Alkenes, C15-18 α-, sulfurized

Endpoint summary

Additional information

In vitro Gene Mutation in Bacteria

The potential of the test material to cause mutagenic effects in bacteria was assessed in accordance with the standardised guideline OECD 471 under GLP conditions. The study was assigned a reliability score of 1 according to the criteria of Klimisch (1997).

Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 and Escherichia coli strain WP2uvrA were treated with the test material, using the plate incorporation and pre-incubation methods, at six dose levels, both with and without metabolic activation. The dose levels assessed were 50, 167, 500, 1670, 5000 and 10 000 µg/plate.

The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. No toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method.

The vehicle and positive controls were within the normal range.

The test material was considered to be non-mutagenic under the conditions of this test.

 

In vitro Mammalian Cell Cytogenicity

An evaluation of the ability of the test material to induce chromosome aberrations in cultured peripheral human lymphocytes was carried out in vitro in accordance with the standardised guidelines OECD 473 and EU Method B.10 under GLP conditions. The study was assigned a reliability score of 1 according to the criteria of Klimisch (1997).

In the first cytogenetic assay, the test material was tested up to 33 μg/mL for a 3 hour exposure time with a 24 hour fixation time in the absence and presence of 1.8 % (v/v) S9-fraction (the test material precipitated in the culture medium at this dose level).

In the second cytogenetic assay, the test material was tested up to 2500 μg/mL for 24 and 48 hours continuous exposure time with 24 and 48 hour fixation time in the absence of S9-mix. In the presence of S9-mix, the test material was tested up to 33 μg/mL for 3 hours exposure time with 48 hour fixation time (the test material precipitated in the culture medium at these dose levels).

Concurrent positive and negative controls showed the test system to be functioning adequately.

Under the conditions of this study, no biologically relevant effects of the test material on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that the test material does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under these experimental conditions and was therefore considered to be non-clastogenic.

 

In vitro Gene Mutation

The potential of the test material to cause gene mutation in mammalian cells was investigated in vitro in accordance with the standardised guidelines OECD 476 and EU Method B.17 under GLP conditions. The study was assigned a reliability score of 1 according to the criteria of Klimisch (1997).

L5178Y TK +/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase locus) were treated with the test material in two independent experiments.

In Experiment 1, the cells were treated with the test material at concentrations up to 33 µg/mL together with vehicle and positive controls using 3 hour exposure periods both in the absence and presence of 8 % S9 metabolic activation.

In Experiment 2, the cells were treated with the test material at concentrations up to 33 µg/mL together with vehicle and positive controls using a 24 hour exposure period in the absence of metabolic activation and a 3 hour exposure in the presence of 12 % S9 metabolic activation.

The test material did not induce any toxicologically significant dose-related increases in the mutant frequency at any dose level, either with or without metabolic activation, in either the first or the second experiment.

The vehicle controls had acceptable mutant frequency values and the positive control materials induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system.

Under the conditions of this study, the test material was considered to be non-mutagenic to L5178Y cells.

Justification for selection of genetic toxicity endpoint
No single study was selected as key on the basis that multiple studies have been provided to address the different types of genetic toxicity.

Short description of key information:
IN VITRO GENE MUTATION STUDY IN BACTERIA
- Negative (with and without metabolic activation), OECD 471

IN VITRO MAMMALIAN CELL CYTOGENICITY
- Negative (with and without metabolic activation), OECD 473 and EU Method B.10

IN VITRO GENE MUTATION STUDY IN MAMMALIAN CELLS
- Negative (with and without metabolic activation), OECD 476 and EU Method B.17

Endpoint Conclusion:

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for genetic toxicity.