title: The integrated project ReProTect: a novel approach in reproductive toxicity hazard assessment.
abstract: Validated alternative test methods are urgently needed for safety testing of drugs, chemicals and cosmetics. Whereas some animal tests for topical toxicity have been successfully replaced by alternative methods, systemic toxicity testing requires new test strategies in order to achieve an adequate safety level for the consumer. Substantial numbers of animals are required for the current in vivo assays for drugs, chemicals and cosmetics and a broad range of pioneering alternative methods were already developed. These prerequisites motivate the development of a tiered testing strategy based on alternative tests for reproductive toxicity hazard. In the Integrated Project ReProTect, a consortium set up by the European Centre for the Validation of Alternative Methods (ECVAM) takes the lead to manage the development of a testing strategy in the area of reproductive toxicity. The reproductive cycle can be broken down into well-defined sub-elements, namely male and female fertility, implantation and pre/postnatal development. In this project, in vitro, in silico and sensor technologies will be developed, leading to testing strategies, that shall be implemented and disseminated.
authors.affiliation: European Centre for the Validation of Alternative Methods, Joint Research Center, Via Fermi 1, TP 580, 21020 Ispra (VA), Italy.
authors.forename: Lars
authors.initials: L
authors.lastname: Hareng
authors.forename: Cristian
authors.initials: C
authors.lastname: Pellizzer
authors.forename: Susanne
authors.initials: S
authors.lastname: Bremer
authors.forename: Michael
authors.initials: M
authors.lastname: Schwarz
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartung
mesh_terms: D000328:Adult; D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D015509:Developmental Biology; D005062:European Union / Q000458:organization & administration; D005260:Female; D015386:Hazardous Substances / Q000145:classification / Q000633:toxicity*; D006801:Humans; D066298:In Vitro Techniques; D007391:International Cooperation; D008297:Male; D011247:Pregnancy; D012098:Reproduction / Q000187:drug effects*; D018570:Risk Assessment / Q000379:methods; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D015386:Hazardous Substances