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ICH M7 – Regulatory Updates & Industry Practices
• Ames assay: 12 out of 13 compounds tested were mutagenic. DNA adducts were not isolated in 32P-postlabelling studies carried out on two mutagenic compounds. Boronic acids represent “ novel class of bacterial mutagen” that may not act by …
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Basic Immunology Final; practice questions NAME
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database.ich.org8 Acetaldehyde • Mutagenic in Hypoxantine-Phosphoribosyl-Transferase (HPRT) assay in mammalian cells, while negative in Ames • Route specific differences in carcinogenic response • Oral exposure –no relevant carcinogenic response in rats • Highest doses males 246 mg/kg/d, females 260 mg/kg/d • Significant human exposure • Endogenously formed as metabolite of …
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