Registration Dossier

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Key value for chemical safety assessment

Additional information

A bacterial reverse mutation test was conducted by JBC, Inc., Japan, on behalf of VBE Industries, Ltd., Japan , to assess the potential of the test substance Dimethyl carbonate to cause gene mutations. The study was conducted according to Japanese test guidelines, and in compliance with GLP.

Four mutant strains of Salmonella Typhimurium and one mutant strain of Escherichia Coli bacteria were exposed to the test material both in the presence and in the absence of metabolic activation. Concurrent negative and positive controls were assayed with the test substance.

No significant increase (i.e. no two-fold or greater increase in the number of revertant colonies when compared against the control) was seem for any strain exposed to the test substance, either in the presence or absence of metabolic activation.

Dimethyl carbonate was not found to be mutagenic under the test conditions employed.

A bacterial reverse mutation assay was performed by The Robens Institute, UK, on behalf of B.P., UK, to assess the potential of the test substance Dimethyl Carbonate to cause gene mutation.

The method used was the Ames test (Ames, McCann, Yamasaki, 1975). Five mutant strains of Salmonella Typhimurium were incubated with the test material in an agar plate for a period of 72 hours. The test was conducted both in the presence and in the absence of metabolic activation, and negative, vehicle, and positive controls were assessed concurrently with the test substance.

The sample was not toxic up to 5000 µg/plate and did not exhibit mutagenic activity in any strain tested either with or without metabolic activation.

 

An in-vitro chromosome aberration assay was conducted by Istituto Di Recherche Biomediche “Antoine Marxer”, Italy, on behalf of EniChem Synthesis, Italy, to assess the potential of the test substance Dimethyl carbonate to cause chromosome aberrations in human lymphocytes. The study was conducted in accordance with OECD test guidelines and in compliance with GLP.

Human lymphoctyes were exposed to the test substance both in the presence and in the absence of metabolic activation. Concurrent positive and negative controls were assessed along with the test substance. Following exposure, chromosomes were assessed for aberrations.

No statistically relevant increase in the incidence of chromosome aberration was seen in any of the test substance concentrations when compared with the control group, either in the presence or absence of metabolic activation.

The test substance Dimethyl carbonate was concluded not to have shown any mutagenic potential in this chromosome aberration test.

An in-vitro gene mutation study was conducted by Istituto Di Recherche Biomediche “Antoine Marxer”,Italy , on behalf of, EniChem Synthesis,Italy , to assess the potential of the test substance Dimethyl carbonate to cause gene mutations in Chinese hamster lung cells. The study was conducted according to OECD test guidelines, and in compliance with GLP.

No evidence of mutagenic activity was found for the test substance Dimethyl carbonate in this gene mutation assay.

 


Short description of key information:
Two bacterial reverse mutation (i.e. Ames) assays, chromosome aberration assay in human lymphocytes, and a gene mutation assay in Chinese hamster lung were performed; none of the tests indicated any mutagenic potential caused by the test substance Dimethyl carbonate.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Each of the genetic toxicology tests conducted Dimethyl carbonate, concluded that the test substance did not display any mutagenic activity. None of these tests indicate a requirement for classification as dangerous for Dimethyl carbonate.