Registration Dossier
Registration Dossier
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EC number: 406-260-5 | CAS number: 58834-75-6 BTN; VPO CATALYST
Endpoint summary
Administrative data
Description of key information
The No Observed Effect Level (NOEL) was considered to be 200 mg/kg/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Repeated dose toxicity has been investigated in a sub-acute study of 28 days duration in the rat conducted in accordance with OECD/EU test methods. Daily oral administration at a dose level of 1000 mg/kg/day caused the death or debility of the majority of females, with very little apparent effect on the males. No specific target organ of toxicity was identified. The appearance, behaviour and general biology of rats treated at lower doses of 200 or 40 mg/kg/day were essentially indistinguishable from those of the control animals. The No Observed Effect Level (NOEL) was considered to be 200 mg/kg/day.
A sub-chronic study of 90 days duration has been undertaken in the rat using methods similar to OECD test guidelines in place at the time. Vanadium, as sodium metavanadate, was administered in the drinking water at concentrations of 5, 10 and 50 ppm. It was generally well tolerated and did not significantly affect weight gain, nutrition or organ weights. The only changes evident by blood chemistry investigations on termination of the study were slight increases in urea and uric acid in animals treated at 50 ppm, the authors suggesting that these may suggest some alterations in renal function. Microscopic examination of tissues revealed only mild lesions in the kidneys, spleen and lungs, these dose-dependent. Measurable levels of vanadium was significant only in the highest dose group, the authors commenting that the significance of these results and the potential kinetics of accumulation are not known.
Justification for classification or non-classification
According to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification and labelling is not needed for repeated dose toxicity, as the effects observed in the repeated dose toxicity test occurred at dose level(s) above the cut-off values indicated in guidance on classification.
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