Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Concerning skin sensitisation, for diethyl carbonate (DEC) no data were identified in the available literature. Therefore, data for dimethyl carbonate (DMC) are taken into further consideration (read across). The two compounds differ with regard to the length of their ester side chain. DEC contains two ethyl and DMC contains two methyl groups. Structural similarity can be calculated by using different models/algorithms and will then result in a percentage of similarity. Using the mathematical model “Yule” from the OECD toolbox (v 2.3) a structural similarity of 88.89% is calculated (15 out of 28 possible atom pairs match to DEC, 4 out of 6 topological torsions and 4 out of 8 atom centred fragments). Although the calculated value has only an indicative character, it confirms the high structural similarity of both compounds.

Dimethyl carbonate was tested in a reduced LLNA (the protocol for the rLLNA is identical to that of the traditional LLNA with one exception, as only the highest dose level that does not induce systemic toxicity and/or excessive skin irritation is tested for skin sensitizing activity), where concentrations of 0.5, 5 and 50% have been tested. The calculated stimulation indices were given with 0.64, 0.69 and 1.71, i.e. the substance gave no indications for a skin sensitizing potential.

Dimethyl carbonate, tested at 4% in petrolatum, produced no skin sensitising reactions in a maximization test with 25 human volunteers.

Therefore it can be concluded, that also diethyl carbonate will not possess a significant skin sensitising potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Although for diethyl carbonate no experimental studies are available, the read across with data from dimethyl carbonate (high structural similarity of both compounds) is not indicating a significant skin sensitising potential for diethyl carbonate. Therefore, no classification according to EU and GHS criteria is required.