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. 2023 Jun 23;11(2):36–39. doi: 10.14252/foodsafetyfscj.D-23-00007

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
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.