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
A subacute 28 -day oral toxicity study according to EEC Directive 92/69/EEC, B.7 Repeated Dose (28 days) Toxicity (oral) was performed. DEMB was administered daily for 28 days by oral gavage to Wistar rats. One control group and three treated groups (5, 25, 125 mg/kg bw) were tested, each consisting of 5 males and 5 females. The following parameters were evaluated: clinical signs, body weight, food consumption, clinical pathology and macroscopy at termination, organ weights and histopathology on a selection of tissues. In the 5 mg/kg group, no treatment-related findings could be observed. The application of 25 mg/kg resulted in slightly low body weights in females and a Decrease in erythrocyte cell count, haemoglobin and haematocrit in females. In the highest dose-group of 125 mg/kg, all animals died or had to be killed for humane reasons. Based on these results, the NOAEL was set to 25 mg/kg bw resulting in the classification STOT rep Cat.2.
Justification for classification or non-classification
According to Annex VI of the EU Regulation (EC) N0. 1272/2008 (CLP) and Annex I of the EU directive 67/548/EEC, DEMB is
classified as STOT rep Cat. 2 and R48, respectively.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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