Registration Dossier
Registration Dossier
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EC number: 614-406-6 | CAS number: 68308-61-2
Endpoint summary
Administrative data
Description of key information
The test item GARDO TP 10451 was investigated for repeated dose toxicity. The no observed effect level (NOEL) for Gardo TP10451 was considered 1000 mg/kg bw/day.
Key value for chemical safety assessment
Additional information
Gardo TP10451 administered daily by oral gavage for 28 days in Wistar rats did not lead to any toxicologically adverse effects at dose levels of 50, 250 or 1000 mg/kg bw/day. There were no changes in the animal clinical condition, body weight or food consumption. No Gardo TP10451-related effects were noted at clinical pathology evaluation (haematology, coagulation and clinical chemistry). There were no macroscopic or microscopic findings, or changes in the organ weights that could be ascribed to test item administration. In conclusion, under the conditions of this study, the no observed effect level (NOEL) for Gardo TP10451 is considered 1000 mg/kg bw/day.
Justification for classification or non-classification
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