Table 6
Toxicological reference values (TRVs) proposed at EU level
TRV | Value | Reference | Comments |
---|---|---|---|
Group ADI | 0.0014 mg/kg bw per day | Italy (2008a,b) | Based on the LOAEL of 0.43 mg/kg bw per day for increased incidence of bile duct hyperplasia and retinal atrophy observed in a 2‐year study in rats conducted with cyhexatin and applying an increased UF of 300 to account for the use of a LOAEL as point of departure. |
Group ARfD | 0.007 mg/kg bw | Italy (2008a,b) | Based on an overall NOAEL of 0.7 mg/kg bw per day for acute effects (clinical signs, reduced body weight and embryotoxicity) in a multigeneration toxicity study in rats and a developmental toxicity study in rabbits and applying a standard UF of 100. |
ADI: acceptable daily intake; ARfD: acute reference dose; bw: body weight; UF: uncertainty factor.