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EC number: 425-380-9 | CAS number: 7397-46-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
DEMB was tested in two in vitro genotoxicity tests.
In the Ames test which was performed under GLP according to OECD 471, four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) were tested in two independent experiments. DEMB was applied up to concentrations of 5000 ug/plate in the absence and the presence of S9-mix. DEMB did not induce a dose-related increase in the number of revertant colonies both in the absence and the presence of S9-mix.
Secondly, a chromosome aberration test was performed according to GLP and OECD 473. Here DEMB was tested to induce chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (S9 - mix). In the absence of S9 -mix DEMB was tested up to 560 ug/ml for a 24 h and for a 48 h treatment time. In the second experiment DEMB was tested up to 750 ug/ml for a 24 h treatment time. In the presence of 1.8% (v/v) S9 -fraction DEMB was tested up to 560 ug/mg for 3 h and in the second experiment DEMB was tested up to 1000 ug/ml for 3 h. Both in the absence and presence of S9-mix DEMB induced a statistically and biologically significant increases in the number of cells with chromosome aberrations but only at the highest, cytotoxic, concentration of 560 ug/ml and in the absence of a dose-response relationship (at the 24 h fixation time). At the 48 h fixation time the cytotoxic, concentration of 560 ug/ml induced a statistically and biologically significant increase in the number of cells with chromosome aberrations in the absence of S9-mix only. In the absence of S9-mix DEMB induced a statistically and biologically significant increase in the number of cells with chromosome aberrations at the highest, cytotoxic, concentration of 750 ug/mL in the absence of a dose-response relationship. In the presenceof S9-mix DEMB did not induce a statistically and biologically significant increase in the number of cells with chromosome aberrations at all concentrations tested. Finally, an increase in the number of cells with chromosome aberrations was observed only at high and cytotoxic concentrations.
Considering the toxic-profile of DEMB this is probably not the result of DNA-compound interaction, but is the result of an aspecific, indirect cell damaging action finally resulting in chromosome aberrations. Therefore, non-clastogenicity of DEMB may be considered.
Based on the results of both studies it is concluded that DEMB is not mutagenic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
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