Registration Dossier
Registration Dossier
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EC number: 205-524-5 | CAS number: 142-16-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
There is clear evidence to indicate that dioctyl maleate is not mutagenic in a bacterial test system (RL1), with or without metabolic activation.
An in vitro cytogenicity assay (RL1) has been performed with dioctyl maleate in Chinese hamster lung cells (V79) with and without metabolic activation. The frequency of polyploid cells in both parts of the experiment was within the expected range (<10%). Results indicated that dioctyl maleate is not clastogenic.
An in vitro gene mutation assay in mouse lymphoma cells has been performed with dioctyl maleate (RL1). Results showed that dioctyl maleate did not induce mutant colonies.
Overall results showed that dioctyl maleate is not genotoxic.
Short description of key information:
Two bacterial or mammalian gene mutation assays have been conducted.
In addition, an in vitro chromosomal aberration and mouse lymphoma
assays have been conducted.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to criteria in Regulation (EC) No 1272/2008, dioctyl maleate does not have to be classified for genotoxicity.
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