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Administrative data

Key value for chemical safety assessment

Additional information

No study with potassic extracts are available for this endpoint. Nevertheless, data on individual salts of potassic extracts or on substance of the sulfate category exist and have been used in a read-across approach to evaluate the genotoxic potential of potassic extracts. Then, in in vitro Ames test performed according to OECD test guideline 471 with potassium sulfate, calcium sulfate and sodium sulfate showed no mutagenicity with or without metabolic activation in 4 strains of Salmonella typhimurium (TA98, TA100, TA1535 and TA1537) and/or in E. coli bacteria (WP2 uvr A).

In an in vitro study where chromosome aberrations were tested with potassium sulfate in CHO cells according to OECD test guideline 473 also no effects were found. In addition, in vitro TK assay in L5178Y mouse lymphoma cells with calcium sulfate and magnesium sulfate performed according to OECD 476 showed no genotoxicity. In one in vivo study, performed according to OECD test guideline 474, calcium sulfate was administered to mice.Calcium sulfate, up to the test concentration of 5000 mg/kg bw showed negative effect in the micronucleus test. All together, these available data on substance in the sulfate category support the conclusion that no deleterious effects on genetic toxicity are expected with potassic extracts. Then it can be concluded that potassic extracts are highly unlikely to be mutagenic.

Short description of key information:
- Sodium sulfate : negative with and without metabolic activation, in vitro (similar to OECD guideline 471)
- Potassium sulfate: negative with and without metabolic activation, in vitro (according to OECD guideline 471 and 473)
- Calcium sulfate: negative with and without metabolic activation, in vitro (according to OECD guideline 471 and 476)
- Calcium sulfate : negative, in vivo (according to OECD Guideline 474)

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 potassic extracts according to Directive 67/548/EC and the CLP regulation.