Registration Dossier
Registration Dossier
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EC number: 435-860-1 | CAS number: 214417-91-1
Endpoint summary
Administrative data
Description of key information
A reliable 28-day repeated dose oral toxicity study (performed according to OECD test guidelines and GLP principles) with rats is available.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Subacute 28-day oral toxicity with BMH was studied by daily gavage in rats with doses of 0, 50, 150 and 1000 mg/kg bw/day. Dose-related increase in plasma bilirubin levels in mid and high dose rats were observed. Females of the mid and high dose groups showed a dose-related decrease in plasma ALAT levels and an increase in plasma cholesterol levels. Observed cortical hyaline droplets in male kidneys were not accompanied by evidence of kidney damage. As cortical hyaline droplets are a common observation in male rats, and not observed in human kidney, this observation is not considered for human risk assessment. Based on the observed effects on clinical biochemical parameters in mid and high dose rats, the NOAEL is set at 50 mg/kg bw/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; urogenital: kidneys
Justification for classification or non-classification
Based on the available data on repeated dose toxicity, BMH does not need to to be classified for repeated dose toxicity according to the CLP Regulation (EC) No 1272/2008, as no significant toxic effects were observed.
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