Registration Dossier
Registration Dossier
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EC number: 425-380-9 | CAS number: 7397-46-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
An acute oral study was performed in accordance with the OECD-guideline 420 (Fixed dose method). DEMB was applied by oral gavage to two male and two female rats at 2000 mg/kg (10 ml/kg) bw and subsequently to another male and female at 500 mg/kg (10 ml/kg) bw. As all six animals died, a third group, consisting of one male and one female was dosed at 50 mg/kg (10 ml/kg) bw. No mortality occurred at the latter dose level, so the main study was conducted with a fixed dose of 50 mg/kg bw administered to five rats of each sex. The animals were subjected to daily observations. Body weights were determined on days 1, 2, 3, 4, 8 and 15. Macroscopic examination was performed at the end of the experimental period. No mortality occurred but mild signs of toxicity such as a hunched posture and uncoordinated movements were noted in all animals on day 1. Concluding, LD100 lay at a dose of 500 mg/kg and LD0 at a dose of 50 mg/kg. Therefore, DEMB should be labelled as harmful if swallowed.
Justification for classification or non-classification
According to Annex VI of EU Regulation (EC) N0. 1272/2008 (CLP) and Annex I of EU directive 67/548/EEC, DEMB is classified as harmful if swallowed Cat 4 and R22, respectively.
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