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EC number: 688-147-2 | CAS number: 82428-30-6
CLINICAL SIGNS PER STEP
STEP 1: 300 mg/kg bw, 3 females
STEP 2: 2000 mg/kg bw, 3 females
STEP 3: 2000 mg/kg bw, 3 males
One group, with three female WISTAR Crl: WI(Han) rats, was treated with the test item by oral gavage administration at a dosage of 300 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.03 g/mL and administered at a dose volume of 10 mL/kg.
Two groups, one female and one male group each of three WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended with vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at the test institute were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
Sex / No.
Starting dose [mg/kg]
No. of animals
No. of intercurrent deaths
female / 1 -3
female / 4 -6
male / 7 -9
All female animals treated with the test item at a dose of 300 mg/kg and 2000 mg/kg survived until the end of the study showing test-item related signs of toxicity.
One male animal treated with the test item at a dose of 2000 mg/kg had to be sacrificed for ethical reasons on test day 1. All remaining male animals survived until the end of the study.
The most relevant clinical findings in the animals treated with the test item at a dose of 300 mg/kg bw were reduced spontaneous activity and piloerection. All symptoms recovered within the day of treatment.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, bradykinesia, piloerection, eyes closed, eyes half closed, salivation, moving the bedding and kyphosis. All symptoms recovered within up to the 2nd day post-dose. The clinical symptoms were similar in both genders, however, slightly more prominently expressed in male compared to female animals.
Throughout the 14-day observation period, the body weight gain of the surviving animals was within the normal range of variation for this strain.
Macroscopic findings of surviving animals: At necropsy, no treatment-related macroscopic findings were observed in any animal of any step. Macroscopic findings of animals not having survived until the end of the observation period: At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
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