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Additional information

Ames-Test

In a GLP compliant study performed according to OECD guideline 471, the test substanceSulfonium compounds,C11-14-alkylbis(hydroxyethyl),2-hydroxyethyl sulfates (salts)was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA 98) and Escherichia coli (E. coli WP2 uvrA), in a reverse mutation assay (BASF SE, 2013). The test substance was tested both in the standard plate test (1st Experiment: 33μg - 5000μg/plate; 2nd Experiment 1μg - 333μg/plate) and in the preincubation test (1μg - 333μg/plate) both with and without the addition of a metabolizing system (phenobarbital andβ-naphthoflavone induced rat liver S9 mix). No precipitation of the test substance was found with and without S9 mix. Strong bacteriotoxicity was observed in the standard plate and in the preincubation test depending on the strain and test conditions from about 100μg/plate onward. A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substanceSulfonium compounds,C11-14-alkylbis(hydroxyethyl),2-hydroxyethyl sulfates (salts)is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

in vitro Mikronucleus Assay

In a GLP compliant study performed according OECD guideline 487 the test item Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts), dissolved in deionised water, was assessed for its potential to induce micronucleiin V79 cells of the Chinese hamster in vitro in three independent experiments (Harlan CCR, 2013). In Experiment IA the exposure period was 4 hours with metabolic activation. In Experiment IB the exposure period was 4 hours without metabolic activation. In Experiment II the exposure period was 24 hours without metabolic activation and 4 hours with metabolic activation. The cells were prepared 24 hours after start of treatment with the test item.In each experimental group two parallel cultures were analyzed and at least 1000 cells perculture were scored for micronuclei. The highest applied concentration (5000.0 µg/mL) was chosen with respect to the OECD Guideline No. 487.In the absence and presence of S9 mix concentrations showing clear cytotoxicity were not evaluable for cytogenetic damage. No mutagenicity was observed at the concentrations evaluated (Exp IA: 19.5, 39.1, 78.1 µg/mL; Exp IB: 2.3, 4.7, 9.4 µg/mL; Exp II, 24h, without S9 mix: 3.1, 6.3, 12.5 µg/mL; Exp II, 4h, with S9 mix: 30.0, 60.0, 80.0, 100.0 µg/mL). However, in Experiment IA in the presence of S9 mix one statistically significant increase (1.10 % micronucleated cells) was observed after treatment with 78.1 µg/mL. The value is clearly within the range of the laboratory historical solvent control data (0.05 – 1.70 % micronucleated cells) and therefore not biologically relevant.Appropriate mutagens were used as positive controls. They induced statistically significantincreases in the percentage of micronucleated cells.In conclusion, it can be stated that under the experimental conditions reported, the test item Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts) did not induce micronuclei in V79 cells (Chinese hamster cell line) in vitro in the absence and presence of metabolic activation. Therefore, Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts) is considered to be non-mutagenic in this in vitro test system, when tested up to the highest evaluable concentrations.

HPRT-Test

The study was performed to investigate the potential of Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts) to induce gene mu­tations at the HPRT locus in V79 cells of the Chinese hamster. The study was conducted according to OECD 476 guideline and GLP (Harlan, 2013).

The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours.The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation.

The highest concentration applied in the pre-experiments was 1000 µg/mL. The concentration range of the main experiments was limited by cytotoxic effects. The test item was dissolved in deionised water.

No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation.

Appropriate reference mutagens (and DMBA), used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.

In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, Sulfonium compounds, C11-14-alkylbis(hydroxyethyl), 2-hydroxyethyl sulfates (salts) is considered to be non-mutagenic in this HPRT assay.


Short description of key information:
Ames-Test (BASF SE, 2013): negative
in vitro Micronucleus Assay (Harlan, 2013): negative
HPRT-Test (Harland, 2013): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, no classification and labeling is required (according to Directive 67/548/EEC and according to CLP) for genetic toxicity.