving Concepts

    The SEURAT-1 strategy and objectives were presented in 2011. The emphasis now is to further elaborate the proof-of-concept objective. It is appreciated that key SEURAT-1 concepts could be understood on different scientific levels. On the first level, or t ...

    30 April 2014

  23. Preparing for the future

    Taking into account the complexity of the problems to be solved and the broadness of the expertise needed to address the underlying scientific questions, the SEURAT-1 Research Initiative will not be able to finalise the necessary work for full replacement ...

    30 April 2014

  24. Regenerative toxicology: the role of stem cells in the development of chronic toxicities

    Human stem cell lines and their derivatives have been widely discussed as cellular models in predictive toxicology. Huge efforts are currently undertaken to investigate the suitability of stem cells derivatives as unlimited cellular source for the develop ...

    30 April 2014

  25. PBTK modelling platforms and parameter estimation tools to enable animal-free risk assessment: Recommendations from a joint EPAA? EURL ECVAM ADME workshop

    Absorption, distribution, metabolism and excretion (ADME) determine target tissue doses upon human exposure to chemicals. In this respect, ADME is a critical piece of information in the framework of chemical risk assessment. This is especially true in an ...

    30 April 2014