Table 2. 2 Potential adverse effects of a single oral administration of dimesulfazet (women who are pregnant or might be pregnant).
Species | Study | Dose (mg/kg bw per day) | Endpoints relevant to setting NOAEL and ARfD (mg/kg bw per day)1) |
Rabbit | Developmental toxicity study |
0, 5, 15, 50 | Fetuses: 15 Fetuses: Increased number of dams with abnormal fetuses and increased number of abnormal fetuses (with cardiovascular abnormalities) |
ARfD | NOAEL: 15 SF: 100 ARfD: 0.15 |
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The critical study for setting ARfD | Developmental toxicity study in rabbit |
ARfD, Acute reference dose; NOAEL, No-observed-adverse-effect level; SF, Safety factor
1) The adverse effect observed at LOAEL.