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Key value for chemical safety assessment

Additional information

There are publications available in which soluble bismuth salts were tested. There is no indication for genotoxic/mutagenic effects of either colloidal bismuth subcitrate, bismuth subsalicylate or bismuth nitrate in these available publications.

In addition, in an available guideline study with the soluble bismuth hydroxide nitrate oxide the gene mutation potential was determined in the hprt locus of L5178Y mouse lymphoma cells. The study included treatments up to the maximum practicable concentration, 140 µg/mL (limited by solubility in the primary vehicle), in two independent experiments in the absence and presence of rat liver metabolic activation system (S9).

Results show that bismuth hydroxide nitrate oxide does not induce gene mutation in mouse lymphoma cells and should not be classified and labelled according to regulation (EC) No.: 1272/2008.

Read-across substance, bismuth subsalicylate was tested in vitro in a Chromosome Aberration Assay using Chinese hamster V79 lung cells according to OECD Guideline 473. Bismuth subsalicylate test item did not induce a significant level of chromosome aberrations in a repeatable, dose-dependent way in the performed experiments with or without metabolic activation. Therefore, Bismuth subsalicylate is considered not clastogenic in this test system.

Based on available data from publications and on experimental results with read-across substances, bismuth hydroxide nitrate oxide and bismuth subsalicylate, bismuth trinitrate does not need to be classified for genetic toxicity.


Justification for selection of genetic toxicity endpoint
More than one study available - all provided negative results.

Short description of key information:
Bismuth trinitrate (hydrate) was determined to be not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on available data from publications and on experimental results with read-across substances, bismuth hydroxide nitrate oxide and bismuth subsalicylate, bismuth trinitrate does not need to be classified for genetic toxicity.