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.
@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
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)