Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

- Sodium 2-hydroxyethanesulphonate showed negative results in the study for the induction of gene mutations (bacterial reverse mutation assay) by frameshift or base-pair substitutions with and without metabolic activation. The study was performed with the test strains S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 uvr A. Test concentrations up to the limit concentration of 5000 µg/plate or above (up to 10000 mg/plate) were tested in the experiment. The test compound proved to be not toxic to the bacterial strains.

- Sodium 2-hydroxyethanesulphonate also yielded negative results in an in vitro gene mutation study in mammalian cells in concentrations up to 1500 µg/ml (10 mM) in the presence and absence of metabolic activation.

- Sodium 2-Hydroxyethanesulphonate was assessed for its potential to induce micronuclei in human lymphocyte in vitro. The test item did not induce micronuclei. Therefore, Sodium 2-Hydroxyethanesulphonate is considered to be non-mutagenic in this in vitro micronucleus test when tested up to the highest required concentration (10 mM).

In conclusion, Sodium 2-Hydroxyethanesulphonate is not mutagenic in the bacterial reverse mutation assay, the Mouse lymphoma assay and the micronucleus test in human lymphocytes in the presence and absence of metabolic activation up to the tested concentrations.

Short description of key information:
Mutagenic activity of Sodium 2-hydroxyethanesulphonate was investigated in one bacterial reverse mutation assay (Ames test; test strains used: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 uvr A), in an in vitro gene mutation study in mammalian cells (Mouse lymphoma assay) and in one in vitro micronucleus test in human lymphocytes. Negative results were obtained in all tests with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Sodium 2-Hydroxyethanesulphonate was not classified for mutagenicity since this substance did not reveal any mutagenic effect in the bacterial reverse mutation assay in the presence or absence of metabolic activation in concentrations up to 10000 µg/plate, in the in vitro micronucleus test (up to 10 mM) or in the Mouse lymphoma assay in concentrations up to 1500 µg/mL.