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EC number: 204-847-9 | CAS number: 127-52-6
Sodium N-chlorobenzenesulphonamide – Chloramine B (trihydrate) was administered to female rabbits at dose levels of 10, 30 and 90 mg/kg bw/day orally, by gavage from the 6th to 28th day of pregnancy. In addition, a restricted feeding control was employed consisting of untreated dams which were offered the food amount consumed by the high dose dams. Under the present test conditions, the no-observed-effect level (NOEL) was 10 mg/kg bw/day for the dams. Transient slight or moderate reductions were noted for the body weight and food intake of the dams treated with 30 mg /kg bw/day. Distinct reductions of body weight and food consumption, especially during the first days of treatment, were noted at 90 mg/kg bw/day. Similar reductions of body weight and food intake were noted in the untreated dams with restricted feeding.
The no-observed-effect level (NOEL) for the fetal organism also was 10 mg Sodium N-chlorobenzenesulphonamide-Chloramine B (trihydrate)/ kg bw /day. A dose level of 30 mg/ kg bw /day resulted in increased incidences of total skeletal retardations, in particular sternebra(e) not ossified. The severely materno-toxic dose level of 90 mg/kg bw /day resulted in developmental retardations in the form of reduced placental and fetal body weights compared to the control. Skeletal examination (according to DAWSON) revealed increased fetal incidences for variations of the sternum (fusions) and total skeletal variations as well as retardations of the sternum and lumbar vertebral bodies (incomplete or missing ossification) and total skeletal retardations.
No test item related malformations were noted during external, internal or skeletal examination (according to DAWSON) of the fetuses or soft tissue examination of the fetal heads (according to WILSON) at any tested dose level, not even at materno-toxic dose levels.
No embryotoxic changes were noted for the restricted feeding group. In conclusion, the test item possessed no teratogenic properties. Chloramine B trihydrate revealed slight embryotoxicity at materno-toxic dose levels (30 or 90 mg Sodium N-chlorobenzenesulphonamide – Chloramine B/ kg bw/day).
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