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EC number: 603-290-2
CAS number: 128625-52-5
An acute oral toxicity study with the test
item was performed according to the Acute-Toxic-Class Method and OECD
Guideline 423. The study was started with 300 mg/kg in 3 female
rats where no mortality was seen, and continued with further 3 females
treated with 300 mg/kg. Due to the fact, that no mortality was seen in
animal after treatment with 300 mg/kg, 3 further females were treated
with 2000 mg/kg.
Mortality and clinical signs were
monitored for at least 6 hours after administration and then daily. All
animals were weighed before treatment (day 1) and on days 2, 4, 6, 8,
11, 13, and 15. At the end of the observation period, all surviving rats
were sacrificed and subjected to a detailed necropsy. No mortality was
seen after treatment with 300 mg/kg during the course of this study. All
three rats treated with 2000 mg/kg were killed in moribund condition 4
hours after treatment. No clinical signs of toxicity were observed in
all rats treated with 300 mg/kg. All rats treated with 2000 mg/kg showed
locomotor disturbance, abdominal or lateral position and dyspnea. In 2
out of 3 rats incomplete eyelid closure was seen. The body weight
development of the rats treated with 300 mg/kg was inconspicuous
throughout the study. The gross pathology examination revealed no
findings in animals dosed with 300 mg/kg. The animals at 2000 mg/kg
exhibited a dark red or dark grey discoloration of the lung. The
histopathology examination of the lungs of the animals dosed with 2000
mg/kg revealed in all animals blood congestion and in two animals mild
acute alveolar hemorrhages and a perivascular edema. Under the
conditions of the present study, the LD50value is expected to
be between 300 - 2000 mg/kg after single oral administration in rats.
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