Table 1.
Type of substance | μg/person/day (μg/kg-day for 60 kg adult) |
---|---|
Alerts for potential genotoxic carcinogenicity | Kroes: 0.15 (0.0025 μg/kg-day) ICH: 1.5 (0.025 μg/kg-day)a |
4Acetylcholinesterase inhibitors (AChEI) (Organophosphates (OPs)/carbamates) | 18 (0.3 μg/kg-day) |
Cramer Class III | 90 (1.5 μg/kg-day)b |
Cramer Class II | 540 (9.0 μg/kg-day) |
Cramer Class I | 1800 (30 μg/kg-day) |
higher threshold (1.5 μg/person per day) is used for pharmaceutical impurities that are mutagenic or that are suspected of being mutagenic (International Conference on Harmonization (ICH) [44]).