Das Projekt "Detection of endpoints and biomarkers of repeated dose toxicity using in vitro systems (DETECTIVE)" wird vom Umweltbundesamt gefördert und von Universität Köln, Institut für Neurophysiologie durchgeführt. Assessment of repeated dose toxicity is a standard requirement in human safety evaluation and relies on animal testing as no alternatives are currently accepted for regulatory purposes. An integrated research strategy for the replacement of animal tests needs to comprise the development of biomarkers of long-term toxicity in human target cells. To this aim, the DETECTIVE project will set up a screening pipeline of high content, high throughput as well as classical functional and ?-omics? technologies to identify and investigate human biomarkers in cellular models for repeated dose in vitro testing. In view of industrial use in automated high throughput systems, essential questions of repeated dose toxicity such as stability and robustness of readouts will be investigated in a first phase. This will be the foundation for innovative biomarker development based on integration of multiple data streams derived from ?-omics? readouts with traditional toxicological and histopathological endpoint evaluation. Toxicity pathways identified in ?-omics? readouts can thus be further investigated by the functional readouts. DETECTIVE will initially use human hepatic, cardiac and renal models as common target organs of repeated dose toxicity. Ultimately, the strategy for establishing biomarkers will also be applicable to other organs or organ systems affected by systemic toxicants. It is also expected that DETECTIVE will be able to define human toxicity pathways relevant for all organs. Based on integrative statistical analysis, systematic verification and correlation with in vivo data, the most relevant, highly specific, sensitive and predictive biomarkers will be selected. Within DETECTIVE, partners from academia, industry and research will hence generate pathway- and evidence-based understanding of toxic effects, moving toxicology beyond descriptive science towards mechanism-based prediction.
Das Projekt "OpenTox - An open source predictive toxicology Framework (OPENTOX)" wird vom Umweltbundesamt gefördert und von Fraunhofer-Institut für Toxikologie und Experimentelle Medizin (ITEM) durchgeführt. The goal of the OpenTox project is to develop a predictive toxicology framework with a unified access to toxicological data, (Q)SAR models and supporting information. It will provide tools for the integration of data from various sources (public and confidential), for the generation and validation of (Q)SAR models, libraries for the development and integration of new (Q)SAR algorithms, and validation routines. OpenTox will attract toxicological experts without (Q)SAR expertise as well as model and algorithm developers. It will move beyond existing attempts to solve individual research issues, by providing a flexible and user friendly framework that integrates existing solutions and new developments. OpenTox will be relevant for REACH as it gives risk assessors simple access to experimental data, (Q)SAR models and toxicological information that adheres to European and international regulatory requirements. OpenTox will be published as an open source project to allow a critical evaluation of its algorithms, to promote dissemination, and to attract external developers. Facilities for the inclusion of confidential in-house data and for accessing commercial prediction systems will be included. OpenTox will contain high-quality data and (Q)SAR models for chronic, genotoxic and carcinogenic effects. Prime Contractor: Douglas Connect; Zeiningen; Schweiz.
Das Projekt "European coordination action on human biomonitoring (COPHES)" wird vom Umweltbundesamt gefördert und von BIPRO Beratungsgesellschaft für integrierte Problemlösungen GmbH durchgeführt. Objective: This proposal has been elaborated by a consortium of 35 partners coming from 27 European countries and including scientists, government institutions and authorities, NGOs and industry. The main goal is to develop a coherent approach to HBM in Europe as requested by ACTION 3 of the EU Environment and Health Action Plan through coordination of ongoing and planned HBM activities. The project will exploit existing and planned HBM projects and programmes of work and capabilities in Europe. The consortium will investigate what is needed to advance and improve comparability of HBM data across Europe. Work prepared under DG Research and DG Environment activities dealing with development, validation and use of novel biomarkers including non-invasive markers and effect markers will be exploited. Through close collaboration with similar initiatives in the field of Health - such as the EU Health Examination Survey - appropriate economies and efficiencies will be assessed. Key issues such as Ethics and human Biobanks will be addressed. The project will deliver a number of key outputs including: - Tested Proofs of Concept and/or Demonstration project assessing the feasibility of a coordinated approach, including strategies for data interpretation & integration with environmental and health data. - A rationale and strategy for communication and dissemination of information, results and key messages to all stakeholders from the public to policy makers - Training and capacity building will aim to promote knowledge and experience exchange and development in the field of HBM within Europe. A common understanding within all parties involved on the potential of HMB in supporting and evaluating current/future policy making (including e.g. REACH) and for environmental health awareness raising will be promoted This project aim is to significantly advance the process towards a fully operational, continuous, sustainable and scientifically sound EU HBM programme.