【摘 要】
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The standard data requirements of China new chemical registration for substances manufactured or imported in quantifies of 10-100 ton per year, include mainly physic-chemical data, mammalian toxicity
【机 构】
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Dow Chemical China investment Company,Beijing,100738 Chin
【出 处】
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中国毒理学会第七次全国毒理学大会暨第八届湖北科技论坛
论文部分内容阅读
The standard data requirements of China new chemical registration for substances manufactured or imported in quantifies of 10-100 ton per year, include mainly physic-chemical data, mammalian toxicity data like acute oral, dermal and/or inhalation, skin and eye irritation, skin sensitization, 28-day repeat-dose study, genotoxicity studies, reproduction/developmental toxicity screening test, environmental toxicity data like aquatic toxicity on invertebrates, growth inhibition of algae, environmental fate tests like ready biodegradable, bioaccumulation if applicable.In the meantime, the guidance document also request absorption toxicokinetics (TK) data to support the registration.In this work we suggest using the existing standard data and possible additional in vitro and/or in silico data as a basis to conclude on the oral and GI absorption information in lieu of an animal in vivo TK study (OECD 417).
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