國家衛生研究院 NHRI:Item 3990099045/15288
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    题名: International regulatory uses of acute systemic toxicity data and integration of new approach methodologies
    作者: Strickland, J;Haugabrooks, E;Allen, DG;Balottin, LB;Hirabayashi, Y;Kleinstreuer, NC;Kojima, H;Nishizawa, C;Prieto, P;Ratzlaff, DE;Jeong, J;Lee, J;Yang, Y;Lin, PP;Sullivan, K;Casey, W
    贡献者: National Institute of Environmental Health Sciences
    摘要: Chemical regulatory authorities around the world require systemic toxicity data from acute exposures via the oral, dermal, and inhalation routes for human health risk assessment. To identify opportunities for regulatory uses of non-animal replacements for these tests, we reviewed acute systemic toxicity testing requirements for jurisdictions that participate in the International Cooperation on Alternative Test Methods (ICATM): Brazil, Canada, China, the European Union, Japan, South Korea, Taiwan, and the USA. The chemical sectors included in our review of each jurisdiction were cosmetics, consumer products, industrial chemicals, pharmaceuticals, medical devices, and pesticides. We found acute systemic toxicity data were most often required for hazard assessment, classification, and labeling, and to a lesser extent quantitative risk assessment. Where animal methods were required, animal reduction methods were typically recommended. For many jurisdictions and chemical sectors, non-animal alternatives are not accepted, but several jurisdictions provide guidance to support the use of test waivers to reduce animal use for specific applications. An understanding of international regulatory requirements for acute systemic toxicity testing will inform ICATM's strategy for the development, acceptance, and implementation of non-animal alternatives to assess the health hazards and risks associated with acute toxicity.
    日期: 2023-08-30
    關聯: Critical Reviews in Toxicology. 2023 Aug;53(7):385-411.
    Link to: http://dx.doi.org/10.1080/10408444.2023.2240852
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1040-8444&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:001168574500001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85169335179
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