Description: Das Projekt "Optimisation and pre-validation of an in vitro test strategy for predicting human acute toxicity (A-CUTE-TOX)" wird vom Umweltbundesamt gefördert und von Fraunhofer-Institut für Toxikologie und Experimentelle Medizin (ITEM) durchgeführt. Validated alternative test methods are urgently required for safety toxicology of drugs, chemicals and cosmetics. Both REACH and 7th amendment of Cosmetics Directive call for the broad replacement of animal experiments on a short-term. While some animal tests for topical toxicity have been successfully replaced one by one by alternative methods, systemic toxicities require new test strategies in order to achive an adequate safety level. The aim of A-Cute-Tox is to develop a simple and robust in vitro t esting strategy for prediction of human acute systemic toxicity, which could replace the animal acute toxicity tests used today. The involvement of ECVAM in the project management and that of regulators (such as ECB) guarantees of the follow-up. The Scie ntific objectives of the project are: 1. Compilation, critical evaluation and generation of high quality in vitro and in vivo data for comparative analysis. 2. Identifying factors (ADE, metabolism and organ specificity) that influence the correlation betwe en in vitro toxicity (concentration) and in vivo toxicity (dosage), and to define an algorithm that accounts for this. 3. Explore innovative tools and cellular systems to identify new end-points and strategies to better anticipate animal and human toxicit y. 4. To design a simple, robost and reliable in vitro test strategy amenable for robotic testing, associated with the prediction model for acute toxicity. The project will develop the concepts required to compose testing strategies via the continuous imp lementation of novel in vitro and in silico alternatives. The approach requires the dimensions of a transnational Integrated Project, involving prominent toxicity research groups in the EU, close monitoring by and input from the regulatory community and p rofessional managerial steering. In return, it offers the realistic opportunity to achive a substantial reduction of animal experiments in acute systemic toxicity assessments. Prime Contractor: University of Oulu, Administration, Research and Innovation Services; Oulu; Suomi/Finland.
Types:
SupportProgram
Origin: /Bund/UBA/UFORDAT
Tags: Arzneimittel ? Buchhaltung ? Arzneimittelsicherheit ? Gesetzesnovellierung ? Gewährleistung ? Neurotoxizität ? Akute Toxizität ? Versuchstier ? Prognose ? Biotransformation ? Vermeidung von Tierversuchen ? Berechnungsverfahren ? Bewertung ? Daten ? in vitro ? Innovation ? Kosmetisches Mittel ? Management ? Mensch ? Monitoring ? Prognosemodell ? Tierversuch ? Toxikologie ? Vergleichsanalyse ? Tier ? REACH ? Chemikalien ? Strategische Aspekte ? Dienstleistung ? Forschung ? Organ ? Richtlinie ? Stoffwechsel ? Verwaltung ? Planung ? Grenzüberschreitung ? RATIFIKATION ? nephrotoxicity ? DAUER ? EIN ? METHODE ? PROJEKT ? QSAR ? KURZ ? STILLGELEGT ? VERRINGERUNG ? Werkzeug ? ERSATZ ? Acute toxicity testing ? ZUSAMMENSTELLUNG ? Bemessung ? BBB models ? biokinetic modelling ? distribution ? Erlass [Recht] ? gut absorption ? FP6-LIFESCIHEALTH ? NEU ? GEMEINSCHAFT ? BEREICH ? hepatotoxicity ? Konzentrat ? in silico models ? GRUPPE ? in vitro models ?
Region: Lower Saxony
Bounding box: 9.16667° .. 9.16667° x 52.83333° .. 52.83333°
License: cc-by-nc-nd/4.0
Language: Deutsch
Time ranges: 2005-01-01 - 2010-06-30
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