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EC number: 204-649-2
CAS number: 123-76-2
The test item was tested for subchronic toxicity using the OECD Test Guideline No. 408, Repeated Dose 90-day Oral Toxicity Study in Rodents, Adopted 25th June 2018.
Wistar rats of SPF quality were used for testing. The test item was administered in a vehicle (aqua pro iniectione) by stomach tube; oral application to rats occurred daily. The study includes four main groups and two satellite groups of animals. Each main group consisted of 10 males and 10 females; each satellite group consisted of 6 males and 6 females. Main groups contained 3 treated groups (doses 100, 500, 1 000 mg/kg of body weight/day) and one control group (vehicle only). The satellite groups contained one control group (vehicle only) and one treated group (1 000 mg/kg bw/day). The administration period lasted 90 days. Animals in the main groups were then sacrificed, while satellite animals were observed for the next 28 days without treatment.
During the 90-day study clinical observation and health status control were performed daily. The body weight, food consumption were measured weekly and the detailed clinical observation was carried out in the same time interval. Water consumption was measured three times a week. Ophthalmologic examination was performed at the beginning and at the end of the study. Before the end of study the functional observations were performed. The study was completed by urinalysis, haematological and biochemical analysis, and gross necropsy of animals. The organs selected for weighing and histopathological examination were removed. These parameters (except clinical observation during the recovery period) were also checked for the satellite groups of animals.
The oral administration of the test substance to rats by gavage for a period of 90 consecutive days did not cause mortality related with the test item treatment.
No effect of the test item on the body weight, food consumption and water consumption were recorded during the study. Slight changes of these parameters were without toxicological importance.
No clinical findings revealed influence of the test item on clinical status of treated animals and satellite treated animals were recorded.
No toxicologically significant findings were detected during the histopathological examination of organs in animals at the highest dose level and satellite treated animals. The changes found in the organs of control and test animals are, in most cases, spontaneous or agonal changes, which are commonly detected at different frequencies in rats. The observed changes are few and are not caused by the test item. Sporadic findings recorded in adrenal glands, heart, liver, lungs, testes and thymus were not related with test item treatment. Focal ulceration and focal subacute polymorphonuclear inflammation of the esophageal muscle layer are propably caused by esophageal injury during esophageal tube insertion. Other observed changes occur in control and test animals are inconsistent and few in number with no apparent relationship to the effect of the item.
No sings of systemic toxicity were found.
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