1-(2,4-dimethylcyclohex-3-en-1-yl)propan-1-ol

Endpoint summary

Additional information

Ames test:

The mutagenic activity of the substance in the bacterial reverse mutation test was evaluated in accordance with OECD guideline 471 and GLP. The test was performed in two independent experiments using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and the Escherichia coli strain WP2uvrA, in the absence and presence of a liver fraction of Aroclor 1254-induced rats. The dose levels were selected based on observed cytotoxicity. Adequate negative and positive controls were included. In both tests, in all strains tested, in both the absence and presence of S9-mix, the test substance did not induce a more than 2-fold and/or dose related increase in the mean number of revertant colonies compared to the background spontaneous reversion rate observed with the negative control. It is concluded that the results obtained in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and in the Escherichia coli strain WP2 uvrA, in both the absence and presence of the S9-mix, indicate that the test substance is not mutagenic under the conditions employed in this study.

Chromosome aberration test:

The cytogenicity of the test substance was determined in an in vitro mammalian cell chromosome aberration test, performed according to OECD 473 and in compliance with GLP. The test was performed in human lymphocytes in both the absence and presence of a metabolic activation system (S9 -mix). The test substance was dissolved in DMSO and the dose levels were selected based on observed cytotoxicity. Adequate negative and positive controls were included. In the first chromosomal aberration test, in both the absence and presence of S9-mix, the treatment/harvesting times were 4/24 hours (pulse treatment). Cells were treated with 2 - 1000 µg/mL test substance. In the absence and presence of S9-mix, no test substance concentration could be selected that fulfilled the criteria stated in OECD guideline 476 (i.e. a maximum concentration which resulted in 55 ± 5% cytotoxicity). Therefore, the pulse treatment groups, both with and without metabolic activation, were repeated in the second test. In the second test, in the pulse treatment groups both with and without metabolic activation, the treatment/harvesting times were 4/24 hours. In the continuous treatment group without metabolic activation the treatment/harvesting times were 24/24 hours. In the pulse treatment groups in absence of S9 -mix cells were exposed to 50 - 250 µg/mL test substance and in the presence of S9 -mix cells were exposed to 50 - 350 µg/mL test substance. In the continuous group, cells were exposed to 25 - 300 µg/mL test substance. In this chromosomal aberration test, the test substance did not induce a statistically significant increase in the number of aberrant cells, at any of the concentrations and treatment periods analysed, when compared to the number of aberrant cells observed in the solvent control cultures. From the results obtained in two chromosomal aberration tests it is concluded that, the test substance was not clastogenic to cultured human lymphocytes, under the conditions used in this study.

Short description of key information:
Ames test (OECD TG 471): negative
Chromosome aberration test (OECD TG 473): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the Ames test and the chromosome aberration test, the test substance does not have to be classified for mutagenicity in accordance with Regulation (EC) No. 1272/2008.