Carbonic acid, ethyl methyl ester

Endpoint summary

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).