1-Heptanol, 2-propyl-, 1,1'-carbonate

Endpoint summary

Additional information

Ames test:

The test item was tested for its mutagenic potential in a Ames test according to OECD guideline no. 471 and EU method B.13/14. The test item was tested without and with metabolic activation in Salmonella typhimurium tester strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli E. coli WP2 uvrA in concentrations of 33, 100, 333, 1000, 3000, 6000 µg/plate. No bacteriotoxic effect was observed under all test conditions. A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test item is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

HPRT Test:

The test item was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster according to OECD guideline no. 476 and EU method B.17. The study was performed in two independent experiments, using identical experimental procedures. In the first experiment the treatment period was 4 hours with and without metabolic activation. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. Based on the solubility properties of the test item the range finding pre-experiment test was performed using a concentration range of 39.1 to 2500 µg/mL and additionally the undiluted test item (5 µL/mL). The concentration range of the main experiments was limited by the occurrence of phase separation in the pre-experiment. The test item was dissolved in ethanol. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation. Appropriate reference mutagens (EMS and DMBA), used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system. The test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the test item is considered to be non-mutagenic in this HPRT assay.

Micronucleus Test:

The test item was tested in V79 cells with and without metabolic activation by S9 mix in an in vitro micronucleus assay according to OECD guideline no. 487. The test was carried out employing 2 exposure times with metabolic activation: 4 h and without metabolic activation: 4 h (experiment 1) and 24 h (experiment 2). The vehicle was acetone and the following test concentrations were used: in the first experiment 6.3, 12.5, 25.0, 50.0, 100.0, 200.0 µg/mL and in the second experiment 12.5, 25.0, 50.0, 100.0, 200.0 µg/mL. In this study, no biologically relevant increase in the number of micronucleated cells was observed either without S9 mix or after the addition of a metabolizing system. In both experiments in the absence and presence of metabolic activation after 4 and 24 hours treatment with the test substance the values (0.5 – 1.4% micronucleated cells) were close to the concurrent vehicle control values (0.5 – 1.0% micronucleated cells) and clearly within our historical negative control data range (0.1 - 1.8% micronucleated cells). Thus, under the experimental conditions chosen here, the conclusion is drawn that the test item has not the potential to induce micronuclei (clastogenic and/or aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.

Justification for selection of genetic toxicity endpoint
Several equivalent and complementary in vitro studies with the test substance were performed.

Short description of key information:
The test item was tested for mutagenic potential in a reversed bacteria mutation assays (Ames test), a HPRT test and in an in vitro micronucleus assay. The test item revealed no mutagenic actvity in all tests.

Endpoint Conclusion: No adverse effect observed (negative)