Registration Dossier
Registration Dossier
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EC number: 202-440-0 | CAS number: 95-68-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Several bacterial reverse mutation assay (Ames test) have been performed on 24 -Xylidine covering the strains Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537, TA1538 and TA2637. There was no increase in the number of revertant colonies with any of the tester strains without metabolic activation. In the presence of metabolic activation the test substance was mutagenic.
In two mammalian in vitro chromosome aberration studies and an in vitro UDS assay the genotoxic potential of m-Xylidine was examined using Chinese hamster cells and primary hepatocytes, negative results in the absence of metabolic activation were obtained for the CHO cells and positive in case of the of the presence of metabolic activation. Mutagenic properties were obtained from the UDS assay.
From the results obtained with the genotoxicity studies it can be concluded, that m-Xylidine is not mutagenic in without metabolic activation but genotoxic in the presence of metabolic activation.
Short description of key information:
- Ames test: negative without metabolic activation/positive with metabolic activation (3 studies)
- in vitro Chromosome Aberration study in CHO cells: negative without metabolic activation/positive with metabolic activation (2 studies)
- in vitro UDS assay: positive
Endpoint Conclusion:
Justification for classification or non-classification
There are only in vitro studies available to give hint on the genotoxic properties of 2,4-Xylidine. It was shown that the substance does not show any mutagenic effect in the absence of metabolic activation. In the presence of S9 mix m-Xylidine gave a positive response. Based on the existing limited data and considering that these were obtained from in vitro studies exclusively which give only a hint of possible genotoxic mechanisms but fail to reflect the in vivo situation no statement on classification/non-classification with reference to the genotoxicity can be made.
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