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Description of key information

Acute oral LD50 in rats >5000 mg/kg bodyweight.
Acute inhaled LD50 in rats (4h) >5.36 mg/L.
Acute dermal LD50 in rabbits > 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Additional information

An acute oral toxicity study was conducted by IIT Research Institute, USA, on behalf of Amoco Corporation, USA, to determine the acute oral toxicity of the test substance Dimethyl Carbonate. The study was conducted in compliance with GLP.

A group of five male and five female rats were dosed 5 g/kg bodyweight by oral gavage then observed for 14 days.

None of the rats died during the study. Nine rats showed signs of sedation after dosing; this persisted until the morning following dosing on seven of the rats. All rats were considered essentially normal from the second day of the observation period until necropsy.

Based on the results of this study, the acute median lethal oral dose (LD50) of Dimethyl Carbonate in male and females rats was estimated to be greater than 5 g/kg of bodyweight.

An inhalation toxicity study was conducted by IIT Research Institute, USA, on behalf of Amoco Corporation, USA, to determine the acute toxicity by inhalation of the test substance Dimethyl Carbonate. The study was conducted in complaince with GLP.

Five male and five female rats were exposed by full-body exposure to an atmosphere containing the test substance at a vapour concentration of 5.36 mg/L for four hours. The rats were subsequently observed for 14 days for mortality or signs of toxicity.

No rats died during the study. No significant treatment-related clinical signs were observed and all rats gained weight during the study. No treatment-related gross lesions were observed in any rat at necropsy.

On the basis of these results, the 4-hour acute inhalation median lethal concentration (LC50) of Dimethyl Carbonate in male and female rats is estimated to be greater than 5.36 mg/L.

An study was conducted by IIT Research Institute, USA, on behalf of Amoco Corporation, USA, to determine the acute dermal toxicity of the test substance Dimethyl Carbonate. The study was conducted in compliance with GLP.

The skin of five male and five female rabbits was shaved and test substance was applied at 2 g/kg for a period of 24 hours. The test substance was then rinsed off and the animals were observed for 14 days.

No deaths occurred during the study. Dermal irritation was observed within the application sites of all rabbits, but only persisted for 1 - 4 days after exposure.

Based on the results of this study, the acute median lethal dermal dose (LD50) for Dimethyl Carbonate was estimated to be greater than 2 g/kg of body weight.

Justification for classification or non-classification

The acute oral LD50 value was found to be greater than 5000 mg/kg bodyweight. As this value is greater than the limit value of 2000 mg/kg bodyweight, then the test substance dimethyl carbonate does not require classification as dangerous on the basis of acute oral toxicity according to Directive 67/548/EEC. Similarly, as the dermal LD50 value was found to be greater than 2000 mg/kg bodyweight, the test substance does not require classification on the basis of acute dermal toxicity according to the directive.

In the acute inhalation toxicity test, the LD50 value for the test substance (as a vapour) was found to be greater than 5.36 mg/L over 4 hours. According to Directive 67/548/EEC, risk phrase R20 "Harmful by inhalation" applies when the LD50 value is between 2 - 20 mg/L/4h for gases and vapours. The concentration tested did not cause any mortalities in any of the animals exposed, however as this concentration falls inside the concentration band in which classification would apply, the result does not confirm whether classification is required or not.