Bismuth(3+) neodecanoate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with bismuth (3+) neodecanoate is available, thus the genetic toxicity will be addressed with existing data on the individual moieties bismuth and neodecanoate.

Bismuth (3+) neodecanoate is not expected to be genotoxic, since the two moieties bismuth and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Bismuth

Publications are 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, 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 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.

Neodecanoate

Neodecanoic acid is not mutagenic in vitro in bacterial mutation assays (with and without metabolic activation) and was not clastogenic in a cytogenetic assay. Although a test on in vitro gene mutation in mammalian cells is not provided, the bacterial reverse mutation test covering the same endpoint did not show any sign of mutagenic potential with an without metabolic activation. This data suggests that neodecanoic acid is not genotoxic in vitro and likely not genotoxic in vivo.

No classification for genetic toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.

Bismuth (3+) neodecanoate

Bismuth (3+) neodecanoate is not expected to be genotoxic, since the two moieties bismuth and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. Further testing is not required. Thus, bismuth (3+) neodecanoate is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

Bismuth (3+) neodecanoate is not expected to be genotoxic, since the two moieties bismuth and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity. Thus, bismuth (3+) neodecanoate is not to be classified according to regulation (EC) 1272/2008 as genetic toxicant.