Registration Dossier
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EC number: 406-850-2 | CAS number: 133855-98-8 BAS 480 F
Neurotoxicity
Administrative data
Description of key information
The potential neurotoxicity of epoxiconazole was investigated in an acute and a 90-day study in rats. The findings in the acute neurotoxicity study consisted of decreased motor activity and landing foot-splay in females at the high dose level of 2000 mg/kg bw and a reduced motor activity in males at a dose of 1000 mg/kg bw and higher. These findings were only observed at one examination time point, when also piloerection as well as impairment of body weight development were noted. A more subtle effect on activity patterns in epoxiconazole-treated groups was present only on the day of dosing. No other findings were noted. In the absence of any histopathological findings with respect to tissues of the nervous system, this is not regarded as a neurotoxic effect, but reflects an impairment of the general state of health. All observed
effects were reversible within 14 d.
In the 90-day neurotoxicity study in rats, epoxiconazole did not induce any changes in the FOB and motor activity measurements at any dose level. The high dose level of 2000 ppm in males and 3000 ppm in females induced systemic toxicity. Neurohistopathological investigations did not reveal any test substance-related changes on the central or peripheral nervous system. Hence, epoxiconazole did not display any neurotoxic properties after a 90-day dietary administration in rats.
In conclusion, epoxiconazole does not have a neurotoxic potential.
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
Epoxiconazole does not need to be classified for neurotoxicity according to Regulation (EC) 1272/2008.
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