Registration Dossier
Registration Dossier
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EC number: 433-480-9 | CAS number: 623-53-0
Endpoint summary
Administrative data
Description of key information
One key study has been identified as having assessed the repeat-dose oral toxicity of ethyl methyl carbonate.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Repeated dose oral:
The repeated dose toxicity of ethyl methyl carbonate has been determined in a sub-acute oral gavage study in rats. In a 14-day range-finding oral gavage study conducted prior to a 28-day sub-acute study, rats (3 males and 3 females per treatment group) were treated with 0, 500 and 1000 mg/kg/day. No mortality or signs of toxicity were observed in any dose group, although a possible reduction in bodyweight may have occurred in week 2. Based on the findings of the range-finding study, the 28-day oral gavage study used doses of 15, 150 and 1000 mg/kg/day. The only treatment-related clinical finding in the main test was that females of the 1000 mg/kg treatment group displayed isolated cases of hypersalivation after dosing on day 5 and hunched posture from day 14 onwards. No treatment-related signs of toxicity were observed in males of any other dose group (nor in females of the 15 and 150 mg/kg dose group). Based on these findings the NOAEL for male rats is >=1000 mg/kg and the NOAEL for female rats is 1000 mg/kg.
Justification for classification or non-classification
Based on the results of the repeat-dose (subacute) toxicity study via the oral route, ethyl methyl carbonate is:
- Not classified in accordance with the criteria given in Regulation 1272/2008 (EU CLP GHS).
- Not classified in accordance with the criteria given in Directive 67/548/EEC (DSD).
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