使用AcutoX预测急性口服毒性:一种无动物产品且具有代谢相关性的基于人类细胞的试验
Thomas A Ward1, Hannah Goldsby1, Michael Connolly1
1XCellR8 Ltd, Cheshire, United Kingdom.
ALTEX
|August 16, 2024
概括
新型人体体外试验AcutoX使用细胞毒性和肝脏代谢数据评估急性口服毒性. 它准确地预测了EPA和GHS的化学毒性分类,帮助监管评估.
科学领域:
- 毒理学 毒理学 毒理学
- 在体外 (in vitro) 方法
- 化学安全评估 化学安全评估
背景情况:
- 急性口服毒性测试对于化学品安全至关重要.
- 传统的动物试验面临着伦理和效率方面的挑战.
- 开发可靠的体外替代品是一个优先事项.
研究的目的:
- 介绍AcutoX,一种用于评估急性口服毒性的人体体内试验.
- 为了验证AcutoX对EPA和GHS分类的预测准确性.
- 评估AcutoX识别代谢激活或排毒的能力.
主要方法:
- 利用了67种精选化学品的库,涵盖了各种各样的特性.
- 采用了两个细胞毒性终点 (中性红色吸收,MTT代谢).
- 评估了使用和不使用人肝提取物 (S9) 的终点,以获得四个EC50值.
主要成果:
- 预测模型在二元毒性分类中达到73.8% (EPA) 和63.1% (GHS) 的准确性.
- 危险分类在90%以上的案例中提供了保护性预测.
- AcutoX确定了正在发生代谢激活或解毒的化学物质.
结论:
- AcutoX是一种可行的人体体外试验方法,用于评估急性口服毒性.
- 该测试为监管目的提供准确和保护性分类.
- AcutoX提供了对代谢对化学毒性的影响的见解.
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