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EC number: 229-904-5 | CAS number: 6829-22-7
The toxicity of the test item Macrolex Rot E2G (CAS-No. 6829-22-7) following daily oral (gavage) administration for 4 weeks in the rat was determined.
No test item-related in vivo effects and no test item-related histopathological changes were observed.
The daily oral administration of Macrolex Rot E2G for 28 days to Wistar rats at the dose levels of 100, 300 or 1000 mg/kg bw/day did not induce any effects during the in vivo phase. No test item related histopathological changes were noted.
Based on the results of this study, the dose level of 1000 mg/kg bw/day was considered as a No Observed Adverse Effect Level (NOAEL).
The test item Macrolex Rot E2G (CAS-Nr. 6829-22-7) was applied daily per gavage for 4 consecutive weeks in doses of 0 (control), 100, 300 or 1000 mg/kg bw to male and female rats.
Morbidity/mortality checks were performed at least twice daily. Clinical observations were performed daily. A full clinical examination was performed weekly. Individual body weights were recorded weekly. Food consumption was measured weekly for each cage of animals. Modified Irwin test (Neurological Function Assessment) was performed pretest and in week 4. Clinical laboratory determinations were performed in week 4.
All animals were killed at the end of the treatment period and necropsied. Selected organs were weighed. Organ/tissue samples were fixed and preserved at necropsy for all animals. Selected organs/tissues from group 1 (0 mg/kg bw/day) and 4 (1000 mg/kg bw/day) animals killed at the end of the treatment period were examined histopathologically.
A NOAEL of 1000 mg/kg bw/day (highest applied dose) was determined in a subacute toxicity study with Macrolex Rot E2G.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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