Dati Progetto

Num. Contratto

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LSBH-CT-2004-503257

Coordinatore

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UNIV. TUEBINGEN (Germania)

Responsabile ENEA

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SPANO' MARCELLO - SSPT-TECS-BIORISC (CASACCIA)

Sito WEB

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http://www.reprotect.eu/

Descrizione

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Validated alternative test methods are urgently required for safety toxicology of drugs, chemicals and cosmetics. 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 achieve an adequate safety level of the consumer. In the project, ECVAM takes the lead to manage the development of a conceptual framework in the area of reproductive toxicity. The involvement of all stakeholders in the Project Board including the European Consensus Platform on Alternatives (ECOPA), European regulators, OECD, and Industry guarantees an efficient problem solving approach. Reproductive toxicity offers the opportunities that: i) a substantial number of animals are currently required in in-vivo assays; ii) the reproductive system can be broken down into well-defined sub-elements covering the reproductive cycle; iii) a number of pioneering alternatives have already been developed; and iv) the same animal experiments are carried out for drugs, chemicals and cosmetics. The project is composed of four elements, i.e. a) technological development of in vitro and b) sensor technologies c) the strategical development of a conceptual framework d) the dissemination and implementation activities. The project will develop the concepts required to compose testing strategies via the continuous implementation of novel in vitro and in silico alternatives. Problems to be solved include the development of substantial numbers of alternative test methods making use of advanced technologies. This approach requires the dimensions of a transnational Integrated Project, involving some of the most prominent reproductive toxicity research groups in the EU, close monitoring by and input from the regulatory community and professional managerial steering. In return, it offers the realistic opportunity to achieve a substantial reduction of animal experiment.

Attività svolta da ENEA

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Establishment and prevalidation of a high throughput test system for detecting chemical effects on bull spermatozoa using high throughput tests such as the flow cytometric Sperm Chromatin Structure Assay (SCSA) and the Comet assay. ENEA has developed ReProComet (Repair Proficient Comet assay), a test which can circumvent the sperm intrinsic repair deficiency by providing them from an exogenous source such as a cell extract. Our working hypothesis was that the repair enzymes present in the extracts could initiate the removal of chemically induced adducts on sperm DNA, thus forming the DNA strand breaks eventually detectable by the Comet assay. Sperm samples were treated in vitro with a variety of well known mutagenic chemicals and standard Comet assay was run in parallel with the ReProComet. In most cases, a clear-cut dose-dependent effect was measured only after the addition of the cell extract, demonstrating that ReproComet is effectively improving the ability of the standard Comet assay in detecting in vitro chemically induced DNA damage on spermatozoa.

Programma Quadro

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Sesto Programma Quadro UE (2002-2006)

Programma UE

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SCIENZE DELLA VITA (2002-2006)

Tipo Progetto

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IP - Progetto Integrato

Riferimenti ENEA

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Posizione: 844

Atto di Approvazione ENEA: 054/2004/BIOTEC

Codice Atto: 07L35

Unità alla stipula: BIOTEC

Dati Finanziari (in euro)

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Costo eleggibile del progetto: 13.500.250,00 Costo eleggibile per ENEA: 515.765,00

Contributo al progetto: 9.100.000,00 Contributo a ENEA: 257.882,00

Durata

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Anno di stipula: 2004

Durata (in mesi): 48

Data di inizio: 01-07-2004

Data di scadenza: 30-06-2008

Partner (33)

Ruolo	Tipologia	Nome	Nazione
	Università	UNIV. NATURAL RESOURCES AND LIFE SCIENCES WIEN (BOKU)	Austria
	Industrie	EGGCENTRIS NV	Belgio
	Industrie	JANSSEN PHARMACEUTICA N.V.	Belgio
	Industrie	JOHNSON & JOHNSON	Belgio
	Università	UNIV. VRIJE BRUSSEL (VUB)	Belgio
	Istituti di ricerca	VITO - FLEMISH INSTITUTE FOR TECHNOLOGICAL RESEARCH	Belgio
	Istituti di ricerca	VLIZ FLANDERS MARINE INSTITUTE	Belgio
	Università	UNIV. PROF. ASSEN ZLATAROV BOURGAS	Bulgaria
	Università	UNIV. COPENHAGEN	Danimarca
	Università	UNIV. KUOPIO	Finlandia
	Industrie	PFIZER PGRD	Francia
	Industrie	BAYER HEALTHCARE CORPORATION	Germania
	Istituti di ricerca	FEDERAL INSTITUTE FOR RISK ASSESSMENT	Germania
	Industrie	PROTEOSYS AG	Germania
	Università	SCHOOL OF VETERINARY MEDICINE HANNOVER	Germania
PARTNER	Società di consulenza	STEINBEIS-EUROPA-ZENTRUM DER STEINBEIS INNOVATION GMBH	Germania
	Università	UNIV. OF FREIBURG	Germania
COORD	Università	UNIV. TUEBINGEN	Germania
	Istituti di ricerca	CONSORZIO PER L'INCREMENTO ZOOTECNICO SRL	Italia
PARTNER	Istituti di ricerca	ENEA	Italia
	Istituti di ricerca	ISS - ISTITUTO SUPERIORE DI SANITA	Italia
	Istituti di ricerca	ISTITUTO SPERIMENTALE ITALIANO LAZZARO SPALLANZANI	Italia
	Università	UNIV. SIENA	Italia
	Istituti di ricerca	JRC COMMISSION OF THE EUROPEAN COMMUNITIES	Organ. Internazionali
	Industrie	BIO DETECTION SYSTEMS BV	Paesi Bassi
	Altro	ERASMUS MEDICAL CENTER ROTTERDAM	Paesi Bassi
	Istituti di ricerca	RIVM - NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT	Paesi Bassi
	Istituti di ricerca	TNO - NETHERLANDS ORGANISATION FOR APPLIED SCIENTIFIC RESEARCH	Paesi Bassi
	Organismi pubblici NO ricerca	WORLD INSTITUTE FOR HEALTH AND ENVIRONMENT	Paesi Bassi
	Istituti di ricerca	IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY AND MEDICINE	Regno Unito
	Università	UNIV. JOHN MOORES LIVERPOOL	Regno Unito
	Industrie	IN VITRO TESTING INDUSTRIAL PLATFORM	Spagna
	Università	UNIV. UPPSALA	Svezia

Keyword associate al progetto dal database di CORDIS (3)

Keyword
BIOTECHNOLOGY
LIFE SCIENCES
MEDICINE, HEALTH

Altre Keyword non presenti nel database di CORDIS (5)

Altri indici
Alternatives
Genetically engineered cell lines
Glp
In vitro reproduction toxicology
Stem cells