Hexanedioic acid, polymer with 2,2'-oxybis[ethanol]

Endpoint summary

Additional information

The test substance Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] was tested for mutagenicity and the potential to induce chromosome aberrations in three different test systems:

1) Bacterial reverse mutation assay (OECD 471): The test was conducted as a standard plate test and as a preincubation test in the bacteria strains S. typhimurium TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA with test substance concentrations ranging from 33 to 5000 ug/plate. The test substance did not cause a relevant increase in the number of his+ or trp+ revertants in the standard plate test or the preincubation test either in the presence or the absence of metabolic activation.

2) HPRT test (OECD 476): The test was conducted in V79 cells as two independent experiments. Experiment I: 4 hours treatment with and without metabolic activation; experiment II: 4 hours with and 24 hours without metabolic activation. The test substance did not induce a relevant and reproducible increase in mutant frequency up to the maximum concentrations under any experimental conditions.

3) Chromosome aberration test (OECD 473): The test was performed in V79 cells in vitro with test substance concentrations ranging from 12.6 to 3230.0 ug/ml in the medium. Three independent experiments were conducted: a pre-test (experiment I) with an exposure time of 4 hours without S9 mix; experiment IIA with 4 hours (with S9 mix), as well as 18 and 28 hours (without S9 mix) exposure time, respectively; experiment IIB (performed because evaluation of concentrations showing cytotoxicity in experiment IIA after 18 hours treatment without S9 mix was impossible) with 18 hours exposure time without S9 mix but different dose levels than in experiment IIA. The number of cells harboring structural chromosome aberrations in the test item-treated group was not significantly increased in the absence and presence of S9 mix, but was within the range of the solvent control values and the historical solvent control data.

Based on the results of the three assays described above, it can be concluded that the test substance is not mutagenic in bacterial and mammalian cells and does not induce chromosome aberrations in mammalian cells.

Short description of key information:
The test substance Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol] was tested for mutagenicity in mammalian and bacterial cells as well as the potential to induce structural chromosome aberrations in mammalian cells. Under the experimental conditions chosen, the test substance was non-mutagenic in bacteria and V79 cells and did not induce chromosome aberrations in V79 cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Genotoxic effects were observed in neither of the three test systems, and as a result classification according to Regulation (EC) No. 1272/2008 and Directive 65/548/EEC is not warranted.