Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro studies:

Three in vitro genetic toxicity tests were performed to examine the potential of the substance trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide to induce mutations.

In a bacterial mutation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102, with and without the addition of a metabolising system according to OECD method 471 tested up to a concentration of 5000 µg/plate, the substance caused no mutagenic effect neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.

Furthermore an in vitro micronucleus test was conducted. Under the present test conditions, tested up to a concentration of 5000 µg /mL medium in the absence and in the presence of metabolic activation the substance revealed no indications of mutagenic properties in the in vitro micronucleus test.

The substance was tested for mutagenic potential in a gene mutation assay in cultured mammalian cells (HPRT test) both in the presence and absence of metabolic activation. Under the present test conditions, tested up to concentrations of 5000 µg/mL in the experiments without and with metabolic activation the substance was negative in the HPRT-V79 mammalian cell mutagenicity test


Short description of key information:
Three in vitro genetic toxicity tests were performed to examine the potential of the substance trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide to induce mutations. The substance showed no mutagenic properties in the bacterial mutation test, in the in vitro micronucleus test and in the in vitro mammalian gene mutation test (HPRT test).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures and based on the results of the studies trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide is not classified.