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1. Genetic toxicity in vitro testing: The mutagenic effects of the test item were determined in a reverse mutation assay with Salmonella typhimurium. Test systems were the strains TA 97a, TA 98, TA 100., TA 102, and TA 1535 with (+) and without (-) the metabolic activation system S9 (from male Wistar rats). Concentrations tested were 0.005- 0.016 - 0.05 - 0.16 - 0.5 mg/plate. Three replicates per concentration level and control were performed. Based on the results of this study the test item was found to have no mutagenic effects on Salmonella typhimurium strains TA 97a, TA 100, TA 98, TA 102, TA 1535 with (+) and without (-) the metabolic activation system S9 from Wistar rats at concentrations up to 0.5 mg/plate.

The potential of the test item to induce chromosome aberrations was investigated in V79 Chinese hamster lung fibroblasts (V79) in vitro. For each experiment duplicate cell cultures were used for each concentration. The test compound was tested at concentrations of 10 to 200 µg/mL including solvent controls with (+) and without (-) metabolic activation system from Spraque Dawley-rat liver. Up to the highest investigated dose the test compound induced no toxicologically relevant or dose dependent increase in the number of aberrant metaphases. In conclusion, the test item did not induce chromosome aberrations in V79 Chinese hamster cells, either in the presence or in the absence of a metabolic activation system. The test item is not clastogenic in this in vitro chromosome aberration assay under the condition of this report.

An in vitro gene mutation study in mammalian cells was performed to assess the test item for its potential to induce mutations at the HPRT locus using V79 cells of the Chinese Hamster. Based on cytotoxicity observed in experiment I 37.5 µM (-S9) and 180 µM (+S9) were selected as highest concentrations. In experiment II 52.5 µM (-S9) and 230 µM (+S9) were selected as the highest concentrations. No precipitation of the test item was noted in experiment I (4 h exposure +/- S9 avtivation) and experiment II (4h exposure with S9 and 20h exposure without S9 activation). In both experiments no biologically relevant increase of mutants was found after treatment with the test item (+/- S9 activation). No dose response relationship was observed. In conclusion, the test item is considered to be non mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.

2. Genetic toxicity in vivo. No in vivo genetic toxicity test is indicated for Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS) because several in vitro mutagenicity assays in bacteria as well as in mammalian cell systems covering both endpoints, point-mutation and chromosome mutation. All in vitro tests performed with the test item (i.e. in vitro gene mutation test in bacteria, in vitro cytogenicity in mammalian cells (chromosome aberration test) and in vitro gene mutation test in mammalian cells (HPRT)) were negative in result. Furthermore, these results are supported by a number of in vitro genetic toxicity tests with an analogue substance (C13-15 dimethyl hydroxyethylammonium chloride) which is similar in structure (For Read across justification refer to IUCLID section 13 Assessment reports). Tests performed with this analogue are: Chromosome aberration test in CHO cells, L5178YTK +/- Mouse Lymphoma test, UDS-test in primary culture of rat Hepatocytes and Ames test. Results of all these tests with the analogue were also negative and support the negative results of the Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS).


Short description of key information:
Results from three different in vitro test systems with Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS), chlorides are available.

1. Ames test according to OECD 471; result: negative (+/-) metabolic activation system.
2. Chromosome aberration test according to OECD 473; result: negative (+/-) metabolic activation system.
3. HPRT in V79 hamster cells, according to OECD 476; result: negative (+/-) metabolic activation system.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results of all available genetic toxicity tests and the supportive data with an analoue substance in vitro, a classification is not required.