Registration Dossier
Registration Dossier
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EC number: 246-309-6 | CAS number: 24549-06-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity: in vitro
The mutagenic potential in bacteria of the test substance 2-ethyl-6-methylaniline (MEA) was evaluated in a GLP and OECD guideline study (TG 471). Here, the tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 102 were used. Treatments by the plate incorporation method and the pre-incubation method were done for doses up to 5000 µg/ plate. The tester strains were evaluated with and without metabolic activation. No toxic effects of MEA were noted up to 500 µg/plate; whereas higher doses had a strong, strain-specific toxic effect. In this study no biologically relevant and dose dependent increases in revertants was observed in any of the tester strains evaluated with and without metabolic activation. Therefore, 2 Methyl-6-ethylanilin was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test (Lanxess Deutschland GmbH 2009).
No genotoxic potential of MEA was detected in a sister chromatid exchange assay using Chinese Hamster Ovary cells (Hill 1997).
Genetic toxicity: in vivo
In two limited publications of the in vivo micronucleus assay no gentoxic potential of 2-ethyl-6 -methylaniline (MEA) was indicated (Mulholland 1983, ECB 2000).
Short description of key information:
No genotoxic potential of MEA was noted in a bacterial test system (Lanxess Deutschland GmbH 2009). This finding was confirmed in a sister chromatid exchange assay with mammalian cells (Hill 1997). Moreover, in two limited in vivo micronucleus assay studies no genotoxicity of MEA was found.
In conclusion, no in vitro and in vivo genotoxicity of MEA was indicated and thus no classification is required.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification is required according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
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