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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

From the test results it is concluded that sodium sulphate has no genotoxic potential.


 


Short description of key information:


Ames test;


With metabolic activation: two tests, no effects and without metabolic activation: two tests, no effect


 


Mouse Lymphoma L5178Y cells


It is concluded 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.


 


In Vitro Chromosome Aberration test, hamster


It is concluded that under the experimental conditions reported, the test item did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) in vitro.


Therefore, Sodium Sulphate is considered to be non-clastogenic in this chromosome aberration test in the absence and presence of metabolic activation, when tested up to the highest required test item concentration.


 


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on in vitro test results sodium sulphate should not be classified for genotoxic effects.

Based on the results of the in vitro genetic toxicity studies, sodium sulphate does not need to be classified for genotoxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008