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Key value for chemical safety assessment

Additional information

No Ames or chromosome aberration study with magensium sulphate is present.

However, an in vitro Ames test performed according to OECD test guideline 471 with potassium sulphate showed no mutagenicity with or without metabolic activation in 4 strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and in E. coli bacteria (WP2 uvr A). The substance was tested up to the maximum concentration. In a second in vitro study according to OECD test guideline 473, CHO cells were exposed to 217.5, 435, 870, and 1,740 μg/mL with and without metabolic activation. No chromosome abberrations were found.

An in vitro TK assay in L5178Y mouse lymphoma cells with magnesium sulphate performed according to OECD 476 was present, showing no genotoxicity. Cells were exposed to a maximum of 2 µg/mL without metabolic activation and to a maximum of 17 μg/mL with metabolic activation and treated for 3 or 24 hours. Test concentrations were based upon cytotoxicity found in the screening study at

at dose levels of 1 or 3 µg/mL in the absence of metabolic activation for 24 or 3 hours treatment, respectively and at dose levels of 33 µg/mL in the presence of metabolic actvation.

In addition, ammonium sulphate also showed no mutagenicity in several in vitro tests, such as the Ames test and a chromosome aberration study.


Short description of key information:
Only in vitro studies are present for sulphate salts. Potassium and ammonium sulphate were not mutagenic in Ames and chromosome aberration studies. Magensium sulphate itself was negative in a TK assay in mouse lymphoma cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available data indicate that no classification is required with regard to mutagenicity for magnesium sulphate according to Directive 67/548/EC and the CLP directive.

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