2-tert-pentylcyclohexyl acetate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genemutation in bacterial cells, Ames test (OECD TG 471): negative
Genemutation in mammalian cells, the MLA (OECD TG 476): negative
Chromosomal aberrations in mammalian cells, (OECD TG 473): negative

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Bacterial reverse mutation assay (e.g. Ames test)

The mutagenic activity of the substance was evaluated in accordance with OECD 471 and according to GLP principles. The test was performed in two independentplate incorporationexperiments, both in the absence and presence of S9-mix. The dose levels were selected based on the dose range finding experiment. Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant colonies in each of the five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100) and E. Coli WP2 uvrA), both in the absence and presence of S9-metabolic activation. Based on the results of this study it is concluded that the substance is not mutagenic with and without metabolic activation

Additional information: A recent Ames test (2015) is available in the database of Research Institute for Fragrance Materials (RIFM). In an OECD TG 471 study no mutagenicity in bacterial cells was seen.

Mammalian cell gene mutation assay

An in vitro mammalian gene mutation test was performed according to OECD guideline 476 and in compliance with GLP. Mouse lymphoma L5178Y cells were exposed to 2.0, 5.0, 8.0, 11, 14, and 17 µg/mL without metabolic activation and 40, 55, 70, 85, 100, and 115 µg/mL with metabolic activation for 4 hours (expression time 20 and 44 hours). Furthermore, a confirmatory experiment was performed with 5.0, 8.0, 11, 14, 17, 20, 23, and 26 µg/mL test substance for 24-hours without metabolic activation. The mutant frequencies and relative total growth were determined. Positive and solvent controls induced the appropriate response. Under the conditions of the test the results of the definitive and confirmatory mutation assays were considered negative.

In vitro mammalian chromosome aberration test

An in vitro chromosome aberration test was performed according to OECD guideline 473 and in compliance with GLP. Chinese hamster Ovary (CHO) cells were exposed to 10, 20, 30, 35, 40, and 45 μg/mL (without S-9) and 25, 50, 60, 70, 80, and 90 μg/mL (with S-9) in the definitive test. Doses were selected based on a dose range finder. Furthermore a confirmatory test was performed with 10, 20, 25, 30, and 35 μg/mL test substance without S-9. Cells were exposed for 3 hours (+15 hours recovery) in the definitive test and exposed for 18 hours in the confirmatory test. Positive and solvent controls induced the appropriate response. The results from the Definitive and Confirmatory Chromosome Aberration Assays indicate that the test article did not induce a statistically significant increase in the percentage of cells with aberrations both with and without metabolic activation when compared to the solvent controls. Therefore, under the conditions of this test and according to the criteria set for evaluating the test results, the test substance was negative (not clastogenic) in the CHO Chromosome Aberration Assay both with and without metabolic activation.

Justification for classification or non-classification

Based on the results of the Ames test, mouse lymphoma assay, and chromomal aberration test, the substance does not have to be classified for genetic toxicity in accordance with Regulation (EC) No. 1272/2008 and its updates.