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EC number: 948-073-6 | CAS number: -
Acute Oral Toxicity
An acute oral toxicity study was carried out in the female Wistar rat. The study was performed to the standardized guidelines OECD 420, EU Method B.1 and EPA OPPTS 870.1100, under GLP conditions. Under the conditions of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified) (Envigo Research Limited, Ltd, 2016).
An acute oral toxicity study was carried out in the female Wistar rat. The study was performed to the standardized guidelines OECD 420, EU Method B.1 and EPA OPPTS 870.1100, under GLP conditions.
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a solution in dimethyl sulphoxide, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
There were no unscheduled deaths. Signs of systemic toxicity commonly noted were hunched posture, pilo-erection, tiptoe gait and ataxia. Isolated incidents of lethargy and labored respiration were noted in one animal. Animals appeared normal 5, 6 or 11 days after dosing. Two animals showed body weight loss during the first week but weight gains during the second week resulted in body weights within the expected historical range for this strain. Based on historical data from the supplier for this strain, the remaining animals showed expected gains in body weight over the observation period. Epithelial sloughing of the gastric mucosa was noted at necropsy of one animal. No abnormalities were noted at necropsy of the remaining animals.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified).
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