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Administrative data

Key value for chemical safety assessment

Additional information

2,2,4(or 2,4,4)-trimethylhexane-1,6-diisocyanate

did not induce gene mutations in bacteria (Hüls AG 1985, 1993) or in mammalian cells (LPT, 2012) and demonstrate no potential to induce micronuclei in Chinese Hamster Ovary cells in vitro (LPT, 2011) either with or without metabolic activation.

Justification for selection of genetic toxicity endpoint
No study was selected,since all three in vitro genotoxicity enpoint studies (bacterial- and mammalian mutagenicity and in vitro micronucleus assay) showed no genotoxic effects

Short description of key information:
Under the present test conditions the test item 2,2,4(or 2,4,4)-trimethylhexane-1,6-diisocyanate 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 (Micronucleus 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 concluded that 2,2,4(or 2,4,4)-trimethylhexane-1,6-diisocyanate

is not genotoxic in vitro and therefore must not be classified according to the criteria of EC Directive 67/548/EECand EC Regulation 1272/2008.