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开展一项综合项目(Sens-it-iv)以开发体外试验来评估致敏作用的管理工作。

Management of an integrated project (Sens-it-iv) to develop in vitro tests to assess sensitisation.

作者信息

Rovida Costanza, Basketter David, Casati Silvia, de Silva Odile, Hermans Helma, Kimber Ian, Manou Irene, Weltzien Hans Ulrich, Roggen Erwin

机构信息

ECVAM, European Commission Joint Research Centre, Ispra, Italy.

出版信息

Altern Lab Anim. 2007 Jun;35(3):317-22. doi: 10.1177/026119290703500311.

DOI:10.1177/026119290703500311
PMID:17650950
Abstract

Sens-it-iv is an integrated project, funded by European Commission Framework Programme 6, the overall objective of which is to develop in vitro tests and test strategies to be used by the chemical, cosmetic and pharmaceutical industries to assess the risk for potential contact and respiratory sensitisers. Such tests, once formally validated and accepted, will permit the evaluation of the sensitising potential of existing and new chemical entities and the products of the European industries for classification and labelling, as required by the new EU REACH legislation on chemicals, or for the purpose of risk assessment as required by the 7th Amendment to the EU Cosmetics Directive. Sens-it-iv involves 28 partners, representing industries, universities and regulatory bodies, including various institutes in the EU Member States and different competencies, all with the common aim of achieving a final deliverable - increasing the safety of consumer products, whilst reducing animal experimentation. This paper provides an overview of the structure of the project and a detailed description of the organisation of its management.

摘要

Sens-it-iv是一个由欧盟委员会第六框架计划资助的综合项目,其总体目标是开发体外测试和测试策略,供化学、化妆品和制药行业用于评估潜在接触性和呼吸道致敏剂的风险。一旦这些测试经过正式验证和认可,将能够按照欧盟关于化学品的新REACH法规要求,或根据欧盟化妆品指令第七次修订案中风险评估的目的,对现有和新的化学实体以及欧洲工业产品的致敏潜力进行评估,以用于分类和标签标注。Sens-it-iv项目有28个合作伙伴,代表了行业、大学和监管机构,包括欧盟成员国的各个机构以及不同的专业领域,所有合作伙伴都有一个共同目标,即实现最终成果——提高消费品安全性,同时减少动物实验。本文概述了该项目的结构,并详细描述了其管理组织。

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