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Key value for chemical safety assessment

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Additional information

Additional information from genetic toxicity in vivo:

Vinylene carbonate was tested for in vitro bacterial mutagenicity by means of the Ames test according to OECD 471. Reliable positve and negative controls were included. Tester strain WP2uvrA showed negative responses over the entire dose range. 

In the absence of metabolic activation, dose-related increases in reverse mutations were observed in tester stains TA1537, TA98 and TA100. In the presence of metabolic activation, dose-related increases in reverse mutations were observed in tester strains TA1535, TA1537, TA98 and TA100. The observed dose-related increases in reverse mutations both in the absence and presence of metabolic activation are considered biologically relevant. Based on the results of this study it is concluded that Vinylene carbonate is mutagenic in theSalmonella typhimuriumreverse mutation assay and VC is not mutagenic in theEscherichia colireverse mutation assay.

Vinylene carbonate was studied for chromosomal aberration potentialin vitroin Chinese Hamster Lung cells in a test equivalent to OECD 473. Reliable positive and negative controls were included.

The test material induced a statistically significant increase in the frequency of cells with aberrations both in the absence and the presence of metabolic activation. In additions, Vinylene carbonate induced a srtatistically increased incidence in polyploidy cells, both in the absence and in the presence of metabolic activation. Based on these observations Vinylene carbonate is considered clastogenic in vitro.

In vivo chromosome aberration potential for Vinylene carbonate was studied in mice orally dosed once at 150, 300 or 600 mg/kg bw in accordance with OECD 474. Reliable positive and negative controls were included.

There was no evidence of a significant increase in the incidence of micronucleated polychromatic erythrocytes in animals dosed with the test material when compared to the concurrent vehicle control groups. The test material was concluded to be non-genotoxic under the conditions of the test.

Justification for classification or non-classification