Registration Dossier
Registration Dossier
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EC number: 482-110-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a 28 day repeated dose study, oral administration of the test substance to Crl:CD(SD)IGS BR rats at doses of 25, 100 and 250 mg/kg/day by gavage for 28 days resulted in one unscheduled mortality. One control male was found dead on study day 24 due to acute kidney inflammation. All other animals survived to the scheduled necropsies. The macroscopic findings noted were considered to be spontaneous and/or incidental in nature and unrelated to test article administration. There were no test article-related clinical observations or effects on body weight, food consumption, functional observational battery and motor activity data, hematology, serum chemistry and urinalysis parameters and organ weights. Based on the results of this study, 250 mg/kg body weight/day of the test substance was established as the no-observed-effect-level (NOEL).
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
According to EU classification criteria, classification for repeated dose toxicity is not required.
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