Alkenes, C11-14, hydroformylation products, distn. residues, reaction products with maleic anhydride and sodium bisulfite, sodium salts

Endpoint summary

Additional information

In the GLP bacterial reverse mutation assay (OECD guideline 471), the test item Alkenes hydroformylated, sulfosuccinates, sodium salt was assessed for its potential to induce gene mutations in the plate incorporation test (experi­ment I) and the pre-incubation test (experiment II) using Salmonella typhimuriumstrains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia colistrain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate.

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Alkenes hydroformylated, sulfosuccinates, sodium salt at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

A GLP study was performed to investigate the potential of Alkenes, hydroformylated sulfosuccinates, sodium salt to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y according to OECD guideline 476.

The first main experiment performed with short term treatment for 4 hours with and without metabolic activation was terminated prior to the generation of any data on mutagenicity as strong cytotoxic effects completely inhibited cell growth down to low concentrations. The experiment was repeated with a lower concentration range. The data are reported as experiment I. As the cytotoxic range was not quite covered, the experiment was repeated as experiment IA using a somewhat higher concentration range. In the second experiment the cells were treated with the test item for 4 hours with and 24 hours without metabolic activation.

No substantial and reproducible dose dependent increase of the mutation frequency was observed with and without metabolic activation. The mutation frequency did not reach or exceed the threshold of 126 above the corresponding solvent control at acceptable levels of cytotoxicity.

A linear regression analysis (least squares) was performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT(R)11 statistics software.

No significant dose dependent trend of the mutation frequency indicated by a probability value of <0.05 was determined in any of the experimental groups.

In conclusion it can be stated that under the experimental conditions reported the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation.

A GLP study was performed to investigate the potential of Alkenes, hydroformylated sulfosuccinates, sodium salt to induce structural chromosomal aberrations in human lymphocytes in vitro in five independent experiments.

In each experimental group two parallel cultures were analysed. Per culture at least 100 metaphases were evaluated for structural chromosomal aberrations.The highest applied concentration in this study (5000.0 µg/mL of the test item) was chosen with respect to the current OECD Guideline 473.Dose selection of the cytogenetic experiment was performed considering the toxicity data and the occurrence of test item precipitation in accordance with OECD Guideline 473. No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures. In conclusion, it can be stated that under the experimental conditions reported, the test item did not induce structural chromosomal aberrations in human lymphocytes in vitro. Therefore, Alkenes hydroformylated, sulfosuccinates, sodium salt is considered to be non-clastogenic in this chromosome aberration test, when tested up to cytotoxic and/or precipitating concentrations.

Short description of key information:
The genetic toxicity of the test substance was assessed in 3 in vitro studies including a bacterial reverse mutation assay, a mammalian chromosome aberration test and a mammalian gene mutation assay. Negative results were reported in all the studies therefore it can be concluded that the substance is not a genotoxic compound.

Endpoint Conclusion: No adverse effect observed (negative)