1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The purpose of the Ames test according to OECD 471 study was to evaluate the test substance for mutagenic activity (gene mutation) in bacteria without and with the addition of a mammalian metabolic activation system as originally described by AMES et al. (LPT 2012). Under the present test conditions the test item tested up to a cytotoxic concentration of 3160 µg/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation. 

The test item was further tested for mutagenic potential in a gene mutation assay in cultured mammalian cells (V79, genetic marker HPRT) both in the presence and absence of metabolic activation by a rat liver post-mitochondrial fraction (S9 mix) from Aroclor 1254-induced animals (LPT 2012). Under the present test conditions, test item tested up to cytotoxic concentrations of 625 or 1250 µg/mL in the experiments without and with metabolic activation, respectively, was negative in the HPRT-V79 mammalian cell mutagenicity test under conditions where positive controls exerted potent mutagenic effects.

 The purpose of the Chromosome Aberration study was to obtain information on the possible in vitro clastogenic activity of the test item in cultured CHO cells with and without the addition of a mammalian metabolic activation system (LPT 2012). Under the present test conditions, the test item tested up to cytotoxic concentrations in the absence and in the presence of metabolic activation employing two exposure times (without S9) and one exposure time (with S9) revealed no indications of mutagenic properties with respect to chromosomal or chromatid damage. 

 

 

 

 

Additional information

1,3,3 -Trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexane- methylamine did not induce gene mutations in bacteria (OECD TG 471; LPT, Evonik Industries AG, 2012) or in mammalian cells (OECD TG 476; LPT, Evonik Industries AG 2012) and demonstrate no potential to induce chromosome aberrations in Chinese Hamster Ovary cells in vitro (OECD TG 473; LPT, Evonik Industries AG, 2012) either with or without metabolic activation.

Results from genetic toxicity tests in vivo are not available.

Justification for selection of genetic toxicity endpoint
No study was selected, since all three studies were negative.

Short description of key information:
In conclusion, under the present test conditions the test item 1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexane- methylamine tested up to cytotoxic concentrations in the in vitro bacterial mutagenicity assay (Salmonella reverse mutation Assay), the in vitro mammalian mutagenicity assay (HPRT Assay) and the in vitro mammalian cytogenetic assay (Chromosome Aberration Test) each assay carried out without and with metabolic activation, revealed no genotoxic activity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Because all in vitro genotoxicity studies revealed clearly negative results, it can be conluded that there is no evidence that

1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexane- methylamine

has a mutagenic or clastogenic potential and therefore must not be classified according to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008.