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Description of key information

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Dose descriptor:
20 mg/kg bw/day

Additional information

Male and female rats were exposed to the test substance for 90 days by oral gavage at doses of 0, 5, 10 and 20 mg/kg bw/day. The NOEL for both sexes was 5 mg/kg. Although the observations seen at the 10 and 20 mg/kg dose level were attributed to the test substance, they were considered to reflect a state of general malaise, supported by the concurrent clinical observation of lethargy, and were not considered to be neurotoxic. On the basis of these data, the no-observable effect level (NOEL) for the test substance in both the male and female rats was 5 mg/kg. None of the effects seen in this study at the 10 and 20 mg/kg dose levels were considered to be neurotoxic. Therefore, the no-observable adverse effect level (NOAEL) for the study endpoint (neurotoxicity) is 20 mg/kg for both male and female rats.

Justification for classification or non-classification

The test substance did not produce adverse effects that would require classification according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.