确定DNSRI的限度需要同时进行Ames和致癌性实验吗？

Limits of Nitrosamines
#1

按照EMA Q&A，NDSRI的TTC为18ng/day，若我想确定某个NDSRI的毒性用于限度的支持依据，需要同时进行Ames实验和致癌性实验吗？

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#2

If you prefer to use 18 ng/day. No tox testing is required. If you prefer to use higher AI, either use Read-across supported by SAR. If still required you can go for Ames assay (not a traditional assay) and followed by in-vivo follow-up assay.

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#3

非常感谢您的回复，愿您拥有美好的每一天。

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#4

@x.h.yao Thanks for participating in the forum and post the question. Do you mind sharing with us additional details of your particular case? This case studies are really powerful knowledge and information that can help others in the community, and fuel insightful discussions. Thanks

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#5

Hi，早上好！
下面文章中提出，“some regulatory authorities have indicated that nonmutagenicity of N-nitrosamines in Ames tests is not sufficient proof to classify them as nonmutagenic and/or non-carcinogenic” and “The in vivo comet assay, though not a mutagenicity end point per se, has been shown to detect potent genotoxins that are mutagenic in rodent liver (as determined in the assay) and has been proposed as a useful assay to assess the carcinogenic potential of novel N-nitrosamines”
评估来自活性药物成分的新型亚硝胺可接受摄入量的策略.pdf (3.1 MB)