Registration Dossier

Administrative data

Description of key information

Dimethyl carbonate was classified as not irritating to both the skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Of the two dermal irritation studies, one recorded that no irritation had occurred and the other there was slight irritation (Primary Dermal Irritation Score 1.2). Of the two studies, the one which concluded no irritation was considered more reliable (Klimisch score 2 versus Klimisch score 3)

It was noted that the exact composition and purity of the test substance used in each study was not reported. It is considered that the difference in the dermal irritation scores most likely reflected variation in sensitivity between animals.

The results from the key study will be used.

Both of the eye irritation studies reviewed were considered reliable. Both studies concluded that the test substance was a mild eye irritant.

Justification for classification or non-classification

Skin irritation - Although some skin effects were noted in the first study they did not meet the criteria for classification of dimethyl carbonate as a Category 2: irritant (Regulation (EC) No 1272/2008 section 3.2.2.7.1.) A second study concluded that the test substance was slightly irritating, however as the primary irritation score was 1.2 (Draize method of scoring) and the Regulation states that inflammation should be considered significant if mean erythema, eshar, or oedema formation have scores of 2 or higher, it is concluded that the test substance does not require classification as a skin irritant.

Eye irritation - data on unwashed eyes from two rabbit eye irritation studies with 3 and 6 rabbits was reviewed. A positive response according to Regulation (EC) No 1272/2008 was obtained in only 1 rabbit. None of the mean scores at 24, 48 and 72 hours post-instilation was positive. Furthermore all responses had fully reversed within 21 days ( 7days actually).

Therefore the test substance does not require classification as an eye irritant according to regulation (EC) No 1272/2008section 3.3.2.7.1.