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Key value for chemical safety assessment

Additional information

According to Annexes VII and VIII, point 8.4 of Regulation No 1907/2006 information on mutagenicity of substances shall be provided.

No published data or studies for determination the mutagenicity of bismuth metal are available. A new study with this substance can hardly be conducted in accordance with the guidelines, since elemental bismuth is only slightly soluble in water.

However, there are publications available in which soluble bismuth salts were tested. Colloidal bismuth subcitrate was tested to induce sister chromatid exchanges or chromosome aberrations and bismuth subsalicylate and bismuth nitrate were both tested to induce gene mutation in bacterial cells. There is no indication for genotoxic/mutagenic effects of either colloidal bismuth subcitrate, bisuth 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 a rat liver metabolic activation system (S9).

Results show that bismuth hydroxide nitrate oxide does not induce gene mutation in mouse lymphoma cells.

Due to the fact, that soluble bismuth compounds are not mutagenic, it can be considered that bismuth metal as a poorly soluble substance (resulting in a lower bioavailability) is not mutagenic or genotoxic and should not be classified as such.


Short description of key information:
Bismuth metal is not genotoxic by read across.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No data about genetic toxicity of bismuth metal are available.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 no gene mutation potential was determined in the hprt locus of mouse lymphoma cells. Bismuth hydroxide nitrate oxide should not be classified and labelled according to regulation (EC) No.1272/2008.

Due to the fact, that soluble bismuth compounds are not mutagenic, it can be considered that bismuth metal as a poorly soluble substance (resulting in a lower bioavailability) is not mutagenic or genotoxic and should not be classified as such.

Based on available data from publications and on experimental results with bismuth hydroxide nitrate oxide, bismuth metal does not need to be classified for genetic toxicity.

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